# L_2022026EN.01000101.xml

| 7.2.2022 | EN | Official Journal of the European Union | L 26/1 |
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7.2.2022

EN

Official Journal of the European Union

L 26/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/158

of 4 February 2022

amending Implementing Regulation (EU) 2020/1641 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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 129(1) thereof,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (2), and in particular Article 238(3) thereof,

Whereas:

| (1) | Regulation (EU) 2017/625 lays down general rules for the performance of official controls to verify compliance with rules aimed at preventing, eliminating or reducing, to acceptable levels, the risks to which humans and animals are exposed either directly or through the environment. |
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(1)

Regulation (EU) 2017/625 lays down general rules for the performance of official controls to verify compliance with rules aimed at preventing, eliminating or reducing, to acceptable levels, the risks to which humans and animals are exposed either directly or through the environment.

| (2) | In particular, Regulation (EU) 2017/625 lays down general conditions for the entry into the Union of animals and goods from third countries or regions thereof, including food intended for human consumption. Article 129 of Regulation (EU) 2017/625 empowers the Commission to recognise that measures applied by third countries, or regions thereof, are equivalent to the requirements laid down in certain rules referred to in Article 1(2) of that Regulation, if the third countries offer objective proof in this respect. It also empowers the Commission to set out the conditions governing the entry into the Union of such animals and goods from such third countries or regions thereof, in particular with regard to the nature and content of the official certificates or attestations that are to accompany those commodities. |
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(2)

In particular, Regulation (EU) 2017/625 lays down general conditions for the entry into the Union of animals and goods from third countries or regions thereof, including food intended for human consumption. Article 129 of Regulation (EU) 2017/625 empowers the Commission to recognise that measures applied by third countries, or regions thereof, are equivalent to the requirements laid down in certain rules referred to in Article 1(2) of that Regulation, if the third countries offer objective proof in this respect. It also empowers the Commission to set out the conditions governing the entry into the Union of such animals and goods from such third countries or regions thereof, in particular with regard to the nature and content of the official certificates or attestations that are to accompany those commodities.

| (3) | In accordance with Commission Implementing Regulation (EU) 2020/1641 (3), 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 intended for human consumption are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625. |
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(3)

In accordance with Commission Implementing Regulation (EU) 2020/1641 (3), 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 intended for human consumption are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

| (4) | Implementing Regulation (EU) 2020/1641 establishes a model official certificate for imports from the United States of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption. The model official certificate requires an official inspector to certify that the measures applied to the production and placing on the market of those commodities are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625. |
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(4)

Implementing Regulation (EU) 2020/1641 establishes a model official certificate for imports from the United States of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption. The model official certificate requires an official inspector to certify that the measures applied to the production and placing on the market of those commodities are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

| (5) | In line with the measures agreed with the department of the Food and Drug Administration of the United States responsible for the export to the Union of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, the model official certificate established in Implementing Regulation (EU) 2020/1641 should be adapted to the appropriate format for the export to the Union of those commodities. In particular, the model official certificate should inform about the date of departure of the consignments. Furthermore, information should be provided on whether the commodities are certified for human consumption or for the final consumer. |
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(5)

In line with the measures agreed with the department of the Food and Drug Administration of the United States responsible for the export to the Union of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, the model official certificate established in Implementing Regulation (EU) 2020/1641 should be adapted to the appropriate format for the export to the Union of those commodities. In particular, the model official certificate should inform about the date of departure of the consignments. Furthermore, information should be provided on whether the commodities are certified for human consumption or for the final consumer.

| (6) | In addition to the public health requirements of the model official certificate established in Implementing Regulation (EU) 2020/1641, live bivalve molluscs of species listed in Commission Implementing Regulation (EU) 2018/1882 (4), which are intended for human consumption, and products of animal origin from those molluscs, which are intended for further processing in the Union before human consumption, should enter the Union only if they are accompanied by an official certificate that includes the appropriate animal health attestations. Consequently, in order to fulfil animal health requirements that provide guarantees equivalent to those provided for in Union legislation, the model official certificate should include the general animal health requirements for entry into the Union, as set out in Article 6(1), points (a) and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (5), and the specific animal health requirements for entry into the Union of those commodities as 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. |
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(6)

In addition to the public health requirements of the model official certificate established in Implementing Regulation (EU) 2020/1641, live bivalve molluscs of species listed in Commission Implementing Regulation (EU) 2018/1882 (4), which are intended for human consumption, and products of animal origin from those molluscs, which are intended for further processing in the Union before human consumption, should enter the Union only if they are accompanied by an official certificate that includes the appropriate animal health attestations. Consequently, in order to fulfil animal health requirements that provide guarantees equivalent to those provided for in Union legislation, the model official certificate should include the general animal health requirements for entry into the Union, as set out in Article 6(1), points (a) and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (5), and the specific animal health requirements for entry into the Union of those commodities as 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.

| (7) | Implementing Regulation (EU) 2020/1641 should therefore be amended accordingly. |
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(7)

Implementing Regulation (EU) 2020/1641 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2020/1641 is replaced by the text set out in the Annex to this Regulation.

Article 2

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.

Done at Brussels, 4 February 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 95, 7.4.2017, p. 1.

1

(2)  
  OJ L 84, 31.3.2016, p. 1.

2

(3)  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 (OJ L 370, 6.11.2020, p. 4).

3

(4)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

4

(5)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

5

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ANNEX

MODEL OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF LIVE, CHILLED, FROZEN OR PROCESSED BIVALVE MOLLUSCS, ECHINODERMS, TUNICATES AND MARINE GASTROPODS INTENDED FOR HUMAN CONSUMPTION FROM THE UNITED STATES OF AMERICA

Image 1

Image 2

| United States (US) | Veterinary certificate to EU |
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United States (US)

Veterinary certificate to EU

| Part II: Certification | II. | Health information |
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Part II: Certification

II.

Health information

| II.a. | Certificate reference number |
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II.a.

Certificate reference number

II.b.

| II.1. | Public health attestation for live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption
  I, the undersigned hereby certify that:






  — | 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. |
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II.1.

I, the undersigned hereby certify that:

—

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.

| — | The herein described products are labelled as not destined to be immersed or in contact with any EU water |
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—

The herein described products are labelled as not destined to be immersed or in contact with any EU water

| — | All foreign-sourced shellfish material used in these products originates from third countries/establishments/growing areas approved to export live bivalve molluscs to the EU. |
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—

All foreign-sourced shellfish material used in these products originates from third countries/establishments/growing areas approved to export live bivalve molluscs to the EU.

| (1) (2)[II.2. | Animal health attestation for live bivalve molluscs
  (3)
  of listed species intended for human consumption,
  I, the undersigned official veterinarian, hereby certify that the aquatic animals referred to in Box I.18 of Part I meet:






  II.2.1. | the general animal health requirements for entry into the Union, which are set out in Article 6(1), in points (a)(4), and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (1); |
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(1) (2)[II.2.

I, the undersigned official veterinarian, hereby certify that the aquatic animals referred to in Box I.18 of Part I meet:

II.2.1.

the general animal health requirements for entry into the Union, which are set out in Article 6(1), in points (a)(4), and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (1);

| II.2.2. | 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.] |
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II.2.2.

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

n 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 Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to the European Union in this certificate include the United Kingdom in respect of Northern Ireland.

Part I:

| — | Box reference I.8: Region of origin: state of US harvest and code of approved production area. |
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—

Box reference I.8: Region of origin: state of US harvest and code of approved production area.

Part II:

| (1) | Part II.2. of this 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 (2) and which are no longer able to survive as living animals if returned to the aquatic environment; |
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(1)

Part II.2. of this 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 (2) 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; |
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(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. |
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(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.

| (2) | Part II.2 does not apply, and should be deleted when the consignment consists of wild aquatic animals which are landed from fishing vessels. |
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(2)

Part II.2 does not apply, and should be deleted when the consignment consists of wild aquatic animals which are landed from fishing vessels.

| (3) | Species listed in columns 3 and 4 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882 (3). 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. |
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(3)

Species listed in columns 3 and 4 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882 (3). 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.

| (4) | Where disease is relevant and reportable. |
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(4)

Where disease is relevant and reportable.

| (5) | To be signed by:






  — | an official veterinarian when the animal health attestation of part II.2 is completed; |
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(5)

To be signed by:

—

an official veterinarian when the animal health attestation of part II.2 is completed;

| — | a certifying officer or an official veterinarian when the animal health attestation in part II.2 is deleted. |
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—

a certifying officer or an official veterinarian when the animal health attestation in part II.2 is deleted.

[Official veterinarian](5) / [Certifying officer](5)

Name (in capitals)_______________________________

Qualification and title_______________________________

Date_______________________________

Signature_______________________________

Stamp

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(1)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

(2)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

(3)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

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