Decision 2007/554/EC is amended as follows:

1. 1.

   In Article 2, paragraph 4 is replaced by the following:

   4.

   The prohibition set out in paragraph 2 shall not apply to meats bearing the health mark in accordance with Chapter III of Section I of Annex I to Regulation (EC) No 854/2004, provided that:

   a

   the meat is clearly identified, and has been transported and stored since the date of production separately from meat which is not eligible, in accordance with this Decision, for dispatch outside the areas listed in Annex I;

   b

   the meat complies with one of the following conditions:

   1. (i)

      it was obtained before 15 July 2007; or

   2. (ii)

      it is derived from animals reared for at least 90 days prior to the date of slaughter and slaughtered; or in the case of meat obtained from wild game of species susceptible to foot-and-mouth disease (“wild game”) killed, outside the areas listed in Annex I and II; or

   3. (iii)

      it complies with the conditions set out in points (c), (d) and (e);

   c

   the meat was obtained from domestic ungulates or from farmed game of species susceptible to foot-and-mouth disease (“farmed game”), as specified for the respective category of meat in one of the appropriate columns 4 to 7 in Annex III, and complies with the following conditions:

   1. (i)

      the animals have been reared for at least 90 days prior to the date of slaughter on holdings situated within the areas specified in columns 1, 2 and 3 of Annex III, where there has been no outbreak of foot-and-mouth disease during at least that period;

   2. (ii)

      during the 30 days prior to the date of transport to the slaughterhouse, or in the case of farmed game prior to the date of on-farm slaughtering, the animals have remained under the supervision of the competent veterinary authorities on a single holding which is situated in the centre of a circle around the holding of at least 10 km radius, where there has been no outbreak of foot-and-mouth disease during at least that period;

   3. (iii)

      no animal of species susceptible to foot-and-mouth disease has been introduced into the holding referred to in point (ii) during the 21 days prior to the date of loading, or in the case of farmed game prior to the date of on-farm slaughtering, except in the case of pigs coming from a supplying holding which complies with the conditions laid down in point (ii), in which case the period of 21 days may be reduced to 7 days;

   4. (iv)

      the animals or, in the case of farmed game slaughtered on the farm, the carcasses have been transported under official control in means of transport that have been cleaned and disinfected before loading from the holding referred to in point (ii) directly to the designated slaughterhouse;

   5. (v)

      the animals have been slaughtered less than 24 hours following the time of arrival at the slaughterhouse and separately from animals the meat of which is not eligible for dispatch from the area listed in Annex I;

   d

   the meat, if positively marked in column 8 of Annex III, was obtained from wild game, that was killed in areas where there has been no outbreak of foot-and-mouth disease for at least a period of 90 days before the date of killing and at a distance of at least 20 km from areas not specified in columns 1, 2 and 3 of Annex III;

   e

   meat referred to in points (c) and (d) must in addition comply with the following conditions:

   1. (i)

      the dispatch of such meat is only to be authorised by the competent veterinary authority of the United Kingdom, if the establishment of dispatch is situated within the areas specified in columns 1, 2 and 3 of Annex III;

   2. (ii)

      the meat is at all times clearly identified, handled, stored and transported separately from meat which is not eligible for dispatch from the area listed in Annex I;

   3. (iii)

      during post-mortem inspection by the official veterinarian in the establishment of dispatch, or in the case of on-farm slaughtering of farmed game on the holding referred to in point (c)(ii), or in the case of wild game at the game-handling establishment, no clinical signs or post-mortem evidence of foot-and-mouth disease were established;

   4. (iv)

      the meat has remained in the establishments or holdings referred to in point (iii) of this paragraph for at least 24 hours following the post-mortem inspection of the animals referred to in point (c) and (d);

   5. (v)

      in the case where foot-and-mouth disease has been diagnosed in the establishments or holdings referred to in point (iii) of this paragraph, any further preparation of meat for dispatch outside the area listed in Annex I shall only be authorised after the slaughter of all animals present, the removal of all meat and dead animals and not earlier than 24 hours after the completion of the total cleaning and disinfection of those establishments and holdings under the control of an official veterinarian;

   6. (vi)

      the central veterinary authorities shall communicate to the other Member States and the Commission a list of those establishments and holdings which they have approved for the purposes of application of points (c), (d) and (e).

2. 2.

   Article 8 is amended as follows:

   1. (a)

      In paragraph 2, point (j) is replaced by the following:

      1. (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.

   2. (b)

      Paragraph 7 is replaced by the following:

      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 “medical products” or as “medical devices”.

3. 3.

   In Article 17, ‘15 October 2007’ is replaced by ‘15 November 2007’.

4. 4.

   A new Annex III, the text of which is set out in the Annex to the present Decision, is added.