ISSN 1977-0677 |
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Official Journal of the European Union |
L 225 |
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English edition |
Legislation |
Volume 64 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/1 |
COMMISSION DELEGATED REGULATION (EU) 2021/1040
of 16 April 2021
amending Delegated Regulation (EU) 2016/128 as regards the requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children
(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 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(2) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) 2016/128 (2) lays down, among other issues, specific requirements on pesticides and the residues thereof, in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children. |
(2) |
Delegated Regulation (EU) 2016/128 defines residue of pesticides by using the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (3). |
(3) |
However, Article 3(2)(c) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) provides for a more precise definition of pesticide residues. |
(4) |
For reasons of legal certainty and clarity, it is necessary to align the definition of a pesticide residue contained in Delegated Regulation (EU) 2016/128 with the definition contained in Article 3(2)(c) of Regulation (EC) No 396/2005. |
(5) |
Taking into account that the residue definitions for active substances should apply as defined in Regulation (EC) No 396/2005, it is appropriate to include only the parent compounds of the active substances in the lists set out in Annexes II and III to Delegated Regulation (EU) 2016/128, in view of future amendments to Regulation (EC) No 396/2005. |
(6) |
Delegated Regulation (EU) 2016/128 should therefore be amended accordingly. |
HAS ADOPTED THIS REGULATION:
Article 1
Article 3, paragraph 1, of Delegated Regulation (EU) 2016/128 is replaced by the following:
‘1. For the purposes of this Article, ‘residue’ means pesticide residue as referred to in point (c) of Article 3(2) of Regulation (EC) No 396/2005.’.
Article 2
Annexes II and III to Delegated Regulation (EU) 2016/128 are amended in accordance with the Annex to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 181, 29.6.2013, p. 35.
(2) Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (OJ L 25, 2.2.2016, p. 30).
(3) 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).
(4) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
ANNEX
Annexes II and III to Delegated Regulation (EU) 2016/128 are amended as follows:
(1) |
Annex II is replaced by the following: ‘ANNEX II ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(3)
|
(2) |
Annex III is replaced by the following: ‘ANNEX III ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(4)
|
(1) The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005 (the residue definition is mentioned in brackets behind the parent compound of the substance).
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/4 |
COMMISSION DELEGATED REGULATION (EU) 2021/1041
of 16 April 2021
amending Delegated Regulation (EU) 2016/127 as regards the requirements on pesticides in infant formula and follow-on formula
(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 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(2) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) 2016/127 (2) lays down, among other issues, specific requirements on pesticides and the residues thereof in infant formula and in follow-on formula. |
(2) |
Delegated Regulation (EU) 2016/127 defines residue of pesticides by using the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (3). |
(3) |
However, Article 3(2)(c) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) provides for a more precise definition of pesticide residues. |
(4) |
For reasons of legal certainty and clarity, it is necessary to align the definition of pesticide residue contained in Delegated Regulation (EU) 2016/127 with the definition contained in Article 3(2)(c) of Regulation (EC) No 396/2005. |
(5) |
Taking into account that the residue definitions for active substances should apply as defined in Regulation (EC) No 396/2005, it is appropriate to include only the parent compounds of the active substances in the lists set out in Annexes IV and V to Delegated Regulation (EU) 2016/127 in view of future amendments to Regulation (EC) No 396/2005. |
(6) |
Delegated Regulation (EU) 2016/127 should therefore be amended accordingly. |
HAS ADOPTED THIS REGULATION:
Article 1
Article 4, paragraph 1 of Delegated Regulation (EU) 2016/127 is replaced by the following:
‘1. For the purposes of this Article, “residue” means pesticide residue as referred to in point (c) Article 3(2) of Regulation (EC) No 396/2005.’
Article 2
Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 April 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 181, 29.6.2013, p. 35.
(2) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formulae and follow-on formulae and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1).
(3) 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).
(4) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
ANNEX
Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended as follows:
(1) |
Annex IV is replaced by the following: ‘ANNEX IV ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(3)
|
(2) |
Annex V is replaced by the following: ‘ANNEX V ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(4)
|
(1) The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005 (the residue definition is mentioned in brackets behind the parent compound of the substance).
(2) The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005 (the residue definition is mentioned in brackets behind the parent compound of the substance).
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/7 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1042
of 18 June 2021
laying down rules for the application of Directive (EU) 2017/1132 of the European Parliament and of the Council as regards technical specifications and procedures for the system of interconnection of registers and repealing Commission Implementing Regulation (EU) 2020/2244
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (1), and in particular Articles 13i(5) and 24 thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) 2015/884 (2) set out the technical specifications and procedures required for the system of interconnection of registers established by Directive 2009/101/EC of the European Parliament and of the Council (3), which has been codified and repealed by Directive (EU) 2017/1132. Further procedures for the system of interconnection of registers have subsequently been introduced in Directive (EU) 2017/1132 by Directive (EU) 2019/1151 of the European Parliament and of the Council (4). Commission Implementing Regulation (EU) 2020/2244 (5) set out the corresponding technical specifications and procedures and repealed Implementing Regulation (EU) 2015/884. Finally, new procedures for the system of interconnection of registers have been introduced in Directive (EU) 2017/1132 by Directive (EU) 2019/2121 of the European Parliament and of the Council (6) together with a requirement for the Commission to adopt an implementing act setting out the corresponding technical specifications and procedures by 2 July 2021. |
(2) |
It is necessary to lay down technical specifications defining the methods of exchange of information between the register of the company and the register of the branch in case a branch is opened or closed or when changes occur in the data and information of the company. |
(3) |
There is a need to specify what should be the detailed list of data when providing information between the register of the company and the register of the branch in order to ensure efficient exchange of data. |
(4) |
The procedure and technical requirements for the connection of the optional access points for Commission or other Union institutions, bodies, offices or agencies to the platform needs to be specified to ensure consistent rules for the establishment of such access points. |
(5) |
For the exchange of information on disqualified directors established by Directive (EU) 2019/1151 detailed arrangements and technical details need to be laid down to ensure effective, efficient and prompt exchange of information. |
(6) |
There is a need to specify what should be the detailed list of data to be transmitted for the purpose of exchanging information between registers and for the purposes of disclosure as referred to in Articles 86g, 86n, 86p, 123, 127a, 130, 160g, 160n and 160p of Directive (EU) 2017/1132, in order to ensure efficient exchange of data in cross-border operations. |
(7) |
In order to ensure clarity and legal certainty, all the procedures and technical specifications for the system of interconnection of registers required by Directive (EU) 2017/1132 should be included in a single Implementing Regulation. Implementing Regulation (EU) 2020/2244 should therefore be repealed and the technical specifications and procedures set out in that Implementing Regulation should be included in this Regulation. |
(8) |
Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council (7) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (8), as applicable. |
(9) |
The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 10 March 2021. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee on the Interconnection of Central, Commercial and Companies Registers, |
HAS ADOPTED THIS REGULATION:
Article 1
The technical specifications and procedures for the system of interconnection of registers referred to in Article 22(2) of Directive (EU) 2017/1132 are set out in the Annex.
Article 2
Implementing Regulation (EU) 2020/2244 is repealed.
References to the repealed Implementing Regulation (EU) 2015/884 and to Implementing Regulation (EU) 2020/2244 shall be construed as references to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 June 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 169, 30.6.2017, p. 46.
(2) Commission Implementing Regulation (EU) 2015/884 of 8 June 2015 establishing technical specifications and procedures required for the system of interconnection of registers established by Directive 2009/101/EC of the European Parliament and of the Council (OJ L 144, 10.6.2015, p. 1).
(3) Directive 2009/101/EC of the European Parliament and of the Council of 16 September 2009 on coordination of safeguards which, for the protection of the interests of members and third parties, are required by Member States of companies within the meaning of the second paragraph of Article 48 of the Treaty with a view to making such safeguards equivalent (OJ L 258, 1.10.2009, p. 11).
(4) Directive (EU) 2019/1151 of the European Parliament and of the Council of 20 June 2019 amending Directive (EU) 2017/1132 as regards the use of digital tools and processes in company law (OJ L 186, 11.7.2019, p. 80).
(5) Commission Implementing Regulation (EU) 2020/2244 of 17 December 2020 laying down rules for the application of Directive (EU) 2017/1132 of the European Parliament and of the Council as regards technical specifications and procedures for the system of interconnection of registers and repealing Commission Implementing Regulation (EU) 2015/884 (OJ L 439, 29.12.2020, p. 1).
(6) Directive (EU) 2019/2121 of the European Parliament and of the Council of 27 November 2019 amending Directive (EU) 2017/1132 as regards cross-border conversions, mergers and divisions (OJ L 321, 12.12.2019, p. 1).
(7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(8) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
ANNEX
Technical specifications and procedures
Where reference is made in this Annex to ‘registers’, it is to be understood as ‘central, commercial and companies registers’.
The system of interconnection of registers is in this Annex referred to as the ‘Business Registers Interconnection System (BRIS)’.
1. Methods of communication
BRIS shall use service-based methods of electronic communication, such as Web-services, for the purpose of interconnection of registers.
The communication between the portal and the platform, and between a register and the platform, shall be one-to-one communication. The communication from the platform to the registers may be one-to-one or one-to-many.
2. Communication protocols
Secure internet protocols, such as Hypertext Transfer Protocol Secure (HTTPS), shall be used for the communication between the portal, the platform, the registers and the optional access points.
Standard communication protocols, such as Simple Object Access Protocol (SOAP), shall be used for the transmission of structured data and metadata.
3. Security standards
For the communication and distribution of information via BRIS, the technical measures for ensuring minimum information technology security standards shall include:
(a) |
measures to ensure confidentiality of information, including by using secure channels (HTTPS); |
(b) |
measures to ensure the integrity of data while being exchanged; |
(c) |
measures to ensure the non-repudiation of origin of the sender of information within BRIS and the non-repudiation of receipt of information; |
(d) |
measures to ensure logging of security events in line with recognized international recommendations for information technology security standards; |
(e) |
measures to ensure the authentication and authorisation of any registered users and measures to verify the identity of systems connected to the portal, the platform or the registers within BRIS. |
4. Methods of exchange of information between the register of the company and the register of the branch
4.1. Branch disclosure notification
The following method shall be used for the exchange of information between the register of the company and the register of the branch in accordance with Articles 20 and 34 of Directive (EU) 2017/1132:
(a) |
The register of the company shall make available, without delay, to the platform the information on the opening and termination of any winding-up or insolvency proceedings and on the striking-off of the company (‘disclosed information’); |
(b) |
To ensure receipt without delay of the disclosed information, the register of the branch shall request that information from the platform. That request may consist of indicating to the platform the companies on which the register of the branch is interested to receive disclosed information; |
(c) |
Upon that request, the platform shall ensure that the register of the branch has access to the disclosed information without delay. |
4.2. Branch registration notification
The following method shall be used for the exchange of information between the register of the branch and the register of the company in accordance with Article 28a of Directive (EU) 2017/1132:
(a) |
The register of the branch shall send a message, without delay, through BRIS to the register of the company (‘branch registration notification’); |
(b) |
Upon receipt of the notification, the register of the company shall, without delay, send a message acknowledging the receipt of the notification (‘acknowledgement of receipt of branch registration notification’). |
4.3. Branch closure notification
The following method shall be used for the exchange of information between the register of the branch and the register of the company in accordance with Article 28c of Directive (EU) 2017/1132:
(a) |
The register of the branch shall send a message, without delay, through BRIS to the register of the company (‘branch closure notification’); |
(b) |
Upon receipt of the notification, the register of the company shall, without delay, send a message acknowledging the receipt of the notification (‘acknowledgement of receipt of branch closure notification’). |
4.4. Notification on changes to documents and information about the company
The following method shall be used for the exchange of information between the register of the company and the register of the branch in accordance with Article 30a of Directive (EU) 2017/1132:
(a) |
The register of the company shall make available, without delay, to the platform the information on changes to documents and information about the company (‘disclosed information’). The message format shall make it possible to include attachments; |
(b) |
To ensure receipt without delay of the disclosed information, the register of the branch shall request that information from the platform. That request may consist of indicating to the platform the companies on which the register of the branch is interested to receive disclosed information: |
(c) |
Upon that request, the platform shall ensure that the register of the branch has access to the disclosed information without delay. |
(d) |
Upon receipt of the disclosed information, the register of the branch shall, without delay, send a message acknowledging the receipt of the notification (‘acknowledgement of receipt on the notification on changes to documents and information of the company’). |
4.5. Communication errors
Appropriate technical measures and procedures shall be in place to handle any communication error between the register and the platform.
5. List of data to be exchanged between registers
5.1. Branch disclosure notification
For the purposes of this Annex, the exchange of information between registers set out in Articles 20 and 34 of Directive (EU) 2017/1132 shall be referred to as ‘branch disclosure notification’. The proceeding triggering that notification shall be referred to as ‘branch disclosure event’.
For each branch disclosure notification referred to in point 4.1, Member States shall exchange the following data:
Data type |
Description |
Cardinality (1) |
Additional description |
Issuance Date and Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this notification |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Proceeding-related data |
|
1 |
Group of Elements |
Effective Date |
Date when the proceeding affecting the company has come into effect |
1 |
Date |
Proceeding Type |
Type of proceeding leading to a branch disclosure event as referred to in Article 20 of Directive (EU) 2017/1132 |
1 |
Code (Winding-up Opening Winding-up Termination Winding-up Opening and Termination Winding-up Revocation Insolvency Opening Insolvency Termination Insolvency Opening and Termination Insolvency Revocation Striking-off) |
Company data |
|
1 |
Group of Elements |
EUID |
Unique identifier of the company making subject of this notification |
1 |
Identifier See section 9 of this Annex for structure of the EUID |
Alternate ID |
Other identifiers of the company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company making subject of this notification |
1 |
Text |
Registered Office |
Registered office of the company |
1 |
Text |
Register Name |
Name of the register where the company is registered |
1 |
Text |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
5.2. Branch registration notification
For each branch registration notification referred to in point 4.2, Member States shall exchange the following data:
Data type |
Description |
Cardinality (2) |
Additional description |
Issuance Date and Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this notification |
1 |
Party data structure |
Recipient Organisation |
Name/Identifier of the register where the company is registered |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Branch data |
|
1 |
Group of Elements |
Date of registration |
Date when the branch was registered. |
1 |
Date |
Effective date |
Date when the opening of the branch becomes effective, if available |
0 |
Date |
Name of the branch if it is different from the company name |
Name of the branch subject of the notification. If it is the same as the company this field should be left empty |
0 |
Text As referred to in Article 30(1)(d) of Directive (EU) 2017/1132 |
Additional names of the branch |
If the branch has more than one name, the additional names can be included. |
0…n |
Text |
EUID |
Unique identifier of the branch subject of this notification |
1 |
Identifier |
Address of the branch |
Address of the branch subject of the notification |
1 |
Full address |
Company data |
|
1 |
Group of Elements |
EUID |
Unique identifier of the company to which the branch belongs |
1 |
Identifier |
Alternate ID |
Other identifiers of the company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form |
0 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company subject of this notification |
0 |
Text |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
5.3. Branch closure notification
For each branch closure notification referred to in point 4.3, Member States shall exchange the following data:
Data type |
Description |
Cardinality (3) |
Additional description |
Issuance Date and Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this notification |
1 |
Party data structure |
Recipient Organisation |
Name/Identifier of the register where the company is registered |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Branch data |
|
1 |
Group of Elements |
Date of striking off of the branch from the register |
Date when the branch was stricken off from the register |
1 |
Date |
Effective date |
Date when the closure of the branch becomes effective, if available |
0 |
Date |
Name of the branch if it is different from the company name |
Name of the branch subject of the notification. If it is the same as the company this field should be left empty |
0 |
Text As referred to in Article 30(1)(d) of Directive (EU) 2017/1132 |
Additional names of the branch |
If the branch has more than one name, the additional names can be included. |
0…n |
Text |
EUID |
Unique identifier of the branch subject of this notification |
1 |
Identifier |
Company data |
|
1 |
Group of Elements |
EUID |
Unique identifier of the company to which the branch belongs to |
1 |
Identifier |
Alternate ID |
Other identifiers of the company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form |
0 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company subject of this notification |
0 |
Text |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
5.4. Notification on changes to documents and information of the company
For each notification on changes to documents and information of the company referred to in point 4.4, Member States shall exchange the following data:
Data type |
Description |
Cardinality (4) |
Additional description |
||||||||||||||||||||||||||||||||||||||||||||
Issuance Date and Time |
Date and time when the notification was sent |
1 |
Date and Time |
||||||||||||||||||||||||||||||||||||||||||||
Issuing Organisation |
Name/Identifier of the organisation that issues this notification |
1 |
Party data structure |
||||||||||||||||||||||||||||||||||||||||||||
Recipient Organisation |
Name/Identifier of the register where the branch is registered |
1 |
Party data structure |
||||||||||||||||||||||||||||||||||||||||||||
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
||||||||||||||||||||||||||||||||||||||||||||
Proceedings-related data |
|
1 |
Group of Elements |
||||||||||||||||||||||||||||||||||||||||||||
Proceedings Type |
Type of proceeding leading to a notification on changes to documents and information of the company |
1 |
|
||||||||||||||||||||||||||||||||||||||||||||
Date of registration |
Date when the change to documents and information of the company was registered |
1 |
Date |
||||||||||||||||||||||||||||||||||||||||||||
Effective date |
Date when the change to documents and information of the company takes effect, if available |
0 |
Date |
||||||||||||||||||||||||||||||||||||||||||||
Relevant data to be updated, depending on the Proceeding Type |
Change in the company data |
1 |
One of the following:
|
||||||||||||||||||||||||||||||||||||||||||||
Additional data to be, provided optionally regarding point (d) of Article 14 |
Change in the company data |
0…n |
Optional data:
|
||||||||||||||||||||||||||||||||||||||||||||
Company data |
|
1 |
Group of Elements |
||||||||||||||||||||||||||||||||||||||||||||
EUID |
Unique identifier of the company to which the branch belongs |
1 |
Identifier |
||||||||||||||||||||||||||||||||||||||||||||
Alternate ID |
Other identifiers of the company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
The new documents and information referred to in point (f) of Article 14 of Directive (EU) 2017/1132 shall not be sent to the register of the branch if the Member State in question applies the option referred to in the second paragraph of Article 31 of that Directive.
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
6. Cross-border operations
6.1. Cross-border conversion
6.1.1.
(a) |
For the purposes of disclosure referred to in Article 86g(1) of Directive (EU) 2017/1132, the register of the departure Member State shall transmit and make accessible to the public through BRIS the following additional company data:
|
(b) |
For the purposes of disclosure referred to in Article 86g(3) of Directive (EU) 2017/1132, the register of the departure Member State shall transmit and make accessible to the public through BRIS the following additional company data:
|
6.1.2.
(a) |
For each transmission of the pre-conversion certificate referred to in the first subparagraph of Article 86n(1) of Directive (EU) 2017/1132, the register of the departure Member State shall, following the issuance of the certificate according to Article 86m(7), (10) and (11) of that Directive, send to the register of the destination Member State the following data:
|
b) |
For the purposes of making the pre-conversion certificate available through BRIS, according to the second subparagraph of Article 86n(1) of Directive (EU) 2017/1132 the register of the departure Member State shall transmit the following data:
|
6.1.3.
6.1.3.1. Cross-border conversion registration
The registers of the departure and the destination Member States shall make the following information publicly available and accessible through BRIS, according to article 86p(2) of Directive (EU) 2017/1132:
(a) |
Data to be provided by the register of the destination Member State
|
(b) |
Data to be provided by the register of the departure Member State |
The register of the departure Member State shall provide the relevant data upon receipt of the notification under 6.1.3.2.
Data type |
Description |
Cardinality (10) |
Additional description |
Data to be made available to BRIS |
|
1 |
Group of Elements |
EUID |
EUID of the converted company |
1 |
Identifier |
Data to be made publicly available and accessible through BRIS |
|
1 |
Group of Elements |
Striking off or removal as a result of a cross-border conversion |
That the striking off or removal from the register of the company that carried out the cross-border conversion is the result of a cross-border conversion |
1 |
Text |
Date |
Date of striking off or removal of the company that carried out the cross-border conversion from the register |
1 |
Date |
Registration number |
Registration number of the converted company |
1 |
Identifier |
Company name |
Name of the converted company |
1 |
Text |
Legal form |
Type of legal form of the converted company |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
6.1.3.2. Cross-border conversion notification
For each cross-border conversion notification referred to in Article 86p(3) of Directive (EU) 2017/1132, the register of the destination Member State shall send to the register of the departure Member State the following data:
Data type |
Description |
Cardinality (11) |
Additional description |
Issuance Date Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing organisation |
Name/identifier of the organisation that issued this notification (Destination Business Register) |
1 |
Party data structure |
Recipient Organisation |
Name/identifier of the organisation this notification is addressed to (Departure Business Register) |
1 |
Party data structure |
Conversion related data |
|
1 |
Group of Elements |
Effective date of the conversion |
Date on which the cross-border conversion has taken effect |
1 |
Date |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Converted company data |
Converted company as defined in Article 86b(5) |
1 |
Group of Elements |
EUID |
Unique identifier of the converted company |
1 |
Identifier |
Alternate ID |
Other identifiers of the converted company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the converted company |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the converted company |
1 |
Text |
Registered office |
Registered office of the converted company |
1 |
Text |
Register Name |
Name of the register where the converted company is registered |
1 |
Text |
Registration number |
Registration number of the converted company in the register |
1 |
Identifier |
Company data |
Company that carried out the cross-border conversion as defined in Article 86b(1) |
1 |
Group of Elements |
EUID |
Unique identifier of the company that carried out the cross-border conversion |
1 |
Identifier |
Alternate ID |
Other identifiers of the company that carried out the cross-border conversion (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the company that carried out the cross-border conversion |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company that carried out the cross-border conversion |
1 |
Text |
Registered Office |
Registered office of the company that carried out the cross-border conversion |
1 |
Text |
Register Name |
Name of the register where the company that carried out the cross-border conversion was registered |
1 |
Text |
Registration number |
Registration number of the company that carried out the conversion in the register |
1 |
Identifier |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
6.2. Cross-border merger
6.2.1.
(a) |
For the purposes of disclosure referred to in Article 123(1) of Directive (EU) 2017/1132, the register of the Member State of each of the merging companies shall transmit and make accessible to the public through BRIS the following additional company data:
|
(b) |
For the purposes of disclosure referred to in Article 123(3) of Directive (EU) 2017/1132, the register of the Member State of each of the merging companies shall transmit and make accessible to the public through BRIS the following additional company data:
|
6.2.2.
(a) |
For each transmission of the pre-merger certificate referred to in the first subparagraph of Article 127a(1) of Directive (EU) 2017/1132, the register of the Member State of the merging company shall, following the issuance of the certificate according to Article 127(7), (10) and (11) of that Directive, send to the register of the Member State of the company resulting from the merger the following data:
|
(b) |
For the purposes of making the pre-merger certificate available through BRIS, according to the second subparagraph of Article 127a(1) of Directive (EU) 2017/1132, the register of the Member State of the merging company shall transmit the following data:
|
6.2.3.
6.2.3.1. Cross-border merger registration
The registers of the Member States of the merging companies and of the company resulting from the merger shall make the following information publicly available and accessible through BRIS, according to article 130(2) of Directive (EU) 2017/1132:
(a) |
Data to be provided by the register of the company resulting from the merger
|
(b) |
Data to be provided by the register of the Member State of each of the merging companies |
The register of the Member State of each of the merging companies shall provide the relevant data upon receipt of the notification under 6.2.3.2.
Data type |
Description |
Cardinality (17) |
Additional description |
|
Data to be made available to BRIS |
|
1 |
Group of Elements |
|
EUID |
EUID of the company resulting from the merger |
1 |
Identifier |
|
EUID |
EUID of each of the merging companies |
1 |
Identifier |
|
Data to be made publicly available and accessible through BRIS |
|
1 |
Group of Elements |
|
|
Striking off or removal as a result of a cross-border merger |
That the striking off or removal from the register of the merging company is the result of a cross-border merger |
1 |
text |
Date |
Date of striking off or removal of the merging company from the register |
1 |
date |
|
|
|
|
|
|
Registration number |
Registration number of the company resulting from the merger |
1 |
Identifier |
|
Company name |
Name of the company resulting from the merger |
1 |
Text |
|
Legal form |
Type of legal form of the company resulting from the merger |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
|
Data on each of the merging companies |
|
1…n |
Group of Elements |
|
|
|
|
|
|
Registration number |
Registration number of the merging companies |
1 |
Identifier |
|
Company name |
Name of the merging companies |
1 |
Text |
|
Legal form |
Type of legal form of the merging companies |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
6.2.3.2. Cross-border merger notification
For each cross-border merger notification referred to in Article 130(3) of Directive (EU) 2017/1132, the register of the Member State of the company resulting from the cross-border merger shall send to the register of the Member State of each of the merging companies the following data:
Data type |
Description |
Cardinality (18) |
Additional description |
Issuance Date Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing organisation |
Name/identifier of the organisation that issued this notification (Business Register of the company resulting from the cross-border merger) |
1 |
Party data structure |
Recipient Organisation |
Name/identifier of the organisation this notification is addressed to (Business Register of each of the merging companies) |
1 |
Party data structure |
Merger related data |
|
1 |
Group of Elements |
Effective date of the merger |
Date on which the cross-border merger has taken effect |
1 |
Date |
Merger Type |
Type of merger as defined by Article 119(2) of Directive (EU) 2017/1132 |
1 |
Code (Cross-border merger by acquisition under point (a) of Article 119(2) of Directive (EU) 2017/1132 Cross-border merger by formation of new company under point (b) Article 119(2) of Directive (EU) 2017/1132 Cross-border merger of wholly owned company under point (c) Article 119(2) of Directive (EU) 2017/1132 Cross-border merger by acquisition under point (d) of Article 119(2) of Directive (EU) 2017/1132 |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Data of the company resulting from the merger |
Company resulting from the merger |
1 |
Group of Elements |
EUID |
Unique identifier of the company resulting from the merger |
1 |
Identifier |
Alternate ID |
Other identifiers of the company resulting from the merger (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the company resulting from the merger |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company resulting from the merger in the relevant Member State |
1 |
Text |
Registered office |
Registered office of the company resulting from the merger |
1 |
Text |
Register Name |
Name of the register where the company resulting from the merger is registered |
1 |
Text |
Registration number |
Registration number of the company resulting from the merger in the register |
1 |
Identifier |
Company data |
Data on each of the merging companies |
1…n |
Group of Elements |
EUID |
Unique identifier of the merging company |
1 |
Identifier |
Alternate ID |
Other identifiers of the merging company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the merging company |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the merging company |
1 |
Text |
Registered Office |
Registered office of the merging company |
1 |
Text |
Register Name |
Name of the register where the merging company was registered |
1 |
Text |
Registration number |
Registration number of the merging company |
1 |
Identifier |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
6.3. Cross-border division
6.3.1.
(a) |
For the purposes of disclosure referred to in Article 160g(1) of Directive (EU) 2017/1132, the register of the Member State of the company being divided shall transmit and make accessible to the public through BRIS the following additional company data:
|
(b) |
For the purposes of disclosure referred to in Article 160g(3) of Directive (EU) 2017/1132, the register of the Member State of the company being divided shall transmit and make accessible to the public through BRIS the following additional company data:
|
6.3.2.
(a) |
For each transmission of the pre-division certificate referred to in the first subparagraph of Article 160n(1) of Directive (EU) 2017/1132, the register of the Member State of the company being divided shall, following the issuance of the certificate according to Article 160m(7), (10) and (11) of that Directive, send to the register of each recipient company the following data:
|
(b) |
For the purposes of making the pre-division certificate available through BRIS according to the second subparagraph of Article 160n(1) of Directive (EU) 2017/1132, the register of the Member State of the company being divided shall transmit the following data:
|
6.3.3.
6.3.3.1. Cross-border division registration
The registers of the Member State of the company being divided and the registers of the recipient companies shall make the following information publicly available and accessible through BRIS, according to article 160p(2) of Directive (EU) 2017/1132:
(a) |
Data to be provided by the register of each of the recipient companies The register of each of the recipient companies shall provide the relevant data upon receipt of the notification under 6.3.3.3.
|
(b) |
Data to be provided by the register of Member State of the company being divided
|
6.3.3.2. Cross-border division notification according to Article 160p(3) of Directive (EU) 2017/1132
For each cross-border division notification referred to in Article 160p(3) of Directive (EU) 2017/1132, the registers of the recipient companies shall send to the register of the company being divided the following data:
Data type |
Description |
Cardinality (25) |
Additional description |
Issuance Date Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing organisation |
Name/identifier of the organisation that issued this notification (Business Register of each of the recipient companies) |
1 |
Party data structure |
Recipient Organisation |
Name/identifier of the organisation this notification is addressed to (Business Register of the company being divided) |
1 |
Party data structure |
|
|
|
|
Division related data |
|
1 |
Group of Elements |
Date of registration |
Date of registration of the recipient company |
1 |
date |
Recipient company data |
Recipient company as defined in Article 160b(3) of Directive (EU) 2017/1132 |
1 |
Group of Elements |
EUID |
Unique identifier of the recipient company |
1 |
Identifier |
Alternate ID |
Other identifiers of the recipient company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the recipient company |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the recipient company in the Member State of the recipient company |
1 |
Text |
Registered office |
Registered office of the recipient company |
1 |
Text |
Register Name |
Name of the register where the recipient company is registered |
1 |
Text |
Registration number |
Registration number of the recipient company |
1 |
Identifier |
Company data |
Company being divided as defined in Article 160b(2) |
1 |
Group of Elements |
EUID |
Unique identifier of the company being divided |
1 |
Identifier |
Alternate ID |
Other identifiers of the company being divided (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the company being divided |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company being divided |
1 |
Text |
Registered Office |
Registered office of the company being divided |
1 |
Text |
Register Name |
Name of the register where the company being divided is registered |
1 |
Text |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
6.3.3.3. Cross-border division notification according to Article 160p(4) of Directive (EU) 2017/1132
For each cross-border division notification referred to in Article 160p(4) of Directive (EU) 2017/1132, the register in the Member State of the company being divided shall send to the register of each of the recipient companies the following data:
Data type |
Description |
Cardinality (26) |
Additional description |
Issuance Date Time |
Date and time when the notification was sent |
1 |
Date and Time |
Issuing organisation |
Name/identifier of the organisation that issued this notification (Business Register of the company being divided) |
1 |
Party data structure |
Recipient Organisation |
Name/identifier of the organisations this notification is addressed to (Business Registers of the recipient companies) |
1 |
Party data structure |
Division related data |
|
1 |
Group of Elements |
Effective date of the division |
Date on which the cross-border division has taken effect |
1 |
Date |
Division Type |
Type of division as defined by Article 160b(4) of Directive (EU) 2017/1132 |
1 |
Code (Cross-border full division under point (a) of Article 160b(4) of Directive (EU) 2017/1132 Cross-border partial division under point (b) of Article 160b(4) of Directive (EU) 2017/1132 Cross-border division by separation under point (c) of Article 160b(4) of Directive (EU) 2017/1132 |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Recipient companies data |
Recipient company as defined in Article 160b(3) |
1…n |
Group of Elements |
EUID |
Unique identifier of each recipient company |
1 |
Identifier |
Alternate ID |
Other identifiers of each recipient company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of each recipient company |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of each recipient company in the Member State of the recipient company |
1 |
Text |
Registered office |
Registered office of each recipient company |
1 |
Text |
Register Name |
Name of the register where each recipient company is registered |
1 |
Text |
Registration number |
Registration number of each recipient company |
1 |
Identifier |
Company data |
Company being divided as defined in Article 160b(2) |
1 |
Group of Elements |
EUID |
Unique identifier of the company being divided |
1 |
Identifier |
Alternate ID |
Other identifiers of the company being divided (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Legal form |
Type of legal form of the company being divided |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 |
Name |
Name of the company being divided |
1 |
Text |
Registered Office |
Registered office of the company being divided |
1 |
Text |
Register Name |
Name of the register where the company being divided is registered |
1 |
Text |
Registration number |
Registration number of the company being divided |
1 |
Identifier |
The notification message may also include technical data necessary for the proper transmission of the message.
The exchange of information shall also include technical messages necessary for the acknowledgement of receipt, logging and reporting purposes.
7. Structure of the standard message format
The exchange of information between the registers, the platform and the portal shall be based on standard data-structuring methods and shall be expressed in a standard message format such as XML.
8. Data for the platform
The following type of data shall be provided for the platform to perform its functions:
(a) |
Data allowing for the identification of systems that are connected to the platform. Those data could consist of URLs or any other number or code uniquely identifying each system within BRIS; |
(b) |
An index of the particulars listed in Article 19(2) of Directive (EU) 2017/1132. This data shall be used to ensure consistent and quick results of the search service. Where the data is not made available to the platform for indexation, Member States shall make the same particulars available for the purpose of the search service in a way that guarantees the same level of service as provided by the platform; |
(c) |
Unique identifiers of companies referred to in Article 16(1) of Directive (EU) 2017/1132 and unique identifiers of branches referred to in Article 29(4) of Directive (EU) 2017/1132. These identifiers shall be used to ensure the interoperability of registers via the platform; |
(d) |
Any other operational data that is necessary for the platform to ensure the proper and efficient functioning of the search service and the interoperability of registers. Those data may include code lists, reference data, glossaries and related translations of those metadata, as well as logging and reporting data. |
The data and metadata handled by the platform shall be processed and stored in line with the security standards outlined in section 3 of this Annex.
9. Structure and use of the unique identifier
The unique identifier for the purpose of communication between registers shall be referred to as the EUID (European Unique Identifier).
The structure of the EUID shall be compliant with ISO 6523 and shall contain the following elements:
EUID element |
Description |
Additional description |
Country code |
Elements making it possible to identify the Member State of the register |
Mandatory |
Register Identifier |
Elements making it possible to identify the domestic register of origin of the company and of the branch respectively |
Mandatory |
Registration number |
Company/branch number refers to the registration number of the company/branch in the domestic register of origin |
Mandatory |
Verification digit |
Elements making it possible to avoid identification errors |
Optional |
The EUID shall be used to unequivocally identify companies and branches for the purpose of the exchange of information between registers via the platform.
10. Methods of operation of the system and information technology services provided by the platform
For the distribution and exchange of information, the system shall be based on the following technical method of operation:
For the delivery of messages in the relevant language version, the platform shall provide reference data artefacts, such as code lists, controlled vocabularies and glossaries. Where relevant, these shall be translated into the official languages of the Union. Where possible, recognised standards and standardized messages shall be used.
The Commission shall share with the Member State further details on the technical method of operation and the implementation of the information technology services provided by the platform.
11. Search criteria
At least one country shall be selected when running a search.
The portal shall provide the following harmonised criteria for the search:
— |
company name, |
— |
registration number of the company or the branch in the domestic register. |
Further search criteria may be available on the portal.
12. Payment modalities
For the documents and particulars for which Member States charge fees and which are made available on the e-Justice portal via BRIS, the system shall allow users to pay online by using widely used payment modalities such as credit and debit cards.
The system may also provide alternative online payment methods, such as bank transfers or virtual wallets (deposit).
13. Explanatory labels
In relation to the particulars and types of documents listed in Article 14 of Directive (EU) 2017/1132, Member States shall provide the following explanatory labels:
(a) |
A short title for each particular and document (for example: ‘Articles of incorporation’); |
(b) |
As appropriate, a brief description of the content of each document or particular, including, optionally, information on the legal value of the document. |
14. Availability of services
The service time frame shall be 24/7days, with an availability rate of the system of at least 98 % excluding scheduled maintenance.
Member States shall notify the Commission of maintenance activities as follows:
(a) |
5 working days in advance for maintenance operations that may cause an unavailability period of up to 4 hours; |
(b) |
10 working days in advance for maintenance operations that may cause an unavailability period of up to 12 hours; |
(c) |
30 working days in advance for infrastructure computer room maintenance, which may cause up to 6 days unavailability period per year. |
To the extent possible, maintenance operations shall be planned outside working hours (19.00 – 8.00 CET).
Where Member States have fixed weekly service windows, they shall inform the Commission of the time and day of the week when such fixed weekly windows are planned. Without prejudice to the obligations in points (a) to (c) of the second paragraph, if Member States systems become unavailable during such a fixed window, Member States may choose not to notify the Commission on each occasion.
In case of unexpected technical failure of the Member States systems, Member States shall inform the Commission without delay of their system unavailability, and, if known, of the projected resuming of the service.
In case of unexpected failure of the central platform or of the portal, the Commission shall inform the Member States without delay of the platform or portal unavailability, and if known, of the projected resuming of the service.
15. Optional access points
15.1. Optional access points to BRIS according to the first subparagraph of Article 22(4) of Directive (EU) 2017/1132
15.1.1.
Member States shall provide information on the planned timing of the establishment of the optional access points, the number of optional access points that will connect to the platform, and contact details of the person(s) that could be contacted for the purpose of establishing the technical connection.
The Commission shall provide the Member States with the necessary technical details and support for the testing and deployment of the connection of each optional access point to the platform.
15.1.2.
For the connection of optional access points to the platform, Member States shall comply with the relevant technical specifications set out in this Annex, including security requirements for transmission of data via the optional access points.
Where payment is necessary via an optional access point, Member States shall provide the payment methods of their choice and shall handle the related payment operations.
Member States shall carry out appropriate testing before the connection to the platform becomes operational and before any significant changes are made to an existing connection.
After successful connection of the optional access point to the platform, Member States shall inform the Commission of any upcoming significant change of the access point that may affect the functioning of the platform, in particular the closing of the access point. Member States shall provide sufficient technical details in relation to the change, in order to allow for proper integration of any related changes.
Member States shall indicate on each optional access point that the search service is provided via BRIS.
15.2. Optional access points to BRIS according to the second subparagraph of Article 22(4) of Directive (EU) 2017/1132
15.2.1.
The Commission shall assess any request received for the establishment of an optional access point in accordance with the second subparagraph of Article 22(4) of Directive (EU) 2017/1132.
The requester shall provide all the information needed for the proper assessment of the request.
The Commission shall provide the requester with the necessary technical details and support for the testing and deployment of the establishment of each optional access point to the platform.
15.2.2.
For the establishment of optional access points to the platform, the requester shall comply with the relevant technical specifications set out in this Annex, including security requirements for transmission of data via the optional access points.
Where payment is necessary via an optional access point, the requester shall provide the payment methods of their choice and shall handle the related payment operations.
The requester shall carry out appropriate testing before the establishment to the platform becomes operational and before any significant changes are made to an existing connection.
After successful establishment of the optional access point to the platform, the requester shall inform the Commission of any upcoming significant change of the access point that may affect the functioning of the platform, in particular the closing of the access point. The requester shall provide sufficient technical details in relation to the change, in order to allow for proper integration of any related changes.
The requester shall indicate on each optional access point that the search service is provided via BRIS.
15.3. Requirements applicable to optional access points according to Article 22(4), first and second subparagraph
The Commission shall inform the Member States about a request received.
The technical requirements shall also include measures to ensure that optional access points do not affect the correct functioning of BRIS nor compliance with the safety, security and data protection requirements, with due regard to the respective responsibility of each party within the part of the system under its technical control.
16. Exchange of information on disqualified directors
16.1. Introduction
The exchange of information referred to in Article 13i(4) of Directive (EU) 2017/1132 shall cover cases where a person is disqualified from becoming a director of a company of one of the types listed in Annex II to that Directive further to a decision of a court or another competent authority of a Member State based on its national law.
The exchange of information shall not cover cases where, under national law, a person is generally incapable of contracting or restricted in his or her general legal capacity or further to a decision of a court or another competent authority of a Member State based on its national law and therefore unable to become a director of a company of the type referred to in the first paragraph.
The exchange of information shall not cover cases based on specific rules under Union law, such as the rules on fitness and propriety provided under Article 91(1) of Directive 2013/36/EU of the European Parliament and of the Council (27).
Where, in accordance with national law in a Member State, legal persons are allowed to be directors of companies of the type referred to in the first paragraph, such legal persons shall fall under the scope of the exchange of information. Each Member State shall inform the other Member States and the Commission whether this possibility exists in its national law.
16.2. Methods of exchange of information between Member States
The following method shall be used for the exchange of information between the registers in accordance with Article 13i of Directive (EU) 2017/1132.
The queries and the answers under this section shall be transferred through BRIS using end-to-end encryption.
Member States shall exchange the information needed to correlate queries and the answers under this section concerning the same request.
16.2.1.
16.2.1.1. First level query on disqualification
Member States’ competent authorities may request, through BRIS, information from one or more Member States on whether a person who applies to become a director of a company of one of the types listed in Annex II to Directive (EU) 2017/1132 is disqualified or is recorded in any of their registers that contain information relevant for disqualification of directors.
The requesting Member State shall decide to which Member State or Member States the query shall be sent. The queries shall be sent with a view to ensure effective, efficient and prompt exchange of information.
Each query shall cover one single person and shall provide the data for identification of the person. The requesting Member State shall process such data in compliance with Regulation (EU) 2016/679. The Member States shall ensure that only necessary data and only data concerning the applicant in question is exchanged.
16.2.1.2. First level answer on disqualification
Upon receipt of the query, the competent authorities of the requested Member State shall, without delay, provide an answer through BRIS.
The answer shall indicate whether the person identified in the query is disqualified or is recorded in any of the registers of the requested Member State that contain information relevant for disqualification of directors.
In case the answer is that the person is disqualified or is recorded in any of the registers that contain information relevant for disqualification of directors, the requested Member State may indicate in its answer, which specific data provided by the requesting Member State matches the data available in the requested Member State and which specific data included in the query cannot be confirmed by the requested Member State as it is not recorded in its registers.
If it is necessary, the requested Member State may ask the requesting Member State to provide further data to ensure unequivocal identification of the person. Such data shall be processed in compliance with Regulation (EU) 2016/679.
16.2.2.
The exchange for additional information may take place through other appropriate means than BRIS. If the second level of exchange of information is carried out through BRIS, the rules set out in points 16.2.2.1, 16.2.2.2, 16.3.3 and 16.3.4 shall apply.
16.2.2.1. Second level query on disqualification
In case a requested Member State indicates in the first level answer that a given person is disqualified or is recorded in any of its registers that contain information relevant for disqualification of directors, the requesting Member States may request further information from the requested Member State concerning the person identified in the first level query.
The second level query shall cover the same person as the first level query and first level answer.
16.2.2.2 Second level answer on disqualification
The requested Member State may decide, under its national law, which additional information to provide. In case that Member State’s national law does not allow further exchange of information, it shall inform accordingly the requesting Member State.
16.3. Detailed list of data
For the exchange of information on disqualified directors, Member States shall include the following data.
16.3.1.
Data type |
Description |
Cardinality (28) |
Additional description |
Issuance Date and Time |
Date and time when this query was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this query |
1 |
Party data structure |
Recipient Organisation |
Name/Identifier of the register of the requested Member State |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
First level query on disqualification If the person who applies to be a director is a natural person |
|
|
|
First name |
First name of the person who applies to be a director |
1 |
Text |
Surname |
Surname of the person who applies to be a director |
1 |
Text |
Date of birth |
Date of birth of the person who applies to be a director |
1 |
Date |
Further identification data |
Further data processed according to the requesting Member State’s national law and in compliance with Regulation (EU) 2016/679 |
0…n |
Text/date/identifier |
First level query on disqualification If the person who applies to be a director is a legal person |
|
|
|
Name of the legal entity |
Name of the legal entity which applies to be a director |
1 |
Text |
Legal form |
Legal form of the legal entity which applies to be a director |
1 |
Code As referred to in Annex II to Directive (EU) 2017/1132 of the company therein or other legal form if the legal entity falls outside of the scope Directive (EU) 2017/1132 |
EUID |
EUID if it is a company listed in Annex II to Directive (EU) 2017/1132. |
1 |
Identifier |
Other registration number |
Other registration number if not a company listed in Annex II to Directive (EU) 2017/1132. |
0 |
Identifier |
Alternate ID |
Other identifiers of the company (e.g. Legal Entity Identifier) |
0…n |
Identifier |
Member States shall provide information on the means of identification needed for an efficient exchange of information on disqualified directors. That information may consist in providing the data that is necessary to identify the persons covered by a request.
Member States may also use e-identification means for the identification of persons in the exchange of information.
Queries covering a legal person shall be sent only to those Member States which allow legal persons to be directors and which allow disqualification of such legal persons.
16.3.2.
Data type |
Description |
Cardinality (29) |
Additional description |
Issuance Date and Time |
Date and time when this answer was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this answer |
1 |
Party data structure |
Recipient Organisation |
Name/Identifier of the register of the requesting Member State |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Yes/no/no sufficient data for identification |
‘Yes’ if the person is disqualified or is recorded in any of its registers that contain information relevant for disqualification of directors ‘No’ if the person is not disqualified or is not recorded in any of its registers that contain information relevant for disqualification of directors ‘No sufficient data for identification’ if the data provided does not make it possible to unequivocally identify the person and more information is needed. |
1 |
Select an option |
Further identification data required |
Indicate what data is needed for unequivocal identification |
1…n (only if no sufficient data for identification) |
Text/date/identifier |
No second level answer will be provided through BRIS |
If ‘yes’, option to indicate that no answer will be provided for second level query through BRIS |
0 |
Select the option |
16.3.2.1. Provision of further identification data
In case the requested Member State requires further identification data to ensure unequivocal identification, the requesting Member State shall provide the data using the following message format:
Data type |
Description |
Cardinality (30) |
Additional description |
Issuance Date and Time |
Date and time when this query was sent |
1 |
Date and Time |
Issuing Organisation |
Name/Identifier of the organisation that issues this query |
1 |
Party data structure |
Recipient Organisation |
Name/Identifier of the register of the requested Member State |
1 |
Party data structure |
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
Further identification data |
Further data required by the requested Member State to ensure unequivocal identification processed according to the requesting Member State’s national law and in compliance with Regulation (EU) 2016/679 |
1…n |
Text/date/identifier |
16.3.3.
Data type |
Description |
Cardinality (31) |
Additional description |
||||||||||
Issuance Date and Time |
Date and time when this query was sent |
1 |
Date and Time |
||||||||||
Issuing Organisation |
Name/Identifier of the organisation that issues this query |
1 |
Party data structure |
||||||||||
Recipient Organisation |
Name/Identifier of the register of the requested Member State |
1 |
Party data structure |
||||||||||
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
||||||||||
Request further information |
Request for further information |
1…n |
Request further information at least on one of the following:
|
16.3.4.
Data type |
Description |
Cardinality (32) |
Additional description |
||||||||||||
Issuance Date and Time |
Date and time when this answer was sent |
1 |
Date and Time |
||||||||||||
Issuing Organisation |
Name/Identifier of the organisation that issues this answer |
1 |
Party data structure |
||||||||||||
Recipient Organisation |
Name/Identifier of the register of the requesting Member State |
1 |
Party data structure |
||||||||||||
Legislation Reference |
Reference to relevant national or Union legislation |
0…n |
Text |
||||||||||||
Further information |
Request for further information |
1…n |
Further information at least on one of the following:
|
16.4. Operation of the exchange of information
Member States shall indicate if they face difficulties due to high numbers of queries received. In such a case, the Commission and the Member States shall assess the issue with a view of ensuring smooth operation of the exchange of information and further development of the system.
(1) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(2) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided
(3) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(4) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(5) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(6) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(7) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(8) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(9) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(10) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(11) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(12) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(13) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(14) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(15) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(16) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(17) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(18) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(19) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(20) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(21) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(22) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(23) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(24) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(25) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(26) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(27) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
(28) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(29) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(30) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(31) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
(32) Cardinality 0 means that the data is optional. Cardinality 1 means that the data is mandatory. Cardinality 0…n or 1…n means that more than one piece of the same type of data may be provided.
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/52 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1043
of 24 June 2021
on the extension of the transitional provisions related to own funds requirements for exposures to central counterparties set out in Regulation (EU) No 575/2013 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (1), and in particular Article 497(3) thereof,
Whereas:
(1) |
In order to avoid disruption to international financial markets and to prevent penalising institutions established in the Union by subjecting them to higher own funds requirements during the processes of recognition of existing third-country central counterparties (CCPs), Article 497(1) of Regulation (EU) No 575/2013 established a transitional period during which institutions may treat exposures to those third-country CCPs as exposures to qualifying CCPs. |
(2) |
For third-country CCPs that submitted their application for recognition in accordance with Article 25(6) of Regulation (EU) No 648/2012 of the European Parliament and of the Council (2) before 27 June 2019, specifically all third-country CCPs still awaiting recognition by the European Securities and Markets Authority (ESMA), the transitional period is set to expire on 28 June 2021. |
(3) |
The Commission has not yet adopted decisions in accordance with Article 25(6) of Regulation (EU) No 648/2012 for some of the jurisdictions in which those third-country CCPs are established. Such decisions are a prerequisite for ESMA to recognise third-country CCPs. Since those decisions will not be adopted by 28 June 2021, ESMA will not be able to complete by that date the recognition procedures for the third-country CCPs awaiting recognition. |
(4) |
If the transitional period is not extended, institutions established in the Union, or their subsidiaries established outside the Union, having exposures to those third-country CCPs, will be required to increase their own funds for those exposures significantly. This could potentially lead to the withdrawal of those institutions as direct participants in those CCPs or, at least temporarily, to the cessation of the provision of clearing services to those institutions’ clients, and thus cause severe disruption in the markets in which those CCPs operate. Therefore, it is necessary to extend the transitional provision in Article 497(1), point (b)(iii) of Regulation (EU) No 575/2013 by 12 months, until 28 June 2022. |
(5) |
The extension of the transitional provision would leave time for the Commission to finalise its equivalence assessments in accordance with Article 25(6) of Regulation (EU) No 648/2012 and to adopt equivalence decisions where conditions thereof are met. It would also leave time for ESMA to recognise the third-country CCPs concerned. Where a positive equivalence decision would not be adopted by the Commission, an extension would leave time for institutions to properly prepare for the end of the transitional period provided for in Article 497(1) of Regulation (EU) No 575/2013. |
(6) |
This Regulation should apply from the first day after the expiry of the existing transitional period. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the European Banking Committee, |
HAS ADOPTED THIS REGULATION:
Article 1
The transitional period referred to in Article 497(1), point (b)(iii), of Regulation (EU) No 575/2013 is extended until 28 June 2022.
Article 2
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 29 June 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 June 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 176, 27.6.2013, p. 1.
(2) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1).
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/54 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1044
of 22 June 2021
granting a Union authorisation for the single biocidal product ‘Pesguard® Gel’
(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 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 (1), and in particular the first subparagraph of Article 44(5) thereof,
Whereas:
(1) |
On 21 September 2016, Sumitomo Chemical Agro Europe SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘Pesguard® Gel’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HS027052-37 in the Register for Biocidal Products. |
(2) |
‘Pesguard® Gel’ contains pyriproxyfen and clothianidin, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. |
(3) |
On 31 March 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
(4) |
On 13 October 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Pesguard® Gel’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
(5) |
The opinion concludes that ‘Pesguard® Gel’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation. |
(6) |
On 26 October 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
(7) |
The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Pesguard® Gel’. |
(8) |
According to the opinion of the Agency, as regards the non-active substances cis CTAC and dichloromethane contained in ‘Pesguard® Gel’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (3) within the period for the evaluation of the application. Further examination of cis CTAC and dichloromethane should therefore take place. If it is concluded that either cis CTAC or dichloromethane or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Pesguard® Gel’ in accordance with Article 48 of Regulation (EU) No 528/2012. |
(9) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0024951-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product ‘Pesguard® Gel’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 15 July 2021 until 30 June 2031.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 June 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1.
(2) ECHA opinion of 8 October 2020 on the Union authorisation of the biocidal product ‘Pesguard® Gel’ (ECHA/BPC/269/2020), https://echa.europa.eu/it/opinions-on-union-authorisation
(3) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).
ANNEX
Summary of product characteristics for a biocidal product
Pesguard® Gel
Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Authorisation number: EU-0024951-0000
R4BP asset number: EU-0024951-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
Trade name(s) |
Pesguard® Gel |
1.2. Authorisation holder
Name and address of the authorisation holder |
Name |
Sumitomo Chemical Agro Europe SAS |
Address |
Parc d’Affaires de Crécy 10A, rue de la Voie Lactée, 69370 Saint Didier au Mont d’Or, France |
|
Authorisation number |
EU-0024951-0000 |
|
R4BP asset number |
EU-0024951-0000 |
|
Date of the authorisation |
15 July 2021 |
|
Expiry date of the authorisation |
30 June 2031 |
1.3. Manufacturer(s) of the product
Name of manufacturer |
McLaughlin Gormley King Company (MGK) |
Address of manufacturer |
8810 10th Avenue North, MN 55427 Minneapolis United States |
Location of manufacturing sites |
McLaughlin Gormley King Company, 4001 Peavey Road, MN 55318 Chaska United States |
1.4. Manufacturer(s) of the active substance(s)
Active substance |
(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin) |
Name of manufacturer |
Sumitomo Chemical Co. Ltd |
Address of manufacturer |
27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan |
Location of manufacturing sites |
Sumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City„ 870-0106 Oita Japan |
Active substance |
pyriproxyfen |
Name of manufacturer |
Sumitomo Chemical Co. Ltd |
Address of manufacturer |
27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan |
Location of manufacturing sites |
Sumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa„ 033-0022 Aomori Japan |
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Clothianidin |
(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine |
Active Substance |
210880-92-5 |
433-460-1 |
0,526 |
pyriproxyfen |
4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl ether |
Active Substance |
95737-68-1 |
429-800-1 |
0,515 |
Acetic acid |
Ethanoic acid |
Non-active substance |
64-19-7 |
200-580-7 |
0,3 |
Potassium sorbate |
potassium (E,E)-hexa-2,4-dienoate |
Non-active substance |
24634-61-5 |
246-376-1 |
0,5 |
2.2. Type of formulation
RB – Bait (ready for use)
3. HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
May cause an allergic skin reaction. Very toxic to aquatic life with long lasting effects. |
Precautionary statements |
IF ON SKIN:Wash with plenty of water. If skin irritation or rash occurs: Get medical advice. Wear protective gloves. Avoid release to the environment. Dispose of container in accordance with local regulations. Collect spillage. |
4. AUTHORISED USE(S)
4.1. Use description
Table 1. Use # 1 – Professional Use – RTU Bait
Product type |
PT18 – Insecticides, acaricides and products to control other arthropods (Pest control) |
||||||
Where relevant, an exact description of the authorised use |
Insecticide |
||||||
Target organism(s) (including development stage) |
Scientific name: Blattella germanica Common name: German cockroach Development stage: Nymphs Scientific name: Blattella germanica Common name: German cockroach Development stage: Adults Scientific name: Supella longipalpa Common name: Brown-banded cockroach Development stage: Nymphs Scientific name: Supella longipalpa Common name: Brown-banded cockroach Development stage: Adults Scientific name: Blatta orientalis Common name: Oriental Cockroach Development stage: Nymphs Scientific name: Blatta orientalis Common name: Oriental Cockroach Development stage: Adults Scientific name: Periplaneta americana Common name: American Cockroach Development stage: Nymphs Scientific name: Periplaneta americana Common name: American Cockroach Development stage: Adults |
||||||
Field(s) of use |
Indoor In cracks and crevices, or in concealed locations inaccessible to humans or domestic animals: behind refrigerators cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc. |
||||||
Application method(s) |
Bait application A ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene |
||||||
Application rate(s) and frequency |
Pesguard® Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait). In cases of severe infestation, where larger cockroach species are present (B. orientalis or P. americana), in areas that are particularly dirty or cluttered or where alternative sources of food cannot be entirely eliminated the higher application rate (e.g. 2 instead of 1 spot per m2 in case of a light infestation) should be used.
The maximum number of annual applications is 11. |
||||||
Category(ies) of users |
Professional |
||||||
Pack sizes and packaging material |
30 g Polypropylene (PP) syringe Screw top cap High Density Poly Ethylene (HDPE) |
4.1.1. Use-specific instructions for use
See the general directions for use.
4.1.2. Use-specific risk mitigation measures
See the general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See the general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See the general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See the general directions for use.
5. GENERAL DIRECTIONS FOR USE (1)
5.1. Instructions for use
Always read the label or leaflet before use and respect/follow all the instructions provided.
Do not expose bait drops to sunlight or heat (e.g. radiator).
The pre-filled plastic reservoir containing Pesguard® Gel is intended for use with the plunger provided or a specific bait application device common to the pest control industry. Refer to the manufacturer’s instructions for directions on the use of the applicator.
Inject the bait into cracks and crevices, void spaces, or in concealed locations inaccessible to humans or domestic animals where insects may live, feed and breed. Such areas are generally warm/damp and dark (behind refrigerators, cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.). Inspection or trapping to confirm infestation is recommended prior to treatment. Ensure that any alternative food sources are removed and concentrate the bait placements as individual spots at cockroach activity sites. The product should not be applied to areas accessible to children and pets.
Do not apply Pesguard® Gel where it will come into contact with water or in areas that are routinely cleaned. Typically cockroaches will die a few hours after a single feed on Pesguard® Gel. In infested premises, dead cockroaches will normally be seen within 24 hours of treatment.
Remove the cap from the nozzle, touch the top to the surface to be treated, and push down on the plunger. Replace the cap on the dispenser after treatment is completed.
The bait will adhere to non-greasy or non-dusty surfaces and will remain pliable and palatable to cockroaches as long as it is visibly present.
Treated area’s should be visually inspected after 1-2 weeks. Where initial infestation was heavy a second Pesguard® Gel application may be required if the first treatment has been consumed and live cockroaches are still present.
A second visual inspection of bait placements is recommended 2-4 weeks after the initial treatment. Reapply when bait is no longer visibly present, according to the level of infestation (light, medium or heavy). Replace bait before it is completely consumed to keep cockroaches from returning.
Inform the registration holder if the treatment is ineffective.
Spills and residues containing the product need to be removed as chemical waste.
Care should be taken to avoid depositing gel onto exposed surfaces. If gel contacts an exposed surface, remove gel with a paper towel and clean the area with disposable wet wipes.
During follow-up visits, inspect bait placements and re-apply when necessary.
Do not place bait in locations that are routinely washed, as bait will be removed by washing. Do not use this product in or on electrical equipment where a possibility of shock hazard exists. Avoid contact with textiles and clothing, as bait may stain.
5.2. Risk mitigation measures
Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
Do not apply bait in areas where repellent insecticides have been used without thoroughly cleaning the surface with disposable wet tissue. Do not apply repellent insecticides after application of the bait.
Do not apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and animals.
Spills and residues containing the product must be removed as chemical waste.
Avoid placing gel on fabrics or carpets since it may stain some absorbent materials. To prevent staining, exposed bait should be cleaned up immediately with disposable wet wipes.
Cleaning materials must be disposed of as to solid waste.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
This biocidal product contains clothianidin, which is dangerous to bees.
Description of first aid measures
Skin contact: Remove contaminated clothing immediately and wash skin with soap and water. Get medical attention if irritation persists after washing.
Eye contact: If symptoms occur, rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
Ingestion: If swallowed: If symptons occur call a POISON CENTRE or a doctor.
If inhaled: not applicable.
Most important symptoms and effects, both acute and delayed
Eyes: May cause temporary eye irritation.
Emergency measures to protect the environment
Avoid release of the product to the environment.
5.4. Instructions for safe disposal of the product and its packaging
Only pass on empty containers/packaging for recycling.
Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Store away from direct sunlight.
Shelf life: 2 years.
6. OTHER INFORMATION
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/62 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1045
of 24 June 2021
approving didecyldimethyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4
(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 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 (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) |
Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes didecyldimethyl ammonium chloride (DDAC) to be renamed for the purposes of this Regulation as didecyldimethyl ammonium chloride as a result of its evaluation. |
(2) |
Didecyldimethyl ammonium chloride has been evaluated for use in biocidal products of product-type 3, veterinary hygiene biocidal products and product-type 4, food and feed area disinfectants, as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012. |
(3) |
Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 10 September 2012. |
(4) |
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the European Chemicals Agency (4) (‘the Agency’) on 6 October 2020, having regard to the conclusions of the evaluating competent authority. |
(5) |
According to those opinions, biocidal products of product-types 3 and 4 containing didecyldimethyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5(1)(b), (c) and (d) of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with. |
(6) |
Taking into account the opinions of the Agency, it is appropriate to approve didecyldimethyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4 subject to compliance with certain specifications and conditions. |
(7) |
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
Didecyldimethyl ammonium chloride is approved as an active substance for use in biocidal products of product-types 3 and 4 subject to the specifications and conditions set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 June 2021.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
(4) Biocidal Products Committee Opinions on the applications for approval of the active substance didecyldimethylammonium chloride; Product-types: 3 and 4; ECHA/BPC/265/2020 and ECHA/BPC/266/2020, adopted on 6 October 2020.
ANNEX
Common Name |
IUPAC Name Identification Numbers |
Minimum degree of purity of the active substance (1) |
Date of approval |
Expiry date of approval |
Product type |
Specific conditions |
||||||||||
Didecyldimethyl ammonium chloride |
IUPAC name: N,N-Didecyl-N,N-dimethylammonium chloride EC No: 230-525-2 CAS No: 7173-51-5 |
Minimum purity of the active substance evaluated: 908 g/kg dry weight |
1 November 2022 |
31 October 2032 |
3 |
The authorisation of biocidal products is subject to the following conditions:
|
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4 |
The authorisation of biocidal products is subject to the following conditions:
|
(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
(2) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(3) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
(4) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/66 |
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1046
of 23 June 2021
amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,
Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
Whereas:
(1) |
Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin. |
(2) |
Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin. |
(3) |
Regulation (EC) No 1484/95 should therefore be amended accordingly. |
(4) |
Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 June 2021.
For the Commission,
On behalf of the President,
Wolfgang BURTSCHER
Director-General
Directorate-General for Agriculture and Rural Development
(1) OJ L 347, 20.12.2013, p. 671.
(2) OJ L 150, 20.5.2014, p. 1.
(3) Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).
ANNEX
‘ANNEX I
CN code |
Description of goods |
Representative price (EUR/100 kg) |
Security under Article 3 (EUR/100 kg) |
Origin (1) |
0207 14 10 |
Fowls of the species Gallus domesticus, boneless cuts, frozen |
170,6 154,9 192,2 |
45 53 34 |
AR BR TH |
(1) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).’
DIRECTIVES
25.6.2021 |
EN |
Official Journal of the European Union |
L 225/69 |
COMMISSION DELEGATED DIRECTIVE (EU) 2021/1047
of 5 March 2021
amending Directive 2009/43/EC of the European Parliament and of the Council as regards the updating of the list of defence-related products in line with the updated Common Military List of the European Union of 17 February 2020
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (1), and in particular Article 13 thereof,
Whereas:
(1) |
Directive 2009/43/EC applies to defence-related products as set out in its Annex. That Annex is to strictly correspond to the Common Military List of the European Union. |
(2) |
The Common Military List of the European Union was adopted by the Council on 19 March 2007 and has been updated several times. On 17 February 2020, the Council adopted an updated Common Military List of the European Union (2). It is therefore necessary to update the list of defence-related products set out in the Annex to Directive 2009/43/EC. |
(3) |
Directive 2009/43/EC should therefore be amended accordingly. |
(4) |
In accordance with the Joint Political Declaration of Member States and the Commission of 28 September 2011 on explanatory documents (3), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
The Annex to Directive 2009/43/EC is replaced by the text set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 30 September 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 7 October 2021.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 5 March 2021.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX
List of Defence-related Products
Note 1 |
Terms in "quotations" are defined terms. Refer to 'Definitions of Terms used in this List' annexed to this List. |
Note 2 |
In some instances chemicals are listed by name and Chemical abstract service (CAS) number. The list applies to chemicals of the same structural formula (including hydrates) regardless of name or CAS number. CAS numbers are shown to assist in identifying a particular chemical or mixture, irrespective of nomenclature. CAS numbers cannot be used as unique identifiers because some forms of the listed chemical have different CAS numbers, and mixtures containing a listed chemical may also have different CAS numbers. |
ML (1)1 |
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Smooth-bore weapons with a calibre of less than 20 mm, other arms and automatic weapons with a calibre of 12,7 mm (calibre 0,50 inches) or less and accessories, as follows, and specially designed components therefor:
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ML2 |
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Smooth-bore weapons with a calibre of 20 mm or more, other weapons or armament with a calibre greater than 12.7 mm (calibre 0.50 inches), projectors specially designed or modified for military use and accessories, as follows, and specially designed components therefor:
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ML3 |
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Ammunition and fuze setting devices, as follows, and specially designed components therefor:
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ML4 |
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Bombs, torpedoes, rockets, missiles, other explosive devices and charges and related equipment and accessories, as follows, and specially designed components therefor:
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ML5 |
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Fire control, surveillance and warning equipment, and related systems, test and alignment and countermeasure equipment, as follows, specially designed for military use, and specially designed components and accessories therefor:
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ML6 |
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Ground vehicles and components, as follows:
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ML7 |
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Chemical agents, "biological agents", "riot control agents", radioactive materials, related equipment, components and materials, as follows:
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ML8 |
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"Energetic materials", and related substances, as follows:
Technical Notes
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ML9 |
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Vessels of war (surface or underwater), special naval equipment, accessories, components and other surface vessels, as follows:
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ML10 |
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"Aircraft", "lighter-than-air vehicles", "Unmanned Aerial Vehicles" ("UAVs"), aero-engines and "aircraft" equipment, related equipment, and components, as follows, specially designed or modified for military use:
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ML11 |
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Electronic equipment, "spacecraft" and components, not specified elsewhere in this Annex, as follows:
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ML12 |
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High velocity kinetic energy weapon systems and related equipment, as follows, and specially designed components therefor:
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ML13 |
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Armoured or protective equipment, constructions and components, as follows:
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ML14 |
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'Specialised equipment for military training' or for simulating military scenarios, simulators specially designed for training in the use of any firearm or weapon specified by ML1 or ML2, and specially designed components and accessories therefor. Technical Note The term 'specialised equipment for military training' includes military types of attack trainers, operational flight trainers, radar target trainers, radar target generators, gunnery training devices, anti-submarine warfare trainers, flight simulators (including human-rated centrifuges for pilot/astronaut training), radar trainers, instrument flight trainers, navigation trainers, missile launch trainers, target equipment, drone "aircraft", armament trainers, pilotless "aircraft" trainers, mobile training units and training equipment for ground military operations.
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ML15 |
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Imaging or countermeasure equipment, as follows, specially designed for military use, and specially designed components and accessories therefor:
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ML16 |
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Forgings, castings and other unfinished products, specially designed for items specified by ML1 to ML4, ML6, ML9, ML10, ML12 or ML19.
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ML17 |
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Miscellaneous equipment, materials and "libraries", as follows, and specially designed components therefor:
Technical Notes
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ML18 |
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'Production' equipment, environmental test facilities and components, as follows:
Technical Note For the purposes of ML18, the term 'production' includes design, examination, manufacture, testing and checking.
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ML19 |
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Directed Energy Weapon (DEW) systems, related or countermeasure equipment and test models, as follows, and specially designed components therefor:
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ML20 |
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Cryogenic and "superconductive" equipment, as follows, and specially designed components and accessories therefor:
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ML21 |
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"Software" as follows:
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ML22 |
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"Technology" as follows:
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DEFINITIONS OF TERMS USED IN THIS LIST
The following are definitions of the terms used in this List, in alphabetical order.
Note 1 |
Definitions apply throughout the List. The references are purely advisory and have no effect on the universal application of defined terms throughout the List. |
Note 2 |
Words and terms contained in this List of Definitions only take the defined meaning where this is indicated by their being enclosed in "double quotations marks". Definitions of terms between 'single quotation marks' are given in a Technical to the relevant item. Elsewhere, words and terms take their commonly accepted (dictionary) meanings. |
ML8 |
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"Additives" Substances used in explosive formulations to improve their properties. |
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ML8, 10, 14 |
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"Aircraft" A fixed wing, swivel wing, rotary wing (helicopter), tilt rotor or tilt-wing airborne vehicle. |
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"Airship" A power-driven airborne vehicle that is kept buoyant by a body of gas (usually helium, formerly hydrogen) which is lighter than air. |
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ML11 |
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"Automated Command and Control Systems" Electronic systems, through which information essential to the effective operation of the grouping, major formation, tactical formation, unit, ship, subunit or weapons under command is entered, processed and transmitted. This is achieved by the use of computer and other specialised hardware designed to support the functions of a military command and control organisation. The main functions of an automated command and control system are: the efficient automated collection, accumulation, storage and processing of information; the display of the situation and the circumstances affecting the preparation and conduct of combat operations; operational and tactical calculations for the allocation of resources among force groupings or elements of the operational order of battle or battle deployment according to the mission or stage of the operation; the preparation of data for appreciation of the situation and decision-making at any point during operation or battle; computer simulation of operations. |
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ML22 |
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"Basic scientific research" Experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective. |
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ML7, 22 |
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"Biocatalysts" 'Enzymes' for specific chemical or biochemical reactions or other biological compounds which bind to and accelerate the degradation of CW agents. Technical Note 'Enzymes' means "biocatalysts" for specific chemical or biochemical reactions. |
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ML7 |
|
"Biological agents" Pathogens or toxins, selected or modified (such as altering purity, shelf life, virulence, dissemination characteristics, or resistance to UV radiation) to produce casualties in humans or animals, degrade equipment or damage crops or the environment. |
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ML7 |
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"Biopolymers" Biological macromolecules as follows:
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ML4, 10 |
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"Civil aircraft" Those "aircraft" listed by designation in published airworthiness certification lists by civil aviation authorities of one or more EU Member States or Wassenaar Arrangement Participating States to fly commercial civil internal and external routes or for legitimate civil, private or business use. |
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ML21 |
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"Cyber incident response" The process of exchanging necessary information on a cybersecurity incident with individuals or organisations responsible for conducting or coordinating remediation to address the cybersecurity incident. |
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ML1 |
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"Deactivated firearm" A firearm that has been made incapable of firing any projectile by processes defined by the EU Member State's or Wassenaar Arrangement Participating State's national authority. These processes permanently modify the essential elements of the firearm. According to national laws and regulations, deactivation of the firearm may be attested by a certificate delivered by a competent authority and may be marked on the firearm by a stamp on an essential part. |
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ML17 21, 22 |
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"Development" Is related to all stages prior to serial production, such as: design, design research, design analyses, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts. |
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ML21 |
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"Digital computer" Equipment which can, in the form of one or more discrete variables, perform all of the following:
Technical Note Modifications of a stored sequence of instructions include replacement of fixed storage devices, but not a physical change in wiring or interconnections. |
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ML17 |
|
"End-effectors" Grippers, 'active tooling units' and any other tooling that is attached to the baseplate on the end of a "robot" manipulator arm. Technical Note 'Active tooling units' are devices for applying motive power, process energy or sensing to a workpiece. |
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ML8 |
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"Energetic materials" Substances or mixtures that react chemically to release energy required for their intended application. "Explosives", "pyrotechnics" and "propellants" are subclasses of energetic materials. |
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ML6, 13 |
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"Equivalent standards" Comparable national or international standards recognised by one or more EU Member States or Wassenaar Arrangement Participating States and applicable to the relevant entry. |
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ML8, 18 |
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"Explosives" Solid, liquid or gaseous substances or mixtures of substances which, in their application as primary, booster, or main charges in warheads, demolition and other applications, are required to detonate. |
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ML7 |
|
"Expression Vectors" Carriers (e.g. plasmid or virus) used to introduce genetic material into host cells. |
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ML13 |
|
"Fibrous or filamentary materials" Include:
|
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ML15 |
|
"First generation image intensifier tubes" Electrostatically focused tubes, employing input and output fibre optic or glass face plates, multi-alkali photocathodes (S-20 or S-25), but not microchannel plate amplifiers. |
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ML17 |
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"Fuel cell" An electrochemical device that converts chemical energy directly into Direct Current (DC) electricity by consuming fuel from an external source. |
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ML22 |
|
"In the public domain" This means "technology" or "software" which has been made available without restrictions upon its further dissemination.
|
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ML9, 19 |
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"Laser" An item that produces spatially and temporally coherent light through amplification by stimulated emission of radiation. |
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ML17 |
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"Library" (parametric technical database) A collection of technical information, reference to which may enhance the performance of relevant systems, equipment or components. |
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ML10 |
|
"Lighter-than-air vehicles" Balloons and "airships" that rely on hot air or on lighter-than-air gases such as helium or hydrogen for their lift. “Microprogram” A sequence of elementary instructions maintained in a special storage, the execution of which is initiated by the introduction of its reference instruction into an instruction register. |
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ML17 |
|
"Nuclear reactor" Includes the items within or attached directly to the reactor vessel, the equipment which controls the level of power in the core, and the components which normally contain or come into direct contact with or control the primary coolant of the reactor core. |
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ML8 |
|
"Precursors" Speciality chemicals used in the manufacture of explosives. |
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ML 21, 22 |
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"Production" Means all production stages, such as: product engineering, manufacture, integration, assembly (mounting), inspection, testing, quality assurance. |
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|
“Program” A sequence of instructions to carry out a process in, or convertible into, a form executable by an electronic computer. |
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ML8 |
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"Propellants" Substances or mixtures that react chemically to produce large volumes of hot gases at controlled rates to perform mechanical work. |
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ML4, 8 |
|
"Pyrotechnic(s)" Mixtures of solid or liquid fuels and oxidizers which, when ignited, undergo an energetic chemical reaction at a controlled rate intended to produce specific time delays, or quantities of heat, noise, smoke, visible light or infrared radiation. Pyrophorics are a subclass of pyrotechnics, which contain no oxidizers but ignite spontaneously on contact with air. |
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ML22 |
|
"Required" As applied to "technology", refers to only that portion of "technology" which is peculiarly responsible for achieving or exceeding the controlled performance levels, characteristics or functions. Such "required""technology" may be shared by different products. |
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ML7 |
|
"Riot control agents" Substances which, under the expected conditions of use for riot control purposes, produce rapidly in humans sensory irritation or disabling physical effects which disappear within a short time following termination of exposure. (Tear gases are a subset of "riot control agents".) |
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ML17 |
|
"Robot" A manipulation mechanism, which may be of the continuous path or of the point-to-point variety, may use sensors, and has all the following characteristics:
Note The above definition does not include the following devices:
|
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ML11 |
|
"Satellite navigation system" A system consisting of ground stations, a constellation of satellites, and receivers, that enables receiver locations to be calculated on the basis of signals received from the satellites. It includes Global Navigation Satellite Systems and Regional Navigation Satellite Systems. |
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ML4, 11, 21 |
|
"Software" A collection of one or more "programs" or "microprograms" fixed in any tangible medium of expression. |
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ML11 |
|
"Spacecraft" Active and passive satellites and space probes. |
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ML19 |
|
"Space-qualified" Designed, manufactured, or qualified through successful testing, for operation at altitudes greater than 100 km above the surface of the Earth.
|
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ML20 |
|
"Superconductive" Refers to materials, (i.e. metals, alloys or compounds) which can lose all electrical resistance (i.e. which can attain infinite electrical conductivity and carry very large electrical currents without Joule heating). "Critical temperature" (sometimes referred to as the transition temperature) of a specific "superconductive" material is the temperature at which the material loses all resistance to the flow of direct electrical current. Technical Note The "superconductive" state of a material is individually characterised by a "critical temperature", a critical magnetic field, which is a function of temperature, and a critical current density which is, however, a function of both magnetic field and temperature. |
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ML22 |
|
"Technology" Specific information necessary for the "development", "production" or "use" of a product. The information takes the form of 'technical data' or 'technical assistance'. Specified “technology” for this Annex is defined in ML22. Technical Notes
|
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ML10 |
|
"Unmanned aerial vehicle" ("UAV") Any "aircraft" capable of initiating flight and sustaining controlled flight and navigation without any human presence on board. |
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ML21 |
|
"Vulnerability disclosure" The process of identifying, reporting or communicating a vulnerability to, or analysing a vulnerability with, individuals or organisations responsible for conducting or coordinating remediation for the purpose of resolving the vulnerability. |
(1) Military List.
(2) National Institute of Justice (USA) in charge with standard categorization