The following requirements shall apply to the import of blood and blood products, excluding those from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals:
The blood products must originate from a plant for the production of derived products for uses outside the feed chain for farmed animals which meets the specific conditions laid down in this Regulation or from the establishment of collection.
[F1The blood from which blood products for the manufacture of derived products for uses outside the feed chain for farmed animals are produced must have been collected under veterinary supervision:
in slaughterhouses:
approved in accordance with Regulation (EC) No 853/2004; or
approved and supervised by the competent authority of the country of collection; or
from live animals in facilities approved and supervised by the competent authority of the country of collection.]
In the case of blood products for the manufacture of derived products for uses outside the feed chain for farmed animals which have been derived from animals belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, they must comply with the conditions of either point (a) or (b):
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check;
in the case of animals other than Suidae and Tayassuidae only: change in pH to pH 5 for two hours, followed by an effectiveness check;
in the case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for a period of at least 12 months and in which vaccination has not been carried out against those diseases for a period of at least 12 months;
where no case of foot-and-mouth disease has been recorded for a period of at least 12 months, and,
in which vaccination has not been carried out against this disease for a period of at least 12 months, or
in which vaccination programmes against foot-and-mouth disease are being officially carried out and controlled in domestic ruminant animals for a period of at least 12 months; in this case, following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the registered establishment or plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In addition to point (b)(i) and (ii) of point 3.1, in the case of animals other than Suidae and Tayassuidae, one of the following conditions must be complied with:
in the third country or region of origin no case of vesicular stomatitis and bluetongue (including the presence of seropositive animals) has been recorded for a period of at least 12 months and vaccination has not been carried out against those diseases for a period of at least 12 months in the susceptible species;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In addition to point (b)(i) and (ii) of point 3.1, in the case of Suidae and Tayassuidae, in the third country or region of origin no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for a period of at least 12 months, vaccination has not been carried out against those diseases for a period of at least 12 months and one of the following conditions are complied with:
in the country or region of origin no case of vesicular stomatitis (including the presence of seropositive animals) has been recorded for a period of 12 months and vaccination has not been carried out against this disease for a period of at least 12 months in the susceptible species;
following the veterinary checks provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported directly to the registered establishment or plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans.
In the case of blood products for the manufacture of derived products for uses outside the feed chain for farmed animals which have been derived from poultry and other avian species, they must comply with the following conditions of either point (a) or (b):
the products must have undergone one of the following treatments guaranteeing the absence of pathogens of the diseases referred to in point (b):
heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check;
irradiation at 25 kGy by gamma rays, followed by an effectiveness check;
heat treatment of at least 70 °C throughout their substance, followed by an effectiveness check;
in case of blood products not treated in accordance with point (a) the products must originate from a third country or region:
which has been free from Newcastle disease and highly pathogenic avian influenza as listed in the Terrestrial Animal Health Code of the OIE, 2010 edition;
which during the last 12 months has not carried out vaccination against avian influenza;
where the poultry or other avian species from which the products derive have not been vaccinated against Newcastle disease with vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than lentogenic virus strains.
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).