# L_2010173EN.01000101.xml

| 8.7.2010 | EN | Official Journal of the European Union | L 173/1 |
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8.7.2010

EN

Official Journal of the European Union

L 173/1

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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 EUROPEAN COMMISSION,

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

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,

Whereas:

| (1) | 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. |
| --- | --- |

(1)

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.

| (2) | 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. |
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(2)

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.

| (3) | 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. |
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(3)

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.

| (4) | 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. |
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(4)

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.

| (5) | 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. |
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(5)

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.

| (6) | 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. |
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(6)

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.

| (7) | 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. |
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(7)

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.

| (8) | 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. |
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(8)

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.

| (9) | 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. |
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(9)

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.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(10)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

For a transitional period until 31 August 2010, 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) respectively of Annex X to Regulation (EC) No 1774/2002 before the date of entry into force of this Regulation.

Until 30 October 2010, Member States shall accept such consignments if the accompanying health certificates were completed and signed before 1 September 2010.

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.

Done at Brussels, 2 July 2010.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 273, 10.10.2002, p. 1.

1

(2)  
  OJ L 224, 18.8.1990, p. 42.

2

(3)  
  OJ L 139, 30.4.2004, p. 55.

3

(4)  Opinion of the Scientific Steering Committee adopted at its meeting of 10 and 11 January 2002 and amended at its meeting of 7 and 8 November 2002.

4

(5)  
  OJ L 132, 22.5.2008, p. 7.

5

(6)  
  OJ L 146, 14.6.1979, p. 15.

6

(7)  
  OJ L 122, 14.5.1997, p. 21.

7

(8)  
  OJ L 44, 17.2.1994, p. 31.

8

(9)  
  OJ L 378, 31.12.1994, p. 11.

9

(10)  
  OJ L 251, 6.10.2000, p. 1.

10

(11)  
  OJ L 258, 12.10.2000, p. 49.

11

(12)  
  OJ L 73, 11.3.2004, p. 1.

12

(13)  
  OJ L 154, 30.4.2004, p. 72.

13

(14)  
  OJ L 295, 25.10.2006, p. 1.

14

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ANNEX

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

| (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; |
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(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; |
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(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; |
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(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 |
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(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. |
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(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; |
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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 |
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(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; |
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(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; |
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—

irradiation at 25 kGy by gamma rays;

| — | change in pH to pH 5 for two hours; |
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—

change in pH to pH 5 for two hours;

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

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”; |
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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). |
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(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 |
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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 |
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(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. |
| --- | --- |

(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; |
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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; |
| --- | --- |

(b)

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

| (c) | glanders:






  (i) | for a period of three years; or |
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(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; |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

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 |
| --- | --- | --- |

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. |
| --- | --- |

(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.’ |
| --- | --- |

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)

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. |
| --- | --- |

(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; |
| --- | --- |

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; |
| --- | --- |

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; |
| --- | --- |

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; |
| --- | --- |

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); |
| --- | --- | --- |

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”; |
| --- | --- |

(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. |
| --- | --- |

(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; |
| --- | --- |

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; |
| --- | --- |

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; |
| --- | --- |

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.’ |
| --- | --- |

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






  Text of image

  Part I: Details of dispatched consignment
  COUNTRY
  Veterinary certificate to EU
  I.1. Consignor
  Name
  Address
  Tel. No

  I.2. Certificate reference number
  I.2.a
  I.3. Central Competent Authority
  I.4. Local Competent Authority
  I.5. Consignee
  Name
  Address
  Postal code
  Tel. No

  I.6. Person responsible for the load in EU
  Name
  Address
  Postal code
  Tel. No

  I.7. Country of origin
  ISO code
  I.8. Region of origin
  Code
  I.9. Country of destination
  ISO code
  I.10. Region of destination
  Code
  I.11. Place of origin
  Name
  Approval number
  Address
  I.12. Place of destination
  Customs warehouse
  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:
  Documentary references:
  I.16. Entry BIP in EU
  I.17. No.(s) of CITES
  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. Identification of container/Seal number
  I.24. Type of packaging
  I.25. Commodities certified for
  Animal feedingstuff
  Further process
  Technical use
  Other
  I.26. For transit through EU to 3rd Country
  3rd country
  ISO code
  I.27. For import or admission into EU
  I.28. Identification of the commodities
  Species
  Approval number of establishments
  Manufacturing plant
  Net weight
  Batch number






  Text of image

  Part II: Certification
  COUNTRY
  Milk and milk products not for human consumption
  II. Health information
  II.a. Certificate reference number
  II.b.
  I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002 (1), and in particular Article 6 and Chapter V of Annex VII thereof, and certify that the milk (2), or the milk products (1) referred to in box I.28 comply with the following conditions:
  II.1. they were produced and derived in ... (insert name of exporting country) (3), ...(insert name of region) (3), which is listed in the Annex to Decision 2004/438/EC, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practiced vaccination against rinderpest during that period;
  II.2. they were produced from raw milk derived from animals which at the time of milking did not show clinical signs of any disease transmissible through milk to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;
  II.3. they are milk or milk products that:
  (2) either [have undergone one of the treatments or combinations thereof described in point II. 4]
  (2) or [where they comprise whey to be fed to animals of species susceptible to foot-and-mouth disease, that whey was collected from milk subjected to one of the treatments described in point II. 4 and
  (2) either [the whey was collected at least 16 hours after clotting and has a pH below 6;]
  (2) or [the whey has been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;]
  (2) or [the whey has been produced on ../../.., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;] (4)]
  II.4. they have been subject to one of the following treatments:
  (2) either [High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test, in combination with:
  (2) either [a subsequent second High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or an equivalent pasteurisation which itself achieves a negative reaction to a phosphatase test;]
  (2) or [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72°C or higher;]
  (2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]
  (2)(4) or [the condition that the milk/milk product has been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;]
  (2)(4) or [the milk/milk product has been produced on .../../..., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;]
  (2) or [sterilisation at a level of at least F03;]]
  (2) or [Ultra High Temperature treatment at 132 °C for at least one second in combination with:
  (2) either [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72 °C or higher,]
  (2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]
  (2)(4) or [the condition that the milk/milk product has been produced at least 21 days before the shipping and in this period no cases of FMD has been detected in the exporting country;]
  (2)(4) or [the milk/milk product has been produced on .../../..., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;]]






  Text of image

  COUNTRY
  Milk and milk products not for human consumption
  II. Health information
  II.a. Certificate reference number
  II.b.
  II.5. every precaution was taken to avoid contamination of the milk/milk product after processing;
  II.6. the milk/milk product was packed:
  (2) either [in new containers,]
  (2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,]
  and the containers are marked so as to indicate the nature of the milk/milk product and bear labels indicating that the product is Category 3 material and not intended for human consumption.
  Notes
  Part I:
  Box reference I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.
  Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity.
  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 Border Inspection Post of the European Union.
  Box reference I.19: use the appropriate Harmonised System (HS) code of the World Customs Organisation: 23.09.10, 23.09.90, 35.01, 35.02 or 35.04.
  Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
  Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
  Box reference I.28: “Manufacturing plant” : provide the registration number of treatment or processing establishment.
  Part II:
  (1) OJ L 273, 10.10.2002, p. 1.
  (2) Delete as appropriate.
  (3) For completion if the authorisation to import into the European Union is restricted to certain regions of the third country concerned.
  (4) this condition applies only to third countries listed in column “A” of Annex I to Decision 2004/438/EC
  The signature and the seal must be in a different colour from that of the printing.
  Note for the importer: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the Border Inspection Post of the European Union.
  Official veterinarian
  Name (in capital letters):
  Qualification and title:
  Date:
  Signature:’

  Stamp: |
| --- | --- | --- |

(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

Image 1

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel. No

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel. No

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel. No

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

I.12. Place of destination

Customs warehouse

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:

Documentary references:

I.16. Entry BIP in EU

I.17. No.(s) of CITES

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. Identification of container/Seal number

I.24. Type of packaging

I.25. Commodities certified for

Animal feedingstuff

Further process

Technical use

Other

I.26. For transit through EU to 3rd Country

3rd country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

Approval number of establishments

Manufacturing plant

Net weight

Batch number

Image 2

Part II: Certification

COUNTRY

Milk and milk products not for human consumption

II. Health information

II.a. Certificate reference number

II.b.

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002 (1), and in particular Article 6 and Chapter V of Annex VII thereof, and certify that the milk (2), or the milk products (1) referred to in box I.28 comply with the following conditions:

II.1. they were produced and derived in ... (insert name of exporting country) (3), ...(insert name of region) (3), which is listed in the Annex to Decision 2004/438/EC, and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately prior to export and has not practiced vaccination against rinderpest during that period;

II.2. they were produced from raw milk derived from animals which at the time of milking did not show clinical signs of any disease transmissible through milk to humans or animals, and which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest;

II.3. they are milk or milk products that:

(2) either [have undergone one of the treatments or combinations thereof described in point II. 4]

(2) or [where they comprise whey to be fed to animals of species susceptible to foot-and-mouth disease, that whey was collected from milk subjected to one of the treatments described in point II. 4 and

(2) either [the whey was collected at least 16 hours after clotting and has a pH below 6;]

(2) or [the whey has been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;]

(2) or [the whey has been produced on ../../.., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;] (4)]

II.4. they have been subject to one of the following treatments:

(2) either [High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds, or an equivalent pasteurisation achieving a negative reaction to a phosphatase test, in combination with:

(2) either [a subsequent second High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or an equivalent pasteurisation which itself achieves a negative reaction to a phosphatase test;]

(2) or [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72°C or higher;]

(2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]

(2)(4) or [the condition that the milk/milk product has been produced at least 21 days before the shipping and in this period no cases of FMD have been detected in the exporting country;]

(2)(4) or [the milk/milk product has been produced on .../../..., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;]

(2) or [sterilisation at a level of at least F03;]]

(2) or [Ultra High Temperature treatment at 132 °C for at least one second in combination with:

(2) either [a subsequent drying process that in the case of milk intended for feeding is combined with additional heating to 72 °C or higher,]

(2) or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;]

(2)(4) or [the condition that the milk/milk product has been produced at least 21 days before the shipping and in this period no cases of FMD has been detected in the exporting country;]

(2)(4) or [the milk/milk product has been produced on .../../..., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;]]

Image 3

COUNTRY

Milk and milk products not for human consumption

II. Health information

II.a. Certificate reference number

II.b.

II.5. every precaution was taken to avoid contamination of the milk/milk product after processing;

II.6. the milk/milk product was packed:

(2) either [in new containers,]

(2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,]

and the containers are marked so as to indicate the nature of the milk/milk product and bear labels indicating that the product is Category 3 material and not intended for human consumption.

Notes

Part I:

Box reference I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity.

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 Border Inspection Post of the European Union.

Box reference I.19: use the appropriate Harmonised System (HS) code of the World Customs Organisation: 23.09.10, 23.09.90, 35.01, 35.02 or 35.04.

Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.

Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.

Box reference I.28: “Manufacturing plant” : provide the registration number of treatment or processing establishment.

Part II:

(1) OJ L 273, 10.10.2002, p. 1.

(2) Delete as appropriate.

(3) For completion if the authorisation to import into the European Union is restricted to certain regions of the third country concerned.

(4) this condition applies only to third countries listed in column “A” of Annex I to Decision 2004/438/EC

The signature and the seal must be in a different colour from that of the printing.

Note for the importer: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the Border Inspection Post of the European Union.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:’

Stamp:

| (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






  Text of image

  Part I: Details of dispatched consignment
  COUNTRY
  Veterinary certificate to EU
  I.1. Consignor
  Name
  Address
  Tel. No

  I.2. Certificate reference number
  I.2.a
  I.3. Central Competent Authority
  I.4. Local Competent Authority
  I.5. Consignee
  Name
  Address
  Postal code
  Tel. No

  I.6. Person responsible for the load in EU
  Name
  Address
  Postal code
  Tel. No

  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. Place of destination
  Customs warehouse
  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
  Documentary references
  I.16. Entry BIP in EU
  I.17.
  I.18. Description of commodity
  I.19. Commodity code (HS code)
  30.02
  I.20. Quantity
  I.21. Temperature of product
  Ambient
  Chilled
  Frozen
  I.22. Number of packages
  I.23. Identification of container/Seal number
  I.24. Type of packaging
  I.25. Commodities certified for
  Technical use
  I.26. For transit to 3rd Country vis-à-vis EU
  3rd country
  ISO code
  I.27. For import or admission into EU
  I.28. Identification of the commodities
  Species (Scientific name)
  Approval number of establishments
  Manufacturing plant






  Text of image

  Part II: Certification
  COUNTRY
  Blood and blood products from equidae for technical purposes
  II. Health information
  II.a. Certificate reference number
  II.b.
  I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002 (1) and in particular Article 4(1)(c), Article 6 and Chapter V of Annex VIII thereto and certify that the blood or blood products of equidae described above :
  II.1. consist of blood or blood products from equidae that satisfy the health requirements below;
  II.2. consist exclusively of blood or blood products of equidae not intended for human nor animal consumption;
  II.3. come from a third country, territory or part thereof listed in Part XIII of Annex XI to Regulation (EC) No 1774/2002 where the following diseases are compulsorily notifiable: African horse sickness, dourine, glanders (Burkholderia mallei), equine encephalomyelitis (all types including VEE), equine infectious anaemia, vesicular stomatitis, rabies, anthrax;
  II.4. have been derived from blood which was collected under the supervision of a veterinarian, from equidae, which on inspection at the time of collection were free from clinical signs of infectious disease:
  (2) either [in slaughterhouses approved in accordance with Regulation (EC) No 853/2004 (3);]
  (2) or [in slaughterhouses approved and supervised by the competent authority of the country of export;]
  (2) or [in facilities approved and supervised by the competent authority of the country of export for the purpose of collecting blood from equidae for the production of blood products for technical purposes;]
  II.5. have been derived from blood which was collected from equidae,
  II.5.1. which on inspection on the date of blood collection did not show clinical signs of any of the compulsorily notifiable diseases listed in Annex A to Directive 90/426/EEC (4) , 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.5.2. which 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) or restrictions for African horse sickness in accordance with Article 5 of Directive 90/426/EEC;
  II.5.3. which had no contact with equidae from a holding which was subject to a prohibition order for animal health reasons pursuant to Article 4(5) of Directive 90/426/EEC.
  II.5.4. which was collected from equidae for which the period for the prohibition order referred to in points II.5.2. and II.5.3 has been determined as followed:
  (2) either [where not all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises disinfected the period of prohibition has been:
  six months in the case of glanders (Burkholderia mallei), beginning on the date on which the equidae infected with the disease are slaughtered;
  six months in the case of equine encephalomyelitis of any type, including Venezuelan equine encephalomyelitis, beginning on the date on which the equidae infected with the disease are slaughtered;
  in the case of equine infectious anaemia, until the date on which, the infected animals having been slaughtered, and the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart;
  during six months from the date of the last recorded case of vesicular stomatitis;
  during one month from the date of the last recorded case of rabies;
  during 15 days from the date of the last recorded case of anthrax.]
  (2) or [if all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises disinfected, the period of prohibition shall be 30 days, beginning on the date on which the animals were slaughtered and the premises disinfected, except in the case of anthrax, where the period of prohibition shall 15 days]






  Text of image

  COUNTRY
  Blood and blood products from equidae for technical purposes
  II. Health information
  II.a. Certificate reference number
  II.b.
  II.6. blood products come from a plant approved by the competent authority of the third country meeting the specific conditions set out in Article 17 or 18 of Regulation (EC) No 1774/2002.
  II.7. blood products have been produced from blood which fulfils the conditions referred in II.4. and II.5 and
  (2) either [has 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 country of collection which during that period and the period of blood collection has been free of:
  (a) African horse sickness for two years
  (b) Venezuelan equine encephalomyelitis for a period of at least two years;
  (c) glanders
  (2) either [for a period of three years;]
  (2) or [for a period of six months where the animals have passed the post-mortem inspection for glanders in the slaughterhouse referred to in II.4, 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;]
  (2) or [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):
  (2) either [heat treatment at a temperature of 65 °C for at least three hours,]
  (2) or [irradiation at 25 kGy by gamma rays,]
  (2) or [change in pH to pH 5 for two hours,]
  (2) or [heat treatment of at least 80 °C throughout their substance]]
  II.8. all precautions have been taken to avoid contamination of the blood and blood products with pathogenic agents during production, handling and packaging;
  II.9. were packed in sealed impermeable containers clearly labelled “NOT FOR HUMAN OR ANIMAL CONSUMPTION” and bearing the approval number of the establishment of collection;
  II.10. were stored in enclosed storage.
  Notes
  Part I:
  Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.
  Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit can only be stored in free zones, free warehouses and custom warehouses.
  Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in case of unloading and reloading.
  Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
  Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
  Box reference I.28: Manufacturing plant: provide the veterinary control number of the registered establishment of collection.






  Text of image

  COUNTRY
  Blood and blood products from equidae for technical purposes
  II. Health information
  II.a. Certificate reference number
  II.b.
  Part II:
  (1) OJ L 273, 10.10.2002, p. 1.
  (2) Delete as appropriate.
  (3) OJ L 139, 30.4.2004, p. 55.
  (4) OJ L 224, 18.8.1990, p. 42.
  The signature and the stamp must be in a different colour to that of the printing.
  Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
  Official veterinarian
  Name (in capital letters):
  Qualification and title:
  Date:
  Signature:’

  Stamp: |
| --- | --- |

(b)

Chapter 4(A) is replaced by the following:

‘CHAPTER 4 (A)

Health certificate

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

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

Image 4

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel. No

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel. No

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel. No

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. Place of destination

Customs warehouse

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

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

30.02

I.20. Quantity

I.21. Temperature of product

Ambient

Chilled

Frozen

I.22. Number of packages

I.23. Identification of container/Seal number

I.24. Type of packaging

I.25. Commodities certified for

Technical use

I.26. For transit to 3rd Country vis-à-vis EU

3rd country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species (Scientific name)

Approval number of establishments

Manufacturing plant

Image 5

Part II: Certification

COUNTRY

Blood and blood products from equidae for technical purposes

II. Health information

II.a. Certificate reference number

II.b.

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002 (1) and in particular Article 4(1)(c), Article 6 and Chapter V of Annex VIII thereto and certify that the blood or blood products of equidae described above :

II.1. consist of blood or blood products from equidae that satisfy the health requirements below;

II.2. consist exclusively of blood or blood products of equidae not intended for human nor animal consumption;

II.3. come from a third country, territory or part thereof listed in Part XIII of Annex XI to Regulation (EC) No 1774/2002 where the following diseases are compulsorily notifiable: African horse sickness, dourine, glanders (Burkholderia mallei), equine encephalomyelitis (all types including VEE), equine infectious anaemia, vesicular stomatitis, rabies, anthrax;

II.4. have been derived from blood which was collected under the supervision of a veterinarian, from equidae, which on inspection at the time of collection were free from clinical signs of infectious disease:

(2) either [in slaughterhouses approved in accordance with Regulation (EC) No 853/2004 (3);]

(2) or [in slaughterhouses approved and supervised by the competent authority of the country of export;]

(2) or [in facilities approved and supervised by the competent authority of the country of export for the purpose of collecting blood from equidae for the production of blood products for technical purposes;]

II.5. have been derived from blood which was collected from equidae,

II.5.1. which on inspection on the date of blood collection did not show clinical signs of any of the compulsorily notifiable diseases listed in Annex A to Directive 90/426/EEC (4) , 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.5.2. which 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) or restrictions for African horse sickness in accordance with Article 5 of Directive 90/426/EEC;

II.5.3. which had no contact with equidae from a holding which was subject to a prohibition order for animal health reasons pursuant to Article 4(5) of Directive 90/426/EEC.

II.5.4. which was collected from equidae for which the period for the prohibition order referred to in points II.5.2. and II.5.3 has been determined as followed:

(2) either [where not all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises disinfected the period of prohibition has been:

six months in the case of glanders (Burkholderia mallei), beginning on the date on which the equidae infected with the disease are slaughtered;

six months in the case of equine encephalomyelitis of any type, including Venezuelan equine encephalomyelitis, beginning on the date on which the equidae infected with the disease are slaughtered;

in the case of equine infectious anaemia, until the date on which, the infected animals having been slaughtered, and the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart;

during six months from the date of the last recorded case of vesicular stomatitis;

during one month from the date of the last recorded case of rabies;

during 15 days from the date of the last recorded case of anthrax.]

(2) or [if all the animals of species susceptible to the disease located on the holding have been slaughtered and the premises disinfected, the period of prohibition shall be 30 days, beginning on the date on which the animals were slaughtered and the premises disinfected, except in the case of anthrax, where the period of prohibition shall 15 days]

Image 6

COUNTRY

Blood and blood products from equidae for technical purposes

II. Health information

II.a. Certificate reference number

II.b.

II.6. blood products come from a plant approved by the competent authority of the third country meeting the specific conditions set out in Article 17 or 18 of Regulation (EC) No 1774/2002.

II.7. blood products have been produced from blood which fulfils the conditions referred in II.4. and II.5 and

(2) either [has 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 country of collection which during that period and the period of blood collection has been free of:

(a) African horse sickness for two years

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

(c) glanders

(2) either [for a period of three years;]

(2) or [for a period of six months where the animals have passed the post-mortem inspection for glanders in the slaughterhouse referred to in II.4, 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;]

(2) or [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):

(2) either [heat treatment at a temperature of 65 °C for at least three hours,]

(2) or [irradiation at 25 kGy by gamma rays,]

(2) or [change in pH to pH 5 for two hours,]

(2) or [heat treatment of at least 80 °C throughout their substance]]

II.8. all precautions have been taken to avoid contamination of the blood and blood products with pathogenic agents during production, handling and packaging;

II.9. were packed in sealed impermeable containers clearly labelled “NOT FOR HUMAN OR ANIMAL CONSUMPTION” and bearing the approval number of the establishment of collection;

II.10. were stored in enclosed storage.

Notes

Part I:

Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.

Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit can only be stored in free zones, free warehouses and custom warehouses.

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

Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.

Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.

Box reference I.28: Manufacturing plant: provide the veterinary control number of the registered establishment of collection.

Image 7

COUNTRY

Blood and blood products from equidae for technical purposes

II. Health information

II.a. Certificate reference number

II.b.

Part II:

(1) OJ L 273, 10.10.2002, p. 1.

(2) Delete as appropriate.

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

(4) OJ L 224, 18.8.1990, p. 42.

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

Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:’

Stamp:

| (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






  Text of image

  Part I: Details of dispatched consignment
  COUNTRY
  Veterinary certificate to EU
  I.1. Consignor
  Name
  Address
  Tel. No

  I.2. Certificate reference number
  I.2.a
  I.3. Central Competent Authority
  I.4. Local Competent Authority
  I.5. Consignee
  Name
  Address
  Postal code
  Tel. No

  I.6. Person responsible for the load in EU
  Name
  Address
  Postal code
  Tel. No

  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. Place of destination
  Customs warehouse
  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
  Documentary references
  I.16. Entry BIP in EU
  I.17.
  I.18. Description of commodity
  I.19. Commodity code (HS code)
  30.02
  I.20. Quantity
  I.21. Temperature of product
  Ambient
  Chilled
  Frozen
  I.22. Number of packages
  I.23. Identification of container/Seal number
  I.24. Type of packaging
  I.25. Commodities certified for
  Technical use
  I.26. For transit to 3rd Country vis-à-vis EU
  3rd country
  ISO code
  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
  Batch number






  Text of image

  Part II: Certification
  COUNTRY
  Treated blood products, excluding those of equidae, for technical products
  II. Health information
  II.a. Certificate reference number
  II.b.
  I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No1774/2002(1) and in particular Article 4(1)(c), Article 6 and Chapter IV of Annex VIII thereof and certify that:
  II.1. the blood products described above consist of blood products that satisfy the requirements below;
  II.2. they consist exclusively of blood products not intended for human or animal consumption;
  II.3. they have been prepared and stored in a plant approved, validated and supervised by the competent authority in accordance with Article 18 or in the establishment of collection and where appropriate Article 11 of Regulation (EC) No 1774/2002 (2), exclusively with the following animal by-products:
  (2) either [— blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;]
  (2) and/or [— blood of slaughtered animals, which is rejected as unfit for human consumption but is not affected by any signs of diseases communicable to humans or animals, derived from carcasses that are fit for human consumption in accordance with Union legislation;]
  (2) and/or [— blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Union legislation;]
  (2) and/or [— blood and blood products originating from live animals that did not show clinical signs of any disease communicable through these products to humans or animals;]
  II.4. the blood from which such products are manufactured has been collected:
  (2) either [in slaughterhouses approved in accordance with Union legislation,]
  (2) or [in slaughterhouses approved and supervised by the competent authority of the third country,]
  (2) or [from live animals in facilities approved and supervised by the competent authority of the third country;]
  (2) [II.5. In case of blood products derived from taxa Artiodactyla, Perissodactyla and Proboscidea including their crossbreeds, other than Suidae and Tayassuidae, the products have undergone one of the following treatments, guaranteeing the absence of pathogens of foot-and-mouth disease, vesicular stomatitis, rinderpest, peste des petits ruminants, Rift Valley fever and bluetongue:
  (2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,]
  (2) or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check,]
  (2) or [change in pH to pH 5 for two hours, followed by an effectiveness check,]
  (2) or [heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check]]
  (2) [II.6. In the case of blood products derived from Suidae, Tayassuidae, poultry and other avian species, the products have undergone one of the following treatments guaranteeing the absence of pathogens of the following diseases: foot-and-mouth disease, vesicular stomatitis, swine vesicular disease, classical swine fever, African swine fever, Newcastle disease and highly pathogenic avian influenza as appropriate to the species;
  (2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,]
  (2) or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check,]
  (2) or [heat treatment of at least 80 °C for Suidae/Tayassuidae (2) and at least 70 °C for poultry and other avian species (2) throughout their substance, followed by an effectiveness check]]
  (2) [II.7. In the case of blood products derived from species other than listed under II.5. or II.6. the products have undergone of the following treatment (please specify): ...;]
  II.8. the products were:
  (2) either [packed in new or sterilised bags or bottles,]






  Text of image

  COUNTRY
  Treated blood products, excluding those of equidae, for technical products
  II. Health information
  II.a. Certificate reference number
  II.b.
  (2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use,]
  the outer packaging or containers bear labels indicating “NOT FOR HUMAN OR ANIMAL CONSUMPTION”;
  II.9. the products were stored in enclosed storage;
  II.10. the products have undergone all precautions to avoid contamination with pathogenic agents after treatment.
  Notes
  Part I:
  Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.
  Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit can only be stored in free zones, free warehouses and custom warehouses approved for that purpose.
  Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in case of unloading and reloading.
  Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.
  Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
  Part II:
  (1) OJ L 273, 10.10.2002, p. 1.
  (2) Keep as appropriate.
  The signature and the stamp must be in a different colour to that of the printing.
  Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
  Official veterinarian
  Name (in capital letters):
  Qualification and title:
  Date:
  Signature:’

  Stamp: |
| --- | --- |

(c)

Chapter 4(D) is replaced by the following:

‘CHAPTER 4 (D)

Health certificate

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

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

Image 8

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel. No

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel. No

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel. No

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. Place of destination

Customs warehouse

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

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

30.02

I.20. Quantity

I.21. Temperature of product

Ambient

Chilled

Frozen

I.22. Number of packages

I.23. Identification of container/Seal number

I.24. Type of packaging

I.25. Commodities certified for

Technical use

I.26. For transit to 3rd Country vis-à-vis EU

3rd country

ISO code

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

Batch number

Image 9

Part II: Certification

COUNTRY

Treated blood products, excluding those of equidae, for technical products

II. Health information

II.a. Certificate reference number

II.b.

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No1774/2002(1) and in particular Article 4(1)(c), Article 6 and Chapter IV of Annex VIII thereof and certify that:

II.1. the blood products described above consist of blood products that satisfy the requirements below;

II.2. they consist exclusively of blood products not intended for human or animal consumption;

II.3. they have been prepared and stored in a plant approved, validated and supervised by the competent authority in accordance with Article 18 or in the establishment of collection and where appropriate Article 11 of Regulation (EC) No 1774/2002 (2), exclusively with the following animal by-products:

(2) either [— blood of slaughtered animals, which is fit for human consumption in accordance with Union legislation, but is not intended for human consumption for commercial reasons;]

(2) and/or [— blood of slaughtered animals, which is rejected as unfit for human consumption but is not affected by any signs of diseases communicable to humans or animals, derived from carcasses that are fit for human consumption in accordance with Union legislation;]

(2) and/or [— blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Union legislation;]

(2) and/or [— blood and blood products originating from live animals that did not show clinical signs of any disease communicable through these products to humans or animals;]

II.4. the blood from which such products are manufactured has been collected:

(2) either [in slaughterhouses approved in accordance with Union legislation,]

(2) or [in slaughterhouses approved and supervised by the competent authority of the third country,]

(2) or [from live animals in facilities approved and supervised by the competent authority of the third country;]

(2) [II.5. In case of blood products derived from taxa Artiodactyla, Perissodactyla and Proboscidea including their crossbreeds, other than Suidae and Tayassuidae, the products have undergone one of the following treatments, guaranteeing the absence of pathogens of foot-and-mouth disease, vesicular stomatitis, rinderpest, peste des petits ruminants, Rift Valley fever and bluetongue:

(2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,]

(2) or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check,]

(2) or [change in pH to pH 5 for two hours, followed by an effectiveness check,]

(2) or [heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check]]

(2) [II.6. In the case of blood products derived from Suidae, Tayassuidae, poultry and other avian species, the products have undergone one of the following treatments guaranteeing the absence of pathogens of the following diseases: foot-and-mouth disease, vesicular stomatitis, swine vesicular disease, classical swine fever, African swine fever, Newcastle disease and highly pathogenic avian influenza as appropriate to the species;

(2) either [heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,]

(2) or [irradiation at 25 kGy by gamma rays, followed by an effectiveness check,]

(2) or [heat treatment of at least 80 °C for Suidae/Tayassuidae (2) and at least 70 °C for poultry and other avian species (2) throughout their substance, followed by an effectiveness check]]

(2) [II.7. In the case of blood products derived from species other than listed under II.5. or II.6. the products have undergone of the following treatment (please specify): ...;]

II.8. the products were:

(2) either [packed in new or sterilised bags or bottles,]

Image 10

COUNTRY

Treated blood products, excluding those of equidae, for technical products

II. Health information

II.a. Certificate reference number

II.b.

(2) or [transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected with a disinfectant approved by the competent authority before use,]

the outer packaging or containers bear labels indicating “NOT FOR HUMAN OR ANIMAL CONSUMPTION”;

II.9. the products were stored in enclosed storage;

II.10. the products have undergone all precautions to avoid contamination with pathogenic agents after treatment.

Notes

Part I:

Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.

Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit can only be stored in free zones, free warehouses and custom warehouses approved for that purpose.

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

Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be included.

Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.

Part II:

(1) OJ L 273, 10.10.2002, p. 1.

(2) Keep as appropriate.

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

Note for the person responsible for the consignment in the European Union: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:’

Stamp:

| (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






  Text of image

  Part I: Details of dispatched consignment
  COUNTRY
  Veterinary certificate to EU
  I.1. Consignor
  Name
  Address
  Tel. No

  I.2. Certificate reference number
  I.2.a
  I.3. Central Competent Authority
  I.4. Local Competent Authority
  I.5. Consignee
  Name
  Address
  Postal code
  Tel. No

  I.6. Person responsible for the load in EU
  Name
  Address
  Postal code
  Tel. No

  I.7. Country of origin
  ISO code
  I.8. Region of origin
  Code
  I.9. Country of destination
  ISO code
  I.10. Region of destination
  Code
  I.11. Place of origin
  Name
  Approval number
  Address
  I.12. Place of destination
  Customs warehouse
  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
  Documentary references
  I.16. Entry BIP in EU
  I.17. No.(s) of CITES
  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. Identification of container/Seal number
  I.24. Type of packaging
  I.25. Commodities certified for
  Animal feedingstuff
  Further process
  Technical use
  Other
  I.26. For transit through EU to 3rd Country
  3rd country
  ISO code
  I.27. For import or admission into EU
  I.28. Identification of the commodities
  Species
  Approval number of establishments
  Manufacturing plant
  Net weight
  Batch number






  Text of image

  Part II: Certification
  COUNTRY
  Horns and horn products and hooves and hoof products intended to produce organic fertilizers or soil improvers
  II. Health information
  II.a. Certificate reference number
  II.b.
  II.1. I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002(1) , and in particular Chapter XV of Annex VIII thereof, and certify that the horns and horn products, excluding horn meal and hooves and hoof products, excluding hoof meal(2) described above:
  (2) either [originate from animals that were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption]
  (2) or [originate from animals that did not show clinical signs of any disease communicable through that product to humans or animals]
  II.2. horns must have undergone a heat treatment for one hour at a core temperature of at least 80°C;
  II.3. horns must have been removed without opening the cranial cavity;
  II.4. at any stage of processing, storage or transport every precaution shall be taken to avoid cross- contamination;
  II.5. were packed:
  (2) either [in new packaging or containers,]
  (2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,]
  and [the packaging or containers are marked so as to indicate the type of the animal by-product (3) and bear labels indicating “NOT FOR HUMAN AND ANIMAL CONSUMPTION” and the name and address of the EU establishment of destination].
  Notes
  Part I:
  Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.
  Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit must only be stored in free zones, free warehouses and custom warehouses.
  Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading.
  Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.
  Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.
  Box reference I.28: Nature of commodity.
  Part II:
  (1) OJ L 273, 10.10.2002, p. 1.
  (2) Delete as appropriate.
  (3) Type of product: horns, horn products, hooves, hoof products.
  The signature and the stamp must be in a different colour to that of the printing.
  Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.
  Official veterinarian
  Name (in capital letters):
  Qualification and title:
  Date:
  Signature:’

  Stamp: |
| --- | --- |

(d)

the following Chapter 18 is added:

‘CHAPTER 18

Health certificate

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

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

Image 11

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel. No

I.2. Certificate reference number

I.2.a

I.3. Central Competent Authority

I.4. Local Competent Authority

I.5. Consignee

Name

Address

Postal code

Tel. No

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel. No

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

I.12. Place of destination

Customs warehouse

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

Documentary references

I.16. Entry BIP in EU

I.17. No.(s) of CITES

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. Identification of container/Seal number

I.24. Type of packaging

I.25. Commodities certified for

Animal feedingstuff

Further process

Technical use

Other

I.26. For transit through EU to 3rd Country

3rd country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

Approval number of establishments

Manufacturing plant

Net weight

Batch number

Image 12

Part II: Certification

COUNTRY

Horns and horn products and hooves and hoof products intended to produce organic fertilizers or soil improvers

II. Health information

II.a. Certificate reference number

II.b.

II.1. I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1774/2002(1) , and in particular Chapter XV of Annex VIII thereof, and certify that the horns and horn products, excluding horn meal and hooves and hoof products, excluding hoof meal(2) described above:

(2) either [originate from animals that were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption]

(2) or [originate from animals that did not show clinical signs of any disease communicable through that product to humans or animals]

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

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

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

II.5. were packed:

(2) either [in new packaging or containers,]

(2) or [in vehicles or bulk containers disinfected prior to loading using a product approved by the competent authority,]

and [the packaging or containers are marked so as to indicate the type of the animal by-product (3) and bear labels indicating “NOT FOR HUMAN AND ANIMAL CONSUMPTION” and the name and address of the EU establishment of destination].

Notes

Part I:

Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import commodity.

Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit must only be stored in free zones, free warehouses and custom warehouses.

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

Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be given.

Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.

Box reference I.28: Nature of commodity.

Part II:

(1) OJ L 273, 10.10.2002, p. 1.

(2) Delete as appropriate.

(3) Type of product: horns, horn products, hooves, hoof products.

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

Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and must accompany the consignment until it reaches the border inspection post.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:’

Stamp:

| (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 (1).
  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 (2).
  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 (3).
  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. |
| --- | --- | --- | --- | --- |

(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 (1).

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 (2).

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 (3).

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.

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 (4),






  — | (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 (4),

—

(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 (5),






  — | (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 (5),

—

(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. |
| --- | --- | --- |

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, |
| --- | --- | --- |

B.

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, |
| --- | --- |

—

(PH) Philippines,

| — | (TW) Taiwan. |
| --- | --- |

—

(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. |
| --- | --- |

C.

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. |
| --- | --- |

A.

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. |
| --- | --- |

B.

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. |
| --- | --- |

C.

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. |
| --- | --- |

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 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. |
| --- | --- |

A.

| 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. |
| --- | --- |

B.

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; |
| --- | --- |

(a)

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

| (b) | Annex I to Commission Decision 2004/211/EC (6); or |
| --- | --- |

(b)

Annex I to Commission Decision 2004/211/EC (6); or

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

(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 |
| --- | --- |

—

(JP) Japan

| — | (EC) Ecuador (7) |
| --- | --- |

—

(EC) Ecuador (7)

| — | (LK) Sri Lanka (8) |
| --- | --- |

—

(LK) Sri Lanka (8)

| — | (TW) Taiwan (9) |
| --- | --- |

—

(TW) Taiwan (9)

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 (10) |
| --- | --- |

—

(KR) South Korea (10)

| — | (MY) Malaysia (10) |
| --- | --- |

—

(MY) Malaysia (10)

| — | (PK) Pakistan (10) |
| --- | --- |

—

(PK) Pakistan (10)

| — | (TW) Taiwan (10). |
| --- | --- |

—

(TW) Taiwan (10).

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. |
| --- | --- |

A.

| 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. |
| --- | --- |

B.

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. |
| --- | --- |

A.

| 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. |
| --- | --- |

B.

| 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. |
| --- | --- |

C.

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. |
| --- | --- |

A.

| 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 |
| --- | --- | --- |

B.

—

(GL) Greenland

| — | (TN) Tunisia. |
| --- | --- |

—

(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. |
| --- | --- |

C.

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.

---

(1)  
  OJ L 154, 30.4.2004, p. 72.

1

(2)  
  OJ L 73, 20.3.2010, p. 1.

2

(3)  
  OJ L 320, 18.11.2006, p. 53.

3

(4)  
  OJ L 226, 23.8.2008, p. 1.

4

(5)  
  OJ L 39, 10.2.2009, p. 12.

5

(6)  
  OJ L 73, 11.3.2004, p. 1.

6

(7)  Petfood of fish origin only.

7

(8)  Dogchews made from hides and skins of ungulates only.

8

(9)  Processed petfood for ornamental fish only.

9

(10)  Gelatine only.’

10

---