7.

Article 5 is replaced by the following: ‘Article 5 Labelling, delivery, record keeping and treatment requirements 1. In addition to the identification requirements provided for in Chapter I of Annex II to Regulation (EC) No 1774/2002, all packages of animal by-products referred to in Article 1(1) of the present Regulation, shall bear a label indicating “PROHIBITED IN FOOD, FEED, FERTILISERS, COSMETICS, MEDICINAL PRODUCTS AND MEDICAL DEVICES”. However, in case of animal by-products intended for medicinal products in accordance with Community legislation a different label may be used which shall indicate “DESTINED FOR MEDICINAL PRODUCTS ONLY”. 2. All packages of animal by-products referred to in Article 1(2), shall bear a label indicating “NOT FOR HUMAN CONSUMPTION”, unless they are dispatched in ready-to-sell packages, indicating that the content is destined for the feeding to pets only or for the use as fishing bait. 3. The animal by-products referred to in Article 1 of the present Regulation shall be delivered to a technical plant dedicated to the use of such materials and which has been approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002. The animal by-products referred to in Article 1(2) may also be delivered: (a) to an intermediate plant approved in accordance with Article 10(1) of Regulation (EC) No 1774/2002; (b) to a storage plant approved in accordance with Article 11(1) of Regulation (EC) No 1774/2002; (c) to a petfood plant approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002; (d) to a holding or establishment keeping animals in accordance with the requirements referred to in Article 23(2)(c) of Regulation (EC) No 1774/2002; (e) to the place of manufacture or the manufacturing establishment, as appropriate, of (i) cosmetic products in accordance with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (6), (ii) veterinary medicinal products in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (7), (iii) medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (8), (iv) medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (9) or (v) in vitro diagnostic devices in accordance with Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (10); or (f) directly for retail sale where the animal by-products are: (i) dispatched in ready-to-sell packages bearing a label with a clear indication that the content is only destined for: — the feeding to pets; or fishing bait (ii) dried by a treatment sufficient to destroy pathogenic organisms, including salmonella; or (iii) in the case of animal by-products referred to in Article 1(2)(b), (c) and, as regards Rodentia, (d) deep frozen; Without prejudice to Commission Regulation (EC) No 811/2003 of 12 May 2003 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the intra-species recycling ban for fish, the burial and burning of animal by-products and certain transitional measures (11), the animal by-products referred to in Article 1(2)(b) of the present Regulation may also be delivered for the use as feed material to a holding or establishment keeping aquatic animals. 4. The owner, operator or their representative of the plants, holdings or establishments referred to in paragraph 3 of this Article shall: (a) keep records in accordance with Article 9 of Regulation (EC) No 1774/2002; (b) ensure that the animal by-products are subjected, where appropriate, to a treatment which satisfies the competent authority in such a way that the resulting material does not pose a risk to animal and public health; (c) further dispatch or use the animal by-products exclusively for purposes authorised by the competent authority.