Commission Implementing Regulation (EU) No 1097/2012
of 23 November 2012
amending 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 as regards dispatch of animal by-products and derived products between Member States
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002, and in particular Article 21(5)(a) and Articles 23(3) and 48(2) thereof,
OJ L 300, 14.11.2009, p. 1.
Whereas:
(1) Regulation (EC) No 1069/2009 lays down public and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products. It also provides rules for placing on the market of animal by-products and derived products.
(2) Commission Regulation (EU) No 142/2011 of 25 February 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, lays down implementing rules for Regulation (EC) No 1069/2009, including rules on the registration of operators, the content of commercial documents which accompany consignments of animal by-products and derived products in trade between Member States and the layout of the notification form which must be provided for certain animal by-products and derived products pursuant to Article 48(1) of Regulation (EC) No 1069/2009.
OJ L 54, 26.2.2011, p. 1.
(3) Pursuant to Regulation (EC) No 1069/2009, operators are to ensure that animal by-products and derived products are traceable at all stages of the chain of collecting, manufacturing, use and disposal, so as to avoid unnecessary disruptions of the internal market in the case of events which are linked to actual or potential risks to public or animal health.
(4) Operators must ensure that activities covered by the scope of animal by-products legislation are registered or approved. However, handling of small quantities of Categories 2 and 3 materials may present negligible risk if they originate from areas where no transmissible disease to humans or animals has been notified. Member States should therefore be authorised to allow particular activities without registration as provided for in Article 23 of Regulation (EC) No 1069/2009. Such a derogation must be limited only to activities concerning the direct supply of the products within the region to the final user, on the local market or to local retail establishments.
(5) Each consignment of animal by-products or derived products to be traded between Member States is to be accompanied by a commercial document. However, it is necessary to amend and extend current requirements on the commercial document to ensure that it includes all necessary information on the safe handling, treatment and intended use or disposal of the concerned material.
(6) On the commercial document operators must specify certain information on the consignment, in particular the category of animal by-products or derived products, nature of commodity and type of treatment. According to Article 3 of Regulation (EU) No 142/2011 there is no need to issue a commercial document for derived products which have been declared as the end point in the manufacturing chain. Also a reference to processing standards in Regulation (EC) No 853/2004 of the European Parliament and of the Council may be removed. Annex VIII to Regulation (EU) No 142/2011 should therefore be amended.
OJ L 139, 30.4.2004, p. 55.
(7) Several animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009 must be authorised in advance by the competent authority of the Member State of destination upon application by the operator. Annex XVI to Regulation (EU) No 142/2011 sets out a standard format for the authorisation of the dispatch of animal by-products and derived products to another Member State. That format should be amended to include information on the end date of validity of authorisations, the volume or mass of the consignment, the name and address of the consignor, the origin of the animal by-products and the place of destination of the consignment. Annex XVI to Regulation (EU) No 142/2011 should therefore be amended.
(8) Regulation (EU) No 142/2011 should therefore be amended accordingly.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:

Article 1 Regulation (EU) No 142/2011 is amended as follows:
(1) in Article 20, point (c) of paragraph 4 is replaced by the following:

‘(c) operators transporting dry untreated wool and hair, provided they are securely enclosed in packaging, and directly dispatched to a plant producing derived products for uses outside the feed chain or to a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents;
(d) operators using small quantities of Categories 2 and 3 materials referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009 or of products derived therefrom, for the purpose of direct supply of the products within the region to the final user, on the local market or to local retail establishments, if the competent authority does not consider such activity to present a risk of spreading any serious transmissible disease to humans or animals; this point shall not apply where those materials are used as feed for farmed animals other than fur animals.’;

(2) Annexes VIII and XVI are amended in accordance with the text in the Annex to this Regulation.
Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 November 2012.
For the Commission
The President
José Manuel Barroso
ANNEX The Annexes to Regulation (EU) No 142/2011 are amended as follows:
(1) in Annex VIII, Chapter III, the model commercial document is replaced by the following:

‘Commercial document
For the transport of animal by-products and derived products not intended for human consumption in accordance with Regulation (EC) No 1069/2009 within the European Union’

(2) in Annex XVI, Chapter III, Section 10 is replaced by the following:

‘Section 10 Standard format for applications for certain authorisations in intra-Union trade
Operators shall apply to the competent authority of the Member State of destination for the authorisation of the dispatch of animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009 in accordance with the following format:’