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Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance)

EU Regulation No 142/2011 · Adopted 25 February 2011 · Extends to United Kingdom

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Commission Regulation (EU) No 142/2011

of 25 February 2011

implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)f1, and in particular Articles 5(2) and 6(1)(b)(ii) and the second subparagraph of Article 6(1), the second subparagraph of Article 6(2), Article 11(2)(b) and (c) and the second subparagraph of Article 11(2), Article 15(1)(b), (d), (e), (h) and (i) and the second subparagraph of Article 15(1), Articles 17(2) and 18(3), Article 19(4)(a), (b) and (c) and the second subparagraph of Article 19(4), Article 20(10) and (11), Article 21(5) and (6), Articles 22(3) and 23(3), Article 27(a), (b), (c) and (e) to (h) and the second subparagraph of Article 27, Articles 31(2), 32(3), Article 40, the first and third subparagraph of Article 41(3), Article 42, Articles 43(3), 45(4), 47(2), Article 48(2), Article 48(7)(a) and (8)(a) and the second subparagraph of Article 48(8) thereof,

Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countriesf2, and in particular Article 16(3) thereof,

Whereas:

(1)

Regulation (EC) No 1069/2009 lays down animal and public health rules for animal by-products and products derived thereof. That Regulation determines the circumstances under which animal by-products are to be disposed of, in order to prevent the spreading of risks for public and animal health. In addition, that Regulation specifies under which conditions animal by-products may be used for applications in animal feed and for various purposes, such as in cosmetics, medicinal products and technical applications. It also lays down obligations for operators to handle animal by-products within establishments and plants which are subject to official controls.

(2)

Regulation (EC) No 1069/2009 provides that detailed rules for the handling of animal by-products and derived products, such as processing standards, hygiene conditions and the format for documentary evidence which has to accompany consignments of animal by-products and derived products for the purposes of traceability are to be adopted by means of implementing measures.

(3)

The detailed rules for the use and disposal of animal by-products in this Regulation should be laid down with a view to the achievement of the objectives of Regulation (EC) No 1069/2009, notably the sustainable use of animal materials, and a high level of protection of public and animal health in the European Union.

(4)

Regulation (EC) No 1069/2009 does not apply to entire bodies or parts of wild animals, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes. In addition, it does not apply to entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice. Regarding those animal by-products from hunting, disposal should be carried out in a way which prevents the transmission of risks, as appropriate for specific hunting practices and in accordance with the good practice as it has been described by the hunting profession.

(5)

Regulation (EC) No 1069/2009 applies to animal by-products for the preparation of game trophies. The preparation of such trophies, as well as the preparations of animals and parts of animals for which other methods, such as plastination, are used, should take place under conditions which prevent the transmission of risks for human or animal health.

(6)

Regulation (EC) No 1069/2009 applies to catering waste if it originates from means of transport operating internationally, such as materials derived from foodstuffs served on board an airplane or a ship arriving in the European Union from a third country destination. Catering waste also falls within the scope of that Regulation, if it is destined for feeding purposes, for processing in accordance with one of the authorised processing methods under this Regulation or for transformation into biogas or for composting. Regulation (EC) No 1069/2009 prohibits the feeding of catering waste to farmed animals, other than fur animals. Therefore, in accordance with Regulation (EC) No 1069/2009, catering waste may be processed and subsequently used, provided that the derived product is not fed to such animals.

(7)

For the sake of consistency of Union legislation, the definition of feed materials in Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EEC and 96/25/EC and Commission Decision 2004/217/ECf3 should be used as a basis for defining feed materials of animal origin in this Regulation.

(8)

Regulation (EC) No 1069/2009 prohibits the dispatch of animal by-products and of derived products from susceptible species from holdings, establishments, plants or zones which are subject to restrictions due to the presence of a serious transmissible disease. In order to provide for a high level of protection of animal health in the Union, the list of diseases in the Terrestrial and Aquatic Animal Health Codes of the World Organisation of Animal Health (hereinafter referred to as ‘OIE’) should be specified as the list of serious transmissible diseases for the purpose of determining the scope of this prohibition.

(9)

Since the incineration and the co-incineration of certain animal by-products do not fall within the scope of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of wastef4, adequate rules for the prevention of health risks arising from such operations should be laid down in this Regulation, taking into account the possible effects on the environment. Residues from the operation of the incineration or co-incineration of animal by-products or derived products should be recycled or disposed of, in accordance with Union environmental legislation, since in particular, that legislation allows for the use of the phosphorous component of ashes in fertilisers and for the handover of ashes from the cremation of pet animals to the owners.

(10)

Products of animal origin or foodstuffs containing such products, should only be disposed of in a landfill, in accordance with Council Directive 1999/31/EC of 26 April 1999 on the landfill of wastef5, 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 foodstuffsf6, in order to mitigate potential health risks.

(11)

The disposal of animal by-products or derived products via the wastewater stream should be prohibited, since that stream is not subject to requirements which would ensure an appropriate control of public and animal health risks. Appropriate measures should be taken to prevent unacceptable risks from accidental disposal of liquid animal by-products, such as from the cleaning of floors and equipments used for processing.

(12)

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directivesf7 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 consumptionf8, except those which are destined for incineration, landfilling or use in a biogas or composting plant. That Regulation has now been repealed and replaced by Regulation (EC) No 1069/2009 from 4 March 2011. In the interests of coherency of Union legislation, the processes whereby animal by-products and derived products are transformed into biogas and composted should comply with the health rules laid down in this Regulation, as well as the measures for the protection of the environment laid down in Directive 2008/98/EC.

(13)

The competent authority of a Member State should be able to authorise alternative parameters for the transformation of animal by-products into biogas or for their composting on the basis of a validation according to a harmonised model. In that case, it should be possible to place digestion residues and compost on the market in the whole European Union. In addition, the competent authority of a Member State should be able to authorise certain parameters for specific animal by-products, such as catering waste and mixtures of catering waste with certain other materials, which are transformed into biogas or composted. Since such authorisations are not issued according to a harmonised model, digestion residues and compost should only be placed on the market within the Member State where the parameters have been authorised.

(14)

In order to prevent the contamination of foodstuffs with pathogenic agents, establishments or plants processing animal by-products should operate on a separate site from slaughterhouses or other establishments in which foodstuffs are processed, in particular in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal originf9, unless the processing of the animal by-products takes place under conditions which have been approved by the competent authority, with a view to preventing the transmission of risks to public and animal health into the food-processing establishments.

(15)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathiesf10 provides that Member States are to carry out annual monitoring programmes for transmissible spongiform encephalopathies (TSEs). Bodies of animals which are used for feeding to certain species, for the purposes of promotion of bio-diversity, should be included in those monitoring programmes to the extent necessary to ensure that those programmes provide sufficient information regarding the prevalence of TSE in a particular Member State.

(16)

Regulation (EC) No 1069/2009 allows the feeding of certain Category 1 material to endangered or protected species of necrophagous birds and to other species living in their natural habitat, for the promotion of biodiversity. Such feeding should be authorised for certain carnivore species referred to in Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and floraf11 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 birdsf12, in order to take into account the natural feeding patterns of those species.

(17)

Regulation (EC) No 1069/2009 has introduced a procedure for the authorisation of alternative methods of use or disposal of animal by-products or derived products. Such methods may be authorised by the Commission following receipt of an opinion from the European Food Safety Authority (hereinafter referred to as ‘EFSA’). In order to facilitate the evaluation of applications by EFSA, a standard format should be laid down which illustrates to applicants the nature of the evidence to be submitted. In accordance with the Treaties, it should be possible to submit applications for alternative methods in the official languages of the Union, as laid down in EEC Council Regulation No 1 determining the languages to the used by the European Economic Communityf13.

(18)

In accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygienef14, feed business operators, other than primary producers, are required to store and transport feed under certain hygienic conditions. Since those conditions provide for an equivalent mitigation of potential risks, compound feedingstuffs derived from animal by-products should not be subject to the requirements of this Regulation regarding storage and transport.

(19)

For the promotion of science and research and to ensure the best possible use of animal by-products and of derived products in the diagnosis of human or animal diseases, the competent authority should be authorised to lay down conditions for samples of such materials for research, educational and diagnostic purposes. However, those conditions should not be laid down for samples of pathogenic agents for which special rules are provided in Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EECf15.

(20)

Directive 97/78/EC exempts animal by-products which are intended for exhibitions, provided that they are not intended to be marketed, and animal by-products intended for particular studies or analyses from veterinary checks in the border inspection post of entry into the Union. That Directive allows for the adoption of implementing measures for those exemptions. In this Regulation, appropriate conditions should be set out for the import of animal by-products and derived products intended for exhibitions and particular studies or analyses, to ensure that no unacceptable risks to public or animal health are spread where such products enter the Union. In the interests of coherency of Union legislation, and in order to provide legal certainty to operators, those conditions and the implementing measures for Directive 97/78/EC should be laid down in this Regulation.

(21)

Following collection, animal by-products should be handled under appropriate conditions which ensure that no unacceptable risks to public or animal health are transmitted. Establishments or plants in which certain operations are carried out before animal by-products are submitted to further processing should be constructed and should operate in a manner which prevents such transmission. This should include establishments or plants where operations involving the handling of animal by-products in accordance with Union veterinary legislation, other than the handling of animal by-products in the course of curative activities of private veterinarians, are carried out.

(22)

Pursuant to Regulation (EC) No 1069/2009, operators are to ensure that animal by-products and derived products are traceable at all stages of the chain of manufacturing, use and disposal, so as to avoid unnecessary disruptions of the internal market in the case of events which are linked to actual or potential risks to public or animal health. Traceability should therefore not only be ensured by operators generating, collecting or transporting animal by-products, but also by operators disposing of animal by-products or derived products, by incineration, co-incineration or landfilling.

(23)

Containers and means of transport which are used for animal by-products or derived products should be maintained in a clean state, so as to prevent contamination. When they are dedicated to the transport of a particular material, such as a liquid animal by-product which does not pose an unacceptable health risk, operators may adjust their measures to ensure the prevention of contamination to the actual risk arising from that material.

(24)

Member States should be authorised to require operators to use the integrated computerised veterinary system (Traces) introduced by Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EECf16 (hereinafter referred to as ‘the TRACES system’) in order to provide proof for the arrival of consignments of animal by-products or derived products at the place of destination. Alternatively, proof for the arrival of consignments should be provided by way of a fourth copy of the commercial document, which is returned to the producer. The experience with the two alternatives should be evaluated after the first year of implementation of this Regulation.

(25)

Regulation (EC) No 853/2004 specifies certain parameters for the treatment of rendered fats, fish oil and egg products which provide an adequate control of possible health risks, when such products are used for purposes other than human consumption. Those parameters should therefore be authorised as alternatives to the treatments for animal by-products which are set out in this Regulation.

(26)

Colostrum and colostrum products should originate from bovine herds which are free of certain diseases as referred to in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swinef17.

(27)

The references to Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic productsf18, 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-agonistsf19, to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal productsf20 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 eggsf21 in the health rules for the trade in unprocessed manure should be updated.

(28)

Certain imported materials for the production of petfood should be handled and used under conditions which are appropriate to the risk which such materials may pose. In particular, provision should be made for their safe channelling to establishments or plants of destination where such materials, as well as Category 3 material, are incorporated into petfood. With respect to the establishments or plants of destination, the competent authority should be authorised to allow the storage of imported materials together with Category 3 material, provided the imported materials can be traced.

(29)

Regulation (EC) No 1069/2009 refers to certain derived products which may be placed on the market in accordance with conditions laid down in certain other Union legislation. That legislation also lays down conditions for the import, collection and movement of animal by-products and derived products for the manufacture of such derived products. However, Regulation (EC) No 1069/2009 applies where that other Union legislation does not lay down conditions concerning risks to public and animal health which may arise from such raw materials. Since such conditions have not been laid down regarding materials which have undergone certain stages of processing prior to their fulfilling the conditions for placing on the market under that other Union legislation, they should be laid down in this Regulation. In particular, the conditions for the import and handling of such materials inside the Union under strict control and documentation requirements should be laid down, so as to prevent the transmission of potential health risks from such materials.

(30)

In particular, adequate health conditions should be laid down in this Regulation for materials which are used for the manufacture of medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human usef22, 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 productsf23, of medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devicesf24, 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 devicesf25, 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 devicesf26 or laboratory reagents (‘the finished products’). If the risks arising from such materials are mitigated due to the purification, concentration in the product or due to the conditions under which they are handled and disposed of, only the requirements of Regulation (EC) No 1069/2009 and of this Regulation in relation to traceability should apply. In such case, the requirements related to the separation of animal by-products of different categories within the establishment or plant producing the finished products should not apply, since the subsequent use of materials for other purposes, in particular their diversion into food or feed can be excluded by the proper application of the rules by the operator, under the responsibility of the competent authority. Consignments of such materials which are to be imported into the Union should be subject to veterinary checks at the border inspection post of entry in accordance with Directive 97/78/EC, in order to ascertain that those products comply with the requirements for their placing on the market within the Union.

(31)

Pursuant to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and import from third countries of equidaef27, certain diseases to which equidae are susceptible are compulsorily notifiable. Blood products from equidae which are intended for purposes other than for feeding, such as blood products intended for veterinary medicinal products, should originate from equidae which did not show clinical signs of those diseases, in order to mitigate the risk of transmission of those diseases.

(32)

It should be permissible to place on the market fresh hides and skins for purposes other than human consumption, provided they comply with the animal health conditions for fresh meat laid down in accordance with Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumptionf28, since those conditions provide for an appropriate mitigation of possible health risks.

(33)

The health rules laid down in this Regulation for the manufacture and placing on the market of game trophies and other preparations from animals which eliminate potential risks should be in addition to the rules for the protection of certain species of wild animals laid down in Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade thereinf29, due to the different objective of that Regulation. Anatomical preparations of animals or animal by-products which have been submitted to a process such as plastination which equally eliminates potential risks should not be subject to animal health restrictions, in order to facilitate the use of such preparations, in particular in education.

(34)

Apiculture by-products which are to be placed on the market should be free of certain diseases to which bees are susceptible that are listed in Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EECf30.

(35)

The European Parliament and the Council have called upon the Commission to determine an end point in the manufacturing chain for oleochemical products, beyond which they are no longer subject to the requirements of Regulation (EC) No 1069/2009. The decision regarding that end point should be taken as soon as an assessment has become available which evaluates the capacity of the oleochemical processes to mitigate potential health risks which may be present in animal fats of any category of material which are processed.

(36)

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirementsf31 should be referred to in this Regulation, in so far as those third countries and other territories should be authorised for the importation of certain animal by-products or derived products, since the risks which arise from those products are identical to those which potentially arise from the import of live animals or fresh meat.

(37)

Further lists of third countries from which certain materials of animal origin may be imported should be referred to for the purposes of determining the third countries from which animal by-products of the respective species may be imported, on the basis of similar considerations concerning health risks and in order to ensure coherency of Union legislation. Such lists have been laid down in Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species and amending Decisions 93/195/EEC and 94/63/ECf32, 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 consumptionf33, 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 permittedf34, 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 requirementsf35 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 requirementsf36.

(38)

Since waste from the photographic industry which uses certain animal by-products such as bovine vertebral column does not only pose risks to public and animal health, but also risks to the environment, it should either be disposed of or exported to the third country of origin of the animal by-products in accordance with Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of wastef37.

(39)

The list of border inspection posts laid down in Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Tracesf38 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 countriesf39 should be used for the purposes of that transit.

(40)

This Regulation should provide that the health certificates which are to accompany consignments of animal by-products or derived products at the point of entry into the Union where the veterinary checks take place should be issued in accordance with principles of certification equivalent to those laid down in Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal productsf40.

(41)

In the interests of consistency of Union legislation, official controls on the entire chain of animal by-products and derived products should be carried out in accordance with the general obligations for official controls which are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rulesf41.

(42)

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

(43)

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

(44)

Following the adoption of Regulation (EC) No 1774/2002, certain implementing acts were adopted, namely Commission Regulation (EC) No 811/2003f42 on the intra-species recycling ban for fish, and the burial and burning of certain animal by-products, Commission Decision 2003/322/ECf43 on the feeding of certain necrophagous birds with certain Category 1 materials, Commission Decision 2003/324/ECf44 on a derogation from the intra-species recycling ban for fur animals, Commission Regulations (EC) No 79/2005f45 on milk and milk-based products, (EC) No 92/2005f46 on means of disposal or uses, (EC) No 181/2006f47 on organic fertilisers and soil improvers other than manure, (EC) No 1192/2006f48 on lists of approved plants and (EC) No 2007/2006f49 on the importation and transit of certain Category 3 intermediate products.

(45)

In addition, certain transitional measures were adopted, in particular Commission Regulation (EC) No 878/2004f50 on the import and handling of certain Category 1 and Category 2 materials, Commission Decision 2004/407/ECf51 on the import of certain materials for the production of photogelatine and Commission Regulation (EC) No 197/2006f52 on handling and disposal of former foodstuffs, to lay down risk-proportionate measures for certain specific uses of animal by-products.

(46)

In order to further simplify Union rules for animal by-products, as requested by the Presidency of the Council at the time of the adoption of Regulation (EC) No 1069/2009, those implementing and transitional measures were reviewed. They should now be repealed and replaced, as necessary, by this Regulation, so as to constitute a coherent legal framework for animal by-products and derived products.

(47)

Regulation (EC) No 1069/2009 applies from 4 March 2011 and accordingly this Regulation should also apply from that date. In addition, it is necessary to provide for a transitional period, in order to give stakeholders time to adjust to the new rules laid down in this Regulation and to place on the market certain products which were produced in accordance with Union health rules applicable before that date, and to allow for a continuation of imports when the requirements of this Regulation become applicable.

(48)

The placing on the market and the export of certain products referred to in Regulation (EC) No 878/2004 should continue to be carried out in accordance with national measures, since the associated risks for the limited amount of materials involved currently allow their regulation at national level, pending possible future harmonisation. Pending the adoption of measures for the collection and disposal of certain limited amounts of products of animal origin from the retail sector on the basis of further evidence, the competent authority should continue to be able to authorise the collection and disposal of such products by other means, provided that an equivalent protection of public and animal health is ensured.

(49)

In accordance with the request expressed by the European Parliament at the time of its agreement to Regulation (EC) No 1069/2009 at first reading, and taking into account the Parliament's more specific suggestions for addressing certain technical issues, a draft of this Regulation has been presented on 27 September 2010 to its Committee for the Environment, Public Health and Food Safety for an exchange of views.

(50)

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

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 300, 14.11.2009, p. 1.

f2

OJ L 24, 30.1.1998, p. 9.

f3

OJ L 229, 1.9.2009, p. 1.

f4

OJ L 332, 28.12.2000, p. 91.

f5

OJ L 182, 16.7.1999, p. 1.

f6

OJ L 139, 30.4.2004, p. 1.

f7

OJ L 312, 22.11.2008, p. 3.

f8

OJ L 273, 10.10.2002, p. 1.

f9

OJ L 139, 30.4.2004, p. 55.

f10

OJ L 147, 31.5.2001, p. 1.

f11

OJ L 206, 22.7.1992, p. 7.

f12

OJ L 20, 26.1.2010, p. 7.

f13

OJ 17, 6.10.1958, p. 385/58.

f14

OJ L 35, 8.2.2005, p. 1.

f15

OJ L 62, 15.3.1993, p. 49.

f16

OJ L 94, 31.3.2004, p. 63.

f17

OJ 121, 29.7.1964, p. 1977/64.

f18

OJ L 262, 27.9.1976, p. 169.

f19

OJ L 125, 23.5.1996, p. 3.

f20

OJ L 125, 23.5.1996, p. 10.

f21

OJ L 343, 22.12.2009, p. 74.

f22

OJ L 311, 28.11.2001, p. 67.

f23

OJ L 311, 28.11.2001, p. 1.

f24

OJ L 169, 12.7.1993, p. 1.

f25

OJ L 331, 7.12.1998, p. 1.

f26

OJ L 189, 20.7.1990, p. 17.

f27

OJ L 192, 23.7.2010, p. 1.

f28

OJ L 18, 23.1.2003, p. 11.

f29

OJ L 61, 3.3.1997, p. 1.

f30

OJ L 268, 14.9.1992, p. 54.

f31

OJ L 73, 20.3.2010, p. 1.

f32

OJ L 73, 11.3.2004, p. 1.

f33

OJ L 175, 10.7.2010, p. 1.

f34

OJ L 320, 18.11.2006, p. 53.

f35

OJ L 226, 23.8.2008, p. 1.

f36

OJ L 39, 10.2.2009, p. 12.

f37

OJ L 190, 12.7.2006, p. 1.

f38

OJ L 296, 12.11.2009, p. 1.

f39

OJ L 21, 28.1.2004, p. 11.

f40

OJ L 13, 16.1.1997, p. 28.

f41

OJ L 165, 30.4.2004, p. 1.

f42

OJ L 117, 13.5.2003, p. 14.

f43

OJ L 117, 13.5.2003, p. 32.

f44

OJ L 117, 13.5.2003, p. 37.

f45

OJ L 16, 20.1.2005, p. 46.

f46

OJ L 19, 21.1.2005, p. 27.

f47

OJ L 29, 2.2.2006, p. 31.

f48

OJ L 215, 5.8.2006, p. 10.

f49

OJ L 379, 28.12.2006, p. 98.

f50

OJ L 162, 30.4.2004, p. 62.

f51

OJ L 151, 30.4.2004, p. 11.

f52

OJ L 32, 4.2.2006, p. 13.

Contents

  1. Chapter I: GENERAL PROVISIONS
  2. 1Subject matter and scope
  3. 2Definitions
  4. 3End point in the manufacturing chain for certain derived products
  5. 4Serious transmissible diseases
  6. Chapter II: DISPOSAL AND USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS
  7. 5Restrictions on the use of animal by-products and derived products
  8. 6Disposal by incineration, disposal or recovery by co-incineration and use as a fuel for combustion
  9. 7Landfilling of certain Category 1 and 3 materials
  10. 8Requirements for processing plants and other establishments
  11. 9Hygiene and processing requirements for processing plants and other establishments
  12. 10Requirements regarding the transformation of animal by-products and derived products into biogas and composting
  13. Chapter III: DEROGATIONS FROM CERTAIN PROVISIONS OF REGULATION (EC) No 1069/2009
  14. 11Special rules on research and diagnostic samples
  15. 12Special rules on trade samples and display items
  16. 13Special feeding rules
  17. 14Feeding of certain species in and outside feeding stations and in zoos
  18. 15Special rules on collection and disposal
  19. Chapter IV: AUTHORISATIONS OF ALTERNATIVE METHODS
  20. 16Standard format for applications for authorisation of alternative methods
  21. Chapter V: COLLECTION, TRANSPORT, IDENTIFICATION AND TRACEABILITY
  22. 17Requirements regarding commercial documents and health certificates, identification, the collection and transport of animal by-products and traceability
  23. Chapter VI: REGISTRATION AND APPROVAL OF ESTABLISHMENTS AND PLANTS
  24. 18Requirements regarding the approval of one or more establishments and plants handling animal by-products on the same site
  25. 19Requirements concerning certain approved establishments and plants handling animal by-products and derived products
  26. 20Requirements concerning certain registered establishments and plants handling animal by-products and derived products
  27. 20aLists of establishments, plants and operators ...
  28. Chapter VII: PLACING ON THE MARKET
  29. 21Processing and placing on the market of animal by-products and derived products for feeding to farmed animals, excluding fur animals
  30. 22Placing on the market and use of organic fertilisers and soil improvers
  31. 23Intermediate products
  32. 24Petfood and other derived products
  33. Chapter VIII: IMPORT, TRANSIT AND EXPORT
  34. 24ASpecial transitional import arrangements
  35. 25Import from a third country, transit and export of animal by-products and of derived products
  36. 26Placing on the market, including importation, and export of certain Category 1 materials
  37. 27Importation from a third country and transit of research and diagnostic samples
  38. 28Importation from a third country and transit of trade samples and display items
  39. 29Specific requirements for certain movements of animal by-products between territories of the Russian Federation Repealed
  40. 29aSpecific requirements for transit through Croatia of animal by-products coming from Bosnia and Herzegovina and destined to third countries Repealed
  41. 30Lists of establishments and plants in third countries
  42. 31Models of health certificates and declarations for importation from a third country and transit
  43. Chapter IX: OFFICIAL CONTROLS
  44. 32Official controls
  45. 33Reapproval of plants and establishments after the grant of a temporary approval
  46. Chapter X: FINAL PROVISIONS
  47. 34Restrictions on the placing on the market of certain animal by-products and derived products for reasons of public and animal health
  48. 35Repeal
  49. 36Transitional measures Repealed
  50. 37Article 37
  51. Signature
  52. Annex IDEFINITIONS AS REFERRED TO IN ARTICLE 2
  53. Annex II: RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS
  54. Intra-species recycling of fur animals Repealed
  55. 1Division 1 Repealed
  56. 2Division 2 Repealed
  57. 3Division 3 Repealed
  58. CHAPTER IIFeeding of farmed animals with herbage
  59. Annex III: DISPOSAL, RECOVERY AND USE AS A FUEL
  60. GENERAL REQUIREMENTS FOR INCINERATION AND CO-INCINERATION
  61. General conditions
  62. 1Operators 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:
  63. 2Division 2
  64. 3Division 3
  65. 4If the incineration or co-incineration plant is located on a livestock holding:
  66. 5Division 5
  67. 6Division 6
  68. Section 2Operating conditions
  69. Incineration and co-incineration residues
  70. 1Division 1
  71. 2Division 2
  72. Measurement of temperature and of other parameters
  73. 1Division 1
  74. 2Division 2
  75. 3Division 3
  76. 4Division 4
  77. Section 5Abnormal operating
  78. HIGH-CAPACITY INCINERATION AND CO-INCINERATION PLANTS
  79. Section 1Specific operating conditions
  80. Water discharges
  81. 1Division 1
  82. 2Storage capacity shall be provided for contaminated rainwater run-off from the plant site or for contaminated water arising from spillage or firefighting operations.
  83. CHAPTER IIILOW-CAPACITY INCINERATION AND CO-INCINERATION PLANTS
  84. GENERAL REQUIREMENTS FOR THE USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS AS A FUEL
  85. General requirements regarding the combustion of animal by-products and derived products as a fuel
  86. 1Operators of combustion plants referred to in Article 6(6) shall ensure that the following conditions are met in the combustion plants under their control:
  87. 2Division 2
  88. 3Division 3
  89. 4Where the combustion plant is located on a holding keeping animals of food producing species:
  90. 5Division 5
  91. 6Division 6
  92. Operating conditions of combustion plants
  93. 1Division 1
  94. 2The gas resulting from the process is raised in a controlled and homogeneous fashion for 2 seconds to a temperature of 850 °C or for 0,2 seconds to a temperature of 1 100 °C.
  95. 3Division 3
  96. 4Division 4
  97. 5Division 5
  98. Combustion residues
  99. 1Division 1
  100. 2Division 2
  101. Breakdown or abnormal operating conditions
  102. 1Division 1
  103. 2Division 2
  104. TYPES OF PLANTS AND FUELS THAT MAY BE USED FOR COMBUSTION AND SPECIFIC REQUIREMENTS FOR PARTICULAR TYPES OF PLANTS
  105. Stationary internal combustion engines
  106. 1Starting material:
  107. 2Methodology:
  108. 3Operating conditions:
  109. On-farm combustion plants in which poultry manure is used as a fuel
  110. 1Type of plant:
  111. 2Starting material and scope:
  112. 3Specific requirements for poultry manure used as a fuel for combustion:
  113. 4Emission limit values and monitoring requirements:
  114. 5Changes of operation and breakdowns:
  115. Combustion plants in which manure of farmed animals other than poultry manure set out in point B is used as a fuel for combustion
  116. 1Type of plant:
  117. 2Starting material:
  118. 3Methodology:
  119. 4Derogation and transitional period:
  120. DCombustion plants in which meat-and-bone meal is used as a fuel for combustion
  121. Annex IV: PROCESSING
  122. REQUIREMENTS FOR PROCESSING PLANTS AND CERTAIN OTHER PLANTS AND ESTABLISHMENTS
  123. General conditions
  124. 1Processing 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:
  125. 2Division 2
  126. 3Division 3
  127. 4Division 4
  128. 5Division 5
  129. 6Division 6
  130. Wastewater treatment
  131. 1Processing 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.
  132. 2Division 2
  133. 3Division 3
  134. 4Division 4
  135. 5Division 5
  136. 6Without 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.
  137. Section 3Specific requirements for the processing of Category 1 and Category 2 materials
  138. Section 4Specific requirements for the processing of Category 3 materials
  139. HYGIENE AND PROCESSING REQUIREMENTS
  140. Section 1General hygiene requirements
  141. General processing requirements
  142. 1Division 1
  143. 2Division 2
  144. Section 3Processing methods for Category 1 and Category 2 material
  145. Processing of Category 3 material
  146. 1The 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:
  147. 2Division 2
  148. 3Division 3
  149. 4Division 4
  150. STANDARD PROCESSING METHODS
  151. Processing method 1 (pressure sterilisation)
  152. Reduction
  153. 1Division 1
  154. Time, temperature and pressure
  155. 2Division 2
  156. 3Division 3
  157. Processing method 2
  158. Reduction
  159. 1Division 1
  160. Time, temperature and pressure
  161. 2After 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.
  162. 3Division 3
  163. Processing method 3
  164. Reduction
  165. 1Division 1
  166. Time, temperature and pressure
  167. 2After 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.
  168. 3Division 3
  169. Processing method 4
  170. Reduction
  171. 1Division 1
  172. Time, temperature and pressure
  173. 2After 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.
  174. 3Division 3
  175. Processing method 5
  176. Reduction
  177. 1Division 1
  178. Time, temperature and pressure
  179. 2After 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.
  180. 3Division 3
  181. Processing method 6 (for Category 3 animal by-products originating from aquatic animal or aquatic invertebrates only)
  182. Reduction
  183. 1The animal by-products must be reduced to a particle size which is no greater than:
  184. Time, temperature and pressure
  185. 2After reduction, the mixture must be heated to:
  186. 3Division 3
  187. Processing method 7
  188. 1Any processing method authorised by the competent authority where the following have been demonstrated by the operator to that authority:
  189. 2Division 2
  190. 3Division 3 Repealed
  191. 4Division 4
  192. 5Division 5
  193. ALTERNATIVE PROCESSING METHODS
  194. General provisions
  195. 1Materials resulting from the processing of Category 1 and 2 materials shall be permanently marked in accordance with the requirements for the marking of certain derived products set out in Chapter V of Annex VIII.
  196. 2Division 2
  197. Processing standards
  198. Alkaline hydrolysis process
  199. 1Starting material
  200. 2Processing method
  201. High pressure high temperature hydrolysis process
  202. 1Starting material
  203. 2Processing method
  204. High pressure hydrolysis biogas process
  205. 1Starting material
  206. 2Processing method
  207. Biodiesel production process
  208. 1Starting material
  209. 2Processing method
  210. Brookes’ gasification process
  211. 1Starting material
  212. 2Processing method
  213. Combustion of animal fat in a thermal boiler process
  214. 1Starting material
  215. 2Processing method
  216. Thermomechanical biofuel production process
  217. 1Starting material
  218. 2Processing method
  219. Hydrolysis with subsequent disposal Repealed
  220. 1Member States concerned Repealed
  221. 2Starting materials Repealed
  222. 3Methodology Repealed
  223. Lime treatment for pig and poultry manure
  224. 1Starting materials
  225. Processing method
  226. (a)The dry matter content of the manure must be determined by using the CEN EN 12880:2000 method ‘Characterization of sludges. Determination of dry residue and water content’.
  227. (b)Division (b)
  228. (c)The particle size of the animal by-products to be processed must be no greater than 12 mm.
  229. (d)The manure must be mixed with quick lime (CaO) which has a medium to high reactivity of less than six minutes to achieve a 40 °C rise in temperature as per the criteria in the reactivity test 5.10 in the CEN EN 459-2:2002 method .
  230. (e)Division (e)
  231. (f)At monitoring points which must be introduced into the stockpile, continuous measurements must be carried out to demonstrate that the mixture in the stockpile reaches a pH of at least 12 during one of the following periods of time, during which period one of the corresponding following temperatures must be achieved:
  232. (g)Division (g)
  233. (h)Division (h)
  234. (i)Operators may demonstrate to the competent authority, by way of a validation according to the following requirements, that a process using a mixing device which is different from the mixing device referred to in point (d) or using dolime (CaOMgO) instead of quick lime is at least as efficient as the process set out in points (a) to (h):
  235. Multi-step catalytic process for the production of renewable fuels
  236. Starting materials
  237. (a)For this process, the following materials may be used:
  238. (b)Division (b)
  239. Processing method
  240. (a)The rendered fat must be submitted to a pre-treatment which consists of:
  241. (b)The pre-treated materials must be submitted to a multi-step catalytic process which consists of a hydro-deoxygenisation step, followed by an isomerisation step.
  242. Ensilage of fish material
  243. 1Starting materials
  244. Processing method
  245. 2.1Division 2.1
  246. 2.2Division 2.2
  247. 2.3Division 2.3
  248. Multiple-step catalytic hydro-treatment for the production of renewable fuels
  249. 1Starting materials
  250. 2Processing method
  251. Disposal and use of derived products
  252. 1Products derived from the processing of:
  253. 2Materials resulting from processing in accordance with:
  254. 3Division 3
  255. Annex V: TRANSFORMATION OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS INTO BIOGAS, COMPOSTING
  256. REQUIREMENTS APPLICABLE TO PLANTS
  257. Biogas plants
  258. 1A 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:
  259. 2By way of derogation from point 1, a pasteurisation /hygienisation unit shall not be mandatory for biogas plants that transform only:
  260. 3If 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.
  261. 4Division 4
  262. Composting plants
  263. 1A 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:
  264. 2By way of derogation from point 1, other types of composting systems may be allowed provided they:
  265. 3If 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.
  266. 4Division 4
  267. HYGIENE REQUIREMENTS APPLICABLE TO BIOGAS AND COMPOSTING PLANTS
  268. 1Division 1
  269. 2Containers, receptacles and vehicles used for transporting untreated material must be cleaned and disinfected in a designated area.
  270. 3Preventive measures against birds, rodents, insects or other vermin must be taken systematically.
  271. 4Division 4
  272. 5Division 5
  273. 6Division 6
  274. 7Division 7
  275. TRANSFORMATION PARAMETERS
  276. Standard transformation parameters
  277. 1Category 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:
  278. 2Category 3 material which is used as raw material in a composting plant must be submitted to the following minimum requirements:
  279. Alternative transformation parameters for biogas and composting plant
  280. 1The 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:
  281. 2By 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:
  282. 3Where 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:
  283. 4Operators may place on the market digestion residues and compost, which have been produced according to parameters which have been authorised by the competent authority:
  284. Standards for digestion residues and compost
  285. 1Division 1
  286. 2Division 2
  287. 3Division 3
  288. Annex VI: SPECIAL RULES ON RESEARCH, FEEDING AND COLLECTION AND DISPOSAL
  289. SPECIAL RULES ON SAMPLES FOR RESEARCH AND OTHER PURPOSES
  290. Research and diagnostic samples
  291. 1Operators shall ensure that consignments of research and diagnostic samples are accompanied by a commercial document, which must specify:
  292. 2Division 2
  293. 3Division 3
  294. 4Unless they are kept for reference purposes, research and diagnostic samples and any products derived from the use of those samples shall be disposed of:
  295. 5Users that handle research and diagnostic samples shall keep a register of consignments of such samples.
  296. 6Division 6
  297. Trade samples and display items
  298. 1Division 1
  299. 2Unless trade samples are kept for reference purposes, they shall be, after the particular studies or analyses have been concluded:
  300. 3Division 3
  301. SPECIAL FEEDING RULES
  302. Section 1General requirements
  303. Feeding of certain species in feeding stations
  304. 1The 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:
  305. 2Division 2 Repealed
  306. Section 3Feeding of wild animals outside feeding stations
  307. Section 4Feeding of zoo animals with Category 1 material
  308. SPECIAL RULES ON COLLECTION AND DISPOSAL
  309. Special disposal rules for animal by-products
  310. 1If 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:
  311. 2The 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:
  312. 3The 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:
  313. 4In 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:
  314. Section 2Burning and burial of animal by-products in remote areas
  315. Section 3Burning and burial of bees and apiculture by-products
  316. CHAPTER IVDISPOSAL BY OTHER MEANS
  317. Annex VII: STANDARD FORMAT FOR APPLICATIONS FOR ALTERNATIVE METHODS
  318. Language regime
  319. 1Division 1
  320. 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  321. Content of applications
  322. 1Applications shall contain all the necessary information to allow the appropriate authority to assess the safety of the proposed alternative method, and in particular describe:
  323. 2The application referred to in paragraph 1 shall moreover:
  324. 3Validated direct measurements as referred to in paragraph 2(d) above shall mean:
  325. 4The HACCP plan referred to in paragraph 2(b) must be based on the critical parameters which are used to obtain the risk reduction, in particular:
  326. 5The applications shall also contain sufficient information on:
  327. 6Applications shall be submitted with documentary evidence, in particular:
  328. 7Division 7
  329. Annex VIII: COLLECTION, TRANSPORT AND TRACEABILITY
  330. COLLECTION AND TRANSPORT
  331. Vehicles and containers
  332. 1Division 1
  333. 2Vehicles 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.
  334. 3Reusable containers must be dedicated to the carriage of a particular animal by-product or derived product to the extent necessary to avoid cross-contamination.
  335. 4Division 4
  336. Temperature conditions
  337. 1Division 1
  338. 2Unprocessed Category 3 material destined for the production of feed material or petfood must be stored and transported chilled, frozen or ensiled, unless:
  339. 3Division 3
  340. Section 3Derogation for collection and transport of Category 3 material comprising of milk, milk-based products and milk-derived products
  341. Section 4Derogation for collection and transport of manure
  342. IDENTIFICATION
  343. 1All necessary measures must be taken to ensure that:
  344. 2During transport and storage, a label attached to the packaging, container or vehicle must:
  345. 3Division 3
  346. 4Division 4
  347. 5Division 5
  348. 6However:
  349. COMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES
  350. 1During transportation, a commercial document in accordance with the model made available or published for the time being by the appropriate authority, or, when required by this Regulation, a health certificate must accompany animal by-products and derived products.
  351. 2The 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.
  352. 3Division 3
  353. 4A commercial document in accordance with the model made available or published for the time being by the appropriate authority 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 Great Britain.
  354. 5Division 5
  355. Model commercial document
  356. Notes
  357. (a)Commercial documents shall be produced, according to the layout of the model made available or published for the time being by the appropriate authority.
  358. It shall be drawn up in English, and may also be drawn up in other languages.
  359. (c)Division (c)
  360. (d)Division (d)
  361. (e)Division (e)
  362. (f)The original of the commercial document must be completed and signed by the responsible person.
  363. (g)Division (g)
  364. (h)Division (h)
  365. (i)Division (i) Repealed
  366. Commercial documentDivision Commercial document Repealed
  367. RECORDS
  368. General provisions
  369. 1The 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:
  370. 2Division 2
  371. 3Division 3
  372. Section 2Additional requirements in case of use for special feeding purposes
  373. Section 3Requirements in case of certain fur animals Repealed
  374. Section 4Requirements for the application of certain organic fertilisers and soil improvers to land
  375. Section 5Requirements for animal by-products derived from aquatic animals and feeding of fish
  376. Section 6Requirements for the burning and burial of animal by-products
  377. Section 7Requirements for photogelatine
  378. MARKING OF CERTAIN DERIVED PRODUCTS
  379. 1In 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:
  380. 2The 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.
  381. 3The marking with GTH shall not be required for:
  382. CHAPTER VITRANSPORT OF DEAD PET ANIMALS Repealed
  383. CHAPTER VIITRANSPORT TO A DETOXIFICATION PLANT OF FISH OILS AND FISHMEAL INTENDED FOR THE PRODUCTION OF FEED MATERIAL Repealed
  384. Annex IX
  385. REQUIREMENTS APPLICABLE TO CERTAIN APPROVED AND REGISTERED ESTABLISHMENTS AND PLANTS
  386. CHAPTER IMANUFACTURING OF PETFOOD
  387. CHAPTER IIHANDLING OF ANIMAL BY-PRODUCTS AFTER THEIR COLLECTION
  388. General requirements
  389. 1Premises and facilities where intermediate operations are carried out shall meet at least the following requirements:
  390. 2Division 2
  391. Hygiene requirements
  392. 1Division 1
  393. 2Division 2
  394. 3Division 3
  395. Section 3Processing standards for hygienisation/pasteurisation
  396. REQUIREMENTS FOR STORAGE OF DERIVED PRODUCTS
  397. Section 1General requirements
  398. Specific requirements for storage of certain milk, milk-based products and milk-derived products
  399. 1Division 1
  400. 2Division 2
  401. REGISTERED OPERATORS
  402. 1Operators of registered plants or establishments or other registered operators shall handle animal by-products and derived products under the following conditions:
  403. 2Division 2
  404. 3Registered operators transporting animal by-products or derived products, other than between premises of the same operator, shall in particular:
  405. Chapter V: CONTAINMENT METHODS
  406. General provisions
  407. 1Division 1
  408. 2Division 2
  409. Methodology
  410. Aerobic maturation and storage of dead-on-farm pigs and certain other porcine material with subsequent incineration or co-incineration.
  411. 1Application
  412. 2Starting materials
  413. Methodology
  414. 3.1General principles
  415. Phases
  416. 3.2.1Filling and storage phase
  417. 3.2.2Maturing phase
  418. 3.2.3Transport and incineration or co-incineration
  419. Hydrolysis with subsequent disposal
  420. 1Application
  421. 2Starting materials
  422. 3Methodology
  423. Annex X: FEED MATERIALS
  424. CHAPTER IGENERAL REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE MARKET
  425. SPECIFIC REQUIREMENTS FOR PROCESSED ANIMAL PROTEIN AND OTHER DERIVED PRODUCTS
  426. Specific requirements for processed animal protein
  427. Raw materials
  428. 1Division 1
  429. 2Processed animal protein derived from farmed insects, intended for the production of feed for farmed animals other than fur animals, may only be obtained from the following insect species:
  430. Processing standards
  431. 1Processed animal protein of mammalian origin must have been submitted to processing method 1 (pressure sterilisation) as set out in Chapter III of Annex IV.
  432. 2Division 2
  433. 3Fishmeal must have been submitted to:
  434. Storage
  435. 1Processed animal protein must be packed and stored in new or sterilised bags or stored in properly constructed bulk bins or in storage sheds.
  436. 2Division 2
  437. 3Equipment for handling processed animal protein must be maintained in a clean and dry condition and must have adequate inspection points so that equipment can be examined for cleanliness.
  438. 4Processed animal protein must be kept dry.
  439. Specific requirements for blood products
  440. ARaw material
  441. BProcessing standards
  442. Specific requirements for rendered fats, fish oil and fat derivatives from Category 3 material
  443. Raw materials
  444. 1Rendered fats
  445. 2Fish oil
  446. BProcessing standards
  447. CHygiene requirements
  448. Specific requirements for milk, colostrum and certain other products derived from milk or colostrum
  449. General requirements
  450. ARaw material
  451. Processing standards
  452. 1Milk must be subjected to one of the following treatments:
  453. 2Division 2
  454. 3Whey to be fed to animals of species susceptible to foot-and-mouth disease and produced from milk treated in accordance with point 1 must:
  455. 4In addition to the requirements set out in points 1, 2 and 3, milk, milk-based products and milk-derived products must meet the following requirements:
  456. 5Division 5
  457. 6Colostrum and colostrum products must:
  458. Derogation for the placing on the market of milk processed in accordance with national standards
  459. 1Division 1
  460. 2Division 2
  461. 3Milk, milk-based products and milk-derived products may be supplied and used as feed material:
  462. 4Division 4
  463. Part IIISpecial requirements for centrifuge or separator sludge
  464. Specific requirements for gelatine and hydrolysed protein
  465. ARaw materials
  466. Processing standards for gelatine
  467. 1Unless the gelatine has been produced in accordance with Section XIV of Annex III to Regulation (EC) No 853/2004, it must be produced by a process that ensures that Category 3 material is subjected to a treatment with acid or alkali, followed by one or more rinses.
  468. 2Division 2
  469. 3Division 3
  470. COther requirements for gelatine
  471. DProcessing standards for hydrolysed protein
  472. Specific requirements for dicalcium phosphate
  473. ARaw materials
  474. Processing standards
  475. 1Dicalcium phosphate must be produced by a process that comprises the three following stages:
  476. 2Division 2
  477. Specific requirements for tricalcium phosphate
  478. ARaw materials
  479. BProcessing standards
  480. Specific requirements for collagen
  481. ARaw materials
  482. Processing standards
  483. 1Unless the collagen has been produced in accordance with the requirements for collagen set out in Section XV of Annex III to Regulation (EC) No 853/2004, it must be produced by a process ensuring that unprocessed Category 3 material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion.
  484. 2Division 2
  485. COther requirements
  486. Specific requirements for egg products
  487. ARaw materials
  488. BProcessing standards
  489. Section 10Specific requirements for feeding to farmed animals, other than fur animals, of certain Category 3 material referred to Article 10(f) of Regulation (EC) No 1069/2009
  490. REQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS
  491. 1Animal by-products from fish or aquatic invertebrates and derived products therefrom that are intended as feed for farmed fish or for other aquaculture species shall:
  492. 2The competent authority may lay down conditions, aimed at preventing unacceptable risks for the transmission of diseases communicable to humans or animals, for the use of aquatic animals and of aquatic and terrestrial invertebrates:
  493. Annex XI: ORGANIC FERTILISERS AND SOIL IMPROVERS
  494. REQUIREMENTS FOR UNPROCESSED MANURE, PROCESSED MANURE AND DERIVED PRODUCTS FROM PROCESSED MANURE
  495. Unprocessed manure
  496. 1Division 1 Repealed
  497. 2Division 2 Repealed
  498. 3Division 3 Repealed
  499. 4Division 4 Repealed
  500. 5Division 5 Repealed
  501. 6Division 6
  502. Section 2Guano from bats, processed manure and derived products from processed manure
  503. REQUIREMENTS FOR CERTAIN ORGANIC FERTILISERS AND SOIL IMPROVERS
  504. Conditions for the production
  505. 1Organic fertilisers and soil improvers, other than manure, digestive tract content, compost, milk, milk-based products, milk-derived products, colostrum, colostrum products and digestion residues from the transformation of animal by-products or derived products into biogas, shall be produced by:
  506. 2Division 2
  507. 3The competent authority shall authorise the component referred to in point 2 according to the following:
  508. 4However, the requirements referred to in point 2 shall not apply:
  509. 5Producers of organic fertilisers and soil improvers must ensure that decontamination of pathogens is carried out prior to their placing on the market, in accordance with:
  510. Section 2Storage and transport
  511. Section 3Requirements for approval of establishments or plants
  512. Annex XIIINTERMEDIATE PRODUCTS
  513. Annex XIII: PETFOOD AND CERTAIN OTHER DERIVED PRODUCTS
  514. CHAPTER IGeneral requirements
  515. Specific requirements for petfood, including dogchews
  516. 1Raw petfood
  517. 2Raw material for processed petfood and for dogchews
  518. 3Processed petfood
  519. 4Division 4
  520. 5Division 5
  521. 6Division 6
  522. 7End point for processed petfood and dogchews
  523. Specific requirements for flavouring innards for the manufacture of petfood
  524. 1Division 1
  525. 2Division 2
  526. 3The end product must be:
  527. CHAPTER IVSpecific requirements for blood and blood products from equidae
  528. Specific requirements for hides and skins of ungulates and products derived therefrom
  529. AEstablishments and plants
  530. Placing on the market of animal by-products and of derived products
  531. 1Division 1
  532. 2Treated hides and skins may be placed on the market, provided that:
  533. End point for hides and skins
  534. 1Division 1
  535. 2The following treated hides and skins may be placed on the market without restrictions in accordance with this Regulation:
  536. 3Division 3
  537. Specific requirements for game trophies and other preparations from animals
  538. ADivision A
  539. BSafe sourcing
  540. Safe treatment
  541. 1Game trophies or other preparations from animals, where for the preparation the animal by-products have been submitted to a treatment or are presented in a state which does not pose any health risks, may be placed on the market, provided they:
  542. 2Game trophies or other preparations, other than those referred to under points B and C.1, which come from animals originating in an area subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible, may be placed on the market, provided that:
  543. Specific requirements for wool, hair, pig bristles, feathers, parts of feathers and down
  544. Raw material
  545. 1Untreated wool, untreated hair, untreated pig bristles and untreated feathers, parts of feathers and down must be Category 3 materials referred to in Article 10(b) (iii), (iv) and (v) and Article 10(h) and (n) of Regulation (EC) No 1069/2009.
  546. 2Movements of pig bristles and wool and hair of animals of the porcine species from regions in which African swine fever is endemic shall be prohibited except for pig bristles and wool and hair of animals of the porcine species that have:
  547. 3The provisions of point 1 shall not apply to decorative feathers or feathers:
  548. BEnd point for wool and hair
  549. CEnd point for feathers and down
  550. CHAPTER VIIISpecific requirements for furs
  551. CHAPTER IXSpecific requirements for apiculture by-products
  552. Specific requirements for rendered fats from Category 1 or Category 2 materials for oleochemical purposes
  553. 1Division 1
  554. 2Division 2
  555. Specific requirements for fat derivatives
  556. 1The following processes may be used to produce fat derivatives from rendered fats derived from Category 1 and Category 2 material:
  557. 2Fat derivatives produced in accordance with this Chapter may only be placed on the market:
  558. 3End point for products derived from rendered fats:
  559. CHAPTER XIISpecific requirements for horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers
  560. CHAPTER XIIISpecific requirements for fish oil for the production of medicinal products
  561. Annex XIV: IMPORTATION, EXPORT AND TRANSIT
  562. SPECIFIC REQUIREMENTS FOR THE IMPORTATION FROM A THIRD COUNTRY INTO AND TRANSIT THROUGH GREAT BRITAIN OF CATEGORY 3 MATERIAL AND DERIVED PRODUCTS FOR USES IN THE FEED CHAIN OTHER THAN FOR PETFOOD OR FOR FEED TO FUR ANIMALS
  563. Section 1Division Section 1
  564. Section 2Imports from a third country of processed animal protein, including mixtures and products other than petfood containing such protein, and compound feeds containing such protein as defined in Article 3(2)(h) of Regulation (EC) No 767/2009
  565. Section 3Imports from a third country of rendered fats
  566. Imports from a third country of milk, milk-based products, milk-derived products, colostrum and colostrum products
  567. AThe following requirements shall apply to the importation from a third country of milk, milk-based products, milk-derived products, colostrum and colostrum products:
  568. BThe following requirements shall apply to the importation from a third country of colostrum and colostrum products:
  569. Section 5Imports from a third country of blood products for the feeding of farmed animals
  570. SPECIFIC REQUIREMENTS FOR THE IMPORTATION FROM A THIRD COUNTRY INTO AND TRANSIT THROUGH GREAT BRITAIN OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN FOR FARMED ANIMALS OTHER THAN FUR ANIMALS
  571. Section 1Specific requirements
  572. Section 2Imports from a third country of blood and blood products, excluding from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals
  573. Section 3Imports from a third country of blood and blood products from equidae
  574. Section 4Imports from a third country of hides and skins of ungulates
  575. Section 5Imports from a third country of game trophies and other preparations from animals
  576. Section 6Imports from a third country of treated feathers, parts of feathers and down
  577. Imports from a third country of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material, organic fertilisers or soil improvers
  578. 1Bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) may be imported from a third country to produce derived products for uses outside the feed chain if:
  579. 2Each consignment must be accompanied by a commercial document stamped by the competent authority supervising the establishment of origin, including the following information:
  580. 3On dispatch to Great Britain, the material must be enclosed in sealed containers or vehicles or carried in bulk in a ship.
  581. 4Division 4
  582. Section 8Imports from a third country of animal by-products for the manufacture of feed for fur animals, petfood, other than raw petfood, and derived products for uses outside the feed chain for farmed animals
  583. Section 9Imports from a third country of rendered fats for certain purposes outside the feed chain for farmed animals
  584. Imports from a third country of fat derivatives
  585. 1Fat derivatives may be imported from a third country if the health certificate accompanying the consignment certifies:
  586. 2Division 2
  587. 3Division 3
  588. Imports from a third country of photogelatine
  589. 1Gelatine which has been produced from material containing bovine vertebral column comprising of Category 1 material in accordance with Article 8(b) of Regulation (EC) No 1069/2009 and which is intended for the photographic industry (photogelatine) may be imported from a third country, provided the photogelatine:
  590. 2Division 2
  591. 3Division 3
  592. 4Division 4
  593. 5In the approved photographic factory of destination, the operator shall ensure that any surpluses or residues of and other waste derived from the photogelatine are:
  594. 6Photogelatine shall be produced according to the following requirements:
  595. Section 12Imports from a third country of horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fertilisers or soil improvers
  596. SPECIAL RULES FOR CERTAIN SAMPLES
  597. Section 1Research and diagnostic samples
  598. Trade samples
  599. 1The competent authority may authorise the import from a third country outside the European Union and transit of trade samples, provided that:
  600. 2Unless the trade samples are kept for reference purposes, they shall be:
  601. 3If trade samples are used for testing of machinery, the testing shall be carried out:
  602. Display items
  603. 1Import from a third country and transit of display items shall take place in accordance with the following conditions:
  604. 2Each consignment must be packed in packaging preventing any leakage and must be accompanied by a commercial document which specifies:
  605. 3After the exhibition or after the artistic activity has been concluded, display items shall be:
  606. SPECIFIC REQUIREMENTS FOR CERTAIN MOVEMENTS OF ANIMAL BY-PRODUCTS
  607. Section 1Imports from a third country of certain Category 1 materials
  608. Imports from a third country of certain materials for purposes other than feeding to farmed land animals
  609. 1The competent authority may authorise the import from a third country of the following materials for purposes other than feeding to farmed land animals, except for feeding to fur animals, provided there is no unacceptable risk for the transmission of diseases communicable to humans or animals:
  610. 2Division 2
  611. CHAPTER VRULES FOR THE EXPORT OF CERTAIN DERIVED PRODUCTS
  612. REQUIREMENTS FOR THE ENTRY OF CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS ORIGINATING FROM, AND RETURNING TO, GREAT BRITAIN FOLLOWING REFUSAL OF ENTRY BY A THIRD COUNTRY
  613. Unpackaged or in bulk animal by-products and derived products, originating from, and returning to, Great Britain following refusal of entry by a third country not listed as a whole or part of its territory in Annex XIV
  614. 1The competent authority ... shall only authorise the entry into Great Britain of consignments of unpackaged or in bulk animal by-products or derived products originating from, and returning to, Great Britain following a refusal of entry by a third country not listed as a whole or part of its territory in Annex XIV for the entry into Great Britain of the type of product, where the following conditions are met:
  615. 2Division 2
  616. 3Division 3
  617. Unpackaged or in bulk animal by-products and derived products originating from, and returning to, Great Britain following refusal of entry by a third country listed as a whole or part of its territory in Annex XIV
  618. 1Division 1
  619. 2Where the products referred to in point 1 have been unloaded, stored, re-loaded or the original seal has been replaced in or upon entry into the third country or part of its territory listed in Annex XIV, the consignment shall be accompanied by an official declaration of the competent authority or other public authority of that third country or territory:
  620. Packaged animal by-products and derived products originating from, and returning to, Great Britain following a refusal of entry by a third country
  621. 1Division 1
  622. 2Where the products referred to in point 1 have been unloaded in a third country, the consignment is accompanied by an official declaration of the competent authority or other public authority of the third country attesting that the products:
  623. Annex XVMODEL HEALTH CERTIFICATES
  624. Notes
  625. (a)Division (a)
  626. (b)Division (b)
  627. (c)Division (c)
  628. (d)Division (d)
  629. (e)Division (e)
  630. (f)Division (f)
  631. (g)Division (g)
  632. (h)Division (h)
  633. (i)Division (i)
  634. (j)Division (j)
  635. CHAPTER 1Health certificate Repealed
  636. CHAPTER 1aHealth certificate Repealed
  637. CHAPTER 2(A)Health certificate Repealed
  638. CHAPTER 2(B)Health certificate Repealed
  639. CHAPTER 3(A)Health certificate Repealed
  640. CHAPTER 3(B)Health certificate Repealed
  641. CHAPTER 3(C)Health certificate Repealed
  642. CHAPTER 3(D)Health certificate Repealed
  643. CHAPTER 3(E)Health certificate Repealed
  644. CHAPTER 3(F)Health certificate Repealed
  645. CHAPTER 4(A)Health certificate Repealed
  646. CHAPTER 4(B)Health certificate Repealed
  647. CHAPTER 4(C)Health certificate Repealed
  648. CHAPTER 4(D)Health certificate Repealed
  649. CHAPTER 5(A)Health certificate Repealed
  650. CHAPTER 5(B)Health certificate Repealed
  651. CHAPTER 5(C)Official declaration Repealed
  652. CHAPTER 6(A)Health certificate Repealed
  653. CHAPTER 6(B)Health certificate Repealed
  654. CHAPTER 7(A)Health certificate Repealed
  655. CHAPTER 7(B)Health certificate Repealed
  656. CHAPTER 8Health certificate Repealed
  657. CHAPTER 9Health certificate Repealed
  658. CHAPTER 10(A)Health certificate Repealed
  659. CHAPTER 10(B)Health certificate Repealed
  660. CHAPTER 11Health certificate Repealed
  661. CHAPTER 12Health certificate Repealed
  662. CHAPTER 13Health certificate Repealed
  663. CHAPTER 14(A)Health certificate Repealed
  664. CHAPTER 14(B)Health certificate Repealed
  665. CHAPTER 15Health certificate Repealed
  666. CHAPTER 16Model declaration Repealed
  667. CHAPTER 17Health certificate Repealed
  668. CHAPTER 18Health certificate Repealed
  669. CHAPTER 19Health certificate Repealed
  670. CHAPTER 20Model declaration Repealed
  671. CHAPTER 21Model declaration Repealed
  672. Annex XVI: OFFICIAL CONTROLS
  673. OFFICIAL CONTROLS IN PROCESSING PLANTS
  674. Supervision of the production
  675. 1The competent authority shall supervise processing plants to ensure compliance with the requirements of Regulation (EC) No 1069/2009 and with this Regulation.
  676. 2Division 2
  677. Validation procedures
  678. 1Prior to issuing an approval for a processing plant, as provided for in Article 44(1) of Regulation (EC) No 1069/2009, the competent authority must check that a validation of the processing plant has been carried out by the operator in accordance with the following procedures and indicators:
  679. 2In the case of a batch pressure system:
  680. 3In the case of a continuous pressure system:
  681. 4Division 4
  682. LISTS OF REGISTERED AND APPROVED ESTABLISHMENTS, PLANTS AND OPERATORS
  683. 1Access to lists of registered and approved establishments, plants and operators
  684. 2Format for national websites
  685. 3Division 3
  686. SPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS
  687. Section 1Official controls regarding marking of derived products
  688. Section 2Official controls in low-capacity incineration plants
  689. Section 3Official controls in remote areas
  690. Section 4Official controls in registered farms for the feeding of fur animals Repealed
  691. Official controls regarding collection centres
  692. 1The competent authority shall:
  693. 2Division 2
  694. Section 6Official controls regarding the feeding of wild animals and certain zoo animals with Category 1 material
  695. Section 7Official controls regarding the application of certain organic fertilisers and soil improvers
  696. Section 8Official controls regarding approved photographic factories
  697. Section 9Official controls regarding certain imported rendered fats
  698. Section 10Standard format for applications for certain authorisations in intra-Union trade Repealed
  699. Section 11Official controls regarding hydrolysis with subsequent disposal
  700. Section 12Official controls regarding plants approved for the combustion of animal by-products