2010R0595 — EN — 01.09.2010 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption

Amended by:

▼B

COMMISSION REGULATION (EU) No 595/2010

of 2 July 2010

amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption

(Text with EEA relevance)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

A transitional period should be provided for after the date of entry into force of this Regulation, in order to provide the necessary time for stakeholders to comply with the new rules and to allow for the continued importation into the Union of animal by-products, as provided for Regulation (EC) No 1774/2002, before the amendments introduced by this Regulation.

Annex XI to Regulation (EC) No 1774/2002 sets out lists of third countries from which Member States may authorise imports of certain animal by-products not intended for human consumption with reference to Council Decision 79/542/EEC ( 6 ), Commission Decision 97/296/EC ( 7 ), Commission Decision 94/85/EEC ( 8 ), Commission Decision 94/984/EC ( 9 ), Commission Decision 2000/585/EC ( 10 ), Commission Decision 2000/609/EC ( 11 ), Commission Decision 2004/211/EC ( 12 ), Commission Decision 2004/438/EC ( 13 ) and Commission Decision 2006/696/EC ( 14 ). These legal acts have been considerably amended or replaced. Annex XI should be amended to take account of amendments made to those Union acts.

Annex X to Regulation (EC) No 1774/2002, as amended by Commission Regulation (EC) No 437/2008' ( 5 ), sets out a single model health certificate for milk and milk products not intended for human consumption originating in third countries for dispatch to or for transit through the Union. Chapter V of Annex VII to Regulation (EC) No 1774/2002 lays down specific requirements for the placing on the market and importation of milk, milk products and colostrum. Point 3 of Section A and point 1.5 of Section B of that Chapter lay down the requirements for whey that is to be fed to animals of species susceptible to foot-and-mouth disease. The model health certificate for the importation of milk and milk products not intended for human consumption is set out Chapter 2 of Annex X to Regulation (EC) No 1774/2002. The requirements for whey set out in that model certificate are stricter than the corresponding requirements for whey in intra-Union trade set out in Chapter V of Annex VII to that Regulation. Accordingly, that model certificate should be amended so that the requirements for the importation of whey are not less favourable than those applicable to the production and marketing of whey in intra-Union trade. The model health certificate in Chapter 2 of Annex X to Regulation (EC) No 1774/2002 should therefore be amended.

Accordingly, a new Chapter XV should be added to Annex VIII to Regulation (EC) No 1774/2002 which specifies the health conditions for the placing on the market, including the importation, of horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, which are intended for the production of organic fertilisers or soil improvers.

In the case of horns, appropriate measures should be taken to prevent the transmission of transmissible spongiform encephalopathy (TSE) when the horns are removed from the skull. The Scientific Steering Committee issued an opinion on TSE infectivity distribution in ruminant tissues ( 4 ). According to that opinion, horns must be removed without opening the cranial cavity, to prevent cross-contamination with TSE agents.

Economic operators have indicated their interest in the use of such animal by-products for the production of organic fertilizers or soil improvers. However, the placing on the market, including the importation of such animal by-products should only be allowed if they originate from animals which are fit for slaughter for human consumption or which did not show clinical signs of any communicable disease and if a treatment has been applied to them which mitigates potential health risks.

Chapter X of Annex VIII to Regulation (EC) No 1774/2002 sets out requirements for the importation of horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material, organic fertilizers or soil improvers.

Chapter V of Annex VIII to Regulation (EC) No 1774/2002 currently sets out harmonised requirements for the placing on the market and importation of serum of equidae. However, certain Member States, trading partners and economic operators have indicated their interest in the use of blood and a wider range of blood products from equidae, both of Union and of third country origin, for technical purposes in the Union. In order to facilitate the use of such blood and of such blood products, it is necessary to lay down animal health requirements for their use for technical purposes. Such requirements should mitigate the potential risks of transmission of certain compulsorily notifiable diseases listed in Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae ( 2 ), on the basis of available scientific evidence. In particular, blood should come from slaughterhouses that have been approved in accordance with 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 ( 3 ) or from facilities approved and supervised by the competent authority of the third country for the purpose of blood collection, such as holdings where animals are kept under special health conditions.

Regulation (EC) No 1774/2002 lays down animal and public health rules concerning animal by-products not intended for human consumption. It provides that processed animal protein and other processed products that could be used as feed material are to be placed on the market only if they have been processed in accordance with Annex VII to that Regulation. In addition, Regulation (EC) No 1774/2002 provides that petfood, dogchews and technical products and those animal by-products referred to in Annex VIII are to be placed on the market only if they meet the specific requirements set out in that Annex.

Having regard to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption ( 1 ), and in particular the first and second subparagraph of Article 32(1) thereof,

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

Article 1

Annexes VIII, X and XI to Regulation (EC) No 1774/2002 are amended in accordance with the Annex to this Regulation.

▼M1

Article 2

For a transitional period until 4 March 2011, Member States shall accept consignments of milk and milk products, serum from equidae and treated blood products, excluding those of equidae, for the manufacture of technical products, which are accompanied by a health certificate completed and signed in accordance with the appropriate model certificates, as set out in Chapter 2, Chapter 4(A) and Chapter 4(D) of Annex X to Regulation (EC) No 1774/2002 before the date of entry into force of this Regulation.

Until 30 April 2011, Member States shall accept such consignments if the accompanying health certificates were completed and signed before 5 March 2011.

▼B

Article 3

This Regulation shall enter into force and apply on the twentieth day following that of its publication in the Official Journal of the European Union.

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

ANNEX

Annexes VIII, X and XI to Regulation (EC) No 1774/2002 are amended as follows:

4. are conveyed following the veterinary checks in the border inspection post at the point of entry into the Union provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, directly to an approved technical plant or an approved storage plant.’

3. are accompanied by a health certificate that conforms to the model set out in Chapter 18 of Annex X, duly completed and signed by the official veterinarian;

2. have been produced in accordance with point A of this Chapter;

1. come from a third country appearing on the list referred to in Part XVIII of Annex XI;

Member States shall authorise the importation of horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilizers or soil improvers provided that they:

(c) be marked with the name and address of the approved technical or storage plant of destination.

(b) be clearly labelled “NOT FOR HUMAN AND ANIMAL CONSUMPTION”;

(a) indicate the type of product (horns, horn products, hooves or hoof products);

5. they shall be packed either in new packaging or containers; or transported in vehicles or bulk containers which have been disinfected prior to loading using a product approved by the competent authority;

4. at any stage of processing, storage or transport, every precaution shall have been taken to avoid cross-contamination;

3. the horns must have been removed without opening the cranial cavity;

2. they must have undergone a heat treatment for one hour at a core temperature of at least 80° C;

(b) did not show clinical signs of any disease communicable through that product to humans or animals.

(a) either have been slaughtered in a slaughterhouse, after undergoing an ante-mortem inspection, and were found fit, as a result of such inspection, for slaughter for human consumption in accordance with Union legislation; or

1. they must originate from animals that:

The placing on the market of horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilizers or soil improvers shall be subject to the following conditions:

Requirements for horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilizers or soil improvers

5. Blood and blood products shall be packed and labelled in accordance with paragraph 3(a) of Section A and shall be accompanied by a health certificate that conforms to the model set out in Chapter 4(A) of Annex X, duly completed and signed by the official veterinarian.’

(b) Part XIII(B) where they have been treated in accordance with paragraph 2(b)(ii) of Section A.

(a) Part XIII(A) where blood has been collected in accordance with paragraph 1 of Section A or where blood products have been produced in accordance with paragraph 2(b)(i) of Section A; or

4. Blood and blood products must come from a third country that appears on the list referred to in the following Parts of Annex XI:

3. Blood products must come from a technical plant approved by the competent authority of the third country meeting the specific conditions laid down in Article 18 of Regulation (EC) No 1774/2002.

(ii) for a period of six months where the animals have shown no clinical signs of glanders (Burkholderia mallei) during the post-mortem inspection in the slaughterhouse referred to in paragraph 1(a), including a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum;

(i) for a period of three years; or

(b) Venezuelan equine encephalomyelitis for a period of at least two years;

In addition, the blood products referred to in paragraph 2(b)(i) of Section A must have been produced from blood collected from equidae which have been kept for a period of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the third country of collection which during that period and the period of blood collection has been free of:

2. The blood products must comply with the conditions set out in paragraph 2 of Section A.

(b) facilities approved, furnished with a veterinary approval number and supervised by the competent authority of the third country for the purpose of collecting blood from equidae for the production of blood products for technical purposes.

(ii) approved and supervised by the competent authority of the third country; or

(i) approved in accordance with Regulation (EC) No 853/2004; or

1. The blood must comply with the conditions set out in paragraph 1(a) of Section A and must be collected under veterinary supervision either in:

Member States shall authorise imports of blood and blood products from equidae for technical purposes subject to the following conditions:

(b) bear the approval number of the establishment of collection referred to in paragraph 1(b).

(a) are clearly labelled “BLOOD AND BLOOD PRODUCTS FROM EQUIDAE, NOT FOR HUMAN OR ANIMAL CONSUMPTION”;

3. Blood and blood products from equidae must be packed in sealed impermeable containers which:

— heat treatment of at least 80 °C throughout their substance.

— change in pH to pH 5 for two hours;

— heat treatment at a temperature of 65 °C for at least three hours;

(ii) has been subjected to at least one of the following treatments, followed by an effectiveness check, for the inactivation of possible causative pathogens for African horse sickness, equine encephalomyelitis of all types including Venezuelan equine encephalomyelitis, equine infectious anaemia, vesicular stomatitis and glanders (Burkholderia mallei):

(i) either fulfils the conditions set out in paragraph 1(a); or

(b) the blood products have been produced from blood which:

(a) all precautions have been taken to avoid contamination of the blood products with pathogenic agents during production, handling and packaging;

2. Blood products may be placed on the market provided that:

(ii) in facilities approved, furnished with a veterinary approval number and supervised by the competent authority for the purpose of collecting blood from equidae for the production of blood products for technical purposes.

(i) in slaughterhouses approved in accordance with Regulation (EC) No 853/2004; or

(b) it has been collected under veterinary supervision either:

(iii) for the periods laid down in Article 4(5) of Directive 90/426/EEC had no contact with equidae from holdings which were subject to a prohibition order for animal health reasons pursuant to that Article and for at least 40 days prior to the date of and during blood collection had no contact with equidae from a Member State or third country not considered free of African horse sickness in accordance with Article 5(2)(a) of that Directive;

(ii) have been kept for at least 30 days prior to the date of and during blood collection on holdings under veterinary supervision which were not subject to a prohibition order pursuant to Article 4(5) of Directive 90/426/EEC or restrictions pursuant to Article 5 thereof;

(i) at inspection on the date of blood collection do not show clinical signs of any of the compulsorily notifiable diseases listed in Annex A to Directive 90/426/EEC and of Equine influenza, Equine piroplasmosis, Equine rhinopneumonitis and Equine viral arteritis listed in point 4 of Article 1.2.3. of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE), 2009 Edition;

(a) it has been collected from equidae which:

1. Blood may be placed on the market provided that:

The placing on the market for technical purposes of blood and blood products from equidae shall be subject to the following conditions:

Requirements for blood and blood products from equidae for technical purposes

(a) Chapter V is replaced by the following:

For horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilizers or soil improvers intended for dispatch to or for transit through (2) the European Union

For treated blood products, excluding those of equidae, for the manufacture of technical products, intended for dispatch to or for transit through (2) the European Union

(c) Chapter 4(D) is replaced by the following:

For the import of blood and blood products from equidae for technical purposes, intended for dispatch to or for transit through (2) the European Union

(b) Chapter 4(A) is replaced by the following:

For milk and milk products not intended for human consumption for dispatch to or for transit through (2) the European Union

(a) Chapter 2 is replaced by the following:

(3) Annex XI is replaced by the following:









‘ANNEX XI

Lists of third countries from which Member States may authorise imports of animal by-products not intended for human consumption

The inclusion of a third country on one of the following lists is a necessary, but not sufficient, condition for the importation of the relevant products from that third country. Imports must also fulfil the relevant animal health and public health requirements. The following descriptions refer to the territories or parts thereof from which imports of certain animal by-products are permitted, as stated in the relevant animal health certificate or declaration laid down in Annex X.

PART I

List of third countries from which Member States may authorise imports of milk and milk products (health certificate, Chapter 2)

Authorised third countries listed in Annex I to Decision 2004/438/EC ( 15 ).

PART II

List of third countries from which Member States may authorise imports of processed animal proteins (excluding fishmeal) (health certificate, Chapter 1)

Third countries listed in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 ( 16 ).

PART III

List of third countries from which Member States may authorise imports of fishmeal and fish oil (health certificate, Chapters 1 and 9)

Third countries listed in Annex II to Commission Decision 2006/766/EC ( 17 ).

PART IV

List of third countries from which Member States may authorise imports of rendered fats (excluding fish oil) (health certificate, Chapters 10(A) and 10(B))

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010.

PART V

List of third countries from which Member States may authorise imports of blood products for feed material (health certificate, Chapter 4(B))

A. Blood products from ungulates

Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which imports of all categories of fresh meat of the respective species are authorised.

B. Blood products from other species

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010.

PART VI

List of third countries from which Member States may authorise imports of animal by-products and blood products (with the exception of those of equidae) intended for technical purposes including pharmaceuticals (health certificate, Chapters 4(C) and 8)

A. Blood products: 1. Untreated blood products of ungulates: Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of fresh meat of any domestic ungulate species is authorised and only for the period indicated in columns 7 and 8 of that Part, — (JP) Japan. 2. Untreated blood products of poultry and other avian species: Third countries or parts of third countries listed in Part 1 of Annex I to Commission Regulation (EC) No 798/2008 ( 18 ), — (JP) Japan. 3. Untreated blood products of other animals: Third countries listed either in Part 1 of Annex II to Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Commission Regulation (EC) No 119/2009 ( 19 ), — (JP) Japan. 4. Treated blood products of any species: Third countries listed in Part 1 to Annex II of Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009, — (JP) Japan.

B. Animal by-products for pharmaceutical use: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009 and the following third countries: — (JP) Japan, — (PH) Philippines, — (TW) Taiwan.

C. Animal by-products for technical purposes other than pharmaceutical uses: third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 from which imports of that category of fresh meat of the respective species is authorised, in Part 1 of Annex I to Regulation (EC) No 798/2008, or in Part 1 of Annex I to Regulation (EC) No 119/2009.

PART VII(A)

List of third countries from which Member States may authorise imports of animal by-products for the manufacture of petfood (health certificate, Chapter 3(F))

A. Animal by-products from equidae and animals of the bovine, ovine, caprine, and porcine species, including farmed and wild animals: Third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which imports of fresh meat for human consumption of those species of animals is authorised.

B. Raw material from poultry including ratites and wild game-birds: Third countries or parts of third countries from which Member States authorise imports of fresh poultrymeat, which are listed in Part 1 of Annex I to Regulation (EC) No 798/2008.

C. Raw material from fish: Third countries listed in Annex II to Decision 2006/766/EC.

D. Raw material from other wild land mammals and Leporidae. Third countries listed 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, from which Member States authorise imports of fresh meat from the same species.

PART VII(B)

List of third countries from which Member States may authorise imports of raw petfood intended for dispatch to the European Union for direct sale or animal by-products to be fed to farmed fur animals (health certificate, Chapter 3(D))

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh meat from the same species and where only bone in meat is authorised.

In the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC.

PART VII(C)

List of third countries from which Member States may authorise imports of flavouring innards for use in the manufacture of petfood, intended for dispatch to the European Union (health certificate, Chapter 3(E))

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh meat from the same species and where only bone in meat is authorised.

In the case of flavouring innards from fish materials, third countries listed in Annex II to Decision 2006/766/EC.

PART VIII

List of third countries from which Member States may authorise imports of pig bristles (health certificate, Chapter 7(A) and 7(B))

A. For untreated pig bristles, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, which are free of African swine fever for the 12 months prior to the date of importation.

B. For treated pig bristles, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, which may not be free of African swine fever for the 12 months prior to the date of importation.

PART IX

List of third countries from which Member States may authorise imports of processed manure and processed manure products for the treatment of soil (health certificate, Chapter 17)

For processed manure and processed manure products, third countries listed in:

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

(b) Annex I to Commission Decision 2004/211/EC ( 20 ); or

(c) Part 1 of Annex I to Regulation (EC) No 798/2008.

PART X

List of third countries from which Member States may authorise imports of petfood and dogchews (health certificate, Chapters 3(A), 3(B) and 3(C))

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

— (JP) Japan

— (EC) Ecuador ( 21 )

— (LK) Sri Lanka ( 22 )

— (TW) Taiwan ( 23 )

PART XI

List of third countries from which Member States may authorise imports of gelatine, hydrolysed protein, collagen, dicalcium phosphate and tricalcium phosphate (health certificate, Chapters 11 and 12)

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

— (KR) South Korea ( 24 )

PART XII

List of third countries from which Member States may authorise imports of apiculture products (health certificate, Chapter 13)

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010.

PART XIII

List of third countries from which Member States may authorise imports of blood and blood products of equidae (health certificate, Chapter 4(A))

A. Untreated blood and blood products: Third countries or parts of third countries listed in Annex I to Decision 2004/211/EC, from which the importation of equidae for breeding and production is allowed.

B. Treated blood products: third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat of domestic equidae.

PART XIV

List of third countries from which Member States may authorise imports of hides and skins of ungulates (health certificate, Chapters 5(A), 5(B) and 5(C))

A. For fresh or chilled hides and skins of ungulates, third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat from the same species.

B. For treated hides and skins of ungulates, third countries or parts of third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010.

C. For treated hides and skins of ruminants that are intended for dispatch to the Union and which have been kept separate for a period of 21 days or which are to undergo transport for a period of 21 uninterrupted days before importation, any third country.

PART XV

List of third countries from which Member States may authorise imports of game trophies (health certificate, Chapters 6(A) and 6(B))

A. For treated game trophies of birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth, hides or skins, any third country.

B. For game trophies of birds consisting of entire parts not having been treated, third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh poultry meat, and the following countries: — (GL) Greenland — (TN) Tunisia.

C. For game trophies of ungulates consisting of entire parts not having been treated, third countries listed in the appropriate columns for fresh meat of ungulates in Part 1 of Annex II to Regulation (EU) No 206/2010, including any restrictions laid down in the column for special remarks for fresh meat.

PART XVI

List of third countries from which Member States may authorise imports of egg products not intended for human consumption that could be used as feed material (health certificate, Chapter 15)

Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and third countries or parts of third countries from which Member States authorise imports of fresh poultry meat, which are listed in Part 1 of Annex I to Regulation (EC) No 798/2008.

PART XVII

List of third countries from which Member States may authorise imports of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material, organic fertilisers or soil improvers (declaration, Chapter 16)

Any third country.

PART XVIII

List of third countries from which Member States may authorise imports of horns and horn products (excluding horn meal) and hooves and hoof products, (excluding hoof meal) intended for the production of organic fertilizers or soil improvers (health certificate, Chapter 18)

Any third country.