Regulation 2011/142 - Implementation of Regulation 1069/2009 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 - Main contents

EN

Official Journal of the European Union

L 54/1

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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).

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).

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.

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).

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).

It is therefore necessary to lay down implementing measures for Regulation (EC) No 1069/2009 in this Regulation.

Regulation (EC) No 1069/2009 repeals Regulation (EC) No 1774/2002 with effect from 4 March 2011.

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.

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.

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.

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.

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.

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.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

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

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.

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;

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

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

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;

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;

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;

fur which fulfils the conditions in Chapter VIII of Annex XIII.

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

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.

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

Category 3 material referred to in Article 10(f) and (g) of Regulation (EC) No 1069/2009, provided that:

the general conditions for processing set out in Section 1;

the requirements for wastewater treatment set out in Section 2;

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

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

the hygiene and processing requirements set out in Chapter II;

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

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

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

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

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

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

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

processed animal protein.

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

processed animal protein.

zoo animals;

fur animals;

dogs from recognised kennels or packs of hounds;

dogs and cats in shelters;

maggots and worms for fishing bait.

zoo animals;

fur animals;

dogs from recognised kennels or packs of hounds;

dogs and cats in shelters;

maggots and worms for fishing bait.

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;

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.

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

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

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

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

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

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

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:

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

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

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

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

operators handling or disposing research and diagnostic samples for educational purposes.

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

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

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

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;

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;

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

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.

unprocessed manure;

untreated feathers and parts of feathers and down;

beeswax in the form of honeycomb.

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

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 %.

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;

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.

those materials must not be Category 1 materials derived from any of the following animals:

those materials must not be intended for any of the following uses:

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;

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

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

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

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;

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;

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

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.

official controls in processing plants as set out in Chapter I;

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.

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

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

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

Regulation (EC) No 811/2003;

Decision 2003/322/EC;

Decision 2003/324/EC;

Regulation (EC) No 878/2004;

Decision 2004/407/EC;

Regulation (EC) No 79/2005;

Regulation (EC) No 92/2005;

Regulation (EC) No 181/2006;

Regulation (EC) No 197/2006;

Regulation (EC) No 1192/2006;

Regulation (EC) No 2007/2006.

provided that they have been produced from one of the following:

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

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

‘blood’ means fresh whole blood;

‘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;

‘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;

‘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;

‘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;

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

‘rendered fats’ means either fats derived from the processing of:

‘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;

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

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

‘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;

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

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

‘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;

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

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

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

‘petfood’ means feed for pet animals and dogchews, which

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

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

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

‘digestion residues’ means residues resulting from the transformation of animal by-products in a biogas plant;

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

‘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;

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

‘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;

‘treated hides and skins’ means derived products from untreated hides and skins, other than dogchews, that have been:

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

‘untreated feathers and parts of feathers’ means feathers and parts of feathers, other than feathers or parts of feathers, which have been treated:

‘untreated wool’ means wool, other than wool which has:

‘untreated hair’ means hair, other than hair which has:

‘untreated pig bristles’ means pig bristles, other than pig bristles which have:

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

‘intermediate product’ means a derived product:

‘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;

‘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;

‘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;

‘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:

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

‘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;

‘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;

‘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;

‘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;

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

‘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;

‘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;

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

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

‘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;

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

‘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;

‘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;

‘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;

‘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;

‘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;

‘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;

‘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.

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:

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.

The feeding referred to in points 1 and 2 shall take place under the following conditions:

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,

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.

manure and guano;

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.

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:

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.

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.

If the incineration or co-incineration plant is located on a livestock holding:

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.

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.

Incineration and co-incineration residues shall be minimised in their amount and harmfulness. Such residues must be recovered, where appropriate, directly in the plant or outside it in accordance with relevant Union legislation or disposed of in an authorised landfill.

Transport and intermediate storage of dry residues, including dust, shall take place in such a way as to prevent dispersal in the environment, such as in closed containers.

Techniques shall be used to monitor the parameters and conditions relevant to the incineration or co-incineration process.

The approval issued by the competent authority, or conditions attached to it, shall lay down temperature measurement requirements.

The functioning of any automated monitoring equipment shall be subject to control and to an annual surveillance test.

Temperature measurement results shall be recorded and presented in an appropriate fashion to enable the competent authority to verify compliance with the permitted operating conditions laid down in this Regulation in accordance with procedures to be decided upon by that authority.

The plants must be equipped for each line with at least one auxiliary burner. This burner shall be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C or 1 100 °C, as applicable. It must also be used during plant start-up and shut-down operations to ensure that the temperature of 850 °C or of 1 100 °C, as applicable, is maintained at all times during these operations and as long as unburned material is in the chamber where the incineration or co-incineration is carried out.

When animal by-products or derived products are introduced into the chamber where the incineration or co-incineration is carried out by a continuous process, the plant must operate an automatic system to prevent the introduction of animal by-products or derived products at start-up, until the temperature of 850 °C or of 1 100 °C, as applicable, has been reached, and whenever the temperature is not maintained.

The operator must operate the incineration plant in such manner that a level of incineration is achieved such that the slag and bottom ashes total organic carbon content is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material. If necessary, appropriate techniques of pre-treatment shall be used.

Sites of high capacity plants, including associated storage areas for animal by-products, shall be designed in such a way as to prevent unauthorised and accidental release of any polluting substances into soil, surface water and groundwater.

Storage capacity shall be provided for contaminated rainwater run-off from the plant site or for contaminated water arising from spillage or firefighting operations.

The operator shall, if necessary, ensure that such rainwater and such water can be tested and treated before discharge, when necessary.

only be used for the disposal of:

when Category 1 materials referred to in Article 8(b) of Regulation (EC) No 1069/2009 are introduced into the low-capacity plant, be equipped with an auxiliary burner;

operate in such way that the animal by-products are completely reduced to ash.

Processing plants shall meet the following requirements, for processing by pressure sterilisation or in accordance with the processing methods referred to in Article 15(1)(b) of Regulation (EC) No 1069/2009:

The processing plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal by-products are received and the means of transport, other than ships, in which they are transported.

Adequate facilities must be provided for the disinfecting of vehicle wheels and the other parts of the vehicle, as appropriate, on leaving the unclean sector of the processing plant.

All processing plants must have a waste-water disposal system meeting the requirements set out by the competent authority in accordance with Union legislation.

The processing plant must have its own laboratory or make use of the services of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority on the basis of an assessment of the capacity of the laboratory to carry out those analyses, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority, to assess the capacity of the laboratory to carry out those analyses.

If on the basis of a risk assessment, the volume of products treated requires the regular or permanent presence of the competent authority, the processing plants must have an adequately equipped lockable room for the exclusive use of the inspection service.

Processing plants processing Category 1 material and other premises where specified risk material is removed, slaughterhouses and processing plants processing Category 2 material shall have a pre-treatment process for the retention and collection of animal material as an initial step in the treatment of wastewater.

The equipment used in the pre-treatment process shall consist of drain traps or screens with apertures with a filter pore or a mesh size of no more than 6 mm in the downstream end of the process or equivalent systems that ensure that the solid particles in the wastewater passing through them are no more than 6 mm.

Wastewater from the premises as referred to in point 1 must enter a pre-treatment process which shall ensure that all wastewater has been filtered through the process before being drained off the premises. No grinding, maceration or any other processing or application of pressure shall be carried out which could facilitate the passage of solid animal material through the pre-treatment process.

All animal material retained in the pre-treatment process in premises as referred to in point 1 shall be collected and transported as Category 1 or Category 2 material, as appropriate, and disposed of in accordance with Regulation (EC) No 1069/2009.

Wastewater having passed the pre-treatment process in premises referred to in point 1 and wastewater from other premises handling or processing animal by-products shall be treated in accordance with Union legislation, without restrictions in accordance with this Regulation.

In addition to the requirements laid down in point 4, the competent authority may oblige operators to treat wastewater originating in the unclean sector of processing plants and in plants or establishments carrying out intermediate operations with Category 1 material or Category 2 material or storing Category 1 material or Category 2 material, in accordance with conditions which ensure that risks from pathogens are mitigated.

Without prejudice to points 1 to 5, the disposal of animal by-products, including blood and milk, or derived products through the wastewater stream shall be prohibited.

However, Category 3 material comprising of centrifuge or separator sludge may be disposed of through the wastewater stream, provided that it has been subject to one of the treatments for centrifuge or separator sludge set out in Part III of Section 4 of Chapter II of Annex X hereto.

Processing plants processing Category 3 materials shall not be located at the same site as processing plants processing Category 1 or Category 2 materials, unless located in a completely separate building.

However, the competent authority may authorise the processing of Category 3 material on a site where handling or processing of Category 1 or Category 2 material takes place, if cross-contamination is prevented due to:

Processing plants processing Category 3 material shall have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies shall be removed before or during processing.

Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records must be kept to show the date of calibration of gauges/recorders.

Material that may not have received the specified heat treatment, such as material discharged at start up or leakage from cookers, must be recirculated through the heat treatment or collected and reprocessed or disposed of in accordance with Regulation (EC) No 1069/2009.

The critical control points that determine the extent of the heat treatments applied in processing shall include for each processing method as specified in Chapter III:

In the case of chemical treatments which have been authorised by the competent authority as processing method 7 in accordance with point G of Chapter III, the critical control points that determine the extent of the chemical treatments applied shall include the pH adjustment achieved.

Records shall be maintained for at least two years to show that the minimum process values for each critical control point are applied.

Category 3 material shall be processed in accordance with any of the processing methods 1 to 5 or processing method 7, or, in the case of material originating from aquatic animals, with any of the processing methods 1 to 7, as referred to in Chapter III.

If the particle size of the animal by-products to be processed is more than 50 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 50 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 50 millimetres, the process must be stopped and repairs made before the process is resumed.

The animal by-products with the particle size of no greater than 50 millimetres must be heated to a core temperature of more than 133 °C for at least 20 minutes without interruption at a pressure (absolute) of at least 3 bars. The pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (‘saturated steam’); the heat treatment may be applied as the sole process or as a pre- or post-process sterilisation phase.

The processing may be carried out in batch or continuous systems.

If the particle size of the animal by-products to be processed is more than 150 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 150 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 150 millimetres, the process must be stopped and repairs made before the process is resumed.

After reduction the animal by-products must be heated in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 125 minutes, a core temperature greater than 110 °C is achieved for at least 120 minutes and a core temperature greater that 120 °C is achieved for at least 50 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

The processing must be carried out in a batch system.

If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.

After reduction the animal by-products must be heated in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 95 minutes, a core temperature greater than 110 °C is achieved for at least 55 minutes and a core temperature greater that 120 °C is achieved for at least 13 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

The processing may be carried out in batch or continuous systems.

If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before the process is resumed.

After reduction the animal by-products must be placed in a vessel with added fat and heated in a manner which ensures that a core temperature greater than 100 °C is achieved for at least 16 minutes, a core temperature greater than 110 °C is achieved for at least 13 minutes, a core temperature greater than 120 °C is achieved for at least eight minutes and a core temperature greater that 130 °C is achieved for at least three minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

The processing may be carried out in batch or continuous systems.

If the particle size of the animal by-products to be processed is more than 20 millimetres, the animal by-products must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 20 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks disclose the existence of particles larger than 20 millimetres, the process must be stopped and repairs made before the process is resumed.

After reduction the animal by-products must be heated until they coagulate and then pressed so that fat and water are removed from the proteinaceous material. The proteinaceous material must then be heated in a manner which ensures that a core temperature greater than 80 °C is achieved for at least 120 minutes and a core temperature greater that 100 °C is achieved for at least 60 minutes.

The core temperatures may be achieved consecutively or through a coincidental combination of the time periods indicated.

The processing may be carried out in batch or continuous systems.

The animal by-products must be reduced to a particle size which is no greater than:

They must then be mixed with formic acid to reduce and maintain the pH to 4,0 or lower. The mixture must be stored for at least 24 hours pending further treatment.

After reduction, the mixture must be heated to:

When using a continuous flow system, the progression of the product through the heat converter must be controlled by means of mechanical commands limiting its displacement in such way that at the end of the heat treatment operation the product has undergone a cycle which is sufficient in both time and temperature.

The processing may be carried out in batch or continuous systems.

Any processing method authorised by the competent authority where the following have been demonstrated by the operator to that authority:

Details of the critical control points under which each processing plant satisfactorily complies with the microbiological standards must be recorded and maintained so that the operator and the competent authority can monitor the operation of the processing plant. The information to be recorded and monitored must include the particle size, and, as appropriate, the critical temperature, the absolute time, pressure profile, raw material feed rate and fat recycling rate.

By way of derogation from point 1, the competent authority may authorise the use of processing methods which have been approved prior to the date of entry into application of this Regulation, in accordance with Chapter III of Annex V to Regulation (EC) No 1774/2002.

The competent authority shall permanently or temporarily suspend the application of processing methods referred to in points 1 and 3, if it obtains evidence that any of the circumstances specified in point 1(a) or (b) have substantially changed.

The competent authority shall inform the competent authority of another Member State upon request about the information at its disposal under points 1 and 2 in relation to an authorised processing method.

Materials resulting from the processing of Category 1 and 2 materials, except biodiesel produced in accordance with point D of Section 2 of this Chapter, shall be permanently marked in accordance with the requirements for the marking of certain derived products set out in Chapter V of Annex VIII.

The competent authority of a Member State shall make the results of official controls available to the competent authority of another Member State upon request, when an alternative method is used for the first time in that Member State, in order to facilitate the introduction of the new alternative method.

Either a sodium hydroxide (NaOH) or potassium hydroxide (KOH) solution (or a combination thereof) must be used in an amount that assures approximate molar equivalency to the weight, type and composition of the animal by-products to be digested.

In the case of high fat in the animal by-products that neutralises the base, the added base must be adjusted so that the molar equivalency referred to is achieved.

Animal by-products must be placed in a steel alloy container. The measured amount of alkali must be added either in solid form or as a solution as referred to in point (a).

The container must be closed and the animal by-products and alkali mixture must be heated to a core temperature of at least 150 °C and at a pressure (absolute) of at least 4 bars for at least:

The process must be carried out in a batch system and the material in the vessel must be constantly mixed in order to facilitate the digestion process until the tissues are dissolved and bones and teeth are softened; and

The animal by-products must be treated in such way that the requirements regarding time, temperature and pressure are achieved at the same time.

The animal by-products must be heated to a core temperature of at least 180 °C for at least 40 minutes without interruption at a pressure (absolute) of at least 12 bar, heated by indirect steam application to the biolytic reactor;

The process must be carried out in a batch and the material in the vessel must be constantly mixed; and

The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time.

The animal by-products must be first processed using processing method 1 (pressure sterilisation) as set out in Chapter III in an approved processing plant;

Following the process referred to in point (a), the defatted materials must be treated at a temperature of at least 220 °C for at least 20 minutes at a pressure (absolute) of at least 25 bar, heated in a two-step procedure, first by direct steam injection, secondly indirect in a coaxial heat exchanger;

The process must be carried out in a batch or continuous system and the material is constantly mixed;

The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure are achieved at the same time;

The resulting material must then be mixed with water and anaerobically fermented (biogas transformation) in a biogas reactor;

In the case of starting material of Category 1, the entire process must take place on the same site and in a closed system and the biogas produced during the process must be combusted rapidly in the same plant at a minimum of 900 °C followed by rapid chilling (‘quenching’).

Unless fish oil or rendered fat are used which have been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must be first processed using:

The processed fat must then be processed further using one of the following methods:

The afterburner chamber must be warmed up using natural gas;

The animal by-products must be loaded into the primary chamber of the gasificator and the door must be closed. The primary chamber must have no burners and must be heated instead by the transfer of heat by conduction from the afterburner, which must be underneath the primary chamber. The only air admitted to the primary chamber must be via three inlet valves mounted on the main door to enhance the efficiency of the process;

The animal by-products must be volatilised into complex hydrocarbons and the resultant gases must pass from the primary chamber via a narrow opening at the top of the back wall to the mixing and cracking zones, where they must be broken down into their constituent elements. Finally the gases must pass into the afterburner chamber where they must be burned in the flame of a natural gas fired burner in the presence of excess air;

Each process unit must have two burners and two secondary air fans for back-up in case of burner or fan failure. The secondary chamber must be designed to give a minimum residence time of two seconds at a temperature of at least 950 °C under all conditions of combustion;

On leaving the secondary chamber the exhaust gases must pass through a barometric damper at the base of the stack, which cools and dilutes them with ambient air, maintaining a constant pressure in the primary and secondary chambers;

The process must be carried out over a 24-hour cycle, which includes loading, processing, cool down and ash removal. At the end of the cycle the residual ash must be removed from the primary chamber by a vacuum extraction system into enclosed bags and sealed before transporting;

The gasification of material other than animal by-products must not be permitted.

Unless fish oil or rendered fat are used which has been produced in accordance with Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respectively, the fat fraction derived from animal by-products must first be processed using:

The fat fraction must be separated from the protein and in the case of fat from ruminant origin which is intended to be combusted in another plant, insoluble impurities in excess of 0,15 % by weight must be removed;

Following the process referred to in points (a) and (b), the fat must be:

The combustion of material of animal origin other than animal fat must not be permitted;

The combustion of the fat derived from Category 1 and Category 2 materials shall take place in the same plant where the fat is rendered with the aim of utilising the energy generated for the rendering processes. However, the competent authority may authorise the movement of that fat to other plants for combustion provided that:

The combustion must be carried out in accordance with Union legislation for the protection of the environment, in particular, with reference to the standards of that legislation regarding best available techniques for the control and monitoring of emissions.

The animal by-products must be loaded into a converter and subsequently treated at a temperature of 80 °C for a period of eight hours. During this period, the material must be constantly reduced in size using appropriate mechanical abrasion equipment.

The material must be subsequently treated at a temperature of 100 °C for at least two hours.

The particle size of the resulting material must not be larger than 20 millimetres;

The animal by-products must be treated in such a manner that the requirements regarding time, temperature and pressure set out in points (a) and (b) are achieved at the same time;

During the heat treatment of the material, evaporated water must be continually extracted from the air-space above the biofuel and must be passed through a stainless steel condenser. The condensate must be kept at a temperature of at least 70 °C for at least one hour before being discharged as wastewater;

After the heat treatment of the material, the resulting biofuel from the converter must then be discharged and automatically conveyed by a fully covered and interlocked conveyor to incineration or co-incineration on the same site;

The process must be carried out in a batch mode.

Products derived from the processing of:

Materials resulting from processing in accordance with:

Any resulting waste from the processing of animal by-products in accordance with this Section, such as sludge, filter contents, ash and digestion residues shall be disposed of in accordance with Regulation (EC) No 1069/2009 and with this Regulation.

A biogas plant must be equipped with a pasteurisation/hygienisation unit, which cannot be by-passed for the animal by-products or derived products introduced with a maximum particle size of 12 mm before entering the unit, with:

By way of derogation from point 1, a pasteurisation /hygienisation unit shall not be mandatory for biogas plants that transform only:

If the biogas plant is located on or next to premises where farmed animals are kept and the biogas plant does not only use manure, milk or colostrum which accrues from those animals, the plant shall be located at a distance from the area where such animals are kept.

That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the biogas plant.

In all cases, there must be total physical separation between that biogas plant and the animals and their feed and bedding, with fencing where necessary.

Each biogas plant must have its own laboratory or make use of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority.

A composting plant must be equipped with a closed composting reactor or closed area, which cannot be by-passed for the animal by-products or derived products introduced into the plant, and it must be equipped with the following:

By way of derogation from point 1, other types of composting systems may be allowed provided they:

If the composting plant is located on or next to premises where farmed animals are kept and the composting plant does not only use manure, milk or colostrum which accrues from those animals, the composting plant shall be located at a distance from the area where animals are kept.

That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the composting plant.

In all cases, there must be total physical separation between that composting plant and the animals and their feed and bedding, with fencing where necessary.

Each composting plant must have its own laboratory or make use of an external laboratory. The laboratory must be equipped to carry out necessary analyses and be approved by the competent authority, be accredited according to internationally recognised standards or be subject to regular controls by the competent authority.

Animal by-products must be transformed as soon as possible after arrival at the biogas or composting plant. They must be stored properly until treated.

Containers, receptacles and vehicles used for transporting untreated material must be cleaned and disinfected in a designated area.

That area must be situated or designed so as to prevent risk of contamination of treated products.

Preventive measures against birds, rodents, insects or other vermin must be taken systematically.

A documented pest-control programme must be used for that purpose.

Cleaning procedures must be documented and established for all parts of the premises. Suitable equipment and cleaning agents must be provided for cleaning.

Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and results must be documented.

Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at regular intervals.

Digestion residues and compost must be handled and stored at the biogas or composting plant in such way as to prevent recontamination.

Category 3 material which is used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit must be submitted to the following minimum requirements:

However, Category 3 milk, milk-based products, milk-derived products, colostrum and colostrum products may be used without pasteurisation/hygienisation as raw material in a biogas plant, if the competent authority does not consider them to present a risk of spreading any serious transmissible disease to humans or animals.

The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is introduced into a biogas plant without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.

Category 3 material which is used as raw material in a composting plant must be submitted to the following minimum requirements:

The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is composted without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.

The competent authority may authorise the use of parameters other than the parameters set out in point 1 of Section 1 of Chapter I and other than the standard transformation parameters, provided that the applicant for such use demonstrates that such parameters ensure adequate reduction of biological risks. That demonstration shall include a validation, which shall be carried out in accordance with the following requirements:

By way of derogation from point 1, pending the adoption of rules as referred to in Article 15(2)(a)(ii) of Regulation (EC) No 1069/2009, the competent authority may authorise the use of specific requirements other than those laid down in this Chapter, provided that they guarantee an equivalent effect regarding the reduction of pathogens, for:

Where the materials referred to in point 2(b) or derived products referred to in Article 10(g) of Regulation (EC) No 1069/2009 are the only starting material of animal origin being treated in a biogas or composting plant, the competent authority may authorise the use of specific requirements other than those specified in this Chapter provided that it:

Operators may place on the market digestion residues and compost, which have been produced according to parameters which have been authorised by the competent authority:

Where in the case of point (a) or (b):

Digestion residues or compost, which do not comply with the requirements set out in this Section, shall be resubmitted to transformation or composting, and in the case of Salmonella handled or disposed of in accordance with the instructions of the competent authority.

Operators shall ensure that consignments of research and diagnostic samples are accompanied by a commercial document, which must specify:

Users that handle research and diagnostic samples shall take all necessary measures to avoid the spreading of diseases communicable to humans or animals during the handling of the materials under their control, in particular by way of the application of good laboratory practice.

Any subsequent use of research and diagnostic samples for purposes other than those referred to in point 38 of Annex I shall be prohibited.

Unless they are kept for reference purposes, research and diagnostic samples and any products derived from the use of those samples shall be disposed of:

Users that handle research and diagnostic samples shall keep a register of consignments of such samples.

The register shall include the information referred to in point 1 and the date and method of disposal of the samples and of any derived products.

By way of derogation from points 1, 4 and 5, the competent authority may accept the handling and disposal of research and diagnostic samples for educational purposes under other conditions which ensure that no unacceptable risks for public or animal health arise.

Trade samples and display items may only be transported, used and disposed of in accordance with points 1 to 4 and 6 of Section 1.

Unless trade samples are kept for reference purposes, they shall be, after the particular studies or analyses have been concluded:

After the exhibition or after the artistic activity has been concluded, display items shall be redispatched to the Member State of origin, dispatched or disposed of, in accordance with point 2.

The animal by-products shall be transported to the users or to collection centres in accordance with Sections 1 and 3 of Chapter I of Annex VIII.

Collection centres shall be registered by the competent authority, provided that:

Member States may authorise the use of a processing plant for Category 2 material as a collection centre.

Operators of collection centres supplying material, other than animal by-products originating from aquatic animals and from aquatic invertebrates, to final users must ensure that it undergoes one of the following treatments:

The competent authority may authorise the use of Category 1 material referred to in Article 18(2)(b) of Regulation (EC) No 1069/2009 for the feeding of the following endangered and protected species in feeding stations under the following conditions:

When a Member State applies to the Commission to be included into the list set out under point 1(a), it shall submit:

The competent authority must be satisfied, on the basis of an assessment of the specific situation of the species concerned and their habitat, that the conservation status of the species will be improved;

The competent authority must identify in the authorisation, holdings or herds within a geographically defined feeding zone under the following conditions:

The competent authority must have granted an authorisation to the operator responsible for the feeding. The competent authority shall grant such authorisations provided that:

The authorisation granted by the competent authority must be immediately suspended in the case of:

The operator responsible for the feeding shall:

If the competent authority authorises the disposal of animal by-products on site in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, such disposal may take place:

The burning of animal by-products on the sites referred to in Article 19(1)(b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out in such a way to ensure that they are burnt:

The burial of animal by-products on the sites referred to in Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out to ensure that they are buried:

In the case of disposal in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, the movement of the animal by-products from the place of origin to the place of disposal must be carried out under the following conditions:

10 % of the bovine population of the Member State concerned;

25 % of the ovine and caprine population of the Member State concerned;

10 % of the porcine population of the Member State concerned; and

a percentage of the population of other species which is determined by the competent authority, on the basis of an assessment of the possible risks for public and animal health which arise from the disposal of animals of those species by burning or burial on site.

the materials do not exceed a volume of 20 kg per week from the establishment or plant where the materials are collected, regardless of the species of origin of the materials;

the materials are collected, transported and disposed of by means which prevent the transmission of unacceptable risks to public and animal health;

the competent authority carries out regular checks, including checks on the records kept by operators, in the establishments or plants where the materials are collected, to ensure compliance with the provisions of this Section.

Applications for authorisation of an alternative method of use or disposal of animal by-products or derived products as referred to in Article 20 of Regulation (EC) No 1069/2009 (applications) shall be submitted in one of the official languages of the European Union as referred to in Article 1 of Regulation No 1 of 1958.

Interested parties that submit such applications in a language other than English shall validate the official translation of their application, which EFSA shall provide, prior to the assessment.

The period referred to in Article 20(5) of Regulation (EC) No 1069/2009 shall only start once the interested party has validated the official translation of the application.

Applications shall contain all necessary information concerning the following points, in order to allow EFSA to assess the safety of their proposed alternative method:

Applications shall be submitted with documentary evidence, in particular a flow diagram showing the functioning of the process, the evidence indicated under point 1(c), as well as other evidence aiming to substantiate the explanation given under the framework set out under point 1.

Applications shall include a contact address for the interested party, which shall include the name and full address, telephone and/or fax numbers and/or the electronic mail address of a particular contact person that is responsible as or on behalf of the interested party.

As from the starting point in the manufacturing chain referred to in Article 4(1) of Regulation (EC) No 1069/2009, animal by-products and derived products must be collected and transported in sealed new packaging or covered leak-proof containers or vehicles.

Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with animal by-products or derived products, other than derived products which are placed on the market in accordance with Regulation (EC) No 767/2009 and which are stored and transported in accordance with Annex II to Regulation (EC) No 183/2005, must be maintained in a clean condition.

In particular, unless they are dedicated to the carriage of particular animal by-products or derived products in a way which avoids cross-contamination, they must be:

Reusable containers must be dedicated to the carriage of a particular animal by-product or derived product to the extent necessary to avoid cross-contamination.

However, reusable containers may be used, provided the competent authority has authorised such use:

Packaging material must be disposed of, by incineration or by other means in accordance with Union legislation.

The transport of animal by-products destined for the production of feed material or raw petfood must take place at an appropriate temperature, in the case of animal by-products from meat and meat products which have been destined for purposes other than human consumption, at a maximum of 7 °C, unless they are used for feeding purposes in accordance with Chapter I of Annex II, in order to avoid any risk to animal or public health.

Unprocessed Category 3 material destined for the production of feed material or petfood must be stored and transported chilled, frozen or ensiled, unless:

The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature throughout transport, and allow that temperature to be monitored.

All necessary measures must be taken to ensure that:

During transport and storage, a label attached to the packaging, container or vehicle must:

Member States may establish systems or lay down rules for the colour-coding of packaging, containers or vehicles used for the transport of animal by-products and derived products originating in and remaining on their territory, provided that those systems or rules do not confuse the colour-coding system provided for in point 1(c).

Member States may establish systems or lay down rules for the marking of animal by-products originating in and remaining on their territory provided that those systems or rules do not conflict with the marking requirements set out for derived products in Chapter V of this Annex.

By way of derogation from points 3 and 4, Member States may use the systems or rules referred to in those points for animal by-products originating in but not intended to remain on their territory if the Member State or third country of destination has communicated its agreement.

However:

During transportation, a commercial document in accordance with the model set out in this Chapter, or, when required by this Regulation, a health certificate must accompany animal by-products and derived products.

However, such document or certificate shall not be necessary, provided that:

The commercial document must be produced at least in triplicate (one original and two copies). The original must accompany the consignment to its final destination. The receiver must retain it. The producer must retain one of the copies and the carrier the other.

Member States may require that proof of the arrival of the consignments is provided by the TRACES system or by a fourth copy of the commercial document which is sent back by the receiver to the producer.

Health certificates must be issued and signed by the competent authority.

A commercial document in accordance with the model set out under point 6 shall accompany animal by-products and derived products as from the starting point in the manufacturing chain referred to in Article 4(1) of Regulation (EC) No 1069/2009, during transportation within the Union.

However, in addition to the authorisation to transmit information by way of an alternative system as referred to in the second subparagraph of Article 21(3) of Regulation (EC) No 1069/2009, the competent authority may authorise that animal by-products and derived products which are transported on its territory are accompanied by:

Records and related commercial documents or health certificates shall be kept for a period of at least two years for presentation to the competent authority.

Model commercial document

Notes

The records as referred to in Article 22(1) of Regulation (EC) No 1069/2009 for animal by-products and derived products, other than compound feeds as defined in Article 3(2)(h) of Regulation (EC) No 767/2009, which have been manufactured from animal by-products or from derived products and which are placed on the market in accordance with Article 4 of Regulation (EC) No 767/2009, shall contain:

By way of derogation from point 1 of this Section, operators do not have to keep the information referred to in point 1(a) and points (b)(i), (c)(i) and (iii) and d(ii) and (iii) separately, if they keep a copy of the commercial document laid down in Chapter III for each consignment and make such information available in conjunction with the other information required under point 1 of this Section.

Operators of incineration plants and co-incineration plants shall keep records of the quantities and category of the animal by-products and derived products incinerated or co-incinerated, as applicable, and the date at which those operations were carried out.

in the case of final users, the quantity used, the animals that it is intended to be fed to and the date of use;

in the case of collection centres:

the number of furs and carcases of animals fed with materials originating of their own species; and

each consignment in order to ensure the traceability of the material.

the quantities of organic fertilisers and soil improvers applied;

the date on which the organic fertilisers and soil improvers were applied to land and the places of such application;

the dates, following the application of the organic fertiliser or soil improver, on which livestock has been allowed to graze on the land or on which the land has been cut for herbage to be used for feeding.

the quantities produced each day;

the species of origin, including an indication of whether the aquatic animals were caught in the wild or produced in aquaculture;

in the case of fishmeal from farmed fish which is intended for feeding to farmed fish of another species, the scientific name of the species of origin.

the quantities, categories and species of animal by-products burned or buried;

the date and place of burning and burial.

In processing plants for the processing of Category 1 or Category 2 material, derived products shall be permanently marked with glyceroltriheptanoate (GTH) in such a way that:

The operators of processing plants referred to in point 1 shall have in place a system of monitoring and recording of parameters suitable to demonstrate to the competent authority that the required homogeneous minimum concentration of GTH is achieved.

That monitoring and recording system shall include the determination of the content of intact GTH as triglyceride in a cleaned petroleum-ether 40-70 extract of GTH from samples taken at regular intervals.

The marking with GTH shall not be required for: