Date: 2022-06-30Category: Not ApplicableState: Union GovernmentCountry: Europe
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]
Executive Summary:
This EEA Joint Committee Decision No. 5/2022 amends Annexes I and II to the EEA Agreement to incorporate several EU Commission Regulations regarding veterinary and phytosanitary matters, and technical regulations. The decision incorporates regulations concerning veterinary medicinal products and animal identification. It entered into force on February 5, 2022, contingent upon EEA Agreement notifications or the entry into force of Decision No. 371/2021.
Key Points / Main Content:
* **Amendment of Annex I:**
* Adds Commission Delegated Regulation (EU) 2021/577 regarding the content and format of information for single lifetime identification documents for animals. This act does not apply to Iceland.
* **Amendment of Annex II:**
* Amends point 22 regarding Regulation (EU) 2019/6 with Commission Delegated Regulation (EU) 2021/805.
* Inserts Commission Implementing Regulation (EU) 2021/16 on measures for the Union database on veterinary medicinal products, adapting Article 64 to replace "official languages of the Union" with "official languages of the Contracting Parties to the EEA Agreement."
* Inserts Commission Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment.
* Inserts Commission Delegated Regulation (EU) 2021/578 on data collection requirements for sales and use of antimicrobial medicinal products in animals.
* Inserts Commission Implementing Regulation (EU) 2021/1904 adopting the design of a common logo for the retail of veterinary medicinal products at a distance.
* **Authentic Texts:**
* Icelandic and Norwegian language versions of specified regulations will be published in the EEA Supplement to the Official Journal and are authentic.
Impact Analysis:
* **EEA Member States (excluding Iceland and Liechtenstein in certain areas):**
* Impact: Must incorporate the amended regulations into their national laws and practices concerning veterinary medicinal products, animal identification, and related areas.
* Action Required: Review and update national legislation to align with the incorporated EU regulations; ensure relevant databases and systems are updated; comply with data collection and reporting requirements.
* **Businesses involved in veterinary medicinal products:**
* Impact: Affected by new regulations regarding product databases, variations not requiring assessment, data collection on antimicrobial sales, and logo requirements for online retail.
* Action Required: Adapt business practices to comply with new regulations, including updating product information in databases, adhering to data collection and reporting requirements, and using the common logo for online retail where applicable.
* **Competent Authorities:**
* Impact: Responsible for implementing and enforcing the new regulations.
* Action Required: Update procedures for assessing variations, managing the Union product database, and monitoring compliance with data collection and reporting requirements.
Key Entities Referenced
EEA Joint Committee: The governing body responsible for decisions regarding the European Economic Area (EEA) Agreement.
EEA Agreement: Agreement on the European Economic Area
Commission Delegated Regulation EU 2021/577: A regulation supplementing Regulation EU 2019/6 regarding information for single lifetime identification documents of animals, to be incorporated into the EEA Agreement.
Commission Delegated Regulation EU 2021/578: A regulation supplementing Regulation EU 2019/6 regarding data collection on sales and use of antimicrobial medicinal products in animals, to be incorporated into the EEA Agreement.
Commission Delegated Regulation EU 2021/805: A regulation amending Annex II to Regulation EU 2019/6, to be incorporated into the EEA Agreement.
Commission Implementing Regulation EU 2021/16: A regulation laying down measures for the Union database on veterinary medicinal products, to be incorporated into the EEA Agreement.
Commission Implementing Regulation EU 2021/17: A regulation establishing a list of variations not requiring assessment in accordance with Regulation EU 2019/6, to be incorporated into the EEA Agreement.
Commission Implementing Regulation EU 2021/1904: A regulation adopting the design of a common logo for the retail of veterinary medicinal products at a distance, to be incorporated into the EEA Agreement.
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 2021amending 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 2021establishing 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 2021adopting 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.
(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.L 175/10 EN Official Journal of the European Union 30.6.2022
(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 2021adopting 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.30.6.2022 EN Official Journal of the European Union L 175/11
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
(*) No constitutional requirements indicated.