2011R0142 — EN — 15.03.2013 — 003.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B 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 (Text with EEA relevance) (OJ L 054, 26.2.2011, p.1)

Amended by:









▼B

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

(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 (Animal by-products Regulation) ( 1 ), and in particular Articles 5(2) and 6(1)(b)(ii) and the second subparagraph of Article 6(1), the second subparagraph of Article 6(2), Article 11(2)(b) and (c) and the second subparagraph of Article 11(2), Article 15(1)(b), (d), (e), (h) and (i) and the second subparagraph of Article 15(1), Articles 17(2) and 18(3), Article 19(4)(a), (b) and (c) and the second subparagraph of Article 19(4), Article 20(10) and (11), Article 21(5) and (6), Articles 22(3) and 23(3), Article 27(a), (b), (c) and (e) to (h) and the second subparagraph of Article 27, Articles 31(2), 32(3), Article 40, the first and third subparagraph of Article 41(3), Article 42, Articles 43(3), 45(4), 47(2), Article 48(2), Article 48(7)(a) and (8)(a) and the second subparagraph of Article 48(8) thereof, Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries ( 2 ), and in particular Article 16(3) thereof, Whereas: (1) Regulation (EC) No 1069/2009 lays down animal and public health rules for animal by-products and products derived thereof. That Regulation determines the circumstances under which animal by-products are to be disposed of, in order to prevent the spreading of risks for public and animal health. In addition, that Regulation specifies under which conditions animal by-products may be used for applications in animal feed and for various purposes, such as in cosmetics, medicinal products and technical applications. It also lays down obligations for operators to handle animal by-products within establishments and plants which are subject to official controls. (2) Regulation (EC) No 1069/2009 provides that detailed rules for the handling of animal by-products and derived products, such as processing standards, hygiene conditions and the format for documentary evidence which has to accompany consignments of animal by-products and derived products for the purposes of traceability are to be adopted by means of implementing measures. (3) The detailed rules for the use and disposal of animal by-products in this Regulation should be laid down with a view to the achievement of the objectives of Regulation (EC) No 1069/2009, notably the sustainable use of animal materials, and a high level of protection of public and animal health in the European Union. (4) Regulation (EC) No 1069/2009 does not apply to entire bodies or parts of wild animals, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes. In addition, it does not apply to entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice. Regarding those animal by-products from hunting, disposal should be carried out in a way which prevents the transmission of risks, as appropriate for specific hunting practices and in accordance with the good practice as it has been described by the hunting profession. (5) Regulation (EC) No 1069/2009 applies to animal by-products for the preparation of game trophies. The preparation of such trophies, as well as the preparations of animals and parts of animals for which other methods, such as plastination, are used, should take place under conditions which prevent the transmission of risks for human or animal health. (6) Regulation (EC) No 1069/2009 applies to catering waste if it originates from means of transport operating internationally, such as materials derived from foodstuffs served on board an airplane or a ship arriving in the European Union from a third country destination. Catering waste also falls within the scope of that Regulation, if it is destined for feeding purposes, for processing in accordance with one of the authorised processing methods under this Regulation or for transformation into biogas or for composting. Regulation (EC) No 1069/2009 prohibits the feeding of catering waste to farmed animals, other than fur animals. Therefore, in accordance with Regulation (EC) No 1069/2009, catering waste may be processed and subsequently used, provided that the derived product is not fed to such animals. (7) For the sake of consistency of Union legislation, the definition of feed materials in Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EEC and 96/25/EC and Commission Decision 2004/217/EC ( 3 ) should be used as a basis for defining feed materials of animal origin in this Regulation. (8) Regulation (EC) No 1069/2009 prohibits the dispatch of animal by-products and of derived products from susceptible species from holdings, establishments, plants or zones which are subject to restrictions due to the presence of a serious transmissible disease. In order to provide for a high level of protection of animal health in the Union, the list of diseases in the Terrestrial and Aquatic Animal Health Codes of the World Organisation of Animal Health (hereinafter referred to as ‘OIE’) should be specified as the list of serious transmissible diseases for the purpose of determining the scope of this prohibition. (9) Since the incineration and the co-incineration of certain animal by-products do not fall within the scope of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste ( 4 ), adequate rules for the prevention of health risks arising from such operations should be laid down in this Regulation, taking into account the possible effects on the environment. Residues from the operation of the incineration or co-incineration of animal by-products or derived products should be recycled or disposed of, in accordance with Union environmental legislation, since in particular, that legislation allows for the use of the phosphorous component of ashes in fertilisers and for the handover of ashes from the cremation of pet animals to the owners. (10) Products of animal origin or foodstuffs containing such products, should only be disposed of in a landfill, in accordance with Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste ( 5 ), if they have been processed as defined in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( 6 ), in order to mitigate potential health risks. (11) The disposal of animal by-products or derived products via the wastewater stream should be prohibited, since that stream is not subject to requirements which would ensure an appropriate control of public and animal health risks. Appropriate measures should be taken to prevent unacceptable risks from accidental disposal of liquid animal by-products, such as from the cleaning of floors and equipments used for processing. (12) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives ( 7 ) lays down certain measures to protect the environment and human health. Article 2(2)(b) of that Directive provides that certain matters are excluded from the scope of that Directive to the extent that they are covered by other Union legislation, including animal by-products covered by Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption ( 8 ), except those which are destined for incineration, landfilling or use in a biogas or composting plant. That Regulation has now been repealed and replaced by Regulation (EC) No 1069/2009 from 4 March 2011. In the interests of coherency of Union legislation, the processes whereby animal by-products and derived products are transformed into biogas and composted should comply with the health rules laid down in this Regulation, as well as the measures for the protection of the environment laid down in Directive 2008/98/EC. (13) The competent authority of a Member State should be able to authorise alternative parameters for the transformation of animal by-products into biogas or for their composting on the basis of a validation according to a harmonised model. In that case, it should be possible to place digestion residues and compost on the market in the whole European Union. In addition, the competent authority of a Member State should be able to authorise certain parameters for specific animal by-products, such as catering waste and mixtures of catering waste with certain other materials, which are transformed into biogas or composted. Since such authorisations are not issued according to a harmonised model, digestion residues and compost should only be placed on the market within the Member State where the parameters have been authorised. (14) In order to prevent the contamination of foodstuffs with pathogenic agents, establishments or plants processing animal by-products should operate on a separate site from slaughterhouses or other establishments in which foodstuffs are processed, in particular in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 9 ), unless the processing of the animal by-products takes place under conditions which have been approved by the competent authority, with a view to preventing the transmission of risks to public and animal health into the food-processing establishments. (15) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies ( 10 ) provides that Member States are to carry out annual monitoring programmes for transmissible spongiform encephalopathies (TSEs). Bodies of animals which are used for feeding to certain species, for the purposes of promotion of bio-diversity, should be included in those monitoring programmes to the extent necessary to ensure that those programmes provide sufficient information regarding the prevalence of TSE in a particular Member State. (16) Regulation (EC) No 1069/2009 allows the feeding of certain Category 1 material to endangered or protected species of necrophagous birds and to other species living in their natural habitat, for the promotion of biodiversity. Such feeding should be authorised for certain carnivore species referred to in Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora ( 11 ) and for certain species of birds of prey referred to in Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds ( 12 ), in order to take into account the natural feeding patterns of those species. (17) Regulation (EC) No 1069/2009 has introduced a procedure for the authorisation of alternative methods of use or disposal of animal by-products or derived products. Such methods may be authorised by the Commission following receipt of an opinion from the European Food Safety Authority (hereinafter referred to as ‘EFSA’). In order to facilitate the evaluation of applications by EFSA, a standard format should be laid down which illustrates to applicants the nature of the evidence to be submitted. In accordance with the Treaties, it should be possible to submit applications for alternative methods in the official languages of the Union, as laid down in EEC Council Regulation No 1 determining the languages to the used by the European Economic Community ( 13 ). (18) In accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene ( 14 ), feed business operators, other than primary producers, are required to store and transport feed under certain hygienic conditions. Since those conditions provide for an equivalent mitigation of potential risks, compound feedingstuffs derived from animal by-products should not be subject to the requirements of this Regulation regarding storage and transport. (19) For the promotion of science and research and to ensure the best possible use of animal by-products and of derived products in the diagnosis of human or animal diseases, the competent authority should be authorised to lay down conditions for samples of such materials for research, educational and diagnostic purposes. However, those conditions should not be laid down for samples of pathogenic agents for which special rules are provided in Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC ( 15 ). (20) Directive 97/78/EC exempts animal by-products which are intended for exhibitions, provided that they are not intended to be marketed, and animal by-products intended for particular studies or analyses from veterinary checks in the border inspection post of entry into the Union. That Directive allows for the adoption of implementing measures for those exemptions. In this Regulation, appropriate conditions should be set out for the import of animal by-products and derived products intended for exhibitions and particular studies or analyses, to ensure that no unacceptable risks to public or animal health are spread where such products enter the Union. In the interests of coherency of Union legislation, and in order to provide legal certainty to operators, those conditions and the implementing measures for Directive 97/78/EC should be laid down in this Regulation. (21) Following collection, animal by-products should be handled under appropriate conditions which ensure that no unacceptable risks to public or animal health are transmitted. Establishments or plants in which certain operations are carried out before animal by-products are submitted to further processing should be constructed and should operate in a manner which prevents such transmission. This should include establishments or plants where operations involving the handling of animal by-products in accordance with Union veterinary legislation, other than the handling of animal by-products in the course of curative activities of private veterinarians, are carried out. (22) 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 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. Traceability should therefore not only be ensured by operators generating, collecting or transporting animal by-products, but also by operators disposing of animal by-products or derived products, by incineration, co-incineration or landfilling. (23) Containers and means of transport which are used for animal by-products or derived products should be maintained in a clean state, so as to prevent contamination. When they are dedicated to the transport of a particular material, such as a liquid animal by-product which does not pose an unacceptable health risk, operators may adjust their measures to ensure the prevention of contamination to the actual risk arising from that material. (24) Member States should be authorised to require operators to use the integrated computerised veterinary system (Traces) introduced by Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC ( 16 ) (hereinafter referred to as ‘the TRACES system’) in order to provide proof for the arrival of consignments of animal by-products or derived products at the place of destination. Alternatively, proof for the arrival of consignments should be provided by way of a fourth copy of the commercial document, which is returned to the producer. The experience with the two alternatives should be evaluated after the first year of implementation of this Regulation. (25) Regulation (EC) No 853/2004 specifies certain parameters for the treatment of rendered fats, fish oil and egg products which provide an adequate control of possible health risks, when such products are used for purposes other than human consumption. Those parameters should therefore be authorised as alternatives to the treatments for animal by-products which are set out in this Regulation. (26) Colostrum and colostrum products should originate from bovine herds which are free of certain diseases as referred to in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine ( 17 ). (27) The references to Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products ( 18 ), to Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists ( 19 ), to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products ( 20 ) should be updated and the reference to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs ( 21 ) in the health rules for the trade in unprocessed manure should be updated. (28) Certain imported materials for the production of petfood should be handled and used under conditions which are appropriate to the risk which such materials may pose. In particular, provision should be made for their safe channelling to establishments or plants of destination where such materials, as well as Category 3 material, are incorporated into petfood. With respect to the establishments or plants of destination, the competent authority should be authorised to allow the storage of imported materials together with Category 3 material, provided the imported materials can be traced. (29) Regulation (EC) No 1069/2009 refers to certain derived products which may be placed on the market in accordance with conditions laid down in certain other Union legislation. That legislation also lays down conditions for the import, collection and movement of animal by-products and derived products for the manufacture of such derived products. However, Regulation (EC) No 1069/2009 applies where that other Union legislation does not lay down conditions concerning risks to public and animal health which may arise from such raw materials. Since such conditions have not been laid down regarding materials which have undergone certain stages of processing prior to their fulfilling the conditions for placing on the market under that other Union legislation, they should be laid down in this Regulation. In particular, the conditions for the import and handling of such materials inside the Union under strict control and documentation requirements should be laid down, so as to prevent the transmission of potential health risks from such materials. (30) In particular, adequate health conditions should be laid down in this Regulation for materials which are used for the manufacture of 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 ( 22 ), of 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 ( 23 ), of medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 24 ), of in vitro diagnostic medical devices in accordance with Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 25 ), active implantable medical devices in accordance with Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws of the Member States relating to active implantable medical devices ( 26 ) or laboratory reagents (‘the finished products’). If the risks arising from such materials are mitigated due to the purification, concentration in the product or due to the conditions under which they are handled and disposed of, only the requirements of Regulation (EC) No 1069/2009 and of this Regulation in relation to traceability should apply. In such case, the requirements related to the separation of animal by-products of different categories within the establishment or plant producing the finished products should not apply, since the subsequent use of materials for other purposes, in particular their diversion into food or feed can be excluded by the proper application of the rules by the operator, under the responsibility of the competent authority. Consignments of such materials which are to be imported into the Union should be subject to veterinary checks at the border inspection post of entry in accordance with Directive 97/78/EC, in order to ascertain that those products comply with the requirements for their placing on the market within the Union. (31) Pursuant to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and import from third countries of equidae ( 27 ), certain diseases to which equidae are susceptible are compulsorily notifiable. Blood products from equidae which are intended for purposes other than for feeding, such as blood products intended for veterinary medicinal products, should originate from equidae which did not show clinical signs of those diseases, in order to mitigate the risk of transmission of those diseases. (32) It should be permissible to place on the market fresh hides and skins for purposes other than human consumption, provided they comply with the animal health conditions for fresh meat laid down in accordance with Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 28 ), since those conditions provide for an appropriate mitigation of possible health risks. (33) The health rules laid down in this Regulation for the manufacture and placing on the market of game trophies and other preparations from animals which eliminate potential risks should be in addition to the rules for the protection of certain species of wild animals laid down in Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein ( 29 ), due to the different objective of that Regulation. Anatomical preparations of animals or animal by-products which have been submitted to a process such as plastination which equally eliminates potential risks should not be subject to animal health restrictions, in order to facilitate the use of such preparations, in particular in education. (34) Apiculture by-products which are to be placed on the market should be free of certain diseases to which bees are susceptible that are listed in Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC ( 30 ). (35) The European Parliament and the Council have called upon the Commission to determine an end point in the manufacturing chain for oleochemical products, beyond which they are no longer subject to the requirements of Regulation (EC) No 1069/2009. The decision regarding that end point should be taken as soon as an assessment has become available which evaluates the capacity of the oleochemical processes to mitigate potential health risks which may be present in animal fats of any category of material which are processed. (36) Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements ( 31 ) should be referred to in this Regulation, in so far as those third countries and other territories should be authorised for the importation of certain animal by-products or derived products, since the risks which arise from those products are identical to those which potentially arise from the import of live animals or fresh meat. (37) Further lists of third countries from which certain materials of animal origin may be imported should be referred to for the purposes of determining the third countries from which animal by-products of the respective species may be imported, on the basis of similar considerations concerning health risks and in order to ensure coherency of Union legislation. Such lists have been laid down in Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species and amending Decisions 93/195/EEC and 94/63/EC ( 32 ), Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certifications conditions for introduction into the European Union of raw milk and dairy products intended for human consumption ( 33 ), Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted ( 34 ), Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements ( 35 ) and Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements ( 36 ). (38) Since waste from the photographic industry which uses certain animal by-products such as bovine vertebral column does not only pose risks to public and animal health, but also risks to the environment, it should either be disposed of or exported to the third country of origin of the animal by-products in accordance with Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste ( 37 ). (39) The list of border inspection posts laid down in Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces ( 38 ) should be referred to in the rules for the transit of certain animal by-products and derived products through the European Union between territories of the Russian Federation. The Common Veterinary Entry Document laid down in Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries ( 39 ) should be used for the purposes of that transit. (40) This Regulation should provide that the health certificates which are to accompany consignments of animal by-products or derived products at the point of entry into the Union where the veterinary checks take place should be issued in accordance with principles of certification equivalent to those laid down in Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products ( 40 ). (41) In the interests of consistency of Union legislation, official controls on the entire chain of animal by-products and derived products should be carried out in accordance with the general obligations for official controls which are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ( 41 ). (42) It is therefore necessary to lay down implementing measures for Regulation (EC) No 1069/2009 in this Regulation. (43) Regulation (EC) No 1069/2009 repeals Regulation (EC) No 1774/2002 with effect from 4 March 2011. (44) Following the adoption of Regulation (EC) No 1774/2002, certain implementing acts were adopted, namely Commission Regulation (EC) No 811/2003 ( 42 ) on the intra-species recycling ban for fish, and the burial and burning of certain animal by-products, Commission Decision 2003/322/EC ( 43 ) on the feeding of certain necrophagous birds with certain Category 1 materials, Commission Decision 2003/324/EC ( 44 ) on a derogation from the intra-species recycling ban for fur animals, Commission Regulations (EC) No 79/2005 ( 45 ) on milk and milk-based products, (EC) No 92/2005 ( 46 ) on means of disposal or uses, (EC) No 181/2006 ( 47 ) on organic fertilisers and soil improvers other than manure, (EC) No 1192/2006 ( 48 ) on lists of approved plants and (EC) No 2007/2006 ( 49 ) on the importation and transit of certain Category 3 intermediate products. (45) In addition, certain transitional measures were adopted, in particular Commission Regulation (EC) No 878/2004 ( 50 ) on the import and handling of certain Category 1 and Category 2 materials, Commission Decision 2004/407/EC ( 51 ) on the import of certain materials for the production of photogelatine and Commission Regulation (EC) No 197/2006 ( 52 ) on handling and disposal of former foodstuffs, to lay down risk-proportionate measures for certain specific uses of animal by-products. (46) In order to further simplify Union rules for animal by-products, as requested by the Presidency of the Council at the time of the adoption of Regulation (EC) No 1069/2009, those implementing and transitional measures were reviewed. They should now be repealed and replaced, as necessary, by this Regulation, so as to constitute a coherent legal framework for animal by-products and derived products. (47) Regulation (EC) No 1069/2009 applies from 4 March 2011 and accordingly this Regulation should also apply from that date. In addition, it is necessary to provide for a transitional period, in order to give stakeholders time to adjust to the new rules laid down in this Regulation and to place on the market certain products which were produced in accordance with Union health rules applicable before that date, and to allow for a continuation of imports when the requirements of this Regulation become applicable. (48) The placing on the market and the export of certain products referred to in Regulation (EC) No 878/2004 should continue to be carried out in accordance with national measures, since the associated risks for the limited amount of materials involved currently allow their regulation at national level, pending possible future harmonisation. Pending the adoption of measures for the collection and disposal of certain limited amounts of products of animal origin from the retail sector on the basis of further evidence, the competent authority should continue to be able to authorise the collection and disposal of such products by other means, provided that an equivalent protection of public and animal health is ensured. (49) In accordance with the request expressed by the European Parliament at the time of its agreement to Regulation (EC) No 1069/2009 at first reading, and taking into account the Parliament's more specific suggestions for addressing certain technical issues, a draft of this Regulation has been presented on 27 September 2010 to its Committee for the Environment, Public Health and Food Safety for an exchange of views. (50) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

This Regulation lays down implementing measures:

(a) for the public and animal health rules for animal by-products and derived products laid down in Regulation (EC) No 1069/2009;

(b) concerning certain samples and items exempt from veterinary checks at border inspection posts as provided for in Article 16(1)(e) and (f) of Directive 97/78/EC.

Article 2

Definitions

For the purposes of this Regulation, the definitions set out in Annex I apply.

Article 3

End point in the manufacturing chain for certain derived products

The following derived products may be placed on the market, other than imported, without restrictions, as provided in Article 5(2) of Regulation (EC) No 1069/2009:

(a) biodiesel which fulfils the requirements for the disposal and use of derived products set out in point 2(b) of Section 3 of Chapter IV of Annex IV;

(b) processed petfood which fulfil the specific requirements for processed petfood set out in point 7(a) of Chapter II of Annex XIII;

(c) dogchews which fulfil the specific requirements for dogchews set out in point 7(b) of Chapter II of Annex XIII;

(d) hides and skins of ungulates which fulfil the specific requirements for the end point for those products set out in point C of Chapter V of Annex XIII;

(e) wool and hair, which fulfil the specific requirements for the end point for those products set out in point B of Chapter VII of Annex XIII;

(f) feathers and down, which fulfil the specific requirements for the end point for those products set out in point C of Chapter VII of Annex XIII;

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(g) fur which fulfils the special requirements for the end point for that product set out in Chapter VIII of Annex XIII;

(h) fish oil for the production of medicinal products which fulfils the special requirements for the end point for that product set out in Chapter XIII of Annex XIII;

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(i) gasoline and fuels which fulfil the specific requirements for products from the multi-step catalytic process for the production of renewable fuels set out in point 2(c) of Section 3 of Chapter IV of Annex IV;

(j) oleochemical products derived from rendered fats and which fulfil the requirements set out in Chapter XI of Annex XIII.

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Article 4

Serious transmissible diseases

The diseases listed by the OIE in Article 1.2.3 of the Terrestrial Animal Health Code, 2010 edition, and in Chapter 1.3 of the Aquatic Animal Health Code, 2010 edition, shall be regarded as serious transmissible diseases for the purposes of general animal health restrictions, as provided for in Article 6(1)(b)(ii) of Regulation (EC) No 1069/2009.







CHAPTER II

DISPOSAL AND USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS

Article 5

Restrictions on the use of animal by-products and derived products

1. Operators in the Member States referred to in Chapter I of Annex II shall comply with the conditions for the feeding of fur animals with certain materials derived from bodies or parts of animals of the same species set out in the same Chapter.

2. Operators shall comply with the restrictions on the feeding of farmed animals with herbage from land to which certain organic fertilisers or soil improvers have been applied, as set out in Chapter II of Annex II.

Article 6

Disposal by incineration and co-incineration

1. The competent authority shall ensure that incineration and co-incineration of animal by-products and derived products shall only take place:

(a) in incineration plants and co-incineration plants which have been granted a permit in accordance with Directive 2000/76/EC; or

(b) for plants not required to have a permit under Directive 2000/76/EC, in incineration and co-incineration plants which have been approved by the competent authority to carry out disposal by incineration, or disposal or recovery of animal by-products or derived products, if they are waste, by co-incineration, in accordance with Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009.

2. The competent authority shall only approve incineration plants and co-incineration plants as referred to in point 1(b), in accordance with Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009, if they comply with the requirements set out in Annex III hereto.

3. Operators of incineration plants and co-incineration plants shall comply with the general requirements for incineration and co-incineration set out in Chapter I of Annex III.

4. Operators of high-capacity incineration and co-incineration plants shall comply with the requirements of Chapter II of Annex III.

5. Operators of low-capacity incineration and co-incineration plants shall comply with the requirements of Chapter III of Annex III.

Article 7

Landfilling of certain Category 1 and 3 materials

By way of derogation from Article 12 and Article 14(c) of Regulation (EC) No 1069/2009, the competent authority may authorise the disposal of the following Category 1 and 3 materials in an authorised landfill:

(a) imported petfood or petfood produced from imported materials, from Category 1 material referred to in Article 8(c) of Regulation (EC) No 1069/2009;

(b) Category 3 material referred to in Article 10(f) and (g) of Regulation (EC) No 1069/2009, provided that: (i) such materials have not been in contact with any of the animal by-products referred to in Articles 8 and 9 and Article 10(a) to (e) and (h) to (p) of that Regulation; (ii) at the time when they are destined for disposal, the materials: — referred to in Article 10(f) of that Regulation have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004, and — referred to in Article 10(g) of that Regulation have been processed in accordance with Chapter II of Annex X hereto or in accordance with the specific requirements for petfood set out in Chapter II of Annex XIII hereto; and (iii) the disposal of such materials does not pose a risk to public or animal health.

Article 8

Requirements for processing plants and other establishments

1. Operators shall ensure that processing plants and other establishments under their control comply with the following requirements set out in Chapter I of Annex IV:

(a) the general conditions for processing set out in Section 1;

(b) the requirements for wastewater treatment set out in Section 2;

(c) the specific requirements for the processing of Category 1 and 2 materials set out in Section 3;

(d) the specific requirements for the processing of Category 3 materials set out in Section 4.

2. The competent authority shall only approve processing plants and other establishments, if they comply with the conditions laid down in Chapter I of Annex IV.

Article 9

Hygiene and processing requirements for processing plants and other establishments

Operators shall ensure that establishments and plants under their control comply with the following requirements set out in Annex IV:

(a) the hygiene and processing requirements set out in Chapter II;

(b) the standard processing methods set out in Chapter III, provided such methods are used in the establishment or plant;

(c) the alternative processing methods set out in Chapter IV, provided such methods are used in the establishment or plant.

Article 10

Requirements regarding the transformation of animal by-products and derived products into biogas and composting

1. Operators shall ensure that establishments and plants under their control comply with the following requirements for the transformation of animal by-products and derived products into biogas or for composting set out in Annex V:

(a) the requirements applicable to biogas and composting plants set out in Chapter I;

(b) the hygiene requirements applicable to biogas and composting plants set out in Chapter II;

(c) the standard transformation parameters set out in Section 1 of Chapter III;

(d) the standards for digestion residues and compost set out in Section 3 of Chapter III.

2. The competent authority shall only approve biogas and composting plants, if they comply with the requirements laid down in Annex V.

3. The competent authority may authorise the use of alternative transformation parameters for biogas and composting plants subject to the requirements set out in Section 2 of Chapter III of Annex V.







CHAPTER III

DEROGATIONS FROM CERTAIN PROVISIONS OF REGULATION (EC) No 1069/2009

Article 11

Special rules on research and diagnostic samples

1. The competent authority may authorise the transport, use and disposal of research and diagnostic samples under conditions which ensure the control of the risks to public and animal health.

The competent authority shall in particular ensure that operators comply with the requirements of Chapter I of Annex VI.

2. Operators shall comply with the special rules on research and diagnostic samples set out in Chapter I of Annex VI.

3. Operators may dispatch research and diagnostic samples which consist of the following animal by-products and derived products to another Member State without informing the competent authority of the Member State of origin in accordance with Article 48(1) of Regulation (EC) No 1069/2009 and without the competent authority of the Member State of destination being informed by means of the TRACES system and agreeing to accept the consignment in accordance with Article 48(1) and (3) of that Regulation:

(a) Category 1 and 2 materials and meat-and-bone meal or animal fat derived from Category 1 and 2 materials;

(b) processed animal protein.

Article 12

Special rules on trade samples and display items

1. The competent authority may authorise the transport, use and disposal of trade samples and display items under conditions which ensure the control of the risks to public and animal health.

The competent authority shall in particular ensure that operators comply with the requirements of points 2, 3 and 4 of Section 1 of Chapter I of Annex VI.

2. Operators shall comply with the special rules on trade samples and display items set out in Section 2 of Chapter I of Annex VI.

3. Operators may dispatch trade samples which consist of the following animal by-products and derived products to another Member State without informing the competent authority of the Member State of origin in accordance with Article 48(1) of Regulation (EC) No 1069/2009 and without the competent authority of the Member State of destination being informed by means of the TRACES system and agreeing to accept the consignment in accordance with Article 48(1) and (3) of that Regulation:

(a) Category 1 and 2 materials and meat-and-bone meal or animal fat derived from Category 1 and 2 materials;

(b) processed animal protein.

Article 13

Special feeding rules

1. Operators may feed Category 2 material to the following animals, provided that such material comes from animals which were not killed or did not die as a result of the presence or suspected presence of a disease communicable to humans or animals, subject to compliance with the general requirements laid down in Section 1 of Chapter II of Annex VI and any other conditions that may be laid down by the competent authority:

(a) zoo animals;

(b) fur animals;

(c) dogs from recognised kennels or packs of hounds;

(d) dogs and cats in shelters;

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(e) maggots and worms for fishing bait;

(f) circus animals.

▼B

2. Operators may feed Category 3 material to the following animals subject to compliance with the general requirements laid down in Section 1 of Chapter II of Annex VI and any other conditions that may be laid down by the competent authority:

(a) zoo animals;

(b) fur animals;

(c) dogs from recognised kennels or packs of hounds;

(d) dogs and cats in shelters;

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(e) maggots and worms for fishing bait;

(f) circus animals.

▼B

Article 14

Feeding of certain species in and outside feeding stations and in zoos

1. The competent authority may authorise the use of Category 1 material consisting of entire bodies or parts of dead animals containing specified risk material for the feeding:

(a) in feeding stations, to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity, subject to compliance with the conditions set out in Section 2 of Chapter II of Annex VI;

(b) outside feeding stations, if appropriate without prior collection of the dead animals, to wild animals referred to point 1(a) of Section 2 of Chapter II of Annex VI, subject to compliance with the conditions set out in Section 3 of that Chapter.

2. The competent authority may authorise the use of Category 1 material consisting of entire bodies or parts of dead animals containing specified risk materials and the use of material derived from zoo animals for the feeding of zoo animals subject to compliance with the conditions set out in Section 4 of Chapter II of Annex VI.

Article 15

Special rules on collection and disposal

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If the competent authority authorises the disposal of animal by-products by way of the derogation provided for in Article 19(1)(a), (b), (c), (e) and (f) of Regulation (EC) No 1069/2009, the disposal shall comply with the following special rules set out in Chapter III of Annex VI:

▼B

(a) the special disposal rules for animal by-products set out in Section 1;

(b) the rules for the burning and burial of animal by-products in remote areas set out in Section 2;

(c) the rules for the burning and burial of bees and apiculture by-products set out in Section 3.







CHAPTER IV

AUTHORISATIONS OF ALTERNATIVE METHODS

Article 16

Standard format for applications for authorisation of alternative methods

1. Applications for authorisation of alternative methods of use or disposal of animal by-products or derived products, as referred to in Article 20(1) of Regulation (EC) No 1069/2009, shall be submitted by Member States or interested parties in accordance with the requirements of the standard format for applications for alternative methods set out in Annex VII.

2. Member States shall designate national contact points to provide information on the competent authority responsible for evaluating applications for authorisation of alternative methods of use or disposal of animal by-products.

3. The Commission shall publish a list of national contact points on its website.







CHAPTER V

COLLECTION, TRANSPORT, IDENTIFICATION AND TRACEABILITY

Article 17

Requirements regarding commercial documents and health certificates, identification, the collection and transport of animal by-products and traceability

1. Operators shall ensure that animal by-products and derived products:

(a) comply with the requirements for collection, transport and identification set out in Chapters I and II of Annex VIII;

(b) are accompanied during transport by commercial documents or health certificates in accordance with the requirements set out in Chapter III of Annex VIII.

2. Operators consigning, transporting or receiving animal by-products or derived products shall keep records of consignments and related commercial documents or health certificates in accordance with the requirements set out in Chapter IV of Annex VIII.

3. Operators shall comply with the requirements for the marking of certain derived products set out in Chapter V of Annex VIII.







CHAPTER VI

REGISTRATION AND APPROVAL OF ESTABLISHMENTS AND PLANTS

Article 18

Requirements regarding the approval of one or more establishments and plants handling animal by-products on the same site

The competent authority may grant approval to more than one establishment or plant handling animal by-products on the same site, provided that the transmission of risks to public and animal health between the establishments or plants is excluded by their layout and the handling of animal by-products and derived products within the establishments or plants.

Article 19

Requirements concerning certain approved establishments and plants handling animal by-products and derived products

Operators shall ensure that establishments and plants under their control which have been approved by the competent authority, comply with the requirements set out in the following Chapters of Annex IX hereto where they carry out one or more of the following activities referred to Article 24(1) of Regulation (EC) No 1069/2009:

(a) Chapter I, where they manufacture petfood as referred to in Article 24(1)(e) of that Regulation;

(b) Chapter II, where they store animal by-products as referred to in Article 24(1)(i) of that Regulation and where they handle animal by-products after their collection, by way of the following operations referred to in Article 24(1)(h) of that Regulation: (i) sorting; (ii) cutting; (iii) chilling; (iv) freezing; (v) salting; (vi) preservation by other processes; (vii) removal of hides and skins or removal of specified risk material; (viii) operations involving the handling of animal by-products which are carried out in compliance with obligations under Union veterinary legislation; (ix) hygienisation/pasteurisation of animal by-products destined for transformation into biogas/composting, prior to such transformation or composting in another establishment or plant in accordance with Annex V hereto; (x) sieving;

(c) Chapter III, where they store derived products for certain intended purposes as referred to in Article 24(1)(j) of that Regulation.

Article 20

Requirements concerning certain registered establishments and plants handling animal by-products and derived products

1. Operators of registered plants or establishments or other registered operators shall handle animal by-products and derived products under the conditions set out in Chapter IV of Annex IX.

2. Registered operators transporting animal by-products or derived products, other than between premises of the same operator, shall in particular comply with the conditions set out in point 2 of Chapter IV of Annex IX.

3. Paragraphs 1 and 2 shall not apply to:

(a) approved operators who are transporting animal by-products or derived products as an ancillary activity;

(b) operators who have been registered for transport activities in accordance with Regulation (EC) No 183/2005.

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4. The competent authority may exempt the following operators from the obligation to notify, referred to in Article 23(1)(a) of Regulation (EC) No 1069/2009:

(a) operators handling or generating game trophies or other preparations referred to in Chapter VI of Annex XIII hereto for private or non-commercial purposes;

(b) operators handling or disposing research and diagnostic samples for educational purposes;

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(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.

▼B







CHAPTER VII

PLACING ON THE MARKET

Article 21

Processing and placing on the market of animal by-products and derived products for feeding to farmed animals, excluding fur animals

1. Operators shall comply with the following requirements for the placing on the market, other than the import, of the animal by-products and derived products destined for feeding to farmed animals excluding fur animals, as provided for in Article 31(2) of Regulation (EC) No 1069/2009, set out in Annex X hereto:

(a) the general requirements for the processing and the placing on the market set out in Chapter I;

(b) the specific requirements for processed animal proteins and other derived products set out in Chapter II;

(c) the requirements for certain fish feed and fishing baits set out in Chapter III.

2. The competent authority may authorise the placing on the market, other than the import, of milk, milk-based products and milk-derived products categorised as Category 3 material in accordance with Article 10(e), (f) and (h) of Regulation (EC) No 1069/2009 and which have not been processed in accordance with the general requirements set out in Part I of Section 4 of Chapter II of Annex X hereto, provided that those materials comply with the requirements for the derogation for the placing on the market of milk processed in accordance with national standards set out in Part II of that Section.

Article 22

Placing on the market and use of organic fertilisers and soil improvers

1. Operators shall comply with the requirements for the placing on the market, other than the import, of organic fertilisers and soil improvers, and the use of such products, in particular their application to land, as provided for in Articles 15(1)(i) and 32(1) of Regulation (EC) No 1069/2009, set out in Annex XI hereto.

2. The placing on the market, including the import, of guano from wild sea birds is not subject to any animal health conditions.

3. The competent authority of the Member State where an organic fertiliser or a soil improver, which has been produced from meat-and-bone meal derived from Category 2 material or from processed animal protein, is to be applied to land, shall authorise one or more components which are to be mixed with those materials, in accordance with Article 32(1)(d) of Regulation (EC) No 1069/2009, according to the criteria set out in point 3 of Section 1 of Chapter II of Annex XI hereto.

4. By way of derogation from Article 48(1) of Regulation (EC) No 1069/2009, the competent authorities of a Member State of origin and of a Member State of destination, which share a common border may authorise the dispatch of manure between farms located in border regions of those two Member States subject to appropriate conditions for the control of any possible risks to public or animal health, such as obligations for the operators concerned to keep appropriate records, which are laid down in a bilateral agreement.

5. As provided for in Article 30(1) of Regulation (EC) No 1069/2009, the competent authorities of the Member States shall encourage, where necessary, the development, dissemination and use of national guides for good agricultural practice for the application of organic fertilisers and soil improvers to land.

Article 23

Intermediate products

1. Intermediate products, imported into or in transit through the Union shall comply with the conditions controlling potential risks to public and animal health referred to in Annex XII hereto.

2. Intermediate products which have been transported to an establishment or plant referred to in point 3 of Annex XII hereto, may be handled without further restrictions under Regulation (EC) No 1069/2009 and under this Regulation, provided that:

(a) the establishment or plant has adequate facilities for the receipt of the intermediate products, which prevent the transmission of diseases communicable to humans or animals;

(b) the intermediate products do not pose any risk of transmission of diseases communicable to humans or animals, due to their purification or to other treatments to which the animal by-products in the intermediate product have been submitted, due to the concentration of animal by-products in the intermediate product or due to adequate bio-security measures for the handling of the intermediate products;

(c) the establishment or plant keeps records on the amount of materials received, their category, if applicable, and the establishment, plant or operator to whom they have supplied their products; and

(d) unused intermediate products or other surplus materials from the establishment or plant, such as expired products, are disposed of in accordance with Regulation (EC) No 1069/2009.

3. The operator or owner of the establishment or plant of destination of intermediate products or his representative shall use and/or dispatch the intermediate products exclusively for further mixing, coating, assembling, packaging or labelling.

Article 24

Petfood and other derived products

1. The use of Category 1 material referred to in Article 8(a),(b), (d) and (e) of Regulation (EC) No 1069/2009 for the manufacture of derived products which are intended to be ingested by or applied to humans or animals, other than for derived products referred to in Articles 33 and 36 of that Regulation shall be prohibited.

2. Where an animal by-product or a derived product may be used for feeding to farmed animals or for other purposes referred to in Article 36(a) of Regulation (EC) No 1069/2009, they shall be placed on the market, other than imported, in accordance with the specific requirements for processed animal protein and other derived products set out in Chapter II of Annex X hereto, provided that Annex XIII hereto does not set out any specific requirements for such products.

3. Operators shall comply with the requirements for the placing on the market, other than the import, of petfood, as referred to in Article 40 of Regulation (EC) No 1069/2009, set out in Chapters I and II of Annex XIII hereto.

4. Operators shall comply with the requirements for the placing on the market, other than the import, of derived products, as referred to in Article 40 of Regulation (EC) No 1069/2009, set out in Chapter I and Chapters III to XII of Annex XIII hereto.







CHAPTER VIII

IMPORT, TRANSIT AND EXPORT

Article 25

Import, transit and export of animal by-products and of derived products

1. The importation into and the transit through the Union of the following animal by-products shall be prohibited:

(a) unprocessed manure;

(b) untreated feathers and parts of feathers and down;

(c) beeswax in the form of honeycomb.

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2. The importation into and the transit through the Union of the following shall not be subject to any animal health conditions:

(a) wool and hair which has been factory-washed or which has been treated by another method which ensures that no unacceptable risks remain;

(b) furs which have been dried at an ambient temperature of 18°C for a period of at least two days at a humidity of 55 %;

(c) wool and hair produced from animals other than those of the porcine species, which has been treated by factory-washing which consisting of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide;

(d) wool and hair produced from animals other than those of the porcine species, which is dispatched directly to a plant producing derived products from wool and hair for the textile industry and has been treated by at least one of the following methods: — chemical depilation by means of slaked lime or sodium sulphide, — fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours, — industrial scouring which consists of the immersion of wool and hair in a water-soluble detergent held at 60–70 °C, — storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

(e) wool and hair that is dry and securely enclosed in packaging, produced from animals other than those of the porcine species, which is intended for dispatch to a plant producing derived products from wool and hair for the textile industry and meets all of the following requirements: (i) it was produced at least 21 days before the date of entry into the Union kept in a third country or region thereof which is — listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary guarantees A and F mentioned therein, — free of foot-and-mouth disease, and, in the case of wool and hair from sheep and goats, of sheep pox and goat pox in accordance with the basic general criteria listed in Annex II to Directive 2004/68/EC; (ii) it is accompanied by a importers' declaration as required in accordance with Chapter 21 of Annex XV; (iii) it was presented by the operator to one of the approved Union border inspection posts listed in Annex I to Decision 2009/821/EC where it passed with satisfactory result the documentary check carried out in accordance with Article 4(3) of Directive 97/78/EC.

▼B

3. Operators shall comply with the following specific requirements for the importation into and the transit through the Union of certain animal by-products and derived products, as referred to in Articles 41(3) and 42 of Regulation (EC) No 1069/2009, set out in Annex XIV hereto:

(a) the specific requirements for the import and transit of Category 3 material and derived products for uses in the feed chain, other than for petfood or feed to fur animals, set out in Chapter I of that Annex;

(b) the specific requirements for the import and transit of animal by-products and derived products for uses outside the feed chain for farmed animals, set out in Chapter II of that Annex.

Article 26

Placing on the market, including importation, and export of certain Category 1 materials

The competent authority may authorise the placing on the market, including the importation, and the export of hides and skins derived from animals which have been submitted to an illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or in Article 2(b) of Directive 96/23/EC, and of ruminant intestines with or without content and of bones and bone products containing vertebral column and skull, subject to compliance with the following requirements:

(a) those materials must not be Category 1 materials derived from any of the following animals: (i) animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001; (ii) animals in which the presence of a TSE has been officially confirmed; (iii) animals killed in the context of TSE eradication measures;

(b) those materials must not be intended for any of the following uses: (i) feeding; (ii) application to land from which farmed animals are fed; (iii) the manufacture of: — cosmetic products as defined in Article 1(1) of Directive 76/768/EEC; — active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC; — medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC; — in vitro diagnostic medical devices as defined in Article 1(2)(b) of Directive 98/79/EC; — veterinary medicinal products as defined in Article 1(2) of Directive 2001/82/EC; — medicinal products as defined in Article 1(2) of Directive 2001/83/EC;

(c) the materials must be imported with a label and must comply with the specific requirements for certain movements of animal by-products set out in Section 1 of Chapter IV of Annex XIV hereto;

(d) the materials must be imported in accordance with sanitary certification requirements laid down in national legislation.

Article 27

Importation and transit of research and diagnostic samples

1. The competent authority may authorise the importation and the transit of research and diagnostic samples, comprising derived products or animal by-products, including the animal by-products referred to in Article 25(1), in accordance with conditions which ensure the control of risks to public and animal health.

Such conditions shall include at least the following:

(a) the introduction of the consignment must have been authorised in advance by the competent authority of the Member State of destination; and

(b) the consignment must be sent directly from the point of entry into the Union to the authorised user.

2. Operators shall present research and diagnostic samples which are intended to be imported via a Member State, other than the Member State of destination, at an approved Union border inspection post listed in Annex I to Decision 2009/821/EC. At the border inspection post, those research and diagnostic samples shall not be subject to veterinary checks in accordance with Chapter I of Directive 97/78/EC. The competent authority of the border inspection post shall inform the competent authority of the Member State of destination of the introduction of the research and diagnostic samples by means of the TRACES system.

3. Operators handling research samples or diagnostic samples shall comply with the special requirements for disposal of research and diagnostic samples set out in Section 1 of Chapter III of Annex XIV hereto.

Article 28

Importation and transit of trade samples and display items

1. The competent authority may authorise the importation and the transit of trade samples in accordance with the special rules set out in point 1 of Section 2 of Chapter III of Annex XIV hereto.

2. Operators handling trade samples shall comply with the special rules for handling and disposal of trade samples set out in points 2 and 3 of Section 2 of Chapter III of Annex XIV hereto.

3. The competent authority may authorise the importation and the transit of display items in accordance with the special rules for display items set out in Section 3 of Chapter III of Annex XIV hereto.

4. Operators handling display items shall comply with the conditions for packaging, handling and disposal of display items set out in Section 3 of Chapter III of Annex XIV hereto.

Article 29

Specific requirements for certain movements of animal by-products between territories of the Russian Federation

1. The competent authority shall authorise specific movements of consignments of animal by-products coming from and destined to the Russian Federation directly or via another third country, by road or by rail through the Union, between approved Union border inspection posts listed in Annex I to Decision 2009/821/EC, provided that the following conditions are met:

(a) the consignment shall be sealed with a serially numbered seal at the border inspection post of entry to the Union by the veterinary services of the competent authority;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC shall be stamped ‘ONLY FOR TRANSIT TO RUSSIA VIA THE EU’ on each page by the official veterinarian of the competent authority responsible for the border inspection post;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC shall be complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document provided for in Annex III to Regulation (EC) No 136/2004 by the official veterinarian of the border inspection post of introduction.

2. Unloading or storage, as defined in Article 12(4) or Article 13 of Directive 97/78/EC of such consignments shall not be allowed on the territory of a Member State.

3. Regular audits shall be made by the competent authority to ensure that the number of consignments and the quantities of products leaving the Union territory matches the number and quantities entering.

Article 30

Lists of establishments and plants in third countries

Lists of establishments and plants in third countries shall be entered into the TRACES system in accordance with technical specifications which are published by the Commission on its website.

Each list shall be kept up to date regularly.

Article 31

Models of health certificates and declarations for importation and transit

Consignments of animal by-products and derived products for importation into or transit through the Union shall be accompanied by health certificates and declarations, in accordance with the models set out in Annex XV hereto, at the point of entry into the Union where the veterinary checks take place, as provided for in Directive 97/78/EC.







CHAPTER IX

OFFICIAL CONTROLS

Article 32

Official controls

1. The competent authority shall take the necessary measures to control the entire chain of collection, transport, use and disposal of animal by-products and derived products, as referred to in Article 4(2) of Regulation (EC) No 1069/2009.

Those measures shall be carried out in accordance with the principles for official controls laid down in Article 3 of Regulation (EC) No 882/2004.

2. The official controls referred to in paragraph 1 shall include checks on the keeping of records and other documents required by the rules laid down in this Regulation.

3. The competent authority shall carry out the following official controls, as referred to in Article 45(1) of Regulation (EC) No 1069/2009, in accordance with the requirements set out in Annex XVI hereto:

(a) official controls in processing plants as set out in Chapter I;

(b) official controls of other activities which involve the handling of animal by-products, and derived products as set out in Sections 1 to 9 of Chapter III.

4. The competent authority shall carry out checks on seals which are applied to consignments of animal by-products or derived products.

When the competent authority applies a seal to such consignment which is transported to a place of destination, it must inform the competent authority of the place of destination.

5. The competent authority shall draw up the lists of establishments, plants and operators referred to in Article 47(1) of Regulation (EC) No 1069/2009 in accordance with the format set out in Chapter II of Annex XVI hereto.

6. The competent authority of the Member State of destination shall decide upon the application by an operator concerning the acceptance or refusal of certain Category 1, Category 2 material and meat-and-bone meal or animal fat derived from Category 1 and Category 2 materials, within 20 calendar days from the date of receipt of such application provided that it has been submitted in one of the official languages of that Member State.

7. Operators shall submit applications for the authorisation referred to in paragraph 6 in accordance with the standard format set out in Section 10 of Chapter III of Annex XVI hereto.

Article 33

Reapproval of plants and establishments after the grant of a temporary approval

1. Where a plant or establishment approved for the processing of Category 3 material is subsequently granted temporary approval for the processing of Category 1 or Category 2 material, in accordance with Article 24(2)(b)(ii) of Regulation (EC) No 1069/2009, it shall be prohibited from recommencing the processing of Category 3 material, without first obtaining the approval of the competent authority to recommence processing of Category 3 material in accordance with Article 44 of that Regulation.

2. Where a plant or establishment approved for the processing of Category 2 material is subsequently granted temporary approval for the processing of Category 1 material, in accordance with Article 24(2)(b)(ii) of Regulation (EC) No 1069/2009, it shall be prohibited from recommencing the processing of Category 2 material, without first obtaining the approval of the competent authority to recommence processing of Category 2 material in accordance with Article 44 of that Regulation.







CHAPTER X

FINAL PROVISIONS

Article 34

Restrictions on the placing on the market of certain animal by-products and derived products for reasons of public and animal health

The competent authority shall not prohibit or restrict the placing on the market of the following animal by-products and derived products for public health or animal health reasons other than the rules laid down in Union legislation, and in particular those laid down in Regulation (EC) No 1069/2009 and in this Regulation:

(a) processed animal protein and other derived products referred to in Chapter II of Annex X hereto;

(b) petfood and certain other derived products referred to in Annex XIII hereto;

(c) animal by-products and the derived products imported into or in transit through the Union as referred to in Annex XIV hereto.

Article 35

Repeal

1. The following acts are repealed:

(a) Regulation (EC) No 811/2003;

(b) Decision 2003/322/EC;

(c) Decision 2003/324/EC;

(d) Regulation (EC) No 878/2004;

(e) Decision 2004/407/EC;

(f) Regulation (EC) No 79/2005;

(g) Regulation (EC) No 92/2005;

(h) Regulation (EC) No 181/2006;

(i) Regulation (EC) No 197/2006;

(j) Regulation (EC) No 1192/2006;

(k) Regulation (EC) No 2007/2006.

2. References to the repealed acts shall be construed as references to this Regulation.

Article 36

Transitional measures

1. For a transitional period until 31 December 2011, operators may place on the market organic fertilisers and soil improvers which were produced before 4 March 2011 in accordance with Regulations (EC) No 1774/2002 and (EC) No 181/2006:

(a) provided that they have been produced from one of the following: (i) meat-and-bone meal derived from Category 2 material; (ii) processed animal protein;

(b) even though they have not been mixed with a component to exclude the subsequent use of the mixture for feeding purposes.

2. For a transitional period until 31 January 2012, consignments of animal by-products and of derived products accompanied by a health certificate, declaration or commercial document, which has been completed and signed in accordance with the appropriate model set out in Annex X to Regulation (EC) No 1774/2002 shall continue to be accepted for importation into the Union, provided that such certificates, declarations or documents were completed and signed before 30 November 2011.

3. For a transitional period until ►M4 31 December 2014 ◄ and by way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of Category 3 materials comprising products of animal origin, or of foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise, as referred to in Article 10(f) of that Regulation, by means other than burning or burial on site, as referred to in Article 19(1)(d) of that Regulation, subject to compliance with the requirements for disposal by other means set out in Chapter IV of Annex VI hereto.

Article 37

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 4 March 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

DEFINITIONS AS REFERRED TO IN ARTICLE 2

For the purpose of this Regulation, the following definitions shall apply:

1. ‘fur animals’ means animals kept or reared for the production of fur and not used for human consumption;

2. ‘blood’ means fresh whole blood;

3. ‘feed material’ means those feed materials, as defined in Article 3(2)(g) of Regulation (EC) No 767/2009, that are of animal origin, including processed animal proteins, blood products, rendered fats, egg products, fish oil, fat derivatives, collagen, gelatine and hydrolysed proteins, dicalcium phosphate, tricalcium phosphate, milk, milk-based products, milk-derived products, colostrum, colostrum products and centrifuge or separator sludge;

4. ‘blood products’ means derived products from blood or fractions of blood, excluding blood meal; they include dried/frozen/liquid plasma, dried whole blood, dried/frozen/liquid red cells or fractions thereof and mixtures;

5. ‘processed animal protein’ means animal protein derived entirely from Category 3 material, which have been treated in accordance with Section 1 of Chapter II of Annex X (including blood meal and fishmeal) so as to render them suitable for direct use as feed material or for any other use in feedingstuffs, including petfood, or for use in organic fertilisers or soil improvers; however, it does not include blood products, milk, milk-based products, milk-derived products, colostrum, colostrum products, centrifuge or separator sludge, gelatine, hydrolysed proteins and dicalcium phosphate, eggs and egg-products, including eggshells, tricalcium phosphate and collagen;

6. ‘blood meal’ means processed animal protein derived from the heat treatment of blood or fractions of blood in accordance with Section 1 of Chapter II of Annex X;

7. ‘fishmeal’ means processed animal protein derived from aquatic animals, except sea mammals;

8. ‘rendered fats’ means either fats derived from the processing of: (a) animal by-products; or (b) products for human consumption, which an operator has destined for purposes other than human consumption;

9. ‘fish oil’ means oil derived from the processing of aquatic animals or oil from the processing of fish for human consumption, which an operator has destined for purposes other than human consumption;

10. ‘apiculture by-products’ means honey, beeswax, royal jelly, propolis or pollen not intended for human consumption;

11. ‘collagen’ means protein-based products derived from hides, skins, bones and tendons of animals;

12. ‘gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals;

13. ‘greaves’ means the protein-containing residue of rendering, after partial separation of fat and water;

14. ‘hydrolysed proteins’ means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis of animal by-products;

15. ‘white water’ means a mixture of milk, milk-based products or products derived thereof with water which is collected during the rinsing of dairy equipment including containers used for dairy products, prior to their cleaning and disinfection;

16. ‘canned petfood’ means heat-processed petfood contained within a hermetically sealed container;

17. ‘dogchews’ means products for pet animals to chew, produced from untanned hides and skins of ungulates or from other material of animal origin;

18. ‘flavouring innards’ means a liquid or dehydrated derived product of animal origin used to enhance the palatability values of petfood;

▼M4

19. ‘petfood’ means feed, other than material referred to in Article 24(2), for use as feed for pet animals, and dogchews consisting of animal by-products or derived products which: (a) contain Category 3 material, other than material referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009; and (b) may contain imported Category 1 material comprising of animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;

▼B

20. ‘processed petfood’ means petfood, other than raw petfood, which has been processed in accordance with point 3 of Chapter II of Annex XIII;

21. ‘raw petfood’ means petfood containing certain Category 3 material which has not undergone any preserving process other than chilling or freezing;

22. ‘catering waste’ means all waste food, including used cooking oil originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

▼M4

23. ‘digestion residues’ means residues, including the liquid fraction, resulting from the transformation of animal by-products in a biogas plant;

▼B

24. ‘digestive tract content’ means the content of the digestive tract of mammals and ratites;

25. ‘fat derivatives’ means derived products from rendered fats, which, as regards rendered fats of Category 1 or Category 2 material, have been processed in accordance with Chapter XI of Annex XIII;

26. ‘guano’ means a natural product which has been collected from the excrements of bats or wild sea birds and which is not mineralised;

27. ‘meat-and-bone meal’ means animal protein derived from the processing of Category 1 or Category 2 materials in accordance with one of the processing methods set out in Chapter III of Annex IV;

28. ‘treated hides and skins’ means derived products from untreated hides and skins, other than dogchews, that have been: (a) dried; (b) dry-salted or wet-salted for a period of at least 14 days prior to dispatch; (c) salted for a period of at least seven days in sea salt with the addition of 2 % of sodium carbonate; (d) dried for a period of at least 42 days at a temperature of at least 20 °C; or (e) subject to a preservation process other than tanning;

29. ‘untreated hides and skins’ means all cutaneous and subcutaneous tissues that have not undergone any treatment, other than cutting, chilling or freezing;

30. ‘untreated feathers and parts of feathers’ means feathers and parts of feathers, other than feathers or parts of feathers, which have been treated: (a) with a steam current; or (b) by another method that ensures that no unacceptable risks remain;

▼M2

31. ‘untreated wool’ means wool, other than wool which has: (a) undergone factory washing; (b) been obtained from tanning; (c) been treated by another method that ensures that no unacceptable risks remain; (d) been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the wool in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or (e) been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from wool for the textile industry and has undergone at least one of the following treatments: (i) chemical depilation by means of slaked lime or sodium sulphide; (ii) fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours; (iii) industrial scouring which consists of the immersion of wool in a water-soluble detergent held at 60–70 °C; (iv) storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

32. ‘untreated hair’ means hair, other than hair which has: (a) undergone factory washing; (b) been obtained from tanning; (c) been treated by another method that ensures that no unacceptable risks remain; (d) been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or (e) been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from hair for the textile industry and has undergone at least one of the following treatments: (i) chemical depilation by means of slaked lime or sodium sulphide; (ii) fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours; (iii) industrial scouring which consists of the immersion of hair in a water-soluble detergent held at 60–70 °C; (iv) storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

▼B

33. ‘untreated pig bristles’ means pig bristles, other than pig bristles which have: (a) undergone factory washing; (b) been obtained from tanning; or (c) been treated by another method that ensures that no unacceptable risks remain;

34. ‘display item’ means animal by-products or derived products intended for exhibitions or artistic activities;

35. ‘intermediate product’ means a derived product: (a) which is intended for the manufacture of medicinal products, veterinary medicinal products, medical devices, active implantable medical devices, in vitro diagnostic medical devices or laboratory reagents; (b) whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for that purpose; (c) which however requires some further handling or transformation, such as mixing, coating, assembling, packaging or labelling to make it suitable for placing the product on the market or putting it into service, as applicable, as a medicinal product, veterinary medicinal product, medical device, active implantable medical device, in vitro diagnostic medical device or laboratory reagent;

36. ‘laboratory reagent’ means a packaged product, ready for use, containing animal by-products or derived products and intended as such or in combination with substances of non-animal origin for specific laboratory use as a reagent or reagent product, calibrator or control material to detect, measure, examine or produce other substances;

37. ‘product used for in vitro diagnosis’ means a packaged product, ready for use, containing a blood product or another animal by-product, and used as a reagent, reagent product, calibrator, kit or any other system, whether used alone or in combination, intended to be used in vitro for the examination of samples of human or animal origin, solely or principally with a view to the diagnosis of a physiological state, state of health, disease or genetic abnormality or to determine safety and compatibility with reagents; it does not include donated organs or blood;

38. ‘research and diagnostic samples’ means animal by-products and derived products intended for the following purposes: examination in the context of diagnostic activities or analysis for the promotion of progress in science and technology, in the context of educational or research activities;

39. ‘trade samples’ means animal by-products or derived products intended for particular studies or analyses with a view to carrying out a production process or developing feedingstuffs or other derived products, including testing of machinery, for use in an establishment or plant which is: (a) producing feedingstuffs, or products for uses other than food and feed; or (b) processing animal by-products or derived products;

40. ‘co-incineration’ means the recovery or disposal of animal by-products or derived products, if they are waste, in a co-incineration plant;

41. ‘combustion’ means a process involving the oxidisation of fuel in order to use the energy value of the animal by-products or derived products, if they are not waste;

42. ‘incineration’ means the disposal of animal by-products or derived products as waste, in an incineration plant, as defined in point 4 of Article 3 of Directive 2000/76/EC;

43. ‘incineration and co-incineration residues’ means any residues as defined in point 13 of Article 3 of Directive 2000/76/EC, which are generated by incineration or co-incineration plants treating animal by-products or derived products;

44. ‘colour-coding’ means the systematic use of colours as set out in point 1(c) of Chapter II of Annex VIII for displaying information as provided for in this Regulation on the surface or on part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them;

45. ‘intermediate operations’ means the operations, other than storage, referred to in Article 19(b);

46. ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents;

47. ‘taxidermy’ means the art of preparing, stuffing and mounting the skins of animals with lifelike effect, so that no unacceptable risks to public and animal health may be transmitted through the mounted skin;

48. ‘trade’ means trade in goods between Member States as referred to in Article 28 of the Treaty on the Functioning of the European Union;

49. ‘processing methods’ means the methods listed in Chapters III and IV of Annex IV;

50. ‘batch’ means a unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit;

51. ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of micro-organisms;

52. ‘biogas plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under anaerobic conditions;

53. ‘collection centres’ means premises other than processing plants in which the animal by-products referred to in Article 18(1) of Regulation (EC) No 1069/2009 are collected with the intention to be used for feeding to the animals referred to in the same Article;

54. ‘composting plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under aerobic conditions;

55. ‘co-incineration plant’ means any stationary or mobile plant whose main purpose is the generation of energy or the production of material products as defined in point 5 of Article 3 of Directive 2000/76/EC;

56. ‘incineration plant’ means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste as defined in point 4 of Article 3 of Directive 2000/76/EC;

57. ‘petfood plant’ means premises or facilities for the production of petfood or flavouring innards, as referred to in Article 24(1)(e) of Regulation (EC) No 1069/2009;

58. ‘processing plant’ means premises or facilities for the processing of animal by-products as referred to in Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in accordance with Annex IV and/or Annex X.









ANNEX II

RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS

CHAPTER I

Intra-species recycling of fur animals

1. In Estonia, Latvia and Finland, the following fur animals may be fed with meat-and-bone meal or other products which have been processed in accordance with Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species: ▼M1 (a) foxes (Vulpes vulpes and Alopex lagopus); ▼B (b) raccoon dogs (Nyctereutes procyonides).

2. In Estonia and Latvia, fur animals of the species American mink (Mustela vison) may be fed with meat-and-bone meal or other products which have been processed in accordance with the processing methods set out in Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species.

3. The feeding referred to in points 1 and 2 shall take place under the following conditions: (a) Feeding shall only take place in farms: (i) which have been registered by the competent authority on the basis of an application that is accompanied by documentation proving that there is no reason to suspect the presence of the TSE agent in the population of the species covered by the application; (ii) where an appropriate surveillance system for transmissible spongiform encephalopathies (TSEs) in fur animals is in place on the farm and includes regular laboratory testing of samples for TSE; (iii) which have provided appropriate guarantees that no animal by-product or meat-and-bone meal or other products which have been processed in accordance with Chapter III of Annex IV and which are derived from those animals or their offspring may enter the food or feed chain of other animals than fur animals; (iv) which have had no known contact with any farm with a suspected or confirmed outbreak of TSE; (v) where the operator of the registered farm ensures that: — the carcases of fur animals intended for feeding to animals of the same species are handled and processed separately from carcases not authorised for that purpose, — fur animals fed with meat-and-bone meal or other products which have been processed in accordance with Chapter III of Annex IV and which are derived from animals of the same species are kept separate from animals not being fed with products derived from animals of the same species, — the farm complies with the requirements set out in point 2 of Section 1 of Chapter II of Annex VI and point (2)(b)(ii) of Chapter II of Annex VIII. (b) The operator of the farm shall ensure that meat-and-bone meal or other products derived from one species and intended for the feeding of the same species must: (i) have been processed in a processing plant approved under Article 24(1)(a) of Regulation (EC) No 1069/2009 and using only processing methods 1 to 5 or processing method 7 as set out in Chapter III of Annex IV to this Regulation; (ii) have been produced from healthy animals killed for the production of fur. (c) In the event of any known or suspected contact with any farm with a suspected or confirmed outbreak of TSE, the operator of the farm must immediately: (i) inform the competent authority of such contact; (ii) cease the dispatch of fur animals to any destination without a written authorisation of the competent authority.

CHAPTER II

Feeding of farmed animals with herbage

The following conditions shall apply to the feeding of farmed animals with herbage from land, either by direct access of the animals to that land or by using cut herbage as feed, provided that organic fertilisers or soil improvers have been applied to that land:

(a) The waiting period of at least 21 days referred to in Article 11(1)(c) of Regulation (EC) No 1069/2009 must have been observed,

(b) Only organic fertilisers and soil improvers have been used which comply with Article 32(1) and (2) of Regulation (EC) No 1069/2009 and with Chapter II of Annex XI hereto.

However, those conditions shall not apply, provided only the following organic fertilisers or soil improvers have been applied to land:

(a) manure and guano;

(b) digestive tract content, milk, milk-based products, milk-derived products, colostrum and colostrum products, which the competent authority does not consider to present a risk for the spread of any serious animal disease.









ANNEX III

DISPOSAL AND RECOVERY

CHAPTER I

GENERAL REQUIREMENTS FOR INCINERATION AND CO-INCINERATION

Section 1

General conditions

1. Operators of incineration and co-incineration plants referred to in Article 6(1)(b) of this Regulation shall ensure that the following hygiene conditions are met in the plants under their control: (a) Animal by-products and derived products must be disposed of as soon as possible after arrival, in accordance with conditions laid down by the competent authority. They shall be stored properly until disposal, in accordance with conditions laid down by the competent authority. (b) Plants must have appropriate arrangements for the cleaning and disinfection of containers and vehicles in place, in particular in a designated area from which wastewater is disposed of in accordance with Union legislation, to avoid risks of contamination. (c) Plants must be located on a well-drained hardstanding. (d) Plants must have appropriate arrangements for protection against pests, such as insects, rodents and birds. A documented pest control programme must be used for that purpose. (e) Staff must have access to adequate facilities for personal hygiene such as lavatories, changing rooms and washbasins, if necessary to prevent risks of contamination. (f) Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning. (g) Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented and maintained for at least two years.

2. The operator of an incineration or co-incineration plant shall take all necessary precautions concerning the reception of animal by-products or derived products to prevent, or limit as far as practicable, direct risks to human or animal health.

3. Animals must not have access to the plants, animal by-products and derived products that are awaiting incineration or co-incineration or to ash resulting from the incineration or co-incineration of animal by-products.

4. If the incineration or co-incineration plant is located on a livestock holding: (a) there must be total physical separation between the incineration or co-incineration equipment and the livestock and their feed and bedding, with fencing where necessary; (b) equipment must be dedicated entirely to the operation of the incinerator and not used elsewhere on the holding or, alternatively, cleaned and disinfected before such use; (c) personnel working in the plant must change their outer clothing and footwear before handling livestock or livestock feed.

5. The storage of animal by-products and derived products that are awaiting incineration or co-incineration and of ashes must be in covered, correctly identified and, if appropriate, leak proof containers.

6. Incompletely incinerated animal by-products must be reincinerated or disposed of by other means, other than by disposal in an authorised landfill, in accordance with Articles 12, 13 and 14, as applicable, of Regulation (EC) No 1069/2009.

Section 2

Operating conditions

Incineration or co-incineration plants shall be designed, equipped, built and operated in such a way that the gas resulting from the process is raised in a controlled and homogeneous fashion, even under the most unfavourable conditions, to a temperature of 850 °C for at least 2 seconds or to a temperature of 1 100 °C for 0.2 seconds, as measured near the inner wall or at another representative point of the chamber where the incineration or the co-incineration is carried out, as authorised