Commission Decision of 19 January 2011 concerning certain protection measures against foot-and-mouth disease in Bulgaria (notified under document C(2011) 179) (Text with EEA relevance) (2011/44/EU)

Article 8 U.K. Other animal products

1. Bulgaria shall not dispatch products of animals of the bovine, ovine, caprine and porcine species and other biungulates not mentioned in Articles 2 to 7 produced after 9 December 2010 and coming from the areas listed in Annex I, or obtained from animals originating in the areas listed in Annex I.

Bulgaria shall not dispatch dung and manure of the bovine, ovine, caprine and porcine species and other biungulates from the areas listed in Annex I.

2. The prohibition set out in the first subparagraph of paragraph 1 shall not apply to:

(a) animal products which:

(i)

have been subjected to a heat treatment:

• in a hermetically sealed container with a Fo value of 3,00 or more, or

• in which the centre temperature is raised to at least 70 °C; or

(ii)

were produced outside the areas listed in Annex I in accordance with the conditions laid down in Regulation (EC) No 1774/2002, and which since introduction into Bulgaria have been stored and transported separately from animal products not eligible for dispatch in accordance with paragraph 1;

(b) blood and blood products as defined in points 4 and 5 of Annex I to Regulation (EC) No 1774/2002 which have been subjected to at least one of the treatments provided for in point 4(a) of Part A of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002, followed by an effectiveness check, or have been imported in accordance with Part A of Chapter IV of Annex VIII to Regulation (EC) No 1774/2002;

(c) lard and rendered fats which have been subject to the heat treatment prescribed in point 2(d)(iv) of Part B of Chapter IV of Annex VII to Regulation (EC) No 1774/2002;

(d) animal casings complying with the conditions in Part A of Chapter 2 of Annex I to Directive 92/118/EEC and which have been cleaned, scraped and then either salted, bleached or dried, followed by steps to prevent the recontamination of the casings;

(e) sheep wool, ruminant hair and pigs bristles which have undergone factory washing or have been obtained from tanning and unprocessed sheep wool, ruminant hair and pigs bristles which are securely enclosed in packaging and dry;

(f) petfood conforming to the requirements of points 2, 3 and 4 of Part B of Chapter II of Annex VIII to Regulation (EC) No 1774/2002;

(g) composite products which are not subject to further treatment containing products of animal origin, on the understanding that the treatment was not necessary for finished products, the ingredients of which comply with the respective animal health conditions laid down in this Decision;

(h) game trophies in accordance with points 1, 3 or 4 of Part A of Chapter VII of Annex VIII to Regulation (EC) No 1774/2002;

(i) packed animal products intended for use as in-vitro diagnostic, laboratory reagents;

(j) medicinal products as defined in Directive 2001/83/EC, medical devices manufactured utilising animal tissue which is rendered non-viable as referred to in Article 1(5)(g) of Directive 93/42/EEC, veterinary medicinal products as defined in Directive 2001/82/EC, and investigational medicinal products as defined in Directive 2001/20/EC.

3. Bulgaria shall ensure that the animal products referred to in paragraph 2 to be dispatched to other Member States shall be accompanied by an official certificate which bears the following words:

‘Animal products conforming to Commission Decision 2011/44/EU of 19 January 2011 concerning certain protection measures against foot-and-mouth disease in Bulgaria(1).’

4. By way of derogation from paragraph 3, it shall be sufficient, in the case of the products referred to in paragraph 2(a) to (d) and (f) of this Article that compliance with the conditions for the treatment stated in the commercial document required in accordance with the respective Union legislation is endorsed in accordance with Article 9(1).

5. By way of derogation from paragraph 3 it shall be sufficient, in the case of products referred to in paragraph 2(e) to be accompanied by a commercial document stating either the factory washing or origin from tanning or compliance with the conditions laid down in points 1 and 4 of Part A of Chapter VIII of Annex VIII to Regulation (EC) No 1774/2002.

6. By way of derogation from paragraph 3 it shall be sufficient, in the case of products referred to in paragraph 2(g) which have been produced in an establishment operating HACCP and an auditable standard operating procedure which ensures that pre-processed ingredients comply with the respective animal health conditions laid down in this Decision, that this is stated on the commercial document accompanying the consignment, endorsed in accordance with Article 9(1).

7. By way of derogation from paragraph 3, it shall be sufficient, in the case of products referred to in paragraph 2(i) and (j), to be accompanied by a commercial document stating that the products are for use as in-vitro diagnostic, laboratory reagents, medical products or medical devices, provided that the products are clearly labelled ‘for in-vitro diagnostic use only’ or ‘for laboratory use only’, as ‘medicinal products’ or as ‘medical devices’.

8. Derogating from the provisions in paragraph 3, it shall be sufficient, in the case of composite products that fulfil the conditions set out in Article 6(1) of Decision 2007/275/EC that they are accompanied by a commercial document, which bears the following words:

‘These composite products are shelf stable at ambient temperature or have clearly undergone in their manufacture a complete cooking or heat treatment process throughout their substance, so that any raw material is de-natured’.

(1)

OJ L 19, 22.1.2011, p. 20.’