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)
Modified by
- Regulation (EC) No 1069/2009 of the European Parliament and of the Councilof 21 October 2009laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation), 32009R1069, November 14, 2009
- Commission Regulation (EU) No 35/2011of 18 January 2011amending Regulation (EU) No 595/2010 as regards an extension of the transitional period for the use of certain health certificates for milk and milk products, serum from equidae and treated blood products, excluding those of equidae, for the manufacture of technical products(Text with EEA relevance), 32011R0035, January 19, 2011
(1) Annex VIII is amended as follows: (a) Chapter V is replaced by the following: "CHAPTER V Requirements for blood and blood products from equidae for technical purposes A. Placing on the market The placing on the market for technical purposes of blood and blood products from equidae shall be subject to the following conditions: 1. Blood may be placed on the market provided that: (a) it has been collected from equidae which: (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; (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; (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;
(b) it has been collected under veterinary supervision either: (i) in slaughterhouses approved in accordance with Regulation (EC) No 853/2004; or (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.
2. Blood products may be placed on the market provided that: (a) all precautions have been taken to avoid contamination of the blood products with pathogenic agents during production, handling and packaging; (b) the blood products have been produced from blood which: (i) either fulfils the conditions set out in paragraph 1(a); or (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 ):heat treatment at a temperature of 65 °C for at least three hours; irradiation at 25 kGy by gamma rays; change in pH to pH 5 for two hours; heat treatment of at least 80 °C throughout their substance.
3. Blood and blood products from equidae must be packed in sealed impermeable containers which: (a) are clearly labelled "BLOOD AND BLOOD PRODUCTS FROM EQUIDAE, NOT FOR HUMAN OR ANIMAL CONSUMPTION"; (b) bear the approval number of the establishment of collection referred to in paragraph 1(b).
B. Importation Member States shall authorise imports of blood and blood products from equidae for technical purposes subject to the following conditions: 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: (a) slaughterhouses (i) approved in accordance with Regulation (EC) No 853/2004; or (ii) approved and supervised by the competent authority of the third country; or
(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.
2. The blood products must comply with the conditions set out in paragraph 2 of Section A. 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: (a) African horse sickness in accordance with Article 5(2)(a) of Directive 90/426/EEC; (b) Venezuelan equine encephalomyelitis for a period of at least two years; (c) glanders: (i) for a period of three years; or (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;
(d) vesicular stomatitis for six months.
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. 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: (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 (b) Part XIII(B) where they have been treated in accordance with paragraph 2(b)(ii) of Section A.
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) the following Chapter XV is added: "CHAPTER XV 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 A. Placing on the market 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: 1. they must originate from animals that: (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 (b) did not show clinical signs of any disease communicable through that product to humans or animals.
2. they must have undergone a heat treatment for one hour at a core temperature of at least 80° C; 3. the horns must have been removed without opening the cranial cavity; 4. at any stage of processing, storage or transport, every precaution shall have been taken to avoid cross-contamination; 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; 6. the packaging or containers must: (a) indicate the type of product (horns, horn products, hooves or hoof products); (b) be clearly labelled "NOT FOR HUMAN AND ANIMAL CONSUMPTION"; (c) be marked with the name and address of the approved technical or storage plant of destination.
B. Importation 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: 1. come from a third country appearing on the list referred to in Part XVIII of Annex XI; 2. have been produced in accordance with point A of this Chapter; 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; 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."
(2) Annex X is amended as follows: (a) Chapter 2 is replaced by the following: "CHAPTER 2 Health certificate For milk and milk products not intended for human consumption for dispatch to or for transit through ( 2 ) the European Union(b) Chapter 4(A) is replaced by the following: "CHAPTER 4 (A) Health certificate 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(c) Chapter 4(D) is replaced by the following: "CHAPTER 4 (D) Health certificate 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(d) the following Chapter 18 is added: "CHAPTER 18 Health certificate 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
(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 OJ L 154, 30.4.2004, p. 72 .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 OJ L 73, 20.3.2010, p. 1 .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 OJ L 320, 18.11.2006, p. 53 .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 OJ L 226, 23.8.2008, p. 1 .(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 OJ L 39, 10.2.2009, p. 12 .(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 OJ L 73, 11.3.2004, p. 1 .(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 Petfood of fish origin only. (LK) Sri Lanka Dogchews made from hides and skins of ungulates only. (TW) Taiwan Processed petfood for ornamental fish only.
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 Gelatine only." (MY) Malaysia Gelatine only. (PK) Pakistan Gelatine only. (TW) Taiwan Gelatine only.
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. ----------------------OJ L 154, 30.4.2004, p. 72 .OJ L 73, 20.3.2010, p. 1 .OJ L 320, 18.11.2006, p. 53 .OJ L 226, 23.8.2008, p. 1 .OJ L 39, 10.2.2009, p. 12 .OJ L 73, 11.3.2004, p. 1 .Petfood of fish origin only. Dogchews made from hides and skins of ungulates only. Processed petfood for ornamental fish only. Gelatine only." Gelatine only. Gelatine only. Gelatine only.
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