Decision of the EEA Joint Committee No 5/2022 of 4 February 2022 amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1053]
Date: 2022-02-04
Institutions: EEA Joint Committee
Subjects: European Economic Area, export (EU), import (EU), labelling, market approval, pharmaceutical legislation, pharmacology, revision of an agreement, veterinary inspection, veterinary medicinal product




L_2022175EN.01000901.xml










30.6.2022   


EN


Official Journal of the European Union


L 175/9








            DECISION OF THE EEA JOINT COMMITTEE No 5/2022
of 4 February 2022
         
amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1053]


THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:







(1)


Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (1) is to be incorporated into the EEA Agreement.












(2)


Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (2) is to be incorporated into the EEA Agreement.












(3)


Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (3) is to be incorporated into the EEA Agreement.












(4)


Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database) (4) is to be incorporated into the EEA Agreement.












(5)


Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (5) is to be incorporated into the EEA Agreement.












(6)


Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (6) is to be incorporated into the EEA Agreement.












(7)


This Decision concerns, inter alia, legislation regarding live animals other than fish and aquaculture animals. Legislation concerning these matters shall not apply to Iceland, as specified in paragraph 2 of the Introductory Part of Chapter I of Annex I to the EEA Agreement.












(8)


This Decision concerns, inter alia, legislation regarding veterinary matters. Legislation regarding veterinary matters shall not apply to Liechtenstein as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein, as specified in the sectoral adaptations to Annex I to the EEA Agreement.












(9)


By virtue of Decision of the EEA Joint Committee No 371/2021 of 10 December 2021 (7), Delegated Regulations (EU) 2021/577 and (EU) 2021/578 and Implementing Regulation (EU) 2021/1904 do not apply to Liechtenstein.












(10)


Annexes I and II to the EEA Agreement should therefore be amended accordingly,





HAS ADOPTED THIS DECISION:



Article 1
The following is inserted after point 3b (Commission Implementing Regulation (EU) 2021/963) in Part 4.1 of Chapter I of Annex I to the EEA Agreement:






‘3c.



32021 R 0577: Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (OJ L 123, 9.4.2021, p. 3).
This act shall not apply to Iceland.’
                        






Article 2
Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:






1.


The following is added in point 22 (Regulation (EU) 2019/6 of the European Parliament and of the Council):






 



                                    ‘, as amended by:






—



32021 R 0805: Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 (OJ L 180, 21.5.2021, p. 3).’
                                          


















2.


The following is inserted after point 22 (Regulation (EU) 2019/6 of the European Parliament and of the Council):






‘22a.



32021 R 0016: Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database) (OJ L 7, 11.1.2021, p. 1).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
In Article 6(4), the words “official languages of the Union” shall be replaced by “official languages of the Contracting Parties to the EEA Agreement”.










22b.



32021 R 0017: Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 7, 11.1.2021, p. 22).










22c.



32021 R 0578: Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (OJ L 123, 9.4.2021, p. 7).










22d.



32021 R 1904: Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (OJ L 387, 3.11.2021, p. 133).’










Article 3
The texts of Delegated Regulations (EU) 2021/578 and (EU) 2021/805 and Implementing Regulations (EU) 2021/16, (EU) 2021/17 and (EU) 2021/1904 in the Icelandic and Norwegian languages and Delegated Regulation (EU) 2021/577 in the Norwegian language, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.


Article 4
This Decision shall enter into force on 5 February 2022, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*), or on the day of the entry into force of Decision of the EEA Joint Committee No 371/2021, whichever is the later.


Article 5
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.




Done at Brussels, 4 February 2022.


For the EEA Joint Committee


The President

Nicolas VON LINGEN
            





(1)  
            OJ L 123, 9.4.2021, p. 3.

(2)  
            OJ L 123, 9.4.2021, p. 7.

(3)  
            OJ L 180, 21.5.2021, p. 3.

(4)  
            OJ L 7, 11.1.2021, p. 1.

(5)  
            OJ L 7, 11.1.2021, p. 22.

(6)  
            OJ L 387, 3.11.2021, p. 133.

(7)  Not yet published in Official Journal.

(*)  No constitutional requirements indicated.