# L_2022002EN.01000101.xml

| 6.1.2022 | EN | Official Journal of the European Union | L 2/1 |
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6.1.2022

EN

Official Journal of the European Union

L 2/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/7

of 5 January 2022

amending Annex V to Implementing Regulation (EU) 2020/2235 as regards the animal health requirements for the entry into the Union of dairy products contained in shelf-stable composite products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal origin (1), and in particular Article 7(2), point (a), 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 Articles 238(3) and 239(3) thereof,

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) (3), and in particular Article 90, first paragraph, points (a) and (e), and Article 126(3) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2020/692 (4) supplements the animal health rules laid down in Regulation (EU) 2016/429, as regards, inter alia, the entry into the Union of consignments of certain products of animal origin. More particularly, Article 163 of that Delegated Regulation, as recently amended by Commission Delegated Regulation (EU) 2021/1703 (5), lays down specific requirements for the entry into the Union of products of animal origin contained in shelf-stable composite products. Among others, that Article lays down risk-mitigating treatment requirements applicable to dairy products contained in such composite products taking into account the health status of the third country or territory, or zone thereof of origin. |
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(1)

Commission Delegated Regulation (EU) 2020/692 (4) supplements the animal health rules laid down in Regulation (EU) 2016/429, as regards, inter alia, the entry into the Union of consignments of certain products of animal origin. More particularly, Article 163 of that Delegated Regulation, as recently amended by Commission Delegated Regulation (EU) 2021/1703 (5), lays down specific requirements for the entry into the Union of products of animal origin contained in shelf-stable composite products. Among others, that Article lays down risk-mitigating treatment requirements applicable to dairy products contained in such composite products taking into account the health status of the third country or territory, or zone thereof of origin.

| (2) | Commission Implementing Regulation (EU) 2020/2235 (6) lays down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 as regards models of, inter alia, attestations for the entry into the Union of certain products of animal origin. More specifically, Annex V to Implementing Regulation (EU) 2020/2235 sets out a model private attestation by the operator entering shelf-stable composite products into the Union in accordance with Article 14 of Commission Delegated Regulation (EU) 2019/625 (7). |
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(2)

Commission Implementing Regulation (EU) 2020/2235 (6) lays down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 as regards models of, inter alia, attestations for the entry into the Union of certain products of animal origin. More specifically, Annex V to Implementing Regulation (EU) 2020/2235 sets out a model private attestation by the operator entering shelf-stable composite products into the Union in accordance with Article 14 of Commission Delegated Regulation (EU) 2019/625 (7).

| (3) | The private attestation set out in Annex V to Implementing Regulation (EU) 2020/2235 should be replaced by an updated version taking into account the requirements with respect to risk-mitigating treatments for dairy products laid down in Delegated Regulation (EU) 2020/692, as amended by Delegated Regulation (EU) 2021/1703. |
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(3)

The private attestation set out in Annex V to Implementing Regulation (EU) 2020/2235 should be replaced by an updated version taking into account the requirements with respect to risk-mitigating treatments for dairy products laid down in Delegated Regulation (EU) 2020/692, as amended by Delegated Regulation (EU) 2021/1703.

| (4) | Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly. |
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(4)

Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.

| (5) | As Implementing Regulation (EU) 2020/2235 applies from 21 April 2021, in the interest of legal certainty, the amendments to be made to Regulation (EU) 2020/2235 by this Regulation should take effect as a matter of urgency. |
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(5)

As Implementing Regulation (EU) 2020/2235 applies from 21 April 2021, in the interest of legal certainty, the amendments to be made to Regulation (EU) 2020/2235 by this Regulation should take effect as a matter of urgency.

| (6) | 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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(6)

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

Annex V to Implementing Regulation (EU) 2020/2235 is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 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, 5 January 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 139, 30.4.2004, p. 55.

1

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

2

(3)  
  OJ L 95, 7.4.2017, p. 1.

3

(4)  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).

4

(5)  Commission Delegated Regulation (EU) 2021/1703 of 13 July 2021 amending Delegated Regulation (EU) 2020/692 as regards the animal health requirements for the entry into the Union of products of animal origin contained in composite products (OJ L 339, 24.9.2021, p. 29).

5

(6)  Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).

6

(7)  Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18).

7

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ANNEX

‘ANNEX V

MODEL PRIVATE ATTESTATION BY THE OPERATOR ENTERING SHELF-STABLE COMPOSITE PRODUCTS INTO THE UNION IN ACCORDANCE WITH ARTICLE 14 OF DELEGATED REGULATION (EU) 2019/625

Image 1

| Part II: Attestation | II. Health information | II.a | Attestation | II.b | IMSOC reference |
| --- | --- | --- | --- | --- | --- |
| I, the undersigned, ...
  (name, address, and full details of the importer)
  as responsible for the entry into the Union of the consignment of composite products described in Part I declare that the composite products accompanied by this attestation:






  1. | comply with the applicable requirements referred to in Article 126(2) of Regulation (EU) 2017/625 of the European Parliament and of the Council (A); |

Part II: Attestation

II. Health information

II.a

Attestation

II.b

IMSOC reference

I, the undersigned, ...

(name, address, and full details of the importer)

as responsible for the entry into the Union of the consignment of composite products described in Part I declare that the composite products accompanied by this attestation:

1.

comply with the applicable requirements referred to in Article 126(2) of Regulation (EU) 2017/625 of the European Parliament and of the Council (A);

| 2. | do not need to be stored or transported under controlled temperature; |
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2.

do not need to be stored or transported under controlled temperature;

| 3. | contain no other processed meat than gelatine, collagen or highly refined products referred to in Annex III, Section XVI, to Regulation (EC) No 853/2004 of the European Parliament and of the Council (B); |
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3.

contain no other processed meat than gelatine, collagen or highly refined products referred to in Annex III, Section XVI, to Regulation (EC) No 853/2004 of the European Parliament and of the Council (B);

| 4. | contain the following list of ingredients of plant origin and of processed products of animal origin(2):
  ...; |
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4.

contain the following list of ingredients of plant origin and of processed products of animal origin(2):

...;

| 5. | contain processed products of animal origin, for which requirements are laid down in Annex III to Regulation (EC) No 853/2004 originating from the following approved establishment(s)(3):
  ...; |
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5.

contain processed products of animal origin, for which requirements are laid down in Annex III to Regulation (EC) No 853/2004 originating from the following approved establishment(s)(3):

...;

| 6. | contain processed products of animal origin which originate from third countries or regions thereof authorised to export each processed product of animal origin to the Union as listed in Commission Decision 2011/163/E (C); |
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6.

contain processed products of animal origin which originate from third countries or regions thereof authorised to export each processed product of animal origin to the Union as listed in Commission Decision 2011/163/E (C);

| 7. | originate from third countries or regions thereof authorised to export meat products, dairy products, colostrum-based products, fishery products or egg products to the Union on the basis of the Union animal and public health requirements and which are listed at least for one of these products of animal origin pursuant to Commission Implementing Regulation (EU) 2021/405 (D) and Commission Implementing Regulation (EU) 2021/404 (E); |
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7.

originate from third countries or regions thereof authorised to export meat products, dairy products, colostrum-based products, fishery products or egg products to the Union on the basis of the Union animal and public health requirements and which are listed at least for one of these products of animal origin pursuant to Commission Implementing Regulation (EU) 2021/405 (D) and Commission Implementing Regulation (EU) 2021/404 (E);

| 8. | have been produced in an establishment which fulfils hygiene standards, recognised to be equivalent to those required by Regulation (EC) No 852/2004 of the European Parliament and of the Council (F); |
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8.

have been produced in an establishment which fulfils hygiene standards, recognised to be equivalent to those required by Regulation (EC) No 852/2004 of the European Parliament and of the Council (F);

| 9. | have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council (G), and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006 (H); |
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9.

have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council (G), and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006 (H);

| 10. | contain dairy products, which:







  (4)(5) either | have not undergone a specific risk-mitigating treatment provided for in Annex XXVII to Commission Delegated Regulation (EU) 2020/692 (I); |
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10.

contain dairy products, which:

(4)(5) either

have not undergone a specific risk-mitigating treatment provided for in Annex XXVII to Commission Delegated Regulation (EU) 2020/692 (I);

| (4)(6) or | have undergone a specific risk-mitigating treatment provided for in column A or B of the table set out in Annex XXVII to Delegated Regulation (EU) 2020/692; |
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(4)(6) or

have undergone a specific risk-mitigating treatment provided for in column A or B of the table set out in Annex XXVII to Delegated Regulation (EU) 2020/692;

| (4)(7) or | have undergone a specific risk-mitigating treatment at least equivalent to one of the treatments provided for in column B of the table set out in Annex XXVII to Delegated Regulation (EU) 2020/692; |
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(4)(7) or

have undergone a specific risk-mitigating treatment at least equivalent to one of the treatments provided for in column B of the table set out in Annex XXVII to Delegated Regulation (EU) 2020/692;

| 11. | contain egg products, which have undergone a specific risk-mitigating treatment at least equivalent to one of the treatments provided for in the table set out in Annex XXVIII to Delegated Regulation (EU) 2020/692(4). |
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11.

contain egg products, which have undergone a specific risk-mitigating treatment at least equivalent to one of the treatments provided for in the table set out in Annex XXVIII to Delegated Regulation (EU) 2020/692(4).

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

Date

Qualification and title of the importer(8)

Stamp

Signature

| (2) | Please list the ingredients in descending order of weight. Grouping certain ingredients by dairy products, fishery products, egg products, products of non-animal origin as relevant is allowed. |
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(2)

| (3) | Please introduce the approval number of the establishment(s) having produced the processed products of animal origin contained in the composite product and the third country or territory, or zone thereof, where the approved establishment is located, as provided for in Article 4(2) of Regulation (EC) No 853/2004, and indicated by the importing food business operator. |
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(3)

| (4) | Keep as appropriate. |
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(4)

| (5) | Only if:






  (a) | the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is listed for the entry into the Union of raw milk and dairy products not subject to a risk-mitigating treatment in accordance with Annex XVII to Implementing Regulation (EU) 2021/404 (J);
  and |
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(5)

(a)

the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is listed for the entry into the Union of raw milk and dairy products not subject to a risk-mitigating treatment in accordance with Annex XVII to Implementing Regulation (EU) 2021/404 (J);

and

| (b) | the approved establishment of origin of the raw milk or the dairy product (indicated in point 5 of Part II of the attestation) is located:






  (i) | in a third country or territory, or zone thereof listed for the entry into the Union of raw milk and dairy products not subject to a risk-mitigating treatment in accordance with Annex XVII to Implementing Regulation (EU) 2021/404; or |
| --- | --- | --- |

(b)

the approved establishment of origin of the raw milk or the dairy product (indicated in point 5 of Part II of the attestation) is located:

(i)

in a third country or territory, or zone thereof listed for the entry into the Union of raw milk and dairy products not subject to a risk-mitigating treatment in accordance with Annex XVII to Implementing Regulation (EU) 2021/404; or

| (ii) | in the Union. |
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(ii)

in the Union.

| (6) | Only if:






  (a) | the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is listed for the entry into the Union of dairy products subject to a risk-mitigating treatment in accordance with Annex XVIII to Implementing Regulation (EU) 2021/404;
  and |
| --- | --- | --- |

(6)

(a)

the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is listed for the entry into the Union of dairy products subject to a risk-mitigating treatment in accordance with Annex XVIII to Implementing Regulation (EU) 2021/404;

and

| (b) | the approved establishment of origin of the raw milk or the dairy product (indicated in point 5 of Part II of the attestation) is located:






  (i) | in a third country or territory, or zone thereof listed for the entry into the Union of dairy products subject to a risk-mitigating treatment in accordance with Annex XVIII to Implementing Regulation (EU) 2021/404; or |
| --- | --- | --- |

(b)

the approved establishment of origin of the raw milk or the dairy product (indicated in point 5 of Part II of the attestation) is located:

(i)

in a third country or territory, or zone thereof listed for the entry into the Union of dairy products subject to a risk-mitigating treatment in accordance with Annex XVIII to Implementing Regulation (EU) 2021/404; or

| (ii) | in the Union. |
| --- | --- |

(ii)

in the Union.

| (7) | If:






  (a) | the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is not listed for the entry into the Union of raw milk and/or dairy products in Annexes XVII or XVIII to Implementing Regulation (EU) 2021/404;
  and |
| --- | --- | --- |

(7)

(a)

the third country or territory, or zone thereof of origin of the composite product (ISO country code inserted in Box I.7 of Part I of the attestation) is not listed for the entry into the Union of raw milk and/or dairy products in Annexes XVII or XVIII to Implementing Regulation (EU) 2021/404;

and

| (b) | the approved establishment of origin of the dairy product (indicated in point 5 of Part II of the attestation) is located:






  (i) | in a third country or territory, or zone thereof listed for the entry into the Union of raw milk and/or dairy products in accordance with Annex XVII or XVIII to Implementing Regulation (EU) 2021/404; or |
| --- | --- | --- |

(b)

the approved establishment of origin of the dairy product (indicated in point 5 of Part II of the attestation) is located:

(i)

in a third country or territory, or zone thereof listed for the entry into the Union of raw milk and/or dairy products in accordance with Annex XVII or XVIII to Implementing Regulation (EU) 2021/404; or

| (ii) | in the Union. |
| --- | --- |

(ii)

in the Union.

| (8) | Importer: Representative of the importing food business operators as laid down in Article 14(1) of Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18). |
| --- | --- |

(8)

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

A

(B)  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).

B

(OJ L 139, 30.4.2004, p. 55)

(C)  Commission Decision 2011/163/EU of 16 March 2011 on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC (OJ L 70, 17.3.2011, p. 40).

C

(D)  Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).

D

(E)  Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 1).

E

(F)  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

F

(G)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

G

(H)  Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).

H

(I)  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).

I

(J)  Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1).

J

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