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Date: 18-Jan-2024 Category: Not Applicable State: Union Government Country: Europe

Decision of the EEA Joint Committee No 106/2021 of 19 March 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/92]

Issued by EEA Joint Committee · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The EEA Joint Committee Decision No 106/2021 amends Annex II to the EEA Agreement to incorporate Commission Implementing Regulations (EU) 2020/1685 and (EU) 2020/1712. These regulations classify the substances bupivacaine and lidocaine regarding their maximum residue limits.

Key Changes

  • Annex II to the EEA Agreement is amended to include Commission Implementing Regulation (EU) 2020/1685, which pertains to the classification of bupivacaine regarding its maximum residue limit.
  • Annex II to the EEA Agreement is also amended to include Commission Implementing Regulation (EU) 2020/1712, which pertains to the classification of lidocaine regarding its maximum residue limit.
  • The decision stipulates that the Icelandic and Norwegian language versions of Implementing Regulations (EU) 2020/1685 and (EU) 2020/1712 will be published in the EEA Supplement to the Official Journal of the European Union and will be authentic.
  • The decision entered into force on 20 March 2021, following the completion of notifications under Article 103(1) of the EEA Agreement.

Impact Analysis

Pharmaceutical Companies and Veterinary Medicine Manufacturers

  • Action Items: Review current usage and residue levels of bupivacaine and lidocaine in products. Ensure compliance with the new maximum residue limits. Update product documentation and labeling as necessary.

Food Producers and Processors

  • Action Items: Implement monitoring programs to ensure that animal products do not exceed the maximum residue limits for bupivacaine and lidocaine. Work with veterinarians and suppliers to ensure responsible use of these substances in animals intended for food production.

Regulatory Agencies (EEA Member States)

  • Action Items: Update national regulations to reflect the changes introduced by Commission Implementing Regulations (EU) 2020/1685 and (EU) 2020/1712. Implement monitoring and enforcement programs to ensure compliance.

Veterinarians

  • Action Items: Stay informed about the updated maximum residue limits for bupivacaine and lidocaine. Adjust prescribing and administration practices to ensure compliance with the regulations. Educate animal owners about the importance of adhering to withdrawal periods.

Consumers

  • Action Items: No specific action items for consumers, but awareness of food safety regulations is beneficial.

Key Entities Referenced

EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement. Commission Implementing Regulation (EU) 2020/1685: Regulation amending Regulation (EU) No 37/2010 to classify bupivacaine regarding its maximum residue limit. Commission Implementing Regulation (EU) 2020/1712: Regulation amending Regulation (EU) No 37/2010 to classify lidocaine regarding its maximum residue limit. EEA Agreement: The Agreement on the European Economic Area. Regulation (EU) No 37/2010: The base regulation that is being amended by the two implementing regulations regarding maximum residue limits.
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Official Journal EN of the European Union L series 2024/92 18.1.2024 DECISION OF THE EEA JOINT COMMITTEE No 106/2021 of 19 March 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/92] 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) 2020/1685 of 12 November 2020 amending Regulation (EU) No 37/2010 to classify the substance bupivacaine as regards its maximum residue limit(1)is to be incorporated into the EEA Agreement. (2) Commission Implementing Regulation (EU) 2020/1712 of 16 November 2020 amending Regulation (EU) No 37/2010 to classify the substance lidocaine as regards its maximum residue limit(2)is to be incorporated into the EEA Agreement. (3) Annex II to the EEA Agreement should therefore be amended accordingly, HAS ADOPTED THIS DECISION: Article 1 The following indents are added in point 13 (Commission Regulation (EU) No 37/2010) of Chapter XIII of Annex II to the EEA Agreement: ‘- 32020 R 1685: Commission Implementing Regulation (EU) 2020/1685 of 12 November 2020(OJ L 379, 13.11.2020, p. 44), - 32020 R 1712: Commission Implementing Regulation (EU) 2020/1712 of 16 November 2020(OJ L 384, 17.11.2020, p. 3).’ Article 2 The texts of Implementing Regulations (EU) 2020/1685 and (EU) 2020/1712 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 3 This Decision shall enter into force on 20 March 2021, provided that all the notifications under Article 103(1) of the EEA Agreement have been made*. Article 4 This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union. (1) OJ L 379, 13.11.2020, p. 44. (2) OJ L 384, 17.11.2020, p. 3. * No constitutional requirements indicated. ELI: http://data.europa.eu/eli/dec/2024/92/oj 1/2EN OJ L, 18.1.2024 Done at Brussels, 19 March 2021. For the EEA Joint Committee The President Clara GANSLANDT 2/2 ELI: http://data.europa.eu/eli/dec/2024/92/oj

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