Commission Implementing Regulation (EU) 2020/1641 of 5 November 2020 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America (Text with EEA relevance)

Article 1

Subject matter and scope

This Regulation lays down rules concerning the entry into the Union of consignments of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption from the States of Massachusetts and Washington of the United States.

Article 2

Definition

For the purpose of this Regulation, the following definition shall apply:

‘Bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I to Regulation (EC) No 853/2004.

Article 3

Equivalence

The measures applied in the States of Massachusetts and Washington of the United States for the protection of public health in relation to the production and placing on the market of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption for which the Combined Nomenclature codes have been laid down in Part Two of Annex I to Regulation (EEC) No 2658/87 are equivalent to the requirements laid down in the rules referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

Article 4

Official certificate

Article 5

Entry into force

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.

ANNEX

Part I:   Description of consignment

Part II:   Certification

II.1. Public health attestation I, the undersigned hereby certify that: II.1.1. The herein described products comply with and were produced in accordance with relevant US standards and requirements of the US molluscan shellfish regulatory control program. II.1.2. The herein described products are labelled as not destined to be immersed or in contact with any Union’s water. II.1.3. All foreign-sourced shellfish material used in these products originates from third countries or regions thereof listed in Annex VIII to Commission Implementing Regulation (EU) 2021/405 and from establishments/growing areas authorised for entry into the Union of consignments of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods.

(¹) (⁷) II.2. Attestation as regards Commission Delegated Regulation (EU) 2023/905 I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EU) 2019/6 of the European Parliament and of the Council and Delegated Regulation (EU) 2023/905 and hereby certify that the [live bivalve molluscs] (¹) [live echinoderms] (¹) [live tunicates] (¹) [live marine gastropods] (¹) of on-land aquaculture origin and the products of animal origin derived therefrom described in Part I were produced in accordance with these requirements, and in particular, that the aquaculture animals from which the products have been derived have not been administered antimicrobial medicinal products for growth promotion or yield increase or antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 as set out in Article 3 of Delegated Regulation (EU) 2023/905 and originate from a third country or region thereof listed in the Annex to Commission Implementing Regulation (EU) 2024/2598 (⁸).

(²) (³) [II.3. Animal health attestation for live bivalve molluscs (⁴) of listed species intended for human consumption I, the undersigned official veterinarian, hereby certify that the aquatic animals referred to in box I.27 of Part I meet: II.3.1. the general animal health requirements for entry into the Union, which are set out in Article 6(1), in points (a) (⁵), and (b), Article 6(2) and Article 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692; II.3.2. the specific animal health requirements for entry into the Union of the commodities to which this certificate applies, which are set out in Article 167, points (a), (c)(ii), (c)(iii) and (d), and Article 169(1) and (2) of Delegated Regulation (EU) 2020/692.]

Notes

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023 (OJ L 102, 17.4.2023, p. 87)) in conjunction with Annex 2 to that Framework, references to the Union in this animal health/official certificate include the United Kingdom in respect of Northern Ireland.

Part I:

Part II:

(¹)Keep if appropriate/delete if not applicable.

(²)Part II.3. of this animal health/official certificate applies only to the following commodities of live bivalve molluscs intended for human consumption:

(a) molluscs of listed species transported without water which are packaged and labelled for human consumption in accordance with the specific requirements for those animals as set out in Regulation (EC) No 853/2004 of the European Parliament and of the Council and which are no longer able to survive as living animals if returned to the aquatic environment;

(b) molluscs of listed species transported without water which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packaging as set out in Regulation (EC) No 853/2004;

(c) molluscs of listed species transported without water which are packaged and labelled for human consumption in accordance with the specific requirements for those animals as set out in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing.

(³)Part II.3 of this animal health/official certificate does not apply and shall be deleted when the consignment consists of wild aquatic animals which are landed from fishing vessels.

(⁴)Species listed in columns 3 and 4 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882. Species listed in column 4 of that table shall only be regarded as vectors under the conditions set out in Article 171(1) of Delegated Regulation (EU) 2020/692.

(⁵)Where disease is relevant and reportable.

(⁶)To be signed by:

— an official veterinarian when the animal health attestation of Part II.3 is completed,

— a certifying officer or an official veterinarian when the animal health attestation in Part II.3 is deleted.

(⁷)Applicable to consignments entering the Union as from 3 September 2026.

(⁸)Or listed in other implementing acts adopted in accordance with Article 5 of Delegated Regulation (EU) 2023/905.