# L_2016126EN.01001301.xml

| 14.5.2016 | EN | Official Journal of the European Union | L 126/13 |
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14.5.2016

EN

Official Journal of the European Union

L 126/13

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/759

of 28 April 2016

drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1) and in particular Articles 8(1) and 9(4) thereof,

Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (2), and in particular Article 11(1) thereof,

Whereas:

| (1) | Regulation (EC) No 854/2004 requires products of animal origin to be imported only from a third country or a part of third country that appears on a list drawn up in accordance with that Regulation. |
| --- | --- |

(1)

Regulation (EC) No 854/2004 requires products of animal origin to be imported only from a third country or a part of third country that appears on a list drawn up in accordance with that Regulation.

| (2) | Commission Decision 2003/812/EC (3) draws up lists of third countries from which Member States are to authorise imports of certain products for human consumption subject to Council Directive 92/118/EEC (4). Those lists include a list of third countries or parts of third countries from which imports of gelatine intended for human consumption are authorised. However, there is no list which covers collagen, or raw materials for the production of gelatine and collagen, for human consumption. It is appropriate to draw up such lists. |
| --- | --- |

(2)

Commission Decision 2003/812/EC (3) draws up lists of third countries from which Member States are to authorise imports of certain products for human consumption subject to Council Directive 92/118/EEC (4). Those lists include a list of third countries or parts of third countries from which imports of gelatine intended for human consumption are authorised. However, there is no list which covers collagen, or raw materials for the production of gelatine and collagen, for human consumption. It is appropriate to draw up such lists.

| (3) | In accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council (5), food business operators importing products of animal origin are to ensure that the documents accompanying the consignment meet the requirements of Article 14 of Regulation (EC) No 854/2004. Commission Regulation (EC) No 2074/2005 (6) lays down model certificates for imports of certain products of animal origin intended for human consumption. Those model certificates include outdated references to previous legislation that need to be updated. |
| --- | --- |

(3)

In accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council (5), food business operators importing products of animal origin are to ensure that the documents accompanying the consignment meet the requirements of Article 14 of Regulation (EC) No 854/2004. Commission Regulation (EC) No 2074/2005 (6) lays down model certificates for imports of certain products of animal origin intended for human consumption. Those model certificates include outdated references to previous legislation that need to be updated.

| (4) | Third countries, parts of third countries and territories listed in Annex II to Commission Decision 2006/766/EC (7), in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 (8), in Part 1 of Annex I to Commission Regulation (EC) No 119/2009 (9) or in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 (10) meet the Union requirements with regard to imports of fresh meat and certain fishery products. Those lists could also be used for imports of raw materials for the production of gelatine and collagen. However, less strict requirements should apply if those raw materials have been subjected to certain treatments as provided for in Sections XIV and XV of Annex III to Regulation (EC) No 853/2004. |
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(4)

Third countries, parts of third countries and territories listed in Annex II to Commission Decision 2006/766/EC (7), in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 (8), in Part 1 of Annex I to Commission Regulation (EC) No 119/2009 (9) or in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 (10) meet the Union requirements with regard to imports of fresh meat and certain fishery products. Those lists could also be used for imports of raw materials for the production of gelatine and collagen. However, less strict requirements should apply if those raw materials have been subjected to certain treatments as provided for in Sections XIV and XV of Annex III to Regulation (EC) No 853/2004.

| (5) | Raw materials for the production of gelatine and collagen, whether or not treated, introduced into the Union for transit to a third country, pose a negligible risk to public health. Such raw materials, even when treated, should, however, comply with the relevant animal health requirements. Accordingly, a list of third countries, parts of third countries and territories should be drawn up and model certificates for transit, and storage before transit, of raw materials and treated raw materials for the production of gelatine and collagen should be laid down. |
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(5)

Raw materials for the production of gelatine and collagen, whether or not treated, introduced into the Union for transit to a third country, pose a negligible risk to public health. Such raw materials, even when treated, should, however, comply with the relevant animal health requirements. Accordingly, a list of third countries, parts of third countries and territories should be drawn up and model certificates for transit, and storage before transit, of raw materials and treated raw materials for the production of gelatine and collagen should be laid down.

| (6) | Due to the geographical situation of Kaliningrad, specific animal health conditions should be laid down for transit via the Union of consignments of raw materials and treated raw materials for the production of gelatine or collagen to and from Russia, which only concern transit through Latvia, Lithuania and Poland. |
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(6)

Due to the geographical situation of Kaliningrad, specific animal health conditions should be laid down for transit via the Union of consignments of raw materials and treated raw materials for the production of gelatine or collagen to and from Russia, which only concern transit through Latvia, Lithuania and Poland.

| (7) | In the interest of clarity and simplification of Union legislation, and without prejudice to Commission Decision 2003/863/EC (11), the lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction of frogs' legs, snails, gelatine, collagen, raw materials and treated raw materials for the production of gelatine and collagen, and honey, royal jelly and other products of apiculture for human consumption, and the model certificates for those products, should be set out in an Annex to this Regulation. Consequently, the corresponding existing certificates should be deleted from Annex VI to Regulation (EC) No 2074/2005. |
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(7)

In the interest of clarity and simplification of Union legislation, and without prejudice to Commission Decision 2003/863/EC (11), the lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction of frogs' legs, snails, gelatine, collagen, raw materials and treated raw materials for the production of gelatine and collagen, and honey, royal jelly and other products of apiculture for human consumption, and the model certificates for those products, should be set out in an Annex to this Regulation. Consequently, the corresponding existing certificates should be deleted from Annex VI to Regulation (EC) No 2074/2005.

| (8) | In order to ensure the safety of certain highly refined products of animal origin, specific requirements have been inserted in Annex III to Regulation (EC) No 853/2004. Therefore it is appropriate to draw up the list of countries from which those products may be imported and lay down a model certificate for those products. |
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(8)

In order to ensure the safety of certain highly refined products of animal origin, specific requirements have been inserted in Annex III to Regulation (EC) No 853/2004. Therefore it is appropriate to draw up the list of countries from which those products may be imported and lay down a model certificate for those products.

| (9) | As the lists of third countries, parts of third countries and territories from which Member States are to authorise imports of furred farm game meat products and feathered farm game meat products and leporidae (rabbit and hare) meat and their meat products have been laid down in Commission Decision 2007/777/EC (12) and in Regulation (EC) No 119/2009 respectively, Decision 2003/812/EC becomes redundant and should be repealed. |
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(9)

As the lists of third countries, parts of third countries and territories from which Member States are to authorise imports of furred farm game meat products and feathered farm game meat products and leporidae (rabbit and hare) meat and their meat products have been laid down in Commission Decision 2007/777/EC (12) and in Regulation (EC) No 119/2009 respectively, Decision 2003/812/EC becomes redundant and should be repealed.

| (10) | It is appropriate to introduce a transitional period to allow Member States and food business operators to adapt to the new requirements laid down in this Regulation. |
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(10)

It is appropriate to introduce a transitional period to allow Member States and food business operators to adapt to the new requirements laid down in this Regulation.

| (11) | 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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(11)

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:

CHAPTER 1

IMPORTS OF CERTAIN PRODUCTS OF ANIMAL ORIGIN

Article 1

Lists of third countries, parts of third countries and territories

The third countries, parts of third countries and territories from which Member States are to authorise the import of the following products of animal origin intended for human consumption are set out in the relevant Parts of Annex I:

| (a) | frogs' legs, Part I; |
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(a)

frogs' legs, Part I;

| (b) | snails, Part II; |
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(b)

snails, Part II;

| (c) | gelatine and collagen, Part III; |
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(c)

gelatine and collagen, Part III;

| (d) | raw materials for the production of gelatine and collagen, Part IV; |
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(d)

raw materials for the production of gelatine and collagen, Part IV;

| (e) | treated raw materials for the production of gelatine and collagen, Part V; |
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(e)

treated raw materials for the production of gelatine and collagen, Part V;

| (f) | honey, royal jelly and other products of apiculture, Part VI; |
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(f)

honey, royal jelly and other products of apiculture, Part VI;

| (g) | the following highly refined products, Part VII:






  (i) | chondroitin sulphate; |
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(g)

the following highly refined products, Part VII:

(i)

chondroitin sulphate;

| (ii) | hyaluronic acid; |
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(ii)

hyaluronic acid;

| (iii) | other hydrolysed cartilage products; |
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(iii)

other hydrolysed cartilage products;

| (iv) | chitosan; |
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(iv)

chitosan;

| (v) | glucosamine; |
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(v)

glucosamine;

| (vi) | rennet; |
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(vi)

rennet;

| (vii) | isinglass; |
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(vii)

isinglass;

| (viii) | amino acids that are authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council (13). |
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(viii)

amino acids that are authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council (13).

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Article 2

Model certificates

1.   The model certificates for imports into the Union of the products referred to in Article 1 are set out in Annex II as follows:

| (a) | frogs' legs, Part I; |
| --- | --- |

(a)

frogs' legs, Part I;

| (b) | snails, Part II; |
| --- | --- |

(b)

snails, Part II;

| (c) | gelatine, Part III; |
| --- | --- |

(c)

gelatine, Part III;

| (d) | collagen, Part IV; |
| --- | --- |

(d)

collagen, Part IV;

| (e) | raw materials for the production of gelatine and collagen, Part V; |
| --- | --- |

(e)

raw materials for the production of gelatine and collagen, Part V;

| (f) | treated raw materials for the production of gelatine and collagen, Part VI; |
| --- | --- |

(f)

treated raw materials for the production of gelatine and collagen, Part VI;

| (g) | honey, royal jelly and other products of apiculture, Part VII; |
| --- | --- |

(g)

honey, royal jelly and other products of apiculture, Part VII;

| (h) | the following highly refined products, Part VIII:






  (i) | chondroitin sulphate; |
| --- | --- | --- |

(h)

the following highly refined products, Part VIII:

(i)

chondroitin sulphate;

| (ii) | hyaluronic acid; |
| --- | --- |

(ii)

hyaluronic acid;

| (iii) | other hydrolysed cartilage products; |
| --- | --- |

(iii)

other hydrolysed cartilage products;

| (iv) | chitosan; |
| --- | --- |

(iv)

chitosan;

| (v) | glucosamine; |
| --- | --- |

(v)

glucosamine;

| (vi) | rennet; |
| --- | --- |

(vi)

rennet;

| (vii) | isinglass; |
| --- | --- |

(vii)

isinglass;

| (viii) | amino acids that are authorised as food additives in accordance with Regulation (EC) No 1333/2008. |
| --- | --- |

(viii)

amino acids that are authorised as food additives in accordance with Regulation (EC) No 1333/2008.

Those certificates must be completed in accordance with the explanatory notes set out in Annex IV and the notes in the relevant certificate.

2.   Electronic certification and other systems agreed between the Union and the third country concerned may be used.

CHAPTER 2

TRANSIT OF CERTAIN PRODUCTS OF ANIMAL ORIGIN

Article 3

Lists of third countries, parts of third countries and territories

The third countries, parts of third countries and territories from which Member States are to authorise the transit through the Union of raw materials and treated raw materials for the production of gelatine and collagen intended for human consumption bound for a third country, either by immediate transit or after storage in the Union in accordance with Article 12(4) and Article 13 of Council Directive 97/78/EC (14), are set out in Parts IV and V of Annex I to this Regulation, respectively.

14

Article 4

Model certificate

1.   The model certificate for the transit through the Union of the raw materials and treated raw materials referred to in Article 3 is set out in Annex III.

That certificate must be completed in accordance with the notes set out in Annex IV and in the relevant model certificate.

2.   Electronic certification and other systems harmonised at Union level may be used.

Article 5

Derogation for transit through Latvia, Lithuania and Poland

1.   By way of derogation from Article 3, transit by road or by rail between the specific, designated border inspection posts in Latvia, Lithuania and Poland, listed and marked with special remark 13 in Annex I to Commission Decision 2009/821/EC (15), of consignments of the raw materials or treated raw materials referred to in Article 3 of this Regulation coming from and bound for Russia, directly or via another third country, shall be authorised where the following conditions are met:

| (a) | the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry; |
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(a)

the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry;

| (b) | the documents accompanying the consignment, as provided for in Article 7 of Directive 97/78/EC, are stamped with the words ‘Only for transit to Russia via the EU’ on each page by the official veterinarian at the border inspection post of entry; |
| --- | --- |

(b)

the documents accompanying the consignment, as provided for in Article 7 of Directive 97/78/EC, are stamped with the words ‘Only for transit to Russia via the EU’ on each page by the official veterinarian at the border inspection post of entry;

| (c) | the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with; |
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(c)

the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

| (d) | the consignment is certified as acceptable for transit on the common veterinary entry document issued by the official veterinarian at the border inspection post of entry. |
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(d)

the consignment is certified as acceptable for transit on the common veterinary entry document issued by the official veterinarian at the border inspection post of entry.

2.   The consignments referred to in paragraph 1 shall not be unloaded or put into storage, as referred to in Article 12(4) or in Article 13 of Directive 97/78/EC, within the Union.

3.   Regular audits shall be conducted by the competent authority to ensure that the number of consignments referred to in paragraph 1 and the corresponding quantities of products leaving the Union correspond with the number and quantities which have been introduced in the Union.

CHAPTER 3

FINAL PROVISIONS

Article 6

Amendment

Annex VI to Regulation (EC) No 2074/2005 is amended as follows:

| (1) | in Section I, Chapters I, II, III and VI are deleted; |
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(1)

in Section I, Chapters I, II, III and VI are deleted;

| (2) | Appendices I, II, III and VI are deleted. |
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(2)

Appendices I, II, III and VI are deleted.

Article 7

Repeal

Decision 2003/812/EC is repealed.

Article 8

Transitional provisions

Consignments of products of animal origin in respect of which the relevant certificates have been issued in accordance with Regulation (EC) No 2074/2005 may continue to be introduced into the Union provided that the certificate was signed before 3 December 2016.

Article 9

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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 April 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 18, 23.1.2003, p. 11.

1

(2)  
  OJ L 139, 30.4.2004, p. 206.

2

(3)  Commission Decision 2003/812/EC of 17 November 2003 drawing up lists of third countries from which Member States are to authorise imports of certain products for human consumption subject to Council Directive 92/118/EEC (OJ L 305, 22.11.2003, p. 17).

3

(4)  Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and import into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC, and, as regards pathogens, Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49).

4

(5)  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).

5

(6)  Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).

6

(7)  Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted (OJ L 320, 18.11.2006, p. 53).

7

(8)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

8

(9)  Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for import into, or transit through, the Community of meat and wild leporidae, of certain wild land mammals and farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12).

9

(10)  Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).

10

(11)  Commission Decision 2003/863/EC of 2 December 2003 on health certificates for the importation of animal products from the United States of America (OJ L 325, 12.12.2003, p. 46).

11

(12)  Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49).

12

(13)  Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

13

(14)  Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).

14

(15)  Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces (OJ L 296, 12.11.2009, p. 1).

15

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ANNEX I

Lists of third countries, parts of third countries and territories as referred to in Article 1

PART I

FROGS' LEGS

Third countries and territories listed in the column ‘Countries’ of Annex II to Decision 2006/766/EC, except those for which a restriction is mentioned in the column ‘Restrictions’ of that Annex, and the following countries or territories:

| COUNTRY ISO CODE | COUNTRY/TERRITORY |
| --- | --- |
| MK (*1) | former Yugoslav Republic of Macedonia |

COUNTRY ISO CODE

COUNTRY/TERRITORY

MK (*1)

former Yugoslav Republic of Macedonia

PART II

SNAILS

Third countries and territories listed in the column ‘Countries’ of Annex II to Decision 2006/766/EC, except those for which a restriction is mentioned in the column ‘Restrictions’ of that Annex, and the following countries/territories:

| COUNTRY ISO CODE | COUNTRY/TERRITORY |
| --- | --- |
| MD | Moldova |
| MK (*2) | former Yugoslav Republic of Macedonia |
| SY | Syria |

COUNTRY ISO CODE

COUNTRY/TERRITORY

MD

Moldova

MK (*2)

former Yugoslav Republic of Macedonia

SY

Syria

PART III

GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A

Gelatine and collagen derived from bovine, ovine, caprine, porcine and equine animals, both farmed and wild

Third countries and territories listed in column 1 of Part 1 of Annex II to Regulation (EU) No 206/2010 and the following countries or territories:

| COUNTRY ISO CODE | COUNTRY/TERRITORY |
| --- | --- |
| KR | Republic of Korea |
| MY | Malaysia |
| PK | Pakistan |
| TW | Taiwan |

COUNTRY ISO CODE

COUNTRY/TERRITORY

KR

Republic of Korea

MY

Malaysia

PK

Pakistan

TW

Taiwan

SECTION B

Gelatine and collagen derived from poultry including ratites and feathered game

Third countries and territories listed in column 1 of Part 1 of Annex I to Regulation (EC) No 798/2008.

SECTION C

Gelatine and collagen derived from fishery products

All third countries and territories listed in the column ‘Countries’ of Annex II to Decision 2006/766/EC, regardless of whether a restriction is mentioned in the column ‘Restrictions’ of that Annex.

SECTION D

Gelatine and collagen derived from leporidae and from wild land mammals not referred to in Section A

Third countries listed in column 1 of Part 1 of Annex I to Regulation (EC) No 119/2009.

PART IV

RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A

Raw materials from bovine, ovine, caprine, porcine and equine animals, both farmed and wild

Third countries, territories and parts thereof listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which introduction into the Union of that category of fresh meat of the respective species is authorised as specified in that Part of that Annex, unless such introduction is limited by supplementary guarantees A or F as indicated in column 5.

SECTION B

Raw materials from poultry including ratites and feathered game

Third countries, parts of third countries and territories listed in Part 1 of Annex I to Regulation (EC) No 798/2008 from which imports of fresh poultry meat of the respective species is authorised as specified in that Part of that Annex.

SECTION C

Raw materials from fishery products

Third countries and territories listed in the column ‘Countries’ of Annex II to Decision 2006/766/EC, subject to the restrictions mentioned in the column ‘Restrictions’ of that Annex.

SECTION D

Raw materials from leporidae and from wild land mammals not referred to in Section A

Third countries listed in column 1 of Part 1 of Annex I to Regulation (EC) No 119/2009 from which imports of fresh meat of the respective species is authorised as specified in that Part of that Annex.

PART V

TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A

Treated raw materials from bovine, ovine, caprine, porcine and equine animals, both farmed and wild

Third countries and territories and parts thereof listed in column 1 of Part 1 of Annex II to Regulation (EU) No 206/2010 and the following countries or territories:

| COUNTRY ISO CODE | COUNTRY/TERRITORY |
| --- | --- |
| KR | Republic of Korea |
| MY | Malaysia |
| PK | Pakistan |
| TW | Taiwan |

COUNTRY ISO CODE

COUNTRY/TERRITORY

KR

Republic of Korea

MY

Malaysia

PK

Pakistan

TW

Taiwan

SECTION B

Treated raw materials from poultry including ratites and feathered game

Third countries and territories listed in column 1 of Part 1 of Annex I to Regulation (EC) No 798/2008.

SECTION C

Treated raw materials from fishery products

All third countries and territories listed in the column ‘Countries’ of Annex II to Decision 2006/766/EC regardless of whether a restriction is mentioned in the column ‘Restrictions’ of that Annex.

SECTION D

Treated raw materials from leporidae and wild land mammals not referred to in Section A

Third countries listed in column 1 of Part 1 of Annex I to Regulation (EC) No 119/2009.

SECTION E

Treated raw materials referred to in Annex III to Regulation (EC) No 853/2004, Section XIV, Chapter I point 4(b)(iii) and Section XV, Chapter I, point 4(b)(iii)

Third countries, parts of third countries and territories referred to in Part IV of this Annex.

PART VI

HONEY, ROYAL JELLY AND OTHER PRODUCTS OF APICULTURE INTENDED FOR HUMAN CONSUMPTION

Third countries and territories listed in the column ‘Country’ in the Annex to Commission Decision 2011/163/EU (1) and marked with an ‘X’ in the column ‘Honey’ in that Annex.

PART VII

HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS FOR HUMAN CONSUMPTION

| (a) | In the case of raw materials derived from ungulates including equidae, third countries and territories listed in column 1 of Part 1 of Annex II to Regulation (EU) No 206/2010 and the following countries or territories:






  COUNTRY ISO CODE | COUNTRY/TERRITORY |
| --- | --- | --- |
| KR | Republic of Korea |
| MY | Malaysia |
| PK | Pakistan |
| TW | Taiwan |

(a)

In the case of raw materials derived from ungulates including equidae, third countries and territories listed in column 1 of Part 1 of Annex II to Regulation (EU) No 206/2010 and the following countries or territories:

COUNTRY ISO CODE

COUNTRY/TERRITORY

KR

Republic of Korea

MY

Malaysia

PK

Pakistan

TW

Taiwan

| (b) | In the case of the raw materials derived from fishery products, all third countries and territories listed in the column ‘Countries’ in Annex II to Decision 2006/766/EC, regardless of whether a restriction is mentioned in the column ‘Restrictions’ of that Annex. |
| --- | --- |

(b)

In the case of the raw materials derived from fishery products, all third countries and territories listed in the column ‘Countries’ in Annex II to Decision 2006/766/EC, regardless of whether a restriction is mentioned in the column ‘Restrictions’ of that Annex.

| (c) | In the case of raw materials derived from poultry, third countries and territories listed in column 1 of Part 1 of Annex I to Regulation (EC) No 798/2008. |
| --- | --- |

(c)

In the case of raw materials derived from poultry, third countries and territories listed in column 1 of Part 1 of Annex I to Regulation (EC) No 798/2008.

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(*1)  The former Yugoslav Republic of Macedonia; provisional code that does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject in the United Nations.

(*2)  The former Yugoslav Republic of Macedonia; provisional code that does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject in the United Nations.

(1)  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).

---

ANNEX II

Model certificates as referred to in Article 2

PART I

MODEL CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN OR PREPARED FROGS' LEGS INTENDED FOR HUMAN CONSUMPTION

Image 1

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

02.08.90

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 2

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Treatment type

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 3

COUNTRY

Model FRG Frogs’ legs

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that the frogs' legs described above were produced in accordance with those requirements, in particular that they:

— come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004;

and

— originate from frogs that have been bled, prepared and, where appropriate, chilled, frozen or processed, packaged and stored in a hygienic manner in accordance with the requirements of Section XI of Annex III to Regulation (EC) No 853/2004.

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in the event of unloading and reloading.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

— Box reference I.28: Treatment type: fresh, treated.

Part II:

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Part II: Certification

Official inspector

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART II

MODEL CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN, SHELLED, COOKED, PREPARED OR PRESERVED SNAILS INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN, SHELLED, COOKED, PREPARED OR PRESERVED SNAILS INTENDED FOR HUMAN CONSUMPTION

Image 4

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 5

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species (scientific name)

Treatment type

Approval number of establishments

Number of packages

Net weight

Manufacturing plant

Image 6

COUNTRY

Model SNS Snails

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that the snails described above were produced in accordance with those requirements, in particular that they:

— come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004;

and

— have been handled and, where appropriate, shelled, cooked, prepared, preserved, frozen, packaged and stored in a hygienic manner in accordance with the requirements of Section XI of Annex III to Regulation (EC) No 853/2004.

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 03.07, 16.05.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

— Box reference I.28: Treatment type: fresh, treated.

Part II:

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Part II: Certification

Official inspector

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART III

MODEL CERTIFICATE FOR IMPORTS OF GELATINE INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF GELATINE INTENDED FOR HUMAN CONSUMPTION

Image 7

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 8

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Date production

(dd/mm/yyyy)

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 9

COUNTRY

Model GEL Gelatine intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that the gelatine described above was produced in accordance with those requirements, in particular that:

— it comes from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004;

— it has been produced from raw materials that met the requirements of Chapters I and II of Section XIV of Annex III to Regulation (EC) No 853/2004;

— it has been manufactured in compliance with the conditions set out in Chapter III of Section XIV of Annex III to Regulation (EC) No 853/2004;

— it satisfies the criteria of Chapter IV of Section XIV of Annex III to Regulation (EC) No 853/2004 and of Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1);

and if from ruminant origin, except for gelatine derived from hides and skins of ruminants,

(1) either

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;

— the animals from which the gelatine was derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

— if in the country or region there have been BSE indigenous cases:

(i) it comes from animals which were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

— the animals from which the gelatine was derived passed ante-mortem and post-mortem inspections;

— the animals from which the gelatine destined for export was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the gelatine does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

Part II: Certification

Image 10

COUNTRY

Model GEL Gelatine intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

— the gelatine is derived from animals which passed ante-mortem and post-mortem inspections;

— the gelatine is derived both from animals born, continuously reared and slaughtered in a country or region with negligible BSE risk in accordance with Article 5(2) of Regulation (EC) No 999/2001, and, if there have been BSE indigenous cases in the country or region, born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced, and from animals born in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk, and which have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the gelatine does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region with an undetermined BSE risk;

— the animals from which the gelatine was derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

— the animals from which the gelatine was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the gelatine is not derived from:

(i) specified risk material as defined in Annex V to Regulation (EC) No 999/2001;

(ii) nervous and lymphatic tissues exposed during the deboning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the heading of 35.03.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

Image 11

COUNTRY

Model GEL Gelatine intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

Part II:

(1) Delete as appropriate.

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Official veterinarian Name (in capital letters):

Qualification and title:

Date: Signature:

Stamp:

PART IV

MODEL CERTIFICATE FOR IMPORTS OF COLLAGEN INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF COLLAGEN INTENDED FOR HUMAN CONSUMPTION

Image 12

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 13

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Date production

(dd/mm/yyyy)

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 14

COUNTRY

Model COL Collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that the collagen described above was produced in accordance with those requirements, in particular that:

— it comes from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004;

— it has been produced from raw materials that met the requirements of Chapters I and II of Section XV of Annex III to Regulation (EC) No 853/2004;

— it has been manufactured in compliance with the conditions set out in Chapter III of Section XV of Annex III to Regulation (EC) No 853/2004;

— it satisfies the criteria of Chapter IV of Section XV of Annex III to Regulation (EC) No 853/2004 and of Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1);

and if from ruminant origin, except for collagen derived from hides and skins of ruminants,

(1) either

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;

— the animals from which the collagen was derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

— if in the country or region there have been BSE indigenous cases:

(i) it comes from animals which were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

— the animals from which the collagen was derived passed ante-mortem and post-mortem inspections;

— the animals from which the collagen destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the collagen does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

Part II: Certification

Image 15

COUNTRY

Model COL Collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

— the collagen is derived from animals which passed ante-mortem and post-mortem inspections;

— the collagen is derived both from animals born, continuously reared and slaughtered in a country or region with negligible BSE risk in accordance with Article 5(2) of Regulation (EC) No 999/2001, and, if there have been BSE indigenous cases in the country or region, born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced, and from animals born in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk, and which have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the collagen does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [it comes from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region with an undetermined BSE risk;

— the animals from which the collagen was derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

— the animals from which the collagen was derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the collagen was not derived from:

(i) specified risk material as defined in Annex V to Regulation (EC) No 999/2001;

(ii) nervous and lymphatic tissues exposed during the deboning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.18: This certificate may also be used for import of collagen casings.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the heading of 35.04 or 39.17.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

Image 16

COUNTRY

Model COL Collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

Part II:

(1) Delete as appropriate.

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Official veterinarian

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART V

MODEL CERTIFICATE FOR IMPORTS OF RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION
   (1)

MODEL CERTIFICATE FOR IMPORTS OF RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION

1

Image 17

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 18

I.25. Commodities certified for:

Production of gelatine / collagen for human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Nature of commodity

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 19

COUNTRY

Model RCG Raw materials for the production of gelatine / collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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), 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) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206) and certify that the raw materials described above comply with those requirements, in particular that:

— (1) [bones, hides and skins of domestic and farmed ruminant animals, pigs and poultry and tendons and sinews described above derive from animals which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection,]

and/or

— (1) [wild game hides, skins and bones described above derive from killed animals whose carcasses have been found fit for human consumption following post-mortem inspection,]

and/or

— (1) [fish skins and bones described above derive from plants manufacturing fishery products for human consumption authorised for export,]

(1) and

[if from ruminant origin, except for hides and skins of ruminants,

(1) either:

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;

— the animals from which the raw materials of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

— if in the country or region there have been BSE indigenous cases:

(i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii) the raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;]

(1) or:

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

— the animals from which the raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

Part II: Certification

Image 20

COUNTRY

Model RCG Raw materials for the production of gelatine / collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

— animals from which the raw materials of bovine, ovine and caprine animal origin intended for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;]

(1) or

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

— the animals from which the raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

— the raw materials of bovine, ovine and caprine animal origin intended for export are derived both from animals which were born, continuously reared and slaughtered in a country or region with negligible BSE risk in accordance with Article 5(2) of Regulation (EC) No 999/2001, and, if there have been BSE indigenous cases in the country or region, born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced, and from animals born in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk, and which have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region with an undetermined BSE risk;

— the animals from which the raw materials of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

— the animals from which the raw materials of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the raw materials of bovine, ovine and caprine animal origin are not derived from:

(i) specified risk material as defined in Annex V to Regulation (EC) No 999/2001;

(ii) nervous and lymphatic tissues exposed during the de-boning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]]

Image 21

COUNTRY

Model RCG Raw materials for the production of gelatine / collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) [II.2. Animal Health Attestation

I, the undersigned official veterinarian, certify that the raw materials described above:

II.2.1. consist of animal products that satisfy the animal health requirements below;

II.2.2. have been obtained in the territory of (1) either [: ] (1) or [ ] (2) (3) (4) from:

(1) either [II.2.2.1 animals that come from holdings and have remained in that territory since birth or for at least the last 3 months before slaughter; and

(1) either [(i) that are of the species referred to in Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1), fulfilling all the relevant animal health import requirements laid down in that Regulation, and that were slaughtered for human consumption on a date for which import into the European Union of fresh meat from animals of those species was authorised from the country or territory thereof in accordance with Column 8 of Part 1 of Annex II to that Regulation;]

(1) or [(ii) that are of the species referred to in Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12), fulfilling all the relevant animal health import requirements laid down in that Regulation.]]

(1) or [II.2.2.1 poultry that have remained in that territory since hatching or have been imported as day-old chicks or slaughter poultry from (a) third country(ies) listed for that commodity in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1) under conditions at least equivalent to those in that Regulation, and consist of species referred to in that Regulation, fulfilling all the relevant animal health import requirements laid down in that Regulation, and were slaughtered for human consumption on a date for which import into the European Union of meat from animals of those species was authorised from the country or territory thereof in accordance with Column 6 B of Part 1 to Annex I to that Regulation.]

(1) or [II.2.2.1 animals that have been killed in the wild in that territory(5); and captured and killed in an area:

(i) in which within 25 km there has been no case/outbreak of any of the following diseases for which the animals are susceptible: foot and mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza during the prior 30 days, nor of classical or African swine fever during the prior 40 days and

(ii) that is situated at a distance that exceeds 20 km from the borders separating another territory of a country or part thereof, which is not authorised at these dates for exporting these raw materials to the European Union, and

(iii) in which after killing they were transported within 12 hours for chilling either to a collection centre and immediately afterwards to a game establishment, or directly to a game establishment;]

Image 22

COUNTRY

Model RCG Raw materials for the production of gelatine / collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.2.3. have been obtained in an establishment around which, within a radius of 10 km, there has been no case/outbreak of the following diseases for which the animals are susceptible: foot and mouth disease, rinderpest, Newcastle disease or highly pathogenic avian influenza, classical or African swine fever during the prior 30 days or, in the event of a case of one of those diseases, the preparation of raw materials for exportation to the European Union has been authorised only after the removal of all meat and the total cleaning and disinfection of the establishment under the control of an official veterinarian; and:

II.2.4. have been obtained and prepared without contact with other materials not complying with the conditions required above, and it has been handled so as to avoid contamination with pathogenic agents; and

II.2.5. have been transported in clean and sealed containers or lorries.]

Notes

Part I:

— Box reference I.8: Provide the code of territory as appearing in Annex II to Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted (OJ L 320, 18.11.2006, p. 53) and/or Part 1 of Annex I to Regulation (EC) 798/2008 and/or in Part 1 of Annex I to Regulation (EC) No 119/2009 and/or Part 1 of Annex II to Regulation (EU) No 206/2010.

— Box reference I.11: Place of origin: name and address of the dispatch establishment; registration or approval number as appropriate.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 02.08, 03.05, 05.05, 05.06, 05.11.91, 05.11.99, 41.01, 41.02, 41.03.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

— Box reference I.28: Nature of commodity: hides, skins, bones, tendons and sinews;

Approval number of establishments: registration or approval number as appropriate;

Manufacturing plant: includes slaughterhouse, factory vessel, cutting plant, game handling establishment and processing plant.

Part II:

(1) Delete as appropriate. In case of products derived from fishery products, the whole section II.2 should be deleted.

(2) The name and ISO code number of the exporting country or territory or zone as laid down in:

— the Annexes to Decision 2006/766/EC;

— Annex I to Regulation (EC) 798/2008;

Image 23

COUNTRY

Model RCG Raw materials for the production of gelatine / collagen intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

— Part 1 of Annex II to Regulation (EC) No 119/2009;

— Part 1 of Annex II to Regulation (EU) No 206/2010.

(3) If parts of the materials were derived from animals originating from an(other) third country(ies) listed in Annex II to Regulation (EU) No 206/2010 for import of that commodity into the Union, then the code(s) of country(ies) or territory(ies) and of the third country slaughtering the animals shall be indicated (the material cannot come from a country or territory that has supplementary guarantees A or F as indicated in column 5 of that Annex).

(4) If the materials were derived from slaughter poultry originating from an(other) third country(ies) listed in Part 1 of Annex I to Regulation (EC) No 798/2008 for imports of that commodity into the Union, then the code(s) of country(ies) or territory(ies) and of the third country slaughtering the poultry shall be indicated.

(5) Only for countries from where game meat intended for human consumption of the same animal species is authorised for importation into the European Union.

— The signature and the stamp must be in a different colour to that of the printing.

NB Note for the person responsible for the consignment in the EU: this certificate is only for veterinary purposes and has to accompany the consignment until it reaches the border inspection post. The consignment must be transported directly to the manufacturing plant of destination.

Official veterinarian

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART VI

MODEL CERTIFICATE FOR IMPORTS OF TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION

Image 24

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 25

I.25. Commodities certified for:

Production of gelatine / collagen for human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Nature of commodity

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 26

COUNTRY

Model TCG Treated raw materials for the production of gelatine and collagen

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, certify that the treated raw materials described above comply with the following requirements:

— they have been derived from establishments under the control of and listed by the competent authority

and,

— (1) [bones, hides and skins of domestic and farmed ruminant animals, pigs and poultry described above are derived from animals which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection,]

(1) and/or

— [wild game hides, skins and bones described above are derived from killed animals whose carcasses have been found fit for human consumption following post-mortem inspection,]

(1) and/or

— [fish skins and bones described above are derived from plants manufacturing fishery products for human consumption authorised for export,]

and

(1) either [they are dried bones of species from bovine, ovine, caprine, porcine and equine animals, including farmed and wild animals, poultry including ratites and feathered game for the production of collagen or gelatine, they derived from healthy animals slaughtered in a slaughterhouse, and they have been treated as follows:

(1) either [crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70 °C for at least 30 minutes, minimum 80 °C for at least 15 minutes, or minimum 90 °C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350 °C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700 °C.]

(1) or [sun-dried for a minimum of 42 days at an average temperature of at least 20 °C.]

(1) or [acid treatment such that the pH is maintained at less than 6 to the core for at least one hour before drying.]]

(1) or [they are hides and skins of farmed ruminant animals, pig skins, poultry skins or wild game hides and skins, they derived from healthy animals and they:

(1) either [have undergone an alkali treatment which ensures a PH>12 to the core followed by salting for at least 7 days]

(1) or [were dried for at least 42 days at a temperature of at least 20 °C.]

(1) or [have undergone an acid treatment that provides at least a pH of less than 5 to the core for a minimum of one hour.]

(1) or [have undergone an alkali treatment which ensures a pH > 12 to the core for at least 8 hours.]]

(1) or [they are bones, hides or skins of farmed ruminant animals, pig skins, poultry skins, fish skins and wild game hides and skins from third countries, parts of third countries and territories referred to in Part IV of Annex I to this Regulation that have undergone any other treatment than those listed above, and that come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with Regulation (EC) No 853/2004

and

(1) [if from ruminant origin, except for hides and skins of ruminants,

Part II: Certification

Image 27

COUNTRY

Model TCG Treated raw materials for the production of gelatine and collagen

II. Health information

II.a. Certificate reference No

II.b.

(1) either:

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1) as a country or region posing a negligible BSE risk;

— the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

— if in the country or region there have been BSE indigenous cases:

(i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii) the treated raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;]

(1) or:

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

— the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

— animals from which the treated raw materials of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the treated raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;]

(1) or

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

— the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

— the treated raw materials of bovine, ovine and caprine animal origin intended for export are derived both from animals which were born, continuously reared and slaughtered in a country or region with negligible BSE risk in accordance with Article 5(2) of Regulation (EC) No 999/2001, and, if there have been BSE indigenous cases in the country or region, born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced, and from animals born in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk, and which have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

Image 28

COUNTRY

Model TCG Treated raw materials for the production of gelatine and collagen

II. Health information

II.a. Certificate reference No

II.b.

— the treated raw materials of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]

(1) or

— [they come from a country or a region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region with an undetermined BSE risk;

— the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

— the animals from which the treated raw materials of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

— the treated raw materials of bovine, ovine and caprine animal origin are not derived from:

(i) specified risk material as defined in Annex V to Regulation (EC) No 999/2001;

(ii) nervous and lymphatic tissues exposed during the de-boning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals.]]]

(1) [II.2. Animal Health Attestation

I, the undersigned official veterinarian, certify that the treated raw materials described above:

II.2.1. consist of animal products that satisfy the animal health requirements below;

II.2.2. have been obtained in the territory(ies) of: (1) [ ] (1) or [ ] (2) (3)

II.2.3. have been obtained and prepared without contact with other materials not complying with the conditions required above, and have been handled so as to avoid contamination with pathogenic agents;

II.2.4. have been transported in clean and sealed containers or lorries.]

Notes

Part I:

— Box reference I.8: Provide the code of territory as appearing in Annex II to Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted (OJ L 320, 18.11.2006, p. 53) or in Part 1 of Annex I to Commission Regulation (EC) 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1) or in Part 1 of Annex I to Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12) or in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).

— Box reference I.11: Place of origin: name and address of the dispatch establishment and approval number or competent authority identification number as appropriate.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

Image 29

COUNTRY

Model TCG Treated raw materials for the production of gelatine and collagen

II. Health information

II.a. Certificate reference No

II.b.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 03.05, 05.05, 05.06, 05.11.91, 05.11.99, 41.01, 41.02, 41.03.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

— Box reference I.28: Nature of commodity: hides, skins, bones, tendons and sinews;

Approval number of establishments: approval number or competent authority identification number as appropriate;

Manufacturing plant: includes slaughterhouse, factory vessel, cutting plant, game handling establishment and processing plant;

Approval number: when applicable.

Part II:

(1) Delete as appropriate. In case of products derived from fishery products, the whole section II.2 should be deleted.

(2) The name and ISO code number of the exporting country or territory or zone as laid down in:

— Part 1 of Annex II to Regulation (EU) No 206/2010;

— Annex I to Regulation (EC) 798/2008;

— Part 1 of Annex II to Regulation (EC) No 119/2009.

(3) If parts of the materials were derived from animals originating from an(other) third country(ies) listed in Annex I to Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (OJ L 126, 14.5.2016, p. 13), the code(s) of country(ies) or territory(ies) shall be indicated.

— The signature and the stamp must be in a different colour to that of the printing.

NB Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and has to accompany the consignment until it reaches the border inspection post. The consignment must be transported directly to the manufacturing plant of destination.

— The time of transportation may be included in the duration of treatment.

Official veterinarian

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART VII

MODEL CERTIFICATE FOR IMPORTS OF HONEY, ROYAL JELLY AND OTHER APICULTURE PRODUCTS INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF HONEY, ROYAL JELLY AND OTHER APICULTURE PRODUCTS INTENDED FOR HUMAN CONSUMPTION

Image 30

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 31

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Treatment type

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 32

COUNTRY

Model HON Honey, royal jelly and other apiculture products

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that honey, royal jelly and other apiculture products described above were produced in accordance with those requirements, in particular that they:

— come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004;

— have been handled and, where appropriate, prepared, packaged and stored in a hygienic manner in accordance with the requirements of Annex II to Regulation (EC) No 852/2004;

and

— the guarantees covering live animals and products thereof provided by the residue plans submitted in accordance with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10), and in particular Article 29 thereof, are fulfilled.

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment. Approval number means registration number.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the following headings: 04.09, 04.10.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

— Box reference I.28: Treatment type: Indicate 'ultrasonication', 'homogenisation', ultrafiltration', 'pasteurisation', 'no thermal treatment'.

Approval number of establishments: approval number or competent authority identification number as appropriate

Part II:

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Part II: Certification

Official inspector

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

PART VIII

MODEL CERTIFICATE FOR IMPORTS OF HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS INTENDED FOR HUMAN CONSUMPTION

MODEL CERTIFICATE FOR IMPORTS OF HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS INTENDED FOR HUMAN CONSUMPTION

Image 33

COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6.

I.7. Country of origin

ISO code

I.8.

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 34

I.25. Commodities certified for:

Human consumption

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Date production

(dd/mm/yyyy)

Approval number of establishments

Manufacturing plant

Number of packages

Net weight

Image 35

COUNTRY

Model HRP Highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.1. Public Health Attestation

I, the undersigned, declare that I am aware of the relevant provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1), 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) and 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) and certify that the highly refined products described above were produced in accordance with those requirements, in particular:

— that they come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004;

— that they have been handled and, where appropriate, prepared, packaged and stored in a hygienic manner in accordance with the requirements of Annex II to Regulation (EC) No 852/2004;

— that they comply with the requirements of Section XVI of Annex III to Regulation (EC) No 853/2004;

and

— (1) [if amino acids, that

(i) human hair was not used as a source for their manufacture; and

(ii) they comply with Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ((OJ L 354, 31.12.2008, p. 16)]

Notes

Part I:

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship). Separate information is to be provided in case of unloading and reloading.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the heading of 21.06.90, 29.22, 29.30, 29.32, 35.07, 35.03 or 39.13.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: Identification of container/Seal number: only where applicable.

Part II:

(1) Delete as appropriate.

— The colour of the stamp and signature must be different from that of the other particulars in the certificate.

Part II: Certification

Official veterinarian Name (in capital letters):

Qualification and title:

Date: Signature:

Stamp:

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(1)  Unless covered by Part VI.

1

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ANNEX III

MODEL CERTIFICATE FOR THE TRANSIT THROUGH THE UNION, IMMEDIATE TRANSIT OR AFTER STORAGE, FOR RAW MATERIALS OR TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN FOR HUMAN CONSUMPTION

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COUNTRY:

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postcode

Tel.

I.6. Person responsible for the consignment in EU

Name

Address

Postcode

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name

Address

I.12. Place of destination

Customs warehouse Ship supplier

Name Approval number

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentation references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21. Temperature of product

Ambient Chilled Frozen

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

Image 37

I.25. Commodities certified for:

Production of gelatine / collagen for human consumption

I.26. For transit through EU to third country

Third country ISO code

I.27.

I.28. Identification of the commodities

Species

(scientific name)

Manufacturing plant

Number of packages

Net weight

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COUNTRY

Model TRANSIT/STORAGE

II. Health information

II.a. Certificate reference number

II.b.

II.1. Public Health Attestation

I, the undersigned official veterinarian, hereby certify, that the raw materials or treated raw materials described in Part I:

II.1.1. come from a country or region authorised for imports into the EU as laid down in Part 1 of Annex I to Commission Regulation (EC) 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1) or in Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12) or in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1), and

II.1.2. comply with the relevant animal health conditions as laid down in the animal health attestation in the model certificate in Part V or VI of Annex II to Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (OJ L 126, 14.5.2016, p. 13).

Notes

This certificate is meant for transit and storage in accordance with Article 12(4) or Article 13 of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9) of raw materials or treated raw materials for the production of gelatine/collagen for human consumption of:

(1) domestic bovine animals (including Bubalus and Bison species and their cross-breeds);

(2) domestic ovine animals (Ovis aries) or domestic caprine animals (Capra hircus);

(3) domestic porcine animals (Sus scrofa);

(4) domestic solipeds (Equus caballus, Equus asinus and their cross-breeds);

(5) farmed non-domestic animals of the order Artiodactyla (excluding bovine animals (including Bison and Bubalus species and their cross-breeds), Ovis aries, Capra hircus, Suidae and Tayassuidae), and of the families Rhinocerotidae and Elephantidae;

(6) wild non-domestic animals of the order Artiodactyla (excluding bovine animals (including Bison and Bubalus species and their cross-breeds), Ovis aries, Capra hircus, Suidae and Tayassuidae), and of the families Rhinocerotidae and Elephantidae;

(7) farmed non-domestic animals belonging to the Suidae, Tayassuidae, or Tapiridae families;

(8) wild non-domestic animals belonging to the Suidae, Tayassuidae, or Tapiridae families;

(9) wild solipeds belonging to the subgenus Hippotigris (zebra);

(10) wild leporidae (rabbits and hares);

(11) wild land mammals other than ungulates and leporidae;

(12) farmed rabbits;

(13) poultry;

(14) farmed ratites;

(15) wild game;

(16) fish.

Part II: Certification

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COUNTRY

Model TRANSIT/STORAGE

II. Health information

II.a. Certificate reference number

II.b.

Part I:

— Box reference I.8: Provide the code of territory as appearing in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Part 1 of Annex I to Regulation (EC) No 119/2009 or Part 1 of Annex I to Regulation (EC) No 798/2008 or Annex II to Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted (OJ L 320, 18.11.2006, p. 53).

— Box reference I.11: Place of origin: name and address of the dispatch establishment.

— Box reference I.12: Address (and approval number if known) of the warehouse in a free zone, free warehouse, customs warehouse or ship chandler shall be included.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the EU.

— Box reference I.19: Use the appropriate Harmonised System (HS) code under the heading of 02.08, 03.05, 05.04, 05.05, 05.06, 05.11.91, 05.11.99, 41.01, 41.02, 41.03.

— Box reference I.20: Indicate total gross weight and total net weight.

— Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included.

— Box reference I.28: Manufacturing plant: provide the registration number, approval number or competent authority identification number of establishment as appropriate. It includes slaughterhouse, factory vessel, cutting plant, game handling establishment and processing plant.

Official veterinarian or Official inspector

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

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ANNEX IV

EXPLANATORY NOTES FOR COMPLETING THE CERTIFICATES

(referred to in Articles 2(1) and 4(1))

| (a) | Certificates shall be issued by the exporting third country, based on the models set out in Annexes II and III according to the layout of the model that corresponds to the products of animal origin concerned.
  They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country or part thereof.
  If the Member State of destination imposes, for the products of animal origin concerned, additional certification requirements, attestations to certify that those requirements are fulfilled shall also be incorporated in the original form of the certificate. |
| --- | --- |

(a)

Certificates shall be issued by the exporting third country, based on the models set out in Annexes II and III according to the layout of the model that corresponds to the products of animal origin concerned.

They shall contain, in the numbered order that appears in the model, the attestations that are required for any third country and, as the case may be, those supplementary guarantees that are required for the exporting third country or part thereof.

If the Member State of destination imposes, for the products of animal origin concerned, additional certification requirements, attestations to certify that those requirements are fulfilled shall also be incorporated in the original form of the certificate.

| (b) | Where the model certificate states that certain statements shall be kept as appropriate, statements which are not relevant, may be crossed out nd initialled and stamped by the certifying officer, or completely deleted from the certificate. |
| --- | --- |

(b)

Where the model certificate states that certain statements shall be kept as appropriate, statements which are not relevant, may be crossed out nd initialled and stamped by the certifying officer, or completely deleted from the certificate.

| (c) | A separate and unique certificate must be provided for the products of animal origin that are exported from a territory or territories or zone or zones of the same exporting country listed or referred to in Annex I which are consigned to the same destination and transported in the same railway wagon, lorry, aircraft or ship. |
| --- | --- |

(c)

A separate and unique certificate must be provided for the products of animal origin that are exported from a territory or territories or zone or zones of the same exporting country listed or referred to in Annex I which are consigned to the same destination and transported in the same railway wagon, lorry, aircraft or ship.

| (d) | The original of each certificate shall consist of a single sheet of paper, or, where more text is required it must be in such a form that all sheets of paper required are part of an integrated whole and indivisible. |
| --- | --- |

(d)

The original of each certificate shall consist of a single sheet of paper, or, where more text is required it must be in such a form that all sheets of paper required are part of an integrated whole and indivisible.

| (e) | The certificate shall be drawn up in at least one of the official languages of the Member State of the border inspection post of entry of the consignment into the EU and of the Member State of destination. However, those Member States may authorise the certificate to be drawn up in the official language of another Member State, and accompanied, if necessary, by an official translation. |
| --- | --- |

(e)

The certificate shall be drawn up in at least one of the official languages of the Member State of the border inspection post of entry of the consignment into the EU and of the Member State of destination. However, those Member States may authorise the certificate to be drawn up in the official language of another Member State, and accompanied, if necessary, by an official translation.

| (f) | If for reasons of identification of the items of the consignment (schedule in point I.28 of the model certificate), additional sheets of paper are attached to the certificate, those sheets of paper shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying officer, on each of the pages. |
| --- | --- |

(f)

If for reasons of identification of the items of the consignment (schedule in point I.28 of the model certificate), additional sheets of paper are attached to the certificate, those sheets of paper shall also be considered as forming part of the original of the certificate by the application of the signature and stamp of the certifying officer, on each of the pages.

| (g) | When the certificate, including additional sheets of paper referred to in (f), comprises more than one page, each page shall be numbered, (page number) of (total number of pages), at the end of the page and shall bear the certificate reference number that has been designated by the competent authority at the top of the pages. |
| --- | --- |

(g)

When the certificate, including additional sheets of paper referred to in (f), comprises more than one page, each page shall be numbered, (page number) of (total number of pages), at the end of the page and shall bear the certificate reference number that has been designated by the competent authority at the top of the pages.

| (h) | The original of the certificate must be completed and signed by an official veterinarian or by another designated official inspector where this is provided for in the model certificate. The competent authorities of the exporting third country shall ensure that rules of certification equivalent to those laid down in Council Directive 96/93/EC (1) are followed.
  The colour of the signature shall be different from that of the printing. This requirement also applies to stamps other than those embossed or watermarked. |
| --- | --- |

(h)

The original of the certificate must be completed and signed by an official veterinarian or by another designated official inspector where this is provided for in the model certificate. The competent authorities of the exporting third country shall ensure that rules of certification equivalent to those laid down in Council Directive 96/93/EC (1) are followed.

The colour of the signature shall be different from that of the printing. This requirement also applies to stamps other than those embossed or watermarked.

| (i) | The certificate reference number referred to in boxes I.2 and II.a. must be issued by the competent authority. |
| --- | --- |

(i)

The certificate reference number referred to in boxes I.2 and II.a. must be issued by the competent authority.

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(1)  Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products (OJ L 13, 16.1.1997, p. 28).

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