L_2010173EN.01000101.xml

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:

Blood may be placed on the market provided that:

(a)

it has been collected from equidae which:

(i)

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

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

(iii)

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

(b)

it has been collected under veterinary supervision either:

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

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

Blood products may be placed on the market provided that:

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

(b)

the blood products have been produced from blood which:

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

(ii)

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

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

—	irradiation at 25 kGy by gamma rays;

—	change in pH to pH 5 for two hours;

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

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

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

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

B. Importation

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

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

(a)

slaughterhouses

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

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

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

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

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

(a)	African horse sickness in accordance with Article 5(2)(a) of Directive 90/426/EEC;

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

(c)

glanders:

(i)	for a period of three years; or

(ii)

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

(d)	vesicular stomatitis for six months.

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

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

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

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

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

(b)

the following Chapter XV is added:

‘CHAPTER XV

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

A. Placing on the market

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

they must originate from animals that:

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

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

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

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

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

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

the packaging or containers must:

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

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

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

B. Importation

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

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

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

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

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

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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;]

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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

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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]

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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;

(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.

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(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

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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,]

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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.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

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