ISSN 1977-0677

Official Journal

of the European Union

L 73

European flag  

English edition

Legislation

Volume 62
15 March 2019


Contents

 

II   Non-legislative acts

page

 

 

INTERNATIONAL AGREEMENTS

 

*

Council Decision (EU) 2019/407 of 4 March 2019 on the conclusion, on behalf of the European Union, of the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean

1

 

 

Agreement to prevent unregulated high seas fisheries in the Central Arctic Ocean

3

 

 

REGULATIONS

 

*

Council Implementing Regulation (EU) 2019/408 of 14 March 2019 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

9

 

*

Council Implementing Regulation (EU) 2019/409 of 14 March 2019 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

16

 

*

Commission Implementing Regulation (EU) 2019/410 of 29 November 2018 laying down implementing technical standards with regard to the details and structure of the information to be notified, in the field of payment services, by competent authorities to the European Banking Authority pursuant to Directive (EU) 2015/2366 of the European Parliament and of the Council ( 1 )

20

 

*

Commission Delegated Regulation (EU) 2019/411 of 29 November 2018 supplementing Directive (EU) 2015/2366 of the European Parliament and of the Council with regard to regulatory technical standards setting technical requirements on development, operation and maintenance of the electronic central register within the field of payment services and on access to the information contained therein ( 1 )

84

 

*

Commission Regulation (EU) 2019/412 of 14 March 2019 on amending Regulation (EC) No 1126/2008 adopting certain international accounting standards in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council as regards International Accounting Standards 12 and 23 and International Financial Reporting Standards 3 and 11 ( 1 )

93

 

*

Commission Implementing Regulation (EU) 2019/413 of 14 March 2019 amending Implementing Regulation (EU) 2015/1998 as regards third countries recognised as applying security standards equivalent to the common basic standards on civil aviation security ( 1 )

98

 

*

Commission Regulation (EU) 2019/414 of 14 March 2019 implementing Regulation (EC) No 1177/2003 of the European Parliament and of the Council concerning Community statistics on income and living conditions (EU-SILC) as regards the 2020 list of target secondary variables on over-indebtedness, consumption and wealth as well as labour ( 1 )

105

 

 

DECISIONS

 

*

Council Decision (CFSP) 2019/415 of 14 March 2019 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

110

 

*

Council Decision (CFSP) 2019/416 of 14 March 2019 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

117

 

*

Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System RAPEX established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)

121

 

*

Commission Decision (EU) 2019/418 of 13 March 2019 amending Decisions (EU) 2017/1214, (EU) 2017/1215, (EU) 2017/1216, (EU) 2017/1217, (EU) 2017/1218 and (EU) 2017/1219 (notified under document C(2019) 1851)  ( 1 )

188

 

 

Corrigenda

 

*

Corrigendum to Commission Delegated Regulation (EU) 2019/401 of 19 December 2018 amending Regulation (EU) No 389/2013 establishing a Union Registry ( OJ L 72, 14.3.2019 )

193

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

INTERNATIONAL AGREEMENTS

15.3.2019   

EN

Official Journal of the European Union

L 73/1


COUNCIL DECISION (EU) 2019/407

of 4 March 2019

on the conclusion, on behalf of the European Union, of the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43, in conjunction with point (a)(v) of the second subparagraph of Article 218(6) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament (1),

Whereas:

(1)

The Union is exclusively competent, under the Common Fisheries Policy, to adopt measures for the conservation of marine biological resources and to enter into agreements with third countries and international organisations in this respect.

(2)

Pursuant to Council Decision 98/392/EC (2) and 98/414/EC (3), the Union is a contracting party to the United Nations Convention on the Law of the Sea of 10 December 1982 (‘the Convention’) and to the Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982, relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory fish stocks (‘the Fish Stocks Agreement’). Both the Convention and the Fish Stocks Agreement require all States to cooperate in conserving and managing the living resources of the sea. The Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean (‘the Agreement’) fulfils this obligation.

(3)

Regulation (EU) No 1380/2013 of the European Parliament and of the Council (4) provides that the Union is to conduct its external fisheries relations in accordance with its international obligations and policy objectives, as well as the objectives and principles set out in Articles 2 and 3 of that Regulation, in order to ensure sustainable exploitation, management and conservation of marine biological resources and the marine environment. The Agreement is consistent with those objectives.

(4)

On 31 March 2016, the Council authorised the Commission to negotiate, on behalf of the Union, an international agreement to prevent unregulated high seas fisheries in the central Arctic Ocean. Those negotiations were successfully concluded on 30 November 2017. In accordance with Council Decision (EU) 2018/1257 (5), the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean was signed on 3 October 2018, subject to its conclusion at a later date.

(5)

Becoming a party to the Agreement will promote consistency in the Union's conservation approach across oceans and reinforce its commitment to the long-term conservation and sustainable use of marine biological resources globally, and is therefore in the Union's interest.

(6)

The Agreement should be approved,

HAS ADOPTED THIS DECISION:

Article 1

The Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean (‘the Agreement’) is hereby approved on behalf of the Union.

The text of the Agreement is attached to this Decision.

Article 2

The President of the Council shall designate the person(s) empowered to deposit, on behalf of the Union, the instruments of approval provided for in Article 15 of the Agreement.

Article 3

This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 4 March 2019.

For the Council

The President

A. ANTON


(1)  Consent of 12 February 2019 (not yet published in the Official Journal).

(2)  Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1).

(3)  Council Decision 98/414/EC of 8 June 1998 on the ratification by the European Community of the Agreement for the implementing of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 14).

(4)  Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

(5)  Council Decision (EU) 2018/1257 of 18 September 2018 on the signing, on behalf of the European Union, of the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic Ocean (OJ L 238, 21.9.2018, p. 1).


15.3.2019   

EN

Official Journal of the European Union

L 73/3


AGREEMENT

to prevent unregulated high seas fisheries in the Central Arctic Ocean

The Parties to this Agreement,

RECOGNIZING that until recently ice has generally covered the high seas portion of the central Arctic Ocean on a year-round basis, which has made fishing in those waters impossible, but that ice coverage in that area has diminished in recent years;

ACKNOWLEDGING that, while the central Arctic Ocean ecosystems have been relatively unexposed to human activities, those ecosystems are changing due to climate change and other phenomena, and that the effects of these changes are not well understood;

RECOGNIZING the crucial role of healthy and sustainable marine ecosystems and fisheries for food and nutrition;

RECOGNIZING the special responsibilities and special interests of the central Arctic Ocean coastal States in relation to the conservation and sustainable management of fish stocks in the central Arctic Ocean;

NOTING in this regard the initiative of the central Arctic Ocean coastal States as reflected in the Declaration Concerning the Prevention of Unregulated High Seas Fishing in the Central Arctic Ocean signed on 16 July 2015;

RECALLING the principles and provisions of treaties and other international instruments relating to marine fisheries that already apply to the high seas portion of the central Arctic Ocean, including those contained in:

 

the United Nations Convention on the Law of the Sea of 10 December 1982 (‘the Convention’);

 

the Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks of 4 August 1995 (‘the 1995 Agreement’); and

 

the 1995 Code of Conduct for Responsible Fisheries and other relevant instruments adopted by the Food and Agriculture Organization of the United Nations;

UNDERLINING the importance of ensuring cooperation and coordination between the Parties and the North-East Atlantic Fisheries Commission, which has competence to adopt conservation and management measures in part of the high seas portion of the central Arctic Ocean, and other relevant mechanisms for fisheries management that are established and operated in accordance with international law, as well as with relevant international bodies and programs;

BELIEVING that commercial fishing is unlikely to become viable in the high seas portion of the central Arctic Ocean in the near future and that it is therefore premature under current circumstances to establish any additional regional or subregional fisheries management organizations or arrangements for the high seas portion of the central Arctic Ocean;

DESIRING, consistent with the precautionary approach, to prevent the start of unregulated fishing in the high seas portion of the central Arctic Ocean while keeping under regular review the need for additional conservation and management measures;

RECALLING the 2007 United Nations Declaration on the Rights of Indigenous Peoples;

RECOGNIZING the interests of Arctic residents, including Arctic indigenous peoples, in the long-term conservation and sustainable use of living marine resources and in healthy marine ecosystems in the Arctic Ocean and underlining the importance of involving them and their communities; and

DESIRING to promote the use of both scientific knowledge and indigenous and local knowledge of the living marine resources of the Arctic Ocean and the ecosystems in which they occur as a basis for fisheries conservation and management in the high seas portion of the central Arctic Ocean,

HAVE AGREED as follows:

Article 1

Use of Terms

For the purposes of this Agreement:

(a)

‘Agreement Area’ means the single high seas portion of the central Arctic Ocean that is surrounded by waters within which Canada, the Kingdom of Denmark in respect of Greenland, the Kingdom of Norway, the Russian Federation and the United States of America exercise fisheries jurisdiction;

(b)

‘fish’ means species of fish, molluscs and crustaceans except those belonging to sedentary species as defined in Article 77 of the Convention;

(c)

‘fishing’ means searching for, attracting, locating, catching, taking or harvesting fish or any activity that can reasonably be expected to result in the attracting, locating, catching, taking or harvesting of fish;

(d)

‘commercial fishing’ means fishing for commercial purposes;

(e)

‘exploratory fishing’ means fishing for the purpose of assessing the sustainability and feasibility of future commercial fisheries by contributing to scientific data relating to such fisheries;

(f)

‘vessel’ means any vessel used for, equipped to be used for, or intended to be used for fishing.

Article 2

Objective of this Agreement

The objective of this Agreement is to prevent unregulated fishing in the high seas portion of the central Arctic Ocean through the application of precautionary conservation and management measures as part of a long-term strategy to safeguard healthy marine ecosystems and to ensure the conservation and sustainable use of fish stocks.

Article 3

Interim Conservation and Management Measures Concerning Fishing

1.   Each Party shall authorize vessels entitled to fly its flag to conduct commercial fishing in the Agreement Area only pursuant to:

(a)

conservation and management measures for the sustainable management of fish stocks adopted by one or more regional or subregional fisheries management organizations or arrangements, that have been or may be established and are operated in accordance with international law to manage such fishing in accordance with recognized international standards; or

(b)

interim conservation and management measures that may be established by the Parties pursuant to Article 5, paragraph 1(c)(ii).

2.   The Parties are encouraged to conduct scientific research under the framework of the Joint Program of Scientific Research and Monitoring established pursuant to Article 4 and under their respective national scientific programs.

3.   A Party may authorize vessels entitled to fly its flag to carry out exploratory fishing in the Agreement Area only pursuant to conservation and management measures established by the Parties on the basis of Article 5, paragraph 1(d).

4.   The Parties shall ensure that their scientific research activities involving the catching of fish in the Agreement Area do not undermine the prevention of unregulated commercial and exploratory fishing and the protection of healthy marine ecosystems. The Parties are encouraged to inform each other about their plans for authorizing such scientific research activities.

5.   The Parties shall ensure compliance with the interim measures established by this Article, and with any additional or different interim measures they may establish pursuant to Article 5, paragraph 1(c).

6.   Consistent with Article 7 of the 1995 Agreement, coastal States Parties and other Parties shall cooperate to ensure the compatibility of conservation and management measures for fish stocks that occur in areas both within and beyond national jurisdiction in the central Arctic Ocean in order to ensure conservation and management of those stocks in their entirety.

7.   Other than as provided in paragraph 4 above, nothing in this Agreement shall be interpreted to restrict the entitlements of Parties in relation to marine scientific research as reflected in the Convention.

Article 4

Joint Program of Scientific Research and Monitoring

1.   The Parties shall facilitate cooperation in scientific activities with the goal of increasing knowledge of the living marine resources of the central Arctic Ocean and the ecosystems in which they occur.

2.   The Parties agree to establish, within two years of the entry into force of this Agreement, a Joint Program of Scientific Research and Monitoring with the aim of improving their understanding of the ecosystems of the Agreement Area and, in particular, of determining whether fish stocks might exist in the Agreement Area now or in the future that could be harvested on a sustainable basis and the possible impacts of such fisheries on the ecosystems of the Agreement Area.

3.   The Parties shall guide the development, coordination and implementation of the Joint Program of Scientific Research and Monitoring.

4.   The Parties shall ensure that the Joint Program of Scientific Research and Monitoring takes into account the work of relevant scientific and technical organizations, bodies and programs, as well as indigenous and local knowledge.

5.   As part of the Joint Program of Scientific Research and Monitoring, the Parties shall adopt, within two years of the entry into force of this Agreement, a data sharing protocol and shall share relevant data, directly or through relevant scientific and technical organizations, bodies and programs, in accordance with that protocol.

6.   The Parties shall hold joint scientific meetings, in person or otherwise, at least every two years and at least two months in advance of the meetings of the Parties that take place pursuant to Article 5 to present the results of their research, to review the best available scientific information, and to provide timely scientific advice to meetings of the Parties. The Parties shall adopt, within two years of the entry into force of this Agreement, terms of reference and other procedures for the functioning of the joint scientific meetings.

Article 5

Review and Further Implementation

1.   The Parties shall meet every two years or more frequently if they so decide. During their meetings, the Parties shall, inter alia:

(a)

review implementation of this Agreement and, when appropriate, consider any issues relating to the duration of this Agreement in accordance with Article 13, paragraph 2;

(b)

review all available scientific information developed through the Joint Program of Scientific Research and Monitoring, from the national scientific programs, and from any other relevant sources, including indigenous and local knowledge;

(c)

on the basis of the scientific information derived from the Joint Program of Scientific Research and Monitoring, from the national scientific programs, and from other relevant sources, and taking into account relevant fisheries management and ecosystem considerations, including the precautionary approach and potential adverse impacts of fishing on the ecosystems, consider, inter alia, whether the distribution, migration and abundance of fish in the Agreement Area would support a sustainable commercial fishery and, on that basis, determine:

(i)

whether to commence negotiations to establish one or more additional regional or subregional fisheries management organizations or arrangements for managing fishing in the Agreement Area; and

(ii)

whether, once negotiations have commenced pursuant to subparagraph (i) above and once the Parties have agreed on mechanisms to ensure the sustainability of fish stocks, to establish additional or different interim conservation and management measures in respect of those stocks in the Agreement Area.

(d)

establish, within three years of the entry into force of this Agreement, conservation and management measures for exploratory fishing in the Agreement Area. The Parties may amend such measures from time to time. These measures shall provide, inter alia, that:

(i)

exploratory fishing shall not undermine the objective of this Agreement;

(ii)

exploratory fishing shall be limited in duration, scope and scale to minimize impacts on fish stocks and ecosystems and shall be subject to standard requirements set forth in the data sharing protocol adopted in accordance with Article 4, paragraph 5;

(iii)

a Party may authorize exploratory fishing only on the basis of sound scientific research and when it is consistent with the Joint Program of Scientific Research and Monitoring and its own national scientific program(s);

(iv)

a Party may authorize exploratory fishing only after it has notified the other Parties of its plans for such fishing and it has provided other Parties an opportunity to comment on those plans; and

(v)

a Party must adequately monitor any exploratory fishing that it has authorized and report the results of such fishing to the other Parties.

2.   To promote implementation of this Agreement, including with respect to the Joint Program of Scientific Research and Monitoring and other activities undertaken pursuant to Article 4, the Parties may form committees or similar bodies in which representatives of Arctic communities, including Arctic indigenous peoples, may participate.

Article 6

Decision-Making

1.   Decisions of the Parties on questions of procedure shall be taken by a majority of the Parties casting affirmative or negative votes.

2.   Decisions of the Parties on questions of substance shall be taken by consensus. For the purpose of this Agreement, ‘consensus’ means the absence of any formal objection made at the time the decision was taken.

3.   A question shall be deemed to be of substance if any Party considers it to be of substance.

Article 7

Dispute Settlement

The provisions relating to the settlement of disputes set forth in Part VIII of the 1995 Agreement apply, mutatis mutandis, to any dispute between Parties relating to the interpretation or application of this Agreement, whether or not they are also Parties to the 1995 Agreement.

Article 8

Non-Parties

1.   The Parties shall encourage non-parties to this Agreement to take measures that are consistent with the provisions of this Agreement.

2.   The Parties shall take measures consistent with international law to deter the activities of vessels entitled to fly the flags of non-parties that undermine the effective implementation of this Agreement.

Article 9

Signature

1.   This Agreement shall be open for signature at Ilulissat on 3 October 2018 by Canada, the People's Republic of China, the Kingdom of Denmark in respect of the Faroe Islands and Greenland, Iceland, Japan, the Republic of Korea, the Kingdom of Norway, the Russian Federation, the United States of America and the European Union and shall remain open for signature for 12 months following that date.

2.   For signatories to this Agreement, this Agreement shall remain open for ratification, acceptance or approval at any time.

Article 10

Accession

1.   For the States listed in Article 9, paragraph 1 that have not signed this Agreement, and for the European Union if it has not signed this Agreement, this Agreement shall remain open for accession at any time.

2.   After the entry into force of this Agreement, the Parties may invite other States with a real interest to accede to this Agreement.

Article 11

Entry into Force

1.   This Agreement shall enter into force 30 days after the date of receipt by the depositary of all instruments of ratification, acceptance, or approval of, or accession to, this Agreement by those States and the European Union listed in Article 9, paragraph 1.

2.   After entry into force of this Agreement, it shall enter into force for each State invited to accede pursuant to Article 10, paragraph 2 that has deposited an instrument of accession 30 days after the date of deposit of that instrument.

Article 12

Withdrawal

A Party may withdraw from this Agreement at any time by sending written notification of its withdrawal to the depositary through diplomatic channels, specifying the effective date of its withdrawal, which shall be at least six months after the date of notification. Withdrawal from this Agreement shall not affect its application among the remaining Parties or the duty of the withdrawing Party to fulfill any obligation in this Agreement to which it otherwise would be subject under international law independently of this Agreement.

Article 13

Duration of this Agreement

1.   This Agreement shall remain in force for an initial period of 16 years following its entry into force.

2.   Following the expiration of the initial period specified in paragraph 1 above, this Agreement shall remain in force for successive five-year extension period(s) unless any Party:

(a)

presents a formal objection to an extension of this Agreement at the last meeting of the Parties that takes place prior to expiration of the initial period or any subsequent extension period; or

(b)

sends a formal objection to an extension to the depositary in writing no later than six months prior to the expiration of the respective period.

3.   The Parties shall provide for an effective transition between this Agreement and any potential new agreement establishing an additional regional or subregional fisheries management organization or arrangement for managing fishing in the Agreement Area so as to safeguard healthy marine ecosystems and ensure the conservation and sustainable use of fish stocks in the Agreement Area.

Article 14

Relation to Other Agreements

1.   The Parties recognize that they are and will continue to be bound by their obligations under relevant provisions of international law, including those reflected in the Convention and the 1995 Agreement, and recognize the importance of continuing to cooperate in fulfilling those obligations even in the event that this Agreement expires or is terminated in the absence of any agreement establishing an additional regional or subregional fisheries management organization or arrangement for managing fishing in the Agreement Area.

2.   Nothing in this Agreement shall prejudice the positions of any Party with respect to its rights and obligations under international agreements and its positions with respect to any question relating to the law of the sea, including with respect to any position relating to the exercise of rights and jurisdiction in the Arctic Ocean.

3.   Nothing in this Agreement shall prejudice the rights, jurisdiction and duties of any Party under relevant provisions of international law as reflected in the Convention or the 1995 Agreement, including the right to propose the commencement of negotiations on the establishment of one or more additional regional or subregional fisheries management organizations or arrangements for the Agreement Area.

4.   This Agreement shall not alter the rights and obligations of any Party that arise from other agreements compatible with this Agreement and that do not affect the enjoyment by other Parties of their rights or the performance of their obligations under this Agreement. This Agreement shall neither undermine nor conflict with the role and mandate of any existing international mechanism relating to fisheries management.

Article 15

Depositary

1.   The Government of Canada shall be the depositary for this Agreement.

2.   Instruments of ratification, acceptance, approval or accession shall be deposited with the depositary.

3.   The depositary shall inform all signatories and all Parties of the deposit of all instruments of ratification, acceptance, approval or accession and perform such other functions as are provided for in the 1969 Vienna Convention on the Law of Treaties.

Done at Ilulissat on this third day of October, 2018, in a single original, in the Chinese, English, French and Russian languages, each text being equally authentic.

 


REGULATIONS

15.3.2019   

EN

Official Journal of the European Union

L 73/9


COUNCIL IMPLEMENTING REGULATION (EU) 2019/408

of 14 March 2019

implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EU) No 269/2014 of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (1), and in particular Article 14(1), (3) and (4) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 17 March 2014, the Council adopted Regulation (EU) No 269/2014.

(2)

On the basis of a review by the Council, the information concerning certain persons and entities in Annex I to Regulation (EU) No 269/2014 should be amended and the entry for one deceased person should be deleted.

(3)

Annex I to Regulation (EU) No 269/2014 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 269/2014 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 March 2019.

For the Council

The President

G. CIAMBA


(1)  OJ L 78, 17.3.2014, p. 6.


ANNEX

Annex I to Regulation (EU) Regulation (EU) No 269/2014 is amended as follows:

(1)

the entry concerning the following person is deleted:

96.

Alexander Vladimirovich ZAKHARCHENKO;

(2)

the entries concerning the persons and entities listed below are replaced by the following entries:

Persons

 

Name

Identifying information

Reasons

Date of listing

‘19.

Aleksandr Viktorovich VITKO

(Александр Викторович ВИТКО)

DOB: 13.9.1961

POB: Vitebsk (Belarusian SSR)

Former Commander of the Black Sea Fleet, Admiral. Deputy Commander in Chief of the Russian Navy.

Responsible for commanding Russian forces that have occupied Ukrainian sovereign territory.

17.3.2014

22.

Dmitry Olegovich ROGOZIN

(Дмитрий Олегович РОГОЗИН)

DOB: 21.12.1963

POB: Moscow

Former Deputy Prime Minister of the Russian Federation. Publicly called for the annexation of Crimea.

Since 2018 holds the position of General Director in a State corporation.

21.3.2014

31.

Valery Kirillovich MEDVEDEV

(Валерий Кириллович МЕДВЕДЕВ)

Valeriy Kyrylovych MEDVEDIEV

(Валерiй Кирилович МЕДВЕДЄВ)

DOB: 21.8.1946

POB: Shmakovka, Primorsky region

Former Chair of Sevastopol Electoral Commission (until 26 May 2017). Responsible for administering the Crimean referendum. Responsible under the Russian system for signing referendum results.

Remains active in supporting separatist actions or policies.

21.3.2014

35.

Oleg Yevgenyvich BELAVENTSEV

(Олег Евгеньевич БЕЛАВЕНЦЕВ)

DOB: 15.9.1949

POB: Moscow

Former Plenipotentiary Representative of the President of the Russian Federation into the so-called “Crimean Federal District”, responsible for the implementation of the constitutional prerogatives of the Russian Head of State on the territory of the annexed Autonomous Republic of Crimea. Former non-permanent member of the Russian Security Council.

Former Plenipotentiary Representative of the President of the Russian Federation into the North Caucasus Federal District (until June 2018).

Remains active in supporting separatist actions or policies.

29.4.2014

36.

Oleg Genrikhovich SAVELYEV

(Олег Генрихович САВЕЛЬЕВ)

DOB: 27.10.1965

POB: Leningrad

Former Minister for Crimean Affairs. Responsible for the integration of the annexed Autonomous Republic of Crimea into the Russian Federation.

Former Deputy Chief of Staff of the Russian Government, responsible for the organisation of the work of the Governmental Commission on the socioeconomic development of the so-called “Republic of Crimea”.

Chief of Staff of the Audit Chamber of the Russian Federation.

29.4.2014

46.

Denys Volodymyrovych PUSHYLIN (Денис Володимирович ПУШИЛIН)

Denis Vladimirovich PUSHILIN (Денис Владимирович ПУШИЛИН)

DOB: 9.5.1981 or 9.5.1982

POB: Makiivka (Donetsk oblast)

One of the leaders of the “Donetsk People's Republic”. Participated in the seizure and occupation of the regional administration in Donetsk in 2014. Until 4 September 2015 so-called Deputy Chairman of the “People's Council” of the so-called “Donetsk People's Republic”. Since 4 September 2015“Chairman” of the “People's Council of the Donetsk People's Republic”. So-called “acting Head of the Donetsk People's Republic” after 7 September 2018. So-called “Head of the Donetsk People's Republic” following the so-called elections of 11 November 2018.

29.4.2014

55.

Igor Nikolaevich BEZLER (a.k.a. Bes (devil))

(Игорь Николаевич БЕЗЛЕР)

Ihor Mykolayovych BEZLER

(Iгор Миколайович БЕЗЛЕР)

DOB: 30.12.1965

POB: Simferopol, Crimea

One of the former leaders of the self-proclaimed militia of Horlivka. He took control of the Security Service of Ukraine's Office in Donetsk region building and afterwards seized the Ministry of Internal Affairs' district station in the town of Horlivka. He has links to Igor Strelkov/Girkin under whose command he was involved in the murder of the Peoples' Deputy of the Horlivka's Municipal Council Volodymyr Rybak.

Remains active in supporting separatist actions or policies.

12.5.2014

83.

Ekaterina Yurievna GUBAREVA

(Екатерина Юрьевна ГУБАРЕВА)

Kateryna Yuriyivna GUBARIEVA (HUBARIEVA)

(Катерина Юрiївна ГУБАРЄВА)

DOB: 5.7.1983 or 10.3.1983

POB: Kakhovka (Kherson oblast)

In her capacity of former so-called “Minister of Foreign Affairs” she was responsible for defending the so-called “Donetsk People's Republic”, thus undermining the territorial integrity, sovereignty and independence of Ukraine. In taking on and acting in this capacity she has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine. Remains active in supporting separatist actions and policies.

Former Member of the so-called “People's Council” of the “Donetsk People's Republic” (until November 2018).

25.7.2014

89.

Oksana TCHIGRINA

Oksana Aleksandrovna CHIGRINA (CHYHRYNA)

(Оксана Александровна ЧИГРИНА)

DOB: possibly 23.7.1981

Former spokesperson of the so-called “government” of the so-called “Lugansk People's Republic” who made declarations justifying, inter alia, the shooting down of a Ukrainian military airplane, the taking of hostages, fighting activities by the illegal armed groups, which have as a consequence undermined the territorial integrity, sovereignty and unity of Ukraine.

Former spokesperson of the Press Service of LNR.

Remains active in supporting separatist actions or policies.

30.7.2014

91.

Sergey Vadimovich ABISOV

(Сергей Вадимович АБИСОВ)

Sergiy (Serhiy) Vadymovych ABISOV

(Сергiй Вадимович АБIСОВ)

DOB 27.11.1967

POB: Simferopol, Crimea

By accepting his appointment as so-called “Minister of Interior of the Republic of Crimea” by the President of Russia (decree No 301) on 5 May 2014 and by his actions as so-called “Minister of Interior” he has undermined the territorial integrity, sovereignty and unity of Ukraine.

Dismissed as so-called “Minister of Interior of the Republic of Crimea” in June 2018.

30.7.2014

97.

Vladimir Petrovich KONONOV (a.k.a. “Tsar”)

(Владимир Петровнч КОНОНОВ)

Volodymyr Petrovych KONONOV

(Володимир Петрович КОНОНОВ)

DOB: 14.10.1974

POB: Gorsky, Luhansk Oblast

As of 14 August 2014, he replaced Igor Strelkov/Girkin, as the so-called “Defence minister” of the “Donetsk People's Republic”. He has reportedly commanded a division of separatist fighters in Donetsk since April 2014 and has promised to solve the strategic task of repelling Ukraine's military aggression. Kononov has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine.

Dismissed as so-called “Defence minister” in September 2018.

12.9.2014

102.

Andrei Nikolaevich RODKIN

(Андрей Николаевич РОДКИН)

DOB: 23.9.1976

POB: Moscow

Former Moscow Representative of the so-called “Donetsk People's Republic”. In his statements he has, inter alia, talked about the militias' readiness to conduct a guerrilla war and their seizure of weapon systems from the Ukrainian armed forces. He has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine.

One of the former leaders of the “Union of Donbas Volunteers”.

Remains active in supporting separatist actions or policies.

12.9.2014

103.

Aleksandr Akimovich KARAMAN

(Александр Акимович КАРАМАН)

Alexandru CARAMAN

DOB: 26.7.1956

POB Cioburciu, Slobozia district, now Republic of Moldova

Former so-called “Deputy Prime Minister for Social Issues” of the “Donetsk People's Republic”. Associated with Vladimir Antyufeyev, who was responsible for the separatist “governmental” activities of the so-called “Government of the Donetsk People's Republic”. He has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine. Protégé of Russia's former Deputy Prime Minister Dmitry Rogozin. Former Head of the Administration of the Council of Ministers of the “Donetsk People's Republic”.

Until March 2017, so-called “Plenipotentiary representative of the President” of the so-called “Pridnestrovian Moldavian Republic” to the Russian Federation.

Remains active in supporting separatist actions or policies.

12.9.2014

120.

Sergey Yurievich KOZYAKOV

(Сергей Юрьевич КОЗЬЯКОВ)

Serhiy Yuriyovych KOZYAKOV

(Сергiй Юрiйович КОЗЬЯКОВ)

DOB: 29.9.1982 or 23.9.1982

In his former capacity as so-called “Head of the Luhansk Central Election Commission” he was responsible for organising the so-called “elections” of 2 November 2014 in the “Luhansk People's Republic”. These “elections” were in breach of Ukrainian law and therefore illegal. Between October 2015 and December 2017 so-called “Minister of Justice” of the “Luhansk People's Republic”.

In taking on and acting in these capacities, and in organising the illegal “elections”, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Continues to support and legitimise separatist policies in cooperation with separatist authorities.

29.11.2014

122.

Larisa Leonidovna AIRAPETYAN (a.k.a. Larysa AYRAPETYAN, Larisa AIRAPETYAN or Larysa AIRAPETYAN)

(Лариса Леонидовна АЙРАПЕТЯН)

(Лариса Леонiдiвна АЙРАПЕТЯН)

DOB: 21.2.1970

Former so-called “Health Minister” of the so-called “Lugansk People's Republic”. Stood as a candidate in the so-called “elections” of 2 November 2014 to the post of the “Head” of the so-called “Lugansk People's Republic”.

These “elections” are in breach of Ukrainian law and therefore illegal.

In taking on and acting in this capacity, and in participating formally as a candidate in the illegal “elections”, she has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Remains active in supporting separatist actions or policies.

29.11.2014

129.

Yevgeniy Eduardovich MIKHAYLOV (a.k.a. Yevhen Eduardovych MYCHAYLOV)

(Евгений Эдуардович МИХАЙЛОВ)

(Євген Едуардович МИХАЙЛОВ)

DOB: 17.3.1963

POB: Arkhangelsk

Former so-called “Minister of the Council of Ministers” (head of the administration for governmental affairs) of the “Donetsk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Remains active in supporting separatist actions or policies.

29.11.2014

132.

Vladyslav Mykolayovych DEYNEGO (a.k.a. Vladislav Nikolayevich DEYNEGO)

(Владислав Миколайович ДЕЙНЕГО)

(Владислав Николаевич ДЕЙНЕГО)

DOB: 12.3.1964

POB: Romny, Sumy oblast

Ромны, Сумская область

Former “Deputy Head” of the “People's Council” of the so-called “Lugansk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Currently so-called “acting Minister of Foreign Affairs” of the so-called “Lugansk People's Republic”.

29.11.2014

138.

Alexandr Vasilievich SHUBIN

(Александр Васильевич ШУБИН)

DOB: 20.5.1972 or 30.5.1972

POB: Luhansk

Former so-called “Minister of Justice”, of the illegal so-called “Luhansk People's Republic”. Former chairman of the “Central Election Commission” of the so-called “Luhansk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Dismissed as chairman of the “Central Election Commission” of the so-called “Luhansk People's Republic” in June 2018.

16.2.2015

142.

Aleksandr Yurievich TIMOFEEV

(Александр Юрьевич ТИМОФЕЕВ)

Oleksandr Yuriyovych TYMOFEYEV

(Олександр Юрiйович ТИМОФЕЄВ)

DOB: 15.5.1971

POB: Nevinnomyssk, Stavropol Krai

Невинномысск, Ставропольский край

Former so-called “Minister of Finance and Taxes” of the “Donetsk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Dismissed as so-called “Minister of Finance and Taxes” in September 2018.

16.2.2015

149.

Andrei Valeryevich KARTAPOLOV

(Андрей Валерьевич КАРТAПOЛOВ)

DOB: 9.11.1963

POB: GDR (DDR)

Former Commander of the Western Military District. Former Director of the Main Operations Department and deputy chief of the General Staff of the Armed Forces of the Russian Federation. Actively involved in shaping and implementing the military campaign of the Russian forces in Ukraine.

According to the stated activities of the general staff, by exercising operational control over the armed forces, he was actively involved in shaping and implementing the Russian government policy threatening the territorial integrity, sovereignty and independence of Ukraine.

Deputy Minister of Defence since July 2018.

16.2.2015’

Entities

 

Name

Identifying information

Reasons

Date of listing

‘4.

So-called “Donetsk People's Republic”

“Донецкая народная республика”

“Donétskaya naródnaya respúblika”

Official information:

https://dnr-online.ru/

http://smdnr.ru/

https://dnrsovet.su/

https://denis-pushilin.ru/

The so-called “Donetsk People's Republic” was declared on 7 April 2014.

Responsible for organizing the illegal referendum on 11 May 2014. Declaration of independence on 12 May 2014.

On 24 May 2014, the so-called “People's Republics” of Donetsk and Lugansk signed an agreement on the creation of the so-called “Federal State of Novorossiya”.

This is in breach of Ukrainian constitutional law, and, as a consequence, of international law, thus undermining the territorial integrity, sovereignty and independence of Ukraine.

It is also involved in the recruitment to illegal armed separatist groups, thus threatening the stability or security of Ukraine.

25.7.2014

5.

So-called “Federal State of Novorossiya”

“Федеративное государство Новороссия”

“Federativnoye Gosudarstvo Novorossiya”

Official press releases:

http://novopressa.ru/

http://novorossia-tv.ru/

http://novorossia.today/

http://novorossiia.ru/

https://www.novorosinform.org/

On 24 May 2014, the so-called “People's Republics” of Donetsk and Lugansk signed an agreement on the creation of the unrecognised so-called “Federal State of Novorossiya”.

This is in breach of Ukrainian constitutional law, and, as a consequence, of international law, thus threatening the territorial integrity, sovereignty and independence of Ukraine.

25.7.2014

24.

Donetsk Republic (Public organisation)

Донецкая республика

Official information:

http://oddr.info/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Donetsk People's Republic” on 2 November 2014 and 11 November 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine. Founded by Andriy PURGIN and was headed by Alexander ZAKHARCHENKO. Nominated in 2018 Denis PUSHYLIN to be “Head” of the so-called “Donetsk People's Republic”.

29.11.2014

25.

Peace to Luhansk Region (Mir Luganschine)

Мир Луганщине

https://mir-lug.info/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Luhansk People's Republic”2 November 2014 and 11 November 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014

26.

Free Donbass (a.k.a. “Free Donbas”, “Svobodny Donbass”)

Свободньιй Донбасс

http://www.odsd.ru/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Donetsk People's Republic”2 November 2014 and 11 November 2018. These elections are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014

28.

Luhansk Economic Union (Luganskiy Ekonomicheskiy Soyuz)

Луганский экономический союз

Official information:

https://nslnr.su/about/obshchestvennye-organizatsii/337/

https://vk.com/public97306393

“Social organisation” that presented candidates in the illegal so-called “elections” of the so-called “Luhansk People's Republic”2 November 2014 and 11 November 2018. Nominated a candidate, Oleg AKIMOV, to be “Head” of the so-called “Luhansk People's Republic” in 2014 and member of the so-called “People's Council of the Luhansk People's Republic” in 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014’


15.3.2019   

EN

Official Journal of the European Union

L 73/16


COUNCIL IMPLEMENTING REGULATION (EU) 2019/409

of 14 March 2019

implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EU) No 269/2014 of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (1), and in particular Article 14(1) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 17 March 2014, the Council adopted Regulation (EU) No 269/2014.

(2)

In view of the use of force by the Russian Federation that led to the detention of Ukrainian servicemen and the seizure of vessels on 25 November 2018 in the Kerch Strait, which constituted a violation of international law as well as of the sovereignty and territorial integrity of Ukraine, the Council considers that eight persons should be added to the list of persons, entities and bodies subject to restrictive measures as set out in Annex I to Regulation (EU) No 269/2014.

(3)

Annex I to Regulation (EU) No 269/2014 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The persons listed in the Annex to this Regulation shall be added to the list set out in Annex I to Regulation (EU) No 269/2014.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 March 2019.

For the Council

The President

G. CIAMBA


(1)  OJ L 78, 17.3.2014, p. 6.


ANNEX

The following persons are added to the list of persons set out in the Annex I to Regulation (EU) No 269/2014:

 

Name

Identifying information

Reasons

Date of listing

‘176.

Sergey Nikolayevich STANKEVICH

(Сергей Николаевич СТАНКЕВИЧ)

Gender: male;

DOB: 27.1.1963

Head of Border Directorate of the Federal Security Service of the Russian Federation for “Republic of Crimea and City of Sevastopol”, Rear Admiral. In this capacity, he was responsible for actions of the coast guard naval fleet of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

177.

Andrey Borisovich SHEIN

(Андрей Борисович ШЕИН)

Gender: male;

DOB: 10.6.1971

Deputy Head of Border Directorate – Head of Coast Guard Unit of the Federal Security Service of the Russian Federation for “Republic of Crimea and City of Sevastopol.” In this capacity, he participated in operations against Ukrainian ships and their crew during the actions of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

178.

Aleksey Mikhailovich SALYAEV

Aleksey Mikhailovich SALYAYEV

Oleksii Mykhailovych SALIAIEV

(Алексей Михайлович САЛЯЕВ, Олексій Михайлович САЛЯЄВ)

Gender: male;

DOB: 22.8.1978

Commanding officer of the border patrol boat “Don” (side markings 353) of the Border Guard Service of the Federal Security Service of the Russian Federation. He was in command of the vessel that actively participated in actions of the Russian Federation against Ukrainian vessels and their crew on 25 November 2018, and conducted ramming of the estuary tug, “Yany Kapu”, of the Ukrainian Navy. Those actions prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

179.

Andrei SHIPITSIN / SHYPITSIN

(Андрей ШИПИЦИН / ШИПІЦИН)

Gender: male;

DOB: 25.12.1969

Commanding officer of the border patrol boat “Izumrud” of the Border Guard Service of the Federal Security Service of the Russian Federation. He was in command of the vessel that actively participated in actions of the Russian Federation against Ukrainian vessels and their crew on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

180.

Aleksey Vladimirovich SHATOKHIN / Oleksii Volodymyrovich SHATOKHIN

(Алексей Владимирович ШАТОХИН / Олексій Володимирович ШАТОХІН)

Gender: male;

DOB: 26.1.1971

Head of the Service of the Kerch Control Point for the “Republic of Crimea and City of Sevastopol” of the Federal Security Service of the Russian Federation. He participated in operations against Ukrainian vessels during the actions of the Russian Federation against Ukrainian vessels and their crews on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

181.

Ruslan Alexandrovich ROMASHKІN

(Руслан Александрович РОМАШКИН)

Gender: male;

DOB: 15.6.1976

Head of the Service of the Control Point in the “Republic of Crimea and City of Sevastopol” of the Federal Security Service of the Russian Federation. In this role, he was responsible for coordinating the actions of Russian Federation forces against Ukrainian vessels and their crews on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

182.

Sergey Alekseevich SHCHERBAKOV

(Сергей Алексеевич ЩЕРБАКОВ; Сергій Олексійович ЩЕРБАКОВ)

Gender: male;

DOB: 2.11.1986

Commanding officer of the anti-submarine ship “Suzdalets” of the Black Sea Fleet of the Russian Federation. He commanded the ship which participated in the actions of the Russian Federation against Ukrainian ships and their crews on 25 November 2018, and actively participated in the blockade of tugboat “Yani Kapu” and seizure of the armed gunboat “Nikopol”. Those actions prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

183.

Aleksandr Vladimirovich DVORNIKOV

(Александр Владимирович ДВОРНИКОВ)

Gender: male;

DOB: 22.8.1961

POB: Ussuriysk, Primorskiy Krai, Russian Federation

Commander of the Southern Military District of the Russian Armed Forces, Colonel-General and responsible for military forces in the region, including illegally annexed Crimea and Sevastopol. In this role he was responsible for the actions of the Black Sea Fleet and other military forces of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019’


15.3.2019   

EN

Official Journal of the European Union

L 73/20


COMMISSION IMPLEMENTING REGULATION (EU) 2019/410

of 29 November 2018

laying down implementing technical standards with regard to the details and structure of the information to be notified, in the field of payment services, by competent authorities to the European Banking Authority pursuant to Directive (EU) 2015/2366 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (1), and in particular the third subparagraph of Article 15(5) thereof,

Whereas:

(1)

The European Banking Authority (EBA) is, pursuant to Directive (EU) 2015/2366, to establish and operate an electronic, central register containing a list of all payment institutions and electronic money institutions and their respective agents and branches. For those purposes, it is necessary that competent authorities notify to EBA details allowing payment service users and other interested parties to easily and unequivocally identify each entity entered in the register and the territory in which that entity conducts or intends to conduct activities. The payment service users should also be able to identify the payment services and electronic money services provided by those entities.

(2)

The electronic central register should also include service providers excluded from the scope of Directive (EU) 2015/2366 carrying out an activity referred to in any of points (i) and (ii) of point (k) and point (l) of Article 3 of that Directive that have notified their respective competent authority pursuant to Article 37(2) or (3) of that Directive. In order to ensure a consistent interpretation and application of those provisions throughout the Union, the information contained in the register about those service providers should include a short description of their activities, as provided by competent authorities, including information on the underlying payment instrument used and a general description of the service provided.

(3)

In order to enable consumers to easily understand the information contained in the electronic central register, that information should be presented in a clear and unambiguous way. The presentation of the information contained in the register should take national language specificities into account.

(4)

To ensure a uniform provision of information, a standardised format should be used by competent authorities for the purposes of transmitting information to EBA.

(5)

This Regulation is based on the draft implementing technical standards submitted by EBA to the Commission.

(6)

EBA has conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

Article 1

Details and format of the information to be notified pursuant to Article 15(1) of Directive (EU) 2015/2366

1.   For the purposes of Article 15(1) of Directive (EU) 2015/2366, competent authorities shall notify information to EBA in accordance with paragraphs 2 to 9.

2.   As regards payment institutions, and their branches providing services in a Member State other than their home Member State, competent authorities shall notify the details specified in Table 1 of the Annex using the format set out in that Table.

3.   As regards natural or legal persons benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366, competent authorities shall notify the details specified in Table 2 of the Annex using the format set out in that Table.

4.   As regards account information service providers, and their branches providing services in a Member State other than their home Member State, competent authorities shall notify the details specified in Table 3 of the Annex using the format set out in that Table.

5.   As regards electronic money institutions, and their branches providing services in a Member State other than their home Member State, competent authorities shall notify the details specified in Table 4 of the Annex using the format set out in that Table.

6.   As regards legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC of the European Parliament and of the Council (3), competent authorities shall notify the details specified in Table 5 of the Annex using the format set out in that Table.

7.   As regards agents of payment institutions, account information service providers and electronic money institutions which provide payment services in any Member State, agents of natural or legal persons benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366 and agents of legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC, competent authorities shall notify the details specified in Table 6 of the Annex using the format set out in that Table.

8.   As regards the institutions referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU of the European Parliament and of the Council (4) that are entitled under national law to provide payment services, competent authorities shall notify the details specified in Table 7 of the Annex using the format set out in that Table.

9.   As regards service providers carrying out services under points (i) and (ii) of point (k) and point (l) of Article 3 of Directive (EU) 2015/2366, competent authorities shall notify the details specified in Table 8 of the Annex using the format set out in that Table.

Article 2

Entry into force

This Regulation shall enter into force on the the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 November 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 337, 23.12.2015, p. 35.

(2)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

(3)  Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7).

(4)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).


ANNEX

Table 1 — Information on payment institutions

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Payment institution’

2

Name of the payment institution

Text (250 characters)

The official name of the payment institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the institution shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

For Member States where there is more than one official national language, all official names of the institution shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the payment institution

Text (250 characters)

The commercial name of the payment institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the institution in another language based on the Latin alphabet.

If the payment institution uses more than one commercial name, all of the commercial names of the institution could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the payment institution's head office

 

The address of the payment institution's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the payment institution

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Authorisation number — a number or code appointed to an authorised payment institution by the competent authority of a Member State in the territory of which the entity has been established;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the payment institution to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

The payment services for which the payment institution has been authorised

Multiple pre-defined options (between 1 and 13 options)

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

8

Current authorisation status of the payment institution

Text (10 characters)

Current authorisation status of the payment institution chosen from a pre-defined list:

1.

☐ Authorised

2.

☐ Withdrawn

9

Date of authorisation

Numeric (8 characters)

The date of authorisation of the payment institution. Depending on the practice of the respective competent authority, this date could be either the date when the payment institution was authorised by the competent authority or the date when it was included in its national public register.

10

Date of withdrawal (where applicable)

Numeric (8 characters)

The date of withdrawal of authorisation of the payment institution. This is the date when the authorisation of the payment institution was withdrawn.

11

Host Member States where the payment institution provides or intends to provide payment services through the freedom to provide services and the respective payment services that were notified to the host competent authority

Multiple pre-defined options (up to 31 options, which have up to 13 pre-defined sub-options)

Host Member States where the payment institution provides or intends to provide payment services through the freedom to provide services and the respective payment services that were notified to the host competent authority:

Austria:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Belgium:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Bulgaria:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Croatia:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Cyprus:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Czech Republic:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Denmark:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Estonia:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Finland:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

France:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Germany:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Greece:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Hungary:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Iceland:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Ireland:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Italy:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Latvia:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Liechtenstein:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Lithuania:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Luxembourg:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Malta:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Netherlands:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Norway:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Poland:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Portugal:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Romania:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Slovakia:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Slovenia:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Spain:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Sweden:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

United Kingdom:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

12

Name of the branch of the payment institution established in a Member State other than the home Member State of the payment institution

Text (up to 200 characters)

The official name of the branch used in the register shall be either the name of the payment institution or the designated name of the respective branch. It shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the branch shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the name or the trade name of the branch into the Latin alphabet, or a translation or an alternative name of the branch in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the branch shall be entered. The names shall be separated by a ‘/’ character.

13

The address of the principal branch of the payment institution in the host Member State

 

The address of the principal branch of the payment institution in the host Member State shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

13.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

13.2.

City

Text (100 characters)

 

13.3.

Street address

Text (50 characters per address line)

 

13.4.

Postcode

Text (35 characters)

 

14

Host Member States where the payment institution provides or intends to provide payment services through the freedom of establishment via a branch and the respective payment services that were notified to the host competent authority

Multiple pre-defined options (up to 31 options, which have up to 13 pre-defined sub-options)

Host Member States where the payment institution provides or intends to provide payment services through the freedom of establishment via a branch and the respective payment services that were notified to the host competent authority:

Same options as row 11 of this table.


Table 2 — Information on natural or legal persons benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Exempted payment institution’.

2

Name of the exempted payment institution

Text (250 characters)

The official name of the exempted payment institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the institution shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the institution shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the exempted payment institution

Text (250 characters)

The commercial name of the exempted payment institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the institution in another language based on the Latin alphabet.

If the exempted payment institution uses more than one commercial name, all of the commercial names of the institution could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the exempted payment institution's head office

 

The address of the exempted payment institution's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the exempted payment institution

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the exempted payment institution to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

The payment services for which the exempted payment institution has been registered

Multiple pre-defined options (between 1 and 13 options)

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

8

Current registration status of the exempted payment institution

Text (10 characters)

Current registration status of the exempted payment institution status chosen from a pre-defined list:

1.

☐ Registered

2.

☐ Withdrawn

9

Date of registration

Numeric (8 characters)

The date of registration of the exempted payment institution. Depending on the practice of the competent authority, this date could be either the date when the exempted payment institution was registered with the competent authority or the date when it was included in the national public register.

10

Date of withdrawal (where applicable)

Numeric (8 characters)

The date of withdrawal of registration of the exempted payment institution. This is the date when the registration of the exempted payment institution was withdrawn.


Table 3 — Information on account information service providers

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Account information service provider’.

2

Name of the account information service provider

Text (250 characters)

The official name of the account information service provider shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the provider shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the provider's name into the Latin alphabet, or a translation or an alternative name of the provider in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the provider shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the account information service provider

Text (250 characters)

The commercial name of the account information service provider shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

If the account information service provider uses more than one commercial name, all of the commercial names of the institution could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the account information service provider's head office

 

The address of the account information service provider's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the account information service provider

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the account information service provider to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

The payment services for which the account information service provider has been registered

Text (26 characters)

Pre-defined option — ‘Account information services’

8

Current registration status of the account information service provider

Text (10 characters)

Current registration status of the account information service provider chosen from a pre-defined list:

1.

☐ Registered

2.

☐ Withdrawn

9

Date of registration

Numeric (8 characters)

The date of registration of the account information service provider. Depending on the practice of the competent authority, this date could be either the date when the account information service provider was registered with the competent authority or the date when it was included in the national public register.

10

Date of withdrawal (where applicable)

Numeric (8 characters)

The date of withdrawal of registration of the account information service provider. This is the date when the registration of the account information service provider was withdrawn.

11

Host Member States where the account information service provider provides or intends to provide account information services through the freedom to provide services

Multiple pre-defined options (up to 31 options)

Host Member States where the account information service provider provides or intends to provide account information services through the freedom to provide services:

 

☐ Austria

 

☐ Belgium

 

☐ Bulgaria

 

☐ Croatia

 

☐ Cyprus

 

☐ Czech Republic

 

☐ Denmark

 

☐ Estonia

 

☐ Finland

 

☐ France

 

☐ Germany

 

☐ Greece

 

☐ Hungary

 

☐ Iceland

 

☐ Ireland

 

☐ Italy

 

☐ Latvia

 

☐ Liechtenstein

 

☐ Lithuania

 

☐ Luxembourg

 

☐ Malta

 

☐ Netherlands

 

☐ Norway

 

☐ Poland

 

☐ Portugal

 

☐ Romania

 

☐ Slovakia

 

☐ Slovenia

 

☐ Spain

 

☐ Sweden

 

☐ United Kingdom

12

Name of the branch of the account information service provider established in a Member State other than the home Member State of the account information service provider

Text (up to 200 characters)

The official name of the branch used in the register shall be either the name of the account information service provider, or the designated name of the respective branch. It shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the branch shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the name or the trade name of the branch into the Latin alphabet, or a translation or an alternative name of the branch in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the branch shall be entered. The names shall be separated by a ‘/’ character.

13

The address of the principal branch of the account information service provider in the host Member State

 

The address of the principal branch of the account information service provider in the host Member State shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

13.1.

Country

Text (2 characters)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

13.2.

City

Text (100 characters)

 

13.3.

Street address

Text (50 characters per address line)

 

13.4.

Postcode

Text (35 characters)

 

14

Host Member States where the account information service provider provides or intends to provide account information services through the freedom of establishment via a branch

Multiple pre-defined options (up to 31 options)

Host Member States where the account information service provider provides or intends to provide payment services through the freedom of establishment via a branch:

 

☐ Austria

 

☐ Belgium

 

☐ Bulgaria

 

☐ Croatia

 

☐ Cyprus

 

☐ Czech Republic

 

☐ Denmark

 

☐ Estonia

 

☐ Finland

 

☐ France

 

☐ Germany

 

☐ Greece

 

☐ Hungary

 

☐ Iceland

 

☐ Ireland

 

☐ Italy

 

☐ Latvia

 

☐ Liechtenstein

 

☐ Lithuania

 

☐ Luxembourg

 

☐ Malta

 

☐ Netherlands

 

☐ Norway

 

☐ Poland

 

☐ Portugal

 

☐ Romania

 

☐ Slovakia

 

☐ Slovenia

 

☐ Spain

 

☐ Sweden

 

☐ United Kingdom


Table 4 — Information on electronic money institutions

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Electronic money institution’.

2

Name of the electronic money institution

Text (250 characters)

The official name of the electronic money institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the institution shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the institution shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the electronic money institution

Text (250 characters)

The commercial name of the electronic money institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the institution in another language based on the Latin alphabet.

If the electronic money institution uses more than one commercial name, all of the commercial names of the institution could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the electronic money institution's head office

 

The address of the electronic money institution's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the electronic money institution

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Authorisation number — a number or code appointed to an authorised electronic money institution by the competent authority of a Member State in the territory of which the entities have been established;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the electronic money institution to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

The electronic money and payment services for which the electronic money institution has been authorised

Multiple pre-defined options (between 1 and 15 options)

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

8

Current authorisation status of the electronic money institution

Text (10 characters)

Current authorisation status of the electronic money institution chosen from a pre-defined list:

1.

☐ Authorised

2.

☐ Withdrawn

9

Date of authorisation

Numeric (8 characters)

The date of authorisation of the electronic money institution. Depending on the practice of the competent authority, this date could be either the date when the electronic money institution was authorised by the competent authority or the date when it was included in its national public register.

10

Date of withdrawal (where applicable)

Numeric (8 characters)

The date of withdrawal of authorisation of the electronic money institution. This is the date when the authorisation of the electronic money institution was withdrawn.

11

Host Member States where the electronic money institution provides or intends to provide services through the freedom to provide services and the respective services that were notified to the host competent authority

Multiple pre-defined options (up to 31 options, which have up to 14 pre-defined sub-options)

Host Member States where the electronic money institution provides or intends to provide services through the freedom to provide services and the respective services that were notified to the host competent authority:

Austria:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Belgium:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Bulgaria:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Croatia:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Cyprus:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Czech Republic:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Denmark:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Estonia:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Finland:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

France:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Germany:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Greece:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Hungary:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Iceland:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Ireland:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Italy:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Latvia:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Liechtenstein:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Lithuania:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Luxembourg:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Malta:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Netherlands:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Norway:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Poland:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Portugal:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Romania:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Slovakia:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Slovenia:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Spain:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

Sweden:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

United Kingdom:

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

7.

☐ Payment initiation services

8.

☐ Account information services

12

Name of the branch of the electronic money institution established in a Member State other than the home Member State of the electronic money institution

Text (up to 200 characters)

The official name of the branch entered in the register shall be either the name of the electronic money institution, or the designated name of the respective branch. It shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the branch shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the name or the trade name of the branch into the Latin alphabet, or a translation or an alternative name of the branch in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the branch shall be entered. The names shall be separated by a ‘/’ character.

13

The address of the principal branch of the electronic money institution in the host Member State

 

The address of the principal branch of the electronic money institution in the host Member State shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

13.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

13.2.

City

Text (100 characters)

 

13.3.

Street address

Text (50 characters per address line)

 

13.4.

Postcode

Text (35 characters)

 

14

Host Member States where the electronic money institution provides or intends to provide services through the freedom of establishment via a branch and the respective services that were notified to the host competent authority

Multiple pre-defined options (up to 31 options, which that have up to 14 pre-defined sub-options)

Host Member States where the electronic money institution provides or intends to provide services through the freedom of establishment via a branch and the respective services that were notified to the host competent authority:

Same options as row 11 from this table.


Table 5 — Information on legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Exempted electronic money institution’.

2

Name of the exempted electronic money institution

Text (250 characters)

The official name of the exempted electronic money institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the institution shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the institution shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the exempted electronic money institution

Text (250 characters)

The commercial name of the exempted electronic money institution shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the institution in another language based on the Latin alphabet.

If the exempted electronic money institution uses more than one commercial name, all of the commercial names of the institution could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the exempted electronic money institution's head office

 

The address of the exempted electronic money institution's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the exempted electronic money institution

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the exempted electronic money institution to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

The electronic money and payment services for which the exempted electronic money institution has been registered

Multiple pre-defined options (between 1 and 15 options)

The electronic money services from a pre-defined list:

☐ Issuing, distribution and redemption of electronic money

The payment services from a pre-defined list:

1.

☐ Services enabling cash to be placed on a payment account as well as all the operations required for operating a payment account

2.

☐ Services enabling cash withdrawals from a payment account as well as all the operations required for operating a payment account

3.

Execution of payment transactions, including transfers of funds on a payment account with the user's payment provider or with another payment service provider:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

4.

Execution of payment transactions where the funds are covered by a credit line for a payment service user:

a)

☐ execution of direct debits, including one-off direct debits

b)

☐ execution of payment transactions through a payment card or a similar device

c)

☐ execution of credit transfers, including standing orders

5.

☐ Issuing of payment instruments

☐ acquiring of payment transactions

6.

☐ Money remittance

8

Current registration status of the exempted electronic money institution

Text (10 characters)

Current registration status of the exempted electronic money institution status chosen from a pre-defined list:

1.

☐ Registered

2.

☐ Withdrawn

9

Date of registration

Numeric (8 characters)

The date of registration of the exempted electronic money institution. Depending on the practice of the competent authority, this date could be either the date when the exempted electronic money institution was registered with the competent authority or the date when it was included in its national public register.

10

Date of withdrawal (where applicable)

Numeric (8 characters)

The date of withdrawal of registration of the exempted electronic money institution. This is the date when the registration of the exempted electronic money institution was withdrawn.


Table 6 — Information on agents

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Agent’.

2

Name of the agent

Text (250 characters)

The official name of the agent shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the agent shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the agent's name into the Latin alphabet, or a translation or an alternative name of the agent in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the agent shall be entered. The names shall be separated by a ‘/’ character.

3

Address of the agent

 

The address of the agent's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

3.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

3.2.

City

Text (100 characters)

 

3.3.

Street address

Text (50 characters per address line)

 

3.4.

Postcode

Text (35 characters)

 

4

National identification number of the agent

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

5

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the agent to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

6

Name of the natural or legal person on behalf of which the agent provides payment services

Text (250 characters)

The official name of the natural or legal person on behalf of which the agent provides payment services shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the natural or legal person shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the natural or legal person's name into the Latin alphabet, or a translation or an alternative name of the natural or legal person in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the natural or legal person shall be entered.

7

National identification number of the natural or legal person on behalf of which the agent provides payment services

Alphanumeric (50 characters)

The national identification number could be one of the following codes used by the home CA that provides information to the EBA:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Authorisation number — a number or code appointed to an authorised payment or electronic money institution by the competent authority of a Member State in the territory of which the entities have been established;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

8

Current registration status of the agent

Text (10 characters)

Current registration status of the agent chosen from a pre-defined list:

1.

☐ Active

2.

☐ Inactive


Table 7 — Information on institutions referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that are entitled under national law to provide payment services

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services’

2

Name of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services

Text (250 characters)

The official name of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the institution shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's name into the Latin alphabet, or a translation or an alternative name of the institution in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the institution shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services

Text (250 characters)

The commercial name of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the institution's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the institution in another language based on the Latin alphabet.

If the institution uses more than one commercial name, all of the commercial names of the institution could be entered. These names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the head office of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that are is entitled under national law to provide payment services

 

The address of the head office of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that are is entitled under national law to provide payment services shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the institution referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU that is entitled under national law to provide payment services

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the payment institution to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.


Table 8 — Format of the information on service providers carrying out services under points (i) and (ii) of point (k) and point (l) of Article 3 of Directive (EU) 2015/2366

Row

Field

Maximum length of the field

Format

1

Type of natural or legal person

Pre-defined text

Pre-defined option — ‘Service provider excluded from the scope of PSD2’.

2

Name of the service provider excluded from the scope of PSD2

Text (250 characters)

The official name of the service provider excluded from the scope of PSD2 shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The name of the service provider shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the service provider's name into the Latin alphabet, or a translation or an alternative name of the service provider in another language based on the Latin alphabet.

In Member States where there is more than one official national language, all official names of the service provider shall be entered. The names shall be separated by a ‘/’ character.

3

Commercial name of the service provider excluded from the scope of PSD2

Text (250 characters)

The commercial name of the service provider excluded from the scope of PSD2 shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide either a transcription of the service provider's commercial name into the Latin alphabet, or a translation or an alternative commercial name of the service provider in another language based on the Latin alphabet.

If the service provider excluded from the scope of PSD2 uses more than one commercial name, all of the commercial names of the service provider could be entered. Those names shall be separated by a ‘/’ character.

This field is optional for competent authorities to provide.

4

Address of the service provider excluded from the scope of PSD2

 

The address of the service provider's head office shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic and Latin. The address shall be provided in the national language of the respective Member State. Member States that use the Hellenic Alphabet or Cyrillic script shall also provide a transcription into the Latin alphabet or a common English name.

In Member States where there is more than one official national language, the address shall be provided in at least one official language of the jurisdiction. If the address is provided in more than one official national language, they shall be separated by a ‘/’ character.

4.1.

Country

Pre-defined text (options)

The Member States of the EU and the other EEA Member States:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

4.2.

City

Text (100 characters)

 

4.3.

Street address

Text (50 characters per address line)

 

4.4.

Postcode

Text (35 characters)

 

5

National identification number of the service provider excluded from the scope of PSD2

Alphanumeric (50 characters)

The national identification number may be one of the following codes:

 

National identification number for natural and legal persons used in the respective Member State;

 

Legal entity identifier — a code that allows legally distinct entities that engage in financial transactions to be uniquely identified;

 

Registration number — a number or code used by the competent authority of a Member State in its national public register;

 

Other equivalent means of identification — any means of identification of natural and legal persons used by the competent authority in its national public register.

6

The name of the competent authority responsible for the operation of the national public register

Text (100 characters)

The name of the competent authority which has provided the information about the service provider excluded from the scope of PSD2 to the EBA and is accountable for that information. The name of the competent authority shall be selected from a pre-defined list.

7

Description of the activities of the service provider excluded from the scope of PSD2

Text (up to 500 characters)

The description of the activities of the service provider excluded from the scope of PSD2 shall be entered in free text using any of the following language character sets: Hellenic Alphabet, Cyrillic or Latin. The description of the activities of the service provider shall be provided in the national language of the respective Member State.

8

Exclusion under which the service provider carries out activities

Multiple pre-defined options

Exclusion under which the service provider carries out activities chosen from a pre-defined list:

1.

Services based on specific payment instruments that can be used only in a limited way that meet one of the following conditions:

1.1.

☐ instruments allowing the holder to acquire goods or services only in the premises of the issuer or within a limited network of service providers under direct commercial agreement with a professional issuer

1.2.

☐ instruments which can be used only to acquire a very limited range of goods or services

or

2.

Payment transactions by a provider of electronic communications networks or services provided in addition to electronic communications services for a subscriber to the network or service:

2.1.

☐ for purchase of digital content and voice-based services, regardless of the device used for the purchase or consumption of the digital content and charged to the related bill

2.2.

☐ performed from or via an electronic device and charged to the related bill within the framework of a charitable activity or for the purchase of tickets

9

Current registration status of the service provider excluded from the scope of PSD2

Text (up to 10 characters)

Current registration status of the service provider excluded from the scope of PSD2 chosen from a pre-defined list:

1.

☐ Active

2.

☐ Inactive


15.3.2019   

EN

Official Journal of the European Union

L 73/84


COMMISSION DELEGATED REGULATION (EU) 2019/411

of 29 November 2018

supplementing Directive (EU) 2015/2366 of the European Parliament and of the Council with regard to regulatory technical standards setting technical requirements on development, operation and maintenance of the electronic central register within the field of payment services and on access to the information contained therein

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (1), and in particular the third subparagraph of Article 15(4) thereof,

Whereas:

(1)

Pursuant to Article 15(1) of Directive (EU) 2015/2366, the European Banking Authority (EBA) is required to develop, operate and maintain an electronic central register that contains information as notified by the competent authorities in accordance with paragraph 2 of that Article.

(2)

In order to ensure that the information contained in the electronic central register is accurately presented, EBA should ensure that the insertion or modification of information is carried out in a secure manner. To that end, EBA should grant personal access to the application of the register to members of the staff of the competent authorities. EBA and the competent authorities which have decided to transmit information to EBA automatically should ensure that safe and proportionate encryption techniques are used in the end-points and throughout the transmission of the information.

(3)

Considering that it is necessary that the electronic central register contains standardised and consistent information for all payment institutions and electronic money institutions established in the Union, presented in the same format, the application of the register should perform data validation before any information inserted or modified by the competent authorities is made publicly available.

(4)

It is necessary to ensure the authenticity, integrity and non-repudiation of the information contained in the electronic central register. EBA should therefore guarantee that the information is safely stored and that any inserted or modified information has been properly recorded.

(5)

In order to enable payment service users and other interested parties to use the electronic central register efficiently, it is necessary that the application of the register be developed in a way that guarantees that it operate in a reliable manner and be accessible without interruptions.

(6)

It is desirable that the users of the electronic central register be able to efficiently search the information in the register. Therefore, the information should be searchable on the basis of a number of different search criteria.

(7)

In order to fulfil the needs of the payment industry, EBA should make the content of the register available for download through a standardised file. This would enable all interested parties to automatically search information in that file

(8)

This Regulation is based on the draft regulatory technical standards submitted by EBA to the Commission.

(9)

EBA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

CHAPTER 1

GENERAL PROVISIONS

Article 1

Internal users of the register

1.   For the purposes of this Regulation, a member of the staff of a competent authority who is responsible for manually inserting and modifying information in the electronic central register of the European Banking Authority (EBA) (the ‘electronic central register’) shall be an internal user.

2.   Each competent authority shall appoint at least two members of its staff as internal users.

3.   Competent authorities shall notify EBA of the identity of the persons referred to in paragraph 2.

Article 2

Management of the register

EBA shall manage the list of internal users, provide the internal users with the authentication details, and provide technical support to the competent authorities.

Article 3

Access by internal users

1.   The application of the electronic central register shall be accessible to internal users only by using two-factor authentication.

2.   EBA shall provide a default username and password and the other security credentials to the internal users for accessing the application of the electronic central register.

3.   Internal users shall be required to change their default username and password at their first log-in into the application of the electronic central register.

4.   EBA shall ensure that the authentication method applied allows the identification of each internal user.

5.   EBA shall ensure that the application of the electronic central register does not allow information to be inserted or modified in the electronic central register by persons who do not have access to the application of the register or who do not have the appropriate permissions to do so.

Article 4

Public users

1.   For the purposes of this Regulation, public users of the electronic central register shall be payment service users and other interested parties, who access the electronic central register through the website of EBA.

2.   Public users shall be able to access the electronic central register without using access credentials.

3.   The access of public users to the electronic central register shall allow them only to read, search and download the information contained in the register. Public users shall not have any rights to modify the content of the register.

4.   When public users access the electronic central register, the website of EBA shall display the search criteria specified in Article 15(1).

CHAPTER 2

TRANSMISSION OF INFORMATION BY COMPETENT AUTHORITIES TO EBA

Article 5

Transmission of information by competent authorities to EBA

1.   Competent authorities shall transmit to EBA the information to be contained in the electronic central register manually via a web user interface or automatically via an application to application interface.

2.   Competent authorities shall notify EBA about their preferred approach for transmission of information under paragraph 1.

3.   Competent authorities which have notified EBA that their preferred approach is to transmit information automatically shall be allowed to transmit information manually upon prior notification to EBA.

4.   Competent authorities shall provide EBA with a hyperlink to their national public register. EBA shall make those hyperlinks publicly available in the electronic central register.

Article 6

Manual insertion and modification of information

1.   Competent authorities which have decided to transmit information to EBA manually shall insert or modify information for their Member States in the web application of the electronic central register. The information shall be entered in the format specified in paragraphs 2 to 9 of Article 1 of the Commission Implementing Regulation (EU) 2019/410 (3).

2.   The manually inserted or modified information shall be made publicly available in the electronic central register after it has been validated by the application of that register in accordance with Article 8.

3.   When manually inserted or modified information fails to be validated by the application of the electronic central register, the information shall be rejected and not be made publicly available. The internal user shall make the insertion or modification once again using the corrected information.

4.   EBA shall insert a date and time stamp in the manually inserted or modified information in the electronic central register. That date and time stamp shall display the moment of the last change to the register.

5.   Competent authorities shall ensure that all amendments to the content of their national public registers related to the granting or withdrawal of authorisation or registration are inserted in the electronic central register of EBA on the same day.

Article 7

Automated transmission of information

1.   Competent authorities which have decided to transmit information to EBA automatically shall transmit the information directly from the applications of their national public registers to the application of the electronic central register.

2.   EBA and the competent authorities shall ensure secure transmission of information between the applications of their respective registers in order to safeguard the authenticity, integrity and non-repudiation of the information transmitted, using strong and widely recognised encryption techniques.

3.   Competent authorities shall transmit to EBA in a single batch file with a common standard and structured format (‘the batch file’) the whole set of information set out in paragraphs 2 to 9 of Article 1 of the Implementing Regulation (EU) 2019/410 contained in their national public registers.

4.   The transmission of the batch file shall take place at least once each day on which the content of a national public register has been amended.

5.   Where competent authorities amend the content of their national public registers in relation to the granting or withdrawal of authorisation or registration and they are unable to transmit those changes automatically, they shall insert them manually on the same day.

6.   EBA shall allow the competent authorities to transmit a batch file once a day irrespective of whether the content of their national public registers has been amended.

7.   The information automatically transmitted to the electronic central register shall be made publicly available in the register as soon as possible after the batch file has been processed and validated by the application of the electronic central register in accordance with Article 8 and at the latest by the end of the day on which the batch file was processed and validated. All information previously transmitted, or manually inserted by a competent authority, which is publicly available in the electronic central register shall be replaced by the subsequently transmitted information by that competent authority.

8.   EBA shall not allow competent authorities to transmit a new batch file before they have received the outcome of the validation of their previously transmitted batch file.

9.   Where automatically transmitted information fails to be validated by the application of the electronic central register, the whole set of information contained in the batch file shall be rejected and not be made publicly available in that register.

10.   EBA shall insert a date and time stamp in the information automatically transmitted to the application of the electronic central register. That date and time stamp shall display the moment of the last synchronisation between the electronic central register and the national public registers.

Article 8

Validation of information

1.   The application of the electronic central register shall validate information transmitted by competent authorities to EBA in order to avoid any missing information or duplication of information.

2.   In order to avoid any missing information, the application of the electronic central register shall perform data validation on the fields filled in or transmitted by the competent authorities to EBA with the exception of the field for the commercial name of the natural or legal person.

3.   In order to avoid duplication of the information, the application of the register shall perform data validation on each of the following fields:

(a)

for payment institutions, natural or legal persons benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366, account information service providers, electronic money institutions, legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC of the European Parliament and of the Council (4), the institutions referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU of the European Parliament and of the Council (5) and the persons whose authorisation or registration was withdrawn:

(i)

the national identification number;

(ii)

the relevant type of natural or legal person as referred to in paragraphs 2 to 9 of Article 1 of Implementing Regulation (EU) 2019/410;

(iii)

authorisation or registration date;

(b)

for agents of payment institutions, natural or legal person benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366, account information service providers, electronic money institutions and legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC:

(i)

the national identification number of the agent;

(ii)

the national identification number of the natural or legal person on behalf of which the agent provides payment services;

(iii)

registration date;

(c)

for service providers carrying out services under points (i) and (ii) of point (k) and point (l) of Article 3 of Directive (EU) 2015/2366:

(i)

the national identification number of the service provider;

(ii)

the exclusion under which the service provider carries out activities;

(iii)

the registration date.

4.   Where the status of authorisation or registration of a natural or legal person, which has agents providing payment services on its behalf, has changed from ‘authorised’ or ‘registered’ to ‘withdrawn’, the application of the electronic central register shall not perform data validation on the agents linked to that person.

5.   Competent authorities shall receive a response from the application of the electronic central register about the result of the data validation process as soon as possible in a clear and unequivocal way. The result of the data validation shall also include the percentage change to the content of the information previously transmitted.

6.   Where the transmitted information fails the validation process, EBA shall include in its response to the competent authorities all the reasons for the rejection.

7.   In the event of a failed validation where the amendments to the content of the national public register are related to granting or withdrawal of authorisation or registration, competent authorities which transmit information automatically shall, by the end of the day on which the validation failed, transmit a corrected or updated batch file with the whole set of information or manually insert the new amendments made to the content of their national public registers related to the granting or withdrawal of authorisation or registration.

8.   For the purposes of the validation of national identification numbers competent authorities shall notify to EBA the types and the formats of the national identification numbers which they use in their national registers.

9.   The application of the electronic central register shall enable competent authorities to insert an agent more than once in the register where the agent provides payment services on behalf of more than one natural or legal person. Each insertion shall be treated as a separate record.

Article 9

Information concerning agents

1.   EBA and the competent authorities shall ensure that agents inserted in the electronic central register are linked to the natural or legal person on behalf of which they provide payment services.

2.   Where a natural or legal person, which has agents providing payment services on its behalf, has its status of authorisation or registration changed from ‘authorised’ or ‘registered’ to ‘withdrawn’, the status of the agents linked to that natural or legal person shall be changed from ‘active’ to ‘inactive’.

Article 10

Responsibility of competent authorities

1.   Competent authorities shall be responsible for the accuracy of information manually inserted in or automatically transmitted to the application of the electronic central register about the natural or legal persons authorised or registered by them, as well as the agents and service providers carrying out services under points (i) and (ii) of point (k) and point (l) of Article 3 of Directive (EU) 2015/2366 listed in their national public registers.

2.   The application of the electronic central register shall enable internal users and applications of the national public registers to insert or modify the information for which their respective competent authority is responsible.

3.   Competent authorities shall not be able to modify the information for which other competent authorities are responsible.

4.   Competent authorities shall not be able to insert information concerning payment institutions, natural or legal persons benefiting from an exemption pursuant to Article 32 of Directive (EU) 2015/2366 and their agents, account information service providers, the institutions referred to in points (4) to (23) of Article 2(5) of Directive 2013/36/EU, electronic money institutions, legal persons benefiting from an exemption pursuant to Article 9 of Directive 2009/110/EC and their agents, and service providers carrying out services under points (i) and (ii) of point (k) and point (l) of Article 3 of Directive (EU) 2015/2366, established in another host Member State.

CHAPTER 3

NON-FUNCTIONAL REQUIREMENTS

Article 11

Safety requirements

1.   The application data of the electronic central register shall be backed up and the backup copies shall be stored for the purposes of disaster recovery.

2.   In the event that any security issues are detected, EBA shall be able to immediately shut down the application of the electronic central register and prevent any access to the server.

3.   The application of the electronic central register shall be able to recover from crashes without undue delay and to continue its normal operation.

4.   In the event that the application of the electronic central register is down and cannot process batch files transmitted by the competent authorities, that application shall process the most recent files which were transmitted by each competent authority after restoring its normal operation.

5.   EBA shall notify the competent authorities of any failure or down-time of the application of the electronic central register.

6.   Where a failure of the application of the electronic central register has affected the processing of a batch file transmitted by a competent authority, EBA shall request the competent authority to submit a new batch file. Where the competent authority is unable to do so, it shall request EBA to roll-back the data to the version that was submitted with the last validated batch file prior to the failure.

7.   EBA shall develop its register in accordance with the international standards for cyber security.

Article 12

Availability and performance requirements

1.   The electronic central register shall be able to accommodate the initial set of data currently existing in the public registers maintained by the competent authorities.

2.   The application of the electronic central register shall be able to accommodate an increase in the volume of the information received from competent authorities. Such an increase shall not affect the availability of the register.

3.   EBA shall ensure that the electronic central register becomes available immediately after normal operation has been restored following any failure of the application of the register.

4.   The automated transmission of information referred to in Article 7 shall not affect the availability of the electronic central register.

5.   EBA shall inform public users of any unavailability of the electronic central register as well as of the reasons for that unavailability and the recovery of that register by displaying that information on its website

Article 13

Maintenance and support requirements

1.   EBA shall monitor the operation of the application of the register, analyse its performance and, where necessary, introduce changes to ensure that the application complies with the requirements set out in this Regulation.

2.   EBA shall monitor the regular transmission and update of information in the electronic central register by the competent authorities.

3.   EBA shall review the suitability of the non-functional requirements specified in this Chapter on a regular basis.

4.   EBA shall provide support to the competent authorities in relation to the operation of the electronic central register. For that purpose EBA shall introduce a functionality in the application of the register enabling competent authorities to submit a query. EBA shall put all such queries in a queue.

5.   EBA shall respond to the queries referred to in paragraph 4 without undue delay by the end of the day on which the query was made. EBA shall respond to the queries in order of reception.

6.   EBA shall provide the competent authorities with a testing environment and support for that technical environment.

7.   EBA shall establish a designated channel for communication of incidents related to the operation of the electronic central register.

Article 14

Audit trail

1.   The electronic central register shall enable recording of all the information transmitted by competent authorities to EBA.

2.   The electronic central register shall enable recording of all automated or manual actions performed by the applications of the national public registers or by internal users respectively, as well as the time when those actions were performed.

3.   EBA shall be able to access the data recorded pursuant to paragraphs 1 and 2.

4.   EBA shall be able to extract reports from the data recorded pursuant to paragraphs 1 and 2 which enable it to monitor and interpret the information transmitted by the competent authorities.

CHAPTER 4

ACCESS TO THE INFORMATION

Article 15

Search of information

1.   The electronic central register shall enable users of the register to search information in the register on the basis of different search criteria including each of the following:

(a)

the relevant type of natural or legal person as referred to in paragraphs 2 to 9 of Article 1 of Implementing Regulation (EU) 2019/410;

(b)

the name of the natural or legal person;

(c)

the national identification number of the natural or legal person;

(d)

the name of the competent authority responsible for the operation of the national public register;

(e)

the country where the natural or legal person is established;

(f)

the city where the natural or legal person is established;

(g)

the payment services and electronic money services provided;

(h)

the host Member State in which the authorised or registered payment institution, electronic money institution or account information service provider provides services or has notified its intention to provide services;

(i)

the payment and electronic money services provided in the host Member State;

(j)

the status of authorisation or registration;

(k)

the date of authorisation or registration;

(l)

the date of withdrawal of authorisation or registration.

2.   The electronic central register shall perform the search of information when at least one of the search criteria is filled in.

3.   The electronic central register shall enable users of the register to use any combination of the criteria specified in paragraph 1.

4.   The electronic central register shall enable users of the register to select the information in items (a), (d), (e) and (j) of paragraph 1 from a drop-down menu.

5.   The electronic central register shall enable users of the register to select the search criteria referred to in points (g), (h) and (i) of paragraph 1 from a multi-select menu.

6.   EBA shall ensure that searches that enable the use of symbols or signs to replace individual characters and/or words (wildcard searches) are available for users of the register to increase the breadth of a search.

7.   EBA shall inform the users of the register how to use the symbols referred to in paragraph 6 by displaying the information on its website.

Article 16

Display of search results

1.   The electronic central register shall display as search results all natural and legal persons which meet the search criteria filled in by the user of the register.

2.   The information displayed concerning the natural and legal persons shall include the following:

(a)

the name of the person;

(b)

the national identification number of the person;

(c)

the country where it is established;

(d)

the city where it is established;

(e)

the relevant type of natural or legal person as referred to in paragraphs 2 to 9 of Article 1 of Implementing Regulation (EU) 2019/410;

(f)

the payment services and electronic money services provided.

3.   When selecting the name of a natural or legal person from the displayed search results, the information specified in paragraphs 2 to 9 of Article 1 of Implementing Regulation (EU) 2019/410 shall be displayed for the respective person, including the latest date and time stamp inserted by EBA.

4.   Agents shall be displayed both as a separate record and as part of the record of the natural or legal person on behalf of which they provide payment services.

5.   EBA shall accurately display in the electronic central register the information transmitted by the competent authorities and ensure that the information displayed is complete.

Article 17

Download of information

1.   EBA shall make the content of the electronic central register available for manual and automated download by public users of the register by copying the content to a standardised file.

2.   EBA shall update the standardised file referred to in paragraph 1 at least twice a day at pre-determined intervals. EBA shall disclose the pre-determined intervals for such updates.

CHAPTER 6

FINAL PROVISIONS

Article 18

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 November 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 337, 23.12.2015, p. 35.

(2)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

(3)  Commission Implementing Regulation (EU) 2019/410 of 29 November 2018 laying down implementing technical standards with regard to the details and structure of the information to be notified, in the field of payment services, by competent authorities to EBA pursuant to Directive (EU) 2015/2366 of the European Parliament and of the Council (see page 20 of this Official Journal).

(4)  Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7).

(5)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).


15.3.2019   

EN

Official Journal of the European Union

L 73/93


COMMISSION REGULATION (EU) 2019/412

of 14 March 2019

on amending Regulation (EC) No 1126/2008 adopting certain international accounting standards in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council as regards International Accounting Standards 12 and 23 and International Financial Reporting Standards 3 and 11

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (1), and in particular Article 3(1) thereof,

Whereas:

(1)

By Commission Regulation (EC) No 1126/2008 (2) certain international standards and interpretations that were in existence at 15 October 2008 were adopted.

(2)

On 12 December 2017, the International Accounting Standards Board (IASB) published Annual Improvements to International Financial Reporting Standards 2015-2017 Cycle (the annual improvements), in the framework of its regular improvement process which aims at streamlining and clarifying the standards. The objective of the annual improvements is to address non-urgent, but necessary issues discussed by the IASB during the project cycle on areas of inconsistency in International Financial Reporting Standards or where clarification of wording is required.

(3)

Following the consultations with the European Financial Advisory Group, the Commission concludes that the amendments to International Accounting Standard (IAS) 12 Income Taxes, IAS 23 Borrowing Costs, International Financial Reporting Standard (IFRS) 3 Business Combinations and IFRS 11 Joint Arrangements meet the criteria for adoption set out in Article 3(2) of Regulation (EC) No 1606/2002.

(4)

Regulation (EC) No 1126/2008 should therefore be amended accordingly.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Accounting Regulatory Committee,

HAS ADOPTED THIS REGULATION:

Article 1

(a)

International Accounting Standard (IAS) 12 Income Taxes is amended as set out in the Annex to this Regulation;

(b)

IAS 23 Borrowing Costs is amended as set out in the Annex to this Regulation;

(c)

International Financial Reporting Standard (IFRS) 3 Business Combinations is amended as set out in the Annex to this Regulation;

(d)

IFRS 11 Joint Arrangements is amended as set out in the Annex to this Regulation.

Article 2

Each company shall apply the amendments referred to in Article 1, at the latest, as from the commencement date of its first financial year starting on or after 1 January 2019.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 March 2019.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 243, 11.9.2002, p. 1.

(2)  Commission Regulation (EC) No 1126/2008 of 3 November 2008 adopting certain international accounting standards in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council (OJ L 320, 29.11.2008, p. 1).


ANNEX

Annual Improvements to IFRS® Standards 2015–2017 Cycle

Amendments to

IFRS 3 Business Combinations

Paragraphs 42A and 64O are added.

Additional guidance for applying the acquisition method to particular types of business combinations

A business combination achieved in stages

42A

When a party to a joint arrangement (as defined in IFRS 11 Joint Arrangements) obtains control of a business that is a joint operation (as defined in IFRS 11), and had rights to the assets and obligations for the liabilities relating to that joint operation immediately before the acquisition date, the transaction is a business combination achieved in stages. The acquirer shall therefore apply the requirements for a business combination achieved in stages, including remeasuring its previously held interest in the joint operation in the manner described in paragraph 42. In doing so, the acquirer shall remeasure its entire previously held interest in the joint operation.

EFFECTIVE DATE AND TRANSITION

Effective date

64O

Annual Improvements to IFRS Standards 2015–2017 Cycle, issued in December 2017, added paragraph 42A. An entity shall apply those amendments to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after 1 January 2019. Earlier application is permitted. If an entity applies those amendments earlier, it shall disclose that fact.

Amendments to

IFRS 11 Joint Arrangements

Paragraph B33CA and paragraph C1AB are added.

Accounting for acquisitions of interests in joint operations

B33CA

A party that participates in, but does not have joint control of, a joint operation might obtain joint control of the joint operation in which the activity of the joint operation constitutes a business as defined in IFRS 3. In such cases, previously held interests in the joint operation are not remeasured.

EFFECTIVE DATE

C1AB

Annual Improvements to IFRS Standards 2015–2017 Cycle, issued in December 2017, added paragraph B33CA. An entity shall apply those amendments to transactions in which it obtains joint control on or after the beginning of the first annual reporting period beginning on or after 1 January 2019. Earlier application is permitted. If an entity applies those amendments earlier, it shall disclose that fact.

Amendments to

IAS 12 Income Taxes

Paragraphs 57A and 98I are added, the heading of the example below paragraph 52B is amended and paragraph 52B is deleted.

MEASUREMENT

52B

[Deleted]

Example illustrating paragraphs 52A and 57A

RECOGNITION OF CURRENT AND DEFERRED TAX

57A

An entity shall recognise the income tax consequences of dividends as defined in IFRS 9 when it recognises a liability to pay a dividend. The income tax consequences of dividends are linked more directly to past transactions or events that generated distributable profits than to distributions to owners. Therefore, an entity shall recognise the income tax consequences of dividends in profit or loss, other comprehensive income or equity according to where the entity originally recognised those past transactions or events.

EFFECTIVE DATE

98I

Annual Improvements to IFRS Standards 2015–2017 Cycle, issued in December 2017, added paragraph 57A and deleted paragraph 52B. An entity shall apply those amendments for annual reporting periods beginning on or after 1 January 2019. Earlier application is permitted. If an entity applies those amendments earlier, it shall disclose that fact. When an entity first applies those amendments, it shall apply them to the income tax consequences of dividends recognised on or after the beginning of the earliest comparative period.

Amendments to

IAS 23 Borrowing Costs

Paragraph 14 is amended, and paragraphs 28A and 29D are added.

RECOGNITION

Borrowing costs eligible for capitalisation

14.

To the extent that an entity borrows funds generally and uses them for the purpose of obtaining a qualifying asset, the entity shall determine the amount of borrowing costs eligible for capitalisation by applying a capitalisation rate to the expenditures on that asset. The capitalisation rate shall be the weighted average of the borrowing costs applicable to all borrowings of the entity that are outstanding during the period. However, an entity shall exclude from this calculation borrowing costs applicable to borrowings made specifically for the purpose of obtaining a qualifying asset until substantially all the activities necessary to prepare that asset for its intended use or sale are complete. The amount of borrowing costs that an entity capitalises during a period shall not exceed the amount of borrowing costs it incurred during that period.

TRANSITIONAL PROVISIONS

28A

Annual Improvements to IFRS Standards 2015–2017 Cycle, issued in December 2017, amended paragraph 14. An entity shall apply those amendments to borrowing costs incurred on or after the beginning of the annual reporting period in which the entity first applies those amendments.

EFFECTIVE DATE

29D

Annual Improvements to IFRS Standards 2015–2017 Cycle, issued in December 2017, amended paragraph 14 and added paragraph 28A. An entity shall apply those amendments for annual reporting periods beginning on or after 1 January 2019. Earlier application is permitted. If an entity applies those amendments earlier, it shall disclose that fact.

15.3.2019   

EN

Official Journal of the European Union

L 73/98


COMMISSION IMPLEMENTING REGULATION (EU) 2019/413

of 14 March 2019

amending Implementing Regulation (EU) 2015/1998 as regards third countries recognised as applying security standards equivalent to the common basic standards on civil aviation security

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (1), and in particular Article 4(3) thereof,

Whereas:

(1)

Commission Regulation (EC) No 272/2009 (2) supplements the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008.

(2)

That same Regulation (EC) No 272/2009 charges the Commission with the recognition of the equivalence of security standards of third countries, in accordance with the criteria set out in Part E of the Annex to that Regulation.

(3)

The Annex to Commission Implementing Regulation (EU) 2015/1998 (3) lists the third countries recognised as applying security standards equivalent to the common basic standards.

(4)

The Commission has received confirmation from the United Kingdom of Great Britain and Northern Ireland that it will maintain its regulations and standards on aviation security equivalent to the Union legislation beyond the date of its withdrawal from the European Union on 30 March 2019.

(5)

The Commission has verified that the United Kingdom of Great Britain and Northern Ireland satisfies the criteria set out in Part E of the Annex to Regulation (EC) No 272/2009.

(6)

The Commission has established an appropriate process to reattribute to the other Member States the responsibility for the designation of air carriers, third country regulated agents and third country known consignors, currently designated by the United Kingdom as ACC3, RA3 and KC3 respectively, and that this process should be regulated through transitional implementing provisions.

(7)

The Commission and the Member States acknowledge the valuable contribution to the functioning of the EU secure supply chain of ACC3, RA3 and KC3 provided by the EU aviation security validators approved by the United Kingdom of Great Britain and Northern Ireland, and the opportunity to provide for the Member States to take over the responsibility for their approval as from 30 March 2019.

(8)

Implementing Regulation (EU) 2015/1998 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 19 of Regulation (EC) No 300/2008,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2015/1998 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Article 3

This Regulation shall apply from the day following that of which the Treaties cease to apply to and in the United Kingdom of Great Britain and Northern Ireland pursuant to Article 50(3) of the Treaty on European Union, subject to any possible withdrawal agreement concluded in accordance with Article 50(2) of the Treaty on European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 March 2019.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 97, 9.4.2008, p. 72.

(2)  Commission Regulation (EC) No 272/2009 of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council (OJ L 91, 3.4.2009, p. 7).

(3)  Commission Implementing Regulation (EU) 2015/1998 of 5 November 2015 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 299, 14.11.2015, p. 1).


ANNEX

The Annex to Implementing Regulation (EU) 2015/1998 is amended as follows:

(1)

In Chapter 3, Attachment 3-B is replaced by the following:

ATTACHMENT 3-B

AIRCRAFT SECURITY

THIRD COUNTRIES, AS WELL AS OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, THAT ARE RECOGNISED AS APPLYING SECURITY STANDARDS EQUIVALENT TO THE COMMON BASIC STANDARDS ON CIVIL AVIATION SECURITY

As regards aircraft security, the following third countries, as well as other countries and territories to which, in accordance with Article 355 of the Treaty on the Functioning of the European Union, Title VI of Part Three of that Treaty does not apply, have been recognised as applying security standards equivalent to the common basic standards on civil aviation security:

 

Canada

 

Faroe Islands, in regard to Vagar airport

 

Greenland, in regard to Kangerlussuaq airport

 

Guernsey

 

Isle of Man

 

Jersey

 

Montenegro

 

Republic of Singapore, in regard to Singapore Changi Airport

 

United Kingdom of Great Britain and Northern Ireland

 

United States of America

The Commission shall immediately notify the appropriate authorities of the Member States if it has information indicating that security standards applied by the third country or other country or territory concerned with a significant impact on overall levels of aviation security in the Union are no longer equivalent to the common basic standards of the Union.

The appropriate authorities of the Member States shall be notified without delay when the Commission has information about actions, including compensatory measures, confirming that the equivalency of relevant security standards applied by the third country or other country or territory concerned is re-established.’;

(2)

In Chapter 4, Attachment 4-B is replaced by the following:

ATTACHMENT 4-B

PASSENGERS AND CABIN BAGGAGE

THIRD COUNTRIES, AS WELL AS OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, THAT ARE RECOGNISED AS APPLYING SECURITY STANDARDS EQUIVALENT TO THE COMMON BASIC STANDARDS ON CIVIL AVIATION SECURITY

As regards passengers and cabin baggage, the following third countries, as well as other countries and territories to which, in accordance with Article 355 of the Treaty on the Functioning of the European Union, Title VI of Part Three of that Treaty does not apply, have been recognised as applying security standards equivalent to the common basic standards on civil aviation security:

 

Canada

 

Faroe Islands, in regard to Vagar airport

 

Greenland, in regard to Kangerlussuaq airport

 

Guernsey

 

Isle of Man

 

Jersey

 

Montenegro

 

Republic of Singapore, in regard to Singapore Changi Airport

 

United Kingdom of Great Britain and Northern Ireland

 

United States of America

The Commission shall immediately notify the appropriate authorities of the Member States if it has information indicating that security standards applied by the third country or other country or territory concerned with a significant impact on overall levels of aviation security in the Union are no longer equivalent to the common basic standards of the Union.

The appropriate authorities of the Member States shall be notified without delay when the Commission has information about actions, including compensatory measures, confirming that the equivalency of relevant security standards applied by the third country or other country or territory concerned is re-established.’;

(3)

In Chapter 5, Attachment 5-A is replaced by the following:

ATTACHMENT 5-A

HOLD BAGGAGE

THIRD COUNTRIES, AS WELL AS OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, THAT ARE RECOGNISED AS APPLYING SECURITY STANDARDS EQUIVALENT TO THE COMMON BASIC STANDARDS ON CIVIL AVIATION SECURITY

As regards hold baggage, the following third countries, as well as other countries and territories to which, in accordance with Article 355 of the Treaty on the Functioning of the European Union, Title VI of Part Three of that Treaty does not apply, have been recognised as applying security standards equivalent to the common basic standards on civil aviation security:

 

Canada

 

Faroe Islands, in regard to Vagar airport

 

Greenland, in regard to Kangerlussuaq airport

 

Guernsey

 

Isle of Man

 

Jersey

 

Montenegro

 

Republic of Singapore, in regard to Singapore Changi Airport

 

State of Israel, in regard to Ben Gurion International Airport

 

United Kingdom of Great Britain and Northern Ireland

 

United States of America

The Commission shall notify without delay the appropriate authorities of the Member States if it has information indicating that security standards applied by the third country or other country or territory concerned with a significant impact on overall levels of aviation security in the Union are no longer equivalent to the common basic standards of the Union.

The appropriate authorities of the Member States shall be notified without delay when the Commission has information about actions, including compensatory measures, confirming that the equivalency of relevant security standards applied by the third country or other country or territory concerned is re-established.’;

(4)

In chapter 6, the following point 6.8.1.6 is added:

‘6.8.1.6

Following the notification by the United Kingdom of Great Britain and Northern Ireland of its intention to withdraw from the European Union pursuing Article 50 of the TEU, the ACC3 designations issued by this Member State are subject to the following provisions:

(a)

The responsibility for the current designations is transferred to the appropriate authority of the Member State listed in the Annex to Commission Regulation (EC) No 748/2009, as amended for the purposes of the withdrawal of the United Kingdom from the Union.

(b)

The responsibility for ACC3 designations of air carriers not listed in the Annex to Commission Regulation (EC) No 748/2009, as amended, is transferred to the appropriate authority as identified in point 6.8.1.1 (c).

(c)

The appropriate authority of the Member State as described in points (a) and (b) may agree with its counterpart in another Member State, for the latter to accept responsibility for the ACC3 designation of a given air carrier. In doing so, the concerned Member States shall promptly inform the Commission.

(d)

The Commission will inform the appropriate authority of the United Kingdom about the Member States taking over the responsibility of its ACC3 designations.

(e)

The appropriate authority of the United Kingdom shall make available to the appropriate authority of the receiving Member State, copy of the necessary documentation on which basis it had designated the air carriers listed in point (a) as ACC3. This shall include, at least, the complete validation report, the security programme and if applicable, the roadmap that was agreed with the relevant air carrier.

(f)

Provided the obligations in point (e) are satisfied, the transfer of responsibility for ACC3 designations shall occur on the day of withdrawal of the United Kingdom from the European Union.

(g)

ACC3 designations of air carriers operating exclusively to the United Kingdom shall be discontinued.

(h)

ACC3 designations transferred shall remain valid until their expiry and the receiving Member State takes over the responsibilities and obligations described in this Regulation.

(i)

The Commission will facilitate the administrative transition including the listing of the ACC3 details into the Union database on supply chain security.’

(5)

In chapter 6, the following point 6.8.4.10 is added:

‘6.8.4.10

Following the notification by the United Kingdom of Great Britain and Northern Ireland of its intention to withdraw from the European Union pursuing Article 50 of the TEU, designations of RA3 and KC3 issued by this Member State are subject to the following provisions:

(a)

The responsibility for RA3 or KC3 designation of an entity consisting of a branch or a subsidiary company of an airline operator, or of an air carrier itself, is transferred to the appropriate authority of the Member State identified in point 6.8.1.1 of this Regulation;

(b)

The responsibility for RA3 or KC3 designation of an entity not directly linked to an air carrier is transferred to the appropriate authority of the Member State identified in point 6.8.1.1 as holding the responsibility for the national or major air carrier of the third country where the RA3 or KC3 operates.

(c)

The responsibility for RA3 or KC3 designation of an entity not falling under points (a) or (b), is transferred to the appropriate authority of the Member State identified in point 6.8.1.1 as holding the responsibility for one of the Union air carriers operating from the airport where the RA3 or KC3 operates, or the closest airport to the site of this entity.

(d)

The appropriate authority of the Member State as described in points (a) to (c) may agree with its counterpart in another Member State, for the latter to accept responsibility for the RA3 or KC3 designation of a given entity or airline operator. In doing so, the concerned Member States shall promptly inform the Commission.

(e)

The Commission will inform the appropriate authority of the United Kingdom about the Member States taking over the responsibility of its RA3 and KC3 designations.

(f)

The appropriate authority of the United Kingdom shall make available to the appropriate authority of the receiving Member State, copy of the necessary documentation on which basis it had designated an entity or an airline operator as RA3 or KC3. This shall include, at least, the complete validation report and the security programme of the relevant entity or airline operator.

(g)

Provided the obligations in point (f) are satisfied, the transfer of responsibility for RA3 and KC3 designations shall occur on the day of withdrawal of the United Kingdom from the European Union.

(h)

RA3 and KC3 designations transferred shall remain valid until their expiry and the receiving Member State takes over the responsibilities and obligations described in this Regulation.

(i)

The Commission will facilitate the administrative transition including the listing of the RA3 and KC3 details into the Union database on supply chain security.’

(6)

In Chapter 6, Attachment 6-F is replaced by the following:

ATTACHMENT 6-F

CARGO AND MAIL

6-Fi

THIRD COUNTRIES, AS WELL AS OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, THAT ARE RECOGNISED AS APPLYING SECURITY STANDARDS EQUIVALENT TO THE COMMON BASIC STANDARDS ON CIVIL AVIATION SECURITY

As regards cargo and mail, the following third countries have been recognised as applying security standards equivalent to the common basic standards on civil aviation security:

 

Montenegro

 

United Kingdom of Great Britain and Northern Ireland

The Commission shall notify without delay the appropriate authorities of the Member States if it has information indicating that security standards applied by the third country or other country or territory concerned with a significant impact on overall levels of aviation security in the Union are no longer equivalent to the common basic standards of the Union.

The appropriate authorities of the Member States shall be notified without delay when the Commission has information about actions, including compensatory measures, confirming that the equivalency of relevant security standards applied by the third country or other country or territory concerned is re-established.

6-Fii

THIRD COUNTRIES, AS WELL AS OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, FOR WHICH ACC3 DESIGNATION IS NOT REQUIRED, ARE LISTED IN COMMISSION IMPLEMENTING DECISION C(2015)8005.

6-Fiii

VALIDATION ACTIVITIES OF THIRD COUNTRIES, AS WELL AS OF OTHER COUNTRIES AND TERRITORIES TO WHICH, IN ACCORDANCE WITH ARTICLE 355 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION, TITLE VI OF PART THREE OF THAT TREATY DOES NOT APPLY, THAT ARE RECOGNISED AS EQUIVALENT TO EU AVIATION SECURITY VALIDATION.

No provisions adopted yet.’;

(7)

In chapter 11, the following points 11.6.3.9 and 11.6.3.10 are added:

‘11.6.3.9

As from the date of withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union pursuing Article 50 of the TEU, the following provisions apply in respect of EU aviation security validators approved by this Member State to perform validations in respect of airlines, operators and entities seeking respectively ACC3, RA3 and KC3 designation:

(a)

they are no longer recognised in the Union;

(b)

the EU aviation security validations performed before the date of withdrawal of the United Kingdom from the Union, including the EU validation reports issued before that date remain valid for the purpose of the designation of air carriers, operators and entities they have validated;

11.6.3.10

Individuals and entities indicated in the previous point may seek approval as EU aviation security validator by the appropriate authority of a Member State. The approving Member State shall:

(a)

Obtain from the appropriate authority of the United Kingdom the necessary documentation on which basis the individual or legal entity had been approved as EU aviation security validator;

(b)

Verify that the applicant fulfils the Union requirements in this Chapter. If the appropriate authority is satisfied, it may approve the individual or the entity as EU aviation security validator for a period not exceeding the approval that was granted by the appropriate authority of the United Kingdom;

(c)

Promptly inform the Commission that will ensure the listing of the EU aviation security validator into the Union database on supply chain security.’


15.3.2019   

EN

Official Journal of the European Union

L 73/105


COMMISSION REGULATION (EU) 2019/414

of 14 March 2019

implementing Regulation (EC) No 1177/2003 of the European Parliament and of the Council concerning Community statistics on income and living conditions (EU-SILC) as regards the 2020 list of target secondary variables on over-indebtedness, consumption and wealth as well as labour

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1177/2003 of the European Parliament and of the Council of 16 June 2003 concerning Community statistics on income and living conditions (EU-SILC) (1), and in particular Article 15(2)(f) thereof,

Whereas:

(1)

Regulation (EC) No 1177/2003 established a common framework for the systematic production of European statistics on income and living conditions, in order to ensure that comparable and up-to-date cross-sectional and longitudinal data on income and on the level and composition of poverty and social exclusion are available at national and Union level.

(2)

Pursuant to Article 15(2)(f) of Regulation (EC) No 1177/2003, implementing measures are to be adopted each year to specify the target secondary areas and variables to be included in the cross-sectional component of EU-SILC that year. Implementing measures specifying the target secondary variables and their identifiers for the 2020 module on over-indebtedness, consumption and wealth as well as labour should therefore be adopted.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The list of target secondary variables and identifiers for the 2020 module on over-indebtedness, consumption and wealth as well as labour, part of the cross-sectional component of EU-SILC, shall be as set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 March 2019.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 165, 3.7.2003, p. 1.


ANNEX

The target secondary variables and identifiers for the 2020 module on over-indebtedness, consumption and wealth as well as labour — part of the cross-sectional component of European Union Statistics on Income and Living Conditions (EU-SILC) — shall be as follows:

1.   Units

Selected information on labour shall be provided for all current household members or, if applicable, for all selected respondents aged 16 and over.

Information on over-indebtedness, consumption and wealth applies at household level and refers to the household as a whole.

2.   Mode of data collection

For variables that apply at individual level, the mode of data collection is a personal interview with all current household members or, if applicable, with all selected respondents aged 16 and over.

For variables that apply at household level, the mode of data collection is a personal interview with the household respondent.

Proxy interviews are allowed as an exception for persons temporarily absent or incapacitated.

Data can be obtained from registers.

3.   Reference period

The target variables relate to different types of reference periods:

Current reference period for over-indebtedness variables except for two variables on ‘Arrears on non-housing bills’ and ‘Amount due last month on loans (excluding mortgages on purchase of main residence)’.

Past 12 months for variable ‘Arrears on non-housing bills’.

Last month for variable ‘Amount due last month on loans (excluding mortgages on purchase of main residence)’.

Last month for the consumption variables.

Current reference period for the wealth variables.

Current reference period for the labour variable ‘Public/private employment sector’.

Income reference period for the labour variable ‘Months with any work’.

Period of unemployment during the income reference period for the labour variable ‘Registration of unemployment’.

4.   Data transmission

The target secondary variables shall be sent to the Commission (Eurostat) in the household data file (H-file) and in the personal data file (P-file) after the target primary variables.

 

Testing module 2020

Over-indebtedness, consumption and wealth as well as labour

Variable name

Code

Target variable

Over-indebtedness

HI020

 

Arrears on non-housing bills

1

Yes, once

2

Yes, twice or more

3

No

HI020_F

1

Filled

– 1

Missing

– 2

N/A (no non-housing bills)

– 7

N/A (HB010≠2020)

HI090

 

Number of loans (excluding mortgages on purchase of main residence)

Number (2 digits) 00-99

HI090_F

1

Filled

– 1

Missing

– 7

N/A (HB010≠2020)

HI100

1-selected, 2- not selected

Purpose of loans (excluding mortgages on purchase of main residence)

HI100_01

1, 2

Property (incl. household furniture, appliances and interior decoration)

HI100_02

1, 2

Car, motorcycle, caravan, van, bike or other means of transport

HI100_03

1, 2

Holidays

HI100_04

1, 2

Healthcare

HI100_05

1, 2

Education

HI100_06

1, 2

To cover daily living expenses

HI100_07

1, 2

Personal loan to finance own business

HI100_08

1, 2

To refinance loan

HI100_09

1, 2

Other (not listed above)

HI100_F

1

Filled

– 1

Missing

– 2

N/A (number of loans = 0)

– 7

N/A (HB010≠2020)

HI110

1-selected, 2- not selected

Source of loans (excluding mortgages on purchase of main residence)

HI110_01

1, 2

Bank or other financial institution (e.g. credit union, microcredit provider)

HI110_02

1, 2

Payday loan company or pawnbroker/cash converter

HI110_03

1, 2

Private sources (e.g. family, friends)

HI110_04

1, 2

Other

HI110_F

1

Filled

– 1

Missing

– 2

N/A (number of loans = 0)

– 7

N/A (HB010≠2020)

HI120

 

Amount due last month on loans (excluding mortgages on purchase of main residence)

0-99999999 (amount)

HI120_F

1

Filled

– 1

Missing

– 2

N/A (number of loans = 0)

– 7

N/A (HB010≠2020)

Consumption

HC010

 

Food at home

0-999999 (amount)

HC010_F

1

Filled

– 1

Missing

– 7

N/A(HB010≠2020)

HC020

 

Food or drink outside home

0-999999 (amount)

HC020_F

1

Filled

– 1

Missing

– 2

N/A (no food outside home)

– 7

N/A(HB010≠2020)

HC030

 

Public transport

0-999999 (amount)

HC030_F

1

Filled

– 1

Missing

– 2

N/A (no public transport used)

– 7

N/A(HB010≠2020)

HC040

 

Private transport

1-999999 (amount)

HC040_F

1

Filled

– 1

Missing

– 2

N/A (no private transport used)

– 7

N/A(HB010≠2020)

HC050

 

Savings (in a typical month)

1

Household puts money aside

2

Household needs to draw on savings

3

Household needs to borrow money

4

Household neither puts money aside nor needs to draw on savings or borrow

HC050_F

1

Filled

– 1

Missing

– 7

N/A(HB010≠2020)

Wealth

HV010

 

Value of main residence

1-99999999999 (amount)

HV010_F

1

Filled

– 1

Missing

– 2

N/A (not an owner)

– 7

N/A (HB010≠2020)

HV070

 

Total left to repay for the mortgage on main residence (OPTIONAL)

1-99999999999 (amount)

HV070_F

1

Filled

– 1

Missing

– 2

N/A (no mortgage)

– 7

N/A (HB010≠2020)

HV020

 

Possession of real estate other than main residence

1

Yes

2

No

HV020_F

1

Filled

– 1

Missing

– 7

N/A (HB010≠2020)

HV080

 

Ability to maintain the same standard of living using savings

1

< 3 months

2

3-6 months

3

6-12 months

4

> 12 months

HV080_F

1

Filled

– 1

Missing

– 7

N/A (HB010≠2020)

Labour

PL230

 

Public/private employment sector

1

Public

2

Private

3

Mixed

PL230_F

1

Filled

– 1

Missing

– 2

N/A (PL031≠1,2)

– 3

Non-selected respondent

– 7

N/A (PB010≠2020)

PL250

 

Months with any work

0-12 Number of months

PL250_F

1

Filled

– 1

Missing

– 3

Non-selected respondent

– 7

N/A (PB010≠2020)

PL280

 

Registration of unemployment

1

Unemployed and registered for the whole period

2

Unemployed and registered for part of the period

3

Unemployed and not registered at all

PL280_F

1

Filled

– 1

Missing

– 2

N/A (PL211≠5)

– 3

Non-selected respondent

– 7

N/A (PB010≠2020)


DECISIONS

15.3.2019   

EN

Official Journal of the European Union

L 73/110


COUNCIL DECISION (CFSP) 2019/415

of 14 March 2019

amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 17 March 2014, the Council adopted Decision 2014/145/CFSP (1).

(2)

On 12 September 2018, the Council adopted Decision (CFSP) 2018/1237 (2), thereby renewing the measures provided for in Decision 2014/145/CFSP for a further six months.

(3)

In view of the continuing undermining or threatening of the territorial integrity, sovereignty and independence of Ukraine, Decision 2014/145/CFSP should be renewed for a further six months.

(4)

The Council has reviewed the individual designations set out in the Annex to Decision 2014/145/CFSP and decided to amend the information concerning certain individuals and entities.

(5)

The entry for one deceased person should be deleted from the list of designated persons and entities.

(6)

Decision 2014/145/CFSP should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Article 6 of Decision 2014/145/CFSP, the second paragraph is replaced by the following:

‘This Decision shall apply until 15 September 2019.’.

Article 2

The Annex to Decision 2014/145/CFSP is amended as set out in the Annex to this Decision.

Article 3

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 14 March 2019.

For the Council

The President

G. CIAMBA


(1)  Council Decision 2014/145/CFSP of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (OJ L 78, 17.3.2014, p. 16).

(2)  Council Decision (CFSP) 2018/1237 of 12 September 2018 amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (OJ L 231, 14.9.2018, p. 27).


ANNEX

The Annex to Decision 2014/145/CFSP is amended as follows:

(1)

the entry concerning the following person is deleted:

96.

Alexander Vladimirovich ZAKHARCHENKO;

(2)

the entries concerning the persons and entities listed below are replaced by the following entries:

Persons

 

Name

Identifying information

Reasons

Date of listing

‘19.

Aleksandr Viktorovich VITKO

(Александр Викторович ВИТКО)

DOB: 13.9.1961

POB: Vitebsk (Belarusian SSR)

Former Commander of the Black Sea Fleet, Admiral. Deputy Commander in Chief of the Russian Navy.

Responsible for commanding Russian forces that have occupied Ukrainian sovereign territory.

17.3.2014

22.

Dmitry Olegovich ROGOZIN

(Дмитрий Олегович РОГОЗИН)

DOB: 21.12.1963

POB: Moscow

Former Deputy Prime Minister of the Russian Federation. Publicly called for the annexation of Crimea.

Since 2018 holds the position of General Director in a State corporation.

21.3.2014

31.

Valery Kirillovich MEDVEDEV

(Валерий Кириллович МЕДВЕДЕВ)

Valeriy Kyrylovych MEDVEDIEV

(Валерiй Кирилович МЕДВЕДЄВ)

DOB: 21.8.1946

POB: Shmakovka, Primorsky region

Former Chair of Sevastopol Electoral Commission (until 26 May 2017). Responsible for administering the Crimean referendum. Responsible under the Russian system for signing referendum results.

Remains active in supporting separatist actions or policies.

21.3.2014

35.

Oleg Yevgenyvich BELAVENTSEV

(Олег Евгеньевич БЕЛАВЕНЦЕВ)

DOB: 15.9.1949

POB: Moscow

Former Plenipotentiary Representative of the President of the Russian Federation into the so-called “Crimean Federal District”, responsible for the implementation of the constitutional prerogatives of the Russian Head of State on the territory of the annexed Autonomous Republic of Crimea. Former non-permanent member of the Russian Security Council.

Former Plenipotentiary Representative of the President of the Russian Federation into the North Caucasus Federal District (until June 2018).

Remains active in supporting separatist actions or policies.

29.4.2014

36.

Oleg Genrikhovich SAVELYEV

(Олег Генрихович САВЕЛЬЕВ)

DOB: 27.10.1965

POB: Leningrad

Former Minister for Crimean Affairs. Responsible for the integration of the annexed Autonomous Republic of Crimea into the Russian Federation.

Former Deputy Chief of Staff of the Russian Government, responsible for the organisation of the work of the Governmental Commission on the socioeconomic development of the so-called “Republic of Crimea”.

Chief of Staff of the Audit Chamber of the Russian Federation.

29.4.2014

46.

Denys Volodymyrovych PUSHYLIN (Денис Володимирович ПУШИЛIН)

Denis Vladimirovich PUSHILIN (Денис Владимирович ПУШИЛИН)

DOB: 9.5.1981 or 9.5.1982

POB: Makiivka (Donetsk oblast)

One of the leaders of the “Donetsk People's Republic”. Participated in the seizure and occupation of the regional administration in Donetsk in 2014. Until 4 September 2015 so-called Deputy Chairman of the “People's Council” of the so-called “Donetsk People's Republic”. Since 4 September 2015“Chairman” of the “People's Council of the Donetsk People's Republic”. So-called “acting Head of the Donetsk People's Republic” after 7 September 2018. So-called “Head of the Donetsk People's Republic” following the so-called elections of 11 November 2018.

29.4.2014

55.

Igor Nikolaevich BEZLER (a.k.a. Bes (devil))

(Игорь Николаевич БЕЗЛЕР)

Ihor Mykolayovych BEZLER

(Iгор Миколайович БЕЗЛЕР)

DOB: 30.12.1965

POB: Simferopol, Crimea

One of the former leaders of the self-proclaimed militia of Horlivka. He took control of the Security Service of Ukraine's Office in Donetsk region building and afterwards seized the Ministry of Internal Affairs' district station in the town of Horlivka. He has links to Igor Strelkov/Girkin under whose command he was involved in the murder of the Peoples' Deputy of the Horlivka's Municipal Council Volodymyr Rybak.

Remains active in supporting separatist actions or policies.

12.5.2014

83.

Ekaterina Yurievna GUBAREVA

(Екатерина Юрьевна ГУБАРЕВА)

Kateryna Yuriyivna GUBARIEVA (HUBARIEVA)

(Катерина Юрiївна ГУБАРЄВА)

DOB: 5.7.1983 or 10.3.1983

POB: Kakhovka (Kherson oblast)

In her capacity of former so-called “Minister of Foreign Affairs” she was responsible for defending the so-called “Donetsk People's Republic”, thus undermining the territorial integrity, sovereignty and independence of Ukraine. In taking on and acting in this capacity she has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine. Remains active in supporting separatist actions and policies.

Former Member of the so-called “People's Council” of the “Donetsk People's Republic” (until November 2018).

25.7.2014

89.

Oksana TCHIGRINA

Oksana Aleksandrovna CHIGRINA (CHYHRYNA)

(Оксана Александровна ЧИГРИНА)

DOB: possibly 23.7.1981

Former spokesperson of the so-called “government” of the so-called “Lugansk People's Republic” who made declarations justifying, inter alia, the shooting down of a Ukrainian military airplane, the taking of hostages, fighting activities by the illegal armed groups, which have as a consequence undermined the territorial integrity, sovereignty and unity of Ukraine.

Former spokesperson of the Press Service of LNR.

Remains active in supporting separatist actions or policies.

30.7.2014

91.

Sergey Vadimovich ABISOV

(Сергей Вадимович АБИСОВ)

Sergiy (Serhiy) Vadymovych ABISOV

(Сергiй Вадимович АБIСОВ)

DOB 27.11.1967

POB: Simferopol, Crimea

By accepting his appointment as so-called “Minister of Interior of the Republic of Crimea” by the President of Russia (decree No 301) on 5 May 2014 and by his actions as so-called “Minister of Interior” he has undermined the territorial integrity, sovereignty and unity of Ukraine.

Dismissed as so-called “Minister of Interior of the Republic of Crimea” in June 2018.

30.7.2014

97.

Vladimir Petrovich KONONOV (a.k.a. “Tsar”)

(Владимир Петровнч КОНОНОВ)

Volodymyr Petrovych KONONOV

(Володимир Петрович КОНОНОВ)

DOB: 14.10.1974

POB: Gorsky, Luhansk Oblast

As of 14 August 2014, he replaced Igor Strelkov/Girkin, as the so-called “Defence minister” of the “Donetsk People's Republic”. He has reportedly commanded a division of separatist fighters in Donetsk since April 2014 and has promised to solve the strategic task of repelling Ukraine's military aggression. Kononov has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine.

Dismissed as so-called “Defence minister” in September 2018.

12.9.2014

102.

Andrei Nikolaevich RODKIN

(Андрей Николаевич РОДКИН)

DOB: 23.9.1976

POB: Moscow

Former Moscow Representative of the so-called “Donetsk People's Republic”. In his statements he has, inter alia, talked about the militias' readiness to conduct a guerrilla war and their seizure of weapon systems from the Ukrainian armed forces. He has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine.

One of the former leaders of the “Union of Donbas Volunteers”.

Remains active in supporting separatist actions or policies.

12.9.2014

103.

Aleksandr Akimovich KARAMAN

(Александр Акимович КАРАМАН)

Alexandru CARAMAN

DOB: 26.7.1956

POB Cioburciu, Slobozia district, now Republic of Moldova

Former so-called “Deputy Prime Minister for Social Issues” of the “Donetsk People's Republic”. Associated with Vladimir Antyufeyev, who was responsible for the separatist “governmental” activities of the so-called “Government of the Donetsk People's Republic”. He has therefore supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine. Protégé of Russia's former Deputy Prime Minister Dmitry Rogozin. Former Head of the Administration of the Council of Ministers of the “Donetsk People's Republic”.

Until March 2017, so-called “Plenipotentiary representative of the President” of the so-called “Pridnestrovian Moldavian Republic” to the Russian Federation.

Remains active in supporting separatist actions or policies.

12.9.2014

120.

Sergey Yurievich KOZYAKOV

(Сергей Юрьевич КОЗЬЯКОВ)

Serhiy Yuriyovych KOZYAKOV

(Сергiй Юрiйович КОЗЬЯКОВ)

DOB: 29.9.1982 or 23.9.1982

In his former capacity as so-called “Head of the Luhansk Central Election Commission” he was responsible for organising the so-called “elections” of 2 November 2014 in the “Luhansk People's Republic”. These “elections” were in breach of Ukrainian law and therefore illegal. Between October 2015 and December 2017 so-called “Minister of Justice” of the “Luhansk People's Republic”.

In taking on and acting in these capacities, and in organising the illegal “elections”, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Continues to support and legitimise separatist policies in cooperation with separatist authorities.

29.11.2014

122.

Larisa Leonidovna AIRAPETYAN (a.k.a. Larysa AYRAPETYAN, Larisa AIRAPETYAN or Larysa AIRAPETYAN)

(Лариса Леонидовна АЙРАПЕТЯН)

(Лариса Леонiдiвна АЙРАПЕТЯН)

DOB: 21.2.1970

Former so-called “Health Minister” of the so-called “Lugansk People's Republic”. Stood as a candidate in the so-called “elections” of 2 November 2014 to the post of the “Head” of the so-called “Lugansk People's Republic”.

These “elections” are in breach of Ukrainian law and therefore illegal.

In taking on and acting in this capacity, and in participating formally as a candidate in the illegal “elections”, she has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Remains active in supporting separatist actions or policies.

29.11.2014

129.

Yevgeniy Eduardovich MIKHAYLOV (a.k.a. Yevhen Eduardovych MYCHAYLOV)

(Евгений Эдуардович МИХАЙЛОВ)

(Євген Едуардович МИХАЙЛОВ)

DOB: 17.3.1963

POB: Arkhangelsk

Former so-called “Minister of the Council of Ministers” (head of the administration for governmental affairs) of the “Donetsk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Remains active in supporting separatist actions or policies.

29.11.2014

132.

Vladyslav Mykolayovych DEYNEGO (a.k.a. Vladislav Nikolayevich DEYNEGO)

(Владислав Миколайович ДЕЙНЕГО)

(Владислав Николаевич ДЕЙНЕГО)

DOB: 12.3.1964

POB: Romny, Sumy oblast

Ромны, Сумская область

Former “Deputy Head” of the “People's Council” of the so-called “Lugansk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Currently so-called “acting Minister of Foreign Affairs” of the so-called “Lugansk People's Republic”.

29.11.2014

138.

Alexandr Vasilievich SHUBIN

(Александр Васильевич ШУБИН)

DOB: 20.5.1972 or 30.5.1972

POB: Luhansk

Former so-called “Minister of Justice”, of the illegal so-called “Luhansk People's Republic”. Former chairman of the “Central Election Commission” of the so-called “Luhansk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Dismissed as chairman of the “Central Election Commission” of the so-called “Luhansk People's Republic” in June 2018.

16.2.2015

142.

Aleksandr Yurievich TIMOFEEV

(Александр Юрьевич ТИМОФЕЕВ)

Oleksandr Yuriyovych TYMOFEYEV

(Олександр Юрiйович ТИМОФЕЄВ)

DOB: 15.5.1971

POB: Nevinnomyssk, Stavropol Krai

Невинномысск, Ставропольский край

Former so-called “Minister of Finance and Taxes” of the “Donetsk People's Republic”.

In taking on and acting in this capacity, he has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and further destabilised Ukraine.

Dismissed as so-called “Minister of Finance and Taxes” in September 2018.

16.2.2015

149.

Andrei Valeryevich KARTAPOLOV

(Андрей Валерьевич КАРТAПOЛOВ)

DOB: 9.11.1963

POB: GDR (DDR)

Former Commander of the Western Military District. Former Director of the Main Operations Department and deputy chief of the General Staff of the Armed Forces of the Russian Federation. Actively involved in shaping and implementing the military campaign of the Russian forces in Ukraine.

According to the stated activities of the general staff, by exercising operational control over the armed forces, he was actively involved in shaping and implementing the Russian government policy threatening the territorial integrity, sovereignty and independence of Ukraine.

Deputy Minister of Defence since July 2018.

16.2.2015’

Entities

 

Name

Identifying information

Reasons

Date of listing

‘4.

So-called “Donetsk People's Republic”

“Донецкая народная республика”

“Donétskaya naródnaya respúblika”

Official information:

https://dnr-online.ru/

http://smdnr.ru/

https://dnrsovet.su/

https://denis-pushilin.ru/

The so-called “Donetsk People's Republic” was declared on 7 April 2014.

Responsible for organizing the illegal referendum on 11 May 2014. Declaration of independence on 12 May 2014.

On 24 May 2014, the so-called “People's Republics” of Donetsk and Lugansk signed an agreement on the creation of the so-called “Federal State of Novorossiya”.

This is in breach of Ukrainian constitutional law, and, as a consequence, of international law, thus undermining the territorial integrity, sovereignty and independence of Ukraine.

It is also involved in the recruitment to illegal armed separatist groups, thus threatening the stability or security of Ukraine.

25.7.2014

5.

So-called “Federal State of Novorossiya”

“Федеративное государство Новороссия”

“Federativnoye Gosudarstvo Novorossiya”

Official press releases:

http://novopressa.ru/

http://novorossia-tv.ru/

http://novorossia.today/

http://novorossiia.ru/

https://www.novorosinform.org/

On 24 May 2014, the so-called “People's Republics” of Donetsk and Lugansk signed an agreement on the creation of the unrecognised so-called “Federal State of Novorossiya”.

This is in breach of Ukrainian constitutional law, and, as a consequence, of international law, thus threatening the territorial integrity, sovereignty and independence of Ukraine.

25.7.2014

24.

Donetsk Republic (Public organisation)

Донецкая республика

Official information:

http://oddr.info/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Donetsk People's Republic” on 2 November 2014 and 11 November 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine. Founded by Andriy PURGIN and was headed by Alexander ZAKHARCHENKO. Nominated in 2018 Denis PUSHYLIN to be “Head” of the so-called “Donetsk People's Republic”.

29.11.2014

25.

Peace to Luhansk Region (Mir Luganschine)

Мир Луганщине

https://mir-lug.info/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Luhansk People's Republic”2 November 2014 and 11 November 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014

26.

Free Donbass (a.k.a. “Free Donbas”, “Svobodny Donbass”)

Свободньιй Донбасс

http://www.odsd.ru/

Public “organisation” that presented candidates in the so-called “elections” of the so-called “Donetsk People's Republic”2 November 2014 and 11 November 2018. These elections are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014

28.

Luhansk Economic Union (Luganskiy Ekonomicheskiy Soyuz)

Луганский экономический союз

Official information:

https://nslnr.su/about/obshchestvennye-organizatsii/337/

https://vk.com/public97306393

“Social organisation” that presented candidates in the illegal so-called “elections” of the so-called “Luhansk People's Republic”2 November 2014 and 11 November 2018. Nominated a candidate, Oleg AKIMOV, to be “Head” of the so-called “Luhansk People's Republic” in 2014 and member of the so-called “People's Council of the Luhansk People's Republic” in 2018. These “elections” are in breach of Ukrainian law and therefore illegal.

In participating formally in the illegal “elections” it has therefore actively supported actions and policies which undermine the territorial integrity, sovereignty and independence of Ukraine, and to further destabilise Ukraine.

29.11.2014’


15.3.2019   

EN

Official Journal of the European Union

L 73/117


COUNCIL DECISION (CFSP) 2019/416

of 14 March 2019

amending Decision 2014/145/CFSP concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)

On 17 March 2014, the Council adopted Decision 2014/145/CFSP (1).

(2)

In view of the use of force by the Russian Federation that led to the detention of Ukrainian servicemen and the seizure of vessels on 25 November 2018 in the Kerch Strait, which constituted a violation of international law as well as of the sovereignty and territorial integrity of Ukraine, the Council considers that eight persons should be added to the list of persons, entities and bodies subject to restrictive measures as set out in the Annex to Decision 2014/145/CFSP.

(3)

The Annex to Decision 2014/145/CFSP should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The persons listed in the Annex to this Decision shall be added to the list set out in the Annex to Decision 2014/145/CFSP.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 14 March 2019.

For the Council

The President

G. CIAMBA


(1)  Council Decision 2014/145/CFSP of 17 March 2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine (OJ L 78, 17.3.2014, p. 16).


ANNEX

The following persons are added to the list of persons set out in the Annex to Decision 2014/145/CFSP:

 

Name

Identifying information

Reasons

Date of listing

‘176.

Sergey Nikolayevich STANKEVICH

(Сергей Николаевич СТАНКЕВИЧ)

Gender: male;

DOB: 27.1.1963

Head of Border Directorate of the Federal Security Service of the Russian Federation for “Republic of Crimea and City of Sevastopol”, Rear Admiral. In this capacity, he was responsible for actions of the coast guard naval fleet of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

177.

Andrey Borisovich SHEIN

(Андрей Борисович ШЕИН)

Gender: male;

DOB: 10.6.1971

Deputy Head of Border Directorate — Head of Coast Guard Unit of the Federal Security Service of the Russian Federation for “Republic of Crimea and City of Sevastopol”. In this capacity, he participated in operations against Ukrainian ships and their crew during the actions of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

178.

Aleksey Mikhailovich SALYAEV

Aleksey Mikhailovich SALYAYEV

Oleksii Mykhailovych SALIAIEV

(Алексей Михайлович САЛЯЕВ, Олексій Михайлович САЛЯЄВ)

Gender: male;

DOB: 22.8.1978

Commanding officer of the border patrol boat “Don” (side markings 353) of the Border Guard Service of the Federal Security Service of the Russian Federation. He was in command of the vessel that actively participated in actions of the Russian Federation against Ukrainian vessels and their crew on 25 November 2018, and conducted ramming of the estuary tug, “Yany Kapu”, of the Ukrainian Navy. Those actions prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

179.

Andrei SHIPITSIN / SHYPITSIN

(Андрей ШИПИЦИН / ШИПІЦИН)

Gender: male;

DOB: 25.12.1969

Commanding officer of the border patrol boat “Izumrud” of the Border Guard Service of the Federal Security Service of the Russian Federation. He was in command of the vessel that actively participated in actions of the Russian Federation against Ukrainian vessels and their crew on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

180.

Aleksey Vladimirovich SHATOKHIN / Oleksii Volodymyrovich SHATOKHIN

(Алексей Владимирович ШАТОХИН / Олексій Володимирович ШАТОХІН)

Gender: male;

DOB: 26.1.1971

Head of the Service of the Kerch Control Point for the “Republic of Crimea and City of Sevastopol” of the Federal Security Service of the Russian Federation. He participated in operations against Ukrainian vessels during the actions of the Russian Federation against Ukrainian vessels and their crews on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

181.

Ruslan Alexandrovich ROMASHKІN

(Руслан Александрович РОМАШКИН)

Gender: male;

DOB: 15.6.1976

Head of the Service of the Control Point in the “Republic of Crimea and City of Sevastopol” of the Federal Security Service of the Russian Federation. In this role, he was responsible for coordinating the actions of Russian Federation forces against Ukrainian vessels and their crews on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

182.

Sergey Alekseevich SHCHERBAKOV

(Сергей Алексеевич ЩЕРБАКОВ; Сергій Олексійович ЩЕРБАКОВ)

Gender: male;

DOB: 2.11.1986

Commanding officer of the anti-submarine ship “Suzdalets” of the Black Sea Fleet of the Russian Federation. He commanded the ship which participated in the actions of the Russian Federation against Ukrainian ships and their crews on 25 November 2018, and actively participated in the blockade of tugboat “Yani Kapu” and seizure of the armed gunboat “Nikopol”. Those actions prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019

183.

Aleksandr Vladimirovich DVORNIKOV

(Александр Владимирович ДВОРНИКОВ)

Gender: male;

DOB: 22.8.1961

POB: Ussuriysk, Primorskiy Krai, Russian Federation

Commander of the Southern Military District of the Russian Armed Forces, Colonel-General and responsible for military forces in the region, including illegally annexed Crimea and Sevastopol. In this role he was responsible for the actions of the Black Sea Fleet and other military forces of the Russian Federation against Ukraine on 25 November 2018 which prevented access by Ukrainian vessels to their coast on the Sea of Azov, thereby undermining the territorial integrity and sovereignty of Ukraine and undermining the security of Ukraine through the disruption of the movements and operability of Ukrainian naval vessels.

Those actions also supported the consolidation of the illegal annexation of the Crimean peninsula into the Russian Federation.

15.3.2019’


15.3.2019   

EN

Official Journal of the European Union

L 73/121


COMMISSION IMPLEMENTING DECISION (EU) 2019/417

of 8 November 2018

laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system

(notified under document C(2018) 7334)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular the third subparagraph of Article 11(1) and point 8 of Annex II thereof,

Having regard to Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, setting out the requirements for accreditation and market surveillance on the marketing of products and repealing Regulation (EEC) No 339/93 (2),

After consulting the Advisory Committee, set up by Article 15 of Directive 2001/95/EC,

Whereas:

(1)

Article 12 of Directive 2001/95/EC establishes a European Union Rapid Information System (‘RAPEX’) for the rapid exchange of information between the Member States and the Commission on measures and action taken on products posing a serious risk to the health and safety of consumers.

(2)

Point 8 of Annex II to Directive 2001/95/EC requires the guidelines to be regularly updated in the light of new developments and experience. Commission Decision 2010/15/EU (3) was the first and only update of the guidelines.

(3)

In view of new developments and in order to ensure more efficient and effective notification procedures in line with best practice, a further update of the guidelines is required.

(4)

Terminology and references have become obsolete as has the means of communication between the Commission and the Member States authorities and between the authorities themselves.

(5)

New tools that have been developed over the last years for the proper functioning of RAPEX (wiki's, interface between RAPEX and other market surveillance systems) have to be taken into consideration in the guidelines.

(6)

Criteria for the RAPEX notification, following the new developments, have become unclear and need to be clarified.

(7)

Cross-border online sales of goods have increased. This development needs to be reflected in the notification techniques as well as in the follow-up instruments to be used.

(8)

Regulation (EC) No 765/2008 extends the application of RAPEX provided for in Article 12 of Directive 2001/95/EC also to products covered by that legislation. Extending the application of RAPEX raises some issues that need to be clarified in the guidelines.

(9)

Regulation (EC) No 765/2008 applies to consumer products and to professional products such as some medical devices. That Regulation covers a broader scope of risks, other than those related to the health and safety of consumers, such as security and environmental risks. Therefore, a risk can concern not only consumers but also an indeterminate group of people referred to as ‘end-users’.

(10)

Article 22 of Regulation (EC) No 765/2008 provides therefore that measures taken against products presenting a serious risk to health and safety or other relevant public interests should be notified via RAPEX.

(11)

Directive 2001/95/EC and Regulation (EC) No 765/2008 are complementary and provide a system to improve the safety of non-food products.

(12)

RAPEX helps to prevent and restrict the supply of products posing a serious risk to health and safety or, in the case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests. It enables the Commission to monitor the effectiveness and consistency of market surveillance and enforcement activities in the Member States.

(13)

RAPEX provides a basis for identifying the need for action at EU level and makes for consistent enforcement of EU product safety requirements and therefore contributes to the smooth functioning of the single market.

(14)

The notification procedure established under Article 11 of Directive 2001/95/EC provides for an exchange of information between the Member States and the Commission on measures adopted on products posing a less than serious risk to the health and safety of consumers. It helps to ensure a consistent, high level of consumer health and to preserve the single market.

(15)

Article 23 of Regulation (EC) No 765/2008 provides for an information support system where Member States make available to the Commission the information required by the same Article on products presenting a less than serious risk.

(16)

According to the applicable legislation, Member States are not obliged to provide such information in the RAPEX system.

(17)

Article 16 of the GPSD provides an obligation for Member States and the Commission to make available to the public information relating to risks to consumer health and safety posed by products.

(18)

To ensure a coherent system of information for products posing a risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests, it would be desirable that available information concerning dangerous products covered by Article 23 of Regulation (EC) No 765/2008 could also be made available in the RAPEX system.

(19)

In order to enable the functioning of the RAPEX system, guidelines should be drawn up on the various aspects of these notification procedures and, in particular, to establish the content of notifications. These should include the information to be contained in the notification, criteria for notifications involving risks that do not or cannot go beyond the territory of the Member State and criteria for the classification of notifications according to the degree of urgency. The guidelines should also lay down operating arrangements, including deadlines for the various steps of the notification and follow-up notification procedures as well as confidentiality rules.

(20)

To ensure that notification procedures are properly applied, the guidelines should also set out risk assessment methods with criteria for identifying risks taking into consideration also the management of risks.

(21)

In the light of point 2 in Annex II to Directive 2001/95/EC, the new guidelines include a set of risk assessment guidelines for consumer products and refer also to professional products, which specify the criteria for identifying serious risks.

(22)

The guidelines should be addressed to all Member States authorities participating in the RAPEX network pursuant to Directive 2001/95/EC and Regulation EC No 765/2008, including market surveillance authorities responsible for monitoring the compliance of products with safety requirements and authorities in charge of external border controls,

HAS ADOPTED THIS DECISION:

Article 1

The guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC and its notification system are set out in the Annex to this Decision.

Article 2

Decision 2010/15/EU is repealed.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 8 November 2018.

For the Commission

Věra JOUROVÁ

Member of the Commission


(1)  OJ L 11, 15.1.2002, p. 4.

(2)  OJ L 218, 13.8.2008, p. 30.

(3)  Commission Decision 2010/15/EU of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (OJ L 22, 26.1.2010, p. 1).


ANNEX

GUIDELINES FOR THE MANAGEMENT OF THE EUROPEAN UNION RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF DIRECTIVE 2001/95/EC (THE GENERAL PRODUCT SAFETY DIRECTIVE) AND ITS NOTIFICATION SYSTEM

PART I

SCOPE AND ADDRESSEES OF THE GUIDELINES

1.    Scope, objectives and update

1.1.   Scope

The ‘Guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety’ (the ‘Guidelines’) are adopted by the Commission (1) under Article 11(1) and Annex II, point 8, of Directive 2001/95/EC (the ‘GPSD’). The Commission is assisted by an advisory committee composed of the representatives from EU Member States and established under Article 15(3) of the GPSD.

Point 8 of Annex II to the GPSD states that: ‘The Commission shall prepare and regularly update, in accordance with the procedure laid down in Article 15(3), guidelines concerning the management of RAPEX by the Commission and Member States.’.

Article 11 of the GPSD prescribes that Member States should inform the Commission of measures taken which restrict the placing on the market of products — or require their withdrawal or recall — to the extent that such information is not eligible for the type of notification Article 12 of the GPSD provides for, nor does it qualify for any other notification under any specific Community legislation.

Article 22 of Regulation (EC) No 765/2008, provides that, where a Member State takes or intends to take a measure that prevents, restricts or imposes specific conditions on the marketing and use of products posing a serious risk to the health, safety and other relevant public interests of the end-users, it must immediately notify such a measure to the Commission using RAPEX.

Article 23 of Regulation (EC) No 765/2008 provides that Member States must make available to the Commission the information at their disposal, and not already provided under Article 22, on products presenting a (less than serious) risk.

Article 16 of the GPSD provides an obligation for Member States and the Commission to make available to the public information relating to risks to consumer health and safety posed by products. It would therefore be opportune that all information on measures adopted against products posing a risk, insofar as product safety is at stake, are contained in the system intended for this purpose. Member States are therefore encouraged to provide RAPEX with the measures adopted against products posing a risk and entering into the scope of application of the GPSD or Regulation (EC) No 765/2008. The information can be provided directly in RAPEX. In case the information has to be notified in another information system according to Regulation (EC) No 765/2008 (2), the Member State can generate a RAPEX notification from within the information system (see Part II, Chapters 1.2(h) and 2.2 of these Guidelines).

Whereas the GPSD applies only to consumer products posing a risk to the health and safety of consumers, Regulation (EC) No 765/2008 applies to consumer products but also professional products covered by EU harmonisation legislation (such as certain medical devices and marine equipment). It also covers a broader scope of risk, in addition to those related to the health and safety of consumers, such as security and environmental risks. Therefore, a risk can concern not only consumers but also, where Regulation (EC) No 765/2008 applies, other ‘end-users’.

Risk Assessment Guidelines of Appendix 6 on Part III are an integral part of the RAPEX Guidelines. They are the instruments that enable determining the level of risk of a product and therefore help to identify the measures to be adopted.

The Risk Assessment Guidelines refer to the level of risk as well as to the possible injuries caused by a single product. The risk assessment for a single product must be accompanied by sound risk management. For example, the risk level for a defective household electrical appliance posing a risk of fire may be only ‘low’, meaning that the probability of a single appliance causing a fatal fire during the lifetime of the appliance is less than one in a million. Nevertheless, if millions of the defective appliances have been placed on the market, it is almost inevitable that fatal fires will occur if appropriate measures are not taken.

Member States (3), applicant countries, countries which are parties to the European Economic Area (EEA) Agreement as well as other non-EU countries and international organisations that are granted access to RAPEX (on the conditions defined in Article 12(4) of the GPSD), participate in the system according to the rules provided for in the GPSD and these Guidelines (4).

1.2.   Objectives

The objectives of these Guidelines are to:

(a)

streamline the processes for the notification mechanisms;

(b)

set out the notification criteria for the notification mechanisms;

(c)

define the content of notifications and follow-up notifications sent under the notification mechanism, in particular what data are required and which forms are to be used;

(d)

establish follow-up activities to be taken by Member States upon receipt of a notification and the type of information to be provided;

(e)

describe the handling of notifications and follow-up notifications by the Commission;

(f)

set deadlines for the various types of action taken under the notification mechanisms;

(g)

set out the practical and technical arrangements needed at Commission and Member State level for the notification mechanisms to be employed effectively and efficiently; and

(h)

establish risk assessment methods and, in particular, criteria for identifying serious risks.

1.3.   Update

The Guidelines will be regularly updated by the Commission in accordance with the advisory procedure on the basis of experience and new developments in the product safety area.

2.    Addressees of the Guidelines

The Guidelines are addressed to all Member States authorities acting on product safety and participating in the RAPEX network, including market surveillance authorities responsible for monitoring the compliance of products with safety requirements and authorities in charge of external border controls.

3.    Products

3.1.   Products covered by these Guidelines

These Guidelines cover two sets of products: the products covered by the GPSD and the products covered by Regulation (EC) No 765/2008.

3.1.1.   Products covered by the GPSD

Under Article 2(a) of the GPSD, consumer products for the purpose of these Guidelines are:

(a)   ‘products intended for consumers’— products that are designed and manufactured for and made available to consumers;

(b)   ‘migrating products’ (5) — products that are designed and manufactured for professionals, which are likely, however, under reasonably foreseeable conditions, to be used by consumers. These are products manufactured for professionals that are made available to consumers, who can purchase and operate them without any special knowledge or training, e.g. a power drill, an angle grinder and a table saw designed and manufactured for professionals, but also supplied on the consumer market (i.e. consumers can readily purchase them in shops and operate them on their own without any special training).

Both products intended for consumers and migrating products can be given to consumers free of charge, can be purchased by consumers and can be provided to consumers in the context of a service. All three situations are covered by RAPEX.

According to Article 2 (a) of the GPSD, products provided to consumers in the context of a service are to be considered as including:

(a)

products supplied to consumers that are taken away and used outside the premises of a service provider, such as cars and lawn-mowing machines rented or leased in rental shops, and tattoo inks and implants (that are not classified as medical devices) implanted beneath the skin of a consumer by a service provider;

(b)

products used on the premises of a service provider, provided that consumers themselves actively operate a product (e.g. start the machine, have the option of stopping it, and affect its operation by changing its position or intensity during use). Sun-beds used in tanning salons and fitness centres are examples of such products. Use of the products by consumers must be active, and involve a significant degree of control. Merely passive use, such as the use of a shampoo by a person whose hair is washed by a hairdresser, or the use of a bus by its passengers, does not qualify as use by consumers.

3.1.2.   Products covered by Regulation (EC) No 765/2008

Under Regulation (EC) No 765/2008, products for the purpose of RAPEX are to be considered the products according to the scope and definitions contained in Article 15 of the same Regulation whether intended for consumers or for professional users.

3.2.   Products not covered by these Guidelines

These Guidelines do not cover:

(a)

Products that are covered by specific and equivalent notification mechanisms established by other EU legislation, notably:

(i)

food and feed and other products covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council (6);

(ii)

medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council (7), and Directive 2001/82/EC of the European Parliament and of the Council (8);

(iii)

medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council (9);

(iv)

active implantable medical devices covered by Council Directive 90/385/EEC (10).

(b)

Products that are not covered by the definition of a ‘product’ as laid down in Article 2(a) of the GPSD, notably:

(i)

second-hand products or products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect (Article 2(a) of the GPSD);

(ii)

equipment used or operated by a professional service provider to supply a service, e.g. equipment on which consumers ride or travel and equipment which is operated by a service provider and not by the consumer (recital 9 of the GPSD);

(c)

Products which do not enter into the definition of product contained in Article 15(4) of Regulation (EC) No 765/2008.

4.    Measures

4.1.   Types of measures

Preventive and restrictive measures can be taken in relation to products posing a risk either on the initiative of the economic operator who placed and/or distributed it on the market (‘voluntary measures’), or as ordered by an authority of a Member State competent to monitor the compliance of products with the safety requirements (‘compulsory measures’).

For the purpose of these Guidelines, the compulsory measures and voluntary measures are defined as follows:

(a)   Compulsory measures: measures adopted or decided to be adopted by Member State authorities, often in the form of an administrative decision, which oblige an economic operator to take preventive, corrective or restrictive action in relation to a specific product that they made available on the market.

(b)   Voluntary measures:

(i)

preventive and restrictive measures adopted on a voluntary basis by an economic operator, i.e. without any intervention of an authority of a Member State;

(ii)

recommendations and agreements with economic operators in their respective activities concluded by Member State authorities; this includes agreements which are not in written form and result in preventive or restrictive action taken by economic operators in their respective activities in relation to products posing a serious risk that they made available on the market.

4.2.   Categories of measures

Article 8(1)(b) to (f) of the GPSD provides a list of the different categories of measures that are notifiable under RAPEX when the conditions for notification are fulfilled, including the following measures:

(a)

marking a product with appropriate warnings on the risk(s) it may present;

(b)

making the marketing of a product subject to prior conditions;

(c)

warning consumers and end-users of the risks that could be posed by a product;

(d)

temporary ban on the supply, offer to supply and display of a product;

(e)

ban on the marketing of a product and any accompanying measures, i.e. measures required to ensure compliance with the ban;

(f)

withdrawal of a product from the market;

(g)

recall of a product from consumers;

(h)

destruction of a withdrawn or recalled product.

For the purpose of RAPEX, the term ‘withdrawal’ is used exclusively for measures aimed at preventing the distribution, display and offer of a product posing a risk to consumers or other end-users, while the term ‘recall’ is used only for measures aimed at achieving the return of such a product that has already been made available to consumers or other end-users by a producer or distributor.

4.3.   Requirements of the measures

Under Article 12(1) of the GPSD and Article 22 of Regulation (EC) No 765/2008 concerning serious risks, both compulsory and voluntary measures are to be notified in RAPEX.

Preventive and restrictive measures adopted on a voluntary basis by an economic operator, i.e. without any intervention of an authority of a Member State concerning a product posing a serious risk and the related preventive or restrictive measures initiated by an economic operator should be immediately notified to the competent authorities of Member States as indicated in Article 5(3) of the GPSD and in Article 22(2) and (3) of Regulation (EC) No 765/2008.

All categories of preventive and restrictive measures taken in relation to the marketing and use of consumer products posing a serious risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) No 765/2008, posing a serious risk to the health, safety or other relevant public interests of the end-users are subject to the notification obligation under RAPEX.

4.4.   Exclusion of generally applicable compulsory measures

Generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products due to the serious risk they pose to the health and safety of consumers should not be notified to the Commission through the RAPEX application. All such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose — and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. — are notified to the Commission under Directive (EU) 2015/1535 of the European Parliament and of the Council (11).

5.    Risk Levels

5.1.   Serious risk

Before an authority of a Member State decides to submit a RAPEX notification, it always performs an appropriate risk assessment (see Part III, Appendix 6 of these Guidelines or the complementary EU general risk assessment methodology for products covered by Regulation (EC) No 765/2008 (12)) in order to assess whether the product to be notified poses a serious risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) No 765/2008, a serious risk to the health, safety or to other relevant public interests (for example, security or the environment) of the end-users, and thus whether one of the RAPEX notification criteria is met.

5.2.   Less than serious risk

Notifications sent in accordance with Article 11 of the GPSD or Article 23 of Regulation (EC) No 765/2008 are generally considered as notifications for products posing a less than serious risk. Notifications of such products, contrary to notifications for products presenting a serious risk, do not necessarily involve an obligation for follow-up activities by other Member States unless the nature of the product or of the risk so requires (see Part II Chapter 3.4.6.1).

5.3.   Risk assessment method

Part III, Appendix 6 to these Guidelines sets out a risk assessment method that can be used by Member State authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary. Equally, you may need to consult the complementary EU general risk assessment methodology as referred to in Chapter 5.1 in case the product concerned is covered by Regulation (EC) No 765/2008.

A specific tool (‘RAG’ or Risk Assessment Guidelines (13)) is available on the RAPEX website and in the RAPEX application to perform risk assessments, which takes accounts of the principles provided for in Appendix 6.

5.4.   Assessing authority

The risk assessment is always performed or checked by the authority of a Member State that either carried out the investigation and took appropriate measures, or which monitored the voluntary action taken with regard to a product posing a risk by an economic operator.

Any unclear issues are resolved by the RAPEX Contact Point (see Part II, Chapter 5.1) with the authority responsible before a notification is transmitted through the RAPEX application.

6.    Cross-border effects

6.1.   International event

Under Article 12 of the GPSD and Article 22 of Regulation (EC) No 765/2008, a Member State submits a RAPEX notification only if it considers that the effects of the risk(s) posed by a product go or can go beyond its territory (‘cross-border effects’ or ‘international event’).

In the light of the free movement of products in the internal market, and the fact that products are imported into the EU through different distribution channels and that consumers buy products during stays abroad and via the internet, national authorities are encouraged to interpret the cross-border effects criterion in a fairly broad sense. An Article 12 of the GPSD or Article 22 notification of Regulation (EC) No 765/2008, therefore, is submitted where:

(a)

it cannot be excluded that a product posing a risk has been sold in more than one EU Member State; or

(b)

it cannot be excluded that a product posing a risk has been sold via the internet; or

(c)

the product originates from a third country and is likely to have been imported into the EU through multiple distribution channels.

6.2.   Local event

Measures adopted in relation to a product posing a serious risk that can only have a local effect (‘Local event’) are not notified under Article 12 of the GPSD. This applies in situations where an authority of a Member State has concrete and strong reasons to exclude the possibility that a product has been and or will be made available (by any means) in other Member States, e.g. measures taken with regard to a local product manufactured and distributed only in one Member State. In its evaluation, the authorities of the Member State have to take carefully into consideration the possibility that a product could be sold online or through new emerging distribution channels.

A notification in relation to a product posing a serious risk involving a local event only requires to be submitted to the Commission insofar as it involves information likely to be of interest to Member States from the product safety standpoint, and in particular if they are in response to a new type of risk which has not yet been notified, a new type of risk arising from a combination of products or a new type or category of products.

Such notification is to be submitted under Article 11 with reference to the second subparagraph of Article 11(1), of the GPSD.

PART II

EU RAPID INFORMATION SYSTEM ‘RAPEX’ ESTABLISHED UNDER ARTICLE 12 OF THE GENERAL PRODUCT SAFETY DIRECTIVE

1.    Introduction

1.1.   Objectives of RAPEX

Article 12 of the GPSD establishes an EU Rapid Information System (‘RAPEX’).

RAPEX plays an important role in the area of product safety. It complements other actions taken both at national and at EU level to ensure a high level of product safety in the EU.

RAPEX data helps to:

(a)

prevent and restrict the supply of dangerous products;

(b)

monitor the effectiveness and consistency of market surveillance and enforcement activities carried out by Member State authorities;

(c)

identify needs and provide a basis for action at EU level; and

(d)

make for consistent enforcement of the EU product safety requirements and therefore contribute to the smooth functioning of the single market.

1.2.   Components of RAPEX

RAPEX consists of several complementary components, which are crucial for its effective and efficient operation. The most important are:

(a)

the legal framework that regulates how the system operates (i.e. the GPSD and the Guidelines);

(b)

the online application (‘the RAPEX application’), which allows Member States and the Commission to exchange information rapidly via a web-based platform;

(c)

the RAPEX Contact Points network, which consists of the single RAPEX Contact Points responsible for operating RAPEX in all Member States (see Part II, Chapter 5.1);

(d)

the national RAPEX networks established in all Member States, which include the RAPEX Contact Point (see Part II, Chapter 5.1) and all the authorities involved in ensuring product safety;

(e)

the Commission RAPEX team in the department responsible for the GPSD, which examines and validates documents submitted through the RAPEX application, and maintains and ensures correct operation of RAPEX;

(f)

the RAPEX website (14), which provides summaries of RAPEX notifications as well as weekly updates;

(g)

RAPEX publications, such as RAPEX statistics, RAPEX annual reports and other promotional materials; and

(h)

the interface between RAPEX and ICSMS, which consists on a link between both systems that facilitates the encoding of RAPEX notifications based on investigation data already available in ICSMS. By filling in the appropriate fields in ICSMS, a RAPEX notification can be automatically submitted.

2.    Notification criteria

RAPEX applies to measures which prevent, restrict or impose specific conditions on the marketing and use of products posing a serious risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) No 765/2008, to measures which prevent, restrict or impose specific conditions on the marketing and use of products posing a serious risk to the health, safety or other relevant public interests (for example, security or the environment) of the end-users.

2.1.   Mandatory participation in RAPEX: Article 12 of the GPSD and Article 22 of Regulation (EC) No 765/2008

Under the GPSD and Regulation (EC) No 765/2008, the participation of Member States in RAPEX is mandatory. According to Article 12 of the GPSD and Article 22 of Regulation (EC) No 765/2008 Member States have a legal obligation to notify the Commission both compulsory and voluntary measures when the following four notification criteria are met:

(a)

the product falls under the scope of application of the GPSD or under the scope of application of Regulation (EC) No 765/2008;

(b)

the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’);

(c)

the product poses a serious risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end-users;

(d)

it cannot be ruled out that the effect of the serious risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end-users, goes beyond the territory of the notifying Member State.

2.2.   Non-mandatory participation in RAPEX: Article 11 of the GPSD and Article 23 of Regulation (EC) No 765/2008

According to Article 11 of the GPSD, Member States should inform the Commission of measures taken which restrict the placing on the market of products — or require their withdrawal or recall — insofar such information does not qualify for an Article 12 nor any other notification set out in any specific Community legislation.

For the sake of simplification and efficiency gains, Member States may also make use of the RAPEX application to notify measures taken against products which would not qualify for submitting an Article 12 notification in the terms outlined herein.

Where the following four notification criteria are met, Member States have a legal obligation to notify the Commission under Article 11 of the GPSD:

(a)

the product concerned is a consumer product;

(b)

it is subject to restrictive measures adopted by national authorities (compulsory measures);

(c)

it poses a less than serious risk to the health and safety of consumers and the effects of which can or do go beyond the territory of one Member State or, it poses a serious risk to the health and safety of consumers and the effect of which do not or cannot go beyond its territory yet the measures adopted involve information likely to be of interest to other Member States from a product safety standpoint (15);

(d)

The measures adopted do not have to be notified under any other notification procedure established by EU law.

Notwithstanding the fact that Article 11 of the GPSD does not contain an explicit obligation to notify voluntary measures adopted against products posing a less than serious risk, Article 16 of the GPSD requires Member States and the Commission to make information relating to risks to consumer health and safety available to the public. Therefore, for the sake of coherence in the notification system and to effectively implement the obligations both Member States and the Commission have according to Article 16 of the GPSD, Member States are recommended to notify in RAPEX also voluntary measures adopted by the producers and distributors against products posing a less than serious risk.

According to Article 23 of Regulation (EC) No 765/2008 Member States provide the Commission with information at their disposal, and not already provided under Article 22, on products presenting a (less than serious) risk. Contrary to Article 22 of this Regulation, Article 23 does not oblige Member States to submit a notification to RAPEX with this information. Article 16 of the GPSD obliges, though, the Commission and the Member States to make public the information they may have relating to risks to consumer health and safety. For the sake of coherence and to effectively implement the obligations contained in Article 16 of the GPSD, the most pragmatic solution could be for RAPEX to contain all measures adopted against products presenting serious and less than serious risks to consumer health and safety both for GPSD products and products covered by Regulation (EC) No 765/2008, and in the latter case, also to other relevant public interests of the end-users. Therefore, when measures are adopted and provided through ICSMS according to Article 23 of Regulation (EC) No 765/2008, Member States are encouraged to notify such information in RAPEX. This can be done either by submitting a separate notification in RAPEX or through ICSMS.

A link between both systems facilitates the encoding of notifications based on investigation data already available in ICSMS. (See Part II, Chapter 1.2(h)).

Image 1

Type of risk

Product covered by the GPSD

Product covered by Regulation (EC) 765/2008

Measure adopted

Cross-border effect

Unsufficient Identification Information

Information Involving new risk

NOTIFICATION TYPE

Serious risk

Article 12 of the GPSD

Article 11 of the GPSD

Article 22 of Regulation (EC) No 765/2008

Indistinctly

For information

Indistinctly

Information to ICSMS

RAPEX notification encouraged

Less than serious risk

Compulsory measures

Article 11 of the GPSD

Voluntary measures

For information

Article 23 of Regulation (EC) No 765/2008

RAPEX notification encouraged

Pending

For information (if relevant)

A notification scheme is included in Part III, Appendix 3 of these Guidelines providing further clarification on the notification criteria referred to in Part II Chapter 2 of these Guidelines.

3.    Notifications

3.1.   Types of notification

3.1.1.   Notifications

The Authorities of the Member States are required to submit a notification to the RAPEX system in the following cases:

(a)

where all the RAPEX notification criteria laid down in Article 12 of the GPSD (16) are met, a Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as an ‘Article 12 notification’.

(b)

where all the RAPEX notification criteria are met and, in addition, a product poses a life-threatening risk and/or there have been fatal accidents, and in other cases where a RAPEX notification requires emergency action by all Member States, the notifying Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as a ‘Notification requiring emergency action’.

(c)

where all RAPEX notification criteria laid down in Article 22 of Regulation (EC) No 765/2008 (17) are met, a Member State prepares and submits to the Commission a RAPEX notification classified in the RAPEX application as an ‘Article 22 notification’.

Where all notification criteria laid own in Article 11 of the GPSD (18) are met, a Member State prepares and submits to the Commission a notification, which, when notified in RAPEX is classified as an ‘Article 11 notification’.

Moreover, Member States are encouraged to submit a notification where the criteria laid down in Article 23 of Regulation (EC) No 765/2008 are met (19).

Following the abovementioned reasoning in Part II Chapter 2, Member States are encouraged to prepare and submit, either directly or indirectly, to the Commission a notification classified in RAPEX as an ‘Article 23 notification’ when the criteria laid down in the same article are met.

Before sending a notification to the Commission, the RAPEX Contact Point (see Part II, Chapter 5.1) of the notifying Member State checks that all notification criteria are met.

3.1.2.   Notifications for information

If the criteria laid down in these Guidelines for the notifications listed in Part II Chapters 2.1 and 2.2 of these Guidelines are not met, the RAPEX Contact Point (see Part II, Chapter 5.1) may choose to use the RAPEX application to send the information concerned for information purposes. Such notifications are classified in RAPEX as ‘Notifications for information’ and they may be sent in the following situations:

(a)

Where all the RAPEX notification criteria laid down in Article 12 of the GPSD or in Article 22 of Regulation (EC) No 765/2008 are met but a notification does not contain all the information (mainly on product identification and distribution channels) necessary for other Member States to ensure follow-up (20) to such a notification. A notification where the product name, brand and picture are missing and thus the notified product cannot be correctly identified and it cannot be distinguished from other products of the same category or type that are available on the market, is an example of a notification that can be distributed through the RAPEX application as ‘Notification for information’. Assessment as to whether a notification contains sufficient information for other Member States to ensure follow-up activities is always on a case-by-case basis.

(b)

Where a Member State is aware of the fact that a consumer product that is available on the EU market poses a serious risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) 765/2008, is aware of the fact that a consumer or a professional product poses a serious risk to the health and safety or other relevant public interests of the end-users, but preventive and restrictive measures have not yet been taken by the producer or distributor or adopted or decided to be adopted by an authority of a Member State. If information on such a product is distributed through the RAPEX application before measures are taken, the notifying Member State subsequently informs the Commission (as soon as possible and not later than the deadlines specified in Appendix 4 to these Guidelines) of the final decision taken with regard to the notified product (mainly, what type of preventive or restrictive measures were taken or why such measures were not taken). Where the notifying Member State takes measures at a later stage, it informs the Commission, who will update the notification in application of Article 12 of the GPSD or Article 22 of Regulation (EC) No 765/2008.

(c)

Where a Member State decides to notify preventive and restrictive measures taken in relation to a consumer product posing a serious risk to the health and safety of consumers which has only local effects (‘local event’). If, however, as explained in Part I, Chapter 6.2, a notification by ‘local event’ involves information on product safety likely to be of interest for other Member States, it should be sent as if it were a notification under Article 11 of the GPSD.

(d)

Where a notification concerns a product whose safety aspects (especially the level of risk posed to the health and safety of consumers) are subject to discussion at EU level to ensure a common approach between Member States to risk assessment and/or enforcement action (21).

(e)

Where a decision cannot be taken with certainty that one or more of the notification criteria are met, but a notification involves information on product safety likely to be of interest for other Member States.

When sending a ‘Notification for information’, the RAPEX Contact Point (see Part II, Chapter 5.1) clearly states the reasons for so doing.

3.2.   Content of notifications

3.2.1.   Scope of data

Notifications sent to the Commission through the RAPEX application include the following types of data:

(a)

Information enabling the notified product to be identified, i.e. product category, product name, brand, model and/or type number, barcode, batch or serial number, customs code, description of the product and its packaging accompanied by pictures showing the product, its packaging and labels. Detailed and accurate product identification is a key element for market surveillance and enforcement, as it allows national authorities to identify the notified product, to distinguish it from other products of the same or similar type or category that are available on the market and to find it on the market and take or agree on appropriate measures.

(b)

Information establishing the product's origin, i.e. country of origin, name, address and contact details, such as telephone number and e-mail address, of a manufacturer and exporters. In particular, Member States provide all available information on manufacturers and exporters located in third countries that cooperate closely with the EU on product safety. The following documents are also to be attached to the form where available: copies of orders, sales contracts, invoices, shipping documents, customs declarations, etc. These documents should be transmitted in pdf format or any other format accepted by the application. Detailed information on third country producers allows the Commission to promote more effective enforcement in those countries and helps to reduce the number of products posing a risk to consumers exported into the EU.

(c)

Wherever possible, information about where exactly the product has been made available (a major store, local shop or market, online, etc.).

(d)

Information on the safety requirements applicable to the notified product, including the reference number and name of the applicable legislation and standards.

(e)

A risk description of the notified product, including a description of the results of laboratory or visual tests, test reports and certificates proving non-compliance of the notified product with the safety requirements, a complete risk assessment with conclusions and information on known accidents or incidents (see Part I Chapter 3.3.1 of these Guidelines).

(f)

Information on the supply chains of the notified product in the Member States and, in particular, information on the countries of destination, plus information on importers and also, if available, on distributors of the notified product in Europe.

(g)

Information on measures taken, in particular, the type (compulsory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. national, local), and date of entry into force and duration of the measure (e.g. permanent, temporary).

(h)

Indication of whether a notification, part of it and/or attachment(s) are covered by confidentiality. Requests for confidentiality are always accompanied by a justification clearly stating the reasons for such a request.

(i)

Information on whether the product is counterfeit, when available. For this purpose, the Commission will provide Member States with any specific tools available at European level to facilitate the identification of counterfeit products.

(j)

Information on reported accidents related to the product, indicating when possible the reasons for the accident (risk related to the use made by the user or inherent to the product).

(k)

Additional information on whether the notification has been submitted in the context of a coordinated enforcement activity at European level.

(l)

Information on whether the authorities of a Member State envisage sending other notifications related to the same product or similar products. This should be indicated in the original notification.

Member States are encouraged to look for and provide information on the supply chains of the notified product in non-EU countries that cooperate closely with the EU on product safety.

3.2.2.   Completeness of data

Notifications should be as complete as possible. The elements to be contained in the notification are listed in Appendix 1 to these Guidelines and are included in the RAPEX application. All fields of the notification template should be completed with the required data. Where the required information is not available at the time a notification is submitted, this is clearly indicated and explained on the form by the notifying Member State. Once the missing information becomes available, the notifying Member State updates its notification. The updated notification is examined by the Commission before being validated and distributed through the system.

RAPEX Contact Points provide all national authorities that participate in the RAPEX network with instructions on the scope of data required to complete the notification. This helps to ensure that the information provided by these authorities to the RAPEX Contact Point is correct and complete (see Part II, Chapter 5.1).

Where part of the information required by these Guidelines is not yet available, Member States should nonetheless comply with the established deadlines and not delay sending a RAPEX notification on a product that poses a life-threatening risk to the health and safety of consumers or other end-users and/or where a RAPEX notification requires emergency action by Member States.

Before submitting a notification, the RAPEX Contact Point checks (to avoid any unnecessary duplication) that the product concerned has not already been notified through the RAPEX application by another Member State. If the product has already been notified, rather than creating a new notification, the RAPEX Contact Point submits a follow-up notification to the existing notification and provides any additional information that may be relevant for authorities in other Member States, such as additional vehicle identification numbers, a detailed list of importers and distributors, additional test reports, etc. (See also Part II, Chapter 5.1).

3.2.3.   Updating of data

The notifying Member State informs the Commission (as soon as possible and not later than by the deadlines specified in Appendix 4 to these Guidelines) of any developments that require changes to a notification transmitted through the RAPEX application. In particular, Member States inform the Commission of any changes (e.g. following a ruling by a court during an appeal procedure) to the status of the notified measures, to the risk assessment and to new decisions regarding confidentiality.

The Commission examines the information provided by the notifying Member State and updates the information concerned in the RAPEX application and on the RAPEX website, where necessary.

3.2.4.   Responsibility for the information transmitted

Responsibility for the information provided lies with the notifying Member State (22).

The notifying Member State and the national authority responsible ensure that all data provided through the RAPEX application are accurate so as to avoid any confusion with similar products of the same category or type that are available on the EU market.

The authority(ies) involved in the notification procedure (e.g. by performing the risk assessment of the notified product or by providing information on distribution channels) take responsibility for the information provided through the RAPEX application. The RAPEX Contact Point checks and validates all notifications received from the authorities responsible before transmitting them to the Commission (See also Part II, Chapter 5.1).

Any action taken by the Commission, such as examining notifications, validating and distributing them through the RAPEX application and publishing them on the RAPEX website, does not imply any assumption of responsibility for the information transmitted, which remains with the notifying Member State.

3.3.   Actors and roles involved in the notification process

The parties involved in the notification process and their responsibilities therein are the following:

3.3.1.   Economic operators

Economic operators are not directly involved in the submission of notifications in the RAPEX application.

However, in case of a product posing a risk, economic operators shall immediately inform the competent authorities in all Member States where the product was made available. The conditions and details for providing such information are laid down in Annex I to the GPSD.

Such information will be dealt with by the Member State where the notifying producer/distributor is established (‘Main Member State’).

The transmission of information on products posing a risk can be submitted by economic operators through the ‘Product Safety Business Alert Gateway’, a tool available on the RAPEX website (see Part II Chapter 5.3.2). Economic operators should include a detailed description of the risk of the product and can make use of the ‘RAG tool’ available for this purpose (see Part I Chapter 5.3).

Risk assessments carried out by economic operators are not binding on Member State authorities who are responsible for carrying out their own risk assessment. It is therefore possible for an authority of a Member State to come to a different conclusion regarding the risk assessment provided in an alert submitted via the ‘Business Gateway’.

3.3.2.   Member States authorities

Member States authorities notify the Commission through the RAPEX application about both compulsory and voluntary measures taken on their own territory against products posing a risk.

Member States establish the roles for the creation, submission and follow-up of notifications in RAPEX.

3.3.3.   Authorities in charge of external border controls

Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EU of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the EU border) should be notified to the Commission through the RAPEX application in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.

3.3.4.   European Commission

The Commission may inform the RAPEX Contact Points (see Part II, Chapter 5.1) regarding products posing serious risks, imported into or exported from the Community and the European Economic Area (23).

The Commission may transmit information to the Member States about products of EU and non-EU origin posing a risk that, according to the information available, are likely to be on the EU market. This mainly concerns information that the Commission receives from third countries, international organisations, businesses or other rapid alert systems.

This information might be circulated amongst Member States by means other than the RAPEX application.

3.4.   Workflow

3.4.1.   Creation of a notification

3.4.1.1.   By a national authority

According to the national arrangements, different national authorities involved in the RAPEX process (local/regional market surveillance authorities, external border control authorities, etc.) may be allowed to create a notification.

3.4.1.2.   By the Commission

In certain cases, the Commission may create a notification as explained in point 3.3.4.

3.4.2.   Submission of notifications to the Commission

The RAPEX Contact Point is responsible for the submission of all notifications for validation by the Commission. (See Part II, Chapter 5.1).

3.4.3.   Examination of notifications by the Commission

The Commission checks all notifications received through the RAPEX application before transmitting them to Member States to ensure that they are correct and complete.

3.4.3.1.   Correctness

When assessing the correctness of a notification, the Commission checks in particular that:

(a)

The notification meets all the relevant requirements set out in the GPSD or in Article 22 of Regulation (EC) No 765/2008 and in these Guidelines;

(b)

the notified product has not already been notified (to avoid any unnecessary duplication, including between ICSMS and RAPEX);

(c)

the notification submitted for validation by the notifying Member State is classified in accordance with the criteria set out in Part II Chapter 2 of these Guidelines;

(d)

the information provided including the risk assessment takes due account of the applicable legislation and the relevant standards;

(e)

the correct notification procedure has been used.

3.4.3.2.   Completeness

Once a notification is confirmed as correct, the Commission checks that it is complete. Part II, Chapters 3.2.1 and 3.2.2 of these Guidelines act as a point of reference. Special attention is given to the parts of a notification concerning product identification, risk description, measures, traceability and distribution channels.

The Commission is not responsible for performing a risk assessment of the product, but only for checking that the notification includes an appropriate risk assessment containing all the elements listed in Part II Chapter 3.2.1 of these Guidelines (with the exceptions referred to in point 3.4.3.3). See also Part I Chapter 5.1 of these Guidelines.

3.4.3.3.   Validation of notifications without a detailed risk assessment

Member States should submit a risk assessment for every notification but in certain cases, the Commission may validate notifications that are submitted without a detailed and individual risk assessment:

(a)   Notifications of products posing chemical risks

The risk level of a product may be considered to be serious if it contains a chemical substance either banned or in a concentration above the limit established by European legislation. Therefore, in cases where measures are taken against products containing a chemical substance subject to a restriction contained in EU Legislation, a notification may be submitted without a detailed risk assessment.

(b)   Notifications of cosmetic products

Validation of notifications that do not include a detailed risk assessment may equally be possible for cosmetic products containing banned or restricted substances, which are backed up by an EU scientific committee opinion supporting that such presence of substances above the established limits poses a risk to the health and safety of consumers. For this specific product sector, other factors (e.g. concentration or time of exposure) may need to be taken into consideration.

Nevertheless, if measures have been taken against a product containing not authorised chemical substances for which no scientific opinion has been issued confirming that the product poses a risk, a proper risk assessment may be required depending on a case-by-case analysis to prove that the product poses a serious or less than serious risk. In cases where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.

As regards products that are subject to restrictive measures by market surveillance authorities based on the presence of a chemical substance mentioned in the list of ingredients which is subject to restrictions contained in EU Legislation and where there is no scientific data assessing the risk, notifications need to be assessed on a case-by-case basis. In case where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.

(c)   Notification of other products

Where there is well-documented evidence that certain features of certain products consistently lead to a specific risk and risk level (e.g., the presence of any drawstrings or functional cords in the head, neck or upper chest on garments intended for young children always implies a serious risk), no further risk assessment is required for that given product.

3.4.3.4.   Requests for additional information

Should, during examination, the Commission have questions regarding a notification, it may suspend validation of the notification and ask the notifying Member State for additional information or clarification. This additional information is provided by the notifying Member State by the deadline specified in the Commission's request for information.

3.4.3.5.   Investigation

Where necessary, the Commission may carry out an investigation to assess the safety of a product. This investigation may be conducted in particular where there are serious doubts as to the risks posed by the product notified via the RAPEX application. These doubts can either arise during the examination of a notification by the Commission, or be brought to the attention of the Commission by a Member State (e.g. through a follow-up notification) or by a third party (e.g. a producer).

As part of such investigations, the Commission may, in particular:

(a)

ask any Member State to provide information or clarification;

(b)

ask for an independent risk assessment and independent testing (laboratory or visual) of the product under investigation;

(c)

consult the Scientific Committees, the Joint Research Centre or any other institution specialising in the safety of consumer products;

(d)

convene the GPSD Committee, Consumer Safety Network and/or RAPEX Contact Points meetings, as well as consult the relevant Working Groups to discuss developments in an investigation.

Where an investigation concerns a product notified through the RAPEX application, the Commission may suspend validation of a notification or, where such a notification has already been validated and distributed through the RAPEX application, temporarily remove the overview published on the RAPEX website. After an investigation, and depending on the outcome, the Commission (after consulting the notifying Member State, where necessary) may in particular validate and distribute through the RAPEX application the previously suspended notification, uphold the validated notification in the RAPEX application (with any changes) or permanently withdraw the notification from RAPEX.

The Commission informs all Member States of the following:

(a)

its decision to launch an investigation, clearly stating the reasons for its decision;

(b)

its decision to close an investigation, presenting its conclusions and changes to the investigated notification(s) (if any);

(c)

all the relevant developments during an investigation.

3.4.4.   Validation and distribution of notifications

The Commission validates and distributes through the RAPEX application, by the deadlines specified in Appendix 5 to these Guidelines, all notifications assessed as correct and complete during the examination.

Where, during an examination, a request for additional information or clarification was sent to the notifying Member State (followed by a reminder, if necessary), the Commission may take the following decisions:

(a)

where the additional information or clarification requested has been provided, the Commission re-examines the notification and may validate it with the changed classification where necessary (e.g. from a ‘Notification for information’ to an ‘Article 12 notification’) or keep it on hold until further clarification;

(b)

where the additional information or clarification requested has not been provided within a specified deadline or it is insufficient, the Commission takes a decision on the basis of the information provided and, depending on the circumstances, may either validate it after changing the classification (e.g. from an ‘Article 12 notification’ to ‘Notification for information’) or decide not to validate it.

Once a common approach to risk assessment and/or enforcement has been agreed between Member States, depending on the circumstances and the views of the Member States, the Commission may take one of the following actions:

(a)

keep the notifications concerned in the RAPEX application;

(b)

change the classification of the notifications stored in the RAPEX application;

(c)

withdraw notifications from RAPEX (24).

3.4.5.   Publication of notifications

3.4.5.1.   Disclosure of information as a general rule

The public has the right to be informed about products posing a risk. To meet this obligation, the Commission publishes overviews of new notifications on the RAPEX website (25).

For external communication reasons, the RAPEX website will in future be called ‘Safety Gate’.

Member States equally provide the public with information in the national languages on products posing a serious risk to consumers and on measures taken to address this risk. Such information may be distributed via the internet, on paper, by electronic media, etc.

The information made available to the public is a summary of a notification and includes in particular the elements which allow the identification of the product, as well as the information about the risks and measures taken to prevent or restrict those risks. The Commission and the Member States may decide to disclose other elements of the notifications to the public, only when this information, due to its nature, is not confidential (professional secrets) and does not need to be protected.

The following notifications are made available on the RAPEX website, in line with the requirements laid down in Article 16 of the GPSD:

(a)

notifications submitted falling under the scope of Article 12 of the GPSD;

(b)

notifications submitted falling under the scope of Article 22 of Regulation (EC) No 765/2008;

(c)

notifications submitted falling under the scope of Article 11 of the GPSD for products posing less than serious risk, the cross-border effect of which has also been recognised. As Chapter 3.4 provides for, the cross-border effect ascertains whether such a scenario is to be notified under Article 11;

(d)

notifications submitted falling under the scope of Article 23 of Regulation (EC) No 765/2008 concerning products presenting risks that are less than serious and regardless of whether the measures taken were compulsory or voluntary (26);

(e)

notifications submitted for information only if the notifying Member State so requests by ticking the ad hoc box in RAPEX, especially when voluntary measures are adopted and the products concerned are sufficiently identified. The publication of these notifications might need to be considered from the standpoint of securing an appropriate risk management.

3.4.5.2.   Exceptions to the general rule

Member States and the Commission should not disclose to the public any information about a product notified through the RAPEX application if such disclosure undermines the protection of court proceedings, monitoring and investigation activities or professional secrecy, except for information relating to the safety properties of products which must be made public if circumstances so require to protect the health and safety of consumers, or, in case of products covered by Regulation (EC) No 765/2008, also to protect other relevant public interests of the end-users (27).

3.4.5.3.   Requests for confidentiality

A notifying Member State may request confidentiality of a notification. Such a request clearly indicates the part(s) of the notification that should be kept confidential.

Furthermore, each request for confidentiality is accompanied by a justification clearly stating the reasons (28).

Requests for confidentiality are subject to examination by the Commission. The Commission checks that the request is complete (i.e. that it states which parts of the notification are covered by confidentiality and that it contains a justification) and justified (i.e. that it is in line with the provisions of the GPSD and these Guidelines). A decision as to the validity of the request is taken by the Commission after consulting the respective RAPEX Contact Point. (See Part II, Chapter 5.1).

3.4.5.4.   Handling of notifications covered by confidentiality

Article 16(2) of the GPSD states that the protection of professional secrecy or confidentiality shall not prevent the dissemination to the competent authorities of information relevant for ensuring the effectiveness of market monitoring and surveillance activities. Notifications covered partially or fully by confidentiality are examined by the Commission and, after being validated and distributed through the RAPEX application, they are subject to the usual follow-up activities by the Member States. The confidentiality of a notification or parts of it does not prevent it from being handled and distributed through the RAPEX application to the competent national authorities.

The only significant difference in the handling and follow-up procedures is that the Commission and Member States should not disclose any parts of a notification that are confidential to the public. These parts have to remain confidential and thus they should not be published in any form. Member State authorities that receive confidential information through the RAPEX application ensure that it is protected when performing their activities.

3.4.5.5.   Withdrawal of request for confidentiality

The notifying Member State withdraws its request for confidentiality immediately after the authority in that Member State becomes aware that the justification for such a request is no longer valid, and informs the Commission accordingly. The Commission informs all Member States of the withdrawal of confidentiality on receipt of such a request by the notifying Member State.

A notification that is no longer covered by full or partial confidentiality is made available to the public in line with the ‘general rules’ applying to publication of notifications set out in these Guidelines.

3.4.6.   Follow-up to notifications

3.4.6.1.   Follow-up to the different types of notification

Member States ensure appropriate follow-up to ‘Article 12 notifications’, ‘Article 12 notifications requiring emergency action’, notifications under Article 22 of Regulation (EC) No 765/2008 and to information on products posing a risk sent by the Commission (Chapter 3.3.4) as soon as possible and by the deadlines specified in Appendix 4 to these Guidelines at the latest.

Notifications for information as well as notifications under Article 11 of the GPSD and notifications under Article 23 of Regulation (EC) No 765/2008 (notification for less than serious risks) do not require any specific follow-up activities. These notifications often do not contain the data needed for effective and efficient enforcement regarding the notified product (e.g. the notified product and/or measures are not sufficiently identified) or the level of the risk is not considered to be serious.

Although there is no specific need for a follow-up in the referred cases, it is still important that Member States verify whether they disagree with the consideration of the risk as less than serious so they may eventually make a follow-up upon the information of a different risk assessment. Member States are therefore encouraged to ensure follow-up to such notifications where the notified product is likely to have been made available to consumers on their market and product identification allows measures to be taken.

3.4.6.2.   Objectives of the follow-up activities

On receipt of a notification, a Member State examines the information provided in the notification and takes appropriate action in order to:

(a)

establish whether the product was marketed on its territory;

(b)

assess what preventive or restrictive measures should be taken with regard to the notified product found on its market, taking into account the measures taken by the notifying Member State and any special circumstances that could justify different types of measures or no action being taken;

(c)

perform additional risk assessment and testing of the notified product, if necessary;

(d)

collect any additional information that may be relevant for other Member States (e.g. information on distribution channels of the notified product in other Member States).

3.4.6.3.   Follow-up techniques

To ensure efficient and effective follow-up, best practice follow-up techniques should be employed by national authorities, including:

(a)   Checks on the market

National authorities organise regular (planned and random) checks on the market in order to establish whether consumer products notified through the RAPEX application are made available to consumers. When the Member State is mentioned as a country of destination, reinforced checks on the market shall be carried out, notably by contacting the economic operator(s) indicated in the notification.

(b)   Cooperation with business associations

National authorities provide, when necessary, business associations with overviews of the most recent notifications and enquire whether any of the notified products were produced or distributed by their members. National authorities provide businesses only with summaries of notifications, such as the weekly overviews published on the RAPEX website. Whole notifications should not be transmitted to third parties, as certain information (e.g. details of the risk description or information on distribution channels) is often confidential and should be protected.

(c)   Publication of RAPEX data via the internet or other electronic and paper media

National authorities regularly alert consumers and businesses about consumer products notified through the RAPEX application via their websites and/or other media, e.g. referring consumers and business to the RAPEX website. Information published in this way allows consumers to check whether they have and use products posing a risk and often provides the authority with useful feedback.

(d)   Online checks

National authorities regularly perform online checks to try to identify whether products notified via RAPEX are available on online markets. Online check techniques may include web-crawling, data mining, data scraping, etc.

National authorities apply various follow-up techniques in parallel and ideally do not limit their activities to only one of them.

The Member State in which a manufacturer, a representative or an importer of the notified product is established (‘Main Member State’) ensures appropriate follow-up to notifications distributed through the RAPEX application. The ‘Main Member State’ often has better legal and technical means of obtaining information on the notified case, which will help other Member States to undertake effective follow-up activities.

3.4.7.   Withdrawal/removal of notifications

3.4.7.1.   Permanent withdrawal of a notification from RAPEX

Notifications distributed through the RAPEX application are kept in the system for an unlimited period of time. The Commission may, however, in the situations presented in this Chapter, permanently withdraw a notification from RAPEX.

3.4.7.1.1.   Situations where withdrawal of a submitted or validated notification is possible

(a)

There is proof that one or more of the notification criteria (29) are not met and thus a notification is not justified. This concerns cases in particular where it is established that the original risk assessment was performed incorrectly and that the notified product does not pose a risk. It also covers situations where the notified measures were successfully challenged in court or in other proceedings and they are no longer valid.

(b)

No measures have been taken with regard to a product notified through the RAPEX application (for information) before it was decided to adopt measures or take action (30).

(c)

After a discussion held at EU level, Member States agree that it is not useful to exchange information on certain safety aspects that have been notified through the RAPEX application (31).

(d)

There is proof that products covered by a notification are no longer marketed and there is proof that all items that had been made available have already been withdrawn from the market and retrieved in all Member States.

Withdrawal of a notification that has been submitted or validated cannot be requested on the basis of the fact that the notified product has been subject to changes needed for it to comply with all the applicable safety requirements, unless proof is provided that all the products (items) concerned that had been made available have been withdrawn and retrieved in all Member States and that they are no longer marketed.

3.4.7.1.2.   Request for permanent or temporary withdrawal by Member States

The Commission may withdraw notifications from RAPEX only at the request of the notifying Member State, as the latter takes full responsibility for the information transmitted through the system. Other Member States, however, are encouraged to inform the Commission of any facts that may justify withdrawal.

3.4.7.1.3.   Content of the request for permanent or temporary withdrawal

Every request for withdrawal is accompanied by a justification stating the reasons and by all available documents supporting those reasons. The Commission examines each request and checks the justification and the supporting documents in particular. The Commission may request additional information, clarification or the opinion of the notifying Member State and/or other Member States before taking any decision.

3.4.7.1.4.   Decision to withdraw

Should, on the basis of the justification provided, the Commission decide to withdraw a notification from RAPEX, it removes it from:

(a)

the RAPEX application (or makes it otherwise invisible to all users of the system);

(b)

the RAPEX website (if necessary).

The Commission informs all Member States of the withdrawal of a notification by mail or through other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.

3.4.7.2.   Temporary removal of a notification from the RAPEX website

3.4.7.2.1.   Situations where temporary removal is possible

Where justified, the Commission may temporarily remove a notification from the RAPEX website, especially where the notifying Member State suspects that a risk assessment submitted in a notification has been performed incorrectly and thus the notified product may not pose a risk. A notification can be temporarily removed from the RAPEX website until the risk assessment of the notified product has been clarified.

3.4.7.2.2.   Request for temporary removal by Member States

The Commission may temporary remove notifications from the RAPEX application only at the request of the notifying Member State, as the latter takes full responsibility for the information transmitted through the application. Other Member States, however, are encouraged to inform the Commission of any facts that may justify such removal.

3.4.7.2.3.   Content of the request for temporary removal

Every request for temporary removal is accompanied by a justification stating the reasons and by all available documents supporting those reasons. The Commission examines each request and checks the justification and the supporting documents in particular. The Commission may request additional information, clarification or the opinion of the notifying Member State and/or other Member States before taking any decision.

3.4.7.2.4.   Decision to remove

Should, on the basis of the justification provided, the Commission decide to remove a notification from the RAPEX website, it informs all Member States by e-mail or by other equally effective means and, if necessary, also the public by publishing a corrigendum on the RAPEX website.

3.4.7.2.5.   Re-publishing of a notification temporarily removed

The notifying Member State immediately informs the Commission when the reasons for the removal of a notification from the RAPEX website are no longer valid. In particular, it informs the Commission of the results of any new risk assessment to enable the Commission to determine whether to maintain a notification in the RAPEX application and to re-publish it on the RAPEX website or to withdraw it permanently from RAPEX (following a request from the notifying Member State).

The Commission may re-publish a notification on the RAPEX website following a justified request from the notifying Member State after the risk assessment has been clarified.

The Commission informs the other Member States of the re-publishing of a notification on the RAPEX website by e-mail or by other equally effective means and also the public by replacing the corrigendum with a new one on the RAPEX website.

3.4.8.   Notifications older than ten years

The Commission will place all notifications older than ten years in a separate section of the RAPEX website. These notifications will still be available for public consultation.

3.5.   Timing and deadlines for notifications

3.5.1.   Timing of the notification

Article 12(1) of the GPSD and Article 22 of Regulation (EC) No 765/2008 require Member States to immediately notify the Commission through the RAPEX application of preventive and restrictive measures concerning products posing serious risks. This provision applies to both compulsory and voluntary measures, although the timing of the notification is different.

(a)   Compulsory measures

These measures are notified through the RAPEX application immediately after being adopted or after the decision to adopt them has been taken, even if an appeal against them at national level is likely, if they are already under appeal or they are subject to publication requirements.

This approach is consistent with the objective of RAPEX, i.e. to ensure the rapid exchange of information between Member States and the Commission in order to prevent the supply and use of products that pose a risk.

(b)   Voluntary measures

Under Article 5(3) of the GPSD and Article 22 of Regulation (EC) No 765/2008, economic operators are obliged to notify the competent Member State authorities of voluntary action and measures taken to prevent risks to consumers posed by products they have made available on the market (ideally by means of a ‘Business Gateway’ notification). The authority of a Member State receiving this kind of notification uses this information as the basis for a notification (if all the notification criteria are met) and sends it immediately after receipt of the ‘Business Gateway’ notification.

Where voluntary measures are adopted in the form of an agreement between an economic operator and an authority of a Member State or on the basis of a recommendation from an authority to a producer or distributor, a notification is submitted immediately after the conclusion of such an agreement or the adoption of such a recommendation.

To ensure common application of the notification obligation, Part III, Appendix 4 to these Guidelines lays down specific deadlines for submitting notifications to the Commission via the RAPEX application (32).

3.5.2.   Deadlines (33)

Member States notify the Commission of preventive and restrictive measures adopted as soon as possible and by the deadlines specified in Part III, Appendix 4 to these Guidelines at the latest. Appropriate arrangements are in place at national level concerning the transmission of information between national authorities in charge of product safety and the RAPEX Contact Point to ensure that the deadlines are met. (See Part II, Chapter 5.1).

The deadlines provided apply irrespective of any appeal procedure or official publication requirement.

3.5.3.   Emergency situations

All notifications concerning products posing a serious risk requiring emergency action are preceded by a telephone call from the RAPEX Contact Point to the Commission RAPEX Team's mobile telephone number to facilitate immediate action and follow-up. This rule applies in particular to notifications transmitted at weekends or during holiday periods. (See also Part II, Chapter 5.1).

4.    Follow-up activities

4.1.   Communication of follow-up activities

Member States notify the Commission of any findings subsequent to their follow-up activities in relation to RAPEX notifications (i.e. ‘Article 12 notifications’ and ‘Notifications requiring emergency action’ as well as notifications under Article 22 of Regulation (EC) No 765/2008) and information on products posing a risk sent by the Commission (Chapter 3.3.4).

In addition, Member States are encouraged to notify the Commission of any follow-up activities regarding notifications for less than serious risks and for information.

4.2.   Content of follow-up notifications

4.2.1.   Scope of data

Findings resulting from follow-up activities are communicated to the Commission in the form of follow-up notifications. To harmonise the type of information and to keep the workload to a minimum, Member States submit follow-up notifications in particular in the following situations:

(a)   A notified product has been found on the market

A follow-up notification is sent when national authorities find the notified product on the market or at the external border. This follow-up notification contains the full details of the product in question (e.g. name, brand, model number, bar code, batch number) plus information on the total number of items found on the market. Furthermore, the following details of the measures taken are communicated: type (compulsory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. country-wide, local), date of entry into force and duration (e.g. permanent, temporary). If the notified product was found on the market but no measures were adopted, specific reasons justifying no measures being taken should be given in the follow-up notification.

To reduce the burden on the national authorities as regards their follow-up practice, Member States do not need to inform the Commission (unless the Commission asks to be informed) of the conclusions of follow-up activities by means of a follow-up notification when the notified product is not found on the market.

(b)   Different risk assessment

A follow-up notification is sent when the conclusions of a risk assessment performed by an authority of the reacting Member State differ from the conclusions set out in the original notification. This follow-up notification contains a detailed risk description (including the results of tests, a risk assessment and information on known accidents and incidents), accompanied by supporting documents (test reports, certificates, etc.). Furthermore, the reacting Member State should prove that the risk assessment submitted with its follow-up notification was performed on the same product as the one notified, i.e. the same brand, name, model number, batch number, origin, etc.

(c)   Additional information

A follow-up notification is sent when national authorities collect additional information (during their follow-up activities) that may be useful for market surveillance and enforcement in other Member States.

Member States are encouraged to collect additional information that may be relevant for authorities both in other Member States and in third countries that cooperate closely with the EU on product safety. Details include product origin (e.g. information on the country of origin, manufacturer and/or exporters) and information on the supply chains (e.g. information on the countries of destination, importers and distributors). The country carrying out the follow-up activities attaches all available supporting documents to the follow-up notification, such as copies of orders, sales contracts, invoices, customs declarations, etc.

Member States may also indicate whether certain follow-up actions have been performed although the product has not been found in their territory.

4.2.2.   Completeness of follow-up notifications

The RAPEX Contact Point of the reacting Member State, together with the responsible authority, ensures that all data provided in their follow-up notification is accurate and complete and that there is no confusion with other similar products that are available on the EU market. (See also Part II, Chapter 5.1).

The standard follow-up notification template is provided in Part III, Appendix 2 to these Guidelines. Should certain relevant information not be available when a follow-up notification is submitted, the reacting Member State indicates this on the follow-up form. Once this information becomes available, the reacting Member State may request that its follow-up notification be updated. The updated follow-up notification is examined by the Commission before it is validated and distributed through the system.

The RAPEX Contact Point provides all authorities in its own Member State that participate in the RAPEX network with instructions on the scope of the data required to complete the follow-up notification template correctly. This helps to ensure that information provided by these authorities to the Contact Point is correct and complete. (See Part II, Chapter 5.1).

4.2.3.   Updating of validated follow-up notifications

The reacting Member State informs the Commission (as soon as possible and by the deadlines specified in Part III, Appendix 4 to these Guidelines at the latest) of any developments that may require changes to a follow-up notification distributed through the RAPEX application. In particular, Member States inform the Commission of changes in the status of the measures taken or in the risk assessment submitted with their follow-up notification.

The Commission examines the information provided by the reacting Member State and if necessary updates the information concerned.

4.2.4.   Responsibility for follow-up notifications

Responsibility for the information provided in follow-up notifications lies with the notifying Member State (34).

The authority(ies) involved in the follow-up activities (e.g. by carrying out the risk assessment or by adopting restrictive measures) take responsibility for the information provided in follow-up notifications. The RAPEX Contact Point checks and validates all follow-up notifications prepared by the respective authorities before transmitting them to the Commission. (See also Part II, Chapter 5.1).

Any action taken by the Commission, such as examining and validating follow-up notifications, does not imply any assumption of responsibility for the information transmitted, which remains with the Member State submitting the follow-up notification.

4.2.5.   Response to follow-up notifications

Member States may respond to any follow-up notifications regarding their own notification(s) by starting a discussion on the online collaborative space put at the disposal of Member States for the exchange of information (see Part II Chapter 5.3.2). This ensures that the response is visible to all members of RAPEX.

4.3.   Actors and roles involved in follow-up activities

The parties involved in the follow-up notification process and their responsibilities therein are the following:

4.3.1.   Economic operators (35)

Economic operators are not directly involved in the submission of follow-up notifications. However, economic operators must cooperate with national authorities and provide them with any information concerning a product which is the subject of an existing notification in order to facilitate the creation and submission of follow-up notifications via the RAPEX application.

4.3.2.   Market surveillance authorities

Market surveillance authorities notify the European Commission through the RAPEX application about any follow-up activities or other information regarding notifications.

4.3.3.   European Commission

The European Commission examines and validates follow-up notifications according to the specifications included in Part II, Chapter 4.2.

4.4.   Workflow

4.4.1.   Creation and submission of a follow-up notification by a Member State

The RAPEX Contact Point is responsible for the submission of follow-up notifications via the RAPEX application. (See Part II, Chapter 5.1).

4.4.2.   Examination of follow-up notifications by the Commission

4.4.2.1.   Correctness and completeness

The Commission checks all follow-up notifications received through the RAPEX application before they are validated and transmitted to the Member States. These checks focus on the correctness and completeness of the information provided.

The Commission checks if a follow-up notification meets all the relevant requirements set out in the GPSD and in these Guidelines and if the correct procedure was applied. Once the correctness of a follow-up notification is confirmed, the Commission checks its completeness. Chapter 4.2.2 of these Guidelines is to be used as a point of reference for this examination.

The Commission pays special attention to follow-up notifications containing risk assessments. It verifies, in particular, that the risk description is complete, clearly presented and well documented, and that the risk assessment clearly relates to the product covered by a notification.

4.4.2.2.   Requests for additional information

Before validating a follow-up notification, the Commission may request the reacting Member State to provide additional information or clarification within a given deadline. Validation of a follow-up notification may be conditional upon receipt of the data requested.

The Commission may request the opinion of any Member State and, in particular, the notifying Member State on a validated follow-up notification. The Member State submits its opinion to the Commission within a deadline specified by the latter. Furthermore, the notifying Member State informs the Commission whether any changes to the notification (e.g. to the risk assessment) or to its status (e.g. permanent withdrawal from the system) are necessary.

4.4.3.   Validation and distribution of follow-up notifications

All follow-up notifications assessed as correct and complete are validated and distributed by the Commission according to the deadlines specified in Appendix 5 to these Guidelines.

The Commission does not validate follow-up notifications with a risk assessment different from that of the notification they refer to, if the risk assessment is not complete, clearly presented and well documented, or if it is not shown that the risk assessment was performed in relation to the product covered by the notification.

4.4.4.   Permanent withdrawal of a follow-up notification from RAPEX

Follow-up notifications distributed through the RAPEX application are kept in the system as long as the notification to which they are attached. The Commission may permanently withdraw a validated follow-up notification from the RAPEX application if a notification to which this follow-up notification is attached has been withdrawn from RAPEX (in accordance with Part II, Chapter 3.4.7.1.1 of these Guidelines). Furthermore, the Commission may withdraw a validated follow-up notification where it clearly provides incorrect information, and in particular where:

(a)

the product found on the market by the reacting Member State is different from the product covered by the notification;

(b)

the measures adopted by the reacting Member State are successfully challenged in court or in other proceedings and subsequently withdrawn;

(c)

the risk assessment performed by the reacting Member State is proven to be incorrect or relates to a different product from the one covered by the notification.

The provisions of Chapters 3.4.7.1.2 and 3.4.7.1.3 apply.

Once the Commission decides to withdraw a follow-up notification it is removed from RAPEX (or otherwise made invisible to users of the system).

The Commission informs all Member States of the withdrawal of a follow-up notification via the online collaborative space referred to in Part II, Chapter 5.3.2 or through other equally effective means.

4.5.   Deadlines for submitting follow-up notifications

Member States submit follow-up notifications to the Commission as soon as possible and by the deadlines specified in Appendix 4 to these Guidelines at the latest.

Appropriate arrangements are established at national level concerning the transmission of information between all competent authorities and the RAPEX Contact Point to ensure that the deadlines are met. (See Part II, Chapter 5.1).

The deadlines apply irrespective of any appeal procedure or official publication requirement.

4.6.   Requests for confidentiality

A reacting Member State may request confidentiality in its follow-up notification. Such requests clearly state which part(s) of the follow-up notification should be kept confidential. Furthermore, all requests for confidentiality are accompanied by justification clearly stating the reasons.

Requests for confidentiality are examined by the Commission to determine that they are justified (i.e. in line with the provisions of the GPSD and these Guidelines) and complete (i.e. it states which parts of the form that it covers and if it contains a justification). The final decision on confidentiality is taken by the Commission after consultation of the responsible RAPEX Contact Point. (See Part II, Chapter 5.1).

The Commission and the Member States treat follow-up notifications with requests for confidentiality in the same way as the other follow-up notifications. The confidentiality of a follow-up notification or parts of it does not prevent it from being distributed through the RAPEX application to the competent national authorities. However, neither the Commission nor the Member States should disclose any parts of a follow-up notification that are confidential to the public. This information is confidential and therefore cannot be published in any form.

The Member State submitting the follow-up notification withdraws its request for confidentiality immediately after it becomes aware that the reasons for such a request are no longer valid. The Commission informs all Member States of the withdrawal of the confidentiality after the receipt of such a request from the reacting Member State.

5.    RAPEX networks

5.1.   RAPEX National Contact Points

Each Member State establishes a single RAPEX Contact Point to operate RAPEX at national level. The Member States decide within which national authority to set up the RAPEX contact point. Each Member State also organises its national RAPEX network to ensure the efficient flow of information between the national contact point and the various authorities participating in RAPEX. (See Part I Chapter 5.4 and Part II, Chapter 1.2).

5.1.1.   Organisation

Each Member State gives the national Contact Point the resources and information it needs to perform its tasks and, in particular, to operate the system with effective back-up/business continuity.

The RAPEX Contact Point has a separate email account for RAPEX, accessible to all officials in that contact point (e.g. rapex@ …). Professional or private email accounts of officials in charge of the RAPEX Contact Point should not be used as the email account of the RAPEX Contact Point. The RAPEX Contact Point also has a direct phone number through which it can be reached during and outside working hours.

5.1.2.   Tasks

The main tasks of the RAPEX Contact Point are to:

(a)

organise and steer the work of the national RAPEX network, in accordance with the rules set out in these Guidelines;

(b)

train and assist all authorities in the network in the use of RAPEX;

(c)

ensure that all RAPEX tasks stemming from the GPSD and these Guidelines are performed correctly and, in particular, that all required information (i.e. notifications, follow-up notifications, additional information, etc.) is provided to the Commission without delay;

(d)

transmit information between the Commission and the national market surveillance authorities and authorities in charge of external border controls;

(e)

check and validate the completeness of the information received from all authorities before transmission to the Commission through the RAPEX application;

(f)

check before submitting a notification whether a product has already been notified or information on that product has been exchanged through the RAPEX application (to avoid any duplication);

(g)

participate in RAPEX Contact Point Working Group meetings and other events on the operation of RAPEX;

(h)

suggest possible improvements to the operation of the system;

(i)

inform the Commission immediately of any technical problems with the functioning of the RAPEX application;

(j)

coordinate all national activities and initiatives carried out in relation to RAPEX;

(k)

explain to stakeholders how RAPEX operates and clarify their obligations, particularly for the business notification obligation set out in Article 5(3) of the GPSD.

5.2.   RAPEX networks established at EU and national levels

5.2.1.   The RAPEX Contact Point Network

The Commission organises and steers the work of the RAPEX Contact Point Network. This network consists of all RAPEX Contact Points appointed in the Member States and European Economic Area (EEA) countries.

The Commission regularly convenes meetings of the RAPEX Contact Point Network to discuss the operation of the system (e.g. to communicate the latest developments concerning RAPEX, to exchange experience and ‘know-how’), and to improve cooperation between the RAPEX Contact Points.

5.2.2.   RAPEX networks established at national level

The RAPEX Contact Points organise and steer the work of their own ‘RAPEX national network’. The network consists of:

(a)

the RAPEX Contact Point;

(b)

market surveillance authorities responsible for monitoring the safety of products; and

(c)

authorities in charge of external border controls.

RAPEX Contact Points are encouraged to provide for the organisation and operation of the RAPEX national network so as to ensure that all the authorities involved are aware of their roles and responsibilities as regards the operation of RAPEX. This should be consistent with the information contained in these Guidelines.

The RAPEX Contact Points are encouraged to facilitate regular and continuous exchange of information and discussion with their national network in order to discuss with all the authorities involved how RAPEX is organised, how it operates and, if necessary, to give training courses.

5.3.   RAPEX internal communication tools, practical and technical arrangements for RAPEX and best practice

5.3.1.   Languages

The use of languages in notifications and follow-up notifications, as well as communications between the RAPEX Contact Points and the Commission, must take account of the objectives of RAPEX and must ensure a rapid exchange of information between Member States and the Commission on products posing serious risks.

To facilitate the work of the network, Member States authorities are encouraged to use the existing EC eTranslation webpage to ensure all Member States understand what is being communicated through RAPEX.

A link to this translation tool to submit documents or extracts from texts for translation from and into all EU languages (36) is available in the collaborative space. (See Part II, Chapter 5.3.2).

5.3.2.   RAPEX online tools

(a)   RAPEX system

The Commission has established and maintains a web-based application for use as a communication tool for the purpose of RAPEX. Member States use this system to create and submit notifications and follow-up notifications through the RAPEX application, and the Commission uses it to validate and distribute the documents it receives.

The Commission provides access to the system to all RAPEX Contact Points, competent national authorities and the relevant Commission departments. The Commission lays down the rules for granting access to the system and gives access to as many users as possible, taking into account needs and technical limitations.

Where the RAPEX system is temporarily not operational (for reasons other than regular and planned maintenance work), Member States should only submit notifications of serious risks to the Commission (i.e. ‘Article 12 notifications’, ‘Article 12 notifications requiring emergency action’ or ‘Article 22 of Regulation (EC) No 765/2008) notifications’.

The submission of other notifications and follow-up notifications is suspended until the RAPEX system is re-established. While the system is not operational, RAPEX notifications should be sent to the Commission by email to: just-rapex@ec.europa.eu or to another email address communicated in advance. If email transmission is not possible, RAPEX notifications are sent to the Commission by any other means considered appropriate (37).

(b)   ‘Product Safety Business Alert Gateway’

The ‘Product Safety Business Alert Gateway’ (also known as the ‘Business Gateway’) is intended to simplify the practical aspects of the obligation on producers and distributors, or their authorised representative, under Article 5(3) of the GPSD to notify the competent national authorities of the Member States if they know or ought to know, on the basis of the information in their possession and as professionals, that a product they have placed on the market is dangerous.

The ‘Business Gateway’ consists of two elements: (i) the notification template and (ii) the online database. The notification template is reserved for use by producers and distributors to inform the competent national authorities of the Member States that a product they have placed on the market is dangerous, in line with their obligation under Article 5(3) of the GPSD. The online database is intended for use by Member States national authorities responsible for receiving notifications of dangerous consumer products submitted by producers and distributors. The competent national authority may use the information provided to submit a RAPEX notification if all criteria for this are met.

(c)   Collaborative space

The Commission also manages a collaborative space to exchange information between the Commission and the Member States competent national authorities. This includes the EU Consumer Product Safety platform, open to the RAPEX Contact Points and their colleagues working on product safety issues in the competent national authorities for all RAPEX-related issues. Requests for access to the space must be made by the RAPEX Contact Points in the relevant Member State and authorised by the Commission.

This space also includes a section, managed by the Commission, containing useful tips and information on the functioning of RAPEX and input from the Member States.

(d)   ‘RAG tool’ (38)

The Commission has developed this tool available on the RAPEX website to facilitate the risk assessment of products notified through the RAPEX system, in accordance with the principles laid down in Appendix 6.

5.3.3.   Contact details

The Commission provides the RAPEX Contact Points with the contact details of the Commission's RAPEX team, including names, email addresses and telephone numbers.

The RAPEX Contact Points provide the Commission with their contact details, including the names of officials working within the Contact Point, the name and address of the authority where the RAPEX Contact Point is established, the email addresses and phone numbers of officials. Any changes to the contact details are immediately communicated to the Commission by the RAPEX Contact Point. The Commission publishes and updates a list of contact details of the RAPEX Contact Points on the RAPEX website.

Member States process contact details including personal data in application of the EU's data protection legislation. On the information exchange through RAPEX, Member States should process personal data ensuring that it circulates and is distributed only as far as it is strictly necessary.

5.3.4.   Operation of RAPEX outside regular working hours

RAPEX operates non-stop. The Commission and the RAPEX Contact Points ensure that officials responsible for operating RAPEX can always be contacted (by phone, e-mail or other equally effective means) and that they can take whatever action is necessary, including in an emergency and outside regular working hours, such as weekends and holidays.

The Commission provides the RAPEX Contact Points with an emergency telephone number, which should be used to contact the Commission RAPEX team outside of working hours, with priority over any other communication channels.

The RAPEX Contact Points provide the Commission with their contact details, including the phone numbers of officials who can be contacted during and outside working hours. Any changes to the contact details are immediately communicated to the Commission by the RAPEX Contact Points.

PART III

APPENDICES

1.    Fields and information included in notifications  (39)

Fields that will be published on the web are shaded.

Notification Form

Section 1: General information

Case number

Creation date

Validation/distribution date

Notification type *

Notifying country

Full Contact details of the Notifying Authority *

Section 2: Product

Professional / Consumer Product

Product category *

OECD Portal category (if known)

Product (what the product is) *

Name *

Brand *

Type/number of model: *

Batch number/Bar code *

Customs code *

Product and packaging description *

Total number of items covered by the notification (if known) *

Photos:

Section 3: Regulations and standards applicable

Legal provisions (directive, decision, regulation, etc.) *

Standards *

Proof of conformity *

Is the product counterfeit? *

Certificates

Section 4: Traceability

Country of origin (where the product manufactured) *

Countries of destination *

Full Contact details of the manufacturer or its representative(s) *

Full Contact details of the exporter(s) *

Full Contact details of the importer(s) *

Full Contact details of the distributor(s) *

Full Contact details of the retailer(s) *

Is the product (also) sold online?

Please give details: URL

Section 5: Risk assessment

Risk category *

Risk level

Summary of test results *

Description of the technical issue that leads to the highest risk level

Risk description (how the technical defect leads to the risk) *

EU Legal provisions and /or Standards against which the product was tested and did not comply with *

Information on known incidents and accidents *

Section 6: Measures

Type of measures adopted *

If Voluntary:

Type of economic operator taking notified measure(s) *

Name of economic operator taking notified measure(s) *

If Compulsory:

Name of authority ordering the notified measure(s) *

Type of economic operator to whom the measure(s) were ordered *

Category of measures *

Date of entry into force *

Duration *

Scope *

Has the notification been sent by a producer or a distributor under Article 5(3) of the GPSD? *

URL link to company recall page (if available)

Section 7: Confidentiality

Is the notification confidential? *

Scope of confidentiality

Justification

Section 8: Other

Additional information

Justification for sending ‘Notification for information’

Annexes

Photos (products, packaging and label)

Certificates

Test report and risk assessment

Notification sent by an economic operator through ‘Business Gateway’

Adopted measures

* Indicates a mandatory field.

2.    Fields and information included in follow-up notifications  (40)

Fields that will be published on the web are shaded.

Section 1: General information

Case number

Validated notification type

Notifying country

Creation date

Validation/distribution date

Submission number

Follow up notification number

Reacting country

Full contact details of the notifying authority

Validated notification product category

Notified product

Notified name

Product (what the product is)

Name (on the product or the packaging)

Brand (on the product or the packaging)

Type/number of model

Batch number/Bar code (or other information to identify which products are affected)

Photos (products, packaging and label)

Section 2: Type of follow-up notification

Product found *

Total number of items found (if known) *

Measures adopted / Measures not adopted

Type of measures adopted *

If Voluntary:

Type of economic operator taking notified measure(s) *

Name of economic operator taking notified measure(s) *

If Compulsory:

Name of authority ordering the notified measure(s) *

Type of economic operator to whom the measure(s) were ordered *

Category of measures *

Date of entry into force *

Duration *

Scope *

Adopted measures

URL link to company recall page (if available):

Different risk assessment *

Risk category *

Summary of the test results (description of technical defects) *

Indication of legal provisions and standards (with clauses) against which the product was tested *

Different risk assessment *

Information on known incidents and accidents *

Attachments (certificates, test report and risk assessment …)

Additional information *

Complementary information on distribution channels and/or product's origin

Complementary information on the risk assessment

Other complementary information

Section 3: Confidentiality

Is the follow-up confidential? *

Scope of confidentiality

Justification

Annexes

Photos (product, packaging and label)

Test reports and risk assessments

Certificates

Adopted measures

* Indicates a mandatory field

3.    Notification scheme

Image 2

Notification for information (if relevant) (1)

Enough identification information?

Notification encouraged

Product covered by Regulation (EC) No 765/2008? (3)

Information involving new risk?

Notification for information encouraged

Product covered by Regulation (EC) No 765/2008 (3)

Notification for information recommended

Article 12 GPSD/22 Regulation (EC) No 765/2008 notification

Risk level established and measure adopted?

Enough identification information?

Article 11 GPSD notification

Notification for information

Cross-border effect? (2)

Voluntary means?

Cross-border effect? (2)

Serious risk?

No

Yes

No

No

No

Yes

No

No

No

ongoing

Yes

No

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

(1) To be upgraded when a measure is adopted.

(2) The notion of cross-border effect should be interpreted in a broad sense (see Part II Chapter 6.1 of these Guidelines).

(3) See Part I, Chapter 3.1 of these Guidelines.

4.    Deadlines for member states

Member States are required to act within the deadlines indicated unless duly justified

Notification procedure

Action

Deadline

 

Notifications

Send ‘Article 12 notification requiring emergency action’

Within 3 days after:

adoption or decision to adopt ‘Compulsory measures’, or

receipt of information on ‘Voluntary measures’.

Send ‘Article 12 notification’ or Article 22 Regulation (EC) No 765/2008 notification

Within 10 days after:

adoption or decision to adopt ‘Compulsory measures’, or

receipt of information on ‘Voluntary measures’.

Confirm measures if the notification was sent before deciding to adopt measures

Within 45 days after submission of the notification

Update to a notification

Within 5 days after receipt of the information on developments requiring changes to a notification

Follow-up notifications

Ensure follow-up activities to:

‘Article 12 notification requiring emergency action’

Within 20 days after receipt of a notification

‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification

Within 45 days after receipt of a notification

Send follow-up notification to:

‘Article 12 notification requiring emergency action’

Within 3 days after:

the notified product was found on the market, or

the completion of a risk assessment with different results, or

receipt of additional information

‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification

Within 5 days after:

the notified product was found on the market, or

the completion of a risk assessment with different results, or

receipt of additional information

Update to a follow-up notification

Within 5 days after receipt of information or developments requiring changes to a follow-up notification

Notification procedure established under Article 11 of the GPSD

Notifications

Send ‘Article 11 notification’

Within 10 days after adoption of ‘Compulsory measures’

Update to the notification

Within 5 days after receipt of information on developments requiring changes to the notification

5.    Deadlines for the Commission

Notification procedure

Action

Deadline

EU Rapid Information System ‘RAPEX’ established under Article 12 of the GPSD

Notifications

Validate ‘Article 12 notification requiring emergency action’

Within 3 days after receipt of a notification

Validate ‘Article 12 notification’ as well as Article 22 of Regulation (EC) No 765/2008 notification

Within 5 days after receipt of a notification

Validate ‘Notification for information’

Within 10 days after receipt of a notification

Follow-up notifications

Validate follow-up notification sent to ‘Article 12 notification requiring emergency action’

Within 3 days after receipt of a follow-up notification

Validate follow-up notification sent to ‘Article 12 notification’ and to ‘Notification sent by the European Commission’ as well as Article 22 of Regulation (EC) No 765/2008 notification

Within 5 days after receipt of a follow-up notification

Validate follow-up notification sent to ‘Notification for information’

Within 10 days after receipt of a follow-up notification

Notification procedure established under Article 11 of the GPSD

Notifications

Validate ‘Article 11 notification’

Within 10 days after receipt of a notification

Follow-up notifications

Validate follow-up notifications sent to ‘Article 11 notification’

Within 10 days after receipt of a follow-up notification

RISK ASSESSMENT GUIDELINES FOR CONSUMER PRODUCTS (41)

1.    Introduction

Consumer products may cause harm when used, e.g. a hot flat-iron that can cause burns, scissors or knives that can cause cuts, or a household cleaner that can damage the skin. This kind of damage is not a usual occurrence because general knowledge or instructions teach how to use consumer products safely. Nevertheless, the risk of damage remains.

This risk can be assessed in different ways. A range of methods have been used to quantify risk for consumer products, such as a nomograph method (42), a matrix method (43), and the method previously recommended for the EU's RAPEX rapid alert system (44). While the general principles for risk assessment have always been agreed, how to quantify risks has been under permanent development. This has led to diverging results and ensuing discussions, as well as to consideration of what the best possible practice might be.

The purpose of these risk assessment guidelines is therefore to improve the situation and, within the framework of the Directive on General Product Safety (45), to provide a transparent and practicable method for appropriate use by Member States' competent authorities when they assess the risks of non-food consumer products. These guidelines are based on a risk assessment method developed for other purposes, adapted to the specific requirements of non-food consumer products.

A certain amount of training will of course be needed before these guidelines can be put into practice, but expertise in risk assessment will greatly facilitate this task. This will be backed by exchanges of views between risk assessors, since expertise and experience accumulated through the years is invaluable.

In building up a risk assessment method in small, manageable steps, these guidelines help to focus on the relevant issues of a product, its user(s) and its use(s), and to identify possible divergences of views between risk assessors from the onset, thus avoiding time-consuming discussions. They should thus lead to consistent and robust risk assessment results based on evidence and science, and consequently to widely acceptable consensus on the risks that the many non-food consumer products may present.

A quick overview and a flow chart on how to prepare a risk assessment pursuant to these guidelines is provided in section 5 — ‘Consumer products’ mean non-food consumer products throughout these guidelines.

These guidelines do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation, such as in the area of chemicals, cosmetics, pharmaceuticals or medical devices. It is highly recommended to use this specific guidance, since it is tailor-made, but it will always be for the risk assessor to decide how best to assess the risks of a product.

Nor are these guidelines to be used by manufacturers ‘just to avoid serious risks’ when designing and manufacturing products. Consumer products have to be safe, and these guidelines aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe.

2.    Risk assessment — an overview

2.1.   Risk — Combination of hazard and probability

Risk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damage. Nevertheless, people take risks while being aware of the possible damage, because the damage does not always happen. For example:

Climbing a ladder always includes the possibility of falling off and injuring oneself. ‘Falling off’ is therefore ‘built into the ladder’; it is an intrinsic part of using a ladder and cannot be excluded. ‘Falling off’ is thus called the intrinsic hazard of a ladder.

This hazard, however, does not always materialise, since many people climb ladders without falling off and injuring themselves. This suggests that there is a certain likelihood (or probability), but no certainty, of the intrinsic hazard materialising. Whereas the hazard always exists, the probability of it materialising can be minimised, for example by the person climbing the ladder being careful.

Using a household cleaner with sodium hydroxide to free blocked sewage water pipes always entails the possibility of very severe damage to the skin, if the product comes into contact with skin, or even of permanent blindness if drops of the product get into the eye. This is because sodium hydroxide is very corrosive, meaning that the cleaner is intrinsically hazardous.

Nevertheless, when the cleaner is handled properly, the hazard does not materialise. Proper handling may include wearing plastic gloves and protective glasses. Skin and eyes are then protected, and the probability of damage is much reduced.

Risk is thus the combination of the severity of possible damage to the consumer and the probability that this damage should occur.

2.2.   A risk assessment in three steps

It takes three steps to determine the risk:

1.

Anticipate an injury scenario in which the intrinsic product hazard harms the consumer (see table 1). Determine how severe the consumer's injury is.

A yardstick for quantifying the intrinsic product hazard is the extent of the adverse effect that it can cause to the health of a consumer. The risk assessor therefore anticipates an ‘injury scenario’ that describes step by step how the hazard leads to the injury of a consumer (see table 2). In short, the injury scenario describes the accident that the consumer has with the product in question, and the severity of the consumer's injury caused by that accident.

An injury can vary in severity, depending on the hazard of the product, on the way the product is used by the consumer, on the type of consumer who uses the product, and much more (see section 3). The more severe the injury, the more severe the hazard that caused it, and vice versa. The ‘severity of the injury’ is therefore a means of quantifying the hazard. These guidelines propose 4 levels of severity, from injuries that are normally completely reversible to very serious injuries that cause more than approximately 10 % of permanent disability or even death (see table 3).

2.

Determine the probability of the consumer being injured in practice by the intrinsic product hazard.

While the injury scenario describes how the consumer is injured by the hazard, the scenario only happens with a certain probability. The probability can be expressed as a fraction, such as ‘> 50 %’ or ‘> 1/1 000’ (see left-hand side of table 4).

3.

Combine the hazard (in terms of severity of the injury) with the probability (in terms of a fraction) to obtain the risk.

This combination can be made by looking up both values in the appropriate table (see table 4); the table will provide the level of risk in terms of ‘serious’, ‘high’, ‘medium’ and ‘low’ risk.

Where different injury scenarios are foreseeable, the risk for each of those scenarios should be determined the highest risk being labelled as ‘the risk’ of the product. The highest risk is normally crucial because only action on the highest risk can effectively provide a high level of protection.

On the other hand, an identified risk may be lower than the highest risk, but require specific risk reduction action. It is then important also to take measures against that risk so that all risks are effectively reduced.

Once the three steps have been carried out, the risk assessment is basically complete. A flow chart on building a risk assessment is at the end of section 5.

2.3.   Some useful tips

Seek information

As can be seen from the examples of Chapter 2.1, each of the three steps of a risk assessment (see point 2.2) requires anticipation of what might happen and how likely it is to happen, since the product under consideration will normally not have caused an accident, and thus the risk will not have materialised (yet). Previous experience with similar products will help in this exercise, as will any other information about the product, such as design, mechanical stability, chemical composition, operation, instructions for use, including possible risk management advice, type of consumers it is intended for (and those for which it is not), test reports, accident statistics, the EU Injury Database (IDB) (46), information about consumer complaints, about the behaviour of different consumers when they are using the product, and about product recalls. Product requirements laid down in legislation, in product standards or in checklists (such as in ISO 14121: Safety of machinery — Risk assessment) can also be useful sources of information.

Nevertheless, the products to be assessed may be quite specific and thus these sources may not contain the information required. The information collected may also be incomplete, inconsistent, or not fully plausible. This may be the case in particular for accident statistics, when only the product category is registered. The absence of an accident history, a small number of accidents or low severity of accidents should not be taken as a presumption of low risk. Product-specific statistics also have to be viewed with great care, since the product may have changed over time, be it in design or composition. The information must always be critically assessed.

Feedback from expert colleagues can be particularly useful, since they can draw from their real-life experience and pro vide suggestions that are not immediately obvious when assessing a product risk. They may also give advice when assessing the risk for different types of consumers, including vulnerable consumers such as children (see table 1), since the latter may handle a product differently. They may also help to assess the risk for different injuries that a product may cause, and the way in which those injuries emerge through the use of the product. They can also judge whether an injury scenario is ‘totally unperceived’, too unlikely, and then guide the risk assessor towards more realistic assumptions.

Thus, feedback from experienced colleagues, although not an obligation, can be helpful in several aspects. A risk assessor from an authority could seek advice from colleagues in that same authority, in other authorities, in industry, in other countries, in scientific groupings, and elsewhere. Conversely, any risk assessor in industry could use his contacts with authorities and others when a new or improved product is to be assessed before it is placed on the market.

New information obtained should of course be used to update any existing risk assessment.

Make a sensitivity analysis of your risk assessment

If all information searches and queries to expert colleagues do not provide the required, very specific data, a so-called sensitivity analysis might help. In this analysis a lower and a higher value than previously chosen is assumed for each parameter of the risk assessment, and taken through the entire risk assessment procedure. The resulting risk levels will show how sensitive the risk level reacts to the input of lower and higher values. In this way the range in which the real risk of the product will be can be estimated.

If the most likely value of each parameter can be estimated, then those most likely values should be taken through the procedure, and the resulting risk level will be the most likely risk.

An example of a sensitivity analysis is illustrated in section 6.

Let others check your risk assessment

Feedback from colleagues will also help when finalising the risk assessment. They will be able to provide advice on the assumptions and estimations made during the three steps referred to in point 2.2. They will feed in their experience and thus help to generate a more robust, more solid, more transparent and ultimately more acceptable risk assessment. It is therefore recommended that, ideally, advice be sought from expert colleagues, possibly in the form of a group discussion, before concluding a risk assessment. These groups, of perhaps 3 to 5 members, should include a combination of expertise appropriate to the product under assessment: engineers, chemists, (micro-)biologists, statisticians, product safety managers, and others. Group discussion will be particularly useful when a product is new on the market and has never been assessed before.

Risk assessments should be solid and realistic. However, since they require a number of assumptions, different risk assessors may come to different conclusions in view of the data and other evidence they have been able to find or because of their diverging experience. It is thus necessary for risk assessors to talk to one another in order to reach agreement or, at least, consensus. The step-by-step risk assessment described in these guidelines, however, should make such discussions more productive. Each step in a risk assessment must be clearly described in detail. Thus, any point of disagreement can be quickly identified, and consensus can more easily be reached. This will make risk assessments more acceptable.

Document your risk assessment

It is important to document your risk assessment, describing the product and all the parameters that you chose while developing it, such as test results, the type(s) of consumers you chose for your injury scenario(s), and the probabilities with the underlying data and assumptions. This will enable you to demonstrate unambiguously how you estimated the level of risk, and it will also help you to update your assessment while keeping track of all changes.

Several hazards, several injuries — but only one risk

When several hazards, several injury scenarios or differing severities of injuries or probabilities have been identified, each of those should be carried through the entire risk assessment procedure in order to determine the risk for each. As a result, the product may have several risk levels. The overall risk of the product is then the highest risk level identified, because action on the highest risk level is normally the most effective way of risk reduction. Only in special cases may a less-than-highest risk be considered particularly important, since it may require specific risk management measures.

As an example of several risks, a hammer may have a weak head and a weak grip, each of which may break when the hammer is used, and the consumer may be injured. If the relevant scenarios lead to different risk levels, the highest risk should be reported as ‘the risk’ of the hammer.

It could be argued that:

the apparently most significant hazard should be decisive, since it would lead to the most severe injuries. In the example of the hammer in point 2.1, this could be the hammer head breaking, since pieces of the broken head could fly into one's eye, possibly blinding the user. The hammer grip breaking, on the other hand, would never split into small pieces that could do as much damage to the eyes;

However, this would be a hazard assessment, not a risk assessment. A risk assessment also looks at the probability of an injury actually happening. Thus, the ‘most significant hazard’ might cause an injury that is much less likely than a lesser hazard, and therefore present a lower risk. Conversely, a scenario leading to a less severe injury may be much more likely than a scenario resulting in death, and the less severe injury may therefore present a higher risk;

the highest probability for an injury scenario to happen should be the decisive factor for ‘the risk’ of the product. In the example of the hammer in point 2.1, if the hammer grip is very weak, the most likely injury scenario would be from the grip breaking, and that should therefore be decisive.

However, this would not consider the seriousness of eye injuries that the hammer head breaking could cause. Looking at probability alone would not therefore give the whole picture.

In conclusion, risk is a balanced combination of both the hazard and the probability of the injury that the hazard can cause. Risk describes neither the hazard, nor the probability, but both at the same time. Taking the highest risk as ‘the risk’ of the product will ensure the most effective product safety (apart from specific risks requiring specific risk management, as referred to at the beginning of this section.

Can risks cumulate?

Several injury scenarios leading to several risks can be developed for virtually every product. For example, an angle grinder may present the risk of an electric shock, because electrical wires may be too exposed, and the risk of fire, because the machine may overheat and ignite during normal use. If both risks are considered to be ‘high’, do they add up to the grinder posing an overall ‘serious risk’?

Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury. The overall likelihood of an injury is therefore greater. This does not mean that the overall risk is automatically higher, however:

The overall probability is not calculated by simply adding up probabilities. More complex calculations are necessary, and these always result in a probability that is lower than the sum of all probabilities.

There is difference of a factor of 10 between two succeeding probability levels (table 4). This means that a lot of different scenarios of the same level would be needed to result in higher overall probability (and possibly risk).

Probability values are estimations which may not be totally accurate, as they often err on the ‘safe’ side in order to ensure a high level of protection. It is therefore more useful to look at a more accurate estimation of the probability of a scenario leading to the highest risk than to add up rough estimations of probabilities of all sorts of scenarios.

With a little effort hundreds of injury scenarios could be developed. If risks were simply added together, the overall risk would depend on the number of injury scenarios generated and could increase ‘endlessly’. This does not make sense.

Thus, risks are not simply cumulated. However, if more than one relevant risk exists, action to manage the risks may need to be taken more rapidly or may need to be more pronounced. For example, with two risks, a product may need to be immediately taken off the market and recalled, whereas, with a single risk, halting sales could be sufficient.

Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time. Thus, consideration is given to the link between risk and risk management (section 4).

Compliance with limit values in legislation and standards

In market surveillance, consumer products are often tested against limit values or requirements laid down in legislation and in product safety standards. A product that complies with the limit value(s) or requirement(s) (47) is presumed to be safe in terms of the safety characteristics covered by those value(s) or requirement(s). This assumption can be made because the risks of a product from its intended and reasonably foreseeable use are taken into account when establishing the limit value(s) or requirement(s). Manufacturers thus need their products to comply with these values or requirements, because they then only have to look at risks with their products that are not be covered by those limit value(s) or requirement(s).

An example of a limit value in:

legislation is the limit of 5 mg/kg benzene in toys which must not be exceeded, as per point 5 of Annex XVII, to the REACH Regulation (48), as amended by Commission Regulation (EC) No 552/2009 (49);

a standard is the small parts cylinder: small parts of a toy for children under 36 months must not fit entirely into the cylinder described in the Toys Standard (50). If they do, they present a risk;

The product is presumed not to be safe where it fails to comply with established limit values. For limit values laid down in:

legislation, such as on cosmetics or restrictions on marketing and use, the product must not be made available on the market;

standards, the manufacturer may nevertheless try to provide evidence that his product is as safe as if it were compliant with the standard's limit value by way of a fully-fledged risk assessment on his product. However, this may require more effort, and may be impossible in cases such as the small parts cylinder referred to in the first bullet of this list, than actually manufacturing the product in compliance with the standard's limit value.

Non-compliance with limit values does not automatically mean that the product presents a ‘serious risk’ (which is the highest risk level covered by these guidelines). Therefore, to ensure appropriate risk reduction measures, a risk assessment will be required for those parts of a product that do not comply with or are not covered by legislation or a standard.

Furthermore, some products, such as cosmetics, require a risk assessment even when they are compliant with the limit values laid down in legislation. This risk assessment should provide evidence of the safety of the whole product (51).

In conclusion, compliance with limit values in legislation or in standards provides presumption of safety, but such compliance may not be sufficient.

Specific risk assessment guidelines in specific cases

For chemicals there are specific instructions on how to prepare a risk assessment (52), and therefore they are not dealt with in detail in these guidelines. Nevertheless, they follow the same principles as for ‘normal’ consumer products:

hazard identification and assessment — this is the same as determining the severity of the injury, as described in section 2.2;

exposure assessment — in this step, exposure is expressed as the likely dose of the chemical that the consumer may take up via oral, inhalation or dermal routes, separately or jointly, when using the product as anticipated in the injury scenario. This step is the same as determining the probability that the injury will indeed occur;

risk characterisation — this step basically consists of comparing the dose of the chemical that the consumer is likely to take up (= exposure) with the derived no-effect level (DNEL) of that chemical. Should the exposure be sufficiently lower than the DNEL, in other words, should the risk characterisation ratio (RCR) be clearly below 1, risk is considered to be adequately controlled. This is the same as determining the risk level. Risk management measures may not be needed if the level of risk is sufficiently low.

Since a chemical may possess several hazards, risk is normally determined for the ‘leading health effect’, which is the health effect (or ‘endpoint’ such as acute toxicity, irritation, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction) considered to be the most important.

For cosmetics, there is also specific guidance (53), and there may be specific guidance for other products or purposes.

It is highly recommended to use such specific guidance, since it is tailored to the specific cases in question. Nevertheless, where the data required by the specific guidance do not exist or cannot be estimated the present guidelines may be used for a preliminary risk assessment. This risk assessment will have to be carried out with due care and attention in order to avoid any misinterpretation.

3.    Building a risk assessment step by step

This section describes in detail what points have to be taken into account and what questions have to be asked when preparing a risk assessment.

3.1.   The product

The product should be identified unambiguously. This includes the product name, the brand, the model name, the type number, a possible production lot number, any certificate that may come with the product, a child-resistant fastening if there is one, the identity of the person who placed it on the market, and the country of origin. A picture of the product, the packaging and the marking plate (if appropriate) and a test report(s) identifying the product hazard(s) can also be considered to be part of the product description.

In particular cases, the hazard may be limited to a distinct part of the product, which can be separate from it and also separately available to consumers. In such cases, it is sufficient only to assess the distinct part of the product. Recharge able batteries of notebook computers which may overheat are an example of this.

The description of the product includes any label that may be relevant for risk assessment, in particular warning labels. Instructions for use may also contain relevant information on the risk of the product and how to keep it as low as possible, for example by using personal protective equipment or by excluding children from using the product. An example of this is a chain saw.

Products may also need to be self-assembled by consumers before use, such as self-assembled furniture. Are the assembly instructions clear enough for the ready-to-use product to meet all the relevant safety requirements? Or could consumers make mistakes when putting the product together that could lead to unforeseen risks?

A risk assessment should always consider the entire life time of a product. This is particularly important when a new product has been developed and its risks are assessed. Will age and usage change the type or the extent of the hazard? Will new hazards appear with increasing product age or perhaps through reasonably foreseeable inappropriate use? How long is the ‘time to product failure’? What is the product's lifetime, including shelf life? How long is the product used in practice by the consumer before it becomes waste?

Additional considerations may need to be taken into account when a product becomes unusable after a certain time period, even though it has never been used. Examples are electric blankets or heating pads. The electric cords in the products are usually thin and become fragile after ten years, even if the product has never been used. The heating cords can come into contact with each other, can cause a short-circuit and set the bedclothes on fire.

Finally, the packaging of the product should also be included in any risk assessment.

3.2.   The product hazard

Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses the product. It can appear in different forms:

mechanical hazard, such as sharp edges that can cut fingers, or tight openings in which someone can trap their fingers;

choking hazard, such as from small parts that come loose from a toy, which may be swallowed by a child and make the child choke;

suffocation hazard, such as from the drawstrings of an anorak hood which may lead to strangulation;

electrical hazard, such as from live electrical parts that can cause an electric shock;

heat or fire hazard, such as a heater fan that overheats, catches fire and causes burns;

thermal hazard, such as the hot outer surface of an oven that can cause a burn;

chemical hazard, such as a toxic substance that can poison a consumer immediately upon ingestion, or a carcinogenic substance that can cause cancer in the long term. Some chemicals may damage the consumer only after repeated exposure;

microbiological hazard, such as a bacteriological contamination of cosmetics which may cause a skin infection;

noise hazard, such as ring tones from toy mobile phones that are much too loud and can damage children's hearing capacity;

other hazards, such as explosion, implosion, sonic and ultrasonic pressure, fluid pressure, or radiation from laser sources.

For the purpose of these guidelines, hazards have been grouped, linked to the size, shape and surface of a product, to potential, kinetic or electric energy, to extreme temperatures, and others, as shown in table 2. The table is for guidance only, and any risk assessor should adapt the scenario to the product under consideration. Of course not every type of hazard applies to every product.

Nevertheless, table 2 should help risk assessors to look for and identify all possible hazards in consumer products that are being assessed. Where a product has several hazards, each hazard should be taken separately with its own risk assessment and the highest risk identified as ‘the risk’ of the product. Of course, risks requiring specific risk management measures should also be reported, to ensure that all risks can be reduced.

Note that a single hazard may lead to several injuries in the same scenario. For example, malfunctioning brakes on a motor cycle could cause an accident and result in damage to the driver's head, hands and legs, and could even cause burns if the petrol bursts into flames in the accident. In this case, all injuries would belong to the same injury scenario, and the severity of all injuries together would have to be estimated. Of course, these injuries together are very serious. Several injuries in different scenarios should, however, not be added.

In the daily practice of market surveillance, it may be sufficient to assess the risk from even a single hazard. If the risk from that hazard provides for risk management action, that action can be taken without further ado. Nevertheless, the risk assessor should be sure that the risk identified is (one of) the highest risk(s), to ensure that the risk management action is sufficiently effective. This is always the case when the risk is serious, since this is the highest possible risk level proposed in these guidelines. In cases of less than serious risk, however, further risk assessments might be necessary and possibly specific risk management at a later stage. In conclusion, experience with risk assessment in market surveillance practice will limit the number of required risk assessments to a minimum.

Hazard identification by tests and standards

Hazards are often identified and quantified by tests. These tests and how to carry them out may be laid down in European or international product standards. Compliance of a product with a ‘harmonised’ European standard (‘EN …’), of which the references have been published in the Official Journal, provides presumption of safety (albeit only for the safety characteristics covered by the value(s) or standard(s)). It can be presumed in such cases that the product presents only a minimum risk and a high level of protection with regard to the specific hazard tested.

Nevertheless, there may be instances where presumption of safety is not the case, and in such cases a particularly well-documented risk assessment will have to be prepared, including a call for amendment to the harmonised standard.

On the other hand, if a product fails the test, a risk can normally be assumed, unless the manufacturer can provide evidence that the product is safe.

Products may still present a risk even though they do not cause injuries

Products may not be hazardous but can nevertheless cause a risk, due to not being fit for their intended use. Examples of this can be observed in the area of personal protective equipment or life-saving equipment, such as reflective jackets that car drivers put on after an accident. These jackets are meant to get the attention of oncoming drivers and traffic participants to warn them of the accident, in particular at night. However, they might not be seen if the reflector stripes are too small or do not reflect sufficiently, and do not therefore protect users as they should. These jackets therefore pose a risk even though they are not hazardous in themselves. Another example is a sunscreen product which displays ‘high protection’ (sun protection factor of 30) on the label but provides only ‘low protection’ (factor of 6). This can lead to severe sunburn.

3.3.   The consumer

The abilities and behaviour of the consumer using the product may greatly influence the level of risk. It is therefore of prime importance to have a clear idea of the type of consumer pictured in the injury scenario.

It may be necessary to generate injury scenarios with different types of consumers in order to identify the highest risk and thus ‘the risk’ of the product. It is not enough, for example, to consider only the most vulnerable consumers, because the probability of their suffering adverse effects in the scenario may be so low that the risk is lower than in an injury scenario with a non-vulnerable consumer.

Consideration should also be given to people who are not actually using the product, but who may be in the vicinity of the user. For example, a chain saw may cause splinters to fly around and hit a bystander in the eye. Thus, although the risk from the chain saw may be effectively managed by the user him- or herself wearing protective equipment and complying with any other risk management measures specified by the manufacturer, bystanders may be under serious threat. Consequently, warnings should be given, for example in the chain saw instructions for use, about the risks to bystanders and how to minimise such risks.

Thus, when developing an injury scenario, the following aspects should be taken into account regarding the type of consumer and how they use the product. This is not a complete list, but it should encourage risk assessors to describe their injury scenarios with the necessary level of detail. It should be noted that ‘consumer’ also means people who are not actually using the product, but who may be affected by virtue of being nearby:

Intended/non-intended user: The intended user of a product may use the product with ease because he goes by the instructions or because he is familiar with this kind of product, including its apparent and non-apparent hazard(s). The hazard of the product may not then materialise, and the product risk could be minor.

The non-intended user may not be familiar with the product and may not recognise the hazard(s). He therefore runs the risk of injury, and the consumer risk is thus higher.

Thus, the risk may be different for an intended and a non-intended user, depending on the product and the way it is used.

Vulnerable consumers: Several categories of vulnerable and very vulnerable consumers can be distinguished: children (0 to 36 months, > 36 months to < 8 years, 8 to 14 years) and others such as the elderly (see table 1). They all have less capacity to recognise a hazard, for example children who, when touching a hot surface, notice the heat only after some 8 seconds (and then are already burnt), whereas adults notice heat immediately.

Vulnerable consumers may also have problems taking account of warning labels, or may have particular problems using a product they have never used before. They may also act in a way that makes them more exposed, for example young children crawling and mouthing. Children may also be attracted to products because of their appeal, which makes them a high risk in the hands of children. On the other hand, supervision by parents or other adults should normally prevent children from running straight into trouble.

Furthermore, consumers who are not usually vulnerable may become vulnerable in specific situations, for example when the instructions or warnings on a product are in a foreign language that the consumer does not understand.

Finally, in the particular case of chemicals, children may be more susceptible to the toxicity of chemicals than the average adult. Therefore, children should not be treated as if they were ‘small adults’.

In conclusion, a product that is normally safe for an average adult may not be safe for vulnerable consumers. This has to be taken into account when determining the severity and probability of an injury (see section 3.5) and thus the risk.

Intended and reasonably foreseeable use: Consumers may use a product for other purposes than the one for which it is intended, although the instructions are clearly understandable, including any warnings. Therefore, as warnings may not be fully effective, other uses than the intended ones also have to be taken into account in a risk assessment. This aspect is particularly important for the manufacturer of a product, since he has to ensure that the product is safe under any reasonably foreseeable conditions of use.

Reasonably foreseeable use may have to be based on experience, because there may be no information available in official accident statistics or other sources of information. It may then be difficult to draw the line between ‘reasonably foreseeable’ and ‘totally unperceived’ scenarios. Nevertheless, even ‘totally unperceived’ scenarios can be considered under these guidelines, even when they lead to very severe injuries, because such scenarios will always have very low probability. This possibly safeguards against such scenarios having too much of an influence in determining the overall risk of the product.

Frequency and duration of use: Different consumers may use a product often or not so often, and for longer or shorter periods of time. This depends on the attractiveness of the product and the ease with which it can be used. Daily or long-term use could make a consumer entirely familiar with a product and its specifics, including its hazards, instructions and warning labels, thus making the risk minor. On the other hand, daily or long-term use may make the consumer too used to the product and lead to user fatigue where he recklessly ignores instructions and warnings, thus increasing the risk.

Finally, daily or long-term use may also accelerate product ageing, and any parts that cannot withstand such frequent use may quickly fail and cause a hazard, and possibly an injury, which also increases the risk.

Hazard recognition and protective behaviour and equipment: Some products are known for their hazards, such as scissors, knives, do-it-yourself drilling machines, chain saws, roller blades, bicycles, motor bikes and cars. In all these cases, the product hazard is clearly known or readily recognisable, or described in the instructions, which will include risk management measures. The consumer can then act carefully or use personal protective equipment such as gloves, helmets or seat-belts, thereby using the product in a way that minimises the risk.

In other cases, the product hazard may not be so readily recognisable, such as a short-circuit within an electric iron, warning labels may be overlooked or misunderstood, and consumers will only rarely be able to take preventive measures.

Consumer behaviour in the event of an incident: Where the hazard impinges on the consumer it may cause injury. It is thus important for a risk assessment to consider how the consumer may react. Will he put the product to one side calmly and take preventive action, such as combating a fire caused by the product, or will he throw it away in a panic? Vulnerable consumers, especially children, may after all not behave the same as other, non-vulnerable consumers.

The consumer's cultural background and the way a product is used in his home country may influence the risk of a product. Manufacturers in particular have to take account of these cultural differences when launching a new product on a market. Manufacturers' experience in this area can thus be a valuable source of information for authorities preparing a risk assessment.

3.4.   Injury scenario: Steps leading to injury(ies)

Most injury scenarios consist of the following three main steps:

1.

the product has a ‘defect’ or can lead to a ‘dangerous situation’ during its foreseeable lifetime;

2.

the ‘defect’ or ‘dangerous situation’ results in an accident;

3.

the accident results in an injury.

These three main steps can be divided into further steps to show how the product hazard can lead to injury and the like. Nevertheless, these ‘steps to injury’ have to be clear and concise, and not exaggerate the detail or the number of steps. With experience, it will be increasingly easier to identify the conditions for the occurrence of any given injury and the ‘shortest path to injury’ (or ‘critical path to injury’).

It is probably easiest to start with a scenario with the consumer for whom the product is intended where the consumer uses the product as per the instructions or, if there are none, according to normal handling and use. If this assessment produces the highest risk level, there is normally no need to carry out further assessments, and appropriate risk reduction measures can be taken. Similarly, where an incident is reported in a specific consumer complaint, a single injury scenario may be sufficient to conclude as to appropriate risk reduction measures.

Otherwise, further scenarios could be developed to include vulnerable consumers, in particular children (see table 1), slight or more pronounced deviations from normal use, use under different climate conditions, such as very cold or very hot, unfavourable conditions of use, such as without proper daylight or illumination, use as suggested when the product was sold (for instance, a lamp sold in a toy shop should also be assessed for its risk when used by a child), use over the entire life-time (including wear and tear), etc. Each scenario should be considered through the entire risk assessment procedure.

Where the product displays several hazards, injury and thus risk scenarios should be developed for each of them. Nevertheless, a plausibility check as to whether an injury scenario might lead to a risk requiring action can limit the number of injury scenarios.

From all the scenarios generated, the scenario providing the highest risk (= ‘the risk’ of the product) will normally be decisive for the risk reduction measures to be taken, because action on the highest risk reduces the risk most effectively. An exception to the rule might be a specific, less-than-highest risk stemming from a different hazard, which could be managed by specific measures and should, of course, also cover the highest risk.

As a rule of thumb, injury scenarios can lead to the highest risk level when:

the injury(ies) considered are in the highest severity levels (levels 4 or 3);

the overall probability of an injury scenario is quite high (at least > 1/100).

Table 4 provides further guidance in this respect. This might help to limit the number of scenarios.

Of course, the number of injury scenarios remains the responsibility of the risk assessor, and it depends on the number of factors that need to be taken into account when determining ‘the risk’ of the product. It is therefore impossible to give a specific number of injury scenarios that may be necessary in a specific case.

To help develop a suitable number of scenarios, these guidelines provide a table with typical injury scenarios (table 2). These should be adapted to the specific product, consumer type and other circumstances.

3.5.   Severity of injury

The injury that a hazard can cause to the consumer can have different degrees of severity. The severity of the injury thus reflects the effect the hazard has on the consumer under the conditions described in the injury scenario.

The severity of the injury can depend on:

the type of hazard (see list of hazards of section 3.2 in table 2). A mechanical hazard, such as sharp edges, can cause cuts to the fingers; these are immediately noticed, and the consumer will take action to heal his injuries. On the other hand, a chemical hazard may cause cancer. This normally passes unnoticed, and the illness may appear only after many years, and is considered to be very severe since cancer is very difficult to cure, if at all;

how powerful the hazard is. For example, a surface heated to 50 °C may cause slight burns, whereas a surface at 180 °C will cause severe burns;

how long the hazard impinges on the consumer. A short contact time with an abrasion hazard may scratch the consumer's skin only superficially, whereas a longer time may take off large parts of the skin;

what body part is injured. For example, penetration by a sharp point into the skin of the arm is painful, but penetration into an eye is a more serious and perhaps a life-affecting injury;

what impact the hazard has on one or several body parts. An electrical hazard may cause an electric shock with unconsciousness and, subsequently, a fire which may damage the lungs when the unconscious person inhales the smoke;

the type and behaviour of the consumer. A product labelled with a warning message can be used, without harm, by an adult consumer, because the consumer adjusts to using the product. On the other hand, a child or other vulnerable consumer (see table 1) who cannot read or understand the warning label may be very seriously injured.

To quantify the severity of injury(ies), table 3 in these guidelines shows how to classify injuries into four categories, depending on the reversibility of an injury, i.e. whether recovery from an injury is possible and to what extent. This categorisation is for guidance only, and a risk assessor should change the category if necessary, and report it in the risk assessment.

Where several injury scenarios are considered in the risk assessment, the severity of each injury should be classified separately, and considered throughout the entire risk assessment process.

An example: A consumer uses a hammer to knock a nail into a wall. The hammer head is too weak (due to incorrect material) and it breaks, one of the pieces flying into the eye of the consumer so hard that it causes blindness. The injury is thus an ‘eye injury, foreign body in eye: permanent loss of sight (one eye)’, which is a level 3 injury in table 3.

3.6.   Probability of injury

The ‘probability of injury’ is the probability that injury scenario may indeed materialise during the expected lifetime of the product.

This probability is not easy to estimate; but when a scenario is described in distinct steps, each step can be given a certain probability, and multiplying these partial probabilities together gives the overall probability of the scenario. This stepwise approach should make it easier to estimate the overall probability. Of course, where several scenarios are developed, each scenario requires its own overall probability.

Where an injury scenario is nevertheless described in a single step, the probability of the scenario can also only be determined in a single overall step. This would only be a ‘guesstimate’, however, which could be severely criticised and thus call the entire risk assessment into question. A more transparent assignment of probabilities to a several-step scenario is therefore preferable, especially as the partial probabilities can be built on undisputable evidence.

These guidelines distinguish between 8 levels of probability to classify overall probability: from < 1/1 000 000 to > 50 % (see left-hand side of table 4). The following example of a hammer head that breaks when the user knocks a nail into a wall should illustrate how to assign a probability to each step, and how to classify overall probability:

Step 1:

The hammer head breaks when the user tries to knock a nail into a wall because the material of the hammer head is too weak. The weakness was determined in a test, and with the reported weakness the probability of the hammer head breaking during the otherwise expected lifetime of the hammer is put at 1/10.

Step 2:

One of the pieces of the hammer hits the user when it breaks. The probability of this happening is put at 1/10, since the area of upper body exposed to the pieces flying off is considered to be 1/10 of the half-sphere in front of the wall. Of course, if the user were standing very close to the wall, his body would take a larger share of the half-sphere, and the probability would be higher.

Step 3:

The piece hits the user on the head. The head is estimated to be about 1/3 of the upper body, and the probability is therefore 1/3.

Step 4:

The piece hits the user in the eye. The eyes are considered to be about 1/20 of the area of the head, and therefore the probability is 1/20.

Multiplying the probabilities of these steps together gives an overall probability for the scenario of 1/10 × 1/10 × 1/3 × 1/20 = 1/6 000. This translates into > 1/10 000 (see left-hand side of table 4).

Once the overall probability has been calculated for an injury scenario, it should be checked for plausibility. This requires rather a lot of experience, thus suggesting that the assistance of persons experienced in risk assessment should be sought (see section ‘Let others check your risk assessment’). As experience is gained with these guidelines estimating probability should become easier, and an increasing number of examples will become available to facilitate this task.

Assigning probabilities to different injury scenarios for the same product may lead to the following:

When the product is used by more vulnerable consumers in a scenario, the probability may have to be raised in general because more vulnerable consumers can be injured more easily. This applies in particular to children, since children do not normally have the experience to take preventive action, on the contrary (see also ‘Vulnerable consumers’ in section 3.3).

When the risk is readily recognisable, including through warning labels, the probability may have to be lowered because the user will use the product more carefully in order to avoid injury as far as possible. This may not apply to an injury scenario with a (young) child or other vulnerable user (see table 1) who cannot read.

When accidents have been reported that fit into the injury scenario, the probability for that scenario could increase. In cases where accidents have only rarely been reported, or are not known at all, it may be useful to ask the manufacturer of the product whether he is aware of any accident or adverse effect caused by the product.

When a fairly large number of conditions are needed for the injury to occur, the overall probability of the scenario would normally be lower.

When the conditions needed for the injury to occur are easily met, this may increase the probability.

When the test results of the product fail by a large margin to come within the limit values required (by the relevant standard or legislation), the probability of the injury (scenario) occurring may be higher than if the product performed close to the limit values.

The ‘probability of injury’ in this instance is the probability that the injury scenario may actually happen. Probability does not therefore describe the general exposure of the population to the product, calculated, for example, by considering the millions of product items sold on the market and then considering that a few of them might fail. Considerations of this kind do, however, play a role when determining the appropriate risk reduction measures (see section 4).

Also, accident statistics, even if product-specific, have to be considered with care when used for to estimate probability. The circumstances of the accident may not be reported in sufficient detail, the product may have changed over time, or the manufacturer may be different, and so on. In addition, light accidents may not have been reported to those collecting the data for the statistics. None the less, accident statistics can shed light on injury scenarios and their probability.

3.7.   Determination of risk

Once the severity of the injury and the probability have been determined, if possible for several injury scenarios, the risk level then needs to be looked up in table 4. Table 4 combines both the severity of the injury and the probability, and the highest risk is ‘the risk’ of the product. Risks requiring specific risk management measures should also be reported, to ensure that all risks are reduced to a minimum.

These guidelines distinguish between 4 levels of risk: serious, high, medium and low. The risk level between neighbouring severities of injury or probability normally changes by 1 level. This is consistent with the general experience that risk does not increase incrementally when input factors change gradually. However, where the severity of injury increases from level 1 to level 2 (on the right-hand side of table 4), some risk levels increase by 2 levels, namely from medium to serious and from low to high. This is due to the fact that these guidelines include 4 graduations of severity of injury, whereas the original method (see Introduction) included 5. Nevertheless, 4 graduations are considered normal for consumer products, since they make for a sufficiently robust estimation of severity; 5 levels would be too sophisticated since neither the severity of the injury nor the probability can be determined with very high precision.

At the end of the risk assessment, be it for an individual injury scenario or for the overall risk of the product, the plausibility of the risk level and uncertainties in the estimates should be considered. This may mean verifying that the risk assessor has used the best information available to make his estimations and assumptions. Feedback from colleagues and other experts can also be helpful.

A sensitivity analysis can also be very valuable (see example in section 6.3). How does the risk level change when the severity of injury or probability changes by 1 level up or down? If the risk level does not change at all, it is quite plausible that it has been estimated correctly. If it changes, however, the risk level may be borderline. It is then necessary to reconsider the injury scenarios and the assigned severity of injury(ies) and probability(ies). At the end of the sensitivity analysis the risk assessor should be confident that the risk level is sufficiently plausible and that he can document it and pass the information on.

4.    From risk to action: how to manage risk responsibly

Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer's health. Although action is separate from risk assessment, some points are raised here to illustrate the possible follow-up of identified risks.

Within market surveillance, action will often be taken in contact between the authority and the manufacturer, importer or distributor. This can help the authority to determine the most effective and efficient way of managing the risk.

With a serious risk in a consumer product, measures to reduce the risk may include withdrawal from the market or recall. Lower levels of risk normally lead to less rigorous measures. It may then be sufficient to add warning labels on the product or to improve the instructions to make the product safe. Thus, whatever the level of risk, the authority should consider whether to take action, and if so, what action.

Nevertheless, there is no automatic link from risk to action. When a product shows several less-than-serious risks, and its overall risk is thus not serious, urgent action may be necessary since any of the risks may materialise quite quickly. The pattern of risks in the product may indicate a lack of quality control in production (54).

It is also important to take account of exposure of the population as a whole. Where there are a large number of products on the market and the product is therefore used by a large number of consumers, even a single less-than-serious risk may require quick action to avoid adverse effects to the health of consumers.

Less-than-serious risks may also require action when the product concerned could cause fatal accidents, even though such accidents may be extremely unlikely. This could be the case with a fastening on a beverage container, which could come loose and be swallowed by a child, causing the child to choke to death. A simple change of design to the lid could eliminate the risk, and no further action might be required. Even a selling-off period may be granted if the risk of a fatal accident were indeed extremely small.

Other risk-related aspects may be the public perception of risk and its likely consequences, cultural and political sensitivities and how it is portrayed in the media. These aspects may be especially relevant when the consumers concerned are vulnerable, in particular children. It will be up to the national market surveillance authority(ies) to determine what measures are required.

Taking action to counteract a risk may also depend on the product itself and the ‘minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection’ (55). This minimum risk will probably be much lower for toys, where children are involved, than for a chain-saw, which is known to be so high-risk that solid protective equipment is required to keep the risk at a manageable level.

Finally, even if there is no risk, action may be necessary, for example, when a product is non-compliant with the applicable regulation/legislation (e.g. incomplete markings).

In conclusion, there is no automatic link from risk to action. Surveillance authorities will take account of a range of factors such as those indicated in section 3.3. The principle of proportionality always has to be considered, and action has to be effective.

5.    How to prepare a risk assessment — in brief

1.   Describe the product and its hazard.

Describe the product unambiguously. Does the hazard concern the entire product or only a (separable) part of the product?

Is there only one hazard within the product? Are there several hazards? See table 2 for guidance. Identify the standard(s) or legislation applicable to the product.

Identify the standard(s) or legislation applicable to the product.

2.   Identify the type of consumer you want to include in your injury scenario with the hazardous product.

Start with the intended user and the intended use of the product for your first injury scenario. Take other consumers (See table 1) and uses for further scenarios.

3.   Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected.

Describe the steps to the injury(ies) clearly and concisely, without exaggerating the details (‘shortest path to injury’, ‘critical path to injury’). If there are several concurrent injuries in your scenario, include them all in that same scenario.

When you describe the injury scenario, consider the frequency and duration of use, hazard recognition by the consumer, whether the consumer is vulnerable (in particular children), protective equipment, the consumer's behaviour in the case of an accident, the consumer's cultural background, and other factors that you consider important for the risk assessment.

See section 3.3 and table 2 for guidance.

4.   Determine the severity of the injury.

Determine the level of severity (1 to 4) of the injury to the consumer. If the consumer suffers from several injuries in your injury scenario, estimate the severity of all those injuries together.

See table 3 for guidance.

5.   Determine the probability of the injury scenario.

Assign a probability to each step of your injury scenario. Multiply the probabilities to calculate the overall probability of your injury scenario.

See left-hand side of table 4 for guidance.

6.   Determine the risk level.

Combine the severity of the injury and the overall probability of the injury scenario and check the risk level in table 4.

7.   Check whether the risk level is plausible.

If the risk level does not seem plausible, or if you are uncertain about the severity of injury(ies) or about the probability(ies), move them one level up and down and recalculate the risk. This ‘sensitivity analysis’ will show you whether the risk changes when your input changes.

If the risk level remains the same, you can be quite confident of your risk assessment. If it changes easily, you may want to err on the safe side and take the higher risk level as ‘the risk’ of the consumer product.

You could also discuss the plausibility of the risk level with experienced colleagues.

8.   Develop several injury scenarios to identify the highest risk of the product.

If your first injury scenario identifies a risk level below the highest risk level set out in these guidelines, and if you think that the product may pose a higher risk than the one identified,

select other consumers (including vulnerable consumers, in particular children);

identify other uses (including reasonably foreseeable uses),

in order to determine which injury scenario puts the product at its highest risk.

The highest risk is normally ‘the risk’ of the product that allows the most effective risk management measures. In specific cases, a particular hazard may lead to a less-than-highest risk and require specific risk management measures. This has to be taken duly into account.

As a rule of thumb, injury scenarios may lead to the highest risk level set out in these guidelines where:

the injury(ies) considered are at least at levels 3 or 4; —

the overall probability of an injury scenario is at least > 1/100.

See table 4 for guidance.

9.   Document and pass on your risk assessment.

Be transparent and also set out all the uncertainties that you encountered when making your risk assessment.

Examples for reporting risk assessments are provided in section 6 of these guidelines.

Image 3

Schematic flow of risk assessment

Pass on the risk assessment

Highest risk identified?

Yes

No

6. Look up the Risk in Table 4

See table 4: Probability levels from high (&gt; 50 %) to low (&lt; 1/1 000 000)

See table 3: Severity of injury

— Laceration, cut

— Bruising

— Concussion

— Entrapment/pinching

— Sprain, strain, musculoskeletal disorder

— Dislocation

— Fracture

— Crushing

— Amputation

— etc.

5. Determine the probability

Assign a probability to each step.

Multiply to get the overall probability

4. Determine the severity of the injury

3. Describe the Injury scenario in several steps: ‘Shortest path to injury’

See table 1: Consumer types, incl. vulnerable consumers (in particular children)

— Intended/non-intended user

— Intended and reasonably foreseeable use

— Frequency and duration of use

— Hazard recognition/protective behaviour …

— Consumer behaviour in the case of an incident

— Consumer's cultural background

See table 2: Hazards …

— Size, shape and surface

— Potential energy

— Kinetic energy

— Electrical energy

— Extreme temperatures

— Radiation

— Fire and explosion

— etc.

2. Identify consumer(s)

1. Describe the product unambiguously, and its hazard(s)

6.    Examples

6.1.   Folding chair

Image 4

A folding chair has a folding mechanism constructed in such a way that the user's fingers can get trapped between the seat and the folding mechanism. This can lead to fractures or even loss of one or more fingers.

Determination of risk(s)

Injury scenario

Injury type and location

Severity of injury

Probability of injury

Overall probability

Risk

Person unfolds the chair, grips seat close to the back corner by mistake (Person inattentive/ distracted), finger gets caught between seat and backrest

Minor pinching of finger

1

Unfolding the chair

1

1/500

Low risk

Gripping the seat at back corner while unfolding

1/50

 

Finger gets caught

1/10

> 1/1 000

Minor pinching

1

 

Person unfolds the chair, grips seat at the side by mistake (Person inattentive/ distracted), finger gets caught between seat and link

Minor pinching of finger

1

Unfolding the chair

1

1/500

Low risk

Gripping the seat at the side while unfolding

1/50

 

Finger gets caught

1/10

> 1/1 000

Minor pinching

1

 

Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat close to the corner by mistake (Person inattentive/ distracted), finger gets caught between seat and backrest

Fracture of finger

2

Unfolding the chair

1

1/500 000

Low risk

Chair clamps

1/1 000

 

Gripping the seat at corners while unfolding

1/50

 

Finger gets caught

1/10

> 1/1 000 000

Fracture of finger

1

 

Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat at the side by mistake (Person inattentive/ distracted), finger gets caught between seat and link

Fracture of finger

2

Unfolding the chair

1

1/500 000

Low risk

Chair clamps

1/1 000

 

Gripping the seat at the side while unfolding

1/50

 

Finger gets caught

1/10

> 1/1 000 000

Fracture of finger

1

 

Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and backrest

Loss of digit

3

Sitting on chair

1

1/6 000

High risk

Moves the chair while sitting

1/2

 

Grips chair at rear part while moving

1/2

 

Chair partially folds, creating a gap between the backrest and seat

1/3

> 1/10 000

Finger is between backrest and seat

1/5

 

Finger gets caught

1/10

 

Loss of (part of) finger

1/10

 

Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and link

Loss of digit

3

Sitting on chair

1

1/6 000

High risk

Moves the chair while sitting

1/2

 

Grips chair at rear part while moving

1/2

 

Chair partially folds, creating a gap between the backrest and seat

1/3

> 1/10 000

Finger is between backrest and seat

1/5

 

Finger gets caught

1/10

 

Loss of (part of) finger

1/10

 

The overall risk of the folding chair is thus ‘high risk’.

6.2.   Socket protectors

Image 5

This case deals with socket protectors. These are devices that users (parents) put into the electrical socket outlets to stop small children from accessing live parts by putting a long metal object into one of the holes in the outlet and getting a (fatal) electric shock.

The holes in this particular protector (where the pins of the plug go through) are so narrow that the pins can get stuck. This means that the user may pull the protector off the outlet when the plug is pulled out. The user may not notice this happening.

Determination of risk(s)

Injury scenario

Injury type and location

Severity of injury

Probability of injury

Overall probability

Risk

Protector is removed from the socket, which becomes unprotected.

Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and is electrocuted.

Electrocution

4

Removal of protector

9/10

27/160 000

Serious risk

Not noticing the removal of protector

1/10

 

Child is playing with thin conductible object

1/10

 

Child is unattended when playing

1/2

> 1/10 000

Child inserts the object into the socket

3/10

 

Access to voltage

1/2

 

Electrocution due to voltage (without circuit interrupter)

1/4

 

Protector is removed from the socket, which becomes unprotected.

Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and sustains shock.

Burns 2nd degree

1

Removal of protector

9/10

81/160 000

Low risk

Not noticing the removal of protector

1/10

 

Child is playing with thin conductible object

1/10

 

Child inserts the object into the socket

3/10

 

Access to voltage

1/2

> 1/10 000

Child is unattended when playing

1/2

 

Burn due to electric current (without circuit interrupter)

3/4

 

Socket unprotected.

Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and is electrocuted.

Electrocution

4

Child is playing with thin conductible object

1/10

3/80 000

High risk

Child is unattended when playing

1/100

 

Child inserts the object into the socket

3/10

 

Access to voltage

1/2

> 1/100 000

Electrocution due to voltage (without circuit interrupter)

1/4

 

The overall risk of the socket protectors is thus ‘serious’.

6.3.   Sensitivity analysis

The factors used to calculate the risk of an injury scenario, namely the severity of the injury and the probability, often have to be estimated. This creates uncertainty. Probability in particular can be difficult to estimate, since the behaviour of consumers, for example, can be difficult to predict. Does a person perform a certain action often or only occasionally?

It is therefore important to consider the level of uncertainty of the two factors and to make a sensitivity analysis. The purpose of this analysis is to establish how much the risk level varies when the estimated factors vary. The example provided on the table below only shows the variation of probability, since the severity of the injury is usually predicted with more certainty.

A practical way of performing the sensitivity analysis is to repeat the risk assessment for a certain scenario, but to use a different probability for one or more steps in the scenario. For example, a candle containing seeds could cause a fire, because the seeds can catch fire and generate high flames. Furniture or curtains can catch fire and persons not in the room could inhale toxic fumes and suffer fatal poisoning:

Injury scenario

Injury type and location

Severity of injury

Probability of injury

Resulting probability

Risk

Seeds or beans catch fire generating high flames. Furniture or curtains catch fire. Persons are not in room, but inhale toxic fumes.

Fatal poisoning

4

Seeds or beans catch fire: 90 % (0,9)

People not in the room for some time: 30 % (0,3)

Furniture or curtains catch fire: 50 % (0,5) (depends on surface on which candle is placed)

Persons inhale toxic fumes: 5 % (0,05)

0 00675 > 1/1 000

Serious

The probability levels for the steps in the scenario were estimated as shown in the table.

The overall probability is 0,00675, which corresponds to > 1/1 000 in table 4. This leads to the conclusion of ‘serious risk’. Note that the exact probability is closer to 1/100 than to 1/1 000, which already gives some confidence in the risk level because it is a little deeper in the serious risk area of table 4 than the > 1/1 000 row suggests.

Suppose we are uncertain about the 5 % probability that persons inhale the toxic fumes. We could put it at a much lower 0,1 % (0 001 = 1 in a thousand). If we recalculate with that assumption, the overall probability is 0,000135, which translates into > 1/10 000. Nevertheless, the risk is still serious. Even if for some reason the probability were to be a factor of 10 lower, the risk would still be high. Therefore, although the probability may vary 10- or 100-fold, we still find a serious or high risk (the latter being quite close to ‘serious’). Thus, this sensitivity analysis lets us confidently assess the risk as serious.

In general, however, risk assessment should be based on ‘reasonable worst cases’: not too pessimistic on every factor, but certainly not too optimistic.

Table 1

Consumers

Consumers

Description

Very vulnerable consumers

Very young children: 0 to 36 months

Others: Persons with extensive and complex disabilities

Vulnerable consumers

Young children: Children older than 36 months and younger than 8 years.

Older children: Children 8 to 14 years

Others: Persons with reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly, including those over 65, with some reduction in their physical and mental capabilities), or lack of experience and knowledge

Other consumers

Consumers other than very vulnerable or vulnerable consumers


Table 2

Hazards, typical injury scenarios and typical injuries

Hazard group

Hazard

(product property)

Typical injury scenario

Typical injury

Size, shape and surface

Product is obstacle

Person trips over product and falls; or person bumps into product

Bruising; fracture, concussion

Product is impermeable to air

Product covers mouth and/or nose of a person (typically a child), or covers internal airway

Suffocation

Product is or contains small part

Person (child) swallows small part; the part gets stuck in larynx and blocks airways

Choking, internal airway obstruction

Possible to bite off small part from product

Person (child) swallows small part; the part gets stuck in the digestive tract

Digestive tract obstruction

Sharp corner or point

Person bumps into sharp corner or is hit by moving sharp object; this causes a puncture or penetration injury

Puncture; blinding, foreign body in eye; hearing, foreign body in ear

Sharp edge

Person touches sharp edge; this lacerates the skin or cuts through tissues

Laceration, cut; amputation

Slippery surface

Person walks on surface, slips and falls

Bruising; fracture, concussion

Rough surface

Person slides along rough surface; this causes friction and/or abrasion

Abrasion

Gap or opening between parts

Person puts a limb or body in opening and finger, arm, neck, head, body or clothing is trapped; injury occurs due to gravity or movement

Crushing, fracture, amputation, strangulation

Potential energy

Low mechanical stability

Product tips; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces

Bruising; dislocation; sprain; fracture, concussion; crushing; electric shock; burns

Low mechanical strength

Product collapses by overloading; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces

Bruising; dislocation; fracture, concussion; crushing; electric shock; burns

High position of user

Person at high position on the product loses balance, has no support to hold on to and falls from height

Bruising; dislocation; fracture, concussion; crushing

Elastic element or spring

Elastic element or spring under tension is suddenly released; person in the line of movement is hit by the product

Bruising; dislocation; fracture, concussion; crushing

Pressurised liquid or gas, or vacuum

Liquid or gas under pressure is suddenly released; person in the vicinity is hit; or implosion of the product produces flying objects

Dislocation; fracture, concussion; crushing; cuts (see also under fire and explosion)

Kinetic Energy

Moving product

Person in the line of movement of the product is hit by the product or run over

Bruising; sprain; fracture, concussion; crushing

Parts moving against one another

Person puts a body part between the moving parts while they move together; the body part gets trapped and put under pressure (crushed)

Bruising; dislocation; fracture; crushing

Parts moving past one another

Person puts a body part between the moving parts while they move close by (scissor movement); the body part gets trapped between the moving parts and put under pressure (shearing)

Laceration, cut; amputation

Rotating parts

A body part, hair or clothing of a person is entangled by the rotating part; this causes a pulling force

Bruising; fracture; laceration (skin of the head); strangulation

Rotating parts close to one another

A body part, hair or clothing of a person is drawn in by the rotating parts; this causes a pulling force and pressure on the body part

Crushing, fracture, amputation, strangulation

Acceleration

Person on the accelerating product loses balance, has no support to hold on to and falls with some speed

Dislocation; fracture, concussion; crushing

Flying objects

Person is hit by the flying object and depending on the energy sustains injuries

Bruising; dislocation; fracture, concussion; crushing

Vibration

Person holding the product loses balance and falls; or prolonged contact with vibrating product causes neurological disorders, osteoarticular disorder, trauma of the spine, vascular disorder

Bruising; dislocation; fracture; crushing

Noise

Person is exposed to noise from the product. Tinnitus and hearing loss may occur depending on sound level and distance

Hearing injury

Electrical Energy

High/low voltage

Person touches part of the product that is at high voltage; the person receives an electric shock and may be electrocuted

Electric shock

Heat production

Product becomes hot; a person touching it may sustain burns; or the product may emit molten particles, steam, etc., that hits a person

Burn, scald

Live parts too close

Electric arc or sparks occur between the live parts. This may cause a fire and intense radiation

Eye injury; burn, scald

Extreme temperatures

Open flames

A person near the flames may sustain burns, possibly after clothing catches fire

Burn, scald

Hot surfaces

Person does not recognise the hot surface and touches it; the person sustains burns

Burn

Hot liquids

Person handling a container of liquid spills some of it; the liquid falls on the skin and causes scalds

Scald

Hot gases

Person breathes in the hot gases emitted from a product; this causes lung burn; or prolonged exposure to hot air causes dehydration

Burn

Cold surfaces

Person does not recognise the cold surface and touches it; the person sustains frostbite

Burn

Radiation

Ultraviolet radiation, laser

Skin or eyes of a person are exposed to radiation emitted by the product

Burn, scald; neurological disorders; eye injury; skin cancer, mutation

High intensity electromagnetic field (EMF) source; low frequency or high frequency (microwave)

Person is close to the electromagnetic field (EMF) source, body (central nervous system) is exposed

Neurological (brain) damage, leukaemia (children)

Fire and explosion

Flammable sub stances

Person is near the flammable substance; an ignition source sets the substance on fire; this causes injuries to the person

Burn

Explosive mixtures

Person is near the explosive mixture; an ignition source causes an explosion; the person is hit by the shock wave, burning material and/or flames

Burn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear

Ignition sources

The ignition source causes a fire; a person is injured by flames, or intoxicated by gases from the house fire

Burn; poisoning

Overheating

Product overheats; fire, explosion

Burn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear

Toxicity

Toxic solid or fluid

Person ingests substance from product,

e.g. by putting it in mouth, and/or substance gets on skin

Acute poisoning; irritation, dermatitis

Person breathes in solid or fluid, for example vomited material (pulmonary aspiration)

Acute poisoning in lungs (aspiration pneumonia); infection

Toxic gas, vapour or dust

Person inhales substance from product; and/or substance gets on skin

Acute poisoning in lungs; irritation, dermatitis

Sensitising substance

Person ingests substance from product,

e.g. by putting it in mouth; and/or substance gets on skin; and/or person inhales gas, vapour or dust

Sensitisation; allergic reaction

Irritating or corrosive solid or fluid

Person ingests substance from product,

e.g. by putting it in mouth, and/or substance gets on skin or in eyes

Irritation, dermatitis; skin burn; eye injury, foreign body in eye

Irritating or corrosive gas or vapour

Person inhales substance from product, and/or substance gets on skin or in eyes

Irritation, dermatitis; skin burn; acute poisoning or corrosive effect in lungs or in eyes

CMR substance

Person ingests substance from product, e.g. by putting it in mouth, and/or substance gets onto skin; and/or person inhales substance as gas, vapour or dust

Cancer, mutation, reproductive toxicity

Microbiological contamination

Microbiological contamination

Person gets into contact with contaminated product by ingestion, inhalation or skin contact

Infection, local or systemic

Product operating hazards

Unhealthy posture

Design causes unhealthy posture of person when operating the product

Strain; musculoskeletal disorder

Overexertion

Design requires use of considerable force when operating the product

Sprain or strain; musculoskeletal disorder

Anatomical unsuitability

Design is not adapted to human anatomy, which makes it difficult or impossible to operate

Sprain or strain

Ignoring personal protection

Design makes it difficult for a person wearing protection to handle or operate the product

Various injuries

Inadvertent (de)activation

Person can easily (de)activate product, which leads to unwanted operation

Various injuries

Operational inadequacy

Design provokes faulty operation by a person; or product with a protective function does not provide expected protection

Various injuries

Failure to stop

Person wants to stop the product, but it continues to operate in situation where this is unwanted

Various injuries

Unexpected start

Product shuts down during a power failure, but resumes operation in a hazardous way

Various injuries

Inability to stop

In an emergency situation, person is not able to stop operation of the product

Various injuries

Inadequately fitting parts

Person tries to fit a part, needs too much force to fit, product breaks; or part is too loosely fitted and becomes loose during use

Sprain or strain; laceration, cut; bruising; entrapment

Missing or incorrectly fitted protection

Hazardous parts are reachable for a per son

Various injuries

Insufficient warning instructions, signs and symbols

User does not notice warning instructions signs and/or does not understand symbols

Various injuries

Insufficient warning signals

User does not see or hear warning signal (optical or audio), causing dangerous operation

Various injuries

NB: This table is for guidance only; the typical injury scenarios should be adapted when preparing a risk assessment. There is specific risk assessment guidance for chemicals, cosmetics and possibly others. It is highly recommended to use this specific guidance when assessing such products. See section 3.2.

Table 3

Severity of injury

Introduction

These risk assessment guidelines distinguish between four levels of injury harm severity. It is important to realise that severity should be assessed completely objectively. The aim is to compare the severity of different scenarios and to set priorities, not to judge the acceptability of a single injury at this stage. Any injury harm that could easily have been avoided will be difficult to accept for a consumer. However, authorities can justifiably invest more effort into avoiding irreversible consequences than into preventing temporary discomfort.

In order to assess the severity of the consequences (acute injury or other damage to health), objective criteria can be found, on the one hand, in the level of medical intervention, and, on the other hand, in the consequences to the further functioning of the victim. Both could be expressed as cost, but the costs of consequences of health damage may be difficult to quantify.

Combining these criteria, the four levels may be defined as follows:

1.

Harm or consequence that after basic treatment (first aid, normally not by a doctor) does not substantially hamper functioning or cause excessive pain; usually the consequences are completely reversible.

2.

Harm or consequence for which a visit to A&E may be necessary, but in general, hospitalisation is not required. Functioning may be affected for a limited period, not more than about 6 months, and recovery is more or less complete.

3.

Harm or consequence that normally requires hospitalisation and will affect functioning for more than 6 months or lead to a permanent loss of function.

4.

Harm or consequence that is or could be fatal, including brain death; consequences that affect reproduction or offspring; severe loss of limbs and/or function, leading to more than approximately 10 % of disability.

The following table, which should be considered as a guide rather than prescriptive or complete, provides examples of injuries at all four levels. National differences may exist, either cultural or caused by different systems of health care and financial arrangements. However, deviating from the proposed classification in the table will affect uniform assessment of risks in the EU; this should be clearly stated and explained in the risk assessment report, and reasons should be given.

Type of injury

Severity of injury

1

2

3

4

Laceration, cut

Superficial

External (deep)

(> 10 cm long on body)

(> 5 cm long on face) requiring stitches

Tendon or into joint

White of eye or cornea

Optic nerve Neck artery Trachea Internal organs

Bronchial tube Oesophagus Aorta

Spinal cord (low)

Deep laceration of internal organs

Severed high spinal cord

Brain (severe lesion/

dysfunction)

Bruising (abrasion/ contusion, swelling, oedema)

Superficial

≤ 25 cm2 on face

≤ 50 cm2 on body

Major

> 25 cm2 on face

> 50 cm2 on body

Trachea

Internal organs (minor)

Heart Brain

Lung, with blood or air in chest

Brain stem

Spinal cord causing paralysis

Concussion

Very short unconsciousness (minutes)

Prolonged unconsciousness

Coma

Entrapment/ pinching

Minor pinching

(Use as appropriate the final outcomes of bruising, crushing, fracture, dislocation, amputation, as applicable.)

(Same outcome as for suffocation/ strangulation.)

Sprain, strain, musculoskeletal disorder

Extremities

Joints

Spine (no dislocation or fracture)

Knee ligaments strain

Ligament or tendon rupture/tear

Muscle tear

Whiplash

Dislocation

Extremities (finger, toe, hand, foot)

Elbow

Jaw

Loosening of tooth

Ankle

Wrist

Shoulder

Hip

Knee

Spine

Spinal column

Fracture

Extremities (finger, toe, hand, foot)

Wrist

Arm

Rib

Sternum

Nose

Tooth

Jaw

Bones around eye

Ankle

Leg

(femur and lower leg)

Hip

Thigh

Skull

Spine (minor compression fracture)

Jaw (severe)

Larynx

Multiple rib fractures Blood or air in chest

Neck

Spinal column

Crushing

Extremities (fingers, toe, hand, foot)

Elbow

Ankle

Wrist

Forearm

Leg

Shoulder

Trachea

Larynx

Pelvis

Spinal cord Mid-low neck Chest

(massive crushing)

Brain stem

Amputation

Finger(s)

Toe(s)

Hand

Foot

(Part of) Arm

Leg

Eye

Both extremities

Piercing, puncturing

Limited depth, only skin involved

Deeper than skin

Abdominal wall (no organ involvement)

Eye

Internal organs

Chest wall

Aorta Heart

Bronchial tube

Deep injuries in organs (liver, kidney, bowel, etc.)

Ingestion

Internal organ injury

(Refer also to internal airway obstruction where the ingested object gets stuck high in the oesophagus.)

Permanent damage to internal organ

Internal air way obstruction

Oxygen flow to brain blocked without permanent consequences

Oxygen flow to brain blocked with permanent consequences

Suffocation/ Strangulation

Oxygen flow to brain blocked without permanent consequences

Fatal suffocation/ strangulation

Submersion/ Drowning

Fatal drowning

Burn/Scald (by heat, cold, or chemical substance)

1°, up to 100 % of body surface

2°, < 6 % of body surface

2°, 6-15 % of body surface

2°, 16-35 % of body surface, or 3°, up to 35 % of body surface

Inhalation burn

2° or 3°, > 35 % of body surface

Inhalation burn requiring respiratory assistance

Electric shock

(See also under burns as electric current can cause burns.)

Local effects (temporary cramp or muscle paralysis)

Electrocution

Neurological disorders

Triggered epileptic seizure

Eye injury, foreign body in eye

Temporary pain in eye without need for treatment

Temporary loss of sight

Partial loss of sight

Permanent loss of sight (one eye)

Permanent loss of sight (both eyes)

Hearing injury, foreign body in ear

Temporary pain in ear without need for treatment

Temporary impairment of hearing

Partial loss of hearing

Complete loss of hearing (one ear)

Complete loss of hearing (both ears)

Poisoning from substances (ingestion, inhalation, dermal)

Diarrhoea, vomiting, local symptoms

Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia

Irreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nerve system

Irreversible damage to nerve system

Fatality

Irritation, dermatitis, inflammation or corrosive effect of substances (inhalation, dermal)

Local slight irritation

Reversible eye damage

Reversible systemic effects

Inflammatory effects

Lungs, respiratory insufficiency, chemical pneumonia

Irreversible systemic effects

Partial loss of sight Corrosive effects

Lungs, requiring respiratory assistance

Asphyxia

Allergic reaction or sensitisation

Mild or local allergic reaction

Allergic reaction, widespread allergic contact dermatitis

Strong sensitisation, provoking allergies to multiple substances

Anaphylactic reaction, shock

Fatality

Long-term damage from contact with substances or from exposure to radiation

Diarrhoea, vomiting, local symptoms

Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia

Damage to nervous system, e.g. Organic Psycho Syndrome (OPS; also called Chronic Toxic Encephalopathy, also known as ‘painters' disease’). Irreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nervous system

Cancer (leukaemia)

Effects on reproduction Effects on offspring

CNS depression

Microbiological infection

 

Reversible damage

Irreversible effects

Infection requiring prolonged hospitalisation, antibiotics-resistant organisms

Fatality

Table 4

Risk level from the combination of the severity of injury and probability

Probability of damage during foreseeable lifetime of the product

Severity of injury

1

2

3

4

High

Image 6

Low

>50 %

H

S

S

S

> 1/10

M

S

S

S

> 1/100

M

S

S

S

> 1/1 000

L

H

S

S

> 1/10 000

L

M

H

S

> 1/100 000

L

L

M

H

> 1/1 000 000

L

L

L

M

< 1/1 000 000

L

L

L

L

S — Serious Risk

H — High risk

M — Medium risk

L — Low risk

Glossary of terms

Hazard: Source of danger involving the chance of being injured or harmed. A means of quantifying the hazard in a risk assessment is the severity of the possible injury or harm.

Product hazard: Hazard created by the properties of a product.

Risk: Balanced combination of a hazard and the probability that damage will occur. Risk describes neither the hazard, nor the probability, but both at the same time.

Risk assessment: Procedure for identifying and assessing hazards, consisting of three steps:

1.

identification of the seriousness of a hazard;

2.

determination of the probability that a consumer will be injured by that hazard;

3.

combination of the hazard with the probability.

Risk level: Degree of risk, which may be ‘serious’, ‘high’, ‘medium’ and ‘low’. When the (highest) level of risk has been identified, the risk assessment is complete.

Risk management: Follow-up action, which is separate from risk assessment and aims to reduce or eliminate a risk.


(1)  In other places of these Guidelines, the term ‘Commission’ generally refers to the RAPEX team established in the Commission department responsible for Directive 2001/95/EC and to the relevant Commission services, where appropriate.

(2)  The Information and Communication System on Market Surveillance (‘ICSMS’). This platform is aimed at facilitating communication between market surveillance bodies in the EU and in EFTA countries on non-compliant products.

(3)  In the context of this document, the term ‘Member States’ must be interpreted as not precluding all other actors from being addressed by the provisions contained in these Guidelines.

(4)  See the latest EC Implementing Decision published on https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm

(5)  See recital 10 of Directive 2001/95/EC.

(6)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(7)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(8)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

(9)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(10)  Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).

(11)  Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

(12)  See EU general risk assessment methodology (Action 5 of Multi-Annual Action Plan for the surveillance of products in the EU (COM(2013)76) providing guidance to authorities with relation to Article 20(2) of Regulation (EC) No 765/2008: http://ec.europa.eu/DocsRoom/documents/17107/attachments/1/translations

(13)  See https://ec.europa.eu/consumers/consumer-safety/rag/#/screen/home

(14)  www.ec.europa.eu/rapex

(15)  See Part I, Chapter 6.2 of these Guidelines.

(16)  See Part II, Chapter 2.2.1 of these Guidelines.

(17)  See Part II, Chapter 2.2.1 of these Guidelines.

(18)  See Part II, Chapter 2.2.2 of these Guidelines.

(19)  See Part II, Chapter 2.2.2 of these Guidelines.

(20)  For more information on follow-up actions, see Part II Chapter 4.4.5 of these Guidelines.

(21)  For more information about notifications where safety aspects are subject to discussions at EU level, see Part II Chapters 3.4.4 and 3.4.7.1.1 of these Guidelines.

(22)  See point 10 of Annex II of Directive 2001/95/EC.

(23)  See point 9 of Annex II of Directive 2001/95/EC.

(24)  For more information on notifications on safety aspects subject to discussions at EU level, see Part II Chapters 3.1.2(d) and 3.4.7.1.1.

(25)  https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.search

(26)  Practice already agreed at the GPSD Committee of 24 September 2012, of which RAPEX Contact Points were informed at the RAPEX Contact Point meeting of 4 October (agenda point 4) and applied since 2013.

(27)  Paragraph 1 of Article 16(1) of Directive 2001/95/EC and Article 23 paragraph 3 in relation to Article 19(5) of Regulation (EC) No 765/2008.

(28)  Article 16(1) and (2) of Directive 2001/95/EC.

(29)  For more information on the notification criteria, see Part I Chapter 2.

(30)  For more information on notifications sent through the RAPEX application before measures are taken, see Chapter 3.1.2(b).

(31)  For more information on notifications on safety aspects subject to discussions at EU level, see Part II Chapters 3.1.2.d and 3.4.4.

(32)  For more information about deadlines, see Part III Appendix 4 of these Guidelines.

(33)  All deadlines mentioned in these Guidelines are expressed in calendar days.

(34)  See point 10 of Annex II of Directive 2001/95/EC.

(35)  For the purpose of these Guidelines, ‘economic operator’ refers to any natural of legal person defined as ‘economic operator’ in Regulation (EC) No 765/2008 or as ‘producer’ and ‘distributor’ in the GPSD.

(36)  https://webgate.ec.europa.eu/etranslation/translateDocument.html

(37)  There is no need to send notifications via the Permanent Representation of a Member State to the EU.

(38)  See Part I, Chapter 5.3 of these Guidelines.

(39)  The fields contained in the template may be updated following developments agreed between the Commission and Member States.

(40)  The fields contained in the template may be updated following developments agreed between the Commission and Member States.

(41)  If you need more information on the Risk Assessment method for harmonised products (both consumer and professional products) in relation to broader categories of public risks protected under EU harmonisation legislation, please refer to Part I, Chapter 5.3.

(42)  Benis HG (1990): A Product Risk Assessment Nomograph, report prepared for the New Zealand Ministry of Consumer Affairs, dated February 1990. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

(43)  Method used by the Belgian authorities. Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices. Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.

(44)  Commission Decision 2004/418/EC of 29 April 2004 laying down guidelines for the management of the EU Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC (OJ L 151, 30.4.2004, p. 83).

(45)  Directive 2001/95/EC.

(46)  https://webgate.ec.europa.eu/idbpa/.

(47)  

NB: uncertainty always has to be taken into account when comparing a test result with a limit. See, for example:

the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation …’ https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue_en

the Summary report on the ‘Preparation of a working document in support of the uniform interpretation of legislative standards and the laboratory quality standards prescribed under Directive 93/99/EEC’. http://ec.europa.eu/food/fs/scoop/9.1_sr_en.pdf

(48)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(49)  OJ L 164, 26.6.2009, p. 7.

(50)  Standard EN 71-1:2005, section 8.2 +A6:2008.

(51)  Article 10 of Regulation (EC) No 1223/2009 (OJ L 342, 22.12.2009, p. 59).

(52)  REACH Regulation and guidance documents on REACH, see http://echa.europa.eu/ European Chemicals Agency (2008). The Guidance on Information Requirements and Chemical Safety Assessment: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

(53)  Commission Implementing Decision 2013/674/EU of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 315, 26.11.2013, p. 82); SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 9th revision, 29 September 2015, SCCS/1564/15, revision of 25 April 2016: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_190.pdf

(54)  See Part I Chapter 1.1, penultimate paragraph.

(55)  This is taken from the definition of ‘safe product’ in Article 2(b) of Directive 2001/95/EC.


15.3.2019   

EN

Official Journal of the European Union

L 73/188


COMMISSION DECISION (EU) 2019/418

of 13 March 2019

amending Decisions (EU) 2017/1214, (EU) 2017/1215, (EU) 2017/1216, (EU) 2017/1217, (EU) 2017/1218 and (EU) 2017/1219

(notified under document C(2019) 1851)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (1), and in particular Article 8(2) thereof,

After consulting the European Union Ecolabelling Board,

Whereas:

(1)

Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products with a reduced environmental impact during their entire life cycle. Specific EU Ecolabel criteria are to be established for each product group.

(2)

Commission Decisions (EU) 2017/1214 (2), (EU) 2017/1215 (3), (EU) 2017/1216 (4), (EU) 2017/1217 (5), (EU) 2017/1218 (6) and (EU) 2017/1219 (7) establish the criteria and related assessment and verifications requirements for, respectively, hand dishwashing detergents, industrial and institutional dishwasher detergents, dishwasher detergents, hard surface cleaning products, laundry detergents, and industrial and institutional laundry detergents.

(3)

A number of national competent bodies that award the EU Ecolabel have informed the Commission of difficulties in implementing some of the criteria established by those Decisions. In particular, substances present as impurities in some ingredients (for example, phosphates) are required under the criteria to be excluded from the final detergent product, regardless of their concentration, but it is not technically feasible at present to remove those impurities.

(4)

The Decisions listed in recital 2 repealed and replaced previous Commission Decisions in the same field. Under the previous Decisions, impurities and by-products were required to comply with the criteria only if they were present in concentrations at or above 0,010 % by weight of final formulation. The Commission has carried out an assessment and concluded that, in line with the previous Decisions, a minimum concentration threshold of 0,010 % by weight of final formulation should be established, for both by-products and impurities from raw materials, for the purposes of compliance with each of the criteria in the Decisions listed in recital 2.

(5)

Decision (EU) 2017/1217 repealed and replaced Commission Decision 2011/383/EU (8) for the product group ‘All-purpose cleaners and sanitary cleaners’. A transitional period of 18 months was laid down in Decision (EU) 2017/1217 so that producers of products awarded the EU Ecolabel on the basis of the criteria set out in Decision 2011/383/EU would have sufficient time to adapt their products to comply with the revised criteria set out in Decision (EU) 2017/1217. That transitional period expires on 26 December 2018. A number of national competent bodies have informed the Commission of the need to prolong the transitional period by six months due to the large volume of applications for renewal of contracts granting the EU Ecolabel. The Commission has carried out an assessment and confirmed the need, exceptionally in this case, to extend the transitional period by six months.

(6)

Decisions (EU) 2017/1218 and (EU) 2017/1219 each include a derogation granted under Article 6(7) of Regulation (EC) No 66/2010 for ε-phthalimido-peroxy-hexanoic acid (PAP) when classified as hazardous to the aquatic environment: Acute Hazard, Category 1 (H400) or as hazardous to the aquatic environment: Chronic Hazard, Category 3 (H412) up to a maximum concentration of 0,6 g/kg of laundry. Those derogations were granted because it was recognised that PAP had an important function as a bleaching agent in detergents covered by those Decisions and because it underwent a high level of degradation during the wash process.

(7)

During the wash process PAP degrades into ε-phthalimido hexanoic acid (PAC). This substance is non-peroxidic, readily biodegradable and not hazardous to the environment. As PAP quickly degrades to PAC and never reaches the discharged water, it is more appropriate to use the degradation factors of PAC for PAP when calculating the critical dilution volume of the product. A similar approach has already been used in Decision (EU) 2017/1219 where separate rules have been applied for the calculation of the critical dilution volume for the substance hydrogen peroxide, which degrades to peracetic acid during the wash process. Decision (EU) 2017/1219 should therefore be amended to apply separate rules for calculating the critical dilution volume for PAP by using the degradation values of PAC.

(8)

PAP is mainly used as a bleaching agent in professional multi-component laundry detergents, not in domestic laundry detergents. The current derogation for PAP in Decision (EU) 2017/1218 is therefore unnecessary and should be removed.

(9)

For the sake of clarity, in the Annex to Decision (EU) 2017/1218, Table 3 should be amended to add a column showing the substance's classification according to Regulation (EC) No 1272/2008.

(10)

Decisions (EU) 2017/1214, (EU) 2017/1215, (EU) 2017/1216, (EU) 2017/1217, (EU) 2017/1218 and (EU) 2017/1219 should therefore be amended accordingly.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:

Article 1

In the Annex to Decision (EU) 2017/1214, in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’.

Article 2

In the Annex to Decision (EU) 2017/1215, in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’.

Article 3

In the Annex to Decision (EU) 2017/1216, in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’.

Article 4

Decision (EU) 2017/1217 is amended as follows:

(a)

in Article 7, paragraph 3 is replaced by the following:

‘3.   EU Ecolabel licences awarded in accordance with the criteria set out in Decision 2011/383/EU may be used until 30 June 2019.’;

(b)

in the Annex, in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’.

Article 5

The Annex to Decision (EU) 2017/1218 is amended as follows:

(a)

in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’;

(b)

in Criterion 5 (Excluded and restricted substances), in point (b)(ii), Table 3 (Derogated substances) is replaced by the table set out in the Annex to this Decision.

Article 6

The Annex to Decision (EU) 2017/1219 is amended as follows:

(a)

in Criterion 1 (‘Toxicity to aquatic organisms’), the last paragraph is replaced by the following:

‘Because of the degradation of certain substances in the wash process, separate rules apply to the following:

hydrogen peroxide (H2O2) — not to be included in calculation of CDV,

peracetic acid — to be included in the calculation as “acetic acid”,

ε-phthalimido-peroxy-hexanoic acid (PAP) — to be included in the calculation as ε-phthalimido hexanoic acid (PAC).

The values to be used to calculate the CDV[ chronic ] for ε-phthalimido hexanoic acid (PAC) shall be as follows:

 

DF(i) = 0,05

 

TF chronic(i) = 0,256 mg/l

 

Aerobic = R

 

Anaerobic = O;’;

(b)

in the Annex, in the section headed ‘Assessment and Verification’, in point (b) (Measurement thresholds), in Table 1, the asterisk note (*) is replaced by the following:

‘(*)

“no limit” means: regardless of the concentration (analytical limit of detection) for all ingoing substances with the exception of by-products and impurities from raw materials, which can be present up to a concentration of 0,010 % by weight in the final formulation;’.

Article 7

This Decision is addressed to the Member States.

Done at Brussels, 13 March 2019.

For the Commission

Karmenu VELLA

Member of the Commission


(1)  OJ L 27, 30.1.2010, p. 1.

(2)  Commission Decision (EU) 2017/1214 of 23 June 2017 establishing the EU Ecolabel criteria for hand dishwashing detergents (OJ L 180, 12.7.2017, p. 1).

(3)  Commission Decision (EU) 2017/1215 of 23 June 2017 establishing the EU Ecolabel criteria for industrial and institutional dishwasher detergents (OJ L 180, 12.7.2017, p. 16).

(4)  Commission Decision (EU) 2017/1216 of 23 June 2017 establishing the EU Ecolabel criteria for dishwasher detergents (OJ L 180, 12.7.2017, p. 31).

(5)  Commission Decision (EU) 2017/1217 of 23 June 2017 establishing the EU Ecolabel criteria for hard surface cleaning products (OJ L 180, 12.7.2017, p. 45).

(6)  Commission Decision (EU) 2017/1218 of 23 June 2017 establishing the EU Ecolabel criteria for laundry detergents (OJ L 180, 12.7.2017, p. 63).

(7)  Commission Decision (EU) 2017/1219 of 23 June 2017 establishing the EU Ecolabel criteria for industrial and institutional laundry detergents (OJ L 180, 12.7.2017, p. 79).

(8)  Commission Decision 2011/383/EU of 28 June 2011 establishing the ecological criteria for the award of the EU Ecolabel to all-purpose cleaners and sanitary cleaners (OJ L 169, 29.6.2011, p. 52).


ANNEX

Substance

Classification according to Regulation (EC) No 1272/2008

Hazard statement

Surfactants

Hazardous to the aquatic environment — Acute Hazard, Category 1

H400: Very toxic to aquatic life

Hazardous to the aquatic environment — Chronic Hazard, Category 3

H412: Harmful to aquatic life with long-lasting effects

Subtilisin

Hazardous to the aquatic environment — Acute Hazard, Category 1

H400: Very toxic to aquatic life

Hazardous to the aquatic environment — Chronic Hazard, Category 2

H411: Toxic to aquatic life with long-lasting effects

Enzymes (1)

Skin Sensitisation, Hazard Category 1, 1A, 1B

H317: May cause allergic skin reaction

Respiratory Sensitisation, Hazard Category 1, 1A, 1B

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled

NTA as an impurity in MGDA and GLDA (2)

Carcinogenicity, Hazard Category 2

H351: Suspected of causing cancer


(1)  

(*2)

Including stabilisers and other auxiliary substances in the preparations.

(2)  

(*3)

In concentrations lower than 0,2 % in the raw material as long as the total concentration in the final product is lower than 0,10 %.

Corrigenda

15.3.2019   

EN

Official Journal of the European Union

L 73/193


Corrigendum to Commission Delegated Regulation (EU) 2019/401 of 19 December 2018 amending Regulation (EU) No 389/2013 establishing a Union Registry

( Official Journal of the European Union L 72 of 14 March 2019 )

On page 5, Article 1:

for:

‘Article 1

In Article 41(4) of Regulation (EU) No 389/2013, the following paragraph is added:

“4.   From the day following the one on which both ratification instruments concerning the Withdrawal Agreement have been deposited, allowances created for 2019 and 2020 shall not be identified with a country code if compliance with Directive 2003/87/EC for emissions taking place during these years is required by an agreement setting out arrangements for the withdrawal of such a Member State from the European Union.”’,

read:

‘Article 1

In Article 41(4) of Regulation (EU) No 389/2013, the following paragraph is added:

“From the day following the one on which both ratification instruments concerning the Withdrawal Agreement have been deposited, allowances created for 2019 and 2020 shall not be identified with a country code if compliance with Directive 2003/87/EC for emissions taking place during these years is required by an agreement setting out arrangements for the withdrawal of such a Member State from the European Union.”’.