Home Europe EEA Joint Committee Decision of the EEA Joint Committee No 305/2023 of 8 Decembe...
Date: 13-Jun-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 305/2023 of 8 December 2023 amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1374]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The decision also repeals Commission Decision 97/747/EC, which is already incorporated into the EEA Agreement.
  • The Decision of the EEA Joint Committee No 305/2023 amends Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement.
  • It incorporates Commission Implementing Regulation (EU) 2022/1646 into the EEA Agreement, which concerns uniform practical arrangements for official controls regarding the use of pharmacologically active substances in veterinary medicinal products and feed additives.

Key Changes

  • Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 is incorporated into Annex I, Chapter I, Part 1.1 after point 11h and into Annex II, Chapter II after point 31w and into Annex II, Chapter XII after point 164ze.
  • Commission Decision 97/747/EC is repealed from Part 7.2 of Annex I.
  • Adaptations are made for Iceland (10) and Norway (95) in Annex II regarding the application of the incorporated regulation.
  • The decision does not apply to Liechtenstein as long as the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein.
  • The decision entered into force on 9 December 2023, following notifications under Article 103(1) of the EEA Agreement.

Impact Analysis

Businesses in the EEA

  • Action Item: Review current practices and procedures to ensure compliance with Regulation (EU) 2022/1646. Update internal control plans and documentation accordingly.

National Control Authorities

  • Action Item: Update national control plans to reflect the requirements of Regulation (EU) 2022/1646. Train personnel on the new procedures and requirements.

Iceland and Norway

  • Action Item: Icelandic and Norwegian authorities and businesses should pay close attention to the specific adaptations outlined in Annex II to ensure compliance.

Liechtenstein

  • Action Item: Monitor the status of the agreement between the European Community and the Swiss Confederation on trade in agricultural products to determine if and when this decision will apply to Liechtenstein.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Implementing Regulation (EU) 2022/1646: Regulation on uniform practical arrangements for the performance of official controls regarding pharmacologically active substances in veterinary medicinal products and feed additives. Commission Decision 97/747/EC: Decision repealed by Implementing Regulation (EU) 2022/1646. EEA Agreement: Agreement on the European Economic Area. European Union: Political and economic union of European countries. Iceland: EEA member state. Norway: EEA member state. Liechtenstein: EEA member state to which this decision does not currently apply.
Official Source Record View Original Source →
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Official Journal EN of the European Union L series 2024/1374 13.6.2024 DECISION OF THE EEA JOINT COMMITTEE No 305/2023 of 8 December 2023 amending Annex I (Veterinary and phytosanitary matters) and Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/1374] 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 Implementing Regulation (EU) 2022/1646 of 23 September 2022on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation(1)is to be incorporated into the EEA Agreement. (2) Implementing Regulation (EU) 2022/1646 repeals Commission Decision 97/747/EC(2), which is incorporated into the EEA Agreement, and which is consequently to be repealed under the EEA Agreement. (3) This Decision concerns legislation regarding veterinary matters, feedingstuffs and foodstuffs. Legislation regarding veterinary matters, feedingstuffs and foodstuffs 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 and the introduction to Chapter XII of Annex II to the EEA Agreement. This Decision is therefore not to apply to Liechtenstein. (4) Annexes I and II to the EEA Agreement should therefore be amended accordingly, HAS ADOPTED THIS DECISION: Article 1 Annex I to the EEA Agreement shall be amended as follows: 1. The following is inserted after point 11h (Commission Delegated Regulation (EU) 2022/1644) in Part 1.1 of Chapter I: ‘11i. 32022 R 1646: Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (OJ L 248, 26.9.2022, p. 32). (1) OJ L 248, 26.9.2022, p. 32. (2) OJ L 303, 6.11.1997, p. 12. ELI: http://data.europa.eu/eli/dec/2024/1374/oj 1/3EN OJ L, 13.6.2024 The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation: The following is added to the table in Annex II: “ Iceland 10 Norway 95 ” ’ 2. The following is inserted after point 31w (Commission Delegated Regulation (EU) 2022/1644) of Chapter II: ‘31x. 32022 R 1646: Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (OJ L 248, 26.9.2022, p. 32). The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation: The following is added to the table in Annex II: “ Iceland 10 Norway 95 ” ’ 3. The text of point 13 (Commission Decision 97/747/EC) in part 7.2 is deleted. Article 2 The following is inserted after point 164ze (Commission Delegated Regulation (EU) 2022/1644) of Chapter XII of Annex II to the EEA Agreement: ‘164zf. 32022 R 1646: Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (OJ L 248, 26.9.2022, p. 32). The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation: The following is added to the table in Annex II: “ Iceland 10 Norway 95 ” ’ 2/3 ELI: http://data.europa.eu/eli/dec/2024/1374/ojEN OJ L, 13.6.2024 Article 3 The text of Implementing Regulation (EU) 2022/1646 in the Icelandic and Norwegian languages, 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 9 December 2023, provided that all the notifications under Article 103(1) of the EEA Agreement have been made(*). 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, 8 December 2023. For the EEA Joint Committee The President Pascal SCHAFHAUSER (*) No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/1374/oj 3/3

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