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Document L:2022:118:FULL

Official Journal of the European Union, L 118, 20 April 2022


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 118

European flag  

English edition

Legislation

Volume 65
20 April 2022


Contents

 

I   Legislative acts

page

 

 

REGULATIONS

 

*

Regulation (EU) 2022/641 of the European Parliament and of the Council of 12 April 2022 amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta ( 1 )

1

 

 

DIRECTIVES

 

*

Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta ( 1 )

4

 

 

II   Non-legislative acts

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2022/643 of 10 February 2022 amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides, industrial chemicals, persistent organic pollutants and mercury and an update of customs codes ( 1 )

14

 

 

DECISIONS

 

*

Council Decision (EU) 2022/644 of 12 April 2022 on the position to be adopted on behalf of the European Union within the International Maritime Organization’s Maritime Safety Committee during its 105th session and within the International Maritime Organization’s Facilitation Committee during its 46th session as regards the adoption of amendments to the resolutions on performance standards in relation to equipment used in the Global Maritime Distress and Safety System and of amendments to the Annex to the Convention on Facilitation of International Maritime Traffic (FAL)

55

 

 

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

 

*

Bilateral Oversight Board for the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety – Record of decision – Decision N°0010 [2022/645]

58

 

*

Bilateral Oversight Board for the Agreement between the United States of America and the European Community on cooperation in the regulation of civil aviation safety – Record of decision – Decision N°0011 [2022/646]

68

 

*

Decision of the EU/ICAO joint Committee of 10 March 2022 on the adoption of a Working Arrangement between the European Union and the International Civil Aviation Organization regarding the cooperation in the area of accident and incident reporting in civil aviation (2022/647)

79

 


 

(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.


I Legislative acts

REGULATIONS

20.4.2022   

EN

Official Journal of the European Union

L 118/1


REGULATION (EU) 2022/641 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 April 2022

amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (3) (the ‘Withdrawal Agreement’) was concluded on behalf of the Union by Council Decision (EU) 2020/135 (4) and entered into force on 1 February 2020. The transition period referred to in Article 126 of the Withdrawal Agreement, during which Union law continued to apply to and in the United Kingdom in accordance with Article 127 of the Withdrawal Agreement, ended on 31 December 2020. On 25 January 2021, the Commission issued a Notice (5) on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicinal products supply from or through Great Britain, namely Cyprus, Ireland, Malta and Northern Ireland, after the end of that transition period. That Notice includes explanations of how the Commission was to apply the Union’s pharmaceutical acquis in those markets with regard to investigational medicinal products. That Notice ceased to apply on 31 December 2021.

(2)

In accordance with the Protocol on Ireland/Northern Ireland (the ‘Protocol’), which forms an integral part of the Withdrawal Agreement, the provisions of Union law listed in Annex 2 to the Protocol apply, under the conditions set out in that Annex, to and in the United Kingdom in respect of Northern Ireland. That list includes Chapter IX of Regulation (EU) No 536/2014 of the European Parliament and of the Council (6) regarding the manufacturing and import of investigational medicinal products and auxiliary medicinal products. Therefore, investigational medicinal products used in clinical trials in Northern Ireland are to comply with those provisions of Union law.

(3)

Regulation (EU) No 536/2014 lays down the rules for investigational medicinal products intended to be used in clinical trials in the Union. That Regulation applies from 31 January 2022.

(4)

In accordance with Article 61(1) of Regulation (EU) No 536/2014, read in conjunction with the Protocol, the import of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the holding of a manufacturing and import authorisation. Cyprus, Ireland, Malta and Northern Ireland have historically relied on the supply of medicinal products, including investigational medicinal products, from or through parts of the United Kingdom other than Northern Ireland, and the supply chains for those markets have not yet been fully adapted to comply with Union law. To ensure that clinical trial participants in Northern Ireland, as well as in Cyprus, Ireland and Malta continue to have access to new, innovative or improved treatments, it is necessary to amend Regulation (EU) No 536/2014 to provide for a derogation from the requirement of the holding of a manufacturing and import authorisation for investigational medicinal products imported into those markets from parts of the United Kingdom other than Northern Ireland. To ensure the quality of those investigational medicinal products and to avoid compromising the integrity of the internal market, certain conditions should be laid down.

(5)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(6)

Regulation (EU) No 536/2014 should therefore be amended accordingly.

(7)

To ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

(8)

To ensure legal continuity for operators active in the pharmaceutical sector and to guarantee the continuous access of participants in clinical trials in Cyprus, Ireland, Malta and Northern Ireland to investigational medicinal products from the date of application of Regulation (EU) No 536/2014, this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union and should apply retroactively from 31 January 2022,

HAVE ADOPTED THIS REGULATION:

Article 1

In Article 61(1) of Regulation (EU) No 536/2014, the following subparagraph is added:

‘However, the import of investigational medicinal products from other parts of the United Kingdom into Northern Ireland and, until 31 December 2024, into Cyprus, Ireland and Malta shall not be subject to the holding of such an authorisation provided that all of the following conditions are fulfilled:

(a)

the investigational medicinal products have undergone certification of batch release either in the Union or in parts of the United Kingdom other than Northern Ireland to verify compliance with the requirements set out in Article 63(1);

(b)

the investigational medicinal products are only made available to subjects in the Member State into which those investigational medicinal products are imported or, if imported into Northern Ireland, are only made available to subjects in Northern Ireland.’

Article 2

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

It shall apply from 31 January 2022.

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

Done at Brussels, 12 April 2022.

For the European Parliament

The President

R. METSOLA

For the Council

The President

C. BEAUNE


(1)  Opinion of 24 February 2022 (not yet published in the Official Journal).

(2)  Position of the European Parliament of 7 April 2022 (not yet published in the Official Journal) and decision of the Council of 12 April 2022.

(3)  OJ L 29, 31.1.2020, p. 7.

(4)  Council Decision (EU) 2020/135 of 30 January 2020 on the conclusion of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 1).

(5)  Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period (2021/C 27/08) (OJ C 27, 25.1.2021, p. 11).

(6)  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).


DIRECTIVES

20.4.2022   

EN

Official Journal of the European Union

L 118/4


DIRECTIVE (EU) 2022/642 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 April 2022

amending Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (3) (the ‘Withdrawal Agreement’) was concluded on behalf of the Union by Council Decision (EU) 2020/135 (4) and entered into force on 1 February 2020. The transition period referred to in Article 126 of the Withdrawal Agreement, during which Union law continued to apply to and in the United Kingdom in accordance with Article 127 of the Withdrawal Agreement, ended on 31 December 2020. On 25 January 2021, the Commission issued a Notice (5) on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicinal products supply from or through Great Britain, namely Cyprus, Ireland, Malta and Northern Ireland, from the end of that transition period until 31 December 2021.

(2)

In accordance with the Protocol on Ireland/Northern Ireland (the ‘Protocol’), which forms an integral part of the Withdrawal Agreement, the provisions of Union law listed in Annex 2 to the Protocol apply, under the conditions set out in that Annex, to and in the United Kingdom in respect of Northern Ireland. That list includes Article 13 of Directive 2001/20/EC of the European Parliament and of the Council (6) regarding the manufacture and import of investigational medicinal products, Directive 2001/83/EC of the European Parliament and of the Council (7) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (8). Therefore, medicinal products placed on the market in Northern Ireland are to comply with those provisions of Union law.

(3)

Directives 2001/20/EC and 2001/83/EC lay down the rules for medicinal products for human use and investigational medicinal products intended to be placed on the market in the Member States.

(4)

Cyprus, Ireland, Malta and Northern Ireland have historically relied on the supply of medicinal products from or through parts of the United Kingdom other than Northern Ireland, and the supply chains for those markets have not yet been fully adapted to comply with Union law. To prevent shortages of medicinal products and ultimately to ensure a high level of public health protection, Directives 2001/20/EC and 2001/83/EC need to be amended to provide for derogations for medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from or through parts of the United Kingdom other than Northern Ireland. In order to ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

(5)

In accordance with Article 13(1) of Directive 2001/20/EC, read in conjunction with the Protocol, the import of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the holding of a manufacturing and import authorisation. To ensure continued access to new, innovative or improved treatments for clinical trial participants in Northern Ireland, as well as in Cyprus, Ireland and Malta after 31 December 2021, such a manufacturing and import authorisation should not be required for investigational medicinal products imported into those markets from parts of the United Kingdom other than Northern Ireland provided that certain conditions are fulfilled. To ensure uniform application of Union law in the Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a temporary nature only.

(6)

Regulation (EC) No 726/2004 lays down Union procedures for the authorisation of medicinal products. Upon authorisation in the Union, medicinal products are available to patients in Northern Ireland. It is possible, however, that the competent authorities of the United Kingdom in respect of parts of the United Kingdom other than Northern Ireland issue a marketing authorisation for a medicinal product before a marketing authorisation has been granted for the same medicinal product in the Union. In such exceptional cases, and in order to ensure that patients in Northern Ireland have access to those medicinal products at the same time as patients in other parts of the United Kingdom, the competent authorities of the United Kingdom in respect of Northern Ireland should be able to supply those medicinal products to patients in Northern Ireland temporarily and until a marketing authorisation is granted or refused in the Union. In order to ensure the full effectiveness of the centralised procedure for granting marketing authorisations set out in Regulation (EC) No 726/2004, those temporary authorisations should be limited in time and should cease to be valid when the Commission takes a decision to grant or refuse the authorisation to market that medicinal product.

(7)

In accordance with Article 8(2) of Directive 2001/83/EC, read in conjunction with the Protocol, a marketing authorisation is only able to be granted to an applicant established in the Union or in Northern Ireland. A number of operators were not able to comply with that requirement by 31 December 2021. To ensure access to certain medicinal products in Northern Ireland, it is crucial that the holders of marketing authorisations granted by the competent authorities of the United Kingdom in respect of Northern Ireland are allowed to be established in parts of the United Kingdom other than Northern Ireland. Similarly, to ensure access to certain medicinal products in Cyprus, Ireland, Malta and Northern Ireland, it is necessary to allow the competent authorities of Cyprus, Ireland, Malta and Northern Ireland to grant marketing authorisations in the context of the mutual recognition or the decentralised procedure to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

(8)

It follows from Articles 17 and 18 of Directive 2001/83/EC, read in conjunction with the Protocol, that applicants for a marketing authorisation wishing to obtain both a marketing authorisation for the United Kingdom in respect of Northern Ireland as well as a marketing authorisation for one or more Member States need to include the United Kingdom in respect of Northern Ireland in the scope of their marketing authorisation application in accordance with the mutual recognition or the decentralised procedure. Where medicinal products are also authorised in parts of the United Kingdom other than Northern Ireland, the requirement to comply with that obligation could hamper the continuous access to medicinal products for patients in Northern Ireland. To avoid that issue, it is necessary to allow applicants in such situations the possibility to apply for a marketing authorisation for the United Kingdom in respect of Northern Ireland either in accordance with the mutual recognition or the decentralised procedure, or in accordance with the national marketing authorisation procedure applicable in relation to the United Kingdom in respect of Northern Ireland. In the case of such a national marketing authorisation procedure, the marketing authorisation should be granted in compliance with Union law, including the requirements on quality, safety and efficacy of medicinal products.

(9)

In accordance with Article 51(1), point (b), of Directive 2001/83/EC, medicinal products imported into the Union are to undergo quality control testing in the Union. Article 20, point (b), of that Directive allows the importers which place medicinal products supplied from or through parts of the United Kingdom other than Northern Ireland on the market in Cyprus, Ireland, Malta or Northern Ireland, or wholesale distributors placing such medicinal products on those markets, to have, in justifiable cases, certain controls carried out in parts of the United Kingdom other than Northern Ireland. Taking into account the historical dependence of Cyprus, Ireland, Malta and Northern Ireland on the supply of medicinal products from or through parts of the United Kingdom other than Northern Ireland and the related risks of shortages of medicinal products in those jurisdictions, a justifiable case within the meaning of Article 20, point (b), of Directive 2001/83/EC should be considered to occur when each batch of the medicinal product concerned is released by a qualified person on a site in the Union or by a qualified person on a site in parts of the United Kingdom other than Northern Ireland applying quality standards equivalent to those laid down in Union law, thereby ensuring an equivalent level of protection of human health. Since Article 20, point (b), of Directive 2001/83/EC only provides for batch testing to be carried out in a third country on a case-by-case basis, it is necessary to lay down conditions harmonising the implementation of that provision with regard to medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from or through parts of the United Kingdom other than Northern Ireland.

(10)

It follows from Article 40(3) of Directive 2001/83/EC, read in conjunction with the Protocol, that importers of medicinal products from third countries into a Member State are to hold a manufacturing authorisation granted by the Member State where the importer is established or, in the case of importers established in Northern Ireland, by the United Kingdom in respect of Northern Ireland. To avoid a situation in which operators withdraw from or significantly reduce medicinal products supply to Cyprus, Ireland, Malta and Northern Ireland, it is necessary to derogate exceptionally from that requirement under certain conditions and to allow imports of medicinal products from or through parts of the United Kingdom other than Northern Ireland into Cyprus, Ireland, Malta and Northern Ireland by wholesale distributors that do not hold the relevant manufacturing authorisation, while ensuring an equivalent level of protection of human health.

(11)

In a situation where medicinal products are exported from a Member State to parts of the United Kingdom other than Northern Ireland, and subsequently imported into Cyprus, Ireland, Malta or Northern Ireland, it should be possible to waive specific controls, namely quality control testing, intended to guarantee the quality of those medicinal products imported from third countries, provided that appropriate arrangements have been made by the Union to ensure that the necessary controls are carried out in the exporting country.

(12)

It follows from Article 48 of Directive 2001/83/EC, read in conjunction with Article 49 of that Directive and with the Protocol, that the manufacturing authorisation holder is to have at its disposal a qualified person who resides and operates in the Union or Northern Ireland. To ensure a continuous access to certain medicinal products to patients in Northern Ireland, it is appropriate to allow the qualified person to reside and operate in parts of the United Kingdom other than Northern Ireland.

(13)

It follows from Article 104(3) of Directive 2001/83/EC, read in conjunction with the Protocol, that the qualified person responsible for pharmacovigilance is to reside and operate in the Union or Northern Ireland. A number of operators were not able to comply with that requirement by 31 December 2021. To ensure that access to certain medicinal products for patients in Northern Ireland is not hampered, it is appropriate to allow the qualified person responsible for pharmacovigilance to reside and operate in parts of the United Kingdom other than Northern Ireland.

(14)

To avoid shortages of medicinal products in Cyprus and Malta, the competent authorities of Cyprus and Malta should be allowed, for public health reasons and for a certain period, to grant, maintain in force and extend marketing authorisations on the basis of Article 126a of Directive 2001/83/EC which rely on marketing authorisations granted by the competent authorities of parts of the United Kingdom other than Northern Ireland, even if the marketing authorisation holder is no longer established in the Union, provided that certain conditions are fulfilled. Since Union law no longer applies in parts of the United Kingdom other than Northern Ireland, it is necessary to provide that the competent authorities of Cyprus and Malta ensure that such authorisations comply with Union law. In order to ensure that the functioning of the Union market is not undermined, it is necessary to establish the conditions for enhanced supervision and enforcement of the rules relevant for the application of the derogations introduced by this Directive. The Commission should monitor developments in parts of the United Kingdom other than Northern Ireland that could affect the level of protection regarding the regulatory functions covered by this Directive. If the Commission finds that the level of protection of public health ensured by the United Kingdom by means of rules governing the production, distribution and use of medicinal products, as well as by means of the effective enforcement of those rules, is no longer essentially equivalent to that guaranteed within the Union, or if the Commission lacks information to assess whether an essentially equivalent level of protection is guaranteed, the Commission should enter into consultation with the United Kingdom to find a mutually agreed remedy to that situation. If no such remedy is found within the prescribed period, the Commission should, as a last resort, be empowered to adopt delegated acts suspending the application of one or more provisions introduced by this Directive.

(15)

In order to ensure transparency, the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland should publish a list of medicinal products to which they intend to apply or have applied the derogations set out in this Directive. In order to make that list easily searchable, it should contain the same information as that included in the package leaflet or summary of product characteristics of the medicinal products concerned.

(16)

Since the objectives of this Directive cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(17)

Directives 2001/20/EC and 2001/83/EC should therefore be amended accordingly.

(18)

In order to ensure legal continuity for operators active in the pharmaceutical sector and to guarantee the continuous access of patients in Cyprus, Ireland, Malta and Northern Ireland to medicinal products, this Directive should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union and the measures adopted by the Member States to comply with it should apply retroactively from 1 January 2022,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

In Article 13(1) of Directive 2001/20/EC, the following subparagraph is added:

‘By way of derogation from the first subparagraph, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta shall allow investigational medicinal products to be imported from parts of the United Kingdom other than Northern Ireland without such an authorisation provided that all of the following conditions are fulfilled:

(a)

the investigational medicinal products imported into Cyprus, Ireland, Malta or Northern Ireland have undergone certification of batch release either in the Union, as provided for in paragraph 3, point (a), or in parts of the United Kingdom other than Northern Ireland in compliance with the requirements set out in paragraph 3, point (b);

(b)

the investigational medicinal products are only made available to subjects in the Member State into which those investigational medicinal products are imported, or, if imported into Northern Ireland, are only made available to subjects in Northern Ireland.’.

Article 2

Directive 2001/83/EC is amended as follows:

(1)

the following Article is inserted:

‘Article 5a

By way of derogation from Article 6, the competent authorities of the United Kingdom in respect of Northern Ireland may temporarily authorise the supply to patients in Northern Ireland of a medicinal product belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 provided that all of the following conditions are fulfilled:

(a)

the medicinal product concerned has been granted a marketing authorisation by the competent authority of the United Kingdom for parts of the United Kingdom other than Northern Ireland;

(b)

the medicinal product concerned is only made available to patients or end-consumers in the territory of Northern Ireland and is not made available in any Member State.

The maximum validity of the temporary authorisation shall be six months. Notwithstanding the specified validity, the temporary authorisation shall cease to be valid if the medicinal product concerned has been granted a marketing authorisation in accordance with Article 10 of Regulation (EC) No 726/2004, or if such marketing authorisation has been refused in accordance with that Article.’;

(2)

in Article 8, the following paragraphs are inserted:

‘2a.   By way of derogation from paragraph 2, marketing authorisations may be granted by the competent authorities of the United Kingdom in respect of Northern Ireland to applicants established in parts of the United Kingdom other than Northern Ireland.

2b.   By way of derogation from paragraph 2, marketing authorisations may be granted by the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, by the competent authorities of Cyprus, Ireland and Malta, in accordance with the mutual recognition or the decentralised procedure laid down in Chapter 4 of this Title, to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

The competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta may extend marketing authorisations already granted prior to 20 April 2022 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

The marketing authorisations granted or extended by the competent authorities of Cyprus, Ireland or Malta in accordance with the first and second subparagraph shall cease to be valid at the latest on 31 December 2026.’;

(3)

the following Article is inserted:

‘Article 18a

1.   By way of derogation from Article 17(1), second subparagraph, Article 17(2) and Article 18, if an application for marketing authorisation is submitted in one or more Member States and in the United Kingdom in respect of Northern Ireland, or if an application for marketing authorisation is submitted in the United Kingdom in respect of Northern Ireland for a medicinal product which is already being examined or has already been authorised in a Member State, the application regarding the United Kingdom in respect of Northern Ireland shall not have to be submitted in accordance with Articles 28 to 39 provided that all of the following conditions are fulfilled:

(a)

the marketing authorisation for the United Kingdom in respect of Northern Ireland is granted by the competent authority for the United Kingdom in respect of Northern Ireland in compliance with Union law, and such compliance with Union law is ensured during the period of validity of that marketing authorisation;

(b)

the medicinal products authorised by the competent authority for the United Kingdom in respect of Northern Ireland are made available to patients or end-consumers only in the territory of Northern Ireland, and they are not made available in any Member State.

2.   The marketing authorisation holder of a medicinal product for which a marketing authorisation has already been granted for the United Kingdom in respect of Northern Ireland in accordance with Articles 28 to 39 before 20 April 2022 shall be allowed to withdraw the marketing authorisation for the United Kingdom in respect of Northern Ireland from the mutual recognition or the decentralised procedure and to submit an application for a marketing authorisation for that medicinal product to the competent authorities of the United Kingdom with respect to Northern Ireland in accordance with paragraph 1.’;

(4)

in Article 20, the following paragraph is added:

‘With regard to quality control testing carried out in parts of the United Kingdom other than Northern Ireland regarding medicinal products included in the list referred to in Article 127d other than those authorised by the Commission, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta may consider that there is a justifiable case within the meaning of point (b) of the first paragraph, without carrying out a case-by-case assessment provided that:

(a)

each batch of the medicinal products concerned is released by a qualified person on a site in the Union or in Northern Ireland or by a qualified person on a site in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in Article 51;

(b)

the establishment designated by the third party conducting the quality control testing is supervised by the competent authority of the United Kingdom, including by performing on-the-spot checks;

(c)

where the batch release is carried out by a qualified person who resides and operates in parts of the United Kingdom other than Northern Ireland, the manufacturing authorisation holder declares that it does not have at its disposal a qualified person who resides and operates in the Union on 20 April 2022.’;

(5)

Article 40 is amended as follows:

(a)

the following paragraph is inserted:

‘1a.   By way of derogation from paragraph 1 of this Article, the competent authorities of the United Kingdom in respect of Northern Ireland and, until 31 December 2024, the competent authorities of Cyprus, Ireland and Malta shall allow medicinal products to be imported from parts of the United Kingdom other than Northern Ireland by holders of a wholesale distribution authorisation as referred to in Article 77(1) that are not in possession of a relevant manufacturing authorisation provided that all of the following conditions are fulfilled:

(a)

the medicinal products have undergone quality control testing either in the Union, as provided for in Article 51(3), or in parts of the United Kingdom other than Northern Ireland in compliance with Article 20, first paragraph, point (b);

(b)

the medicinal products have been subject to batch release by a qualified person in the Union in accordance with Article 51(1) or, for medicinal products authorised by the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland, in parts of the United Kingdom other than Northern Ireland applying quality standards that are equivalent to those laid down in Article 51(1);

(c)

the marketing authorisation for the medicinal product concerned has been granted in accordance with Union law, by the competent authority of a Member State or by the Commission or, as regards medicinal products placed on the market in Northern Ireland, by the competent authority of the United Kingdom in respect of Northern Ireland;

(d)

medicinal products are only made available to patients or end-consumers in the Member State into which the medicinal products are imported, or, if imported into Northern Ireland, are only made available to patients or end-consumers in Northern Ireland;

(e)

the medicinal products bear the safety features referred to in Article 54, point (o).

Article 80, first subparagraph, point (b), shall not apply to imports that fulfil the conditions laid down in the first subparagraph of this paragraph.’;

(b)

the following paragraph is inserted:

‘3a.   For batches of medicinal products which are exported to parts of the United Kingdom other than Northern Ireland from a Member State and subsequently imported into Northern Ireland or, until 31 December 2024, into Cyprus, Ireland or Malta, the controls upon importation referred to Article 51(1), first and second subparagraphs, shall not be required, provided that those batches have undergone such controls in a Member State prior to being exported to parts of the United Kingdom other than Northern Ireland and that they are accompanied by the control reports referred to in Article 51(1), third subparagraph.’;

(6)

in Article 48, the following paragraph is added:

‘3.   Where the manufacturing authorisation is granted by the competent authority of the United Kingdom in respect of Northern Ireland, the qualified person referred to in paragraph 1 may reside and operate in parts of the United Kingdom other than Northern Ireland. This paragraph shall not apply where the manufacturing authorisation holder already has at its disposal a qualified person who resides and operates in the Union on 20 April 2022.’;

(7)

in Article 104(3), the following subparagraph is added:

‘By way of derogation from the second subparagraph, where the marketing authorisation is granted by the competent authority of United Kingdom in respect of Northern Ireland, the qualified person referred to in point (a) of the first subparagraph may reside and operate in parts of the United Kingdom other than Northern Ireland. This subparagraph shall not apply where the marketing authorisation holder already has at its disposal a qualified person who resides and operates in the Union on 20 April 2022.’;

(8)

the following Article is inserted:

‘Article 111c

1.   The Commission shall continuously monitor developments in the United Kingdom that could affect the level of protection regarding the regulatory functions referred to in Article 8(2a) and (2b), Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3) and Article 126c that are carried out in parts of the United Kingdom other than Northern Ireland taking into account, in particular, the following elements:

(a)

the rules governing the granting of marketing authorisations, the obligations of the marketing authorisation holder, the granting of manufacturing authorisations, the obligations of the manufacturing authorisation holder, the qualified persons and their obligations, quality control testing, batch release and pharmacovigilance as laid down in United Kingdom law;

(b)

whether the competent authorities of the United Kingdom ensure the effective enforcement within their territory of the rules referred to in point (a), by means of, inter alia, inspections and audits of marketing authorisation holders, manufacturing authorisation holders and wholesale distributors located in their territories, and on-the-spot checks at their premises regarding the exercise of the regulatory functions referred to in point (a).

2.   Where the Commission finds that the level of protection of public health ensured by the United Kingdom through rules governing the production, distribution and use of medicinal products as well as the effective enforcement of those rules is no longer essentially equivalent to that guaranteed within the Union, or where sufficient information is not available to the Commission to enable it to establish whether an essentially equivalent level of protection of public health is ensured by the United Kingdom, the Commission shall inform the United Kingdom through a written notification of that finding and of the detailed reasons therefor.

For a period of six months following the written notification made pursuant to the first subparagraph, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that written notification. In justified cases, the Commission may extend that period by three months.

3.   If the situation giving rise to the written notification made pursuant to paragraph 2, first subparagraph, is not remedied within the time-limit referred to in paragraph 2, second subparagraph, the Commission shall be empowered to adopt a delegated act specifying the provisions among those referred to in paragraph 1 whose application shall be suspended.

4.   Where a delegated act pursuant to paragraph 3 has been adopted, the provisions referred to in the introductory sentence of paragraph 1 as specified in the delegated act shall cease to apply on the first day of the month following the entry into force of the delegated act.

5.   Where the situation giving rise to the adoption of the delegated act pursuant to paragraph 3 has been remedied, the Commission shall adopt a delegated act specifying those suspended provisions that shall apply again. In that case, the provisions specified in the delegated act adopted pursuant to this paragraph shall apply again on the first day of the month following the entry into force of the delegated act referred to in this paragraph.’;

(9)

Article 121a is amended as follows:

(a)

in paragraph 2, the following subparagraph is added:

‘The power to adopt delegated acts referred to in Article 111c(3) and (5) shall be conferred on the Commission for an indeterminate period of time from 20 April 2022.’;

(b)

paragraph 3 is replaced by the following:

‘3.   The delegation of power referred to in Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) and (5), and Article 120 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.’;

(c)

paragraph 6 is replaced by the following:

‘6.   A delegated act adopted pursuant to Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) or (5), or Article 120 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(10)

the following Article is inserted:

‘Article 126c

1.   By way of derogation from Article 126a, until 31 December 2024, in the absence of a marketing authorisation or of a pending application for a marketing authorisation the competent authorities of Cyprus and Malta may authorise for justified public health reasons the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.

The competent authorities of Cyprus and Malta may also maintain in force or, until 31 December 2024, extend marketing authorisations that were granted pursuant to Article 126a before 20 April 2022 which authorise the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.

Authorisations that are granted, extended or maintained in force pursuant to the first or second subparagraph shall not be valid after 31 December 2026.

2.   By way of derogation from Article 8(2), the competent authorities of Malta and Cyprus may grant marketing authorisations as referred to in paragraph 1 of this Article to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

3.   Where the competent authorities of Cyprus or Malta grant or extend a marketing authorisation as referred to in paragraph 1, they shall ensure compliance with the requirements of this Directive.

4.   Before granting a marketing authorisation pursuant to paragraph 1, the competent authorities of Cyprus or Malta:

(a)

shall notify the marketing authorisation holder in parts of the United Kingdom other than Northern Ireland of the proposal to grant a marketing authorisation or to extend a marketing authorisation under this Article in respect of the medicinal product concerned;

(b)

may request the competent authority in the United Kingdom to submit the relevant information regarding the marketing authorisation of the medicinal product concerned.’;

(11)

the following Articles are inserted:

‘Article 127c

The derogations set out in Article 8(2a) and(2b), Article 18a, Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3a) and Article 126c shall not affect the obligations of the marketing authorisation holder to ensure the quality, safety and efficacy of the medicinal product placed on the markets of Cyprus, Ireland, Malta or Northern Ireland laid down in this Directive.

Article 127d

1.   By 20 May 2022, the competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland shall establish, notify to the Commission and publish on their website a list of medicinal products to which they have applied or intend to apply the derogations as set out in this Directive.

2.   The competent authorities of Cyprus, Ireland, Malta and the United Kingdom in respect of Northern Ireland shall ensure that the list referred to in paragraph 1 is updated and managed in an independent manner, at least on a six-monthly basis.’.

Article 3

1.   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive within a period of four months as from the date of its entry into force. They shall immediately inform the Commission thereof.

They shall apply those measures from 1 January 2022.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 12 April 2022.

For the European Parliament

The President

R. METSOLA

For the Council

The President

C. BEAUNE


(1)  Opinion of 24 February 2022 (not yet published in the Official Journal).

(2)  Position of the European Parliament of 7 April 2022 (not yet published in the Official Journal) and decision of the Council of 12 April 2022.

(3)  OJ L 29, 31.1.2020, p. 7.

(4)  Council Decision (EU) 2020/135 of 30 January 2020 on the conclusion of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 1).

(5)  Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period (2021/C 27/08) (OJ C 27, 25.1.2021, p. 11).

(6)  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).

(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)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).


II Non-legislative acts

REGULATIONS

20.4.2022   

EN

Official Journal of the European Union

L 118/14


COMMISSION DELEGATED REGULATION (EU) 2022/643

of 10 February 2022

amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides, industrial chemicals, persistent organic pollutants and mercury and an update of customs codes

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (1), and in particular Article 23(4), points (a), (b), (c) and (d) thereof,

Whereas:

(1)

Regulation (EU) No 649/2012 implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade (2) (‘the Rotterdam Convention’).

(2)

By Implementing Regulations (EU) 2020/1280 (3), (EU) 2020/892 (4), (EU) 2020/1276 (5), (EU) 2020/18 (6), (EU) 2020/17 (7), (EU) 2020/1246 (8), (EU) 2020/2087 (9), (EU) 2019/1606 (10), (EU) 2020/23 (11), and (EU) 2020/1498 (12), the Commission decided not to renew the approval of the substances benalaxyl, beta-cyfluthrin, bromoxynil, chlorpyrifos, chlorpyrifos-methyl, fenamiphos, mancozeb, methiocarb, thiacloprid and thiophanate-methyl, respectively, as active substances under Regulation (EC) No 1107/2009 of the European Parliament and of the Council (13). The effect of those final regulatory actions is that those substances are banned from all use in the category ‘pesticides’, due to the fact that they have not been approved for any other use in that category. Therefore, those substances should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(3)

The active substances epoxiconazole and mecoprop have been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that those substances are banned from all use in the category ‘pesticides’, due to the fact that they have not been approved for any other use in that category. In addition, the harmonised classification of epoxiconazole and mecoprop under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (14) is sufficient evidence that the substances raise concerns for human health and the environment. Therefore, epoxiconazole and mecoprop should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(4)

The active substance bifenthrin has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that bifenthrin is banned from use in the subcategory ‘pesticide in the group of plant protection products’. That ban amounts to a severe restriction of the use of that substance at the level of the category ‘pesticides’, considering that bifenthrin is only approved for use in biocidal products under Regulation (EU) No 528/2012 of the European Parliament and of the Council (15) for product-type 8 in the subcategory ‘other pesticide including biocides’, and that there are no national authorisations for use of biocidal products containing bifenthrin under that Regulation. In addition, the harmonised classification of bifenthrin under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health and the environment. Therefore, bifenthrin should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(5)

By Implementing Decision (EU) 2018/1251 (16), the Commission decided not to approve empenthrin as an active substance under Regulation (EU) No 528/2012. The effect of that final regulatory action was that empenthrin is banned from all use in the category ‘pesticides’, due to the fact that it has not been approved for any other use in that category. Therefore, empenthrin should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(6)

The active substances azinphos-ethyl, ferbam and hexazinone have been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that those substances are banned from all use in the category ‘pesticides’, due to the fact that they have not been approved for any other use in that category. Therefore, azinphos-ethyl, ferbam and hexazinone should be added to the list of chemicals in Part 2 of Annex I to Regulation (EU) No 649/2012.

(7)

The active substance methomyl has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that methomyl is banned from use in the subcategory ‘pesticide in the group of plant protection products’. That ban amounts to a ban of the use of the substance at the level of the category ‘pesticides’, considering that methomyl has not been approved for any other use in that category. Therefore, methomyl should be added to the list of chemicals in Part 2 of Annex I to Regulation (EU) No 649/2012.

(8)

The substances 2,4-dinitrotoluene (2,4-DNT) and 4,4'-diaminodiphenylmethane (MDA) are listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (17) since they have been previously identified as substances of very high concern. Consequently, those substances are subject to authorisation in accordance with Title VII of Regulation (EC) No 1907/2006. Since no authorisations have been granted, 2,4-dinitrotoluene (2,4-DNT) and 4,4'-diaminodiphenylmethane (MDA) are severely restricted for industrial use. Therefore, those substances should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(9)

The use of the substance mercury is restricted by Regulation (EU) 2017/852 of the European Parliament and of the Council (18), Regulation (EC) No 1907/2006, Directive 2011/65/EU of the European Parliament and of the Council (19) and Directive 2006/66/EC of the European Parliament and of the Council (20), with the effect that the use of mercury is severely restricted for all industrial use. Therefore, mercury should be added to the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(10)

The use of the substance cadmium and of its compounds is severely restricted by Regulation (EC) No 1907/2006 in the subcategory ‘industrial chemical for public use’. That restriction amounts to a severe restriction of the use of the substance at the level of the category ‘industrial chemicals’, considering that cadmium and its compounds are also severely restricted in the subcategory ‘industrial chemical for professional use’. Therefore, cadmium and its compounds should be added to the list of chemicals in Part 2 of Annex I to Regulation (EU) No 649/2012.

(11)

The use of the substance lead is severely restricted by Regulation (EC) No 1907/2006 in the subcategory ‘industrial chemical for public use’. Therefore, lead should be added to the list of chemicals in Part 1 of Annex I to Regulation (EU) No 649/2012 for that subcategory.

(12)

The use of benzene as a constituent of other substances is severely restricted by Regulation (EC) No 1907/2006 in the subcategory ‘industrial chemical for public use’. Therefore, benzene as a constituent of other substances should be added to the list of chemicals in Part 1 of Annex I to Regulation (EU) No 649/2012 for that subcategory.

(13)

The use of the substances bis(pentabromophenyl) ether (decaBDE) and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds is severely restricted by Regulation (EU) 2019/1021 of the European Parliament and of the Council (21) for all industrial use. Therefore, those substances should be added to the list of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(14)

By Implementing Regulation (EU) 2017/1506 (22), the Commission decided to renew the approval of the active substance maleic hydrazide under Regulation (EC) No 1107/2009, with the effect that maleic hydrazide and its choline, potassium and sodium salts are no longer banned for use in the subcategory ‘pesticide in the group of plant protection products’. Therefore, those substances should be removed from the list of chemicals in Part 1 of Annex I to Regulation (EU) No 649/2012.

(15)

At its sixth meeting held from 28 April to 10 May 2013, the Conference of the Parties to the Rotterdam Convention decided to include commercial pentabromodiphenyl ether, including tetra- and pentabromodiphenyl ether, as well as commercial octabromodiphenyl ether, including hexa- and heptabromodiphenyl ether, in Annex III to that Convention, with the effect that those chemicals became subject to the prior informed consent procedure under that Convention. Consequently, those chemicals were added to the list of chemicals in Part 3 of Annex I to Regulation (EU) No 649/2012 by Commission Delegated Regulation (EU) 2015/2229 (23). In order to facilitate the implementation of that listing and in particular the submission of export notifications for certain articles, those chemicals should also be listed in Part 1 of Annex I to Regulation (EU) No 649/2012.

(16)

The entry on commercial octabromodiphenyl ether in Part 3 of Annex I to Regulation (EU) No 649/2012 also covers the substance octabromodiphenyl ether listed in Parts 1 and 2 of Annex I to that Regulation. Therefore, octabromodiphenyl ether should be removed from the lists of chemicals in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.

(17)

At its ninth meeting held from 29 April to 10 May 2019, the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants (‘the Stockholm Convention’) decided to include the substance dicofol in Annex A to that Convention. Consequently, that substance was listed in Part A of Annex I to Regulation (EU) 2019/1021 and should therefore be added to the list of chemicals in Part 1 of Annex V to Regulation (EU) No 649/2012. Since a listing in Part 1 of Annex V to Regulation (EU) No 649/2012 prohibits the export of a substance without any exemption, the listing of dicofol in Parts 1 and 2 of Annex I to that Regulation is no longer required and should be removed.

(18)

At its ninth meeting held from 29 April to 10 May 2019, the Conference of the Parties to the Stockholm Convention decided to include the substance perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex A to that Convention with a number of exemptions and with an obligation for parties to prohibit the export of fire-fighting foams that contain those chemicals. Consequently, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds were listed in Part A of Annex I to Regulation (EU) 2019/1021 and should therefore be added to the list of chemicals in Part 1 of Annex V to Regulation (EU) No 649/2012 as regards its presence in fire-fighting foams.

(19)

At its seventh meeting held from 4 to 15 May 2015, the Conference of the Parties to the Stockholm Convention decided to include the substances pentachlorophenol and its salts and esters in Annex A to that Convention. Consequently, those substances were listed in Part A of Annex I to Regulation (EU) 2019/1021 and should therefore be added to the list of chemicals in Part 1 of Annex V to Regulation (EU) No 649/2012.

(20)

At its fourth meeting held from 4 to 8 May 2009, the Conference of the Parties to the Stockholm Convention decided to include the substances perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride in Annex B to that Convention. That entry was subsequently amended by Decision SC-9/4 in 2019. Those substances are listed in Part A of Annex I to Regulation (EU) 2019/1021 and should therefore be added to the list of chemicals in Part 1 of Annex V to Regulation (EU) No 649/2012.

(21)

Part 1 of Annex V to Regulation (EU) No 649/2012 contains an entry on articles containing concentrations of tetra-, penta-, hexa- and heptabromodiphenyl ether at or above 0,1 % by weight when produced partially or fully from recycled materials or materials from waste prepared for re-use. That entry is based on a restriction set out in Regulation (EC) No 850/2004 of the European Parliament and of the Council (24). The provisions concerning those substances have been amended by Regulation (EU) 2019/1021, which reduces the allowed concentrations in articles and adds decabromodiphenyl ether to the list of polybrominated diphenyl ethers. Those changes should be reflected in Part 1 of Annex V to Regulation (EU) No 649/2012.

(22)

Regulation (EU) 2017/852 prohibits the export of mercury, certain mixtures of metallic mercury with other substances, certain mercury compounds and certain mercury-added products. Those export bans should be reflected in Part 2 of Annex V to Regulation (EU) No 649/2012.

(23)

Pursuant to Article 14(2) of Regulation (EU) No 649/2012, the Commission is required to revise the classification of each chemical listed in Annex I to that Regulation in the light of any changes made in the World Customs Organisation’s Harmonised System Nomenclature or in the European Union’s Combined Nomenclature. A number of classifications of chemicals in the European Union’s Combined Nomenclature have been changed since those chemicals were added to Annex I to Regulation (EU) No 649/2012. Those changes should be reflected in that Annex.

(24)

Regulation (EU) No 649/2012 should therefore be amended accordingly.

(25)

It is appropriate to provide for a reasonable period of time for interested parties to take the measures necessary to comply with this Regulation and for Member States to take the measures necessary for its implementation,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 649/2012 is amended as follows:

(a)

Annex I is replaced by the text in Annex I to this Regulation;

(b)

Annex V is replaced by the text in Annex II to this Regulation.

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.

It shall apply from 1 July 2022.

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

Done at Brussels, 10 February 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 201, 27.7.2012, p. 60.

(2)  OJ L 63, 6.3.2003, p. 29.

(3)  Commission Implementing Regulation (EU) 2020/1280 of 14 September 2020 concerning the non-renewal of the approval of the active substance benalaxyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 301, 15.9.2020, p. 4).

(4)  Commission Implementing Regulation (EU) 2020/892 of 29 June 2020 concerning the non-renewal of the approval of the active substance beta-cyfluthrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 206, 30.6.2020, p. 5).

(5)  Commission Implementing Regulation (EU) 2020/1276 of 11 September 2020 concerning the non-renewal of the approval of the active substance bromoxynil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 300, 14.9.2020, p. 32).

(6)  Commission Implementing Regulation (EU) 2020/18 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 7, 13.1.2020, p. 14).

(7)  Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 7, 13.1.2020, p. 11).

(8)  Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 288, 3.9.2020, p. 18).

(9)  Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non-renewal of the approval of the active substance mancozeb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 423, 15.12.2020, p. 50).

(10)  Commission Implementing Regulation (EU) 2019/1606 of 27 September 2019 concerning the non-renewal of the approval of the active substance methiocarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 250, 30.9.2019, p. 53).

(11)  Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non-renewal of the approval of the active substance thiacloprid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 8, 14.1.2020, p. 8).

(12)  Commission Implementing Regulation (EU) 2020/1498 of 15 October 2020 concerning the non-renewal of approval of the active substance thiophanate-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 342, 16.10.2020, p. 5).

(13)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(14)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(15)  Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

(16)  Commission Implementing Decision (EU) 2018/1251 of 18 September 2018 not approving empenthrin as an existing active substance for use in biocidal products of product-type 18 (OJ L 235, 19.9.2018, p. 24).

(17)  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).

(18)  Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1).

(19)  Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).

(20)  Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1).

(21)  Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).

(22)  Commission Implementing Regulation (EU) 2017/1506 of 28 August 2017 renewing the approval of the active substance maleic hydrazide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 222, 29.8.2017, p. 21).

(23)  Commission Delegated Regulation (EU) 2015/2229 of 29 September 2015 amending Annex I to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L 317, 3.12.2015, p. 13).

(24)  Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).


ANNEX I

‘ANNEX I

LIST OF CHEMICALS

(referred to in Article 7)

PART 1

List of chemicals subject to export notification procedure

(referred to in Article 8)

It should be noted that where chemicals listed in this part of the Annex are subject to the PIC procedure, the export notification obligations set out in Article 8(2), (3) and (4) shall not apply provided that the conditions laid down in Article 8(6), first subparagraph, points (b) and (c), have been fulfilled. Such chemicals, which are identified by the symbol ‘#’ in the list below, are listed again in Part 3 of this Annex for ease of reference.

It should also be noted that where the chemicals listed in this part of the Annex qualify for PIC notification because of the nature of the Union’s final regulatory action, those chemicals are also listed in Part 2 of this Annex. Such chemicals are identified by the symbol ‘+’ in the list below.

Chemical

CAS No

EC No

CN code (*3)

Subcategory (*1)

Use limitation (*2)

Countries for which no notification is required

1,1-Dichloroethene

75-35-4

200-864-0

ex 2903 29 00

i(2)

sr

 

1,1,1-Trichloroethane

71-55-6

200-756-3

ex 2903 19 00

i(2)

b

 

1,1,2-Trichloroethane

79-00-5

201-166-9

ex 2903 19 00

i(2)

sr

 

1,1,1,2-Tetrachloroethane

630-20-6

211-135-1

ex 2903 19 00

i(2)

sr

 

1,1,2,2-Tetrachloroethane

79-34-5

201-197-8

ex 2903 19 00

i(2)

sr

 

1,2-Dibromoethane (Ethylene dibromide) ((#))

106-93-4

203-444-5

ex 2903 62 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

1,2-Dichloroethane (ethylene dichloride) ((#))

107-06-2

203-458-1

ex 2903 15 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

i(2)

b

1,3-Dichloropropene (1)  ((+))

542-75-6

208-826-5

ex 2903 29 00

p(1)

b

 

1,3-Dichloropropene (cis) ((Z)-1,3-dichloropropene)

10061-01-5

233-195-8

ex 2903 29 00

p(1)-p(2)

b-b

 

2-Aminobutane

13952-84-6

237-732-7

ex 2921 19 99

p(1)-p(2)

b-b

 

2-Naphthylamine and its salts ((+))

91-59-8

553-00-4

612-52-2

and others

202-080-4

209-030-0

210-313-6

and others

ex 2921 45 00

i(1)-i(2)

b-b

 

2-Naphthyloxyacetic acid ((+))

120-23-0

204-380-0

ex 2918 99 90

p(1)

b

 

2,4-Dinitrotoluene (2,4-DNT) ((+))

121-14-2

204-450-0

ex 2904 20 00

i(1)-i(2)

sr-b

 

2,4,5-T and its salts and esters ((#))

93-76-5

and others

202-273-3

and others

ex 2918 91 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

3-Decen-2-one ((+))

10519-33-2

234-059-0

ex 2914 19 90

p(1)

b

 

4-Aminobiphenyl (biphenyl-4-amine) and its salts ((+))

92-67-1

2113-61-3

and others

202-177-1

and others

ex 2921 49 00

i(1)-i(2)

b-b

 

4-Nitrobiphenyl ((+))

92-93-3

202-204-7

ex 2904 20 00

i(1)-i(2)

b-b

 

4,4'-Diaminodiphenylmethane (MDA) ((+))

101-77-9

202-974-4

ex 2921 59 90

i(1)-i(2)

sr-b

 

5-Tert-butyl-2,4,6-trinitro-m-xylene ((+))

81-15-2

201-329-4

ex 2904 20 00

i(1)-i(2)

sr-b

 

Acephate ((+))

30560-19-1

250-241-2

ex 2930 90 98

p(1)-p(2)

b-b

 

Acetochlor ((+))

34256-82-1

251-899-3

ex 2924 29 70

p(1)

b

 

Acifluorfen

50594-66-6

256-634-5

ex 2918 99 90

p(1)-p(2)

b-b

 

Alachlor ((#))

15972-60-8

240-110-8

ex 2924 25 00

p(1)

b

 

Aldicarb ((#))

116-06-3

204-123-2

ex 2930 80 00

p(1)-p(2)

b-b

 

Ametryn

834-12-8

212-634-7

ex 2933 69 80

p(1)-p(2)

b-b

 

Amitraz ((+))

33089-61-1

251-375-4

ex 2925 29 00

p(1)-p(2)

b-b

 

Amitrole ((+))

61-82-5

200-521-5

ex 2933 99 80

p(1)

b

 

Anthraquinone ((+))

84-65-1

201-549-0

ex 2914 61 00

p(1)-p(2)

b-b

 

Arsenic compounds

 

 

 

p(2)

sr

 

Asbestos Fibres ((+)):

1332-21-4

and others

 

ex 2524 90 00

 

 

Please refer to PIC circular at www.pic.int/

Actinolite ((#))

77536-66-4

 

ex 2524 90 00

i

b

 

Antophyllite ((#))

77536-67-5

 

ex 2524 90 00

i

b

 

Amosite ((#))

12172-73-5

 

ex 2524 90 00

i

b

 

Crocidolite ((#))

12001-28-4

 

ex 2524 10 00

i

b

 

Tremolite ((#))

77536-68-6

 

ex 2524 90 00

i

b

 

Chrysotile ((+))

12001-29-5, 132207-32-0

 

ex 2524 90 00

i

b

 

Asulam ((+))

3337-71-1

2302-17-2

222-077-1

218-953-8

ex 2935 90 90

p(1)

b

 

Atrazine ((+))

1912-24-9

217-617-8

ex 2933 69 10

p(1)

b

 

Azinphos-ethyl ((+))

2642-71-9

220-147-6

ex 2933 99 80

p(1)-p(2)

b-b

 

Azinphos-methyl ((#))

86-50-0

201-676-1

ex 2933 92 00

p(1)

b

 

Azocyclotin ((+))

41083-11-8

255-209-1

ex 2933 99 80

p(1)

b

 

Benalaxyl ((+))

71626-11-4

275-728-7

ex 2924 29 70

p(1)

b

 

Benfuracarb ((+))

82560-54-1

 

ex 2932 99 00

p(1)

b

 

Bensultap

17606-31-4

 

ex 2930 90 98

p(1)-p(2)

b-b

 

Benzene (2)

71-43-2

200-753-7

ex 2902 20 00

ex 2707 10 00

i(2)

sr

 

Benzene as a constituent of other substances in concentrations equal to, or greater than 0,1 % by weight (2)

 

 

ex 2707 10 00

i(2)

sr

 

Benzidine and its salts ((+))

Benzidine derivatives ((+))

92-87-5

36341-27-2

and others

202-199-1

252-984-8

and others

ex 2921 59 90

i(1)-i(2)

sr-b

 

i(2)

b

 

Benzyl butyl phthalate ((+))

85-68-7

201-622-7

ex 2917 34 00

i(1)-i(2)

sr-b

 

Beta-cyfluthrin ((+))

1820573-27-0

 

ex 2926 90 70

p(1)

b

 

Beta-cypermethrin ((+))

65731-84-2

265-898-0

ex 2926 90 70

p(1)

b

 

Bifenthrin ((+))

82657-04-3

 

ex 2916 20 00

p(1)-p(2)

b-sr

 

Binapacryl ((#))

485-31-4

207-612-9

ex 2916 16 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

i(2)

b

Bis(pentabromophenyl) ether ((+))

1163-19-5

214-604-9

ex 2909 30 38

i(1)-i(2)

sr-b

 

Bitertanol ((+))

55179-31-2

259-513-5

ex 2933 99 80

p(1)

b

 

Bromoxynil ((+))

1689-84-5

3861-41-4

56634-95-8

1689-99-2

216-882-7

223-374-9

260-300-4

216-885-3

ex 2926 90 70

p(1)

b

 

Butralin ((+))

33629-47-9

251-607-4

ex 2921 49 00

p(1)

b

 

Cadmium and its compounds ((+))

7440-43-9

and others

231-152-8

and others

ex 8112

and others

i(1)-i(2)

sr-sr

 

Cadusafos ((+))

95465-99-9

 

ex 2930 90 98

p(1)

b

 

Calciferol

50-14-6

200-014-9

ex 2936 29 00

p(1)

b

 

Captafol ((#))

2425-06-1

219-363-3

ex 2930 80 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Carbaryl ((+))

63-25-2

200-555-0

ex 2924 29 70

p(1)-p(2)

b–b

 

Carbendazim

10605-21-7

234-232-0

ex 2933 99 80

p(1)

b

 

Carbofuran ((#))

1563-66-2

216-353-0

ex 2932 99 00

p(1)

b

 

Carbon tetrachloride

56-23-5

200-262-8

ex 2903 14 00

i(2)

b

 

Carbosulfan ((+))

55285-14-8

259-565-9

ex 2932 99 00

p(1)

b

 

Cartap

15263-53-3

 

ex 2930 20 00

p(1)-p(2)

b-b

 

Chinomethionat

2439-01-2

219-455-3

ex 2934 99 90

p(1)-p(2)

b-b

 

Chlorate ((+))

7775-09-9

10137-74-3

7783-92-8

and others

231-887-4

233-378-2

232-034-9

and others

ex 2829 11 00

ex 2829 19 00

ex 2843 29 00

p(1)

b

 

Chlordimeform ((#))

6164-98-3

228-200-5

ex 2925 21 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Chlorfenapyr ((+))

122453-73-0

 

ex 2933 99 80

p(1)

b

 

Chlorfenvinphos

470-90-6

207-432-0

ex 2919 90 00

p(1)-p(2)

b-b

 

Chlormephos

24934-91-6

246-538-1

ex 2930 90 98

p(1)-p(2)

b-b

 

Chlorobenzilate ((#))

510-15-6

208-110-2

ex 2918 18 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Chloroform

67-66-3

200-663-8

ex 2903 13 00

i(2)

b

 

Chloropicrin ((+))

76-06-2

200-930-9

ex 2904 91 00

p(1)

b

 

Chlorothalonil ((+))

1897-45-6

217-588-1

ex 2926 90 70

p(1)

b

 

Chlorpropham ((+))

101-21-3

202-925-7

ex 2924 29 70

p(1)

b

 

Chlorpyrifos ((+))

2921-88-2

220-864-4

ex 2933 39 99

p(1)

b

 

Chlorpyrifos-methyl ((+))

5598-13-0

227-011-5

ex 2933 39 99

p(1)

b

 

Chlorthal-dimethyl ((+))

1861-32-1

217-464-7

ex 2917 39 95

p(1)

b

 

Chlozolinate ((+))

84332-86-5

282-714-4

ex 2934 99 90

p(1)-p(2)

b-b

 

Cholecalciferol

67-97-0

200-673-2

ex 2936 29 00

p(1)

b

 

Cinidon-ethyl ((+))

142891-20-1

 

ex 2925 19 95

p(1)

b

 

Clothianidin ((+))

210880-92-5

433-460-1

ex 2934 10 00

p(1)

b

 

Coumafuryl

117-52-2

204-195-5

ex 2932 20 90

p(1)-p(2)

b-b

 

Creosote and creosote related substances

8001-58-9

232-287-5

ex 2707 91 00

ex 3807 00 90

 

 

 

61789-28-4

263-047-8

ex 2707 91 00

 

 

 

84650-04-4

283-484-8

ex 2707 40 00

ex 2707 50 00

 

 

 

90640-84-9

292-605-3

ex 2707 91 00

 

 

 

65996-91-0

266-026-1

ex 3807 00 90

ex 2707 99 19

i(2)

b

 

90640-80-5

292-602-7

ex 2707 99 20

 

 

 

65996-85-2

266-019-3

ex 2707 99 80

 

 

 

8021-39-4

232-419-1

ex 3807 00 90

 

 

 

122384-78-5

310-191-5

ex 3807 00 90

 

 

 

Crimidine

535-89-7

208-622-6

ex 2933 59 95

p(1)

b

 

Cyanamide

420-04-2

206-992-3

ex 2853 90 90

p(1)

b

 

Cyanazine

21725-46-2

244-544-9

ex 2933 69 80

p(1)-p(2)

b-b

 

Cybutryne ((+))

28159-98-0

248-872-3

ex 2933 69 80

p(2)

b

 

Cyclanilide ((+))

113136-77-9

419-150-7

ex 2924 29 70

p(1)

b

 

Cyfluthrin

68359-37-5

269-855-7

ex 2926 90 70

p(1)

b

 

Cyhalothrine

68085-85-8

268-450-2

ex 2926 90 70

p(1)

b

 

Cyhexatin ((+))

13121-70-5

236-049-1

ex 2931 90 00

p(1)

b

 

DBB (Di-μ-oxo-di-n-butylstannio-hydroxyborane/dioxastannaboretan-4-ol)

75113-37-0

401-040-5

ex 2931 90 00

i(1)

b

 

Desmedipham ((+))

13684-56-5

237-198-5

ex 2924 29 70

p(1)

b

 

Diarsenic pentaoxide ((+))

1303-28-2

215-116-9

ex 2811 29 90

i(1)-i(2)

sr-b

 

Diazinon ((+))

333-41-5

206-373-8

ex 2933 59 10

p(1)

b

 

Dibutyltin compounds

683-18-1

77-58-7

1067-33-0

and others

211-670-0

201-039-8

213-928-8

and others

ex 2931 90 00

i(2)

sr

 

Dichlobenil ((+))

1194-65-6

214-787-5

ex 2926 90 70

p(1)

b

 

Dicloran ((+))

99-30-9

202-746-4

ex 2921 42 00

p(1)

b

 

Dichlorvos ((+))

62-73-7

200-547-7

ex 2919 90 00

p(1)-p(2)

b-b

 

Didecyldimethylammonium chloride

7173-51-5

230-525-2

ex 2923 90 00

p(1)

b

 

Diisobutyl phthalate ((+))

84-69-5

201-553-2

ex 2917 34 00

i(1)-i(2)

sr-b

 

Dimethenamid ((+))

87674-68-8

 

ex 2934 99 90

p(1)

b

 

Dimethoate ((+))

60-51-5

200-480-3

ex 2930 90 98

p(1)

b

 

Diniconazole-M ((+))

83657-18-5

 

ex 2933 99 80

p(1)

b

 

Dinitro-ortho-cresol (DNOC) and its salts (such as ammonium salt, potassium salt and sodium salt) ((#))

534-52-1

208-601-1

ex 2908 92 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

2980-64-5

221-037-0

5787-96-2

 

2312-76-7

219-007-7

Dinobuton

973-21-7

213-546-1

ex 2920 90 10

p(1)-p(2)

b-b

 

Dinoseb and its salts and esters ((#))

88-85-7

and others

201-861-7

and others

ex 2908 91 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

ex 2915 36 00

i(2)

b

Dinoterb ((+))

1420-07-1

215-813-8

ex 2908 99 00

p(1)-p(2)

b-b

 

Dioctyltin compounds

3542-36-7

870-08-6

16091-18-2

and others

222-583-2

212-791-1

240-253-6

and others

ex 2931 90 00

i(2)

sr

 

Diphenylamine ((+))

122-39-4

204-539-4

ex 2921 44 00

p(1)

b

 

Diquat, including diquat dibromide ((+))

2764-72-9

85-00-7

220-433-0

201-579-4

ex 2933 99 80

p(1)

b

 

DPX KE 459 (flupyrsulfuron-methyl) ((+))

150315-10-9

144740-54-5

 

ex 2935 90 90

p(1)

b

 

Dustable powder formulations containing a combination of:

 

 

ex 3808 99 90

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Benomyl at or above 7 %

17804-35-2

241-775-7

ex 2933 99 80

 

 

 

Carbofuran at or above 10 %

1563-66-2

216-353-0

ex 2932 99 00

 

 

 

and Thiram at or above 15 % ((#))

137-26-8

205-286-2

ex 2930 30 00

 

 

 

Empenthrin ((+))

54406-48-3

259-154-4

ex 2916 20 00

p(2)

b

 

Epoxiconazole ((+))

135319-73-2

406-850-2

ex 2934 99 90

p(1)

b

 

Ethalfluralin ((+))

55283-68-6

259-564-3

ex 2921 43 00

p(1)

b

 

Ethion

563-12-2

209-242-3

ex 2930 90 98

p(1)-p(2)

b-b

 

Ethoprophos ((+))

13194-48-4

236-152-1

ex 2930 90 98

p(1)

b

 

Ethoxysulfuron ((+))

126801-58-9

 

ex 2933 59 95

p(1)

b

 

Ethoxyquin ((+))

91-53-2

202-075-7

ex 2933 49 90

p(1)

b

 

Ethylene oxide (Oxirane) ((#))

75-21-8

200-849-9

ex 2910 10 00

p(1)

b

Please refer to PIC circular at www.pic.int/

Fenamidone ((+))

161326-34-7

 

ex 2933 29 90

p(1)

b

 

Fenarimol ((+))

60168-88-9

262-095-7

ex 2933 59 95

p(1)

b

 

Fenamiphos ((+))

22224-92-6

244-848-1

ex 2930 90 98

p(1)

b

 

Fenbutatin oxide ((+))

13356-08-6

236-407-7

ex 2931 90 00

p(1)

b

 

Fenitrothion ((+))

122-14-5

204-524-2

ex 2920 19 00

p(1)

b

 

Fenpropathrin

39515-41-8

254-485-0

ex 2926 90 70

p(1)-p(2)

b-b

 

Fenthion ((+))

55-38-9

200-231-9

ex 2930 90 98

p(1)

sr

 

Fentin acetate ((+))

900-95-8

212-984-0

ex 2931 90 00

p(1)-p(2)

b-b

 

Fentin hydroxide ((+))

76-87-9

200-990-6

ex 2931 90 00

p(1)-p(2)

b-b

 

Fenvalerate

51630-58-1

257-326-3

ex 2926 90 70

p(1)

b

 

Ferbam ((+))

14484-64-1

238-484-2

ex 2930 20 00

p(1)-p(2)

b-b

 

Fipronil ((+))

120068-37-3

424-610-5

ex 2933 19 90

p(1)

b

 

Flufenoxuron ((+))

101463-69-8

417-680-3

ex 2924 21 00

p(1)-p(2)

b-sr

 

Fluoroacetamide ((#))

640-19-7

211-363-1

ex 2924 12 00

p(1)

b

Please refer to PIC circular at www.pic.int/

Flurenol

467-69-6

207-397-1

ex 2918 19 98

p(1)-p(2)

b-b

 

Flurprimidol ((+))

56425-91-3

 

ex 2933 59 95

p(1)

b

 

Flurtamone ((+))

96525-23-4

 

ex 2932 19 00

p(1)

b

 

Furathiocarb

65907-30-4

265-974-3

ex 2932 99 00

p(1)-p(2)

b-b

 

Glufosinate, including glufosinate ammonium ((+))

51276-47-2

77182-82-2

257-102-5

278-636-5

ex 2931 49 90

p(1)

b

 

Guazatine ((+))

108173-90-6

115044-19-4

236-855-3

ex 3808 99 90

p(1)-p(2)

b-b

 

Hexachloroethane

67-72-1

200-666-4

ex 2903 19 00

i(1)

sr

 

Hexazinone ((+))

51235-04-2

257-074-4

ex 2933 69 80

p(1)-p(2)

b-b

 

Imidacloprid

138261-41-3

428-040-8

ex 2933 39 99

p(1)

sr

 

Iminoctadine

13516-27-3

236-855-3

ex 2925 29 00

p(1)-p(2)

b-b

 

Indolylacetic acid ((+))

87-51-4

201-748-2

ex 2933 99 80

p(1)

b

 

Iprodione ((+))

36734-19-7

253-178-9

ex 2933 21 00

p(1)

b

 

Isoproturon ((+))

34123-59-6

251-835-4

ex 2924 21 00

p(1)

b

 

Isoxathion

18854-01-8

242-624-8

ex 2934 99 90

p(1)

b

 

Lead and its compounds

7439-92-1

598-63-0

1319-46-6

7446-14-2

7784-40-9

7758-97-6

1344-37-2

25808-74-6

13424-46-9

301-04-2

7446-27-7

15245-44-0

and others

231-100-4

209-943-4

215-290-6

231-198-9

232-064-2

231-846-0

215-693-7

247-278-1

236-542-1

206-104-4

231-205-5

239-290-0

and others

ex 7801 10 00 , ex 7804 20 00

ex 2836 99 17

ex 3206 49 70

ex 2833 29 60

ex 2842 90 80

ex 2841 50 00

ex 3206 20 00

ex 2826 90 80

ex 2850 00 60

ex 2915 29 00

ex 2835 29 90 , ex 3206 49 70

ex 2908 99 00

i(2)

sr

 

Linuron ((+))

330-55-2

206-356-5

ex 2928 00 90

p(1)

b

 

Malathion

121-75-5

204-497-7

ex 2930 90 98

p(2)

b

 

Maleic hydrazide salts other than choline, potassium and sodium salts

5716-15-4

42489-17-8

36518-59-9

65445-74-1

51137-11-2

and others

227-213-3

255-849-1

253-082-7

265-780-9

and others

ex 2933 99 80

p(1)

b

 

Mancozeb ((+))

8018-01-7

 

ex 3808 92 30

p(1)

b

 

Maneb ((+))

12427-38-2

235-654-8

ex 3824 99 93

p(1)-p(2)

b-b

 

Mecoprop ((+))

7085-19-0

93-65-2

230-386-8

202-264-4

ex 2918 99 90

p(1)

b

 

Mercury ((+))

7439-97-6

231-106-7

ex 2805 40

i(1)-i(2)

sr-b

 

Mercury compounds, including inorganic mercury compounds, alkyl mercury compounds and alkyloxyalkyl and aryl mercury compounds except mercury compounds listed in Annex V ((#))

62-38-4,

26545-49-3

and others

200-532-5,

247-783-7

and others

ex 2852 10 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Methamidophos ((#))

10265-92-6

233-606-0

ex 2930 80 00

p(1)

b

 

Methidathion

950-37-8

213-449-4

ex 2934 99 90

p(1)-p(2)

b-b

 

Methiocarb ((+))

2032-65-7

217-991-2

ex 2930 90 98

p(1)

b

 

Methomyl ((+))

16752-77-5

240-815-0

ex 2930 90 98

p(1)-p(2)

b-b

 

Methyl bromide ((+))

74-83-9

200-813-2

ex 2903 61 00

p(1)-p(2)

b-b

 

Methyl-parathion ((+))  ((#))

298-00-0

206-050-1

ex 2920 11 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Metoxuron

19937-59-8

243-433-2

ex 2924 21 00

p(1)-p(2)

b-b

 

Monocrotophos ((#))

6923-22-4

230-042-7

ex 2924 12 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Monolinuron

1746-81-2

217-129-5

ex 2928 00 90

p(1)

b

 

Monomethyl-dibromo-diphenyl methane

Tradename: DBBT ((+))

99688-47-8

402-210-1

ex 2903 99 80

i(1)

b

 

Monomethyl-dichloro-diphenyl methane;

Tradename: Ugilec 121 or Ugilec 21 ((+))

 

400-140-6

ex 2903 99 80

i(1)-i(2)

b-b

 

Monomethyl-tetrachlorodiphenyl methane;

Tradename: Ugilec 141 ((+))

76253-60-6

278-404-3

ex 2903 99 80

i(1)-i(2)

b-b

 

Monuron

150-68-5

205-766-1

ex 2924 21 00

p(1)

b

 

Naled ((+))

300-76-5

206-098-3

ex 2919 90 00

p(1)-p(2)

b-b

 

Nicotine ((+))

54-11-5

200-193-3

ex 2939 79 10

p(1)

b

 

Nitrofen ((+))

1836-75-5

217-406-0

ex 2909 30 90

p(1)-p(2)

b-b

 

Nonylphenols C6H4(OH)C9H19  ((+))

25154-52-3 (phenol, nonyl-)

246-672-0

ex 2907 13 00

i(1)-i(2)

sr-sr

 

84852-15-3 (phenol, 4-nonyl-, branched)

284-325-5

ex 2907 13 00

 

 

 

11066-49-2 (isononylphenol)

234-284-4

ex 2907 13 00

 

 

 

90481-04-2, (phenol, nonyl-, branched)

291-844-0

ex 2907 13 00

 

 

 

104-40-5(p-nonylphenol)

and others

203-199-4

and others

ex 2907 13 00

 

 

 

Nonylphenol ethoxylates (C2H4O)nC15H24O ((+))

9016-45-9

26027-38-3

68412-54-4

37205-87-1

127087-87-0

and others

 

ex 3402 42 00

ex 3907 29 11

ex 3824 99 92

i(1)-i(2)

sr-sr

 

p(1)-p(2)

b-b

Commercial octabromodiphenyl ether, including

hexabromo diphenyl ether

heptabromo diphenyl ether ((#))

36483-60-0

68928-80-3

253-058-6

273-031-2

ex 3824 88 00

ex 2909 30 38

i(1)-i(2)

b-b

 

Omethoate

1113-02-6

214-197-8

ex 2930 90 98

p(1)-p(2)

b-b

 

Orthosulfamuron ((+))

213464-77-8

 

ex 2933 59 95

p(1)

b

 

Oxadiargyl ((+))

39807-15-3

254-637-6

ex 2934 99 90

p(1)

b

 

Oxasulfuron ((+))

144651-06-9

 

ex 2935 90 90

p(1)

b

 

Oxydemeton-methyl ((+))

301-12-2

206-110-7

ex 2930 90 98

p(1)

b

 

Paraquat ((+))

4685-14-7

1910-42-5

2074-50-2

225-141-7

217-615-7

218-196-3

ex 2933 39 99

p(1)

b

 

Parathion ((#))

56-38-2

200-271-7

ex 2920 11 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Pebulate

1114-71-2

214-215-4

ex 2930 20 00

p(1)-p(2)

b-b

 

Commercial pentabromodiphenyl ether, including

tetrabromo diphenyl ether

pentabromo diphenyl ether ((#))

40088-47-9

32534-81-9

254-787-2

251-084-2

ex 2909 30 31

ex 2909 30 38

ex 3824 88 00

i(1)-i(2)

b-b

 

Pentachloroethane

76-01-7

200-925-1

ex 2903 19 00

i(2)

sr

 

Pentachlorophenol and its salts and esters ((#))

87-86-5

and others

201-778-6

and others

ex 2908 11 00

and others

p(1)-p(2)

b-sr

Please refer to PIC circular at www.pic.int/

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds ((+))

335-67-1

and others

206-397-9

and others

ex 2915 90 70

and others

i(1)-i(2)

sr-b

 

Perfluorooctane sulfonates

(PFOS) C8F17SO2X

(X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) ((+))/ ((#))

1763-23-1

2795-39-3

70225-14-8

56773-42-3

4151-50-2

57589-85-2

68081-83-4

and others

217-179-8

220-527-1

274-460-8

260-375-3

223-980-3

260-837-4

268-357-7

and others

ex 2904 31 00

ex 2904 34 00

ex 2922 16 00

ex 2923 30 00

ex 2935 20 00

ex 2924 29 70

ex 3824 99 92

i(1)

sr

 

Permethrin

52645-53-1

258-067-9

ex 2916 20 00

p(1)

b

 

Phorate ((#))

298-02-2

206-052-2

ex 2930 90 98

p(1)

b

 

Phosalone ((+))

2310-17-0

218-996-2

ex 2934 99 90

p(1)

b

 

Phosphamidon (soluble liquid formulations of the substance that exceed 1 000 g active ingredient/l) ((#))

13171-21-6 (mixture, (E) & (Z) isomers)

23783-98-4 ((Z)-isomer)

297-99-4 ((E)-isomer)

236-116-5

ex 2924 12 00

ex 3808 59 00

p(1)-p(2)

b-b

Please refer to PIC circular at www.pic.int/

Picoxystrobin ((+))

117428-22-5

 

ex 2933 39 99

p(1)

b

 

Polybrominated biphenyls (PBB) except hexabromo-biphenyl ((#))

13654-09-6,

27858-07-7

and others

237-137-2,

248-696-7

and others

ex 2903 99 80

i(1)

sr

Please refer to PIC circular at www.pic.int/

Polychlorinated terphenyls (PCT) ((#))

61788-33-8

262-968-2

ex 2903 99 80

i(1)

b

Please refer to PIC circular at www.pic.int/

Procymidone ((+))

32809-16-8

251-233-1

ex 2925 19 95

p(1)

b

 

Propachlor ((+))

1918-16-7

217-638-2

ex 2924 29 70

p(1)

b

 

Propanil ((+))

709-98-8

211-914-6

ex 2924 29 70

p(1)

b

 

Propham

122-42-9

204-542-0

ex 2924 29 70

p(1)

b

 

Propargite ((+))

2312-35-8

219-006-1

ex 2920 90 70

p(1)

b

 

Propiconazole

60207-90-1

262-104-4

ex 2934 99 90

p(1)

b

 

Propineb ((+))

12071-83-9

9016-72-2

235-134-0

ex 2930 20 00

p(1)

b

 

Propisochlor ((+))

86763-47-5

 

ex 2924 29 70

p(1)

b

 

Pymetrozine ((+))

123312-89-0

 

ex 2933 69 80

p(1)

b

 

Pyrazophos ((+))

13457-18-6

236-656-1

ex 2933 59 95

p(1)-p(2)

b-b

 

Quinoxyfen ((+))

124495-18-7

 

ex 2933 49 90

p(1)

b

 

Quintozene ((+))

82-68-8

201-435-0

ex 2904 99 00

p(1)-p(2)

b-b

 

Rotenone ((+))

83-79-4

201-501-9

ex 2932 99 00

p(1)

b

 

Scilliroside

507-60-8

208-077-4

ex 2938 90 90

p(1)

b

 

Simazine ((+))

122-34-9

204-535-2

ex 2933 69 10

p(1)-p(2)

b-b

 

Strychnine

57-24-9

200-319-7

ex 2939 79 90

p(1)

b

 

Tecnazene ((+))

117-18-0

204-178-2

ex 2904 99 00

p(1)-p(2)

b-b

 

Tepraloxydim ((+))

149979-41-9

 

ex 2932 99 00

ex 3808 93 27

p(1)

b

 

Terbufos

13071-79-9

235-963-8

ex 2930 90 98

p(1)-p(2)

b-b

 

Tetraethyl lead ((#))

78-00-2

201-075-4

ex 2931 10 00

i(1)

sr

Please refer to PIC circular at www.pic.int/

Tetramethyl lead ((#))

75-74-1

200-897-0

ex 2931 10 00

i(1)

sr

Please refer to PIC circular at www.pic.int/

Thallium sulphate

7446-18-6

231-201-3

ex 2833 29 80

p(1)

b

 

Thiacloprid ((+))

111988-49-9

 

ex 2934 10 00

p(1)-p(2)

b-b

 

Thiamethoxam ((+))

153719-23-4

428-650-4

ex 2934 10 00

p(1)

b

 

Thiobencarb ((+))

28249-77-6

248-924-5

ex 2930 20 00

p(1)

b

 

Thiocyclam

31895-22-4

250-859-2

ex 2934 99 90

p(1)-p(2)

b-b

 

Thiodicarb ((+))

59669-26-0

261-848-7

ex 2930 90 98

p(1)

b

 

Thiophanate-methyl ((+))

23564-05-8

245-740-7

ex 2930 90 98

p(1)

b

 

Thiram ((+))

137-26-8

205-286-2

ex 2930 30 00

p(1)-p(2)

b-sr

 

Tolylfluanid ((+))

731-27-1

211-986-9

ex 2930 90 98

p(1)

b

 

Triasulfuron ((+))

82097-50-5

 

ex 2935 90 90

p(1)

b

 

Triazophos

24017-47-8

245-986-5

ex 2933 99 80

p(1)-p(2)

b-b

 

All tributyltin compounds, including: ((#))

 

 

ex 2931 20 00

p(2)

i(1)-i(2)

b

sr-sr

 

Tributyltin oxide

56-35-9

200-268-0

 

Tributyltin fluoride

1983-10-4

217-847-9

 

Tributyltin methacrylate

2155-70-6

218-452-4

 

Tributyltin benzoate

4342-36-3

224-399-8

 

Tributyltin chloride

1461-22-9

215-958-7

 

Tributyltin linoleate

24124-25-2

246-024-7

 

Tributyltin naphthenate

85409-17-2

287-083-9

 

 

and others

and others

 

 

 

 

Trichlorfon ((#))

52-68-6

200-149-3

ex 2931 54 00

p(1)-p(2)

b-b

 

Trichlorobenzene

120-82-1

204-428-0

ex 2903 99 80

i(2)

sr

 

Triclosan ((+))

3380-34-5

222-182-2

ex 2909 50 00

p(2)

b

 

Tricyclazole ((+))

41814-78-2

255-559-5

ex 2934 99 90

p(1)

b

 

Tridemorph

24602-86-6

246-347-3

ex 2934 99 90

p(1)-p(2)

b-b

 

Triflumuron

64628-44-0

264-980-3

ex 2924 21 00

p(2)

b

 

Trifluralin ((+))

1582-09-8

216-428-8

ex 2921 43 00

p(1)

b

 

Triorganostannic compounds other than tributyltin compounds ((+))

 

 

ex 2931 90 00 and others

p(2)

sr

 

i(2)

sr

 

Tris (2-chloroethyl) phosphate ((+))

115-96-8

204-118-5

ex 2919 90 00

i(1)-i(2)

sr-b

 

Tris (2,3-dibromopropyl) phosphate ((#))

126-72-7

204-799-9

ex 2919 10 00

i(1)

sr

Please refer to PIC circular at www.pic.int/

Tris(aziridinyl)phosphinoxide (1,1′,1′-phosphoryltriaziridine)

545-55-1

208-892-5

ex 2933 99 80

i(1)

sr

 

Vamidothion

2275-23-2

218-894-8

ex 2930 90 98

p(1)-p(2)

b-b

 

Vinclozolin ((+))

50471-44-8

256-599-6

ex 2934 99 90

p(1)

b

 

Warfarin

81-81-2

201-377-6

ex 2932 20 90

p(1)

b

 

Zineb

12122-67-7

235-180-1

ex 3824 99 93

ex 3808 92 30

p(1)

b

 

CAS No = Chemical Abstracts Service Registry Number.

PART 2

List of chemicals qualifying for PIC notification

(referred to in Article 11)

This list comprises chemicals qualifying for PIC notification. It does not include chemicals that are already subject to the PIC procedure, which are listed in Part 3 of this Annex.

Chemical

CAS No

EC No

CN code (*6)

Category (*4)

Use limitation (*5)

1,3-Dichloropropene

542-75-6

208-826-5

ex 2903 29 00

p

b

2-Naphthylamine (naphthalen-2-amine) and its salts

91-59-8,

553-00-4,

612-52-2

and others

202-080-4,

209-030-0,

210-313-6

and others

ex 2921 45 00

i

b

2-Naphthyloxyacetic acid

120-23-0

204-380-0

ex 2918 99 90

p

b

2,4-Dinitrotoluene (2,4-DNT)

121-14-2

204-450-0

ex 2904 20 00

i

sr

3-Decen-2-one

10519-33-2

234-059-0

ex 2914 19 90

p

b

4-Aminobiphenyl (biphenyl-4-amine) and its salts

92-67-1

2113-61-3

and others

202-177-1

and others

ex 2921 49 00

i

b

4-Nitrobiphenyl

92-92-3

202-204-7

ex 2904 20 00

i

b

4,4'- Diaminodiphenylmethane (MDA)

101-77-9

202-974-4

ex 2921 59 90

i

sr

5-Tert-butyl-2,4,6-trinitro-m-xylene

81-15-2

201-329-4

ex 2904 20 00

i

sr

Acephate

30560-19-1

250-241-2

ex 2930 90 98

p

b

Acetochlor

34256-82-1

251-899-3

ex 2924 29 70

p

b

Amitraz

33089-61-1

251-375-4

ex 2925 29 00

p

b

Amitrole

61-82-5

200-521-5

ex 2933 99 80

p

b

Anthraquinone

84-65-1

201-549-0

ex 2914 61 00

p

b

Asbestos fibres: Chrysotile

12001-29-5

132207-32-0

 

ex 2524 90 00

i

b

Asulam

3337-71-1

2302-17-2

222-077-1

218-953-8

ex 2935 90 90

p

b

Atrazine

1912-24-9

217-617-8

ex 2933 69 10

p

b

Azinphos-ethyl

2642-71-9

220-147-6

ex 2933 99 80

p

b

Azocyclotin

41083-11-8

255-209-1

ex 2933 99 80

p

b

Benalaxyl

71626-11-4

275-728-7

ex 2924 29 70

p

b

Benfuracarb

82560-54-1

 

ex 2932 99 00

p

b

Benzidine and its salts

Benzidine derivatives

92-87-5

36341-27-2

and others

202-199-1

252-984-8

and others

ex 2921 59 90

i

sr

Benzyl butyl phthalate

85-68-7

201-622-7

ex 2917 34 00

i

sr

Beta-cyfluthrin

1820573-27-0

 

ex 2926 90 70

p

b

Beta-cypermethrin

65731-84-2

265-898-0

ex 2926 90 70

p

b

Bifenthrin

82657-04-3

 

ex 2916 20 00

p

sr

Bis(pentabromophenyl) ether

1163-19-5

214-604-9

ex 2909 30 38

i

sr

Bitertanol

55179-31-2

259-513-5

ex 2933 99 80

p

b

Bromoxynil

1689-84-5

3861-41-4

56634-95-8

1689-99-2

216-882-7

223-374-9

260-300-4

216-885-3

ex 2926 90 70

p

b

Butralin

33629-47-9

251-607-4

ex 2921 49 00

p

b

Cadmium and its compounds

7440-43-9

and others

231-152-8

and others

ex 8112

and others

i

sr

Cadusafos

95465-99-9

 

ex 2930 90 98

p

b

Carbaryl

63-25-2

200-555-0

ex 2924 29 70

p

b

Carbosulfan

55285-14-8

259-565-9

ex 2932 99 00

p

b

Chlorate

7775-09-9

10137-74-3

7783-92-8

and others

231-887-4

233-378-2

232-034-9

and others

ex 2829 11 00

ex 2829 19 00

ex 2843 29 00

p

b

Chlorfenapyr

122453-73-0

 

ex 2933 99 80

p

sr

Chloropicrin

76-06-2

200-930-9

ex 2904 91 00

p

b

Chlorothalonil

1897-45-6

217-588-1

ex 2926 90 70

p

b

Chlorpropham

101-21-3

202-925-7

ex 2924 29 70

p

b

Chlorpyrifos

2921-88-2

220-864-4

ex 2933 39 99

p

b

Chlorpyrifos-methyl

5598-13-0

227-011-5

ex 2933 39 99

p

b

Chlorthal-dimethyl

1861-32-1

217-464-7

ex 2917 39 95

p

b

Chlozolinate

84332-86-5

282-714-4

ex 2934 99 90

p

b

Cinidon-ethyl

142891-20-1

 

ex 2925 19 95

p

b

Clothianidin

210880-92-5

433-460-1

ex 2934 10 00

p

sr

Cybutryne

28159-98-0

248-872-3

ex 2933 69 80

p

b

Cyclanilide

113136-77-9

419-150-7

ex 2924 29 70

p

b

Cyhexatin

13121-70-5

236-049-1

ex 2931 90 00

p

b

Desmedipham

13684-56-5

237-198-5

ex 2924 29 70

p

b

Diarsenic pentaoxide

1303-28-2

215-116-9

ex 2811 29 90

i

sr

Diazinon

333-41-5

206-373-8

ex 2933 59 10

p

sr

Dichlobenil

1194-65-6

214-787-5

ex 2926 90 70

p

b

Dicloran

99-30-9

202-746-4

ex 2921 42 00

p

b

Dichlorvos

62-73-7

200-547-7

ex 2919 90 00

p

b

Diisobutyl phthalate

84-69-5

201-553-2

ex 2917 34 00

i

sr

Dimethenamid

87674-68-8

 

ex 2934 99 90

p

b

Dimethoate

60-51-5

200-480-3

ex 2930 90 98

p

b

Diniconazole-M

83657-18-5

 

ex 2933 99 80

p

b

Dinoterb

1420-07-1

215-813-8

ex 2908 99 00

p

b

Diphenylamine

122-39-4

204-539-4

ex 2921 44 00

p

b

Diquat, including diquat dibromide

2764-72-9

85-00-7

220-433-0

201-579-4

ex 2933 99 80

p

b

DPX KE 459 (flupyrsulfuron-methyl)

150315-10-9

144740-54-5

 

ex 2935 90 90

p

b

Empenthrin

54406-48-3

259-154-4

ex 2916 20 00

p

b

Epoxiconazole

135319-73-2

406-850-2

ex 2934 99 90

p

b

Ethalfluralin

55283-68-6

259-564-3

ex 2921 43 00

p

b

Ethoprophos

13194-48-4

236-152-1

ex 2930 90 98

p

b

Ethoxysulfuron

126801-58-9

 

ex 2933 59 95

p

b

Ethoxyquin

91-53-2

202-075-7

ex 2933 49 90

p

b

Fenamidone

161326-34-7

 

ex 2933 29 90

p

b

Fenarimol

60168-88-9

262-095-7

ex 2933 59 95

p

b

Fenamiphos

22224-92-6

244-848-1

ex 2930 90 98

p

b

Fenbutatin oxide

13356-08-6

236-407-7

ex 2931 90 00

p

b

Fenitrothion

122-14-5

204-524-2

ex 2920 19 00

p

sr

Fenthion

55-38-9

200-231-9

ex 2930 90 98

p

sr

Fentin acetate

900-95-8

212-984-0

ex 2931 90 00

p

b

Fentin hydroxide

76-87-9

200-990-6

ex 2931 90 00

p

b

Ferbam

14484-64-1

238-484-2

ex 2930 20 00

p

b

Fipronil

120068-37-3

424-610-5

ex 2933 19 90

p

sr

Flufenoxuron

101463-69-8

417-680-3

ex 2924 21 00

p

sr

Flurprimidol

56425-91-3

 

ex 2933 59 95

p

b

Flurtamone

96525-23-4

 

ex 2932 19 00

p

b

Glufosinate, including glufosinate ammonium

51276-47-2

77182-82-2

257-102-5

278-636-5

ex 2931 49 90

p

b

Guazatine

108173-90-6

115044-19-4

236-855-3

ex 3808 99 90

p

b

Hexazinone

51235-04-2

257-074-4

ex 2933 69 80

p

b

Indolylacetic acid

87-51-4

201-748-2

ex 2933 99 80

p

b

Iprodione

36734-19-7

253-178-9

ex 2933 21 00

p

b

Isoproturon

34123-59-6

251-835-4

ex 2924 21 00

p

sr

Linuron

330-55-2

206-356-5

ex 2928 00 90

p

b

Mancozeb

8018-01-7

 

ex 3808 92 30

p

b

Maneb

12427-38-2

235-654-8

ex 3824 99 93

p

b

Mecoprop

7085-19-0

93-65-2

230-386-8

202-264-4

ex 2918 99 90

p

b

Mercury

7439-97-6

231-106-7

ex 2805 40

i

sr

Methiocarb

2032-65-7

217-991-2

ex 2930 90 98

p

b

Methomyl

16752-77-5

240-815-0

ex 2930 90 98

p

b

Methyl bromide

74-83-9

200-813-2

ex 2903 61 00

p

b

Methyl parathion ((#))

298-00-0

206-050-1

ex 2920 11 00

p

b

Monomethyl-dibromo-diphenyl methane

Tradename: DBBT

99688-47-8

401-210-1

ex 2903 99 80

i

b

Monomethyl-dichloro-diphenyl methane;

Tradename: Ugilec 121 or Ugilec 21

400-140-6

ex 2903 99 80

i

b

Monomethyl-tetrachlorodiphenyl methane;

Tradename: Ugilec 141

76253-60-6

278-404-3

ex 2903 99 80

i

b

Naled

300-76-5

206-098-3

ex 2919 90 00

p

b

Nicotine

54-11-5

200-193-3

ex 2939 79 10

p

b

Nitrofen

1836-75-5

217-406-0

ex 2909 30 90

p

b

Nonylphenols C6H4(OH)C9H19

25154-52-3 (phenol, nonyl-)

246-672-0

ex 2907 13 00

i

sr

84852-15-3 (phenol, 4-nonyl-, branched)

284-325-5

11066-49-2 (isononylphenol)

234-284-4

90481-04-2, (phenol, nonyl-, branched)

291-844-0

104-40-5 (P-nonylphenol)

and others

203-199-4

and others

Nonylphenol ethoxylates (C2H4O)nC15H24O

9016-45-9

26027-38-3

68412-54-4

37205-87-1

127087-87-0

and others

 

ex 3402 42 00

ex 3907 29 11

ex 3824 99 92

i

sr

p

b

Orthosulfamuron

213464-77-8

 

ex 2933 59 95

p

b

Oxadiargyl

39807-15-3

254-637-6

ex 2934 99 90

p

b

Oxasulfuron

144651-06-9

 

ex 2935 90 90

p

b

Oxydemeton-methyl

301-12-2

206-110-7

ex 2930 90 98

p

b

Paraquat

4685-14-7

1910-42-5

2074-50-2

225-141-7

217-615-7

218-196-3

ex 2933 39 99

p

b

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

335-67-1

and others

206-397-9

and others

2915 90 70

and others

i

sr

Perfluorooctane sulfonate derivatives (including polymers), not covered by

Perfluorooctane sulfonic acid, Perfluorooctane sulfonates, Perfluorooctane sulfonamides, Perfluorooctane sulfonyls

57589-85-2

68081-83-4

and others

260-837-4

268-357-7

and others

ex 2924 29 70

ex 3824 99 92

i

sr

Phosalone

2310-17-0

218-996-2

ex 2934 99 90

p

b

Picoxystrobin

117428-22-5

 

ex 2933 39 99

p

b

Procymidone

32809-16-8

251-233-1

ex 2925 19 95

p

b

Propachlor

1918-16-7

217-638-2

ex 2924 29 70

p

b

Propanil

709-98-8

211-914-6

ex 2924 29 70

p

b

Propargite

2312-35-8

219-006-1

ex 2920 90 70

p

b

Propineb

12071-83-9

9016-72-2

235-134-0

ex 2930 20 00

p

b

Propisochlor

86763-47-5

 

ex 2924 29 70

p

b

Pymetrozine

123312-89-0

 

ex 2933 69 80

p

b

Pyrazophos

13457-18-6

236-656-1

ex 2933 59 95

p

b

Quinoxyfen

124495-18-7

 

ex 2933 49 90

p

b

Quintozene

82-68-8

201-435-0

ex 2904 99 00

p

b

Rotenone

83-79-4

201-501-9

ex 2932 99 00

p

sr

Simazine

122-34-9

204-535-2

ex 2933 69 10

p

b

Tecnazene

117-18-0

204-178-2

ex 2904 99 00

p

b

Tepraloxydim

149979-41-9

 

ex 2932 99 00

ex 3808 93 27

p

b

Thiacloprid

111988-49-9

 

ex 2934 10 00

p

b

Thiamethoxam

153719-23-4

428-650-4

ex 2934 10 00

p

sr

Thiobencarb

28249-77-6

248-924-5

ex 2930 20 00

p

b

Thiodicarb

59669-26-0

261-848-7

ex 2930 90 98

p

b

Thiophanate-methyl

23564-05-8

245-740-7

ex 2930 90 98

p

b

Thiram

137-26-8

205-286-2

ex 2930 30 00

p

sr

Tolylfluanid

731-27-1

211-986-9

ex 2930 90 98

p

sr

Triasulfuron

82097-50-5

 

ex 2935 90 90

p

b

Triclosan

3380-34-5

222-182-2

ex 2909 50 00

p

b

Tricyclazole

41814-78-2

255-559-5

ex 2934 99 90

p

b

Trifluralin

1582-09-8

216-428-8

ex 2921 43 00

p

b

Triorganostannic compounds other than tributyltin compounds

 

 

ex 2931 90 00 and others

p

sr

Tris (2-chloroethyl) phosphate

115-96-8

204-118-5

ex 2919 90 00

i

sr

Vinclozolin

50471-44-8

256-599-6

ex 2934 99 90

p

b

CAS No = Chemical Abstracts Service Registry Number.

PART 3

List of chemicals subject to the PIC procedure

(referred to in Articles 13 and 14)

(The categories shown are those referred to in the Convention)

Chemical

Relevant CAS number(s)

HS code

Pure substance (*8)

HS code

Mixtures containing substance (*8)

Category

2,4,5-T and its salts and esters

93-76-5 ((#))

ex 2918.91

ex 3808.59

Pesticide

Alachlor

15972-60-8

ex 2924.25

ex 3808.93

Pesticide

Aldicarb

116-06-3

ex 2930.80

ex 3808.91

Pesticide

Aldrin (*7)

309-00-2

ex 2903.82

ex 3808.59

Pesticide

Azinphos-methyl

86-50-0

ex 2933.92

ex 3808.59

Pesticide

Binapacryl

485-31-4

ex 2916.16

ex 3808.59

Pesticide

Captafol

2425-06-1

ex 2930.80

ex 3808.59

Pesticide

Carbofuran

1563-66-2

ex 2932.99

ex 3808.91

ex 3808.59

Pesticide

Chlordane (*7)

57-74-9

ex 2903.82

ex 3808.59

Pesticide

Chlordimeform

6164-98-3

ex 2925.21

ex 3808.59

Pesticide

Chlorobenzilate

510-15-6

ex 2918.18

ex 3808.59

Pesticide

DDT (*7)

50-29-3

ex 2903.92

ex 3808.59

Pesticide

Dieldrin (*7)

60-57-1

ex 2910.40

ex 3808.59

Pesticide

Dinitro-ortho-cresol (DNOC) and its salts (such as ammonium salt, potassium salt and sodium salt)

534-52-1

2980-64-5

5787-96-2

2312-76-7

ex 2908.92

ex 3808.91

ex 3808.92

ex 3808.93

Pesticide

Dinoseb and its salts and esters

88-85-7 ((#))

ex 2908.91

ex 3808.59

Pesticide

1,2-Dibromoethane (EDB)

106-93-4

ex 2903.62

ex 3808.59

Pesticide

Endosulfan (*7)

115-29-7

ex 2920.30

ex 3808.91

Pesticide

Ethylene dichloride (1,2-dichloroethane)

107-06-2

ex 2903.15

ex 3808.59

Pesticide

Ethylene oxide

75-21-8

ex 2910.10

ex 3808.59

ex 3824.81

Pesticide

Fluoroacetamide

640-19-7

ex 2924.12

ex 3808.59

Pesticide

HCH (mixed isomers) (*7)

608-73-1

ex 2903.81

ex 3808.59

Pesticide

Heptachlor (*7)

76-44-8

ex 2903.82

ex 3808.59

Pesticide

Hexabromocyclododecane (*7)

25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 and others

ex 2903.89

 

Industrial

Hexachlorobenzene (*7)

118-74-1

ex 2903.92

ex 3808.59

Pesticide

Lindane (*7)

58-89-9

ex 2903.81

ex 3808.59

Pesticide

Mercury compounds, including inorganic mercury compounds, alkyl mercury compounds and alkyloxyalkyl and aryl mercury compounds

10112-91-1 21908-53-2 and others

See also: www.pic.int/

ex 2852.10

ex 3808.59

Pesticide

Methamidophos

10265-92-6

ex 2930.80

ex 3808.59

Pesticide

Monocrotophos

6923-22-4

ex 2924.12

ex 3808.59

Pesticide

Commercial octabromodiphenyl ether, including

 

ex 3824.88

ex 2909.30

ex 3824.88

Industrial

hexabromodiphenyl ether (*7)

36483-60-0

 

heptabromodiphenyl ether (*7)

68928-80-3

 

Parathion

56-38-2

ex 2920.11

ex 3808.59

Pesticide

Commercial pentabromodiphenyl ether, including

 

ex 2909.30

ex 3824.88

Industrial

tetrabromodiphenyl ether (*7)

40088-47-9

pentabromodiphenyl ether (*7)

32534-81-9

Pentachlorophenol and its salts and esters (*7)

87-86-5 ((#))

ex 2908.11

ex 3808.59

ex 3808.91

ex 3808.92

ex 3808.93

ex 3808.94

ex 3808.99

Pesticide

Perfluorooctane sulfonic acid, Perfluorooctane sulfonates, Perfluorooctane sulfonamides, Perfluorooctane sulfonyls (*7)

1763-23-1

2795-39-3

29457-72-5

29081-56-9

70225-14-8

56773-42-3

251099-16-8

4151-50-2

31506-32-8

1691-99-2

24448-09-7

307-35-7

and others

ex 2904.31

ex 2904.34

ex 2904.33

ex 2904.32

ex 2922.16

ex 2923.30

ex 2923.40

ex 2935.20

ex 2935.10

ex 2935.30

ex 2935.40

ex 2904.36

ex 3824.87

Industrial

Phorate

298-02-2

ex 2930.90

ex 3808.91

Pesticide

Toxaphene (*7)

8001-35-2

ex 3808.59

ex 3808.59

Pesticide

Dustable powder formulations containing a combination of:

 

 

ex 3808.92

Severely hazardous pesticide formulation

Benomyl at or above 7 %,

17804-35-2

ex 2933.99

Carbofuran at or above 10 %

1563-66-2

ex 2932.99

and Thiram at or above 15 %

137-26-8

ex 2930.30

Methyl-parathion (emulsifiable concentrates (EC) at or above 19,5 % active ingredient and dusts at or above 1,5 % active ingredient)

298-00-0

ex 2920.11

ex 3808.59

Severely hazardous pesticide formulation

Phosphamidon (soluble liquid formulations of the substance that exceed 1 000 g active ingredient/l)

13171-21-6 (mixture, (E) & (Z) isomers)

23783-98-4 ((Z)-isomer)

297-99-4 ((E)-isomer)

ex 2924.12

ex 3808.59

Severely hazardous pesticide formulation

Asbestos fibres:

 

ex 2524.10

ex 6811.40

Industrial

ex 2524.90

ex 6812.80

Actinolite

77536-66-4

ex 2524.90

ex 6812.99

Anthophyllite

77536-67-5

ex 2524.90

ex 6812.99

Amosite

12172-73-5

ex 2524.90

ex 6812.99

Crocidolite

12001-28-4

ex 2524.10

ex 6812.91

Tremolite

77536-68-6

ex 2524.90

ex 6813.20

Polybrominated biphenyls (PBB)

 

 

 

Industrial

(hexa-) (*7)

36355-01-8

ex 2903.94

ex 3824.82

 

(octa-)

27858-07-7

ex 2903.99

 

 

(deca-)

13654-09-6

ex 2903.99

 

 

Polychlorinated biphenyls (PCB) (*7)

1336-36-3

ex 2903.99

ex 3824.82

Industrial

Polychlorinated terphenyls (PCT)

61788-33-8

ex 2903.99

ex 3824.82

Industrial

Short-chain chlorinated paraffins (*7)

85535-84-8

ex 3824.99

 

Industrial

Tetraethyl lead

78-00-2

ex 2931.10

ex 3811.11

Industrial

Tetramethyl lead

75-74-1

ex 2931.10

ex 3811.11

Industrial

All tributyltin compounds, including:

 

ex 2931.20

ex 3808.59

Pesticide

Industrial

Tributyltin oxide

56-35-9

ex 2931.20

ex 3808.59

 

Tributyltin fluoride

1983-10-4

ex 2931.20

ex 3808.92

Tributyltin methacrylate

2155-70-6

ex 2931.20

 

Tributyltin benzoate

4342-36-3

ex 2931.20

 

Tributyltin chloride

1461-22-9

ex 2931.20

 

Tributyltin linoleate

24124-25-2

ex 2931.20

 

Tributyltin naphthenate

85409-17-2

ex 2931.20

 

Trichlorfon

52-68-6

ex 2931.54

ex 3808.91

Pesticide

Tris (2,3-dibromopropyl) phosphate

126-72-7

ex 2919.10

ex 3824.83

Industrial


(*1)  Subcategory: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for public use.

(*2)  Use limitation: sr — severe restriction, b — ban (for the subcategory or subcategories concerned) according to Union legislation.

(*3)  An ‘ex’ before a code implies that chemicals other than those referred to in the column ‘Chemical’ may also fall under that subheading.

(1)  This entry does not affect the existing entry for 1,3-Dichloropropene (cis) (CAS No 10061-01-5).

(2)  Except motor fuels subject to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58).

((#))  Chemical subject or partially subject to the PIC procedure.

((+))  Chemical qualifying for PIC notification.

(*4)  Category: p — pesticides; i — industrial chemical.

(*5)  Use limitation: sr — severe restriction, b — ban (for the category or categories concerned) according to Union legislation.

(*6)  An ‘ex’ before a code implies that chemicals other than those referred to in the column ‘Chemical’ may also fall under that subheading.

((#))  Chemical subject or partially subject to the PIC procedure.

(*7)  These substances are subject to an export ban in accordance with Article 15(2) of and Annex V to this Regulation.

(*8)  An ‘ex’ before a code implies that chemicals other than those referred to in the column ‘Chemical’ may also fall under that subheading.

((#))  Only the CAS numbers of parent compounds are listed.


ANNEX II

‘ANNEX V

Chemicals and articles subject to export ban

(referred to in Article 15)

PART 1

Persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants (1) according to the provisions thereof.

Description of chemicals/article(s) subject to export ban

Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)

 

Aldrin

EC No 206-215-8

CAS No 309-00-2

CN code ex 2903 82 00

 

Chlordane

EC No 200-349-0

CAS No 57-74-9

CN code ex 2903 82 00

 

Chlordecone

EC No 205-601-3

CAS No 143-50-0

CN code ex 2914 71 00

 

Dicofol

EC No 204-082-0

CAS No 115-32-2

CN code ex 2906 29 00

 

Dieldrin

EC No 200-484-5

CAS No 60-57-1

CN code ex 2910 40 00

 

DDT (1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane)

EC No 200-024-3

CAS No 50-29-3

CN code ex 2903 92 00

 

Endosulfan

EC No 204-079-4

CAS No 115-29-7

CN code 2920 30 00

 

Endrin

EC No 200-775-7

CAS No 72-20-8

CN code ex 2910 50 00

 

Heptabromodiphenyl ether C12H3Br7O

EC No 273-031-2

CAS No 68928-80-3 and others

CN code ex 2909 30 38

 

Heptachlor

EC No 200-962-3

CAS No 76-44-8

CN code ex 2903 82 00

 

Hexabromobiphenyl

EC No 252-994-2

CAS No 36355-01-8

CN code ex 2903 94 00

 

Hexabromocyclododecane

EC No 247-148-4, 221-695-9

CAS No 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 and others

CN code ex 2903 89 80

 

Hexabromodiphenyl ether C12H4Br6O

EC No 253-058-6

CAS No 36483-60-0 and others

CN code ex 2909 30 38

 

Hexachlorobenzene

EC No 204-273-9

CAS No 118-74-1

CN code ex 2903 92 00

 

Hexachlorobutadiene

EC No 201-765-5

CAS No 87-68-3

CN code ex 2903 29 00

 

Hexachlorocyclohexanes, including lindane

EC No 200-401-2, 206-270-8, 206-271-3, 210-168-9

CAS No 58-89-9, 319-84-6, 319-85-7, 608-73-1

CN code ex 2903 81 00

 

Mirex

EC No 219-196-6

CAS No 2385-85-5

CN code ex 2903 83 00

 

Pentabromodiphenyl ether C12H5Br5O

EC No 251-084-2 and others

CAS No 32534-81-9 and others

CN code ex 2909 30 31

 

Pentachlorobenzene

EC No 210-172-0

CAS No 608-93-5

CN code ex 2903 93 00

 

Pentachlorophenol and its salts and esters

EC No 201-778-6 and others

CAS No 87-86-5 and others

CN codes ex 2908 11 00 , ex 2908 19 00 and others

The export ban only applies to fire-fighting foam that contains or may contain PFOA, its salts and PFOA-related compounds.

Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

EC No 206-397-9 and others

CAS No 335-67-1 and others

CN codes ex 2915 90 70 and others

The export ban does not apply when PFOS, its salts and perfluorooctane sulfonyl fluoride is used as a mist suppressant for non-decorative hard chromium (VI) plating in closed loop systems.

Perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride

EC No 217-179-8, 220-527-1, 274-460-8, 260-375-3 and others

CAS No 1763-23-1, 2795-39-3, 70225-14-8, 56773-42-3 and others

CN codes 2904 31 00 , 2904 34 00 , 2922 16 00 , 2923 30 00 and others

 

Polychlorinated biphenyls (PCBs)

EC No 215-648-1 and others

CAS No 1336-36-3 and others

CN code ex 2903 99 80

 

Polychlorinated naphthalenes

EC No 274-864-4

CAS No 70776-03-3 and others

CN code ex 3824 99 92

 

Short-chain chlorinated paraffins

EC No 287-476-5

CAS No 85535-84-8

CN code ex 3824 99 92

 

Tetrabromodiphenyl ether C12H6Br4O

EC No 254-787-2 and others

CAS No 40088-47-9 and others

CN code ex 2909 30 38

The export ban only applies to articles where the sum of the concentration of tetra-, penta-, hexa-, hepta- and decabromodiphenyl ether is 500 mg/kg or more.

By way of derogation from the first paragraph, articles where the concentration is 500 mg/kg or more, due to a higher concentration of decabromodiphenyl ether, are exempted from the export ban, provided that the presence of decabromodiphenyl ether is in compliance with Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).

Tetrabromodiphenyl ether

EC No 254-787-2 and others

CAS No 40088-47-9 and others

CN code ex 2909 30 38

Pentabromodiphenyl ether

EC No 251-084-2 and others

CAS No 32534-81-9 and others

CN code ex 2909 30 31

Hexabromodiphenyl ether

EC No 253-058-6 and others

CAS No 36483-60-0 and others

CN code ex 2909 30 38

Heptabromodiphenyl ether

EC No 273-031-2 and others

CAS No 68928-80-3 and others

CN code ex 2909 30 38

Decabromodiphenyl ether

EC No 214-604-9 and others

CAS No 1163-19-5 and others

CN code ex 2909 30 38

 

Toxaphene

EC No 232-283-3

CAS No 8001-35-2

CN code ex 3808 59 00

PART 2

Chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants according to the provisions thereof.

No

Description of chemicals/article(s) subject to export ban (*1)

Additional details, where relevant (e.g. name of chemical, EC No, CAS No, etc.)

1

Cosmetic soaps containing mercury.

CN codes ex 3401 11 00 , ex 3401 19 00 , ex 3401 20 10 , ex 3401 20 90 , ex 3401 30 00

2

Metallic mercury and mixtures of metallic mercury with other substances, including alloys of mercury, with a mercury concentration of at least 95 % by weight.

CAS No 7439-97-6

EC No 231-106-7

CN code ex 2805 40

3

The following mercury compounds except where they are exported for laboratory-scale research or laboratory analysis:

Cinnabar ore;

Mercury (I) chloride (Cl2Hg2);

Mercury (II) oxide (HgO);

Mercury sulphide (HgS);

Mercury (II) sulphate (HgSO4);

Mercury (II) nitrate (Hg(NO3)2).

CAS No 10112-91-1, 21908-53-2, 1344-48-5, 7783-35-9, 10045-94-0

EC No 233-307-5, 244-654-7, 215-696-3, 231-992-5, 233-152-3

CN codes ex 2852 10 00 , ex 2617 90 00

4

All mixtures of metallic mercury with other substances, including alloys of mercury, not covered by entry 2 and all mercury compounds not covered by entry 3, if the export of that mixture or compound is for the purpose of reclaiming metallic mercury.

Including:

Mercury(I) sulphate (Hg2SO4, CAS No 7783-36-0), mercury(II) thiocyanate (Hg(SCN)2, CAS No 592-85-8), mercury(I) iodide (Hg2I2, CAS No 15385-57-6)

CN codes ex 2852 10 00

5

Compact fluorescent lamps (CFLs) for general lighting purposes:

(a)

CFL.i ≤ 30 watts with a mercury content exceeding 2,5 mg per lamp burner;

(b)

CFL.ni ≤ 30 watts with a mercury content exceeding 3,5 mg per lamp burner.

 

6

The following linear fluorescent lamps for general lighting purposes:

(a)

Triband phosphor < 60 watts with a mercury content exceeding 5 mg per lamp;

(b)

Halophosphate phosphor ≤ 40 watts with a mercury content exceeding 10 mg per lamp.

 

7

High pressure mercury vapour lamps for general lighting purposes.

 

8

The following mercury-added cold cathode fluorescent lamps and external electrode fluorescent lamps for electronic displays:

(a)

short length (≤ 500 mm) with mercury content exceeding 3,5 mg per lamp;

(b)

medium length (> 500 mm and ≤ 1 500 mm) with mercury content exceeding 5 mg per lamp;

(c)

long length (> 1 500 mm) with mercury content exceeding 13 mg per lamp.

 

9

Batteries or accumulators that contain more than 0,0005 % of mercury by weight.

 

10

Switches and relays, except very high accuracy capacitance and loss measurement bridges and high frequency radio frequency switches and relays in monitoring and control instruments with a maximum mercury content of 20 mg per bridge, switch or relay.

 

11

Cosmetics with mercury and mercury compounds, except those special cases included in entries 16 and 17 of Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

 

12

Pesticides, biocides and topical antiseptics that contain mercury or a mercury compound that was intentionally added.

 

13

The following non-electronic measuring devices that contain mercury or a mercury compound that was intentionally added:

(a)

barometers;

(b)

hygrometers;

(c)

manometers;

(d)

thermometers and other non-electrical thermometric applications;

(e)

sphygmomanometers;

(f)

strain gauges to be used with plethysmographs;

(g)

mercury pycnometers;

(h)

mercury metering devices for determination of the softening point.

This entry does not cover the following measuring devices:

non-electronic measuring devices installed in large-scale equipment or used for high precision measurement where no suitable mercury-free alternative is available;

measuring devices more than 50 years old on 3 October 2007;

measuring devices which are to be displayed in public exhibitions for cultural and historical purposes.

 


(1)  OJ L 209, 31.7.2006, p. 3.

(*1)  The export ban shall not apply to any of the following mercury-added products:

(a)

products that are essential for civil protection and military uses;

(b)

products for research, for calibration of instrumentation, or for use as a reference standard;

(c)

switches and relays, cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays and measuring devices, when they are used to replace a component of larger equipment and provided that no feasible mercury-free alternative for that component is available, in accordance with Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of live vehicles (OJ L 269, 21.10.2000, p. 34) and Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).


DECISIONS

20.4.2022   

EN

Official Journal of the European Union

L 118/55


COUNCIL DECISION (EU) 2022/644

of 12 April 2022

on the position to be adopted on behalf of the European Union within the International Maritime Organization’s Maritime Safety Committee during its 105th session and within the International Maritime Organization’s Facilitation Committee during its 46th session as regards the adoption of amendments to the resolutions on performance standards in relation to equipment used in the Global Maritime Distress and Safety System and of amendments to the Annex to the Convention on Facilitation of International Maritime Traffic (FAL)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

Action by the Union in the sector of maritime transport should aim to improve maritime safety and protect the marine environment and human health.

(2)

The Maritime Safety Committee of the International Maritime Organization (‘IMO’), during its 105th session (‘MSC 105’) from 20 to 29 April 2022, is expected to adopt amendments to the resolutions on performance standards in relation to equipment used in order to reflect the modernisation of the Global Maritime Distress and Safety System (GMDSS). Those resolutions comprise A.699(17), A.700(17), MSC.148(77), A.530(13), A.802(19), A.803(19), A.804(19), A.806(19), A.807(19), MSC.149(77), MSC.80(70) and A.811(19).

(3)

The Facilitation Committee of the IMO, during its 46th session (‘FAL 46’) from 9 to 13 May 2022, is expected to adopt amendments to the Annex to the Convention on Facilitation of International Maritime Traffic (‘FAL Convention’).

(4)

It is appropriate to establish the position to be adopted on the Union’s behalf during MSC 105, since the Maritime Safety Committee's resolutions on performance standards are capable of decisively influencing the content of Union law, namely Directive 2014/90/EU of the European Parliament and of the Council (1).

(5)

The adoption of amendments to the MSC resolutions on performance standards would improve the previously adopted performance standards in relation to equipment used in order to reflect the modernisation of the GMDSS. The Union should therefore support the adoption of the amendments to the MSC resolutions.

(6)

It is appropriate to establish the position to be adopted on the Union’s behalf during the 46th session of the Facilitation Committee, since the envisaged amendments to the Annex to the FAL Convention are capable of decisively influencing the content of Union law, namely Directive 2010/65/EU of the European Parliament and of the Council (2) and, as from 15 August 2025, Regulation (EU) 2019/1239 of the European Parliament and of the Council (3).

(7)

The amendments to the Annex to the FAL Convention would bring that Annex closer to the requirements of Regulation (EU) 2019/1239 and the agreed business rules for implementing that Regulation, namely by making electronic transmission through a single window mandatory, preventing data elements from being repeated, preventing paper forms from being used for the transmission of information, and waiving the requirement for manual signatures.

(8)

The Union is neither a member of the IMO, nor a contracting party to the relevant conventions and codes. The Council should therefore authorise the Member States to express the position of the Union.

(9)

The scope of this Decision should be limited to the content of the proposed amendments, to the extent that those amendments are capable of affecting Union common rules and fall under the exclusive competence of the Union. This Decision should not affect the division of competences between the Union and the Member States,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted on behalf of the Union within the International Maritime Organization’s Maritime Safety Committee during its 105th session shall be to support the adoption of the amendments to the following resolutions on performance standards in relation to equipment used in the Global Maritime Distress and Safety System: A.699(17), A.700(17), MSC.148(77), A.530(13), A.802(19), A.803(19), A.804(19), A.806(19), A.807(19), MSC.149(77), MSC.80(70) and A.811(19).

Article 2

The position to be adopted on behalf of the Union within the International Maritime Organization’s Facilitation Committee during its 46th session shall be to support the adoption of the amendments to the Annex to the Convention on Facilitation of International Maritime Traffic.

Article 3

1.   The positions to be adopted on behalf of the Union specified in this Decision cover the amendments concerned to the extent that those amendments fall under the exclusive competence of the Union and are capable of affecting Union common rules. Those positions shall be expressed by the Member States, which are all members of the IMO, acting jointly in the interests of the Union.

2.   Minor changes to the positions referred to in Articles 1 and 2 may be agreed upon without further decision of the Council.

Article 4

Member States are hereby authorised to give their consent to be bound, in the interests of the Union, by the amendments referred to in Articles 1 and 2, to the extent that those amendments fall under the exclusive competence of the Union.

Article 5

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 12 April 2022.

For the Council

The President

C. BEAUNE


(1)  Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).

(2)  Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (OJ L 283, 29.10.2010, p. 1).

(3)  Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, p. 64).


ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

20.4.2022   

EN

Official Journal of the European Union

L 118/58


BILATERAL OVERSIGHT BOARD FOR THE AGREEMENT BETWEEN THE UNITED STATES OF AMERICA AND THE EUROPEAN COMMUNITY ON COOPERATION IN THE REGULATION OF CIVIL AVIATION SAFETY

RECORD OF DECISION

DECISION N°0010 [2022/645]

Noting that Amendment 1 to the Agreement between the United States of America and the European Community on Cooperation in the Regulation of Civil Aviation Safety (the 'Agreement') expands the scope of Article 2.B of the Agreement to include, inter alia, personnel licensing and training;

Further noting that Article 5 of the Agreement, as amended, provides for the development of new Annexes to the Agreement for matters within the scope of the Agreement, which are then, pursuant to Article 19.C, brought into force upon a decision of the Bilateral Oversight Board ('BOB') established pursuant to Article 3,

The BOB hereby decides as follows:

1.

To adopt Annex 3 (Pilot Licensing) to the Agreement as attached to this Decision in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovakian, Slovenian, Spanish and Swedish languages. In case of divergence of interpretation between the different language texts, the English text shall prevail.

2.

To take note of the Joint Declaration to be signed by the Representatives of the Parties concerning the authentication of the Croatian language version of Annex 3.

3.

Annex 3 (Pilot Licensing) to the Agreement shall enter into force on the date of the last signature below.

For the Bilateral Oversight Board:

FEDERAL AVIATION ADMINISTRATION

DEPARTMENT OF TRANSPORTATION

UNITED STATES OF AMERICA

 

EUROPEAN COMMISSION

EUROPEAN UNION

BY:

Mr Ali BAHRAMI

 

BY:

Mr Filip CORNELIS

TITLE:

Associate Administrator for Aviation Safety

 

TITLE:

Director, Aviation

Directorate-General for Mobility and Transport, European Commission

DATE:

19 November 2020

 

DATE:

19 November 2020

PLACE:

Washington, DC

 

PLACE:

Brussels, Belgium


ANNEX 3

PILOT LICENSING

1.   PURPOSE AND SCOPE

1.1.

The Parties have assessed each other's standards, rules, practices, and procedures related to private pilot licensing, including night and instrument ratings for the single-engine piston (SEP) land airplane and multi-engine piston (MEP) land airplane categories, but excluding the type ratings, and concluded that they are sufficiently compatible to permit acceptance of each other's approvals and findings. This Annex covers the reciprocal acceptance of findings of compliance and documentation, and the provision of technical assistance regarding private pilot licensing and compliance monitoring. Nothing in this Annex shall be construed to limit the authority of a Party to act in accordance with Article 15 of the Agreement.

1.2.

The scope of this Annex covers private pilot EU Part-FCL licenses and FAA private pilot certificates, and private pilot privileges included in other EU Part-FCL licenses and FAA pilot certificates, as well as night and instrument ratings, as specified in Appendix 1 to this Annex, in SEP land airplane and MEP land airplane categories in single-pilot operations, excluding any type ratings. EU Part-FCL commercial pilot licenses for airplanes (CPL (A)) and airline transport pilot licenses for airplanes (ATPL (A)) contain private pilot privileges. The multi-crew pilot license (MPL) only contains private pilot privileges if specifically endorsed in the license. Similarly, FAA commercial pilot and air transport pilot certificates contain private pilot privileges. These licenses and pilot certificates are eligible for conversion under the terms of this Annex if the privileges are applicable.

1.3.

The scope of this Annex may be extended to other EU Part-FCL licenses and FAA pilot certificates, ratings and aircraft categories through an amendment to this Annex pursuant to a decision of the Bilateral Oversight Board (BOB) taken in accordance with Article 19.B of the Agreement.

1.4.

The extension of the scope of this Annex shall take place following the necessary confidence-building process conducted by the Technical Agents.

1.5.

This Annex does not apply to any pilot license or pilot certificate issued by another Contracting State to the Convention on International Civil Aviation of 1944 (Chicago Convention) that has been rendered valid by the FAA or by an Aviation Authority, as detailed in the Technical Implementation Procedures - Licensing (TIP-L).

1.6.

This Annex does not limit the right of a holder of an FAA pilot certificate or an EU Part-FCL license issued by an Aviation Authority, to have the pilot certificate or license rendered valid by the other Party in accordance with applicable laws and regulations.

2.   DEFINITIONS

2.1.

In addition to those definitions found in the Agreement, for the purposes of this Annex, the following definitions apply:

(a)

'Class rating' means:

(i)

with respect to an EU Part-FCL license, a valid rating attached to a pilot license. The privileges of the holder of a SEP and MEP class rating are to act as pilot on the class of aircraft specified in the rating as outlined in the 'List of Aeroplanes – Class and Type Ratings and Endorsement List' published on the European Aviation Safety Agency (EASA) website.

(ii)

with respect to an FAA pilot certificate, a classification of aircraft within a category having similar operating characteristics as outlined in Title 14, Code of Federal Regulations (14 CFR) § 61.5 (e.g., single-engine land and multi-engine land).

(b)

'Conversion' means the issuance of an EU Part-FCL license on the basis of an FAA pilot certificate or the issuance of an FAA pilot certificate on the basis of an EU Part-FCL license, in accordance with the provisions of this Annex.

(c)

'Currency' means the acceptance of the privileges of a class or type rating on an FAA pilot certificate, based on the recent experience of the certificate holder. (14 CFR Part 61 and Regulation (EU) No 1178/2011 Annex III Part C).

(d)

'EU Part-FCL license' means a valid flight crew license that complies with the requirements of Part-FCL.

(e)

'FAA pilot certificate' means a valid Federal Aviation Administration pilot certificate that complies with the appropriate requirements prescribed in 14 CFR Part 61.

(f)

'Flight review' means an assessment of flying skills taken with a certified flight instructor holding appropriate FAA examining authority.

(g)

'Instrument rating' means:

(i)

with respect to an EU Part-FCL instrument rating, a valid rating on an EU Part-FCL licence allowing for operation under Instrument Flight Rules (IFR) or in weather conditions less than the minimums prescribed for Visual Flight Rules (VFR) that is restricted to single-engine or multi-engine operation, or in the case of a multi-crew pilot license (MPL) additionally restricted to multi-crew operation.

(ii)