EN    EN EN 
SANCO/7066/2010 rev. 7 
 
 
    
      
 
WORKING DOCUMENT  
 
DOES NOT NECESSARILY REPRESENT THE VIEWS 
OF THE COMMISSION SERVICES 
 EN    EN  EUROPEAN COMMISSION 
Brussels, 10.08.2010 
C(2019)  final 
  
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
implementing Regulation (EC) No 1069/2009 laying down health rules as regards animal 
by-products and derived products not inte nded for human consumption and repealing 
Regulation (EC) No 1774/2002 and implementing Council Directive 97/78/EC as regards 
certain samples and items exempt from veterinary checks at the border (Commission  
Regulation on animal by-products) 
(Text with EEA relevance) 
(Memorandum from Mr Dalli) 
 
 
 EN 3   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
implementing Regulation (EC) No 1069/2009 laying down health rules as regards animal 
by-products and derived products not inte nded for human consumption and repealing 
Regulation (EC) No 1774/2002 and implementing Council Directive 97/78/EC as regards 
certain samples and items exempt from veterinary checks at the border (Commission  
Regulation on animal by-products) 
(Text with EEA relevance) 
 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the 
Council of 21 October 2009 laying down health rules as regards animal by-products and 
derived products  not intended for human consumption and repealing Regulation (EC) No 
1774/2002 (Animal by-products Regulation)1, and in particular Articles 11(2)(b) and (c), 
15(1)(b), (d), (e), (h) and (i), 17 (2), 18(3)(b), 19(4)(a), (b) and (c), 20(10), 21(5), (6), 22(3), 
points (a), (b), (c), (e), (f) and (g) of the fi rst subparagraph of Article 27, and Articles 31(2), 
32(3), 34(2), 40, 41(3), 42, 43(3), 45(4), 47(2) and 48(7)(a) and (8)(a) thereof, 
Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the 
principles governing the organisation of veterinary checks on products entering the Community from third countries
2, and in particular Article 16(3) thereof, 
Whereas: 
(1) The Animal By-products Regulation lays down animal and public health rules for 
animal by-products and products derived thereof. That Regulation determines the circumstances when animal by-products should be disposed of, in order to prevent the 
spreading of risks for public and animal health. Furthermore, 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. That Regulation also obliges operators to handle animal by-products within establishments and plants which are subject to official controls. 
(2) Under the Animal By-products Regulation, the detailed rules for the handling of animal by-products and derived products, such as processing standards, hygiene 
                                                
 
1  OJ L 300, 14.11.2009, p.1. 
2  OJ L 24, 30.1.1998, p.9. EN 4   EN conditions and the format for documentary evidence which has to accompany 
consignments of animal by-products for the purposes of traceability should 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 objectives of the Animal By-products Regulation, notably the sustainable use of an imal materials, and the maintenance of a 
high level of public and animal health in the European Union. 
(4) The Animal By-products Regulation 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. Furthermore, 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) The Animal By-products Regulation 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 is furthermore 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. The Animal By-products Regulation prohibits the feeding of catering waste to farmed animals, other than fur animals. Therefore, catering waste may be processed and subsequently used, provided that the derived product is not fed to such animals. 
(6) 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. 
(7) The Animal By-products Regulation prohibits the movement of animal by-products 
and of derived products from susceptible species from places of origin 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 Animal Health Code 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. 
(8) Since the incineration and to the co-incineration of certain animal by-products is not covered by the scope of Directive 2000/76/EC of the European Parliament and of the 
                                                
 
3  OJ L 229, 1.9.2009, p.1. EN 5   EN Council of 4 December 2000 on the incineration of waste4, 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 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. 
(9) 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, provided that 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. 
(10) The disposal of animal by-products or derived products via the waste water 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. 
(11) In order to prevent the contamination of foodstuffs with pathogenic agents, establishments or plants processing animal by-products should be operating 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
7, 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-p rocessing establishments. 
(12) 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
8 obliges Member States to carry out 
monitoring programmes for transmissible spongiform encephalopathies (TSE). 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 States. 
(13) The Animal By-products Regulation allows the feeding of certain Category 1 material to certain animal species in Member States, for the promotion of biodiversity. Such feeding should be authorised for certain carnivore species referred to in Council Directive 92/43/EC on the conservation of natural habitats and of wild fauna and flora
9 
                                                 
4  OJ L 332, 28.12.2000, p.91. 
5  OJ L 182, 16.7.1999, p.1. 
6  OJ L 139, 30.4.2004, p.1. 
7  OJ L 139, 20.4.2004, p.55. 
8  OJ L 147, 31.5.2001, p.1. 
9  OJ L 206, 22.7.1992, p.7. EN 6   EN 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
10. 
(14) The Animal By-products Regulation has introduced a procedure for the authorisation of alternative methods of disposal or proc essing. Such methods may be authorised by 
the Commission based on a risk assessment carried out by 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 presented. 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 Regulation 1/1958 determining the languages to the used by the European Economic Community
11. 
(15) 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
12, feed 
business operators, other than primary producers, have to store and transport 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.  
(16) 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. Those 
conditions may 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
13. 
(17) According to the Animal By-products Regulation, operators shall 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 linke d 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. 
(18) 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 
                                                
 
10  OJ L 20, 26.1.2010, p.7. 
11  OJ L 17, 6.10.1958, p.385. 
12  OJ L 35, 8.2.2005, p.1. 
13  OJ L 62, 15.3.1993, p.49. EN 7   EN measures to ensure the prevention of contam ination to the actual risk arising from that 
material. 
(19) Member States should be authorised to oblige operators to use the Traces system 
introduced by Commission Decision 2004/292/EC on the introduction of the Traces 
system and amending Decision 92/486/EEC14 (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. 
(20) 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 specifies  
certain parameters for the treatment of rend ered 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. 
(21) Colostrum and colostrums 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
15. 
(22) 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 eggs16 should be updated. 
(23) 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 of 
destination where such materials, as well as Category 3 material, are incorporated into petfood. With respect to the plants of des tination, 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. 
(24) Under the Animal By-products Regulation, certain derived products may be placed on the market in accordance with certain othe r Union legislation. That legislation also 
determines the import, collection and movement of animal by-products and derived products for the manufacture of such derived products. However, the Animal By-products Regulation shall apply where that other Union legislation does not provide 
for conditions providing potential health  risks 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. 
                                                
 
14  OJ L 94, 31.3.2004, p.63. 
15  OJ L 121, 29.7.1964, p.1977, 
16  OJ L 343, 22.12.2009, p.74. EN 8   EN (25) In particular, adequate health conditions should be laid down for materials which are 
used for the manufacture of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics or laboratory reagents ("the finished products"). If risks arising from such materials are mitiga ted due to the purification, concentration 
or due to the conditions under which they are handled and disposed of, only the requirements of the Animal By-products Regulation and of this Regulation in relation to traceability should apply. In such case, th e requirements related to the separation of 
animal by-products of different categories within the establishment or plant producing the finished products should not apply, sin ce 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 European Union should be subject to veterinary checks in the border inspection post 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. 
(26) According to Council Directive 90/426/EEC of 26 June 1990 on animal health 
conditions governing the movement and import from third countries of equidae
17, 
certain diseases to which equidae are sus ceptible are compulsorily notifiable. Blood 
products from equidae which are intended for pu rposes 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. 
(27) It should be possible to place on the market fresh hides and skins for purposes other than human consumption, provided they comp ly with the animal health conditions for 
fresh meat laid down in accordance wi th 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
18, since those conditions provide for an appropriate mitigation of 
possible risks. 
(28) The health rules for the manufacture and placing on the market of game trophies and 
other preparations from animals which eliminate potential risks should be without 
prejudice to the rules for the protection of certain species of wild animals laid down in Council Regulation (EC) No 338/97 of 9 Decem ber 1996 on the protection of species 
of wild fauna and flora by regulating trade therein
19, 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. 
(29) Apiculture by-products 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 a nd imports into the Community of animals, 
                                                
 
17  OJ L 224, 18.8.1990, p.42. 
18  OJ L 18, 23.1.2003, p.11. 
19  OJ L 61, 3.3.1997, p.1. EN 9   EN 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/EEC20. 
(30) The European Parliament and the Council have called upon the Commission to determine an end point in the manufacturing chain for oleochemical products. Such 
decision should be taken on the basis of an assessment of the capacity of the 
oleochemical processes to mitigate potentia l health risks which may be present in 
animal fats of any Category which are processed. 
(31) 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
21 should be referred to in this Regulation, insofar 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.  
(32) 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. Such lists have been laid down by way of 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
22, Commission Decision 2004/438/EC of 29 April 2004 
laying down animal and public health and veterinary certifications conditions for introduction in the Community of heat-treated milk, milk-based products and raw milk intended for human consumption
23, 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 permitted24, 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
25 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 rabbi ts and the veterinary certification 
requirements
26. 
(33) 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 be exported to the country of origin of the 
                                                
 
20  OJ L 268, 14.9.1992, p.54. 
21  OJ L 73, 20.3.2010, p.1. 
22  OJ L 189, 27.5.2004, p.57. 
23  OJ L 154, 30.4.2004, p.72. 
24  OJ L 320, 18.11.2006, p. 53. 
25  OJ L 226, 23.8.2008, p.1. 
26  OJ L 39, 10.2.2009, p.12. EN 10   EN 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 waste27. 
(34) Under Directive 97/78/EC, imported trade samp les, items intended for exhibitions and 
items for particular studies are exempt from veterinary checks at the border of the 
European Union. Pending the adoption of measures under that Directive, the 
conditions under which samples or items are exempt from checks, if they contain animal by-products, should be laid down in this Regulation. 
(35) 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
28 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
29 should be used for the purposes of 
that transit. 
(36) Health certificates which must 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 in Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products
30. 
(37) Official controls on the entire chain of animal by-products and derived products shall 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
31. 
(38)  It is therefore necessary to lay down measures for the implementation of the Animal 
By-products Regulation by way of this Regulation. 
(39) The Animal By-products Regulation repeals 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
32 with effect 
from 4 March 2011.  
(40) For the implementation of Regulation (EC) No 1774/2002, the Commission has 
adopted Regulation (EC) No 811/2003 on the intra-species recycling ban for fish, and 
the burial and burning of certain animal by-products33, Decision 2003/322/EC on the 
                                                 
27  OJ L 190, 12.7.2006, p.1. 
28  OJ L 296, 12.11.2009, p.1. 
29  OJ L 21, 28.1.2004, p.11. 
30  OJ L 13, 16.1.1997, p.28. 
31  OJ L 191, 28.5.2004, p.1. 
32  OJ L 273, 10.10.2002, p.1. 
33  OJ L117, 13.5.2003, p.14.  EN 11   EN feeding of certain necrophagous birds with certain Category 1 materials34, 
Decision 2003/324/EC on a derogation from the intra-species recycling ban for fur 
animals35, which was adapted due to the accession of Estonia by way of Decision 
2004/434/EC36, Regulation (EC) No 79/2005 on milk and milk-based products37, 
Regulation (EC) No 92/2005 on means of disposal or uses38, Regulation (EC) 
No 181/2006 on organic fertilisers and soil improvers other than manure39, Regulation 
(EC) No 1192/2006 on lists of approved plants40 and Regulation (EC) No 2007/2006 
on the importation and transit of cert ain Category 3 intermediate products41.  
(41) The Commission has furthermore adopted certain transitional measures, in particular Regulation (EC) No 878/2004 on the import and handling of certain Category 1 and 
Category 2 materials
42, Decision 2004/407/EC on the import of certain materials for 
the production of photogelatine43 and Regulation (EC) No 197/2006 on handling and 
disposal of former foodstuffs44, to lay down risk-proportionate measures for certain 
specific uses of animal by-products, before the revision of Regulation (EC) No 
1774/2002 was initiated.  
(42) With the objective to further simplify the Union rules for animal by-products, as requested by the Presidency of the Council at the time of the adoption of the Animal By-products Regulation, the provisions laid down in those Commission measures should therefore be reviewed, as necessary, and they should be incorporated into this Regulation, so as to constitute a coherent legal framework. Furthermore, in order to improve the clarity of Union law, the Commission measures for the implementation of Regulation (EC) No 1774/2002 and the transitional measures referred to above should be repealed with effect from entry into application of this Regulation. 
(43) A transitional period should be provided for, following the entry into application of this Regulation, in order to allow stakeholders  to adjust to the new rules, to place on 
the market certain products which have been produced in accordance with the Union 
health rules applicable before the date of en try into application of this Regulation, 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 amou nts 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. 
                                                
 
34  OJ L 117, 13.5.2003, p.32. 
35  OJ L 117, 13.5.2003, p.37. 
36  OJ L 189, 27.5.2004, p. 43. 
37  OJ L 16, 20.1.2005, p.46. 
38 OJ L 19, 21.1.2005, p.27. 
39  OJ L 29, 2.2.2006, p.31. 
40  OJ L 215, 5.8.2006, p.10. 
41  OJ L 379, 28.12.2006, p. 98. 
42  OJ L 162, 30.4.2004, p.62. 
43  OJ L 208, 10.6.2004, p.9. 
44  OJ L 32, 4.2.2006, p.13. EN 12   EN (44) In accordance with the request expressed by the European Parliament at the time of its 
agreement to the Animal By-products Regulation 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 […] to its Committee for the 
Environment, Public Health and Food Safety for an exchange of views. 
(45) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Requirements regarding feeding of fur animals 
 and feeding of farmed animals with herbage 
Requirements regarding the conditions for feed ing of fur animals with certain materials  
derived from bodies or parts of animals of the same species and conditions for the feeding of 
farmed animals with herbage fro m land to which organic fertili sers or soil improvers have 
been applied, as referred to in Article 11(2)(b) and (c) of the Animal By-products Regulation, 
are set out in Annex IV to this Regulation. 
Article 2 
Requirements regarding incineration and co-incineration 
Requirements regarding the conditions for the incineration and the co-incineration of animal 
by-products and derived products, as referred to in Article 15(1)(d) of the Animal By-
products Regulation, are set out in Annex V to this Regulation. 
Article 3 
Requirements regarding combustion 
Requirements regarding the conditions for the combustion of animal by-products and derived 
products, as referred to in Article 15(1)(e) of the Animal By-products Regulation, are set out in Annex VI to this Regulation. 
Article 4 
Requirements regarding processing methods and the obligations of operators processing 
animal by-products 
Requirements regarding processing methods for animal by-products, as referred to in Article 15(1)(b) of the Animal By-products Regulation and requirements regarding certain obligations of operators of establishments or pl ants that are processing animal by-products, as 
referred to in points (a), (b), (c), (e) and (f) of the first subparagraph of Article 27 of the same 
Regulation, are set out in Annex VII to this Regulation. 
Article 5 
Requirements regarding transformation of animal by-products and derived products into EN 13   EN biogas 
 and composting 
Requirements regarding the standard transfor mation parameters for biogas and composting 
plants, as referred to in point (g) of the first subparagraph of Article 27 of the Animal By-
products Regulation, and requirements regarding the hygiene requirements applicable to the handling of animal by-products and derived products in establishments or plants that are composting or transforming animal by-products and derived products into biogas, as referred to in point (b) of the same subparagraph, are set out in Annex VIII to this Regulation. 
Article 6 
Requirements regarding the use of animal by-products for research, other specific purposes 
and special feeding purposes and requirements regarding the collection, transport and 
disposal 
Requirements regarding the health conditions for the use of animal by-products for research 
and for other specific purposes, as referred to in Article 17(1) of the Animal By-products Regulation, requirements regarding the importation of such animal by-products for those purposes, as referred to in Article 17(2), requirements regarding the conditions under which the use of Category 1 material for special feeding purposes may be authorised, as referred to in Article 18(3)(b) of the same Regulation, and requirements regarding conditions for the burial and burning of animal by-products on site and concerning the maximum percentage of animals in remote areas in a Member State, as referred to in Article 19(4)(a) and (b) of the same Regulation, are set out in Annex IX to this Regulation.  
Article 7 
Standard format for applications for alternative methods 
A standard format for applications for alternative methods as referred to in Article 20(10) of the Animal By-products Regulation, is set out in Annex X to this Regulation. 
Article 8 
Requirements regarding commercial documents and health certificates, identification, the 
collection and transport of animal by-products and traceability 
Requirements regarding models for commercial documents and regarding health certificates, 
as referred to in Article 21(5) and (6)(a) of the Animal By-products Regulation, regarding cases where animal by-products or derived products may be transported without documents or certificates, as referred to in point (6)(b) of the same Article, regarding identification, as 
referred to in point (6)(c) of the same Article,  regarding collection and transport, as referred  
in point (6)(d) of the same Article, regarding tr aceability, as referred to in Article 22(3) of the 
same Regulation, and regarding permanent marking, as referred to in Article 15(1)(h) of the same Regulation, are set out in Annex XI to this Regulation. EN 14   EN Article 9 
Requirements regarding establishments and plants handling animal by-products 
Requirements regarding establishments and plants that are handling animal by-products, as 
referred to in points (a), (b) and (c) of the first subparagraph of Article 27 of the Animal By-
products Regulation, are set out in Annex XII to this Regulation. 
Article 10 
 Requirements regarding the placing on the market of animal by-products and derived 
products for feeding to farmed animals 
Requirements regarding the public and animal health conditions for the placing on the market of animal by-products and derived products for feeding to farmed animals, as referred to in Article 31(2) of the Animal By-products Regulation, are set out in Annex XIV to this 
Regulation. 
Article 11 
 Requirements regarding the placing on the market and use of organic fertilisers 
Requirements regarding the placing on the market  of organic fertilisers and the use, in 
particular the application of such fertilisers to land, as referred to in Articles 15(1)(i) and  
32(3) of the Animal By-products Regulation, are set out in Annex XV to this Regulation. 
Article 12 
 Requirements regarding the manufacture of derived products regulated by certain other 
legislation 
Requirements regarding the manufacture of de rived products regulated by certain other 
legislation, in particular as regards their import and movement inside the European Union, as referred to in Articles 21 points (5)(a), (6)(c) and (6)(d) and 41(3), in conjunction with Article 34(2) of the Animal By-products Regulation, are set out in Annex XVI to this Regulation. 
Article 13 
 Requirements regarding the placing on the market of petfood 
 and of other derived products 
Requirements regarding the placing on the market of petfood and of other derived products, as referred to in Article 40 of the Animal By-products Regulation, are set out in Annex XVII to this Regulation. 
Article 14 
 Requirements regarding the import, export and transit of animal by-products 
 and of derived products 
Requirements regarding the import, export and transit of animal by-products and of derived products, as referred to in Articles 41(3), 42 and 43(3) of the Animal By-products Regulation,   are set out in Annex XVIII to this Regulation. EN 15   EN Article 15 
 Requirements regarding models for health certificates  
and declarations 
Requirements regarding models for health certificates and declarations, as referred to in 
Article 42(2)(d) of the Animal By-products Re gulation, are set out in Annex XIX to this 
Regulation. 
Article 16 
 Requirements regarding official controls 
Requirements regarding detailed arrangements for official controls, as referred to in Articles 45(4), 47(2) and 48(7)(a) of the Animal By-products Regulation, are set out in Annex XX to this Regulation. 
Article 17 
Negative harmonisation 
The placing on the market of the animal by-products and the derived products referred to in 
Section II of Annex XIV and in Annex XVII and the import of the animal by-products and the 
derived products referred to in Annex XVIII sh all not be prohibited or restricted for public 
health or animal health reasons other than those laid down in the Animal By-products Regulation, in  this Regulation or in other Union legislation. 
Article 18 
Repeal 
1. The following legal acts shall be repealed with effect from the entry into application of 
this Regulation: 
(a) Regulation (EC) No 811/2003; 
(b) Decision 2003/322/EC; 
(c) Decision 2003/324/EC; (d) Decision 2004/434/EC; 
(e) Regulation (EC) No 878/2004; 
(f) Decision 2004/407/EC; 
(g) Regulation (EC) No 79/2005; 
(h) Regulation (EC) No 92/2005; (i) Regulation (EC) No 181/2006; (j) Regulation (EC) No 197/2006; EN 16   EN (k) Regulation (EC) No 1192/2006; 
(l) Regulation (EC) No 2007/2006. 
2. References to those legal acts shall be cons trued from that date as references to this 
Regulation. 
Article 19 
Transitional measures 
1. For a transitional period until 31 December 2011 and by way of derogation from 
Article 11, operators may place on the market organic fertilisers and soil improvers 
which have been produced from meat and bone meal derived from Category 2 material or from processed animal protein, and which have not been mixed with a 
component to exclude the subsequent use of the mixture for feeding purposes, 
provided that those organic fertilisers an d soil improvers have been produced in 
accordance with Regulations (EC) No 1774/2002 and (EC) No 181/2006, before the 
date of entry into application of this Regulation. 
2. Consignments of animal by-products and of derived products accompanied by a 
health certificate, declaration or commercial document, which has been completed 
and signed in accordance with the appropriate model, as set out in Annex X to Regulation (EC) No 1774/2002 before the date of entry into application of this Regulation, shall continue to be accepted for importation into the Union until 30 September 2011, where those certificates, de clarations or documents were completed 
and signed before 31 August 2011.  
3. Pending the adoption of rules in accordance with the Animal By-products 
Regulation, Member States may continue to authorise the placing on the market, including the importation, and the export of the following animal by-products and derived products, other than those referred to in Article 8(a)(i) and (ii) of the Animal By-products Regulation, for uses other than feeding to farmed animals, application to 
land from which farmed animals are fed, and other than for the manufacture of the 
derived products referred to in Article 33 of the Animal By-products Regulation, in 
accordance with the conditions set out in Ch apter II of Section IV of Annex XVIII to 
this Regulation: 
(a) hides and skins referred to in Article 8(c) of the Animal By-products 
Regulation; 
(b) ruminant intestines with or without content; (c) bones and bone products containing vertebral columns and skull. 
4. For a transitional period until 31 December  2012, Member States may authorise the 
collection, transport and disposal of animal by-products referred to  in Article 10(f) of 
the Animal By-products Regulation by means other than burial or burial on site, in 
accordance with the conditions set out in Section IV of Annex IX to this Regulation. EN 17   EN Article 20 
This Regulation shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall apply from 4 March 2011. 
This Regulation shall be binding in its entirety and directly applicable in all Member States in 
accordance with the Treaties. 
Done at Brussels, […] 
 For the Commission 
 The President  José Manuel BARROSO EN 18   EN Content  
 
ANNEX I........................................................................................................................ .......... 23 
DEFINITIONS.................................................................................................................... .....23 
ANNEX II ....................................................................................................................... ......... 29 
END POINT IN THE MANUFACTURING CHAIN ............................................................. 29 
ANNEX III...................................................................................................................... ......... 31 
ANIMAL HEALTH RESTRICTIONS.................................................................................... 31 
ANNEX IV....................................................................................................................... ........ 32 
RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS.......................................... 32 
ANNEX V ........................................................................................................................ ........ 35 
DISPOSAL AND RECOVERY............................................................................................... 35 
SECTION I...................................................................................................................... ......... 35 
GENERAL REQUIREMENTS FOR INCINE RATION AND CO-INCINERATION........... 35 
SECTION II ..................................................................................................................... ........ 37 
HIGH-CAPACITY PLANTS .................................................................................................. 37 
SECTION III .................................................................................................................... ........ 38 
LOW-CAPACITY PLANTS ................................................................................................... 38 
SECTION IV..................................................................................................................... ....... 38 
LANDFILLING OF CERTAIN MATERIALS....................................................................... 39 
ANNEX VI....................................................................................................................... ........ 40 
COMBUSTION ..................................................................................................................... ..40 
ANNEX VII ...................................................................................................................... ....... 41 
PROCESSING ..................................................................................................................... ....41 
SECTION I...................................................................................................................... ......... 41 
REQUIREMENTS FOR PROCESSING PLANTS AND CERTAIN  OTHER PLANTS AND 
ESTABLISHMENTS................................................................................................. 41 
SECTION II ..................................................................................................................... ........ 45 
HYGIENE AND PROCESSING REQUIREMENTS ............................................................. 45 
SECTION III .................................................................................................................... ........ 47 
STANDARD PROCESSING METHODS .............................................................................. 47 EN 19   EN SECTION IV..................................................................................................................... ....... 52 
ALTERNATIVE METHODS.................................................................................................. 52 
ANNEX VIII ..................................................................................................................... ....... 60 
TRANSFORMATION INTO BIOGAS, COMPOSTING....................................................... 60 
SECTION I...................................................................................................................... ......... 60 
REQUIREMENTS APPLICABLE TO PLANTS ................................................................... 60 
SECTION II ..................................................................................................................... ........ 62 
HYGIENE REQUIREMENTS APPLICABLE TO  BIOGAS AND COMPOSTING PLANTS 62 
SECTION III .................................................................................................................... ........ 62 
TRANSFORMATION PARAMETERS.................................................................................. 62 
ANNEX IX....................................................................................................................... ........ 68 
SPECIAL RULES ON RESEARCH, FEEDING AND  COLLECTION AND DISPOSAL.. 68 
SECTION I...................................................................................................................... ......... 68 
SPECIAL RULES ON SAMPLES FOR RESEARCH AND OTHER PURPOSES............... 68 
SECTION II ..................................................................................................................... ........ 69 
SPECIAL FEEDING RULES.................................................................................................. 69 
SECTION III .................................................................................................................... ........ 76 
SPECIAL RULES ON COLLECTION AND DISPOSAL ..................................................... 76 
SECTION IV..................................................................................................................... ....... 78 
DISPOSAL BY OTHER MEANS........................................................................................... 78 
ANNEX X ........................................................................................................................ ........ 80 
STANDARD FORMAT FOR APPLICATIONS  FOR ALTERNATIVE METHODS ......... 80 
SECTION I...................................................................................................................... ......... 80 
GENERAL PROVISIONS....................................................................................................... 80 
SECTION II ..................................................................................................................... ........ 80 
STANDARD FORMAT .......................................................................................................... 80 
ANNEX XI....................................................................................................................... ........ 83 
COLLECTION, TRANSPORT AND TRACEABILITY........................................................ 83 
SECTION I...................................................................................................................... ......... 83 
COLLECTION AND TRANSPORT....................................................................................... 83 
SECTION II ..................................................................................................................... ........ 85 EN 20   EN IDENTIFICATION................................................................................................................. .85 
SECTION III .................................................................................................................... ........ 88 
COMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES ..................................... 88 
SECTION IV..................................................................................................................... ....... 95 
RECORDS ........................................................................................................................ ....... 95 
SECTION V ...................................................................................................................... ....... 97 
MARKING OF CERTAIN DERIVED PRODUCTS.............................................................. 97 
ANNEX XII ...................................................................................................................... ....... 99 
REQUIREMENTS APPLICABLE TO CERTAIN  APPROVED AND REGISTERED 
ESTABLISHMENTS AND PLANTS....................................................................... 99 
SECTION I...................................................................................................................... ......... 99 
GENERAL REQUIREMENTS ............................................................................................... 99 
SECTION II ..................................................................................................................... ........ 99 
PROCESSING BY ALTERNATIVE METHODS.................................................................. 99 
SECTION III .................................................................................................................... ........ 99 
MANUFACTURING OF PETFOOD...................................................................................... 99 
SECTION IV..................................................................................................................... .....100 
MANUFACTURING OF ORGANIC FERTILISERS  AND SOIL IMPROVERS.............. 100 
SECTION V ...................................................................................................................... .....100 
HANDLING OF ANIMAL BY-PRODUCTS  AFTER THEIR COLLECTION ................. 100 
SECTION VI..................................................................................................................... .....102 
REQUIREMENTS FOR STORAGE OF DERIVED PRODUCTS ...................................... 102 
SECTION VII .................................................................................................................... ....103 
REGISTERED OPERATORS ............................................................................................... 103 
ANNEX XIII ..................................................................................................................... .....105 
OWN CHECKS AND HACCP.............................................................................................. 105 
ANNEX XIV...................................................................................................................... ....106 
FEED MATERIALS.............................................................................................................. 106 
SECTION I...................................................................................................................... ....... 106 
GENERAL REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE 
MARKET................................................................................................................. 106 
SECTION II ..................................................................................................................... ......107 EN 21   EN SPECIFIC REQUIREMENTS FOR PROCESSED ANIMAL PROTEIN AND OTHER 
DERIVED PRODUCTS .......................................................................................... 107 
SECTION III .................................................................................................................... ......117 
REQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS .......................... 117 
ANNEX XV ....................................................................................................................... ....118 
ORGANIC FERTILISERS AND SOIL IMPROVERS......................................................... 118 
SECTION I...................................................................................................................... ....... 118 
REQUIREMENTS FOR UNPROCESSED MANURE, PROCESSED MANURE AND 
DERIVED PRODUCTS FROM PROCESSED MANURE.................................... 118 
SECTION II ..................................................................................................................... ......126 
REQUIREMENTS FOR CERTAIN ORGANIC FERTILISERS  AND SOIL IMPROVERS 126 
ANNEX XVI...................................................................................................................... ....128 
DERIVED PRODUCTS REGULATED BY OTHER UNION LEGISLATION ................. 128 
SECTION I...................................................................................................................... ....... 128 
DERIVED PRODUCTS REFERRED TO  IN ARTICLE 33 OF THE ANIMAL BY-
PRODUCTS REGULATION .................................................................................. 128 
SECTION II ..................................................................................................................... ......128 
INTERMEDIATE PRODUCTS ............................................................................................ 128 
ANNEX XVII ..................................................................................................................... ...132 
PETFOOD AND CERTAIN OTHER DERIVED PRODUCTS ........................................... 132 
ANNEX XVIII .................................................................................................................... ...143 
IMPORT, EXPORT AND TRANSIT.................................................................................... 143 
SECTION I...................................................................................................................... ....... 143 
SPECIFIC REQUIREMENTS FOR IMPORT AND TRANSIT OF CATEGORY 3 
MATERIAL AND DERIVED PRODUCTS FOR USES IN THE FEED CHAIN 
OTHER THAN FOR PETFOOD OR FOR FEED TO FUR ANIMALS................ 143 
SECTION II ..................................................................................................................... ......153 
SPECIFIC REQUIREMENTS FOR THE IMPORT AND TRANSIT OF ANIMAL BY-
PRODUCTS AND DERIVED PRODUCTS FOR USES OUTSIDE THE FEED 
CHAIN FOR FARMED ANIMALS ....................................................................... 153 
SECTION III .................................................................................................................... ......186 
SPECIAL RULES FOR CERTAIN SAMPLES.................................................................... 186 
SECTION IV..................................................................................................................... .....189 EN 22   EN SPECIFIC REQUIREMENTS FOR CERTAIN MOVEMENTS OF ANIMAL BY-
PRODUCTS............................................................................................................. 189 
SECTION V ...................................................................................................................... .....190 
LISTING OF ESTABLISHMENTS AND PLANTS IN THIRD COUNTRIES .................. 190 
ANNEX XIX...................................................................................................................... ....191 
MODEL HEALTH CERTIFICATES.................................................................................... 191 
ANNEX XX ....................................................................................................................... ....338 
OFFICIAL CONTROLS........................................................................................................ 338 
SECTION I...................................................................................................................... ....... 338 
OFFICIAL CONTROLS REGARDING THE ANIMAL BY-PRODUCTS CHAIN ........... 338 
SECTION II ..................................................................................................................... ......338 
OFFICIAL CONTROLS IN PROCESSING PLANTS......................................................... 338 
SECTION III .................................................................................................................... ......342 
SPECIFIC REQUIREMENTS............................................................................................... 342 EN 23   EN ANNEX I  
DEFINITIONS 
I. For the purpose of this Regulation, the following definitions shall apply: 
1. “ apiculture by-products ” means honey, beeswax, royal jelly, propolis or pollen  not 
intended for human consumption; 
2. ‘ 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; 
3. ‘ 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; 
4. ‘ blood ’ means fresh whole blood; 
5. “blood meal ” means processed animal protein derived from the heat treatment of 
blood or fractions of blood in accordance with Chapter I of Section II of Annex XIV; 
6. ‘ 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; 
7. ‘ canned petfood’  means heat-processed petfood contained within a hermetically 
sealed container; 
8. ‘ catering waste’  means all waste food, including used cooking oil originating in 
restaurants, catering facilities and kitchens, including central kitchens and household 
kitchens; 
9. ‘ co-incineration’  means the recovery or  disposal of animal by-products or derived 
products, if they are waste, in a co-inciner ation plant as defined in Article 3 point 5 
of Directive 2000/76/EC; 
10. ‘ collagen ’ means protein-based products derived from hides, skins, bones and 
tendons of animals; 
11. ‘ collection centres’  means premises other than processing plants in which certain 
animal by-products are collected with the intention  to be used for feeding as referred 
to in Article 18(1) of the Animal By-products Regulation ; 
12. ‘ colour-coding ’ means the systematic use of colours as laid down in point 1(c) of 
Section II of Annex XI for displaying information as provided for in this Regulation 
on the surface or of the part of the surface of a packaging, container or vehicle, or on the a label or symbol applied to them; 
13. ' combustion ' means a process involving the oxidisation of fuel in order to use the 
energy value of the animal by-products or derived products;  EN 24   EN 14. ‘ 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; 
15. ‘ digestion residues’  means residues resulting from the transformation of animal by-
products in a biogas plant; 
16. ‘ digestive tract content’  means the content of the digestive tract of mammals and 
ratites; 
17. 'display item' means animal by-products or derived products intended for 
exhibitions or artistic activities;  
18. ‘ dogchews ’ means products for pet animals to chew, produced from untanned hides 
and skins of ungulates or from other material of animal origin; 
19. 'fat derivatives' means derived products from rendered fats, which, as regards 
Category 1 or Category 2 rendered fats, have been processed in accordance with 
Chapter XI of Annex XVII; 
20. ‘ 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, colostrum, colostrum products and centrifuge or separator sludge from milk processing; 
21. ‘ fishmeal ’ means processed animal protein derived from aquatic animals, except sea 
mammals; 
22. ' fishoil ' means oil derived from the processing of aquatic animals or oil from the 
processing of fish for human consumption, in case the latter oils have been destined 
for purposes other than human consumption in accordance with Article 2(1)(b)(i) of the Animal By-products Regulation; 
23. ‘ flavouring innard’  means a liquid or dehydrated derived  product of animal origin 
used to enhance the palatability values of petfood; 
24. ‘ fur animals’  means animals kept or reared for the production of fur and not used for 
human consumption; 
25. ‘ 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 (including fish and poultry); 
26. ‘ greaves ’ means the protein-containing residue of rendering, after partial separation 
of fat and water; 
27. 'guano' means a natural product which has been collected from the excrements of 
bats or wild sea birds and which is not mineralised; EN 25   EN 28. ‘ hermetically sealed container’  means a container that is designed and intended to 
be secure against the entry of micro-organisms; 
29. ‘ hydrolysed proteins’  means polypeptides, peptides and aminoacids, and mixtures 
thereof, obtained by the hydrolysis of animal by-products; 
30. 'incineration' means the disposal of animal by-products or derived products as waste  
in an incineration plant, as defined in Article 3 point 4 of Directive 2000/76/EC;  
31. 'intermediate operations' means the operations referred to in the initial paragraph 
of Section V of Annex XII; 
32. ‘intermediate product’  means a derived product which is intended for the 
manufacture of medicinal products, veterina ry medicinal products, medical devices, 
active implantable medical devices,  in vitro diagnostic medical devices  or laboratory 
reagents; and whose design, transformation and manufacturing stages have been 
sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for that purpose, except for the fact 
that it requires some further handling or transformation, such as mixing, coating, 
assembling, packaging or labelling to make it suitable for placing the product on the 
market or putting it into service, as applicable,  as a medicinal product, veterinary 
medicinal product, medical device, active implantable medical device, in vitro diagnostic medical device or laboratory reagent; 
33. ‘ 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; 
34. 'meat and bone meal' means animal protein derived from the processing of 
Category 1 or Category 2 materials  in accordance with Section III of Annex VII;  
35. ‘ petfood ’ means feed for pet animals and dogchews, which  contain Category 3 
material and which may contain certain imported Category 1 material, as referred to 
in Article 35 point a of the Animal By-products Regulation; 
36. ‘ processed animal protein’ means animal protein derived entirely from Category 3 
material, which have been treated in accordance with Chapter I of Section II of Annex XIV (including blood meal and fishmeal)  so as to render them suitable for 
direct use as feed material or for any othe r use in feedingstuffs, including petfood, or 
for use in organic fertilisers or soil improve rs; however, it does  not include blood 
products, milk, milk-based products, colostrum, colostrum products, centrifuge or separator sludge from milk processing,  gelatine, hydrolysed proteins and dicalcium 
phosphate, eggs and egg-products, including eggshells, tricalcium phosphate and collagen; 
37. 'petfood plant' means premises or facilities for the production of petfood  or 
flavouring innards, as referred to in Article 24(1)(e) of the Animal By-products Regulation; EN 26   EN 38. ‘ processed petfood’  means petfood, other than raw petfood, which has been 
produced in accordance with point 2 of Chapter II of Annex XVII; 
39. ‘ processing methods’  means the methods listed in Sections III and IV of Annex VII; 
40. ‘ processing plant’  means premises or facilities for the processing of animal by-
products as referred to in Article 24(1)(a) of the Animal By-products Regulation; 
41. ‘ 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 no t include donated organs or blood; 
42. ‘ raw petfood’  means petfood containing certain Category 3 material  which has not 
undergone any preserving process other than chilling or freezing; 
43. ‘ rendered fats’  means either fats derived from processing of animal by-products or 
fats derived from the processing of products for human consumption, in case the 
latter fats have been destined for purposes other than human consumption in accordance with Article 2(1)(b)(i) of the Animal By-products Regulation; 
44.  ' research and diagnostic samples ' means animal by-products and derived products 
intended for the examination or analysis for the promotion of progress in science and technology, in the context of diagnostic,  educational or research activities;  
45. “incineration and co-incineration residues ” means any liquid or solid material 
generated by the incineration or co-incineration process of animal by-products, the 
waste-water treatment or other processes within the incineration or co-incineration plant ., provided that those processes are subject to this Regulation; they include 
bottom ash and slag, fly ash and boiler dust; 
46. ‘ tanning’  means the hardening of hides, using vegetable tanning agents, chromium 
salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes 
and quinones, or other synthetic hardening agents; 
47. ' taxidermy ' means the art of preparing, stuffing and mounting the skins of animals 
with lifelike effect, so that no unacceptable risks to public and animal health may be transmitted through the mounted skin; 
48. ' trade' means trade in goods between Member States as referred to in  Article 28 of 
the Treaty on the Functioning of the European Union; 
49.  'trade samples'  means animal by-products or derived products intended for 
particular studies or analyses with a view to carrying out a production process or 
developing feedingstuffs or other derived products, including testing of machinery, for use in an establishment or plant which is: 
(a) producing feedingstuffs or products for uses other than food and feed; or EN 27   EN (b) processing animal by-products or derived products 
50. ‘ untreated hides and skins’  means all cutaneous and subcutaneous tissues that have 
not undergone any treatment, other than cutting, chilling or freezing; 
51. ‘ treated hides and skins ’ means derived products from untreated  hides and skins , 
other than dogchews, that have been: 
(a) dried; 
(b) dry-salted or wet-salted for at least 14 days prior to dispatch; 
(c) salted for seven days in sea salt with the addition of 2 % of sodium carbonate; 
(d) dried for 42 days at a temperature of at least 20° C; or 
(e) subject to a preservation process other than tanning; 
52. ‘ untreated feathers and parts of feathers’  means feathers and parts of feathers, 
other than feathers, which have: 
(a) been treated with a steam current; or 
(b) by another method that ensures that no pathogens remain;  
53. ‘ untreated wool’  means wool, other than wool which has: 
(a) undergone factory washing,  
(b) been obtained from tanning, or 
(c) been treated by another method that ensures that no pathogens remain; 
54. ‘ untreated hair’  means hair, other than hair which has: 
(a) undergone factory washing,  
(b) been obtained from tanning, or  
(c) been treated by another method that ensures that no pathogens remain; 
55. ‘ untreated pig bristles’  means pig bristles, other than pig bristles which have: 
 (a) undergone factory washing,  
(b) been obtained from tanning, or 
(c) been treated by another method that ensures that no pathogens remain; 
56. ' white water' means a mixture of milk , milk-based products or products derived 
thereof with water which is collected duri ng the rinsing of dairy equipment including 
containers used for dairy products, prior to their cleaning and disinfection. EN 28   EN II.3 The definitions set out in Article 3 of the Animal By-products Regulation shall also 
apply. EN 29   EN ANNEX II  
 
END POINT IN THE MANUFACTURING CHAIN 
 
CHAPTER I 
End point for the derived products referred to in  
Article 5(1) of the Animal By-products Regulation 
[…] 
 
CHAPTER II 
End point for the derived products referred to in 
Article 5(2) of the Animal By-products Regulation 
For the derived products referred to in Article 5(2) of the Animal By-products Regulation 
which are listed in the following table in column 2, an end point in the manufacturing chain is 
determined, subject to the conditions listed in column 3 of the table: 
No. Derived product Conditions 
1 Biodiesel  Annex VII, 
Section IV, 
Chapter III, 
point 2(b)(i) 
2 Processed 
petfood and 
dogchews  Annex XVII, 
Chapter II, 
point 7 
3 Hides and skins 
of ungulates Annex XVII, 
Chapter V, point C 
4 Wool Annex XVII, 
Chapter VII, point C 
5 Feathers and 
down Annex XVII, 
Chapter VII, 
point D EN 30   EN 6 Furs Annex XVII,
Chapter VIII EN 31   EN ANNEX III  
 
ANIMAL HEALTH RESTRICTIONS 
CHAPTER I 
Serious transmissible diseases as referred to in  
Article 6(1)(b)(ii) of the Animal By-products Regulation 
Diseases listed by the OIE in Article 1.2.3 of the Terrestrial Animal Health Code, 2009 
edition. 
CHAPTER II 
Conditions for the dispatch of animal by-products as  
referred to in Article 6(2) of the Animal By-products Regulation 
[…] EN 32   EN ANNEX IV  
 
RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS  
 
CHAPTER I 
Checks and controls regarding certain prohibitions as referred to in Article 11(2)(a) of 
the Animal By-products Regulation 
[…] 
CHAPTER II 
Intra-species recycling of fur animals 
1. In Estonia, Finland and Latvia, the following fur animals may be fed with meat-and-
bone meal or other products which have been processed in accordance with Section 
III of Annex VII and which are  derived from bodies or parts of bodies of animals of 
the same species: 
(a) foxes ( vulpes vulpes ); 
(b) raccoon dogs ( Nycteroites procynides ). 
2. In Estonia and Latvia, fur animals of the species American mink ( Mustela vison ) 
may be fed with meat and bone meal  or other products which have been processed in 
accordance with Section III of Annex VII and which are  derived from bodies or parts 
of bodies of animals of the same species.  
3. The feeding referred to in points 1 and 2 shall take place under the following 
conditions: (a) Feeding shall only take place in farms which have been registered by the 
competent authority: 
(i) on the basis of an application that is accompanied by documentation 
proving that there is no reason to suspect the presence of the TSE agent 
in the population of the species covered by the application; 
(ii) where an appropriate surveillance system for TSEs in fur animals is in 
place and includes regular laboratory testing of samples for TSE; 
(iii) provided the farm supplies appropriate guarantees that no animal by-
product or meat-and-bone meal  or other products which have been 
processed in accordance with Secti on III of Annex VII and which are EN 33   EN derived from those animals or their offspring may enter the food or feed 
chain of other animals than fur animals; 
(iv) where the farm has had no known contact with any farm with a suspected 
or confirmed outbreak of TSE; 
(v) where the operator of the registered farm ensures that 
- the carcases of fur animals intended for feeding to animals of the 
same species are handled and processed separately from carcases 
not authorised for that purpose; 
- fur animals fed with meat and bone meal or other products which 
have been processed in accordance with Section III of Annex VII and which are  derived from animals of the same species are kept 
separate from animals not being fed with products  derived from 
animals of the same species. 
- the registered farm complies w ith the requirements set out in 
Chapter I of Section II to Annex IX and point (2)(b)(ix) of  Section 
II of Annex XI. 
(b) The operator of the farm  shall ensure that meat-and-bone meal  or other 
products  derived from one species and intended for the feeding of the same 
species must: 
(i) have been processed in a processing plant approved under Article 
24(1)(a) of the Animal By-products Regulation and using only methods 1 
to 5 or 7 as set out in Section II I of Annex VII to this Regulation; 
(ii) have been produced from health y animals killed for the production of  
fur. 
(c) In the event of any known or suspected contact with any farm with a suspected 
or confirmed outbreak of TSE, the operator of the farm  must immediately: 
(i) inform the competent aut hority of such contact; and 
(ii) cease the dispatch of fur animals to any destination without a written 
authorisation of the competent authority. 
 
CHAPTER III 
Feeding of farmed animals with herbage 
The following conditions shall apply to the feeding of farmed animals with herbage from 
land, either by direct access of the animals to that land or by using cut herbage as feed, 
provided that organic fertilisers or soil im provers have been applied to that land:  EN 34   EN (a) The waiting period referred to in Article 11(1)(c) of the Animal By-products 
Regulation must have  been observed; and  
(b) only organic fertilisers and soil impr overs have been used which comply with 
Article 32 of the Animal By-products Regulation and with Section II of Annex 
XV to this Regulation. 
Those conditions shall not apply, provided on ly the following organic fertilisers or soil 
improvers have been applied to land: 
(a) manure and guano, and  
(b) digestive tract content, milk, milk-based products, colostrum and colostrum 
products, which the competent authority does not consider to present a risk for 
the spread of any serious animal disease. EN 35   EN ANNEX V  
 
DISPOSAL AND RECOVERY 
SECTION I 
GENERAL REQUIREMENTS FOR INCINERATION AND CO-INCINERATION 
Incineration and co-incineration shall take place in plants which have a permit to operate in 
accordance with Directive 2000/76/EC or in plants which have been approved in accordance 
with Article 24(1)(b) or (c)  of the Animal By-products Regulation, as applicable. Plants 
which do not have a permit to operate in accordance with Directive 2000/76/EC  shall be 
approved in accordance with that Article, if they fulfil the conditions laid down in this 
Section. 
CHAPTER I 
General conditions 
1. Operators of incineration and co-incineration plants shall ensure that their plants 
meet the following hygiene conditions: 
(a) Animal by-products and derived products  shall be disposed of as soon as 
possible after arrival, in accordance  with conditions la id down by the 
competent authority. They shall be stor ed properly until disposal, in accordance 
with conditions laid down by the competent authority. 
(b) Plants shall have appropriate arrangements for the cleaning and disinfection of 
containers and vehicles in place, in particular in a designated area from which 
waste water is disposed of in accordance with Union legislation, to avoid risks 
of contamination. 
(c) Plants shall be located on a well-drained hard standing.  
(d) Plants shall have appropriate arrangements for protection against pests, such as 
insects, rodents and  birds. A documented pest control programme shall be used 
for that purpose. 
(e) Staff  shall have access to adequate facilities for personal hygiene such as 
lavatories, changing rooms and washbasins for staff, if necessary to prevent risks of contamination.  
(f) Cleaning procedures shall be established and documented for all parts of the 
premises. Suitable equipment and cleaning agents shall be provided for cleaning. 
(g) Hygiene control shall include regular inspections of the environment and 
equipment. Inspection schedules and results shall be documented and maintained for at least two years. EN 36   EN 2. The operator of an incineration or co-incineration plant shall take all necessary 
precautions concerning the reception of animal by-products to prevent, or limit as far 
as practicable, direct risks to human or animal health. 
3. Animals must not have access to the plants, animal by-products and derived products 
that are awaiting incineration or co-incinera tion or ash resulting from the incineration 
or co-incineration of animal by-products. 
4. If the incineration or co-incineration plant is located on a livestock holding: 
(a) there must be total physical separation between the incineration or co-
incineration equipment and the livestock and their feed and bedding, with 
fencing where necessary; 
(b) equipment must be dedicated entirely to  the operation of the incinerator and not 
used elsewhere on the farm or, alternatively, cleaned and disinfected before 
such use. 
(c) operators working in the plant  must change their outer clothing and footwear 
before handling livestock or livestock feed. 
5. The storage of animal by-products and derived products that are awaiting incineration 
or co-incineration and of ashes must be in covered, correctly identified  and, if 
applicable, leak proof containers. 
6. The operator must check that animal by-p roducts and derived products are incinerated 
in such a way that they are completely reduced to ash.  
7. Incompletely incinerated animal by-products must be re-incinerated or disposed of by 
other means, other than by disposal in an authorised landfill, in  accordance with the 
Animal By-products Regulation. 
CHAPTER II 
Operating conditions 
Incineration or co-incineration plants shall be designed, equipped, built and operated in such a 
way that the gas resulting from the process is raised in a controlled and homogeneous fashion, 
even under the most unfavourable co nditions, to a temperature of 850o C for at least 2 seconds 
or to a temperature of 1100°C for 0.2 seconds, as  measured near the inner wall or at another 
representative point of the chamber where the incineration or the co-incineration is carried 
out, as authorised by the competent authority. 
CHAPTER III 
Incineration and co-incineration residues 
1. Incineration and co-incineration residues resulting from the operation of the 
incineration or co-incineration plant shall be minimised in their amount and EN 37   EN harmfulness. Such residues must be disposed of in an authorised landfill, or recycled, 
where appropriate, directly in the plant or outside in accordance with relevant Union legislation. 
2. 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. 
CHAPTER IV 
Temperature measurement 
1. Techniques shall be used to monitor the parameters and conditions relevant to the 
incineration or co-incineration process.  
2. The approval issued by the competent authority, or conditions attached to it, shall lay 
down temperature measurement requirements. 
3. The functioning of any automated monitoring equipment shall be subject to control 
and to an annual surveillance test. Calibration shall be carried out by means of parallel 
measurements with the reference methods at regular intervals. 
4. Temperature measurement results shall be recorded and presented in an appropriate 
fashion to enable the compet ent authority to verify co mpliance with the permitted 
operating conditions laid down in this Regula tion in accordance with procedures to be 
decided upon by that authority. 
CHAPTER VI 
Abnormal operating 
In the case of a breakdown, or abnormal operating conditions, the operator shall reduce or 
close down operations as soon as practicable until normal operations can be resumed. 
SECTION II 
HIGH-CAPACITY PLANTS 
CHAPTER I 
Specific operating conditions 
Incineration or co-incineration plants with a throughput of more than 50 kg per hour (high-capacity plants) which do not have a permit to operate in accordance with Directive 2000/76/EC shall comply with the following conditions: EN 38   EN (a) The plants shall 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 850o C 
or 1100°C, as applicable. It shall also be used during plant start-up and shut-down operations to ensure that the temperature of 850
o C or of 1100°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. 
(b) When animal by-products are introduced into the chamber where the 
incineration or co-incineration is carried out by a continuous process, the plants 
shall operate an automatic system to prevent the introduction of animal by-
products at start-up, until the temperature of 850° C or of 1100°C, as applicable,  has been reached, and whenever the temperature is not maintained. 
(c) Plants shall have and use temperature measurement equipment. 
CHAPTER II 
Water discharges 
1. 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 in 
accordance with the provisions provided for in relevant Union legislation.  
2. Storage capacity shall be provided for contaminated rainwater run-off from the plant 
site or for contaminated water arising from spillage or fire-fighting operations. The operator shall, if necessary, ensure that su ch rainwater and such water can be tested 
and treated before discharge, when necessary in accordance with relevant Union or national legislation. 
SECTION III 
LOW-CAPACITY PLANTS 
Incineration and co-incineration plants with a maximum throughput of less than 50 kg of 
animal by-products per hour (low-capacity plants) which do not have a permit to operate in accordance with Directive 2000/76/EC shall 
(a) only be used for the disposal of dead pet animals referred to in Article 8(a)(iii) 
of the Animal By-products Regulation or of  animal by-products as referred to 
in Article 8 (b), (e) and (f), 9 or 10  of the same  Regulation; 
(b) when animal by-products referred to in Article 8(b) of the Animal By-products 
are introduced into the low-capacity plant, be equipped with an auxiliary  
burner. 
SECTION IV EN 39   EN LANDFILLING OF CERTAIN MATERIALS 
1. By way of derogation from Article 12 of the Animal By-products Regulation, the 
competent authority may authorise the disposal of processed petfood which has been 
imported or produced in accordance with this Regulation from imported materials as referred to in Article 35(a)(ii) of the Anim al By-products Regulation in an authorised 
landfill, in accordance with Article 5 of Directive 1999/31/EC. 
2. By way of derogation from Article 14 (c) of the Animal By-products Regulation, the 
competent authority may authorise the disposal of Category 3 materials referred to in 
Article 10(f) and (g) of the Animal By-products Regulation in an authorised landfill, in accordance with Article 5 of Di rective 1999/31/EC, provided that: 
(a) such materials have not been in contact with any animal by-product referred to 
in Articles 8, 9 and 10(a) to (e) and (h) to (p) of the Animal By-products 
Regulation;  
(b) at the time when they are destined for disposal, materials: 
(i) referred to in Article 10 (f) of the Animal By-products Regulation have 
undergone processing as defined in Article 2(1)(m) of Regulation (EC) 
No 852/2004; and 
(ii) referred to in Article 10 (g) of the Animal By-products Regulation have 
been processed in accordance with this Regulation; and  
(c) the disposal of such materials does not pose a risk to public or animal health. EN 40   EN ANNEX VI  
COMBUSTION 
[…] EN 41   EN ANNEX VII  
PROCESSING 
SECTION I  
REQUIREMENTS FOR PROCESSING PLANTS AND CERTAIN  
OTHER PLANTS AND ESTABLISHMENTS  
CHAPTER I 
General conditions 
1. Processing plants must meet the following requirements, for processing by pressure 
sterilisation or  in accordance with the methods referred to in Article 15(1)(b) of the 
Animal By-products Regulation:  
(a) Processing plants shall not be situated on the same site as slaughterhouses or 
other establishments which have been approved or registered in accordance 
with Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004, unless the risks to public and animal health resulting from the processing of animal 
by-products, which originate from such slaughterhouses or other establishments, are mitigated by compliance with at least the following 
conditions: 
(i) the processing plant must be physically separated from the 
slaughterhouse or other establishment; where appropriate by locating 
the processing plant in a building that is completely separated from the 
slaughterhouse or other establishment; 
(ii) the following must be installed and operated: 
— a conveyer system which links the processing plant to the 
slaughterhouse or other establishment  and which may not be by-
passed, 
— separate entrances, reception bays, equipment and exits for both the 
processing plant and the slaughterhouse or establishment; 
(iii) measures must be taken to prevent the spreading of risks through the 
operation of personnel which is employed in the processing plant and in the slaughterhouse or other establishment; 
(iv) unauthorised persons and animals mu st not have access to the processing 
plant. 
By way of derogation from points (i) to (iv), in the case of Category 3 
processing plants, the competent authority may authorise other conditions instead of those set out in those points, aimed at mitigating the risks to public 
and animal health, including the risks arising from the processing of Category EN 42   EN 3 material, which originates from off- site establishments approved or 
registered in accordance with Regulation (EC) No 852/2004 or Regulation 
(EC) No 853/2004.  
Member States shall inform the Commission and the other Member States in 
the framework of the Committee referred to  in Article 52(1) of the Animal By-
products Regulation of the use made of this derogation by their competent authorities; 
(b) The processing plant must have a clean and unclean sector, adequately 
separated. The unclean sector must have a covered place to receive animal by-
products and must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid in such a way as to facilitate the draining of 
liquids;  
(c) The processing plant must have adequate facilities including lavatories, 
changing rooms and washbasins for staff;  
(d) The processing plant must have sufficient production capacity for hot water 
and steam for the processing of animal by-products;  
(e) The unclean sector must, if appropriate, contain equipment to reduce the size of 
animal by-products and equipment for loading the crushed animal by-products 
into the processing unit;  
(f) Where heat treatment is required, a ll installations must be equipped with:  
(i) measuring equipment to monitor temperature against time and, if 
applicable for the processing method used, pressure at critical points;  
(ii) recording devices to record continuously the results of these 
measurements in a way so that they  remain accessible for the purpose 
of checks and official controls; and  
(iii) an adequate safety system to prevent insufficient heating;  
(g) To prevent recontamination of the derived product by the introduction of  
animal by-products, there must be a clear separation between the area of the 
plant where incoming material for processing is unloaded and the areas set 
aside for the processing of that product and the storage of the derived product.  
2. The processing plant must have adequate  facilities for cleaning and disinfecting the 
containers or receptacles in which animal by-products are received and the vehicles, 
other than ships, in which they are transported.  
3. 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.  
4. All processing plants must have a waste-water disposal system meeting the 
requirements set out by the competent authority in accordance with Union legislation.  EN 43   EN 5. The processing plant shall 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. 
6. If on the basis of a risk assessment,  the volume of products treated requires regular or 
permanent presence of the competent authority, the processing plants shall have an adequately equipped lockable room for the exclusive use of the inspection service.  
 
CHAPTER II 
Waste water treatment 
1. Category 1 processing plants and other premises where specified risk material is 
removed, slaughterhouses and Category 2 processing plants shall have a pre-treatment 
process for the retention and collection of animal material as an initial step in the 
treatment of waste water. The equipment used in the pre-treatment process shall consist of drain traps or screen 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 ensures that the solid particles in the waste water passing through them are no more 
than 6 mm. 
2. Waste water from the premises as referred to in point 1 must enter a pre-treatment 
process which shall ensure that all waste water has been filtere d 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. 
3. All animal material retained in the pre-trea tment 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 the Animal By-products Regulation. 
4. Waste water originating in the unclean sector  of processing plants shall be treated in 
accordance with conditions laid down by the competent authority, in order to ensure that risks from pathogens are mitigated.  
5. Waste water having passed the pre-treatment process in premises re ferred to in point 1 
and waste water from premises only handling or processing Category 3 material shall 
be treated in accordance with Union legisla tion, without restrictions in accordance 
with this Regulation. 
6. In addition to the pre-treatment referred to in point 4, waste water originating in the 
unclean sector of processing plants shall be treated in accordance with conditions laid down by the competent authority, in order to ensure that risks from pathogens are 
mitigated.  EN 44   EN 7. Without prejudice to points 1 to 5, the disposal of animal by-products including blood 
and milk or derived products through the waste water stream shall be prohibited. 
            However, centrifuge or separator sludge referred to in Article 10(e) of the Animal By-
products Regulation  may be disposed of through the waste water stream, provided that 
it has been subject to one of the treatments referred to in Part III of Chapter IV of 
Section II of Annex XIV. 
 
CHAPTER III 
Re-approval after temporary use 
If the competent authority has granted an approval in accordance with Article 24(2)(b)(ii) of 
the Animal By-products Regulation for the temporary use of a processing plant for the processing of a Category of animal by-products with a higher risk, it shall initiate the procedure for approval in accordance with Article 44 of the Animal By-products Regulation before issuing a new approval for the processing of animal by-products of a lower risk after 
the end of the temporary use. 
CHAPTER IV 
Specific requirements for the processing of Category 1 and Category 2 materials 
The layout of Category 1 and Category 2 processing plants must ensure the total separation of 
Category 1 material from Category 2 material from reception of the raw material until dispatch of the resulting derived product, unless a mixture of Category 1 material and Category 2 material is processed as Category 1 material.  
CHAPTER V 
Specific requirements for the processing of Category 3 materials 
The following requirements apply in addition to  the general requirements laid down in 
Chapter I:  
1. Category 3 processing plants shall not be at the same site as Category 1 or Category 2 
processing plants, unless in a completely separate building.  
2. 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 by way of: (a) the layout of the premises, in particul ar the arrangements for the reception, and 
by way of the further handling of raw materials,  EN 45   EN (b) the layout and the management of the equipment used for processing, including 
the layout and the management of separate processing lines or of cleaning 
procedures which are excluding the propagation of any possible risks to public 
and animal health; and 
(c) the layout and the management of the areas for the temporary storage of the 
end products. 
3. Category 3 processing plants shall have 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.  
 
 
SECTION II 
HYGIENE AND PROCESSING REQUIREMENTS 
CHAPTER I 
General hygiene requirements 
In addition to the general hygiene requirements referred to in Article 25 of the Animal By-
products Regulation, processing plants shall have a documented pest control programme in 
place for the implementation of the arrangements referred to in Article 25(1)(c) of that 
Regulation. EN 46   EN CHAPTER II 
General processing requirements 
1. 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. 
2. Material that may not have received the specified heat treatment, such as material 
discharged at start up or leakage from cookers, must be re-circulated through the heat 
treatment or collected and reprocessed or disposed of in accordance with The Animal By-products Regulation. 
CHAPTER III 
Processing methods for Category 1 and Category 2 material 
Unless the competent authority requires the applic ation of pressure ster ilisation as defined in 
Article 3 no. 19 of the Animal By-products Regulation (method 1), Category 1 and Category 
2 material shall be processed in accordance with methods 2, 3, 4 or 5 as referred to in Section 
III of this Annex. 
CHAPTER IV 
Processing of Category 3 material 
1. The critical control points that determine the extent of the heat treatments applied in 
processing shall  include for each processing method as specified in Section III of this 
Annex:  
(a) raw material particle size;  
(b) temperature achieved in the heat treatment process; 
(c) pressure, if applied to the raw material; and 
(d) duration of the heat treatment process or feed rate to a continuous system. 
Minimum process standards must be specified for each applicable critical 
control point.  
2. The critical control points that determine the extent of the chemical treatments applied 
in processing in accordance with method 7 as  defined in point G of Section III shall 
include the pH adjustment achieved. 
3. Records shall be maintained for at least two years to show that the minimum process 
values for each critical control point are applied. EN 47   EN 4. Category 3 material shall be processed in accordance with methods 1 to 5 and 7, or, in 
the case of material originating from aquatic animals,  with methods 1 to 7,  as referred 
to in Section III of this Annex. 
 
 
SECTION III 
STANDARD PROCESSING METHODS 
A. Pressure sterilisation as defined in Article 3 no. 19 of the Animal By-products 
Regulation (method 1) 
Reduction 
1. If the particle size of the animal by-p roducts 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. 
Time, temperature and pressure 
2. 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 evacua tion 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. 
3. The processing may be carried out in batch or continuous systems. 
 
B. Method 2 
Reduction 
1. 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. 
Time, temperature and pressure EN 48   EN 2. 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 achi eved consecutively or through a 
coincidental combination of the time periods indicated. 
3. The processing must be carried out in a batch system. 
 
C. Method 3 
Reduction 
1. If the particle size of the animal by-p roducts 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. 
Time, temperature and pressure 
2. 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 achi eved consecutively or through a 
coincidental combination of the time periods indicated. 
 3. The processing may be carried out in batch or continuous systems. 
 
D. Method 4 Reduction 
1. If the particle size of the animal by-p roducts 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. EN 49   EN Time, temperature and pressure 
2. 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 achi eved consecutively or through a 
coincidental combination of the time periods indicated. 
3. The processing may be carried out in batch or continuous systems. 
 
E. Method 5 
Reduction 
1. If the particle size of the animal by-p roducts 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. 
Time, temperature and pressure 
2. 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 achi eved consecutively or through a 
coincidental combination of the time periods indicated. 
3. The processing may be carried out in batch or continuous systems. 
 
F. Method 6 (for Category 3 animal by-products originating from aquatic animal or 
aquatic invertebrates only) 
Reduction 
1. The animal by-products must be reduced to at least: 
(a) 50 mm, in case of heat treatment in accordance with paragraph 2(a); or (b) 30 mm, in case of heat treatment in accordance with paragraph 2(b). EN 50   EN They must then be mixed with formic aci d to reduce and maintain the pH to 4.0 
or lower. The mixture must be stored for at least 24 hours pending further 
treatment. 
Time, temperature and pressure 
2. After reduction, the mixture must be heated to: 
(a) a core temperature of at least 90 °C for at least 60 minutes; or 
(b) a core temperature of at least 70 °C for at least 60 minutes. 
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. 
3. The processing may be carried out in batch or continuous systems. 
 
G. Method 7 
1. Any processing method authorised  by the competent authority where the 
following have been demons trated to that authority: 
(a) the identification of relevant hazard s in the starting material, in view of 
the origin of the material, and of the potential risks in view of the animal 
health status of the Member State or the area or zone where the method is 
to be used; 
(b) the capacity of the processing method to reduce those hazards to a level 
which does not pose any significant ri sks to public and animal health; 
(c) the sampling of the final product on a daily basis over a period of 30 
production days in compliance with the following microbiological 
standards: 
(i) Samples of material taken directly after the treatment: 
   Clostridium perfringens absent in 1 g of the products 
(ii) Samples of material taken during or upon withdrawal from storage: 
   Salmonella: absence in 25g: n=5, c=0, m=0, M=0    Enterobacteriaceae: n=5, c=2; m=10; M=300 in 1 g 
   where: 
   n = number of samples to be tested; EN 51   EN  m = threshold value for the numbe r of bacteria; the result is 
considered satisfactory if the number of bacteria in all samples 
does not exceed m; 
M = maximum value for the number of bacteria; the result is 
considered unsatisfactory if the number of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be 
between m and M, the samples still being considered acceptable 
if the bacterial count of the other samples is m or less. 
2. 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. 
3. 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. 
4. The competent authority shall permanently or temporarily suspend the 
application of processing methods referred to under points 1 and 3, if it obtains 
evidence that any of the circumstances referred to in point 1 have substantially 
changed. 
5. 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 method.  EN 52   EN SECTION IV 
ALTERNATIVE METHODS 
CHAPTER I 
General provisions 
1. Materials resulting from the processing of Category 1 and 2 materials, except 
biodiesel produced in accordan ce with point D of Chapter II of this Annex, shall be 
permanently marked in accordance with Section V of Annex XI. 
2. 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. 
CHAPTER II 
Processing standards 
A. Alkaline hydrolysis process 
1. Starting material 
For this process, animal by-products of all Categories may be used. 
2. Processing method 
Alkaline hydrolysis shall be carried out according to the following processing standards: 
(a) Either a sodium hydroxide (NaOH) or  potassium hydroxide (KOH) solution (or 
a combination thereof) is 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 is adjusted so that the molar equivalency referred to is achieved. 
(b) Animal by-products are placed in a steel alloy container. The measured amount 
of alkali is added either in solid form or as a solution as referred to in point (a).  
(c) The container is closed and the animal by-products and alkali mixture are 
heated to a core temperature of at least 150 °C and at a pressure (absolute) of at least 4 bars for at least: 
(i) three hours without interruption; EN 53   EN (ii) six hours without interruption in case of treatment of animal by-
products referred to in Article 8(a)(i) and (ii)  of the Animal By-
products Regulation.  
However, materials derived from animal s referred to in Article 8(a)(ii) 
of the Animal By-products Regulation which are either ruminants not 
requiring TSE testing or ruminants which have been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001 may be processed in accordance with point 2(c)(i); or 
(iii) one hour without interruption in case of animal by-products consisting 
of fish or of poultry materials. 
(d) The process is carried out in a batch system and the material in the vessel is 
constantly mixed in order to  facilitate the digestion process until the tissues are 
dissolved and bones and teeth are softened; and 
(e) The animal by-products are treated in such way that the requirements regarding 
time, temperature and pressure are achieved at the same time.  
B. High pressure high temperature hydrolysis process 
1. Starting material 
For this process, Category 2 and Category 3 materials may be used. 
2. Processing method 
High pressure high temperature hydrolysis shall be carried out according to the following 
processing standards: 
(a) The animal by-products are 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; 
(b) The process is carried out in a batch a nd the material in the vessel is constantly 
mixed; and 
(c) The animal by-products are treated in such a manner that the time-temperature-
pressure requirements are achieved at the same time. 
C. High pressure hydrolysis biogas process 
1. Starting material 
For this process, animal by-products of all Categories may be used. 
2. Processing method 
The high pressure hydrolysis biogas process shall be carried out according to the following 
processing standards: EN 54   EN (a) The animal by-products are first processed using processing method 1 in an 
approved processing plant; 
(b) Following the above process, the defatted materials are 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; 
(c) The process is carried out in a batch or continuous system and the material is 
constantly mixed; 
(d) The animal by-products are treated in such a manner that the time-temperature-
pressure requirements are achieved at the same time; and 
(e) The resulting material is then mixed with water and anaerobically fermented 
(biogas transformation) in a biogas reactor. 
(f) In case of starting material of Category 1, the entire process shall take place on 
the same site and in a closed system and the biogas produced during the 
process shall be combusted rapidly in the same plant at a minimum of 900 °C followed by rapid chilling ("quenching"). 
D. Biodiesel production process 
1. Starting material 
For this process, a fat fraction of animal by-products of all categories may be used. 
2. Processing method 
Biodiesel production shall be carried out acco rding to the following processing standards: 
(a) Unless fish oil or  rendered fat is 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 of animal by-products is first processed using: 
(i) in case of Category 1 or 2 materials, processing method 1 as referred to 
in Section III of this Annex; and 
(ii) in the case of Category 3 materials, any of the processing methods 1 to 
5 or 7 or, in the case of material derived from fish, method s 1 to 7  as 
referred to in Section III of this Annex; 
(b) The processed fat is then processed further using one of the following methods: 
(i) a process whereby the processed fat is separated from the protein and in 
the case of fat from ruminant origin,  insoluble impurities in excess of  
0.15 % by weight are removed, and the processed fat is  subsequently 
submitted to esterfication and transesterfication. 
However, esterfication is not required for processed fat derived from 
Category 3 material. For esterfication the pH is reduced to less than 1 
by adding sulphuric acid (H
2SO 4) or an equivalent acid and the mixture EN 55   EN is heated to 72 °C for at least  two hours during which it is intensely 
mixed. 
Transesterfication shall be carried out by increasing the pH to about 14 
with potassium hydroxide or with an equivalent base at 35 °C to 50 °C 
for at least 15 minutes. Transesterfication shall be carried out twice under the conditions described in this point using a new base solution. This process is followed by refinement of the products including 
vacuum distillation at 150 °C, leading to biodiesel; 
(ii) a process using equivalent process parameters authorised by the 
competent authority. 
 
E. Brookes' gasification process 
1. Starting material 
For this process, Category 2 and Category 3 material may be used. 
2. Processing method 
Brookes' gasification shall be carried out according to the following processing standards: 
(a) The afterburner chamber is warmed up using natural gas. (b) The animal by-products are loaded into the primary chamber of the gasificator 
and the door is closed. The primary chamber has no burners and is heated 
instead by the transfer of heat by conduction from the afterburner, which is 
underneath the primary chamber. The only air admitted to the primary chamber 
is via three inlet valves mounted on the main door to enhance the efficiency of the process. 
(c) The animal by-products are volatilised into complex hydrocarbons and the 
resultant gases pass from the primary chamber via a narrow opening at the top of the back wall to the mixing and cracking zones, where they are broken down 
into their constituent elements. Finall y the gases pass into the afterburner 
chamber where they are burned in the flame of a natural gas fired burner in the 
presence of excess air. 
(d) Each process unit has two burners and two secondary air fans for back-up in 
case of burner or fan failure. The sec ondary chamber is designed to give a 
minimum residence time of two seconds  at a temperature of at least 950
o C 
under all conditions of combustion. 
(e) On leaving the secondary chamber the exhaust gases 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. 
(f) The process is 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 EN 56   EN is removed from the primary chamber by a vacuum extraction system into 
enclosed bags and sealed before transporting. 
(g) The gasification of material other than animal by-products is not permitted. 
 
F. Combustion of animal fat in a thermal boiler process 
1. Starting material 
For this process, a fat fraction derived from animal by-products of all Categories may be used. 
2. Processing method 
Combustion of animal fat in a thermal boiler shall be carried out according to the following 
processing standards: 
(a) Unless fish oil or  rendered fat is 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 is first processed 
using: 
(i) in the case of fat fraction of Category 1 and 2 materials which is  
intended to be combusted in another plant,  
- for the fat fraction from the processing of ruminants which have 
been tested with a negative result in accordance with Article 6(1) of Regulation (EC) No 999/2001 and from the processing  of animals, 
other than ruminants which require TSE testing, any of the processing methods 1 to 5 as referred to in Section III of this 
Annex; 
- for the fat fraction from the processing of other ruminants, 
processing method 1 as referred in Section III of this Annex;  and 
(ii) in the case of Category 1 and 2 materials intended for combustion 
within the same plant and in the case of Category 3 material,  any of the 
processing methods 1 to 5 or 7; in the case the materials are derived from fish, processing methods 1 to 7 as referred to in Section III of this Annex; 
(b) The fat fraction is separated from th e 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 are removed; 
(c) Following the process referred to in (a) and (b), the fat is: 
(i) vaporised in a steam-raising boiler and combusted at a temperature of 
at least 1, 100 °C for at least 0.2 seconds; or 
(ii) processed using equivalent process parameters authorised by the 
competent authority. EN 57   EN (d) The combustion of material of animal  origin other than animal fat is not 
permitted. 
(e) The combustion of the fat derived from Category 1 and Category 2 materials 
shall take place in the same plant wher e 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: 
(i) the plant of destination is authorised for the combustion; 
(ii) approved food or feed processing on the same premises takes place 
under strict conditions of separation. 
(f) The combustion is 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. 
 
G. Thermo-mechanical biofuel production process 
1. Starting material 
For this process, manure and digestive tract c ontent and Category 3 material may be used. 
2. Processing method 
Thermo-mechanical biofuel production shall be carried out according to the following 
processing standards: 
(a) The animal by-products are loaded into a converter and subsequently treated at 
a temperature of 80° C for a period of eight hours. During this period, the 
material is constantly reduced in size using appropriate mechanical abrasion 
equipment. 
(b) The material is subsequently treated at  a temperature of 100 °C for at least two 
hours. 
(c) The particle size of the resulting material must not be larger than 20 
millimetres; 
(d) The animal by-products are treated in such a manner that the time-temperature 
requirements laid down in paragraphs (a) and (b)  are achieved at the same 
time; 
(e) During the heat treatment of the material, evaporated water is continually 
extracted from the air-space above the biofuel and is passed through a stainless steel condenser. The condensate is kept at a temperature of at least 70° C for at least one hour before being discharged as waste water; EN 58   EN (f) After the heat treatment of the materi al, the resulting biofuel from the converter 
is then discharged and automatically conveyed by a fully covered and 
interlocked conveyor to incineration or co-incineration on the same site; 
(g) The process is carried out in a batch mode. 
 
CHAPTER III 
Disposal and use of derived products 
1. Products derived from the processing of  
(a) Category 1 material shall be: 
(i) disposed of in accordance with Article 12(a) or (b) of the Animal By-
products Regulation; 
(ii) disposed of by burial in an aut horised landfill as defined in point 21 of 
Article 3 of the Animal By-products Regulation; 
(iii) transformed into biogas, provided the digestion residues are disposed of 
in accordance with points (i) or (ii); or 
(iv) further processed into fat derivatives for uses other than feeding. 
(b) Category 2 or Category 3 material shall be: 
(i) disposed of as provided for in point 1(a)(i) or (ii), with or without prior 
processing as provided for in Article 12 (a) and (b) of the Animal By-
products Regulation; 
(ii) further processed into fat derivatives for uses other than feeding; 
(iii) used as an organic fertiliser or soil improver; or 
(iv) composted or transformed into biogas. 
2. However, materials resulting from processing in accordance with: 
(a) the alkaline hydrolysis process defined in point A of Chapter II may be 
transformed in a biogas plant and subsequently combusted rapidly at a 
minimum of 900°C, followed by rapid chilling ("quenching"); in case material 
referred to in Article 8(a) and (b) of the Animal By-products Regulation has been used as starting material, the transformation into biogas shall take place 
on the same site as the processing and in a closed system; 
(b) the biodiesel production process may be: EN 59   EN (i) in the case of biodiesel and of resi dues from the distillation of biodiesel, 
used as a fuel without restrictions under this Regulation (end point); 
(ii) in the case of potassium sulphate, used for the production of derived 
products for application to land; 
(iii) in the case of glycerine or digestion residues  
- derived from Category 1 or Category 2  material which has been 
processed in accordance with processing method 1 as referred to in 
Section III of this Annex,  transformed into biogas. 
- derived from Category 3 material, used for feeding. 
3. 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 the Animal By-products Regulation and with this Regulation. EN 60   EN ANNEX VIII  
TRANSFORMATION INTO BIOGAS, COMPOSTING 
SECTION I 
REQUIREMENTS APPLICABLE TO PLANTS 
CHAPTER I 
Biogas plants 
1. A biogas plant shall 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:  
(a) installations for monitoring that the te mperature of 70°C is reached against the 
time of one hour;  
(b) recording devices to record continuously the results of the monitoring 
measurements referred to in (a); and 
(c) an adequate system to prevent insufficient heating. 
2. However, a pasteurization / hygienisation unit shall not be mandatory for biogas 
plants that transform only:  
(a) Category 2 material that has been processed in accordance with processing 
method 1 as referred to in Section III of Annex VII; 
(b) Category 3 material that has been processed in accordance with processing 
methods 1 to 5 and 7, or in the case of material originating from aquatic 
animals, methods 1 to 7, as referred to in Section III of Annex VII; 
(c) Category 3 material that has undergone pasteurisation/hygienisation in another 
approved plant; 
(d) animal by-products which may be used as raw material without processing in 
accordance with Articles 13(e)(ii) of the Animal By-products Regulation and 
with this Regulation; 
(e) if authorised by the competent authority, materials referred to in Article 10(f) 
of the Animal By-products Regulation, which have been processed as defined 
in Article 2(1)(m) of Regulation (EC) No 852/2004 at the time when they are 
destined for purposes other than human consumption, or materials referred to 
in Article 10(g) of the Animal By-products Regulation; or 
(f) if authorised by the competent author ity, materials which are transformed into 
biogas, where the digestion residues are subsequently composted or processed 
or disposed of in accordance with this Regulation. EN 61   EN 3. If the biogas plant is located on or next to premises where farmed animals are kept 
and 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 any case, there must be total physical separation 
between that biogas plant and the animals and their feed and bedding, with fencing 
where necessary.  
4. 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, be accredited according to internationally recogn ised standards or be subject to regular 
controls by the competent authority. 
CHAPTER II 
Composting plants 
1. A composting plant shall be equipped with a closed composting reactor or area, 
which cannot be by-passed for the animal by-products or derived products introduced 
into the plant, with:  
(a) installations for monitoring temperature against time;  
(b) recording devices to record, where appr opriate continuously, the results of the 
monitoring measurements referred to in (a); and  
(c) an adequate safety system to prevent insufficient heating. 
2. However, other types of composting systems may be allowed provided they:  
(a) are managed in such a way that all the material in the system achieves the 
required time and temperature parame ters, including, where appropriate, 
continuous monitoring of the parameters; or  
(b) transform only materials referred to in points 2(a) to (f) of Chapter I; and 
(c) comply with all other relevant  requirements of this Regulation.  
3. If the composting plant is located on or next to premises where farmed animals are 
kept and 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 any case, there must be total 
physical separation between that composting plant and the animals and their feed and 
bedding, with fencing where necessary.  
4. 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 EN 62   EN approved, be accredited according to internat ionally recognised standards or be subject 
to regular controls by the competent authority. 
SECTION II 
HYGIENE REQUIREMENTS APPLICABLE TO  
BIOGAS AND COMPOSTING PLANTS 
1. Animal by-products must be transformed as soon as possible after arrival. They must 
be stored properly until treated. 
2. Containers, receptacles and vehicles used for transporting untreated material must be 
cleaned and disinfected  in a designated area. This area must be situated or designed so 
as to prevent risk of contamination of treated products. 
3. Preventive measures against birds, rodents, insects or other vermin must be taken 
systematically. A documented pest-control programme must be used for that purpose. 
4. Cleaning procedures must be documented and established for all parts of the premises. 
Suitable equipment and cleaning agents must be provided for cleaning.  
5. Hygiene control must include regular inspections of the environment and equipment. 
Inspection schedules and results must be documented. 
6. Installations and equipment must be kept in a good state of repair and measuring 
equipment must be calibrate d at regular intervals. 
7. Digestion residues and compost must be handled and stored at the biogas or 
composting plant in such way as to prevent recontamination. 
SECTION III 
TRANSFORMATION PARAMETERS 
CHAPTER I 
Standard transformation parameters 
1. 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: 
(a) maximum particle size before entering the unit: 12 mm; 
(b) minimum temperature in all material in the unit: 70 °C; and 
(c) minimum time in the unit without interruption: 60 minutes. EN 63   EN However, Category 3 milk, colostrums and milk products and colostrum products 
may be used without pasteurization /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. 
The minimum requirements set out in points (b) and (c) of the first subparagraph 
shall also apply to Category 2 material which is introduced into a biogas plant in 
accordance with Article 13(e)(ii) of the Animal By-products Regulation. 
2. Category 3 material which is  used as raw material in a composting plant must be 
submitted to the following minimum requirements: 
(a) maximum particle size before entering the composting reactor: 12 mm, 
(b) minimum temperature in all material in the reactor: 70 °C; and  
(c) minimum time without interruption: 60 minutes. 
The minimum requirements set out in points (b) and (c) of the first subparagraph 
shall also apply to Category 2 material which is composted in accordance with 
Article 13(e)(ii) of the Animal By-products Regulation. 
 
CHAPTER II 
Alternative transformation parameters for biogas and composting plant 
1. The competent authority may authorise the use of other standardised transformation 
parameters provided an applicant demonstrates that such parameters ensure adequate 
reduction of biological risks. That demonstration shall include a validation, which 
shall be carried out in accordance with points (a) to (f): 
(a) Identification and analysis of possible hazards, including the impact of input 
material, based on a full description of the transformation conditions and 
parameters. 
(b) A risk assessment, which evaluates how the specific transformation conditions 
referred to in (a) are achieved in practice under normal and atypical situations; 
(c) Validation of the intended process by measuring the reduction of 
viability/infectivity of: 
(i) endogenous indicator organisms duri ng the process, where the indicator 
is: 
– consistently present in the raw material in high numbers, EN 64   EN – not less heat resistant to the leth al aspects of the transformation 
process, but also not significantly more resistant than the pathogens 
for which it is being used to monitor, 
– relatively easy to quantify and relatively easy to identify and to 
confirm; or 
(ii) a well-characterised test organism or virus, during exposure, introduced 
in a suitable test body into the starting material. 
(d) The validation of the intended process referred to in (c) must demonstrate that 
the process achieves the follo wing overall risk reduction: 
(i) for thermal and chemical processes by: 
– reduction of 5 log10 of Enterococcus faecalis or Salmonella 
Senftenberg (775W, H2S negative), 
– reduction of infectivity titre of thermo resistant viruses such as parvovirus by at least 3 log10, whenever they are identified as a relevant hazard; and 
(ii) as regards chemical processes also by: 
– reduction of resistant parasites such as eggs of ascaris sp. by at least 99,9 % (3 log10) of viable stages. 
(e) Designing a complete control programme including procedures for monitoring 
the functioning of the process referred to in (c). 
(f) Measures ensuring continuous monitoring and supervision of the relevant 
process parameters fixed in the control programme when operating the plant. 
Details on the relevant process parameters used in a biogas or composting plant 
as well as other critical control points must be recorded and maintained so that the owner, operator or their representative and the competent authority can 
monitor the operation of the plant. Records must be made available to the 
competent authority on request. Information relating to a process authorised 
under this point must be made available to the Commission on request. 
2. However, pending the adoption of rules as re ferred to in Article 15(2)(a) of the Animal 
By-products Regulation, the competent authority may authorise the use of specific requirements other than those laid down in this Section, provided that they guarantee an equivalent effect regarding the reduction of pathogens, for:  
(a) catering waste used as  the only animal by-product in a biogas or composting 
plant; and  EN 65   EN (b) mixtures of catering waste with the following materials: 
(a) manure; 
(b) digestive tract content sepa rated from the digestive tract; 
(c) milk; (d) milk-based products; 
(e) colostrum and colostrums products; 
(f) eggs; 
(g) egg products; and 
(h) materials referred to in Article 10(f) of the Animal By-products 
Regulation, which have undergone processing as defined in Article 
2(1)(m) of Regulation (EC) No 852/2004.  
3. Where manure, digestive tract content sepa rated from the digestive tract, milk, milk-
based products, colostrum, colostrum products, eggs and egg products or animal by-products and derived products referred to in Article 10(f), which have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 and in Article 10(g) of the Animal By-products Regulation 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 Section provided that it: 
(a) does not consider that those material present a risk of spreading any serious 
transmissible disease; 
(b) considers that the residues or compost are unprocessed material and obliges 
operators to handle them in accordance with the Animal By-products 
Regulation and with this Regulation. 
4. 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   
(a) in accordance with point 1; 
(b) in accordance with points 2 and 3, only within the Member State where those 
parameters have been authorised. 
 
CHAPTER III 
Standards for digestion residues and compost EN 66   EN Representative samples of the digestion residues or compost taken during or immediately 
after transformation at the biogas plant or composting at the composting plant in order to monitor the process must comply with the following standards:  
 
Escherichia coli: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;  
 
or  
 
Enterococaceae: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;  
 
and  
 
Representative samples of the digestion residues or compost taken during or on withdrawal 
from storage must comply with the following standards:  
 
Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0  
 
where:  
 n = number of samples to be tested; 
 
m = threshold value for the number of bacteria; the result is considered satisfactory if the 
number of bacteria in all samples does not exceed m; 
 
M = maximum value for the number of bacteria; th e result is considered unsatisfactory if the 
number of bacteria in one or more samples is M or more; and  
 c = number of samples the bacterial count of wh ich may be between m and M, the sample still 
being considered acceptable if the bacterial count of the other samples is m or less.  EN 67   EN Digestion residues or compost, which does not co mply with the requirements set out in this 
Chapter, shall be resubmitted to transformati on or composting, in the case of Salmonella 
handled or disposed of in accordance with the instructions of the competent authority. 
 EN 68   EN ANNEX IX  
SPECIAL RULES ON RESEARCH, FEEDING AND  
COLLECTION AND DISPOSAL 
SECTION I 
SPECIAL RULES ON SAMPLES FOR RESEARCH AND OTHER PURPOSES  
CHAPTER I 
Research and diagnostic samples 
1. Without prejudice to national measures regarding trade in pathogens which are 
foreseen in Article 6 of Directive 92/118/EEC , the competent authority may 
authorise the transport, use and disposal  of research and diagnostic samples under 
conditions which ensure the control of risks to public and animal health.  
2. The consignment must be accompanied by a commercial document, which must 
specify: 
(a)  the description of the material and the animal species of origin;  
(b) the category of the material; 
(c)  the quantity of the material; (d)  the place of origin and the place of dispatch  of the material; 
(e) the name and the address of the consignor; (f) the name and the address of the consignee. 
3. 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 
presence of the materials under their control, in particular by way of the application of good laboratory practice. 
4.  Any subsequent use of research and diagnostic samples for purposes other than those 
referred to in Annex I No. 44 shall be prohibited. 
5. 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: 
(a)  as waste by incineration or co-incineration; 
(b) in case of animal by products or derived products referred to in Article 8 (a) 
(iv), (c) and (d), Article 9 and Article 10 of the Animal By-products  Regulation 
which are part of cell cultures, laborato ry kits or laboratory samples, by a 
treatment  under conditions which are at least equivalent to a validated method EN 69   EN in steam autoclaves45 and subsequent disposal as waste or waste water in 
accordance with relevant Union legislation. 
6.  Users that handle research and diagnostic samples shall keep a register of 
consignments received under this Chapter. The register shall include the information 
referred to in point 2 and the date and method of disposal of the samples and of any derived products.   
7.  By way of derogation from Article 48 (1) to (4) of the Animal By-products 
Regulation, research and diagnostic samples which consist of materials referred to in 
the first paragraph of Article 48(1) or in  Article 48(3) may be sent to another 
Member State without a prior authorisation of the competent authority of that Member State for the receipt,  and without information by means of the TRACES 
system. 
8. By way of derogation from points 2, 5 and 6, 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.  
CHAPTER II 
Trade samples and display items  
1.  Trade samples and display items  may only be transported, used and disposed of in 
accordance with points 1 to 4 and 7 of Chapter I.  
2. Unless trade samples are kept for reference purposes, they shall be, after the 
particular studies or analyses have  been concluded:   
(a) re-dispatched to the Member State of origin; 
(b)  dispatched to another Member State or third country, if such dispatch has been 
authorised by the competent authority of the third country of destination in 
advance; or 
(c)  disposed of or used in accordance with Articles 12 to 14 of the Animal By-
products Regulation. 
3. After the exhibition or after the artistic activity has been concluded, display items 
shall be re-dispatched to the Member State of origin, dispatched or disposed of, in 
accordance with points 2(a) to (c). 
SECTION II 
SPECIAL FEEDING RULES 
                                                
 
45 CEN No.EN 285: 2006 + A2:2009:E Sterilization - Steam Sterilizers - Large Sterilizers, as last amended. EN 70   EN CHAPTER I 
General requirements 
Animal by-products may be fed  to the animals referred to in Article 18(1)(d), (f), (g) and (h)  
of the Animal By-products Regulation at least under the following conditions, in addition to 
any conditions laid down by the competent authority in accordance with Article 18(1) of the 
same Regulation: 
1. The animal by-products shall be transported to the users or to collection centres in 
accordance with Chapters I and III of Section I of Annex XI . 
2. Collection centres shall be registered by the competent authority, provided that: 
(a) they comply with the requirements of Section V of Annex XII, and 
(b) they have adequate facilities for destroying unused material, or send it to an 
approved processing plant or to an approved incineration or co-incineration 
plant in accordance with this Regulation. 
3. Member States may authorise the use of a processing plant for Category 2 material as 
a collection centre. 
4. Operators of collection centres supplying material, other than animal by-products 
originating from aquatic animals and from aq uatic invertebrates, to final users must 
ensure that it undergoes one of the following: 
(a) denaturing with a solution of a colouring agent. The solution must be of such a 
strength that the colouring on the stained material is clearly visible and does 
not disappear when the coloured materials are subject to freezing or chilling, and the whole surface of all pieces of material have been covered with a solution as aforesaid either by immersing the material in, or spraying or 
otherwise applying the solution; 
(b) sterilisation by boiling or steaming under pressure until every piece of material 
is cooked throughout; or 
(c) any other handling or treatment authorised by the competent authority 
responsible for the operator. 
CHAPTER II 
Feeding of certain species in feeding stations 
1. The competent authority may authorise the use of Category 1 material referred to in 
Article 18(2)(b) of the Animal By-products Regulation for the feeding of the following 
endangered and protected species in feeding stations under the following conditions: 
(a) The material is fed to:  EN 71   EN (i) one of the following species of necrophagous birds in the following 
Member States: 
 
Name of the Member State  Animal species 
Bulgaria bearded vulture ( Gypaetus barbatus ) 
black vulture ( Aegypius monachus ) 
Egyptian vulture ( Neophron percnopterus ) 
griffon vulture ( Gyps fulvus ) 
golden eagle ( Aquila chrysaetos ) 
imperial eagle ( Aquila heliaca ) 
white-tailed eagle ( Haliaeetus albicilla ) 
black kite ( Milvus migrans ) 
red kite ( Milvus milvus ) 
Cyprus black vulture ( Aegypius monachus ) 
griffon vulture ( Gyps fulvus ) 
France black vulture ( Aegypius monachus ) 
Egyptian vulture ( Neophron percnopterus ) 
bearded vulture ( Gypaetus barbatus ) 
griffon vulture ( Gyps fulvus ) 
golden eagle( Aquila chrysaetos ) 
white-tailed eagle  (Haliaeetus albicilla ) 
red kite ( Milvus milvus ) 
black kite ( Milvus migrans ) 
Greece bearded vulture ( Gypaetus barbatus ) 
Egyptian vulture ( Neophron percnopterus ) 
griffon vulture ( Gyps fulvus ) 
black vulture ( Aegypius monachus ) EN 72   EN golden eagle ( Aquila chrysaetos ) 
imperial eagle ( Aquila heliaca ) 
white-tailed eagle ( Haliaeetus albicilla 
black kite ( Milvus migrans ) 
Italy bearded vulture ( Gypaetus barbatus ) 
black vulture ( Aegypius monachus ) 
Egyptian vulture ( Neophron percnopterus ) 
griffon vulture ( Gyps fulvus ) 
golden eagle ( Aquila chrysaetos ) 
black kite ( Milvus migrans ) 
red kite ( Milvus milvus ) 
Portugal black vulture ( Aegypius monachus ) 
griffon vulture ( Gyps fulvus ) 
Egyptian vulture ( Neophron percnopterus ) 
golden eagle ( Aquila chrysaetos ) 
Spain bearded vulture ( Gypaetus barbatus ) 
black vulture ( Aegypius monachus ) 
Egyptian vulture ( Neophron percnopterus ) 
griffon vulture ( Gyps fulvus ) 
golden eagle ( Aquila chrysaetos ) 
Spanish imperial eagle ( Aquila adalberti ) 
black kite ( Milvus migrans ) 
red kite ( Milvus milvus ) 
Slovakia imperial eagle ( Aquila heliaca ) 
white-tailed eagle ( Haliaeetus albicilla ) 
golden eagle ( Aquila chrysaetos ) 
black kite ( Milvus migrans ) EN 73   EN red kite ( Milvus milvus ) 
 
or 
(ii) one of the species of the order carnivora which are listed in Annex II to 
Directive 92/43/EEC, in special area s of conservation which have been 
set up under that Directive; or 
(iii) one of the species of the orders falconiformes or strigiformes, which are 
listed in Annex I to Directive 2009/147/EC, in special protection areas 
which have been set up under that Directive; 
(b) The competent authority has granted an authorisation to the operator  
responsible for the feeding station.  
The competent authority shall grant such authorisations provided  
(i) the feeding is not used as an alternative way of disposal of specified 
risk materials or fallen ruminant stock containing them posing a TSE 
risk; 
(ii) an appropriate surveillance system for TSEs as laid down in Regulation 
(EC) No 999/2001 is in place involving regular laboratory testing of samples for TSE; 
(c) The competent authority ensures coordination with any other competent 
authorities responsible for the supervision of the requirements laid down in the 
authorisation; 
(d) The competent authority is 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; 
(e) The authorisation granted by the competent authority: 
(i) refers to and names the species actually concerned; 
(ii) describes in detail the location of the feeding station in the 
geographical area where feeding shall take place; and 
(iii)  is immediately suspended in case of: 
- a suspected or confirmed link to the spread of TSE until the risk 
can be excluded; or 
- non-compliance with any of the rules provided for in this 
Regulation. 
(f) The operator responsible for the feeding shall: EN 74   EN (i) dedicate an area to the feeding that is enclosed and to which access is 
limited to animals of the species to be conserved, if appropriate by 
fences or by other means which correspond to the natural feeding 
patterns of those species; 
(ii) ensure that eligible  bodies  of bovine animals and at least 4 % of 
eligible bodies  of ovine and caprine animals intended to be used for 
feeding are tested prior to that use with a negative result, in the TSE 
monitoring programme carried out in accordance with Annex III to 
Regulation (EC) No 999/2001 and, if applicable, in accordance with a 
decision adopted in accordance with the second subparagraph of Article 6(1b) of the same Regulation; and 
(iii) keep records at least of the number, nature, estimate weight and origin 
of the carcases of the animals used for feeding, the date of the feeding, the location where feeding took place and if applicable, the results of 
the TSE tests. 
2. When a  Member State applies to the Commission  to be included into the list under 
point 1(a) , it shall submit:  
(a) a detailed justification for the extension of the list to certain species of 
necrophagous birds in this Member State, including an explanation of the 
reasons why it is necessary to feed such birds with Category 1 material instead 
of with Category 2 or Category 3 material; and 
(b) an explanation of the measures which will be taken in order to ensure 
compliance with point 1. 
CHAPTER III 
Feeding of wild animals outside feeding stations 
The competent authority may authorise the use of Category 1 material referred to in Article 
18(2)(b) of the Animal By-products Regulation outside feeding stations, if appropriate 
without prior collection of the dead animals, for feeding to wild animals referred to in point 1(a) of Chapter II under the following conditions: 
1. The competent authority is 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; 
2. The competent authority identif ies, within the authorisation,  holdings or herds 
within  a geographically defined feeding zone under the following conditions: 
(a) The feeding zone does not extend to areas where intensive farming of 
animals takes place; EN 75   EN (b) Farmed animals in holdings or herds in  the feeding zone are under the 
regular surveillance of an official veterinarian regarding the prevalence 
of TSE and of diseases transmissible to humans or animals; 
(c) Feeding is immediately suspended in case of: 
(i) a suspected or confirmed link to the spread of TSE in a holding or 
herd,  until the risk can be excluded; or 
(ii) a suspected or confirmed outbreak of a serious disease 
transmissible to humans or animals in a holding or herd,  until the 
risk can be excluded; or 
(ii) non-compliance with any of the rules provided for in this 
Regulation; 
(d) The competent authority specifies, within the authorisation:  
(i) appropriate measures to prevent the transmission of TSE and of 
transmissible diseases from the dead animals to humans or other 
animals, such as measures targeted at the feeding patterns of the species to be conserved, seasonal feeding restrictions, movement 
restrictions for farmed animals and other measures intended to 
control possible risks of transmission of a disease communicable to humans or animals, such as measures relating to species present in the feeding zone for the feeding of which the animal by-products are not used; 
(ii) the responsibilities of persons  or entities in the feeding zone who 
are assisting with the feeding or responsible for farmed animals, in 
relation to the measures referred to under point (i); 
(iii) the conditions for the impositio n of penalties as referred to in 
Article 53 of the Animal By-products Regulation which are 
applicable to infringements of measures referred to under point (i) 
by the persons or entities referred to under point (ii); 
(e) In case the feeding is carried out  without prior collection of the dead 
animals, an estimation of the likely mortality rate of farmed animals in 
the feeding zone and of the likely feeding requirements of the wild 
animals  has been carried out, as a basis for the assessment of the 
potential risks of disease transmission. 
 
CHAPTER IV 
Feeding of zoo animals with Category 1 material EN 76   EN The competent authority may authorise the use of Category 1 material referred to in Article 
18(2)(a) for the feeding of zoo an imals under the following conditions: 
(a) The competent authority has granted an authorisation to the operator  
responsible for the feeding. The competent authority shall grant such 
authorisations provided: 
(i) the feeding is not used as an alternative way of disposal of specified 
risk materials or fallen ruminant stock containing them posing a TSE 
risk; 
(ii) when Category 1 material referred to in Article 8(b)(ii) of the Animal 
By-products Regulation which originates from bovine animals is used, 
an appropriate surveillance system for TSEs as laid down in Regulation 
(EC) No 999/2001 is in place involving regular laboratory testing of 
samples for TSE; 
(b) The authorisation granted by the competent authority is immediately suspended 
in case of: 
(i) a suspected or confirmed link to the spread of TSE until the risk can be 
excluded; or 
(ii) non-compliance with any of the rules provided for in this Regulation; 
(c) The operator responsible for the feeding shall: 
(i) store the material to be used for the feeding and carry out the feeding in 
an enclosed and fenced area to ensure that no carnivorous animal other than the zoo animals for which the au thorisation has be en granted have 
access to the material for the feeding; 
(ii) ensure that ruminant animals intended to be used for feeding are 
included in the TSE monitoring programme carried out in accordance 
with Annex III to Regulation (EC) No 999/2001 and, if applicable, in accordance with a decision adopted in accordance with the second subparagraph of Article 6(1b) of the same Regulation ; and 
(iii) keep records at least of the number, nature, estimated weight and origin 
of the bodies  of the animals used for feeding, the results of the TSE 
tests and the date of the feeding. 
 
SECTION III 
SPECIAL RULES ON COLLECTION AND DISPOSAL 
CHAPTER I 
Special disposal rules for animal by-products EN 77   EN 1. 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 the Animal By-products Regulation, 
such disposal may take place: 
(a) by burning or burial on the premises on which the animal by-products 
originate; 
(b) in an authorised landfill as referred to  in Article 3 point 21 of the Animal By-
products Regulation; or 
(c) by burning or burial at a site which minimises the risk to animal and public 
health and the environment, provided that the site is located within a range of 
distance sufficient to enable the comp etent authority to manage the prevention 
of the risk to animal and public health and the environment; 
2. The burning of animal by-products on the sites referred to in Article 19(1)(b), (c) and 
(e) of the Animal By-products Regulation must be carried out in such a way to ensure 
that they are burnt: 
(a) on a properly constructed pyre and the animal by-products reduced to ash; 
(b) without endangering human health; 
(c) without using processes or methods which could harm the environment, in 
particular through risks to water, air, soil and plants and animals or through 
noise or odours; 
(d) under conditions which ensure that any resulting ash is disposed of by burial in 
an approved landfill. 
3. The burial of animal by-products in the sites laid down in Article 19(1)(a), (b), (c) and 
(e) of the Animal By-products Regulation must  be carried out to ensure that they are 
buried: 
(a) in such a way that carnivorous or omnivorous  animals cannot gain access to 
them; and 
(b) in an authorised landfill as referred to  in Article 3 point 21 of the Animal By-
products Regulation; or in another site without endangering human health and 
using processes or methods which do not harm the environment, in particular 
through risks to water, air, soil and plants and animals, or through noise or 
odours. 
4. In the case of disposal in accordance with Article 19(1)(a), (b), (c) and (e) of the 
Animal By-products Regulation, movement of the animal by-products from the place of origin to the place of disposal must be carried out in such a way that: 
(a) the animal by-products are transported in secure, leak-proof containers or 
vehicles; 
(b) the loading and unloading of the animal by-products is supervised by the 
competent authority, if appropriate; EN 78   EN (c) the vehicle wheels are disinfected upon leaving the site of origin; 
(d) containers and vehicles used for transporting animal by-products are 
thoroughly cleansed and disinfected after unloading of the animal by-products; 
and 
(e) adequate escorts for the vehicles, leak testing and double covering are 
provided, if appropriate. 
CHAPTER II 
Burning and burial of animal by-products in remote areas  
The maximum percentage as referred to in Article 19(2) of the Animal By-products 
Regulation shall not exceed the following: 
(a) 10% of the bovine population of the Member State concerned. 
(b) 15 % of the ovine and caprine population of the Member State concerned; and 
(c) 10% of the porcine population of the Member State concerned. 
CHAPTER III 
Burning and burial of bees and apiculture products 
In the case of bees and apiculture by-products referred to in Article 19(1)(f) of the Animal 
By-products Regulation, the competent authority may authorise disposal by burning or burial 
on site, provided that all necessary measures ar e taken to ensure that the burning or burial 
does not endanger animal or human health or the environment.  
SECTION IV 
DISPOSAL BY OTHER MEANS 
For a transitional period until 31 December 2012, Member States may authorise the 
collection, transport and disposal of Category 3 materials referred to in Article 10(f) of the Animal By-products Regulation by means other than burning or burial on site, as referred to in Article 19(1)(d) of the Animal By-products Regulation, provided that: 
(a) 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. 
(b) The materials are collected, transported and disposed of by means which 
prevent the transmission of unacceptable risks to public and animal health. EN 79   EN (c) 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.  
 EN 80   EN ANNEX X  
 
STANDARD FORMAT FOR APPLICATIONS  
FOR ALTERNATIVE METHODS 
SECTION I 
GENERAL PROVISIONS 
1. The standard format laid down in Section II shall apply to applications for the 
authorisation of alternative methods which are submitted by interested parties or by 
Member States, in accordance with Article 20 of the Animal By-products Regulation. 
2. National contact points which are designated by Member States shall provide 
information on the competent authority responsible as referred to in Article 20(2) of the Animal By-products Regulation to interested parties. The Commission shall 
publish a list of national contact points on its website.  
SECTION II 
STANDARD FORMAT 
CHAPTER I 
Language regime 
1. Applications shall be submitted in one of the official languages of the European Union 
as defined in Article 1 of Regulation 1/1958. 
2. Interested parties that submit their applic ations in a language other than English shall 
validate the official translation of their a pplication, which EFSA will provide, prior to 
the assessment. The period referred to in Article 20(5) of the Animal By-products 
Regulation shall only start once the interested party has validated the official translation. 
CHAPTER II 
Content of applications 
1. Applications shall contain sufficient information on the following points, in order to 
allow EFSA to assess the safety of their proposed alternative method: 
(a) the categories of animal by-products which are supposed to be submitted to the 
alternative method, by reference to the categories referred to in Articles 8,9, 
and 10 of the Animal By-products Regulation; EN 81   EN (b) the identification and characterisati on of risk materials according to the 
following principles: 
Significant risk materials should be identified separately. For each material, the 
likelihood of human and animal exposure under normal and emergency/ 
abnormal operating conditions should be assessed. In case of significant exposure, the potential risk should be assessed. 
(c) the agent risk reduction according to the following principles: 
The risk reduction for human and animal health which can be achieved by the 
process should be estimated on the basis of direct measurements. In case no direct measurement is available, modelling or extrapolation from other 
processes may also be used. In order to demonstrate effective risk reduction, 
the identified hazard (e.g. Salmonella) should be quantified both in the input 
(raw) material and in the resulting output material. For the purpose of this document output material comprises any end-products and by-products deriving from the process. Estimates should be accompanied by evidence. This includes – for measurements – information on the methodology used 
(sensitivity and reliability of the method s used, nature of samples which have 
been analysed and evidence that samples are representative (relevant real 
samples, number of tests performed). If surrogates for prion measurement are used, an explanation should be given of their relevance. In any case it is necessary to provide an evaluation of  the validity with the uncertainties 
involved. 
(d) the risk containment according to the following principles: 
The likely effectiveness of the technical measures used to ensure that the risks 
are contained should be analysed. This analysis should reflect normal and abnormal/ emergency operating conditions including a breakdown of the 
process. Monitoring and surveillance procedures to demonstrate containment 
should be specified. If full containmen t is not achievable, an assessment is 
required of any potential risk. 
(e) the identification of interdependent processes according to the following 
principles: 
Possible indirect impacts which may influence the risk reduction capacity of a particular process should be evaluated. Indirect impacts may arise from transport, storage and safe disposal of end-products and by-products of a process. 
(f) the intended end use of the products according to the following principles: 
The intended end use of products and by-products of a process should be 
specified. The likely risks involved should be calculated from the risk 
reduction estimated in accordance with  (c), which may arise to human and 
animal health. 
 EN 82   EN 2. Applications shall be submitted with do cumentary evidence, in particular a flow 
diagram showing the functioning of the process, the evidence indicated under point 
(1c), as well as other evidence aiming to substantiate the explanation given under the 
framework set out under point 1. 
3. Applications shall include a contact address for the interested party, which shall 
include indications of 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. 
 
 EN 83   EN  
ANNEX XI  
 
COLLECTION, TRANSPORT AND TRACEABILITY 
SECTION I 
COLLECTION AND TRANSPORT 
CHAPTER I 
Vehicles and containers 
1. As from the starting point referred to in Article 4(1) of the Animal By-products 
Regulation,  animal by-products and derived products must be collected and 
transported in sealed new packaging or co vered leak-proof containers or vehicles. 
2. 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 of 
Regulation (EC) No 183/2005, must be mainta ined in a clean condition. In particular, 
they must be, unless they are dedicated to the carriage of particular animal by-products or derived products in a way which avoids cross-contamination: 
(a) clean and dry before use, and 
(b) cleaned, washed and/or disinfected after each use to the extent necessary  to 
avoid cross-contamination . 
3. 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: 
(a) for the carriage of different animal by-products or derived products provided 
that they are thoroughly  cleaned and disinfected, if appropriate,  between the 
different uses in a manner which prevents cross-contamination 
(b) for the carriage of animal by-products or derived products referred to in Article 
10(f) of the Animal By-products Regulation, following their use for the carriage of products intended for human consumption, provided the competent authority has authorised such use under conditions which prevent cross-contamination. 
4. Packaging material must be disposed of, by incineration or by other means in 
accordance with Union legislation. EN 84   EN CHAPTER II  
Temperature conditions 
1 The transport of animal by-products destined for the production of feed material or 
raw pet food 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 in accordance with Article 2(1)(b) of the Animal By-products Regulation, at a maximum of  7°C, unless they are used for feeding purposes 
in accordance with Ch apter II of Annex IV,  to avoid any risk to animal or public 
health. 
2. Unprocessed Category 3 material destined for the production of feed material or pet 
food must be stored and transported chilled, frozen or ensiled, unless: 
(a) it is processed within 24 hours after collection or after the end of storage in 
chilled or frozen form, if the subsequent transport takes place in means of 
transport in which the storag e temperature is maintained; 
(b) in the case of milk or derived products from milk which have not been subject 
to any of the treatments referred to in Chapter IV of Section II of Annex XIV, 
it is transported chilled and in insulated containers, unless risks can be mitigated by other measures, due to the characteristics of the material . 
3 The design of vehicles used for refrigerated transport must ensure the maintenance of 
an appropriate temperature throughout tran sport, and allow that temperature to be 
monitored. 
CHAPTER III 
Derogation for collection and transport of milk, milk-based products and milk-derived 
products, defined as Category 3 material 
Chapter I shall not apply to the collection and transportation of milk products, milk based 
products and milk derived products, defined as Category 3 material, by operators of milk-
processing establishments which have been approved in accordance with Article 4 of 
Regulation (EC) 853/2004, in case they are receiving products which they have previously delivered and which are returned to them, in particular from their customers. 
CHAPTER IV 
Derogation for collection and transport of manure 
By way of derogation from Chapter I, the co mpetent authority may authorise the collection 
and transport of manure transported between tw o points located on the same farm or between 
farmers and users in the same Member State under other conditions which provide for the prevention of unacceptable risks to public and animal health. EN 85   EN  
SECTION II 
IDENTIFICATION 
1. All necessary measures must be taken to ensure that: 
(a) animal by-products and derived products are identifiable and kept separate and 
identifiable during collection where the animal by-products originate and 
during transportation; 
(b) a marking substance for the identification of animal by-products or derived 
products of a specific Category is only used for the Category for which its use is required under this Regulation, or is established or laid down pursuant to 
point 4; and 
(c) animal by-products and derived products are dispatched from one Member 
State to another Member State in packag ing, containers or vehicles which are 
prominently and, at least for the period of transport, indelibly colour-coded for 
displaying information as provided for in this Regulation on the surface or part 
of the surface of a packaging, container or vehicle, or on a label or symbol applied to them as follows: 
(i) in the case of Category 1 materials, using the colour black; 
(ii) in the case of Category 2 materials (other than manure and digestive 
tract content), using the colour yellow; 
(iii) in the case of Category 3 materials, using the colour green with a high 
content of blue to ensure that it is clearly distinguishable from the other 
colours; 
(iv) in the case of imported consignments, the colour referred to for the 
respective material under points (i) to (iii), as from the time when the consignment has passed the border inspection post of first entry. 
2. During transport and storage, a label attached to the packaging, container or vehicle 
must: 
(a) clearly indicate the Category of the animal by-products or of the derived 
products, and 
(b) bear the following words visibly and legibly displayed on the packaging, a 
container or vehicle, as applicable: 
(i) in the case of Category 3 material, “not for human consumption”; 
(ii) in the case of Category 2 material (other than manure and digestive 
tract content) and derived products fr om Category 2 material, “not for 
animal consumption”; however, when Category 2 material is intended 
for the feeding of animals referred to in Article 18(1) of the Animal By-EN 86   EN products Regulation under the conditions provided for or laid down in 
accordance with that Article, the label shall instead indicate “for feeding to …” completed with the name of the specific species of those 
animals for the feeding of whic h the material is intended; 
(iii) in the case of Category 1 material and derived products from Category 1 
material 
- in case they are destined to disposal, “for disposal only”; 
- in case they are destined to the manufacture of petfood, 'for 
manufacture of petfood only'; 
- in case they are destined to the manufacture of a derived product 
referred to in Article 36 of the Animal By-products Regulation, 'for 
manufacture of derived products only. Not for human or animal consumption or for ap plication to land'; 
(iv) in the case of gelatine produced from Category 3 material, ‘gelatine 
suitable for animal consumption’; 
(v) in the case of collagen produced from Category 3 material, “collagen 
suitable for animal consumption"; 
(vi) in the case of raw petfood, "as  petfood only"; 
(vii) in the case of fish and derived products from fish intended for feed for 
fish, treated and packaged before distribution, the name and address of the feed manufacturing establishment of origin, marked clearly and 
legibly, and  
- in the case of fishmeal from wild fish, bearing the words ‘contains 
wild fish only – may be used for the feeding of  farmed fish of all 
species'; 
- in the case of fishmeal from farmed fish, bearing the words 
‘contains farmed fish of the […] species only – may be used for the 
feeding of farmed fish of other fish species only'; 
(viii) in the case of blood products from equidae for purposes other than in 
feed, the words 'blood and blood products from equidae. Not for human or animal consumption'; 
(ix) in the case of horns, hooves and other materials for the production of 
organic fertilisers and soil improver s referred to in Chapter XII of 
Annex XVII, the words 'not for human and animal consumption'; 
(x) in the case of organic fertilisers and soil improvers ‘organic fertilisers 
or soil improvers/ no grazing of  farmed animals or use of crops as 
herbage during at least 21 days following application' ; EN 87   EN (xi) in the case of material used for fe eding in accordance with Chapter I of 
Section II of Annex IX, the name and the address of the collection centre, 
and the indication ‘not for human consumption'; 
(xii) in the case of manure and digestive tract content, “manure”; 
(xiii) in the case of intermediate pro ducts, on the outer packaging, bearing 
the words 'for medicinal products/veterinary medicinal products/ 
medical devices/ active implantable medical devices/ in vitro diagnostic 
medical devices/ laboratory reagents only'; 
(xiv) in the case of research and diagnostic samples, the words 'for research 
and diagnostic purposes', instead of the label text laid down in point 
(a); 
(xv) in the case of trade samples, the words 'trade sample not for human 
consumption', instead of the label text laid down in point (a); 
(xvi) in case of display items, the words 'display item not for human 
consumption', instead of the labe l text laid down in point (a) . 
However, the label referred to in point  (B)(ix) shall not be required for: 
(a) organic fertilisers and soil improver s in ready-to-sell packages of not 
more than 50 kg in weight for use by the final consumer, or  
(b) if authorised by the competent authority of the Member State where the 
organic fertiliser or soil improver is to be applied to land, in big bags of 
not more than 1000 kg in weight, if it is indicated on those packages or bags that they are not destined for application to land to which farmed 
animals have access. 
3. 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). 
4. Without prejudice to point 3 of Annex V to Regulation (EC) No 999/2001, 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 laid down for derived products in Section V of this Annex. 
5. 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. 
6. However: 
(a) points 1 and 2 shall not apply to  the identification of milk products, milk based 
products and milk derived products, defined as Category 3 material, by EN 88   EN operators of milk-processing establishments which have been approved in 
accordance with Article 4 of Regulation (EC) 853/2004, in case they are receiving  products which they have previously delivered and which are 
returned to them, in particular from  their customers; 
(b) the competent authority may authorise the identification of manure which is 
transported between two points located on the same farm or between farms and 
users located in the same Member State by other means, by way of derogation 
from points 1 and 2; 
(c) compound feeds as defined in Article 3(h) of Regulation (EC) No 767/2009  
which have been manufactured from animal by-products or from derived 
products and which are packaged and placed on the market as feed in accordance with Article 4 of Regulation (EC) No 767/2009 do not have to be 
identified in accordance with point 1 and they do not have to be labelled in 
accordance with point 2. 
 
SECTION III 
COMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES 
1. During transportation, a commercial document in accordance with the model set out in 
this Section, 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: 
(a) derived products from Category 3 material and organic fertilisers and soil 
improvers are supplied within the same Me mber State by retailers to final users 
other than business operators; and 
(b) milk products, milk based products and milk derived products which are   
Category 3 materials are collected and returned to operators of milk-processing 
establishments, which have been approved in accordance with Article 4 of 
Regulation (EC) No 853/2004, if those operators are receiving products, in particular from their customers, which they have previously delivered; and 
(c) compound feeds as defined in Article 3(h) of Regulation (EC) No 767/2009  
which have been manufactured from animal by-products or from derived 
products, are placed on the market packaged and labelled in accordance with Article 4 of Regulation (EC) No 767/2009. 
2. 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. EN 89   EN 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 as proof of the arrival of the consignment. 
3. Health certificates must be issued and signed by the competent authority. 
4. 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 
referred to in Article 4(1) of the Animal By-products Regulation,  during transportation 
within the European Union.  
 However, in addition to the authorisati on to transmit information by way of an 
alternative system as referred to in the second subparagraph of the third paragraph of 
Article 21 of the Animal By-products Regulation, the competent authority may 
authorise that  animal by-products and derived products which are transported  on its 
territory are accompanied by: 
(a) a different commercial document, in paper or in electronic form, provided that 
such commercial document contains the information referred to in point (f) of 
the notes under point 6 of this Section;  
(b) a commercial document in which  the quantity of the material is expressed in 
weight or volume  of the material. 
5. 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. 
6. Model commercial document  
Notes 
(a) Commercial documents shall be produced, according to the layout of the model 
appearing in this Section. It shall contain,  in the numbered orde r that appears in the 
model, the attestations that are required for the transportation of animal by-products 
and derived products. 
(b) It shall be drawn up in one of the official languages of the Member State of origin 
and of the Member State of destination, as appropriate. However, it may also be drawn up in other official Union languages, if accompanied by an official translation 
or if previously agreed by the competent authority of the Member State of 
destination.  
(c) The original of each commercial document shall consist of a single sheet of paper, 
both sides, or, where more text is required it shall be in such a form that all sheets of 
paper needed are demonstrably part of an integrated whole and indivisible. 
(d) If for reasons of identification of the items of the consignment, additional sheets of 
paper are attached to the commercial document, these sheets of paper shall also be considered as forming part of the original document by the application of the 
signature of the person responsible for the consignment, on each of the pages. EN 90   EN (e) When the commercial document, including additional sheets of paper referred to in 
(d), comprises more than one page, each page shall be numbered – (page number) of 
(total number of pages) – at the bottom and shall bear the code number of the 
document that has been designated by the responsible person at the top. 
(f) The original of the commercial document must be completed and signed by the 
responsible person.  
The commercial document must specify: 
(i) the date on which the material was taken from the premises; (ii) the description of the material, incl uding the identification of the material 
according to one of the Categories referred to in Articles 8, 9 and 10 of the 
Animal By-products Regulation, the animal species and the specific reference 
to the applicable point in Article 10 for Category 3 material and products derived therefrom which are destined for use as feed material for farmed animals and, if applicable, the ear-tag number of the animal; 
(iii) the quantity of the material, in volu me, weight or number of containers;  
(iv) the place of origin of the material, from where the material is dispatched; 
(v) the name and the address of the carrier of the material; 
(vi) the name and the address of the rece iver and, if applicable, its approval or 
registration number, which has been issued under the Animal By-products 
Regulation or Regulations (EC) No 852/2004 or No 853/2004, as applicable; and 
(vii) if appropriate, the approv al or registration number of the establishment or plant 
of origin, which has been issued under the Animal By-products Regulation or 
Regulations (EC) No 852/2004 or No 853/2004, as applicable, and the nature and the methods of the treatment. 
(g) The colour of the signature of the responsible person shall be different to that of the 
printing. 
(h) The document reference number and the local reference number shall only be issued 
once for the same consignment.  EN 91   EN  
Commercial document 
For the transport of animal by-products and derived products not intended for human 
consumption in accordance with the Animal By-products Regulation within the European Union 
 EN 92   EN EUROPEAN COMMUNITY Commercial document
I.1. Consignor I.2. Document reference number I.2.a.Local reference number:
Name
I.3. Central Competent Authority
Address  
Postal code I.4. Local Competent Authority
I.5. Consignee 
Name
Address
Postal code
I.8.Country of origin  ISO code I.9. Region of origin Code I.10. Country of destination  ISO code I.11. Region of destination Code
I.12. Place of origin I.13. Place of destination
Establishment Establishment Other
Name Approval number Name Approval number
Address Address
Postal code Postal code
I.14. Place of loading I.15. Date and time of departure
Postal code
I.16. Means of transport I.17. Transporter
Aeroplane Ship Railway wagon Name Approval number
Road vehicle Other Address
Identification:
Postal code Member State
I.18. Description of commodity I.19. Commodity code (CN code)
I.20. Number/quantity
I.21 Temperature of products I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/seal number I.24.Type of packaging
I.25. Commodities certified for
Animal feedingstuff Technical use Other
I.26. Transit through third country I.27. Transit through Member States
Third country  ISO code Member State  ISO code
Exit point Code Member State  ISO codeEntry point BIP unit no.: Member State  ISO code
I.28. Export
Third country  ISO codeExit point Code
I.31. Identification of the commodities
Approval number of establishments
Species Nature of commodity Category Treatment type Manufacturing plant Batch number
(Scientific name)Part I : Details of consignment presented
I.29.
I.30.I.7.I.6.
 EN 93   EN EUROPEAN UNION    Animal by-products/derived products not intended for 
human consumption  
 
 II.a. Document reference 
number  II.b. Local reference number  
II. Declaration by the consignor 
I, the undersigned, declare that:  
II.1. the information in Part I is factually correct ; 
II.2. all precautions have been taken to avoid contamination of the animal by-products or derived products with 
pathogenic agents and cross-contam ination between various Categories . 
 Part II: Declaration Signature 
 Done at on   (place) (date)     (signature of the responsible person/consignor) 
   
 (name, in capital letters) 
 
 
 
 
 
 
 Notes 
Part I: y Box reference I.9 and I.11: if appropriate. 
y Box reference I.12 and I.13: approval number or registration number. 
y Box reference I.14: complete if different from ‘I.1. Consignor’. 
y Box reference I.31: 
Animal species: For Category 3 material and products derived therefrom destined for use as feed material. 
Nature of commodity : Enter a commodity chosen among the following list: 'apiculture products’, 
‘blood products’,
 ‘blood’, ‘bloodmeal’, 'derived products' ( unless beyond the end point, in which case no 
commercial document is required ), ‘digestion residues’, ‘digestive tract content’, ‘dogchews’ ( unless 
beyond the end point, in which case  no commercial document is required ), ‘fishmeal’, 'flavouring innards', 
‘gelatine’, ‘greaves’, ‘hides and skins’( unless beyond the end point, in which case no commercial document 
is required ), ‘hydrolysed proteins’, ‘organic fertilizers’, ‘petfood’, ‘processed animal protein’, ‘processed 
petfood’ ( unless beyond the end point, in which case no commercial document is required ), ‘raw petfood’, 
‘rendered fats’, ' compost ', 'processed manure', 'fish oil', 'milk products', 'centrifuge or separator sludge 
from milk processing'; 'dicalciumphosphate', 'tricalciumphosphate', 'collagen', 'egg products', 'serum of 
equidae', 'game trophies', 'wool' (unless beyond the end point, in which case no commercial document is 
required ), 'hair', pig bristles', 'feathers, 'animal by-products for processing'' . 
Category : Categories 1, 2 or 3. In case of Category 3, specify which letter from a to p (as under EN 94   EN Article 10 of Regulation (EC) No 1069/2009 ): 
In the case of animal by-products for use in raw petfood indicate 3a or 3b whether the animal by-products 
are referred to in Article 10(a) or (b) of Regulation (EC) No 1069/2009. 
In the case of hides and skins and products derived there from, indicate 3b(iii) or 3n whether the animal by-
products or derived products are referred to in Article 10 (b)(iii) or (n). 
Where the consignment is made of more than one Ca tegory, indicate the quantity and if applicable the 
number of containers per Category of materials. 
Treatment type : For treated hides and skins, which (a) are not fulfilling the requirements of Regulation 
(EC) No 853/2004 of 29 April 2004 laying down specific hygiene rules for food of animal origin or (b) 
have not undergone the complete process of tanning or (c) are not “wet blue”; or (d) are not “pickled pelts” 
or (e) are not limed (treated with lime and in brine at a pH of 12 to 13 for at least eight hours): enter 
treatment among the following: (a) dried; (b) dry-salted or wet-salted for at least 14 days prior to dispatch; 
(c) salted for seven days in sea salt with the addition of 2 % sodium carbonate; 
For Category  3 materials and derived products from Category 3 material destined for use in feed: if 
appropriate describe the nature and the methods of the treatment. Batch number : enter batch number or ear tag number, if applicable. 
The signature must be in a different colour to that of the printing
 EN 95   EN SECTION IV 
RECORDS 
CHAPTER I 
General provisions 
1. The records as laid down in Article 22 (1) of the Animal By-products Regulation for 
animal by-products and derived products, other than derived products which are 
placed on the market  in accordance with Article 4 of Regulation (EC) No 767/2009, 
shall contain: 
(a) a description of: 
(i) the animal species for Category 3 material and derived products 
therefrom, destined for use as feed material and, if applicable, in the 
case of whole carcasses and heads, the ear-tag number; 
(ii) the quantity of the material. 
(b) in the case of records kept by any person consigning animal by-products or 
derived products, the following information: 
(i) the date on which the material  was taken from the premises;   
(ii) the name and the address of the transporter and of the receiver and, if 
applicable, their approval or registration number. 
(c) in the case of records kept by any person transporting animal by-products or 
derived products, the following information: (i) the date on which the materi al was taken from the premises; 
(ii) the place of origin of the material,  from where the material is dispatched; 
(iii) the name and the address of the receiver and, if applicable, its approval 
or registration number. 
(d) in the case of records kept by any person receiving animal by-products or 
derived products, the following information: 
(i) the date of reception of the material; 
(ii)  the place of origin of the material,  from where the material is dispatched; 
(iii) the name and address of the transporter. 
2. By way of derogation from point 1, operators do not have to keep the information 
referred to in point 1(a), (b)(i), (c)(i) and (iii) and d(ii) and (iv) separately, if they keep EN 96   EN a copy of the commercial document laid down in Section III for each consignment and 
make this information available in conjun ction with the other information required 
under point 1. 
3. Operators of incineration plants and co-incineration plants shall keep records of the 
quantities and category of animal by-products and derived products incinerated or co-
incinerated, as applicable, and the date at which those operations were carried out.  
CHAPTER II 
Additional requirements in case of  
use for special feeding purposes  
In addition to the records required in accordance with Chapter I, operators shall keep the 
following records in relation to relevant material if animal by-products are used for special 
feeding purposes in accordance with Section II of Annex IX: 
1. in the case of final users,  the quantity used, the intended animals of destination and 
the date of use, and 
2. in the case of collection centers: 
(i) the quantity treated in accordance with point 4 of Chapter I of Section II 
of Annex IX; 
(ii) the name and address of each final user using  the material; 
(iii) the premises to which th e material is taken for use; 
(iv) the quantity dispatched, and 
(v) the date on which the material was dispatched. 
CHAPTER III 
Requirements in case of certain fur animals  
The operator of the farm referred to in Chapter II of Annex IV shall keep records at least of:  
(a) the number of furs and carcases of animals fed with materials originating of 
their own species; and 
(b) each consignment in order to ensu re the traceability of the material; 
CHAPTER IV 
Requirements for the application  
of certain organic fertilisers and soil improvers,to land EN 97   EN The person responsible for land to which organic fertilisers and soil improvers, other than the 
materials referred to in the second subparagraph of Chapter III of Annex IV are applied and to which farmed animals have access or from which herbage is cut for feeding to farmed 
animals, shall keep records for at least two years of: 
1. the quantities of organic fertilisers and soil improvers applied; 
2. the date on which and the places where organic fertilisers and soil improvers were 
applied to land; 
3. the dates, following application of the organic fertiliser or soil improver, on which 
livestock has been allowed to graze the land or on which the land has been cut for 
herbage to be used for feeding. 
CHAPTER V 
Requirements for fish by-products and feeding of fish 
Processing plants producing fishmeal or other feed originating from aquatic animals  must 
keep records in relation to: 
(a) the daily records of quantities produced; 
(b) the species of origin , including an indication whether the fish was caught  in 
the wild or produc ed in aquaculture . 
CHAPTER VI 
Requirements for the burial and burning of animal by-products 
In the case of burning or burial as provided for in Article 19 of the Animal By-products 
Regulation , the person responsible for burning or burial shall keep records of: 
(a) the quantities, categories and species of animal by-products buried or burned; 
(b) the date and place of burial and burning. 
CHAPTER VII 
Requirements for photogelatine 
Operators of approved photographic factories referred to in Chapter XII of Section II of 
Annex XVIII shall keep records detailing the purchases and uses of photogelatine, as well as 
the disposal of residues and surplus material.  
SECTION V 
MARKING OF CERTAIN DERIVED PRODUCTS EN 98   EN 1. 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: 
(a) GTH is added to derived products that have undergone a preceding sanitising 
thermal treatment at a core temperat ure of at least 80 °C and remain 
subsequently protected from re-contamination; and 
(b) all derived products contain homogenously throughout the substance a 
minimum concentration of at least 250 mg GTH per kg fat. 
2. 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. 
3. The marking with GTH shall not be required for: 
(a) liquid derived  products destined for biogas or composting plants; 
(b) derived products used for feeding to fur animals in accordance with Chapter II 
of Annex IV; 
(c) biodiesel produced in accordance with point D of Chapter II of Section IV of 
Annex VII; 
(d) derived products obtained in accordance with Article 12(a)(ii), 12(b)(ii) and 
Article 13(a)(ii), 13(b)(ii) and Article 16(e) of the Animal By-products 
Regulation, where such products are: 
(i) moved by a closed conveyer system, which may not be by-passed, and 
provided such a system has been authorised by the competent authority, 
from the processing plant for: 
- immediate direct incineration or co-incineration, or 
- immediate use in accordance with a method approved for Category 
1 and 2 animal by-products in accordance with Section IV of 
Annex VII or 
(ii) intended for purposes referred to in  Article 17 of the Animal By-products 
Regulation   which have been authorised by the competent authority. 
 EN 99   EN  
ANNEX XII  
 
REQUIREMENTS APPLICABLE TO CERTAIN  
APPROVED AND REGISTERED ESTABLISHMENTS AND PLANTS 
SECTION I 
GENERAL REQUIREMENTS  
CHAPTER I 
Co-existence on the same site 
The competent authority may approve more than one establishment or  plant on the same site, 
provided that the transmission of risks to public and animal health between the plants is 
excluded by their layout and the handling of animal by-products and derived products within 
the establishments or plants. 
 
CHAPTER II 
Prevention of cross-contamination within food businesses 
[…] 
 
SECTION II 
PROCESSING BY ALTERNATIVE METHODS  
[…] 
SECTION III 
MANUFACTURING OF PETFOOD 
Establishments or  plants manufacturing petfood as referred to in Article 24(1)(e) of the 
Animal By-products Regulation shall fulfil the following requirements: 
(a) they shall have adequate  facilities for storing and treating incoming material in 
complete safety; and EN 100   EN (b) they shall have adequate facilities for disposing of unused animal by-products 
remaining after the production of the products in accordance with this 
Regulation, or this material must be sent to a processing plant or , in the case of 
Category 3 material, to a biogas or composting plant in accordance with the 
Animal By-products Regulation and with this Regulation. 
 
SECTION IV 
MANUFACTURING OF ORGANIC FERTILISERS 
 AND SOIL IMPROVERS 
[…] 
SECTION V 
HANDLING OF ANIMAL BY-PRODUCTS 
 AFTER THEIR COLLECTION 
The requirements of this Section shall apply to the following operations involving the 
handling of animal by-products after their collectio n, as referred to in Article 24(1)(h) of the 
Animal By-products Regulation and to the storage of animal by-products, as referred to in 
Article 24(1)(i) of the same Regulation: 
(a) sorting; 
(b) cutting; 
(c) chilling; 
(d) freezing; 
(e) salting or other preservation processes; 
(f) removal of hides and skins; 
(g) removal of specified risk material; 
(h) operations involving the handling of an imal by-products which are carried out 
in compliance with obligations under Union veterinary legislation, such as 
post-mortem examination or the taking of samples; 
(i) hygienisation/pasteurisation of animal by-products destined for transformation 
into biogas or composting, prior to such transformation or composting in 
another establishment or plant in accordance with Annex VIII; 
 (j) sieving. EN 101   EN CHAPTER I 
General requirements 
1. Premises and facilities wher e intermediate operations ar e carried out must meet at 
least the following requirements. 
(a) They shall be adequately separated from thoroughfares through which 
contamination may be spread and from  other premises such as slaughterhouses. 
The layout of plants shall ensure the total separation of Category 1 and 
Category 2 material from Category 3 material respectively, from reception 
until dispatch, unless in a completely separate building. 
(b) The plant shall have a covered space to receive and dispatch  animal by-
products, unless the animal by-products are being discharged through 
installations which prevent the spreading of risks to public and animal health, such as through closed tubes for liquid animal by-products.  
(c) The plant shall be constructed in such a way that it is easy to clean and 
disinfect. Floors must be laid down in such a way as to facilitate the draining of liquids. 
(d) The plant must have adequate facilities including lavatories, changing rooms, 
washbasins for staff and, if appropriate, office space which can be made 
available to the staff perf orming official controls. 
(e) The plant shall have appropriate arrangements for protection against pests, 
such as insects, rodents and birds. 
(f) Where it is necessary for the purpose of achieving the objectives of this 
Regulation, plants shall have suitable te mperature-controlled storage facilities 
of sufficient capacity for maintaining animal by-products at appropriate 
temperatures and designed to allow the monitoring and recording of those 
temperatures. 
2. The plant shall have adequate facilities for cleaning and disinfecting the containers or 
receptacles in which animal by-products are received and for the vehicles, other than ships, in which they are transported. Ade quate facilities shall be provided for the 
disinfecting of vehicle wheels. 
CHAPTER II 
Hygiene requirements 
1. The sorting of animal by-products  shall be carried out in such a way as to avoid any 
risk of the propagation of animal diseases. 
2. All the time during storage, animal by-products  shall be handled and stored separately 
from other goods and in such a way as to prevent any propagation of pathogens. EN 102   EN 3. Animal by-products  shall be stored properly, including under appropriate temperature 
conditions, until re-dispatched. 
CHAPTER III 
Processing standards for hygienisation/ pasteurisation 
Hygienisation/ pasteurisation as referred to in poi nt (i) of the initial paragraph of this Section 
shall be carried out in accordance with the processing standards referred to in point 1(a) of 
Chapter I of Section I to Annex VIII. 
 
SECTION VI 
REQUIREMENTS FOR STORAGE OF DERIVED PRODUCTS 
CHAPTER I 
General requirements 
Premises and facilities must meet at least the following requirements. 
1. Premises and facilities storing derived pr oducts from Category 3 material shall not be 
at the same site as premises storing derived products from Category 1 or Category 2 
material, unless cross-contamination is prevented by way of the layout and 
management of the premises, such as by storage in completely separate buildings.  
2. The plant shall: 
(a) have a covered space to receive and dispatch the derived products, unless the 
derived products are 
(i) being discharged through installations which prevent the spreading of 
risks to public and animal health, such as through closed tubes for liquid 
products; or 
(ii) received in packaging, such as in big bags, or in covered leak-proof 
containers or means of transport; 
(b) be constructed in such a way that it is easy to clean and disinfect. Floors must 
be laid down in such a way as to facilitate the draining of liquids; 
(c) have adequate facilities including lava tories, changing rooms and washbasins 
for staff; and 
(d) have appropriate arrangements for protection against pests, such as insects, 
rodents and birds. EN 103   EN 3. The plant shall have adequate facilities for cleaning and disinfecting the containers or 
receptacles in which the derived products are received and the vehicles, other than 
ships, in which they are transported.  
4. Derived  products shall be stored pr operly until re-dispatched. 
CHAPTER II 
Specific requirements for storage of c ertain milk and milk-derived products 
1. The storage of the products referred to in Part II of Chapter IV of Section II of Annex 
XIV shall take place at an appropriate temperature to avoid any risk to public or 
animal health in a dedicated approved or registered storage establishment or  plant or 
in a dedicated, separate storage area within an approved or registered storage 
establishment or plant.  
2. Samples of the final products taken during storage or at the time of withdrawal from 
storage, shall at least comply with the microbiological standards set out in point 1 of 
Section I of Annex XIV. 
SECTION VII 
REGISTERED OPERATORS 
1. Operators of registered plants or establishments or other registered operators shall 
handle animal by-products and derived products under the following conditions: 
(a) Premises shall be constructed in a way permitting their effective cleaning and 
disinfection, where appropriate. 
(b) Premises shall have appropriate arrangements for protection against pests, such 
as insects, rodents and birds. 
(c) Installations and equipment shall be kept in hygienic condition, where 
necessary.  
(d) Animal by-products and derived products shall be stored under conditions 
preventing contamination. 
2. Registered operators transporting animal by-products or derived products, other than 
between premises of the same operator, shall in particular: 
(a) have information at their disposal wi th regard to the identification of their 
vehicles, which allows the verification of the use of the vehicles for the 
transport of animal by-products or derived products; 
(b) clean and disinfect their vehicles, as appropriate; 
(c) take all other necessary measures to prevent contamination and the spreading 
of diseases communicable to humans or animals. EN 104   EN 3. The provisions of this Section shall not apply to: 
(a) approved operators who are transporting animal by-products and derived 
products as an ancillary activity; and  
(b) to operators who have been registered for transport activities in accordance 
with Regulation (EC) No 183/2005.  
4. The competent authority may exempt operators handling or generating game trophies 
or other preparations referred to in Chapter VI of Annex XVII for private or non-
commercial purposes from the obligation to notify which is referred to in Article 
23(1)(a) of the Animal By-products Regulation. EN 105   EN  
ANNEX XIII  
 
OWN CHECKS AND HACCP 
[…] 
 EN 106   EN ANNEX XIV  
FEED MATERIALS 
SECTION I  
GENERAL REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE 
MARKET 
Microbiological standards for derived products  
The following standards shall apply to derived products, other than rendered fats and fish oil 
from the processing of animal by-products, when the processed animal protein, which is 
obtained during the same processing, is subject to sampling to ensure compliance with these standards: 
Samples of the final products taken during or on withdrawal from storage at the processing 
plant must comply with the following standards:  
Salmonella : absence in 25 g: n = 5, c = 0, m = 0, M = 0  
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g  
where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result is considered satisfactory if the 
number of bacteria in all samples does not exceed m;  
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the 
number of bacteria in one or more samples is M or more; and  
c = number of samples the bacterial count of which may be between m and M, the sample still 
being considered acceptable if the bacterial count of the other samples is m or less.  EN 107   EN SECTION II 
SPECIFIC REQUIREMENTS FOR PROCESSED ANIMAL PROTEIN AND OTHER 
DERIVED PRODUCTS 
 
CHAPTER I  
Specific requirements for processed animal protein 
A. Raw materials 
Only animal by-products which are Category 3 or products which are derived from such 
animal by-products, other than materials referred to in Article 10 (n), (o) and (p) of the Animal By-products Regulation may be used for the production of processed animal protein. 
B. Processing standards 
1. Processed animal protein of mammalian origin must have been submitted to 
processing method 1. 
 However,  
(a) porcine blood or fractions of porcine blood for the production of bloodmeal  
may be submitted instead to any of processing methods 1 to 5 or processing 
method 7 provided that in the case of processing method 7, a heat treatment throughout its substance at a temperature of 80 ° C has been applied. 
(b) processed animal protein of mammalian origin  
(i) may be submitted to any of the processing methods 1 to 5 or method 7, 
provided that it is subsequently disposed of or used as a fuel for combustion; 
(ii) in case it is exclusively destined for use in petfood, may have been 
submitted to any of the processing methods 1 to 5 or 7, provided that it 
is transported in dedicated containers that are not used for the transport 
of animal by-products or feedingstuffs for farmed animals, and provided it is consigned directly from a processing plant for Category 3 material to the petfood plant. 
2. Non-mammalian processed animal protein, with the exclusion of fishmeal, must have 
been submitted to any of processing methods 1 to 5 or 7. 
3. Fishmeal must have been submitted:  
(a) to any of the processing methods; or  
(b) to a method which ensures that the product complies with the microbiological 
standards set in Section I.  EN 108   EN C. Storage  
1. Processed animal protein must be packed and stored in new or sterilised bags or stored 
in properly constructed bulk bins or in storage sheds, if authorised by the competent 
authority.  
Sufficient measures must be taken to minimise condensation inside bins, conveyors or 
elevators.  
2. Products in conveyors, elevators and bins must be protected from casual 
contamination. 
3. Processed animal protein handling equipment must be maintained in a clean and dry 
condition and should have adequate inspection points so that equipment can be 
examined for cleanliness. All storage facilit ies must be emptied and cleaned regularly , 
to the extent necessary to prevent contamination. 
4. Processed animal protein must be kept dry. Leakages and condensation in the storage 
area must be prevented.  
CHAPTER II  
Specific requirements for blood products 
A. Raw material  
Only blood referred to in Article 10 a, b(i) and d of the Animal By-products Regulation may 
be used for the production of blood products.  
B. Processing standards  
Blood products must have been submitted to: 
(a) any of processing methods 1 to 5 or 7; or  
(b) a method which ensures that the blood product complies with the 
microbiological standards set out in Section I.  
CHAPTER III 
Specific requirements for rendered fats, fish oil and Category 3 fat derivatives 
A. Raw materials 1. Rendered fats 
Only Category 3 material, other than materials referred to in Article 10 (i), (j), (n), (o) and (p) 
of the Animal By-products Regulation, may be used for the production of rendered fat.  EN 109   EN 2. Fish oil 
Only Category 3 material referred to in Arti cle 10 (i) and (j) of the Animal By-products 
Regulation and Category 3 material of aquatic animal origin referred to in Article 10(e) and 
(f) of the Animal By-products Regulation may be used for the production of fish oil.  
B.  Processing standards  
Unless the fish oil or  rendered fats have been produced in accordance with Sections VIII or 
XII of Annex III to Regulation (EC) No 853/2004,  respectively,  rendered fats must be 
produced using any of the processing methods 1 to 5 or method 7, and fish oils may be 
produced using methods 1 to 7, as referred to in Section III of Annex VII, or fish oil may be produced in accordance with a method which ensures that the product complies with the 
microbiological standards set in point 1 of Section I. 
Rendered fats derived from ruminant animals must be purified in such a way that the 
maximum level of remaining total insoluble impurities does not exceed 0.15 % in weight. 
Fat derivatives from Category 3 rendered fats or from Category 3 fish oil shall be produced in 
accordance with one of the processing methods referred to in Section III of Annex VII.  
C. Hygiene requirements 
Where rendered fat or fish oil is packaged, it must be packaged in new containers or in 
containers that have been cleaned and disinfected if necessary for the prevention of contamination and all precautions must be taken to prevent its recontamination. Where bulk 
transport of the products is intended, the pipe, pumps and bulk tanks and any other bulk 
container or bulk road tanker used in the transportation of the products from the manufacturing plant either directly on to the ship or into shore tanks or direct to plants must 
be clean before use. 
CHAPTER IV 
Specific requirements for milk, colostrum and 
 certain other products derived from milk or colostrum 
PART I 
 
General requirements 
A. Raw material 
Only milk referred to in Article 10 (e) of the Animal By-products Regulation, other than 
centrifuge or separator sludge from milk processing, and milk referred to in Article 10(f) and 
(h) of the Animal By-products Regulation may be used for the production of milk and milk-
based products. 
Colostrum may only be used provided that it originates from live animals that did no show 
any signs of disease communicable through the colostrum to humans or animals. EN 110   EN B. Processing standards  
1. Milk must be subjected to one of the following treatments: 
1.1. sterilisation at an F 0 (∗) value of three or more; 
1.2. UHT (∗∗) combined with one of the following: 
(a) a subsequent physical treatment, by: 
(i) a drying process, combined in the case of milk intended for feeding 
with additional heating to 72 °C or more; or 
(ii) lowering the pH below 6 for at least 1 hour; 
(b) the condition that the milk or milk product has been produced at least 21 days 
before shipping and that during that period no case of foot-and-mouth disease 
has been detected in the Member State of origin; 
1.3. HTST (∗∗∗) applied twice; 
1.4. HTST in combination with one of the following: 
(a) a subsequent physical treatment, by: 
(i) a drying process, combined in the case of milk intended for feeding 
 with additional heating to 72 °C or more; or 
(ii) lowering the pH below 6 for at least 1 hour; 
(b) the condition that the milk or milk product has been produced at least 21 days 
before shipping and that during that period no case of foot-and-mouth disease 
has been detected in the Member State of origin. 
2. Milk products must either be subjected to at least one of the treatments provided for in 
paragraph 1 or be produced from milk treated in accordance with point 1. 
3. Whey  to be fed to animals of species susceptible to foot-and-mouth disease and 
produced from milk treated in accordance with point 1 must: 
(a) either be collected at least 16 hours following milk clotting and its pH must be 
recorded as below 6,0 before transport to animal holdings; or 
                                                 
∗ F0 is the calculated killing effect on bacterial spores. An F 0 value of 3, 00 means that the coldest point in the 
product has been heated sufficiently to achieve the same killing effect as 121 °C (250 °F) in three minutes with 
instantaneous heating and chilling. 
∗∗ UHT = Ultra High Temperature treatment at 132 °C for at least one second. 
*** HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or 
equivalent pasteurisation effect achieving a negative reaction to  a phosphatase test.  
 EN 111   EN (b) have been produced at least 21 days before shipping and during that period no 
case of foot-and-mouth disease has been detected in the Member State of 
origin. 
4. In addition to the requirements laid down in  point 1, 2 and 3, milk and milk products 
must meet the following requirements: 
4.1. after completion of the processing, every precaution must be taken to prevent 
contamination of the products; 
4.2.  the final product must be labelled so as to indicate that it contains Category 3 material 
and is not intended for human consumption, and 
(a)  packed in new containers; or 
(b) transported in bulk in containers or other means of transport that before use 
were thoroughly cleansed and disinfected. 
5. Raw milk must be produced  under conditions offe ring adequate guarantees as regards 
animal health. 
6. Colostrum and colostrum products must: 6.1. be obtained from bovine animals kept on a holding on which all bovine herds are 
recognised as officially tuberculosis-free, officially brucellosis-free and officially
 
enzootic-bovine-leukosis-free as defined in Article 2(2)(d), (f) and (j) of Directive 
64/432/EEC; 
6.2. have been produced at least 21 days before shipping and during that period no case 
of foot-and-mouth disease has been detected in the Member State of origin,  
6.3. have undergone a single HTST treatment (***),  
6.3. comply with the requirements set out in paragraph 4. 
PART II 
 
Derogation for national markets 
1. The following requirements shall apply to the processing, use and storage of milk, 
milk-based products and milk-derived products which fall under the definition of 
Category 3 material, as referred to in Articles 10 (e) of the Animal By-products 
Regulation, other than centrifuge or separator sludge from milk processing, and milk 
referred to in Article 10 (f) and (h) of the Animal By-products Regulation, that have 
not been processed in accordance with Part I of this Chapter. 
2. The competent authority shall authorise m ilk processing establishments approved or 
registered in accordance with Article 4 of Regulation (EC) No 853/2004 to supply milk and milk-derived products for the purposes referred to in point 3 provided the establishment concerned ensures traceability of the products. EN 112   EN 3. Milk and milk-derived products may be supplied and used as feed material  
(a) in the Member State concerned and in cross-border areas where the Member 
States concerned have a mutual agreement to that effect, in the case of derived 
products, including white  water, which have been in contact with raw milk 
and/or milk pasteurised in accordance with Chapter II point II.1(a) or (b) of 
Section IX to Regulation (EC) No 853/2004, if those derived products have been subject to one of the following treatments: 
(i) UHT; 
(ii) sterilisation whereby either an Fc value equal or greater than 3 is 
achieved, or which was carried out at a temperature of at least 115°C for 
15 minutes or equivalent; 
(iii) pasteurisation or sterilisation, other than that referred to under point (ii), 
followed by: 
- in the case of dried milk or dried milk products, a drying process; 
- in the case of an acidified milk product, a process by which the pH 
is reduced and kept for at least one hour at a level below 6; 
(b) in the Member State concerned, 
(i) in the case of derived products, including white water, which have been 
in contact with milk that has only been pasteurised in accordance with 
Chapter II point II(a) of Section IX to Regulation (EC) No 853/2004, and whey produced from non heat-treated milk-based products, which 
has been collected at least 16 hours after milk clotting and where the pH must be recorded as < 6,0 before supplying the whey for feeding, 
provided that they are sent to a limited number of authorised animal 
holdings, fixed on the basis of the risk assessment for the best and worst case scenarios carried out by the Member State concerned in 
preparation of the contingency plans for epizootic diseases, in 
particular foot-and-mouth disease; 
(ii) in the case of raw products, including white  water that has been in 
contact with raw milk and other products for which the treatments  referred to in points (a) and (b) cannot be ensured, provided that they 
are sent to a limited number of authorised animal holdings, fixed on the 
basis of the risk assessment for the best and worst case scenarios carried out by the Member State concerned in preparation of the contingency plans for epizootic diseases, in particular foot-and-mouth disease, and provided that the animals present in the authorised animal holdings can only be moved 
- either directly to a slaughterhouse located in the same Member 
State; or 
- to another holding in the same Member State, for which the 
competent authority guarantees that animals susceptible to foot-EN 113   EN and-mouth disease may leave the holding only either directly to a 
slaughterhouse located in the same Member State, or if the animals have been dispatched to a holding not feeding the products referred 
to in this point (ii) , after a 21-day standstill period has elapsed from 
the introduction of the animals. 
4. By way of derogation to point 3, the competent authority may authorise the supply of 
colostrum which does not comply with the conditions set out in that point, from one 
farmer to another farmer within the same Member State for feeding purposes, under 
conditions which prevent the transmission of health risks. 
PART III 
Special requirements for centrifuge or separator sludge 
Centrifuge or separator sludge from milk proce ssing referred to in Article 10(e) of the Animal 
By-products Regulation must have been subjected to a heat treatment of at least 70°C for 60 
minutes or of at least 80°C for 30 minutes, before it may be placed on the market for feeding to farmed animals. 
CHAPTER V 
Specific requirements for gelatine and hydrolysed protein 
A. Raw materials 
Only animal by-products which are Category 3 or products which are derived from such 
animal by-products, other than materials referred to in Article 10 (m), (n), (o) and (p) of the Animal By-products Regulation may be used for the production of gelatine and hydrolysed 
protein. 
B. Processing standards for gelatine  
1. Unless 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. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of 
filtration and sterilisation. 
2. After having been subjected to the processes referred to in subparagraph 1, gelatine 
may undergo a drying process and, where appropriate, a process of pulverisation or 
lamination.  
3. The use of preservatives, other than sulphur dioxide and hydrogen peroxide, is 
prohibited. 
C. Other requirements for gelatine EN 114   EN Gelatine must be wrapped, packaged, stored  and transported under satisfactory hygiene 
conditions.  
In particular:  
(a) a room or a dedicated place  must be provided for storing materials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a place intended for 
that purpose.  
D. Processing standards for hydrolysed protein  
Hydrolysed protein must be produced using a production process involving appropriate 
measures to minimise contamination. Hydrolysed protein derived from ruminants  shall have a 
molecular weight below 10 000 Dalton. 
In addition, hydrolysed proteins entirely or partly derived from ruminants' hides and skins 
shall be produced in a processing plant dedicated only to hydrolysed protein production, using 
a process involving the preparation of raw Category 3 material by brining, liming and intensive washing followed by:  
(a) exposure of the material to a pH of more than 11 for more than three hours at a 
temperature of more than 80 °C and subsequently by heat treatment at more than 140 °C for 30 minutes at more than 3,6 bar; or  
(b) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, 
followed by heat treatment at 140 °C for 30 minutes at 3 bar. 
CHAPTER VI 
Specific requirements for dicalcium phosphate 
A. Raw materials 
Only animal by-products which are Category 3 or products which are derived from such 
animal by-products, other than materials referred to in Article 10 (m), (n), (o) and (p) of the Animal By-products Regulation may be used for the production of dicalcium phosphate. 
B. Processing standards 1. Dicalcium phosphate must be produced by a process that:  
(a) ensures that all Category 3 bone-materia l is finely crushed and degreased with 
hot water and treated with dilute hydrochloric acid (at a minimum 
concentration of 4 % and a pH of less than 1,5) over a period of at least two days;  
(b) following the procedure at (a), applies a treatment of the obtained phosphoric 
liquor with lime, resulting in a precipitate  of dicalcium phosphate at pH 4 to 7; 
and  EN 115   EN (c) finally, air dries the precipitate of dicalcium phosphate w ith inlet temperature 
of 65 °C to 325 °C and end temperature between 30 °C and 65 °C,  
2. Where dicalcium phosphate is derived from defatted bones, it shall be derived from 
bones referred to in Article 10(a) of the Animal By-products Regulation. 
CHAPTER VII 
Specific requirements for tricalcium phosphate 
A. Raw materials 
Only animal by-products which are Category 3 or products which are derived from such 
animal by-products, other than materials referred to in Article 10 (m), (n), (o) and (p) of the 
Animal By-products Regulation may be used for the production of triclacium phosphate. 
B. Processing standards  
Tricalcium phosphate must be produced by a process that ensures:  
(a) that all Category 3 bone-material is finely crushed and degreased in counter-
flow with hot water (bone chips less than 14 mm);  
(b) continuous cooking with steam at 145 °C during 30 minutes at 4 bars.  (c) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) 
by centrifugation; and  
(d) granulation of the tricalcium phosphate after drying in a fluidised  bed with air 
at 200
0 C. 
CHAPTER VIII 
Specific requirements for collagen 
A. Raw materials 
Only animal by-products which are Category 3 or products which are derived from such 
animal by-products, other than materials referred to in Article 10 (m), (n), (o) and (p) of the Animal By-products Regulation may be used for the production of collagen . 
B. Processing standards  
1. Unless the collagen has been produced in ac cordance with 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. After that treatment collagen may undergo a drying process.  EN 116   EN 2. The use of preservatives, other than th ose permitted under Union legislation shall be 
prohibited. 
C. Other requirements 
Collagen must be wrapped, packaged, stored and transported under satisfactory hygiene 
conditions. In particular: 
(a) a room or a dedicated place  must be provided for storing materials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a place intended for 
that purpose. 
CHAPTER IX 
Specific requirements for egg products 
A. Raw materials 
Only animal by-products referred to in Article 10 (e), (f) and (k)(ii) of the Animal By-
products Regulation may be used for the production of egg products . 
B. Processing standards  
Egg products must have been:  
(a) submitted to any of processing Methods 1 to 5 or 7; or  
(b) submitted to a method and parameters which ensure that the products comply 
with the microbiological standards set in Section I; or  
(c) treated in accordance with Section X,  Chapters I to III of Annex III to 
Regulation (EC) No 853/2004. 
CHAPTER X 
Specific requirements for certain Category 3 material 
Category 3 material referred to in Article 10(f)  of the Animal By-products Regulation may be 
placed on the market for feeding to farmed animals, provided that: 
(a) the material is not composed of and ha s not been in contact with material of 
animal origin: (i) which has neither undergone processing in accordance with this 
Regulation; EN 117   EN (ii) nor undergone processing as defined in Article 2(1)(m) of Regulation 
(EC) No 852/2004; and 
(b) all necessary precautions have been taken to prevent the contamination of the 
material. 
SECTION III 
REQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS 
1. Animal by-products from aquatic animals and  derived products from aquatic animals 
that are intended as feed for farmed fish shall: 
(a) be handled and processed separately from material not authorised for that 
purpose; 
(b) originate 
(i) from  wild fish or other aquatic animals , except sea mammals, landed 
for commercial  purposes, or from animal by-products from wild fish 
originating in plants manufacturing fish products for human 
consumption; or  
(ii) from farmed fish, provided it is fed to farmed fish of another species; and 
(c) be processed in a processing plant to a standard which ensures a 
microbiologically safe product , including with regard to fish pathogens. 
2. The competent authority may, provided there is no unacceptable risk for the 
transmission of diseases communicable to humans or animals authorise the use of 
aquatic animals and of aquatic and terrestrial invertebrates:  
(a) as feed for farmed fish, when the animal by-products have not been processed 
in accordance with point 1(c); 
(b) as fishing bait.  EN 118   EN  
ANNEX XV  
ORGANIC FERTILISERS AND SOIL IMPROVERS   
SECTION I 
REQUIREMENTS FOR UNPROCESSED MANURE, PROCESSED MANURE AND 
DERIVED PRODUCTS FROM PROCESSED MANURE  
CHAPTER I 
Unprocessed manure and guano  
1. Trade in unprocessed manure of species other than poultry or equidae between 
Member States is subject to the following conditions, in addition to the consent of the 
Member State of destination referred to in Article 48(1) of the Animal By-products 
Regulation:  
(a) Trade in unprocessed manure of species other than poultry or equidae is 
prohibited, except for manure: 
(i) from an area which is not subject to restrictions by virtue of a serious 
transmissible disease, and  
(ii) intended for application, under the supervision of the competent 
authorities, to land forming part of a single holding located on both sides 
of the border of two Member States. 
(b) However, the competent authority of the Member State of destination may, 
having regard to the origin of the manure, its destination and animal health 
considerations,  grant specific approval for the introduction on to its territory of: 
(i) manure intended for processing in a plant for the manufacture of derived 
products which are destined  for uses outside the feed chain or manure 
intended  for transformation into biogas or composting in accordance with 
the Animal By-products Regulation and with this Regulation  with a view 
to the manufacture of the products referred to under Chapter II below; the competent authority shall take account of the origin of the manure when approving such plants; or  
(ii) manure intended for applying to land on a holding, provided that the 
competent authority of the Member State of origin has communicated its agreement to such trade.  
(c) in the cases referred to in point (b),  a health attestation in accordance with the 
model set out under point 3 shall be added to the commercial document which accompanies the manure. EN 119   EN 2. Trade in unprocessed poultry manure between Member States  is subject to the 
following conditions, in addition to the cons ent of the Member State of destination 
referred to in Article 48(1) of the Animal By-products Regulation: 
(a) the manure must originate in an area which is not subject to restrictions by 
virtue of Newcastle disease or avian influenza; 
(b) in addition, unprocesse d manure from poultry flocks vaccinated against 
Newcastle disease must not be dispatched to a region which has obtained 
Newcastle disease non-vaccinating status pursuant to Article 15(2) of  Directive 
2009/158/EC; and 
(c) a health attestation in accordance with the model set out under point 3  shall be 
added to the commercial document which accompanies the manure. 
3. Model health attestation to be added to the commercial document EN 120   EN EUROPEAN COMMUNITY Commercial document
I.1. Consignor I.2. Document reference number I.2.a.Local reference number:
Name
I.3. Central Competent Authority
Address  
Postal code I.4. Local Competent Authority
I.5. Consignee 
Name
Address
Postal code
I.8.Country of origin  ISO code I.9. Region of origin Code I.10. Country of destination  ISO code I.11. Region of destination Code
I.12. Place of origin I.13. Place of destination
Establishment Establishment Other
Name Approval number Name Approval number
Address Address
Postal code Postal code
I.14. Place of loading I.15. Date and time of departure
Postal code
I.16. Means of transport I.17. Transporter
Aeroplane Ship Railway wagon Name Approval number
Road vehicle Other Address
Identification:
Postal code Member State
I.18. Description of commodity I.19. Commodity code (CN code)
I.20. Number/quantity
I.21 Temperature of products I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/seal number I.24.Type of packaging
I.25. Commodities certified for
Animal feedingstuff Technical use Other
I.26. Transit through third country I.27. Transit through Member States
Third country  ISO code Member State  ISO code
Exit point Code Member State  ISO codeEntry point BIP unit no.: Member State  ISO code
I.28. Export
Third country  ISO codeExit point Code
I.31. Identification of the commodities
Approval number of establishments
Species Nature of commodity Category Treatment type Manufacturing plant Batch number
(Scientific name)Part I : Details of consignment presented
I.29.
I.30.I.7.I.6.EN 121   EN EUROPEAN UNION    Animal by-
products/derived products not intended for human 
consumption  
 
 II.a. Document reference 
number  II.b. Local reference number  Part II: Declaration 
 
 
 
 
 
 
 Notes 
Part I: y Box reference I.9 and I.11: if appropriate. 
y Box reference I.12 and I.13: appr oval number or registration number . 
y Box reference I.14: complete if different from ‘I.1. Consignor’. 
y Box reference I.31: 
Nature of commodity : 'manure'  
 
 III. Health attestation 
I, the undersigned official veterinarian, declare that I under stand that the competent authority of the place of destination 
has given its consent to the introduction of the unprocessed manure on its territory and that the unprocessed manure 
referred to in box no. I.18 complies with the following conditions: 
a) in case of unprocessed poultry manure(1): 
          [The manure originates from an area which is not subject to restrictions by virtue of Newcastle disease or  
          avian influenza.] EN 122   EN and     [in the case of unprocessed manure from poultry flocks vaccinated against Newcastle disease, the manure      
            is  not dispatched to a region which has obtained Newcastle disease non-vaccinating status pursuant to  
            Article 15(2) of  Directive 2009/158/EC.] 
 
b) in case of unprocessed manure of species other than poultry or equidae(1): 
          [The manure originates from an area which is not subject to restrictions by virtue of a serious transmissible  
          disease.]; 
and      
 
either  [The manure is intended for processing in a plant for the manufacture of derived products which are  
            destined for uses outside the feed chain or manure intended for transformation into biogas or composting  
            in accordance with Regulation (EG) 1069/2009 with a view to the manufacture of processed manure or  
            processed manure products]; 
or     [The manure is intended for applying to land on a holding.]  
Notes 
(1) Delete as appropriate.  
 Official veterinarian  
Name (in capital letters):  Qualification and title: 
Date: Signature: 
Stamp:  EN 123   EN  
4. Unprocessed manure of equidae may be traded between Member States, provided the 
Member State of destination has given its cons ent to the trade as referred to in Article 
48(1) of the Animal By-products Regulation, and provided it does  not originate from 
a holding subject to animal health restrictions pertaining to glanders, vesicular 
stomatitis, anthrax or rabies in accord ance with Article 4(5) of Directive 
90/426/EEC. 
5. In accordance with Article 48(1)(c)(ii) of the Animal By-products Regulation, the 
competent authority may require operators dispatching unprocessed manure from 
another Member State to transmit further information in relation to an intended 
dispatch, such as precise geographical indications regarding the place where the 
manure is to be unloaded, and to store the manure before application to land. 
6. The competent authority may authorise the dispatch of manure transported between 
two points located on the same farm subject to conditions for the control of possible 
health risks, such as obligations for the operators concerned to keep appropriate 
records.  
7. By way of derogation from Article 48(1) of the Animal By-products Regulation, the 
competent authorities of a Member Stat e of origin and a Member State of 
destination, which are sharing a common border, may authorise the dispatch of 
manure between farms located in border regions of the two Member States subject to conditions for the control of possible health risks, such as obligations for the operators concerned to keep appropriate records, which are laid down in a bilateral agreement.  
8. The placing on the market, other than the importation, of guano from wild sea birds 
is not subject to any animal health conditions.  
 
CHAPTER II 
Processed manure, derived products from processed manure and guano from bats 
The placing on the market of processed manure, derived products from processed manure and 
guano from bats shall be subject to the followin g conditions, in addition to the consent of the 
Member State of destination referred to in Article 48(1) of the Animal By-products Regulation: 
(a)  They shall come from a plant for derived products for uses outside the feed 
chain or from a biogas or a composting plant. 
(b) They shall have been subjected to a heat treatment process of at least 70 °C for 
at least 60 minutes and they shall have been subjected to reduction in spore-forming bacteria and toxin formation, where they are identified as a relevant hazard. EN 124   EN (c) However, the competent authority may authorise the use of other standardised 
process parameters than those described in (b) provided an applicant 
demonstrates that such parameters ensure minimising of biological risks. This 
demonstration shall include a validation, which shall be carried out as follows: 
(i) Identification and analysis of possible hazards including the impact of 
input material, based on a full defin ition of the proce ssing conditions, and 
a risk assessment, which evaluates how the specific processing 
conditions are achieved in practice under normal and atypical situations. 
(ii) Validation of the intended process 
(ii-1) by measuring the reduction of viability/infectivity of endogenous 
indicator organisms during the process, where the indicator is: 
– consistently present in the raw material in high numbers, 
– not less heat resistant to the lethal aspects of the treatment process, 
but also not significantly more resistant than the pathogens for which it is being used to monitor, 
– relatively easy to quantify and re latively easy to identify and 
confirm;  
or 
(ii-2) by measuring the reduction of viability/infectivity, during exposure, of a 
well-characterised test organism or virus introduced in a suitable test 
body into the starting material. 
(iii) The validation referred to in point (ii) must demonstrate that the process 
achieves the following overall risk reduction: 
– for thermal and chemical processes by reduction of Enterococcus 
faecalis  by at least 5 log10 and by reduction of infectivity titre of 
thermo resistant viruses such as parvovirus , where they are 
identified as a relevant hazard, by at least 3 log10, 
– for chemical processes also by reduction of resistant parasites such 
as eggs of ascaris sp . by at least 99,9 % (3 log10) of viable stages. 
iv) Designing a complete control programme including procedures for 
monitoring the process. 
(v) Measures ensuring continuous monitoring and supervision of the relevant 
process parameters fixed in the control programme when operating the plant.  EN 125   EN Details on the relevant process parameters used in a plant as well as other 
critical control points shall be record ed and maintained so that the owner, 
operator or their representative and the competent authority can monitor the 
operation of the plant. Information relating to a process authorised under this 
point must be made available to the Commission on request; and 
(d) Representative samples of the manure taken during or immediately after 
processing at the plant in order to monitor the process must comply with the following standards: 
Escherichia coli: n = 5, c = 5, m= 0, M= 1 000 in 1 g; 
or 
Enterococaceae: n = 5, c = 5, m = 0, M = 1 000 in 1 g; 
and 
Representative samples of the manure taken during or on withdrawal from 
storage at the plant of production or the biogas or composting plant must comply with the following standards: 
Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0 
where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria; the result is considered 
satisfactory if the number of bacter ia n all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered 
unsatisfactory if the number of  bacteria in one or more samples is M or more;  
and c = number of samples the bacterial count of which may be between m and M, 
the sample still being considered acceptab le if the bacterial count of the other 
samples is m or less. 
Processed manure or processed manure products not complying with the above 
requirements shall be regarded as unprocessed; 
(e) They must be stored in such a way that once processed contamination or 
secondary infection and dampness is minimised. They must therefore be stored in: 
(i) well-sealed and insulated silos or properly constructed storage sheds, or 
(ii) properly sealed packs, such as  plastic bags or “big bags”. 
 EN 126   EN SECTION II 
REQUIREMENTS FOR CERTAIN ORGANIC FERTILISERS  
AND SOIL IMPROVERS  
CHAPTER I 
Conditions for the production 
1. Organic fertilisers and soil improvers, ot her than manure, digestive tract content, 
compost, milk, colostrum and digestion residues from the transformation of animal 
by-products or derived products into biogas, shall be produced  
(a) by applying processing method 1, when Category 2 material is used as starting 
material; 
(b) by applying any of the processing methods 1 to 7, when  Category 3 material is 
used as starting material. 
2. Organic fertilisers and soil impr overs which consist of or which  have been produced 
from meat and bone meal derived from Category 2 material or from processed animal 
protein, shall be mixed , in a registered establishment or plant, with a component which 
is authorised by the competent authority of  the Member State where the product is to 
be applied to land,  according to the following: 
(a) the component consists of lime, manure, urine,  compost or digestion residues 
from the transformation of animal by-products into biogas or other substances, 
such as mineral fertilisers,  which are not used in animal feed and which 
exclude the subsequent use of the mixt ure for feeding purposes according to 
good agricultural practice; 
(b) the component is determined based on an assessment of the climatic and soil 
conditions for the use of the mixture as  a fertiliser, on indications that the 
component renders the mixture unpalatable to animals or it is otherwise effective in preventing misuse of the mixture for feeding purposes and the requirements laid down in Union legislation or, where applicable, national legislation,  for the protection of the environment regarding the protection of 
soil and groundwater; 
(c) the component is added to a sufficient minimum proportion which ensures that 
the objective referred to  in point (a) is met. 
3. However, the requirements referred  to in point 2 shall not apply to: 
(a) organic fertilisers and soil improvers wh ich are in ready-to-sell packages of not 
more than 50 kg in weight for use by the final consumer, or  
(b) if authorised by the competent authority of the Member State where the organic 
fertiliser or soil improver is to be app lied to land, on the basis of an assessment 
of the likelihood of a potential diversion of the materials to farms keeping EN 127   EN animals or to land to which farmed animals have access, in big bags of not 
more than 1000 kg in weight, in case it is indicated on the packages or big bags that they are not destined to land to  which farmed animals have access. 
4. Producers of organic fertilisers and soil improvers must ensure that decontamination 
of pathogens is carried out prior to thei r application to land , in accordance with: 
– Section I of Annex XIV, in the case of  processed animal protein or derived 
products from Category 2 or Category 3  material; 
– Chapter III of Section III of Annex VIII in the case of compost and digestion 
residues from the transformation of animal by-products or derived products into biogas. 
CHAPTER II 
Storage and transport 
After processing or transformation, organic fe rtilisers and soil improvers shall be properly 
stored and transported  
(a) in bulk, under appropriate conditions that prevent contamination; or 
(b) packaged or in big bags, in the case of organic fertilisers or soil improvers 
destined for sale to final users. 
CHAPTER III 
Application to land 
As referred to in Article 30(1) of the Animal By-products Regulation, the competent authority 
shall encourage, where necessary, the developm ent, dissemination and use of national guides 
to good agricultural practice for the applicatio n of organic fertilisers and soil improvers to 
land. EN 128   EN  
ANNEX XVI  
DERIVED PRODUCTS REGULATED BY OTHER UNION LEGISLATION 
SECTION I  
DERIVED PRODUCTS REFERRED TO  
IN ARTICLE 33 OF THE ANIMAL BY-PRODUCTS REGULATION 
[…] 
SECTION II 
INTERMEDIATE PRODUCTS 
In accordance with Article 34(2) of the Animal By-products Regulation, the following shall 
apply to the importation and transit through the European Union of intermediate products: 
1. The import and transit of intermediate products shall be authorised, provided: 
(a) they are derived from the following materials:  
(i) Category 3 material referred to in Article 10 (a), (b), (d), (e), (f), (g), (h), 
(i), (j), (k), (l) and (m) of the Animal By-products Regulation; 
(ii) products generated by the animals referred to in Article 10 (i), (l) and (m) 
of the Animal By-products Regulation; or 
(iii) mixtures of the materials refe rred to under point (i) and (ii); 
(b) in the case of intermediate products destined for medical devices, in vitro 
diagnostic medical devices and laboratory reagents, they are derived from: (i) materials which fulfil the criteria refe rred to in point (a), except that they 
may have originated from animals re ferred to in Article 8(c) of the 
Animal By-products Regulation; 
(ii) Category 2 material referred to in Article 9 (f) and (h) of the Animal By-
products Regulation; or 
(iii) mixtures of the materials refe rred to under point (i) and (ii); 
(c) in the case of intermediate products destined for active implantable medical 
devices, medicinal products and veterinary medicinal products, they are 
derived from the materials referred to in point (b), in case the competent authority considers the use of such materials justified for the protection of public or animal health; EN 129   EN (d) they come from a third country listed as a member of the OIE in the OIE 
bulletin; 
(e) they come from an establishment or plant registered or approved by the 
competent authority of a third country referred to in point (d), in accordance 
with the conditions set out in point 2; 
(f) each consignment is accompanied by a declaration of the importer in 
accordance with the model declaration set out in Chapter 20 of Annex XIX, 
which must be at least in one of the official languages of the Member State in 
which the inspection at the border inspection post shall be carried out and of the Member State of destination; these Member States may allow other languages and request official translations for declarations in such other languages 
(g) in the case of materials referred to in point (b), the importer demonstrates to the 
competent authority: 
(i) that the materials do not carry any risk of transmission of a disease 
communicable to humans or animals; or 
(ii) that the materials are transported under conditions which prevent the 
transmission of such diseases. 
2. An establishment or plant may be registered or approved by the competent authority 
of a third country, as referred to in point 1(c), provided: (a) the operator or owner of the plant or his representative: 
(i) demonstrates that the plant has adeq uate facilities for the transformation 
of the materials referred to in point 1(a), (b) or (c), as applicable, to 
ensure the completion of the necessary design, transformation and 
manufacturing stages; 
(ii) establishes and implements methods of monitoring and checking the 
critical control points on the basis of the process used; 
(iii) keeps a record of the information obtained pursuant to point (ii) for a 
period of at least two years for submission to the competent authority; 
(iv) informs the competent authority if  any available information reveals the 
existence of a serious animal health or public health risk; 
(b) the competent authority of the third country carries out, at regular intervals, 
inspections of the establishment or plant and supervises the plant in accordance with the following: 
(i) the frequency of inspections and supervision shall depend on the size of 
the plant, the type of products manufactured, risk assessment and 
guarantees offered, based on a system of checks which has been set up in accordance with the HACCP principles; EN 130   EN (b) if the inspection carried out by the competent authority reveals that the 
provisions of this Regulation are not being complied with, the competent 
authority shall take appropriate action; 
(c) the competent authority shall draw up a list of establishments or plants 
approved or registered in accordance with this Section and shall assign an 
official number to each plant, whic h identifies the establishment or plant 
with respect to the nature of its activities; the list and subsequent amendments shall be submitted to the Member State in which the 
inspection at the border inspection post shall be carried out and to the 
Member State of destination. 
3. The intermediate products imported into the Union shall be checked at the border 
inspection post in accordance with Article  4 of Directive 97/78/EC and transported 
directly from the border inspection post either: 
(a) to a registered establishment or plant for the production of the derived products 
referred to in Article 33 of the Animal By-products Regulation, where the 
intermediate products shall be further mixed, used for coating, assembled, 
packaged or labelled before they are placed on the market or put into services 
in accordance with the Union legislation applicable to the derived product; 
(b) to an establishment or plant which has been approved in accordance with 
Article 24(1)(h) of the Animal By-products Regulation, from where they shall only be dispatched to an establishment or plant referred to in point (a) for the uses referred to in that point. 
4. By way of derogation to Article 34(2) of the Animal By-products Regulation, 
intermediate products which have been tr ansported to an establishment or plant 
referred to in point 3, may be handled without further restrictions under the Animal 
By-products Regulation and under this Regulation, provided that: 
(a) the establishment or plant has adequate facilities for the receipt of the 
intermediate products, which prev ent the transmission of diseases 
communicable to humans or animals; 
(b) the intermediate products do not pose any risk of transmission of diseases 
communicable to humans or animals, due to their purification or to other 
treatments to which the animal by-produc ts in the intermediate product have 
been submitted, due to the concentration of animal by-products in the intermediate product or due to adequate bio-security measures for the handling of the intermediate products; 
(c) the establishment or plant keeps records on the amount of materials received, 
their category, if applicable, and the establishment, plant or operator to whom they have supplied their products; and 
(d) unused intermediate products or other surplus materials from the establishment 
or plant, such as expired products, are disposed of in accordance with the Animal By-products Regulation. EN 131   EN 5. Intermediate products in transit through the Union shall be transported in accordance 
with Article 11 of Directive 97/78/EC. 
6. The official veterinarian at the border inspection post concerned shall inform the 
authority in charge of the establishment or  plant at the place of destination of the 
consignment by means of the TRACES system. 
7. The operator or owner of the establishment or plant of destination or his 
representative shall use and/or dispatch the intermediate products exclusively for the 
purposes specified in point 3(a). 
8. The operator or owner of the establishment or plant of destination or his 
representative shall keep records in accordance with Article 22 of the Animal By-
products Regulation and shall provide the competent authority on request with the 
necessary details of purchases, sales, uses, stocks and disposals of surplus of the 
intermediate products for the purposes of checking compliance with this Regulation. 
9. The competent authority shall ensure, in  accordance with Directive 97/78/EC, that 
the consignments of intermediate products are sent from the EU Member State in which the inspection at the border inspection post shall be carried out to the plant of destination, as referred to in point 3(a) or, in the case of transit, to the post of exit. 
10. The competent authority shall carry out documentary checks at regular intervals for 
the purpose of reconciliation of the quantities  of intermediate products imported on 
the one hand, and stocked, used, dispatched or disposed of on the other, in order to check compliance with this Regulation. 
11. For consignments of intermediate products in transit, the competent authorities 
responsible for the border inspection posts of entry and of exit respectively shall cooperate as necessary to ensure that effective checks are carried out and to ensure 
the traceability of such consignments. EN 132   EN ANNEX XVII  
PETFOOD AND CERTAIN OTHER DERIVED PRODUCTS 
CHAPTER I 
General requirements 
1. Without prejudice to Article 35(a)(ii) of the Animal By-products Regulation, the use 
of Category 1 material referred to in Article 8 points (a), (b), (d), (e), (f) and (g) of 
the Animal By-products Regulation for the manufacture of derived products which 
are intended to be ingested by or applied to humans or animals, other than derived 
products referred to in Articles 33 and 36 of the Animal By-products Regulation, is prohibited. 
2. Establishments or plants producing derived products referred to in this Annex and 
petfood plants shall 
(a) have adequate facilities for storing and treating incoming material under 
conditions which prevent the introduction of risks to public and animal health; 
(b) have adequate facilities for disposing of unused animal by-products and 
derived products remaining after production, unless the unused material is sent 
for processing or disposal to another establishment or plant, in accordance with this Regulation. 
3. Where an animal by-product or a derived product can be used for feeding to farmed 
animals and for the purposes referred to in Article 36(a) of the Animal By-products Regulation and this Annex does not contain any specific requirements, the animal by-product or derived product shall only be placed on the market for such purposes 
in accordance with the specific requirements for feed materials laid down in Section 
II of Annex XIV. 
CHAPTER II 
Specific requirements for  petfood   
1. Raw petfood 
Raw petfood may only be manufactured from an imal by-products referred to in Article 
35(a)(iii) of the Animal By-products Regulation . Raw petfood must be packed in new 
packaging preventing any leakage. Effective steps must be taken to ensure that the product is not exposed to contamination throughout the production chain and up to the point of sale.  
2. Raw material for processed petfood and for dogchews 
The only animal by-products that may be used to produce petfood and dogchews are 
those referred to in Article 35(a)(i) and (a )(ii) of the Animal By-products Regulation. EN 133   EN 3. Processed petfood 
(a) Canned petfood must be subjected to heat treatment to a minimum Fc value of 
3. 
(b) Processed petfood other than canned petfood must: 
(i) be subjected to a heat treatment of at least 90°C throughout the substance 
of the final product; 
(ii) be subjected to a heat treatment to at least 90°C of the ingredients of 
animal origin; or 
(iii) be produced as regards feed materials of animal origin exclusively using: 
- animal by-products or derived products from meat or meat products 
which have been subject to a heat treatment of at least 90°C 
throughout their substance; 
- the following derived products which have been produced in 
accordance with the requ irements of this Regulation: milk and milk 
based products, gelatine, hydrolysed protein, egg products, collagen, blood products, processed animal protein including fishmeal, rendered fat, fish oils, dicalcium phosphate, tricalcium phosphate or flavouring innards; 
(iv) if authorised by the competent authority, be subject to a treatment such as 
drying or fermentation, which ensures that the petfood poses no unacceptable risks to public and animal health; 
(v) in the case of animal by-products referred to in Article 10( l) and (m)  of 
the Animal By-products Regulation, and if authorised by the competent 
authority, be subject to a treatment which ensures that the petfood poses no unacceptable risks to public and animal health. 
After production, every precaution must be taken to ensure that such processed 
petfood is not exposed to contamination. 
The processed petfood must be packaged in new packaging. 
4. Dogchews must be subjected to a treatment sufficient to destroy pathogenic 
organisms, including salmonella. 
After that treatment, every precaution must be taken to ensure that such dogchews are 
not exposed to contamination.  
The dogchews must be packed in new packaging. 
5. Random samples must be taken from dogchews and from processed petfood, other 
than from canned petfood and other than from such processed petfood which has been 
treated in accordance in point 3(b)(v), during production and/or during storage (before dispatch) to verify compliance with the following standards: EN 134   EN Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M = 0. 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g 
Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria ; the result is considered satisfactory if 
the number of bacteria in all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered 
unsatisfactory if the number of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count  of which may be between m and M, the 
sample still being considered acceptable if the bacterial count of the other samples is 
m or less. 
6. Random samples must be taken from raw petfood during production and/or during 
storage (before dispatch) to verify compliance with the following standards: 
Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M = 0. 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 5000 in 1 g 
Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria ; the result is considered satisfactory if 
the number of bacteria in all samples does not exceed m; M = maximum value for the number of bacteria; the result is considered 
unsatisfactory if the number of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count  of which may be between m and M, the 
sample still being considered acceptable if the bacterial count of the other samples is 
m or less. 
7. End point for processed petfood and dogchews 
(a) Processed petfood which has been manufactured and packaged in the Union in 
accordance with point 3 and which has been tested in accordance with point 5 
or which has been subject to veterinary checks in accordance with Directive 97/78/EC in a Border Inspection Post may be placed on the market without 
restrictions in accordance  with this Regulation.  
(b) Dogchews which have been manufactured and packaged in the Union in 
accordance with point 4 and which has been tested in accordance with point 5 
or which have been subject to veterinary checks in accordance with Directive 
97/78/EC in a Border Inspection Post may be placed on the market without 
restrictions in accordance  with this Regulation. EN 135   EN  
CHAPTER III 
Specific requirements for  flavouring innards for the manufacture of petfood 
1. Only animal by-products referred to in Article 35 (a) of the Animal By-products 
Regulation may be used for the production of liquid / dehydrated derived  products 
used to enhance the palatability values of pet food. 
2. Flavouring innards must have been submitted to a treatment method and parameters, 
which ensure that the product complies with the microbiological standards laid down 
in point 5 of Chapter II to this Annex. Af ter treatment, every precaution must be taken 
to ensure that the product is not exposed to contamination. 
3. The end product must: 
(a) be packed in new or sterilised packaging; or 
(b) transported in bulk in containers or other means of transport that were 
thoroughly cleaned and disinfected. 
CHAPTER IV 
Specific requirements for blood and blood products from equidae 
The placing on the market of blood and blood products from equidae for purposes other than 
in feed shall be subject to the following conditions:  
1. Blood may be placed on the market for such purposes provided that: 
(a) it has been collected from equidae which: 
(i) at inspection on the date of blood collection do not show clinical signs of any 
of the compulsorily notifiable diseas es listed in Annex A to Directive 
90/426/EEC and of Equine influenza, Equine piroplasmosis, Equine 
rhinopneumonitis and Equine viral arteritis listed in point 4 of Article 1.2.3. 
of the Terrestrial Animal Health Code of the OIE, 2009 Edition;  
(ii)  have been kept for at least 30 days prior to the date of and during blood 
collection on holdings under veterinary supervision which were not subject to a prohibition order pursuant  to Article 4(5) of Directive 90/426/EEC or 
restrictions pursuant to Article 5 thereof;  
(iii) for the periods laid down in Article 4(5) of Directive 90/426/EEC had no 
contact with equidae from holdings which were subject to a prohibition order for animal health reasons pursuant to that Article and for at least 40 days prior to the date of and during blood collection had no contact with equidae from a EN 136   EN Member State or third country not cons idered free of African horse sickness 
in accordance with Article 5(2)(a) of that Directive;  
(b) it has been collected under veterinary supervision either: 
(i) in slaughterhouses approved in accordance with Regulation (EC) No 
853/2004; or  
(ii) in facilities approved, furnished w ith a veterinary approval number and 
supervised by the competent authority for the purpose of collecting blood 
from equidae for the production of blood  products for purposes other than 
feeding. 
2. Blood products may be placed on the market for such purposes  provided that: 
(a) all precautions have been taken to avoid contamination of the blood products with 
pathogenic agents during production, handling and packaging;  
(b) the blood products have been produced from blood which: 
(i)  either fulfils the conditions set out in paragraph 1(a); or 
(ii) has been subjected to at least one of the following treatments, followed by an 
effectiveness check, for the inactivation of possible causative pathogens for 
African horse sickness, equine encephalomyelitis of all types including Venezuelan equine encephalomyelitis, equine infectious anaemia, vesicular 
stomatitis and glanders ( Burkholderia mallei ): 
– heat treatment at a temperature of 65°C for at least three hours;  
– irradiation at 25 kGy by gamma rays; 
– change in pH to pH 5 for two hours; 
– heat treatment of at least 80°C throughout their substance. 
3.  Blood and blood products from equidae must be packed in sealed impermeable 
containers which bear the approval number of the establishment of collection referred to in paragraph 1(b). 
 
CHAPTER V 
Specific requirements for hides and skins of ungulates and products derived therefrom 
A. Establishments and plants 
The competent authority may authorise plants handling hides and skins, including limed 
hides, to supply trimmings and splittings of these hides and skins for the production of gelatine for animal consumption, provided that EN 137   EN (a) the plant fulfils the conditions for a special authorisation in accordance with 
point 5 of Chapter I of Section XIV of Annex III to Regulation (EC) No 
853/2004; 
(b) in case of trimmings and splittings derived from limed hides, the trimmings 
and splittings are submitted to a treatment which ensures that no risks to public 
and animal health remain. 
B. Placing on the market of animal by-products and of derived products 
1. Untreated hides and skins may be placed on the market subject to the health conditions 
applicable to fresh meat pursuant to Directive 2002/99/EC. 
2. Treated hides and skins may be placed on the market, provided that: 
(a) they have not been in contact with other animal products or live animals 
presenting a risk of spreading a serious transmissible disease; and  
(b) the commercial document laid down in Section III of Annex XI contains a 
statement indicating that all precautions have been taken to avoid 
contamination with pathogenic agents. 
C. End point for hides and skins 
1. Hides and skins of ungulates which pursuant to the decision of an operator as referred 
to in Article 2(1)(b) of the Animal By-products Regulation are destined for purposes 
other than human consumption, and which comply with the requirements of 
Regulation (EC) No 853/2004 for raw materials for gelatine or collagen intended for use in food may be placed on the market with out restrictions in accordance with this 
Regulation. 
2. The following treated  hides and skins may be placed on the market without restrictions 
in accordance with this Regulation: 
(a) hides and skins having undergone the complete process of tanning;  
(b) ‘wet blue’; 
(c) 'pickled pelts’; and (d) limed hides (treated with lime and in brine at a pH of 12 to 13 for at least eight 
hours). 
3. By way of derogation from point 2, the competent authority may require that 
consignments of treated hides and skins referred to in point 2(c) and (d) are 
accompanied by a commercial document in accordance with the model set out under 
point 6 of Section III of Annex XI, when they are supplied to establishments or 
plants producing petfood, organic fertilisers or soil improvers or transforming those 
materials into biogas. EN 138   EN CHAPTER VI 
Specific requirements for  game trophies and other preparations from animals 
A. The provisions of this Chapter are without prejudice to the measures adopted pursuant 
to Regulation (EC) No 338/97. 
B. Safe sourcing 
Game trophies and other preparations from animals, where the animal by-products 
have been submitted to a treatment or are presented in a state which does not pose 
any health risks, are not subject to any restrictions, provided they originate: 
(a) from  species other than ungulates, birds and animals of the biological class 
Insecta or Arachnida; and 
(b) from animals originating in an area not subject to restrictions as a result of the 
presence of serious transmissible diseases to which animals of the species 
concerned are susceptible. 
C. Safe treatment 
1. Game trophies or other preparations from animals, where 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: 
(a) originate from ungulates or birds which have undergone a complete taxidermy 
treatment ensuring their preservation at ambient temperatures;  
(b) are mounted ungulates or birds or mounted parts of such animals; or 
(c) have been subject to an anatomical preparation such as by plastination; 
(d) are animals of the biological class Insecta or Arachnida which have been 
subject to a treatment such as drying to prevent any transmission of diseases 
communicable to humans or animals. 
2. Game 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: 
(a) in case of game trophies or other preparations  solely of bone, horns, hooves, 
claws, antlers or teeth,  
(i) they have  been immersed in boiling water for an appropriate time so as 
to ensure that any matter other than bone, horns, hooves, claws, antlers or teeth is removed; EN 139   EN (ii) they have been disinfected with a product authorised by the competent 
authority, in particular with hydrogen peroxide where parts consisting 
of bone are concerned; 
(iii) they have been packaged, immediately after treatment, without being in 
contact with other products of animal origin likely to contaminate 
them, in individual, transparent and closed packages so as to avoid any subsequent contamination; and 
(iv) they are  accompanied by a health  certificate certifying that the above 
conditions have been met; 
(b) in case of game trophies or other preparations  consisting solely of hides or 
skin, 
(i) they have been either  
- dried; 
- dry- or wet-salted for a minimum of 14 days before dispatch; or 
-  subject to a preservation process other than tanning; 
(ii) they have been packaged, immediat ely after treatment, without being in 
contact with other products of animal  origin likely to contaminate them, 
in individual, transparent and closed packages so as to avoid any 
subsequent contamination; and 
(iii) they are accompanied by a document or a health  certificate certifying that 
the above conditions have been met. 
CHAPTER VII 
Specific requirements for  wool, hair, pig bristles, feathers, parts of feathers and down  
A. Raw material 
1. Untreated wool, untreated hair, untreated pig bristles and untreated feathers, parts of 
feathers and down  must be animal by-products referred to in Article 10 (b) (iii), 
(iv),(v), 10(h) and 10(n) of the Animal By-products Regulation .  
They must be securely enclosed in packaging and dry.  
However, in the case of untreated feathers, parts of feathers and down sent directly 
from the slaughterhouse to the processing plant, the competent authority may allow a 
derogation from the requirement to dry the materials, provided that: 
(a) all necessary measures are taken to avoid any possible spread of disease; 
(b) the transport takes place in water-proo f containers and/or vehicles which must 
be cleaned and disinfected immediately after each use. EN 140   EN 2. Movements of pig bristles from regions in which African swine fever is endemic are 
prohibited except for pig bristles that have: 
(a) been boiled, dyed or bleached; or 
(b) undergone some other form of treatment which is certain to kill pathogenic 
agents, provided that evidence to this effect is submitted in the form of a 
certificate from the veteri narian responsible for the place of origin. Factory 
washing may not be regarded as a form of treatment for the purposes of this 
provision. 
3. The provisions of paragraph 1 do not ap ply to decorative feathers or feathers: 
(a) carried by travellers for their private use; or 
(b) in the form of consignments sent to private individuals for non-industrial 
purposes. 
C. End point for wool  
Factory-washed wool and wool which has been treated by another method which ensures that 
no pathogens remain may be placed on the market wi thout restrictions in accordance with this 
Regulation. 
Member States may authorise the placing on the market of untreated wool on their territory 
without restrictions in accord ance with this Regulation, if they are satisfied that no 
unacceptable risks to public and animal health arise from the wool. 
D. End point for feathers and down 
Feathers, parts of feathers and down which ha ve been factory-washed and treated with hot 
steam at 100° C for at least 30 minutes may be placed on the market without restrictions in 
accordance with this Regulation. 
CHAPTER VIII 
Specific requirements for  furs 
End point 
Furs which have been dried at an ambient temperature of 18°C for two days at a humidity of 
55% may be placed on the market without restrictions in accordance with this Regulation. 
CHAPTER IX 
Specific requirements for apiculture by-products 
Apiculture by-products intended exclusively for use in apiculture must: EN 141   EN 1. not come from an area which is subject of a prohibition order associated with an 
occurrence of: 
(a) American foulbrood ( Paenibacillus larvae larvae ), except where the competent 
authority has assessed the risk to be neg ligible, issued a specific authorisation 
for use only in that Member State, and taken all other necessary measures to 
ensure no spread of that disease; 
(b) acariosis ( Acarapis woodi  (Rennie)), except where the area of destination has 
obtained additional guarantees in accordance with Article 14(2) of Directive 
92/65/EEC; 
(c) small hive beetle ( Aethina tumida ); or 
(d) Tropilaelaps spp. ( Tropilaelaps spp ); and 
2. meet the requirements provided for in Article 8(a) of Directive 92/65/EEC. 
CHAPTER X 
Specific requirements for  rendered fats from Category 1 or  Category 2 materials for 
oleochemical purposes  
1. Rendered fats derived from Category 1 material or from Category 2 material for 
oleochemical purposes must be produced using methods 1 to 5 as referred to in 
Section III of Annex VII . 
2. Rendered fats derived from ruminant animals must be purified in such a way that the 
maximum level of remaining total insol uble impurities does not exceed 0.15 % in 
weight. 
CHAPTER XI 
Specific requirements for  fat derivatives 
The following processes may be used to produce fat derivatives from rendered fats derived 
from Category 1 and Category 2 material:  
1. transesterification or hydrolysis at least 200 °C, under corresponding appropriate 
pressure, for 20 minutes (glycerol, fatty acids and esters); 
2. saponification with NaOH 12M (glycerol and soap): 
(a) in a batch process at 95 °C for three hours; or (b) in a continuous process at 140 °C 2 bars (2 000 hPa) for eight minutes; or 
3. hydrogenation at 160°C at 12 bars (12 000 hPa) for 20 minutes. EN 142   EN Fat derivatives produced in accordance with this Chapter may only be placed on the market: 
(a) for uses other than in feed, cosmetics and medicinal products; 
(b) in addition, in the case of fat derivatives from Category 1 material, for uses 
other than in organic fertilisers or soil improvers . 
CHAPTER XII 
Specific 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 
The placing on the market of horns and horn products, excluding horn meal, and hooves and 
hoof products, excluding hoof meal, intended for th e production of organic fertilizers or soil 
improvers shall be subject to the following conditions: 
1. they must originate from animals that: 
(a)  either have been slaughtered in a slaughterhouse, after undergoing an ante-mortem 
inspection, and were found fit, as a result of such inspection, for slaughter for 
human consumption in accordance with Union legislation; or 
(b) did not show clinical signs of any disease communicable through that product to 
humans or animals. 
2.  they must have undergone a heat treatment for one hour at a core temperature of at least 
80° C;  
3. the horns must be removed without opening the cranial cavity; 
4. at any stage of processing, storage or transport, every precaution shall be taken to avoid 
cross-contamination;  
5. they shall be packed either in new packaging or containers; or transported in vehicles or 
bulk containers which have been disinfected prior to loading using a product approved 
by the competent authority; 
6. the packaging or containers must: 
 (a) indicate the type of product (horns, horn products, hooves or hoof products);  (b) be marked with the name and address of the approved or registered 
establishment or plant of destination. EN 143   EN   
ANNEX XVIII  
IMPORT, EXPORT AND TRANSIT 
SECTION I 
SPECIFIC REQUIREMENTS FOR IMPORT AND TRANSIT OF CATEGORY 3 
MATERIAL AND DERIVED PRODUCTS FOR USES IN THE FEED CHAIN OTHER 
THAN FOR PETFOOD OR FOR FEED TO FUR ANIMALS  
CHAPTER I 
As referred to in Article 41(3) of the Animal By-products Regulation, imported consignments 
of Category 3 material and derived products therefrom and consignments of such materials and products in transit: 
(a) must consist of or have been produced from, as applicable, Category 3 material 
referred to in the column "raw materials" of table 1; 
(b) must comply with the import conditions set out in the relevant column of table 
1; 
(c) must come from a third country or part of a third country listed in the relevant 
column of table 1; and 
(d) shall be accompanied during transportation to the point of entry into the Union 
where the veterinary checks take place by the health certificate referred to in 
the relevant column of table 1; or 
(e) shall be presented at the point of entry into the Union where the veterinary 
checks take place accompanied by a document corresponding to the model 
referred to in the relevant column of table 1. 
  
 
  
EN 144   EN Table 1. 
No. Product Raw 
materials 
(reference 
to 
provisions 
of  the 
Animal 
By-
products Regulation
) Import and transit conditions Third countries' lists Certificates/ 
model documents 
1 Processed 
animal 
protein Materials 
referred to 
in Article 
10 (a), (b),  
(d), (e), 
(f), (h), (i), (j), (k), (l) 
and (m) (a) The processed animal protein 
must have been produced in 
accordance with Chapter I of 
Section II of Annex XIV; and 
(b) The processed animal protein 
shall comply with the additional requirements set out in Chapter II 
to this Section. (a) In the case of processed animal proteins 
excluding fishmeal: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010. 
(b) In the case of fishmeal: 
Third countries listed in Annex II to 
Commission Decision 2006/766/EC. Annex XIX, 
Chapter 1 
 
2 Blood 
products 
for feed 
material Materials 
referred to 
in Article 
10 (a),  
(b)(i) and 
(d) The blood products must have 
been produced in accordance with 
Chapter II of Section II of Annex 
XIV. (a) In the case of blood products from 
ungulates: 
Third countries or parts of countries listed in 
part 1 of Annex II to Commission Regulation 
(EU) No 206/2010, from which imports of all 
categories of fresh meat of the respective Annex XIX, 
Chapter 4(B) 
  
EN 145   EN species are authorised. 
(b) In the case of blood products from other 
species: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010 
3 Rendered 
fats and 
fish oil (a) In the 
case of 
rendered fats 
excluding 
fish oil: 
Materials 
referred to 
in Article 
10 (a), (b), 
(d), (e), 
(f),  (g), 
(h), (k) 
and (m)  
(b) In the 
case of 
fish oil: 
Materials 
referred to 
in Article 
10 (e), (h), 
(i) and   (j)  (a) The rendered fat and the fish 
oil must have been produced in 
accordance with Chapter III of 
Section II of Annex XIV; and 
(b) The rendered fat shall comply 
with the additional requirements 
set out in Chapter III to this 
Section. (a) In the case of rendered fats excluding fish 
oil: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010. 
(b) In the case of fish oil: 
Third countries listed in Annex II to 
Commission Decision 2006/766/EC (a) In the case of 
rendered fats 
excluding fish oil: 
Annex XIX, 
Chapter 10 (A) 
(b) In the case of 
fish oil: 
Annex XIX,
Chapter 9  
EN 146   EN  
4 Milk,   
milk-
based 
products, 
colostrum, 
colostrum
products   (a) Milk, 
milk-based 
products: 
 
Materials 
referred to 
in Article 
10 (e), (f) and (h) 
 
(b) Co-
lostrum,  
colostrum 
products 
Materials 
from live 
animals that did 
not show 
any signs 
of disease 
through 
the 
colostrums 
to humans or animals The milk, milk-based products, 
colostrum and colostrum products 
shall comply with the requirements 
set out in Chapter IV to this 
Section. (a)  In the case of milk and milk-based 
products: 
Authorised third countries listed in Annex I to 
Decision 2004/438/EC 
(b)    In the case of colostrum and colostrum 
products: 
Third countries listed as authorised in column 
"A" of Annex I to Decision 2004/438/EC Annex XIX, 
Chapter 2 
5 Gelatine Materials The gelatine and the hydrolysed (a)  Third countries listed in part 1 of Annex (a) In the case of  
EN 147   EN and 
hydro-
lysed 
protein referred to 
in Article 
10 (a), (b), 
(d), (e), 
(f), (g), (i) 
and (j), 
and, in the 
case of 
hydrolysed protein: 
materials 
referred to 
in Article 
10 (h) and 
(k) protein must have been produced 
in accordance with Chapter V of 
Section II to Annex XIV. II to Commission Regulation (EU) No 
206/2010, and the following countries: 
(KR) The Republic of Korea 
(MY) Malaysia  
(PK) Pakistan  
(TW) Taiwan. 
(b)  In the case of hydrolysed proteins from 
fish: 
Third countries listed in Annex II to Commission Decision 2006/766/EC. gelatine: 
Annex XIX, 
Chapter 11 
(b) In the case of 
hydrolysed 
protein: 
Annex XIX, 
Chapter 12 
 
6 Dicalcium 
phosphate Materials 
referred to 
in Article 
10 (a), (b), (d),(e), (f), 
(g), (h), (i) 
and (k) 
 The dicalcium phosphate must 
have been produced in accordance 
with Chapter VI of Section II of 
Annex XIV. Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
and the following countries: 
(KR) The Republic of Korea  (MY) Malaysia  
(PK) Pakistan  
(TW) Taiwan 
 Annex XIX, 
Chapter 12 
 
7 Tri- Materials The tricalcium phosphate must Third countries listed in part 1 of Annex II to Annex XIX,  
EN 148   EN calcium 
phosphate referred to in Article 
10 (a), (b), 
(d),(e), (f), 
(g), (h), (i) 
and (k) have been produced in accordance 
with Chapter VII of Section II of 
Annex XIV. Commission Regulation (EU) No 206/2010, 
and the following countries: 
(KR) The Republic of Korea  
(MY) Malaysia  
(PK) Pakistan  
(TW) Taiwan 
 Chapter 12 
 
8 Collagen Materials 
referred to 
in Article 
10 (a), (b), 
(d), (e) 
and (h)  The collagen must have been 
produced in accordance with 
Chapter VIII of Section II of 
Annex XIV. Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
and the following countries: 
(KR) The Republic of Korea  
(MY) Malaysia  
(PK) Pakistan  
(TW) Taiwan Annex XIX,
Chapter 11 
9 Egg 
products Materials 
referred to 
in Article 
10 points 
(e), (f) and 
(k)(ii)  
 The egg products must have been 
produced in accordance with 
Chapter IX of Section II of Annex 
XIV. Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
and third countries or parts of third countries from which Member States authorise imports 
of fresh poultrymeat, which are listed in Part 
1 of Annex I to Regulation (EC) No 
798/2008. Annex XIX, 
Chapter 15 
  
EN 149   EN CHAPTER II 
Import of processed animal protein 
The following requirements shall apply to the importation of processed animal protein:  
1. Before consignments are released for free circulation within the Union, the competent 
authority must sample processed animal protein from imported consignments  at the 
border inspection post to ensure compliance with the requirements of Section I of 
Annex XIV. 
The competent authority must:  
(a) sample each consignment of products carried in bulk; and  
(b) carry out random sampling of consignments of products packaged in the 
manufacturing plant of origin.  
2. However, when six consecutive tests on bulk consignments originating in a given third 
country prove negative, the competent authority may carry out random sampling of 
subsequent bulk consignments from that third country. If one of these random samples 
proves positive, the competent authority carrying out the sampling must inform the competent authority of the country of origin so that it can take appropriate measures to remedy the situation. The competent authority of the country of origin must bring these measures to the attention of the competent authority carrying out the sampling. In the event of a further positive result from the same source, the competent authority 
must sample each consignment from the same source until six consecutive tests again 
prove negative.  
3. Competent authorities must keep a record for at least three  years of the results of 
sampling carried out on all consignments that have undergone sampling.  
4. Where a consignment proves to  be positive for salmonella or  enterobacteriaceae, it 
must either:  
(a) be dealt with in accordanc e with the procedure laid down by Article 17(2)(a) of 
Directive 97/78/EC; or  
(b) reprocessed in a processing plant or decontaminated by a treatment authorised 
by the competent authority. The consignment must not be released until it has 
been treated, tested for salmonella or enterobacteriaceae, as necessary, by the competent authority in accordance with Section I of Annex XIV, and a negative result obtained.  
EN 150   EN CHAPTER III 
Import of rendered fats  
The following requirements shall apply to the importation of rendered fats: 
Rendered fat shall: 
(a) be entirely or partly derived from porcine raw material and come from a 
country or a part of the territory of a country free from foot-and-mouth disease 
for the previous 24 months and free from classical swine fever and African swine fever for the previous 12 months, 
(b) be entirely or partly derived from poultry raw material and come from a 
country or a part of the territory of a country free from Newcastle disease and 
avian influenza for the previous six months, 
(c) be entirely or partly derived from ruminant raw material and come from a 
country or a part of the territory of a country free from foot-and-mouth disease for the previous 24 months and free from Rinderpest for the previous 12 months, or 
(d) where there has been an outbreak of one of the abovementioned diseases 
during the relevant period mentioned above, have been subjected to one of the following heat treatment processes: 
– at least 70° C for at least 30 minutes, or 
– at least 90° C for at least 15 minutes. 
Details of the critical control points shall be recorded and maintained so that 
the owner, operator or their representative and, as necessary, the competent authority can monitor the operation of the plant; and the recorded information shall include the particle size, critical temperature and, as appropriate, the 
absolute time, pressure profile, raw material feed-rate and fat recycling rate.  
EN 151   EN CHAPTER IV 
Import of milk, milk-based products, colostrum and colostrum products 
A. The following requirements shall apply to  the importation of milk and milk-based 
products: 
1. Milk and milk-based products shall: 
(a) have undergone at least one of the treatments provided for in paragraphs 1.1, 
1.2, 1.3 and point (a) of paragraph 1.4 of Part I of Chapter IV of Section II of 
Annex XIV; 
(b) comply with paragraphs 2 and 4, and, in the case of whey, paragraph 3 of Part I 
of Chapter IV of Section II of Annex XIV. 
2. By way of derogation from paragraph 1.4 of Part I of Chapter IV of Section II, milk 
and milk products may be imported from third countries so authorised in Column “A” 
of Annex I to Commission Decision 2004/438/EC provided that the milk or milk products have undergone a single HTST treatment and: 
(a) have not been shipped before a period of at least 21 days has elapsed after 
production and during that period no case of foot-and-mouth disease has been detected in the exporting third country; or  
(b) have been presented at an EU border inspection post at least 21 days after 
production and during that period no case of foot-and-mouth disease has been detected in the exporting third country. 
B. The following requirements shall apply to the importation of colostrum and 
colostrum products: 
1. The materials shall have undergone a single HTST treatment and:  
(a) have not been shipped before a period of at least 21 days has elapsed after 
production and during that period no case of foot-and-mouth disease has been 
detected in the exporting third country; or  
(b) have been presented at an EU border inspection post at least 21 days after 
production and during that period no case of foot-and-mouth disease has been 
detected in the exporting third country. 
1. The materials shall have been obtained from bovine animals subject to regular 
veterinary inspections to ensure that they come from holdings on which all bovine herds are: 
(a) either recognised as officially tuberculosis free and officially brucellosis free as 
defined in Article 2(2)(d) and (f) of Directive 64/432/EEC or not restricted 
under the national legislation of the third country of origin of the colostrum 
regarding eradication of tuberculosis and brucellosis; and  
EN 152   EN (b) either recognised as official enzoo tic-bovine-leukosis-free as defined in Article 
2(2)(j) of Directive 64/432/EEC or incl uded in an official system for the 
control of enzootic-bovine-leukosis and there has been no evidence as a result 
of clinical and laboratory testing of this  disease in the herd during the past two 
years. 
2. The materials shall have undergone a single HTST treatment (*) and:  
(a) have not been shipped before a period of at least 21 days has elapsed after 
production and during that period no case of foot-and-mouth disease has been 
detected in the exporting third country; or  
(b) have been presented at an EU border inspection post at least 21 days after 
production and during that period no case of foot-and-mouth disease has been detected in the exporting third country. 
3. After completion of the processing, every precaution has been taken to prevent 
contamination of the colostrum or colostrum products. 
4. The final product must bear a label so as to indicate that it contains Category 3 
material and is not intended for human consumption, and that it has been: 
(a) packed in new containers, or  
(b) transported in bulk in containers or other means of transport that before use 
were thoroughly cleaned and disinfected.  
EN 153   EN SECTION II 
SPECIFIC REQUIREMENTS FOR THE IMPORT AND TRANSIT OF ANIMAL BY-
PRODUCTS AND DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN FOR 
FARMED ANIMALS 
CHAPTER I 
General requirements 
1. The importation and the transit  of the following animal by-products are prohibited: 
(a) unprocessed manure; 
(b) untreated feathers, part s of feathers and down; 
(c) beeswax in the form of honeycomb. 
2. The importation and the transit  of guano from wild sea birds are not subject to any 
animal health conditions.  
CHAPTER II 
Specific requirements 
As referred to in Article 41 paragraphs (2)(c) and (3) of the Animal By-products Regulation, 
imported consignments of animal by-products and derived  products and consignments  in 
transit: 
(a) must consist of or have been produced from animal by-products referred to in 
the column "raw materials" of table 2; 
(b) must comply with the import and transit  conditions set out in the relevant 
column of table 2; 
(c) must come from a third country or part of a third country listed in the relevant 
column of table 2; and 
(d) shall be accompanied during transportation to the point of entry into the Union 
where the veterinary checks take place by the health certificate referred to in the relevant column of table 2; or 
(e) shall be presented at the point of entry into the Union where the veterinary 
checks take place accompanied by a document corresponding to the model referred to in the relevant column of table 2 . 
  
EN 154   EN Table 2. 
No. Product Raw 
materials 
(reference 
to 
provisions 
of  the 
Animal 
By-
products Regulation
) Import and transit  conditions Third countries' lists Certificates/ 
model documents  
1 Processed 
manure,  
derived 
products 
from 
processed manure 
and guano 
from bats Material 
referred to 
in Article 
9 (a) The processed manure, the derived 
products from processed manure 
and the guano from bats must have 
been produced in accordance with 
Chapter II of Section I to Annex 
XV. Third countries listed in: 
(a) Part 1 of Annex II to Commission 
Regulation (EU) No 206/2010; 
(b) Annex I to Commission Decision 
2004/211/EC; or 
(c) Part 1 of Annex I to Commission 
Regulation (EC) No 798/2008. Annex XIX, 
Chapter 17 
2 Blood 
products, 
еxcluding 
from 
equidae, 
for the 
manufactuMaterial 
referred to 
in Article 
8 (c) and 
Article 10 
(a), (b), The blood products must have 
been produced in accordance with 
Chapter III. The following third countries: 
(a) in the case of untreated blood products of 
ungulates: 
Third countries or parts of third countries 
listed in Part 1 of Annex II to Commission (a) In the case of 
untreated blood 
products: 
Annex XIX, 
Chapter 4 (C)  
EN 155   EN re of 
derived 
products 
for uses 
outside 
the feed 
chain for 
farmed 
animals  (d) and (h) Regulation (EU) No 206/2010 from which 
imports of fresh meat of any domestic 
ungulate species is auth orised and only for the 
period indicated in column 7 and 8 of that 
Part, 
Japan 
(b) in the case of untreated blood products of 
poultry and other avian species: 
Third countries or parts of third countries 
listed in Part 1 of Annex I to Regulation (EC) 
No 798/2008. 
Japan. 
(c) in the case of untreated blood products of 
other animals: 
Third countries listed either in Part 1 of 
Annex II to Commission Regulation (EU) No 
206/2010, in Part 1 of Annex I to Regulation 
(EC) No 798/2008, or in Part 1 of Annex I to 
Regulation (EC) No 119/2009. 
Japan. 
(d) in the case of treated blood products of 
any species: 
Third countries listed in Part 1 to Annex II of 
Commission Regulation (EU) No 206/2010, (b) In the case of 
treated blood 
products: 
Annex XVIII, 
Chapter 4 (D)  
EN 156   EN in Part 1 of Annex I to Regulation (EC) No 
798/2008 or in Part 1 of Annex I to 
Commission Regulation (EC) No 119/2009 
Japan. 
3 Blood and 
blood 
products 
from equidae Materials 
referred to 
in Article 
10 (a), (b), and (c) The blood and the blood products  
shall comply with the requirements 
set out in Chapter IV. The following third countries: 
(a) in the case of blood that has been collected 
in accordance with point 1 of Chapter IV of 
Annex XVIII or where blood products have been produced in accordance with point 
2(b)(i) of that Chapter: 
Third countries or parts of third countries 
listed in Annex I to Decision 2004/211/EC, 
from which the importation of equidae for 
breeding and production is allowed. 
(b) in the case of blood products which have 
been treated in accordance with point 2(b)(ii) 
of Chapter IV of Annex XVII: 
Third countries listed in Part 1 of Annex II to 
Regulation (EU) No 206/2010, from which Member States authorise imports of fresh 
meat of domestic equidae. Annex XIX, 
Chapter 4(A) 
4 Fresh or 
chilled 
hides and 
skins of Materials referred to 
in Article 
10 (a) and The hides and skins shall comply with the requirements set out in 
Chapter V points 1 and 4. The hides and skins come from a third 
country, or, in the case of regionalisation in 
accordance with Union legislation, a part of a 
third country listed in part 1 of Annex II to Annex XIX, Chapter 5(A)  
EN 157   EN ungulates (b)(iii) Commission Regulation (EU) No 206/2010, 
from which Member States authorise imports 
of fresh meat from the same species. 
5 Treated 
hides and 
skins of 
ungulates Materials referred to 
in Article 
10 (b)(i) 
and (iii) 
and (n)  The hides and skins shall comply 
with the requirements set out in 
Chapter V points 2, 3 and 4. (a) In the case of treated hides and skins of 
ungulates: 
Third countries or parts of third countries 
listed in Part 1 to Annex II to Commission 
Regulation (EU) No 206/2010. 
(b) In the case of treated hides and skins of 
ruminants that are intended for dispatch to the 
European Union and which have been kept 
separate for 21 days or will undergo transport 
for 21 uninterrupted days before importation: 
Any third country. (a) In the case of 
treated hides and 
skins of ungulates:
Annex XIX, 
Chapter 5(B) 
(b) In the case of 
treated hides and 
skins of ruminants 
and of equidae 
that are intended 
for dispatch to the 
European Union 
and which have 
been kept separate 
for 21 days or will 
undergo transport for 21 
uninterrupted days 
before 
importation: 
The official 
declaration set out 
in Annex XIX, 
Chapter 5(C)  
EN 158   EN 6 Game 
trophies 
and other 
pre-
parations 
from 
animals  Materials 
referred to 
in Articles 
9(f) 
derived 
from wild 
animals 
not 
suspected 
of being infected 
with a 
disease 
communic
able to 
humans or 
animals 
and in Article 10 
(a), (b)(i), 
(iii) and 
(v) and (n) The game trophies shall comply 
with the requirements set out in 
Chapter VI. (a) In the case of game trophies referred to in 
Chapter VI paragraph 2: 
Any third country. 
(b) In the case of game trophies referred to in 
Chapter VI paragraph 3: 
(i) Game trophies from birds: 
Third countries listed in Part 1 of Annex I to 
Commission Regulation (EC) No 798/2008, 
from which the Member States authorise 
imports of fresh poultrymeat, and the following countries: 
(GL) Greenland 
(TN) Tunisia. 
(ii) Game trophies from ungulates: 
Third countries listed  in the appropriate 
columns for fresh meat of ungulates in part 1 
of Annex II to Commission Regulation (EU) 
No 206/2010, including any restrictions laid down in the column fo r special remarks for 
fresh meat. (a) In the case of 
game trophies 
referred to in 
Chapter VI point 
2: 
Annex XVIII, 
Chapter 6(A) 
(b) In the case of 
game trophies 
referred to in Chapter VI point 
3: 
Annex XIX, 
Chapter 6(B) 
7 Pig 
bristles Materials 
referred to 
in Article The pig bristles must have been 
obtained from animals originating, 
and slaughtered in a (a) In the case of untreated pig bristles: 
Third countries, or, in the case of (a) If no case of 
African swine 
fever has occurred  
EN 159   EN 10 (b)(iv) slaughterhouse, in the country of 
origin. regionalisation, regions thereof, listed in part 
1 of Annex II to Commission Regulation  
(EU) No 206/2010, which are free of African 
swine fever for the 12 months prior to the date 
of importation. 
(b) In the case of treated pig bristles: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
which may not be free of African swine fever for the last 12 months. during the 12 
previous months: 
Annex XIX, 
Chapter 7(A) 
(b) In case one or 
more cases of 
African swine 
fever have 
occurred during the previous 12 
months: 
Annex XIX, 
Chapter 7(B) 
8 Un-
processed 
wool and 
hair Materials 
referred to 
in Article 
10 (h) and 
(n) The untreated wool and hair must 
be 
(a) securely enclosed in packaging 
and dry; and 
(b) sent directly to a plant 
producing derived products for uses outside the feed chain or a 
plant carrying out intermediate 
operations, under conditions which 
prevent the spreading of 
pathogenic agents. Any third country For imports of 
untreated wool 
and hair, no health 
certificate is 
required. 
9 Treated Materials The treated feathers or parts of Any third country. For imports of  
EN 160   EN feathers, 
parts of 
feathers 
and down  referred to 
in Article 
10 (b)(v),  
(h) and (n) feathers shall comply with the 
requirements set out in Chapter 
VII. pre-treated 
feathers, parts of 
feathers and 
down, no health 
certificate is 
required. 
10 Apiculture 
by-
products Materials referred to in Article 
10 (e) (a) In the case of apiculture by-
products intended for use in apiculture: 
(i) The apiculture by-products 
have been subjected to a 
temperature of -12°C or lower for 
at least 24 hours; or 
(ii) In the case of wax, the material 
has been processed in accordance 
with processing methods 1 to 5 or 
7, as set out in Section III of 
Annex VII, and refined before 
importation. 
(b) In the case of beeswax for 
purposes other than feeding to 
farmed animals, the beeswax has 
been refined or processed in 
accordance with processing 
methods 1 to 5 or 7, as set out in 
Section III of Annex VII before 
importation. (a) In the case of apiculture by-products 
intended for use in apiculture: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
and the following country: 
(CM) Cameroon. 
 
 
(b) In the case of beeswax for purposes other 
than feeding to farmed animals: 
Any third country. (a) In the case of 
apiculture by-products intended 
for use in 
apiculture: 
Annex XIX, 
Chapter 13 
 
(b) In the case of 
beeswax for  
purposes other 
than feeding to 
farmed animals: 
A commercial 
document 
attesting the 
refinement or 
processing.  
EN 161   EN 11 Bones and 
bone 
products 
(excluding 
bone 
meal), 
horns and 
horn 
products 
(excluding horn 
meal) and 
hooves 
and hoof 
products 
(excluding 
hoof 
meal) for uses other 
than as 
feed 
material, 
organic 
fertiliser 
or soil 
improver Materials 
referred to 
in Article 
10 (a) and 
(b)(i), (iii),  
(e) and (h) The products shall comply with the 
requirements set out in Chapter 
VIII. Any third country. The products shall 
be accompanied 
by: 
(a) a commercial 
document as et 
out in Chapter 
VIII point 2; and 
(b) a declaration 
of the importer in 
accordance with Annex XIX, 
Chapter 16 in at 
least one official 
language of the 
Member State 
through which the 
consignment first 
enters the Union and in at least one 
official language 
of the Member 
State of 
destination. 
12 Petfood 
and 
dogchews (a) In the 
case of 
processed 
petfood The petfood and the dogchews 
must have been produced in 
accordance with Chapter II of 
Annex XVII. (a) In the case of raw petfood: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, (a) In the case of 
canned petfood: 
Annex XIX,  
EN 162   EN and 
dogchews: 
Materials 
referred to 
in Article 
35 (a)(i) 
and (ii) 
(b) In the 
case of raw 
petfood: 
Materials 
referred to 
in Article 
35 (a)(iii) in Annex I to Decision 94/984/EC, or in 
Annex I to Commission Regulation (EC) No 
798/2008, from which Member States 
authorise imports of fresh meat from the same 
species and where only bone in meat is 
authorised.  
In the case of fish materials, third countries 
listed in Annex II to Commission Decision 
2006/766/EC. 
(b) In the case of dogchews and petfood other 
than raw petfood: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
and the following countries: 
(JP) Japan 
(EC) Ecuador 
(LK) Sri Lanka 
(TW) Taiwan Chapter 3(A) 
(b) In the case of 
processed petfood 
other than canned 
petfood: 
Annex XIX, 
Chapter 3(B) 
(c) In the case of 
dogchews: 
Annex XIX, 
Chapter 3(C) 
(d) In the case of 
raw petfood: 
Annex XIX, 
Chapter 3(D). 
13 Fla-
vouring 
innards 
for the 
manu-
facture of Materials 
referred to 
in Article 
35 (a)  The flavouring innards must have 
been produced in accordance with 
Chapter III of Annex XVII. Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
from which Member States authorise imports 
of fresh meat from the same species and 
where only bone in meat is authorised.  
In the case of flavouring innards from fish Annex XIX, 
Chapter 3(E)  
EN 163   EN petfood materials, third countries listed in Annex II to 
Commission Decision 2006/766/EC. 
14 Animal 
by-
products 
for the 
manu-
facture of petfood 
other than  
raw 
petfood  
and of derived 
products 
for uses 
outside 
the feed 
chain (a) 
Materials 
referred to 
in Article 
10 (a) to 
(k)  
(b) In the 
case of 
materials 
for the 
manu-
facture of 
petfood, 
materials 
referred to 
in Article 
8 (c) 
 The products shall comply with the 
requirements set out in Chapter IX.(a) In the case of animal by-products for the manufacture of petfood: 
(i) In the case of animal by-products from 
bovine, ovine, caprine, porcine and equine 
animals, including farmed and wild animals: 
Third countries or parts of third countries 
listed in part 1 of Annex II to Commission 
Regulation (EU) No 206/2010, from which 
imports of fresh meat for human consumption 
is authorised. 
(ii) Raw material from poultry including 
ratites: 
Third countries or parts of third countries 
from which Member States authorise imports 
of fresh poultrymeat, which are listed in Part 1 
of Annex I to Commission Regulation (EC) 
No 798/2008. 
(iii) Raw material from fish: 
Third countries listed in Annex II to 
Commission Decision 2006/766/EC. 
(iv) Raw material from other wild land 
mammals and leporidae : (a) In the case of 
animal by-
products for the 
manufacture of 
processed 
petfood: 
Annex XIX, 
Chapter 3(F) 
(b) In the case of 
animal by-
products for the 
manufacture of 
products for uses 
outside the feed 
chain: 
Annex XIX, 
Chapter 8  
EN 164   EN Third countries listed in Part 1 of Annex II to 
Commission Regulation (EU) No 206/2010 or 
in part 1 of Annex I to Regulation (EC) No 
798/2008. 
(b) In the case of animal by-products for the 
manufacture of pharmaceuticals: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010, 
in Part 1 of Annex I to Commission 
Regulation (EC) No 798/2008 or in Part 1 of Annex I to Commission Regulation (EC) No 
119/2009, and the following third countries: 
(JP) Japan 
(PH) Philippines 
(TW) Taiwan. 
(c) In the case of animal by-products for the 
manufacture of products for uses outside the 
feed chain, other than pharmaceuticals: 
Third countries listed in part 1 of Annex II to 
Commission Regulation (EU) No 206/2010 
from which imports of that Category of fresh 
meat of the respective species is authorised, in 
Part 1 of Annex I to Commission Regulation 
(EC) No 798/2008, in Part 1 of Annex I to 
Commission Regulation (EC) No 119/2009,  
EN 165   EN or, in the case of material from fish, third 
countries listed in Annex II to Commission  
Decision 2006/766/EC. 
15 Animal 
by-
products 
for use as 
raw 
petfood Materials 
referred to 
in Article 
10 (a) and 
(b)(i) and 
(ii) The products shall comply with the 
requirements set out in Chapter IX.Third countries listed in part 1 of Annex II to Commission Regulation (EU) No 206/2010, 
from which Member States authorise imports 
of fresh meat from the same species and 
where only bone in meat is authorised.  
In the case of fish materials, third countries 
listed in Annex II to Commission Decision 
2006/766/EC. 
 Annex XIX, 
Chapter 3(D) 
16 Animal 
by-
products 
for use in 
feed for 
fur 
animals  Materials 
referred to 
in Article 
10 (a), b(i) 
and (ii) The products shall comply with the 
requirements set out in Chapter IX.Third countries listed in part 1 of Annex II to Commission Regulation (EU) No 206/2010, 
in Annex I to Commission Regulation (EC) 
No 798/2008, from which Member States 
authorise imports of fresh meat from the same 
species and where only bone in meat is 
authorised.  
In the case of fish materials, third countries 
listed in Annex II to Commission Decision 
2006/766/EC. 
 Annex XIX, 
Chapter 3(D) 
17 Rendered 
fats for (a) In the case of The rendered fats shall comply with the requirements set out in Third countries listed in part 1 of Annex II to Commission Regulation (EU) No 206/2010 Annex XIX, Chapter 10(B)  
EN 166   EN certain 
purposes 
outside 
the feed 
chain materials 
destined to 
the 
production
of 
biodiesel: 
Materials 
referred to 
in Articles 8, 9 and 
10 
(b) In the 
case of 
materials 
destined to 
other 
purposes: 
Materials 
referred to in Article 
8 points 
(c) and 
(d), 
Article 9 
points (c), 
(d) and 
(f)(i) and 
Article 10 Chapter X. and, in the case of fish materials, third 
countries listed in Annex II to Commission 
Decision 2006/766/EC.  
EN 167   EN 18 Fat deri-
vatives (a) In the 
case of fat 
derivatives 
for uses 
outside the 
feed chain: 
Materials 
referred to 
in Article 
8 points (c) and 
(d), 
Article 9 
points (c), 
(d) and 
(f)(i) and 
Article 10 
(b) In the 
case of fat 
derivatives 
for use as 
feed or for 
uses 
outside the 
feed chain: 
Materials 
referred to 
in Article The fat derivatives shall comply 
with the requirements set out in 
Chapter XI. Any third country. (a) In the case of 
fat derivatives for 
uses outside the 
feed chain: 
Annex XIX, 
Chapter 14(A) 
(b) In the case of 
fat derivatives for 
use as feed or for 
uses outside the feed chain: 
Annex XIX, 
Chapter 14(B)  
EN 168   EN 10 
19 Photo-
gelatine Materials 
referred to 
in Article 
8(b) and 
10 The imported photogelatine shall 
comply with the requirements set 
out in Chapter XII. Photogelatine may only be imported from 
establishments of origin in the United States 
and in Japan that are authorised in accordance 
with Chapter XII. Annex XIX, Chapter 19 
20 Horns and 
horn 
products, 
excluding 
horn meal, 
and 
hooves 
and hoof 
products, 
excluding 
hoof meal, for the 
pro-
duction of 
organic 
fertilisers 
or soil 
improvers Materials 
referred to in Article 
10 (a), (b), 
(h) and (n) The products shall comply with the 
requirements set out in Chapter XIII. Any third country. Annex XIX, 
Chapter 18  
EN 169   EN   
EN 170   EN  
CHAPTER III 
Import of blood and blood products, excluding from equidae, for the manufacture of 
derived products for uses outside the feed chain for farmed animals 
The following requirements shall apply to the import of blood and blood products, excluding 
from equidae, for the manufacture of derived products for uses outside the feed chain for farmed animals: 
1. The blood products must originate from a plant for the production of derived products 
for uses outside the feed chain which meets the specific conditions laid down in this 
Regulation or from the establishment of collection. 
2. The blood from which blood products for the manufacture of derived products for uses 
outside the feed chain for farmed animals are produced must have been collected: 
(a) in slaughterhouses approved in accordance with Union legislation; 
(b) in slaughterhouses approved and supervised by the competent authority of the 
third country; or 
(c) from live animals in facilities approved and supervised by the competent 
authority of the third country. 
3. In the case of blood products for the manufacture of derived products for uses outside 
the feed chain for farmed animals which have been derived from animals belonging to 
the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, 
they must comply with the conditions of either point (a) or (b): 
(a) the products have undergone one of the following treatments guaranteeing the 
absence of pathogens of the diseases referred to in point (b): 
(i) heat treatment at a temperature of 65°C for at least three hours, 
followed by an effectiveness check, 
(ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness 
check, 
(iii) heat treatment of at least 80 °C throughout their substance, followed by 
an effectiveness check, 
(iv) in the case of animals other than Suidae and Tayassuidae only: change 
in pH to pH 5 for two hours, followed by an effectiveness check; 
(b) in case of blood products not treated in accordance with point (a) the products 
originate from a country or region:  
EN 171   EN (i) where no case of rinderpest, peste des petits ruminants and Rift Valley 
fever has been recorded for 12 months and in which vaccination has not 
been carried out against those diseases for at least 12 months. 
(ii) where no case of foot-and-mouth disease has been recorded for 
12 months and in which vaccination has not been carried out against 
this disease for at least 12 months 
or 
where no case of foot-and- mouth disease has been recorded for 12 months and 
in which vaccination programmes against foot-and-mouth disease are 
being officially carried out and controlled in domestic ruminant animals 
for at least 12 months; in this case, following the border check provided for in Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive, the products must be transported 
directly to the registered establishment or plant of destination and all 
precautions, including safe disposal of waste, unused or surplus material, 
must be taken to avoid risks of spreading diseases to animals or humans. 
In addition to point (i) and (ii), in the case of animals other than Suidae and 
Tayassuidae, one of the following c onditions must be complied with: 
- in the country or region of origin  no case of vesicular stomatitis and 
bluetongue (including the presence of seropositive animals) has been recorded for 12 months and vaccination has not been carried out against those diseases for at least 12 months in the susceptible 
species, 
- following the border check provided for in Directive 97/78/EC, and 
in accordance with the conditions laid down in Article 8(4) of that 
Directive, the products must be transported directly to the plant of destination and all precautions, including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading diseases to animals or humans. 
In addition to point (i) and (ii), in th e case of Suidae and Tayassuidae, in the 
country or region of origin no case of swine vesicular disease, classical swine fever and African swine fever has been recorded for at least 12 months, vaccination has not been carried out against those diseases for at least 12 months and one of the following conditions are complied with: 
-  in the country or region of or igin no case of vesicular stomatitis 
(including the presence of seropositive animals) has been recorded 
for 12 months and vaccination has not been carried out against this 
disease for at least 12 months in the susceptible species, 
-  following the border check provided for in Directive 97/78/EC, 
and in accordance with the conditions laid down in Article 8(4) of 
that Directive, the products must  be transported directly to the 
registered establishment or plant of destination and all precautions,  
EN 172   EN including safe disposal of waste, unused or surplus material, must 
be taken to avoid risks of spreading diseases to animals or humans. 
4. In the case of blood products for the manufacture of derived products for uses outside 
the feed chain for farmed animals which have been derived from poultry and other 
avian species, they must comply with the conditions of either point (a) or (b): 
(a) the products have undergone one of the following treatments guaranteeing the 
absence of pathogens of the diseases referred to in point (b): 
(i) heat treatment at a temperature of 65°C for at least three hours, 
followed by an effectiveness check, 
(ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness 
check, 
(iii) heat treatment of at least 70°C throughout their substance, followed by 
an effectiveness check; 
(b) in case of blood products not treated in accordance with point (a) the products 
originate from a country or region: 
(i) which has been free from Newcastle disease and highly pathogenic 
avian influenza as defined in the Terrestrial Animal Health Code of the 
OIE, 2009 edition, 
(ii) which during the last 12 months has not carried out vaccination against 
avian influenza, 
(iii) where the poultry or other avian species from which the products 
derive have not been vaccinated against Newcastle disease with 
vaccines prepared from a Newcastle disease master strain showing a higher pathogenicity than lentogenic virus strains. 
CHAPTER IV 
Import of blood and blood products from equidae 
The following requirements shall apply to the import of blood and blood products from equidae: 
1. The blood must comply with the conditions set out in point 1(a) of Chapter IV of Annex 
XVII and must be collected under veterinary supervision either in: 
(a) slaughterhouses  
(i) approved in accordance with Regulation (EC) No 853/2004; or  (ii) approved and supervised by the competent authority of the third country; or  
EN 173   EN (b) facilities approved, furnished with a vete rinary approval number and supervised by 
the competent authority of the third country for the purpose of collecting blood 
from equidae for the production of blood products for purposes other than feeding. 
2. The blood products must comply with the conditions set out in point 2 of Chapter IV of 
Annex XVII. 
In addition, the blood products  referred to in point 2(b)(i) of Chapter IV of Annex XVII  
must be produced from blood collected from equidae which have been kept for a period 
of at least three months, or since birth if less than three months old, prior to the date of collection on holdings under veterinary supervision in the third country of collection which during that period and the period of blood collection has been free of:  
(a) African horse sickness in accordan ce with Article 5(2) (a) of Directive 
90/426/EEC; 
(b) Venezuelan equine encephalomyelitis for a period of at least two years; (c) glanders: 
(i) for a period of three years; or 
(ii) for a period of six months where the animals have shown no clinical signs of 
glanders ( Burkholderia mallei ) during the post-mortem inspection in the 
slaughterhouse referred to in paragraph 1(a), including a careful examination 
of mucous membranes from the trachea, larynx, nasal cavities and sinuses 
and their ramifications, after splitting the head in the median plane and 
excising the nasal septum;  
(d) vesicular stomatitis for six months. 
3. Blood products must come from an approved or registered establishment or plant 
approved by the competent authority of the third country. 
4. Blood and blood products shall be packed and labelled in accordance with point 3(a)
 of 
Chapter IV of Annex XVII. 
CHAPTER V 
Import of hides and skins of ungulates 
The following requirements shall apply to the import of hides and skins of ungulates: 
1. Fresh or chilled hides and skins may be imported if: 
(a) they come from a third country referred to in the applicable column of row 4 of 
Chapter II which, as appropria te to the species concerned: 
(i) for at least 12 months before dispatch, has been free from the following 
diseases:  
EN 174   EN — classical swine fever, 
— African swine fever, and 
— rinderpest, and 
(ii) has been free for at least 12 months before dispatch from foot-and mouth 
disease and where, for 12 months before dispatch, no vaccination has 
been carried out against foot-and-mouth disease; 
(b) they have been obtained from: 
(i) animals that have remained in the territory of the country of origin for 
at least three months before being sl aughtered or since birth in the case 
of animals less that three months old,  
(ii) in the case of hides and skins from bi-ungulates, animals that come 
from holdings in which there has been no outbreak of foot-and mouth 
disease in the previous 30 days, and around which within a radius of 10 km there has been no case of foot-and-mouth disease for 30 days, 
(iii) in the case of hides and skins from swine, animals that come from 
holdings in which there has been no outbreak of swine vesicular disease in the previous 30 days, or of classical or African swine fever in the previous 40 days, and around which within a radius of 10 km there 
has been no case of these diseases for 30 days, or 
(iv) animals that have passed the ante-mortem health inspection at the 
slaughterhouse during the 24 hours before slaughter and have shown no 
evidence of foot-and-mouth disease, rinderpest, classical swine fever, 
African swine fever or swine vesicular disease; and 
(c) they have undergone all precautions to avoid recontamination with pathogenic 
agents. 
2. Treated hides and skins referred to in point C.2 of Chapter V of Annex XVII may be 
imported without any restrictions. 
3. Other treated hides and skins may be imported if: 
(a) they come either from: 
(i) a third country or, in the case of regionalisation in accordance with 
Union legislation, from a part of a third country, appearing on the list 
set out in point (a) of the column "third countries' list" of row 5 of 
Chapter II of this Annex from which imports of fresh meat of the corresponding species are authorised and they have been treated as 
referred to in Annex I, point 51  (a), (b) and (c); 
(ii) a third country appearing on the list set out in point (a) of the applicable 
column of row 5 of Chapter II and they have been treated as referred to in Annex I, point 51 (c) or (d); or  
EN 175   EN (iii) equidae or ruminant animals from a third country appearing on the list 
set out in point (b) of the column "third countries' list" of row 5 of 
Chapter II of this Annex, which have been treated as referred to in 
Annex I, point 51 (a), (b) and (c) and after treatment have been kept 
separate for at least 21 days; and 
(b) in the case of salted hides and skins transported by ship, they have been treated 
as referred to in Annex I, point 51  (b) or (c) and have been kept separated after 
treatment during transportation for at least 14 days in the case of the treatment 
referred to in point (b) or seven days in the case of the treatment referred to in 
point (c) before importation and the health certificate accompanying the consignment attests such treatment an d the duration of the transportation. 
4. Fresh, chilled or treated hides and skins of  ungulates must be imported in containers, 
road vehicles, railway wagons or bales sealed under the responsibility of the 
competent authority of the third country of dispatch. 
CHAPTER VI 
Import of game trophies and other preparations from animals 
The following requirements shall apply to the import of game trophies and other preparations 
from animals: 
1. Game trophies or other pr eparations from animals which fu lfil the conditions referred 
to in points B and C.1 of Chapter VI of  Annex XVII may be imported without 
restrictions. 
2. Treated game trophies or other prepara tions from birds and ungulates, being solely 
bones, horns, hooves, claws, antlers, teeth, hides or skins, from third countries may be 
imported if they comply with the requirements of points C .1(a), C.2(a), (i) to (iii) and 
(b)(i) and (ii) of Chapter VI of Annex XVII.  
 However, in the case of dry-salted or wet- salted skins transported by ship, the skins 
need not be salted 14 days before dispatch, provided that they are salted for 14 days before importation. 
3. Game trophies or other preparations from birds and ungulates consisting of entire 
anatomical parts, not having been treated in any way may be imported if:  
(a) they come from animals originating in an area not subject to restrictions as a 
result of the presence of serious transmissible diseases to which animals of the species concerned are susceptible; 
(b) they were packaged without being in contact with other products of animal 
origin likely to contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination;   
EN 176   EN CHAPTER VII 
Import of treated feathers, parts of feathers and down 
Treated feathers, parts of feathers and down may be imported if: 
(a) they are treated decorative feathers, treated feathers carried by travellers for 
their private use or consignments of trea ted feathers or down sent to private 
individuals for non-industrial purposes; or 
(b) they are accompanied by a commercial document stating that the feathers,  
parts of feathers or down  have been treated with a steam current or by another 
method ensuring the inactivation of pathogens and are securely enclosed in 
packaging and dry; and 
(c) unless the commercial document states that they have been factory washed and 
treated with hot steam at 100°C for at least 30 minutes, they are sent to a 
registered establishment or plant for such treatment. 
CHAPTER VIII 
Import of bones and bone products (excludi ng 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 fertilizers or soil improvers 
1. Bones and bone products (excluding bone meal), horns and horn products (excluding 
horn meal) and hooves and hoof products (excluding hoof meal) may be imported to 
produce derived products for uses outside the food or feed chain if: 
(a) the products are dried before export and not chilled or frozen;  
(b) the products are conveyed only by land and sea from their country of origin 
direct to a border inspection post in the Union and are not transhipped at any 
port or place outside the Union;  
(c) following the document checks provided for in Directive 97/78/EC, the 
products are conveyed directly to the registered establishment or plant of destination. 
2. Each consignment must be accompanied by a commercial document stamped by the 
competent authority supervising the establishment of origin, including the following information: 
(a) the country of origin, 
(b) the name of the establishment or plant of production, 
(c) the nature of the product (dried bone/dried bone product/dried horns/ dried 
horn products/dried hooves/dried hoof products), and  
EN 177   EN (d) the fact that the product was: 
(i) derived from healthy animals slaughtered in a slaughterhouse, or 
(ii) dried for 42 days at an average temperature of at least 20° C, or (iii) heated for one hour to at least 80°C to the core before drying, or 
(iv) ashed for one hour to at least 800°C to the core before drying, or 
(v) underwent an acidification process such that the pH was maintained at 
less than 6 to the core for at least one hour before drying, and is not 
intended at any stage to be diverted for any use in food, feed material, organic fertilizers or soil improvers. 
3. On dispatch to the Union territory, the mate rial must be enclosed in sealed containers 
or vehicles or carried in bulk in a ship. If transported in containers, the containers, and 
in all cases all the accompanying documents, must bear the name and the address of the registered establishment or plant of destination. 
4. Following the border check provided for in Directive 97/78/EC, and in accordance 
with the conditions laid down in Article 8(4)  of that Directive, the material must be 
transported direct to the registered establishment or plant of destination 
CHAPTER IX 
Import 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 
Animal by-products intended for the manufacture of feed for fur animals, petfood, other than 
raw petfood,  and for derived products for uses outside the feed chain may be imported 
provided that: 
1. the animal by-products  have been deep-frozen at the plant of origin or have been 
preserved in accordance with Union legisl ation in such a way to prevent spoiling 
between dispatch and delivery to the establishment or  plant of destination; 
2. the animal by-products  have undergone all precautions to avoid contamination with 
pathogenic agents; 
3. the animal by-products  were packed in new packaging preventing any leakage; 
4. following the border checks provided for in Directive 97/78/EC, and in accordance 
with the conditions laid down in Article 8(4) of that Directive, the animal by-products  
are transported directly either: 
(a) to a petfood plant or a registered establishment or plant of destination, which 
has given the guarantee that the animal by-products shall be used only for the 
purpose of producing the products for which it has been registered or approved,  
EN 178   EN as applicable, as specified by the comp etent authority if necessary, and shall 
not leave the plant untreated other than for direct disposal; or 
(b) to an establishment or plant which has been approved in accordance with 
Article 24 (1)(h) of the Animal  By-products Regulation;  
(c) to a registered user or collection centre, which has given the guarantee that the 
animal by-products shall be used only for permitted purposes, as specified by 
the competent authority if necessary; or 
(d) to an establishment or plant which has been approved in accordance with 
Article 24(1)(a) of the Animal By-products Regulation; 
and 
5.1. in the case of raw material for petfood pro duction referred to in Ar ticle 35(a)( ii) of the 
Animal By-products Regulation, the raw material  shall: 
(a) be marked in the third country before entry into the territory of the Union by a 
cross of liquefied charcoal or activated carbon, on each outer side of each 
frozen block, or, when the raw material is transported in pallets which are not 
divided into separate consignments during transport to the petfood plant of destination, on each outer side of each pallet,  in such a way that the marking 
covers at least 70 % of the diagonal length of the side of the frozen block and is at least 10 cm in width; 
(b) in the case of material which is not frozen, be ma rked in the third country 
before entry into the territory of the Union by spraying it with liquefied charcoal or by applying charcoal powder in such a way that the charcoal is 
clearly visible on the material; 
(c) be transported directly to: 
(i) the petfood plant of destination in accordance with point 4(a) above; or 
(ii) an establishment or plant of destination which has been approved in 
accordance with Article 24 (1)(h) of the Animal By-products 
Regulation, in accordan ce with point 4(b) of this Chapter and from 
there directly to the petfood plant referred to under subpoint (i), provided that the plant of destination: 
– only handles material covered by this point 5.1, or 
– only handles material destined for a petfood plant as referred to under (i); 
 and 
(d) be manipulated to remove the marking provided for in (a) and (b) only in the 
petfood plant of destination and only immediately prior to use of the material  
EN 179   EN for the manufacture of petfood, in accord ance with the conditions applicable to 
petfood produced from Category 3 material in Chapter II of Annex XVII; 
5.2. in the case of consignments made up of raw material, which has been treated as 
referred to in 6.1 above and other non-treated  raw material, all the raw materials in the 
consignment have been marked as laid down in point 5.1(a) and (b) above. 
5.3. the marking referred to in points 5.1 (a) and (b) and 5.2 remains visible from the 
dispatch and until the delivery to the petfood plant of destination. 
6. In the petfood plant of destination, raw material for petfood production referred to in 
Article 35(a)(ii) of the Animal By-produc ts Regulation shall be stored before 
production under conditions authorised by the competent authority, which allow 
official controls on the amounts of material received, used for production and disposed 
of, if applicable. The competent authority may authorise the operator of the petfood plant to store such materials together with Category 3 material. 
CHAPTER X 
Import of rendered fats for certain purposes outside the feed chain 
Rendered fats may be imported for purposes other than the production of feed for farmed 
animals, of organic fertilisers, of cosmetics, of medicinal products or of medical devices, 
provided: 
(a) they are derived from: 
(i) in the case of materials destined to the production of biodiesel, animal 
by-products referred to in Articles 8, 9 and 10 of the Animal By-products 
Regulation; 
(ii) in the case of other materials,   animal by-products referred to in Article 8 
points (c) and (d), Article 9 points (c), (d) and (f)(i) or Article 10 of the Animal By-products Regulation; 
(b) they have been processed by pressure sterilisation or in accordance with one of 
the methods referred to in Section III of Annex VII; 
(c) in the case of fat from ruminant origin , insoluble impurities in excess of 0.15% 
by weight have been removed; 
(d)  they have been marked before ship ment to the European Union so that the 
minimum concentration of GTH referred to  in point 1(b) of Section V of 
Annex XI is achieved; 
(e) they are transported under conditions which prevent contamination; 
(f) they bear labels, on the packaging or container indicating "NOT FOR HUMAN 
OR ANIMAL CONSUMPTION".  
EN 180   EN  
CHAPTER XI 
Import of fat derivatives 
1. Fat derivatives may be imported if the health certificate accompanying the 
consignment states: 
(a) whether the fat derivatives derive from Category 1, 2 or 3 materials; 
(b) in the case of fat deri vatives produced from Category 2 material, that the 
products: 
(i) have been produced using a method that at least meets the standards of 
one of the processes referred to in Chapter XI of Annex XVII, and 
(ii) shall only be used in organic fert iliser or soil improvers or other uses 
outside the feed chain, other than in cosmetics, pharmaceuticals and 
medical devices. 
(c) in the case of fat deri vatives produced from Category 1 material, that the 
products shall only be used in uses outside the feed chain, other than in organic fertilisers, soil improvers, cosmetics, pharmaceuticals and medical devices . 
2. The health certificate provided for in point 1 must be presented to the competent 
authority at the border inspection post at the first point of entry of the goods into the Union, and thereafter a copy must accompany the consignment until its arrival at the plant of destination. 
3. Following the checks provided for in Directive 97/78/EC, and in accordance with the 
conditions laid down in Article 8(4) of that  Directive, the fat derivatives shall be 
transported directly to the registered establishment or  plant of destination. 
CHAPTER XII 
Import of photogelatine 
1. Gelatine which has been produced from material containing bovine vertebral column 
classified as Category 1 material in accordance with Article 8(b) of the Animal By-
products Regulation and which is intended for the photographic industry (photogelatine) may be imported, provided the photogelatine: 
(a) originates from one of the establishments indicated in table 3; 
(b) has been produced in accordance with point 6 of this Chapter; 
(c) is imported through one of the border inspection posts of first entry indicated in 
table 3; and  
EN 181   EN (d) is destined for production in an approved photographic factory indicated in 
table 3.  
EN 182   EN Table 3: Import of photogelatine 
 
Third country of 
origin Plants of origin Member State of 
destination Border inspection post of first entry Approved photographic factories 
Nitta Gelatin 
Inc., 2-22 Futamata 
Yao-City, Osaka 
581-0024 Japan 
 
Jellie Co. Ltd- 
7-1, Wakabayashi 2-Chome, Wakabayashi-
ku, 
Sendai-City; 
Miyagi, 982 Japan  NIPPI Inc. 
Gelatine 
Division 1 Yumizawa-Cho Fujinomiya City 
Shizuoka 
418-0073 Japan The Netherlands Rotterdam FUJIFILM 
Europe B.V., 
Oudenstaart 1, 
5047 TK Tilburg, 
The Netherlands 
United Kingdom Liverpool 
Felixstowe 
Heathrow Kodak Ltd. Headstone Drive, Harrow, MIDDX, 
HA4 4TY, 
The United Kingdom Japan 
Nitta Gelatin 
Inc., 2-22 Futamata 
Yao-City, Osaka 
581-0024 Japan 
 
Czech Republic Hamburg FOMA 
BOHEMIA spol. 
s.r.o. Jana Krušinky 1604 501 04 Hradec 
Králove, 
The Czech  
EN 183   EN Republic 
United Kingdom Liverpool 
Felixstowe 
Heathrow Kodak Ltd. Headstone Drive, Harrow, MIDDX, 
HA4 4TY, 
The United Kingdom United States of 
America Eastman Gelatine Corporation, 
227 Washington 
Street, 
Peabody, MA, 01960 
USA 
Gelita North 
America, 2445 Port Neal Industrial Road 
Sergeant Bluff, 
Iowa, 51054 
USA 
Czech Republic Hamburg FOMA 
BOHEMIA spol. 
s.r.o. 
Jana Krušinky 1604 501 04 Hradec Králove, The Czech 
Republic 
2. Once the photogelatine has entered the Member State of destination, it shall not be 
traded between Member States but shall only be used in the approved photographic 
factory in the same Member State of destination and solely for photographic 
production purposes. 
3. Following the checks provided for in Dire ctive 97/78/EC, and in accordance with the 
conditions laid down in Article 8(4) of that Directive, the photogelatine shall be 
transported directly to the approved photographic factory of destination. 
4. The transport referred to in point 3 shall be carried out in vehicles or containers in 
which the photogelatine is physically separated from any products intended for food 
or feed. 
5. In the approved photographic factory of destination, the operator shall ensure that 
any surpluses or residues of and other waste derived from the photogelatine are:   
EN 184   EN (a) transported in sealed leak-proof containers labelled 'for disposal only' in 
vehicles under satisfactory hygiene conditions; 
(b) disposed of in accordance with Article 12 (a)(i) of the Animal By-products 
Regulation or exported to the country of origin in accordance with Regulation 
(EC) No 1013/2006. 
6. Photogelatine shall be produced according to the following: 
(a) Photogelatine shall only be produced in plants which do not produce gelatine 
for food or feed intended for dispatch to the European Union, and which are 
approved by the competent authority of the third country concerned. 
(b) Photogelatine shall be produced by a process that ensures that raw material is 
treated by processing method 1 as referr ed to in Section III of Annex VII or 
subjected to a treatment with acid or alkali for at least two days, washing with 
water, and: 
(i) following an acid treatment, treati ng with alkaline solution for at least 20 
days; or 
(ii) following an acid treatment, treatin g with an acid solution for 10 to 12 
hours. 
The pH must then be adjusted and the material purified by means of filtration 
and sterilisation at 138-140°C for 4 seconds. 
(c) After having been subjected to the process referred to in point (b), the 
photogelatine may undergo a drying proc ess and, where appropriate, a process 
of pulverisation or lamination. 
(d) The photogelatine shall be wrapped, packaged in new packages, stored and 
transported in sealed leak-proof, labelled containers in a vehicle under 
satisfactory hygiene conditions. If leakage is observed, the vehicle and containers shall be thoroughly cleaned and inspected before re-use. 
(e) Wrapping and packages containing the photogelatine must carry the words 
'photogelatine for the photographic industry only'. 
CHAPTER XIII 
Import of horns and horn products, excluding horn meal,  
and hooves and hoof products, excluding hoof meal,  
intended for the production of organic fertilizers or soil improvers 
Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, intended for the production of organic fer tilizers or soil improvers, may be imported, 
provided. 
1. they have been produced in accordance with Chapter XII of Annex XVII;  
EN 185   EN 2. they are conveyed following the veterinary checks in the border inspection post at the  
point of entry into the Union  provided for in Directive 97/78/EC, and in accordance with 
the conditions laid down in Article 8(4) of that Directive, directly to an approved or  
registered establishment or plant.  
EN 186   EN SECTION III 
SPECIAL RULES FOR CERTAIN SAMPLES 
CHAPTER I 
Research and diagnostic samples 
1.  The import and transit of research and diagnostic samples shall take place in 
accordance with conditions laid down by the competent authority  that ensure the 
control of risks to public and animal health.  
Such conditions should include at least the following:   
(a) the introduction has been authorised in  advance by the competent authority of 
the Member State of destination; 
(b) consignments are to be sent directly  from point of entry into the European 
Union to the authorised user and the competent authority of the place of 
destination is informed by means of the TRACES system .   
2. Research and diagnostic samples referred to in point 1 shall not be subject to 
veterinary checks at the border inspection post in accordance with Council Directive 97/78/EC.  
3.  Research and diagnostic samples and any products derived from the use of those 
samples shall be disposed of:  
(a)  as waste by incineration; or 
(b) in accordance with point 5(b) of Chapter I of Section I of Annex IX in case: 
(i) of quantities not exceeding 2000 ml; and (ii)  if the samples or derived products have been produced and dispatched 
from third countries or parts of third countries, from which Member 
States authorise imports of fresh meat of domestic bovine animals, which 
are listed in Part I of Annex II to Regulation (EC) No 206/2010.  
CHAPTER II 
Trade samples  
1. The competent authority may authorise th e import and transit of trade samples, 
provided: 
(a) they originate from third countries referred to in the column "third countries' 
list" of table 2 of Chapter II of Section II of Annex XVIII;  
EN 187   EN (b) they are accompanied by a health certificate as referred to in Chapter 8 of 
Annex XIX; and 
(c) following the border check provided for in Directive 97/78/EC, and in 
accordance with the conditions laid down in Article 8(4) of that Directive, they 
are transported directly to the approved or registered establishment or plant indicated in the authorisation of competent authority. 
2.  Unless the trade samples are kept for reference purposes, they shall be  disposed of: 
(a) in accordance with Articles 12 to 14 of Regulation (EC) No 1069/2009; or  
(b) re-dispatched to the third country of origin. 
3. If trade samples are used for testing of machinery, the testing shall be carried out: 
(a) with dedicated equipment;  or  
(b) with equipment which is  cleaned and disinfected before it is  used for purposes 
other than the testing. 
During transport to the registered establishment or plant, the trade samples  must be 
packaged in leak-proof containers. 
CHAPTER III 
Display items 
1.  Import and transit of display items  shall take place in accordance with the following 
conditions:  
(a) they originate from third countries referred to in Annex XVIII, Section II, 
Chapter II, point (c) of the fourth column of row 14; 
(b) their introduction has been authorised in advance by the competent authority of 
the Member State where the display item  is intended to be used. 
 (c) after the checks at the border inspection post in accordance with the provisions 
of Directive 97/78/EC, display items  must be sent directly to the authorised 
user.  
2.  Each consignment must be packed in packaging preventing any leakage and must be 
accompanied by a commercial document which specifies: 
(a) the description of the material and the animal species of origin; 
(b) the category of the material; 
(c) the quantity of the material; 
(d) the place of dispatch of the material;  
EN 188   EN (e) the name and the address of the consignor; and 
(f) the name and the address of the consignee; 
(g)  a reference which allows to identify the authorisation of competent authority of 
destination.  
3.  After the exhibition or after the artistic activity has been concluded, display items  
shall be:  
(a) re-dispatched to the country of origin;  
(b)  dispatched to another Member State or third country, if such dispatch has been 
authorised by the competent authority of the Member State or third country of 
destination in advance;  
(c)  disposed of in accordance with Articles 12 to 14 of Regulation (EC) No 
1069/2009.   
EN 189   EN SECTION IV 
SPECIFIC REQUIREMENTS FOR CERTAIN MOVEMENTS OF ANIMAL BY-
PRODUCTS  
CHAPTER I 
Movements between territories of the Russian Federation 
1. This Chapter shall apply to the specific movements of animal by-product 
consignments coming from and destined to the Russian Federation directly or via 
another third country, by road or by rail through the European Union, between 
approved Union border inspection posts listed in Annex I to Decision 2009/821/EC. 
2. Member States shall authorise specific movements referred to in point 1, provided 
that the following conditions are met: 
(a) the consignment shall be sealed with a serially numbered seal at the border 
inspection post of entry to the EC by th e veterinary services of the competent 
authority; 
(b) the documents accompanying the consignment and referred to in Article 7 of 
Directive 97/78/EC shall be stamped “ONLY FOR TRANSIT TO RUSSIA 
VIA THE EC” on each page by the official veterinarian of the competent 
authority responsible for the border inspection post; 
(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC 
shall be complied with; 
(d) the consignment is certified as acceptable for transit on the Common 
Veterinary Entry Document provided for in Annex III to Regulation (EC) No 
136/2004 by the official veterinarian of the border inspection post of introduction. 
5. Unloading or storage, as defined in Article 12(4) or Article 13 of Directive 97/78/EC 
of such consignments shall not be allowed on the territory of a Member State. 
6. Regular audits shall be made by the competent authority to ensure that the number of 
consignments and the quantities of products  leaving the Union territory matches the 
number and quantities entering. 
CHAPTER II 
Import of certain Category 1 materials 
Materials referred to in Article 19(3) of this Regulation shall be imported under the following conditions:  
EN 190   EN 1. The materials shall be imported with a label attached to the packaging, container or 
vehicle which indicates 'Prohi bited in food, feed, fertili sers, cosmetics, medicinal 
products and medical devices'. 
2. The materials shall be directly delivered to an approved or registered establishment 
or plant for the manufacture of derived products, other than the products referred to 
in point 1. 
3. The materials shall be imported in accordance with sanitary certification 
requirements in accordance with national legislation. 
4. Unused or surplus materials shall be used or disposed of in accordance with Article 
12 of the Animal By-products Regulation. 
CHAPTER III 
Import of certain materials for feeding to farmed fish 
The competent authority may, provided there is no unacceptable risk for the transmission of 
diseases communicable to humans or animals, authorise the import of animal by-products from aquatic animals and derived products from aquatic animals and of aquatic and terrestrial invertebrates, subject to sanitary certification re quirements in accordance  with national rules. 
 
SECTION V 
LISTING OF ESTABLISHMENTS AND PLANTS IN THIRD COUNTRIES 
1. As referred to in the second subparagraph of Article 41(4) of the Animal By-products 
Regulation, lists of establishments and plants  in third countries shall be entered into 
the TRACES system in accordance with technical specifications which are published 
by the Commission on its website. 
2. Each list shall be kept up-to-date regularly.   
EN 191   EN  
ANNEX XIX  
MODEL HEALTH CERTIFICATES  
The model health certificates in this Annex sha ll apply to the importation from third countries 
and to the transit through the European Union of the animal by-products and the derived 
products referred to in the respective model health certificates. 
Notes 
(a) Veterinary certificates shall be produced by the 
exporting country, based on the models appearing in this 
Annex, according to the layout of the model that 
corresponds to the animal by-products concerned. They 
shall contain, in the numbered order that appears in the 
model, the attestations that are required for any third country and, as the case may be, those supplementary 
guarantees that are required for the exporting third 
country or part thereof. 
(b)  Where the model certificate states that certain 
statements shall be kept as appropriate, statements which 
are not relevant may be crossed out and initialled and stamped by the certifying officer, or completely deleted 
from the certificate . 
(c) The original of each certificate shall consist of a 
single sheet of paper, both sides, or, where more text is 
required; it shall be in such a form that all sheets of 
paper  needed are part of an integrated whole and 
indivisible. 
(d) It shall be drawn up in at least one of the 
official languages of the EU Member State in which the inspection at the border post shall be carried out and of the EU Member State of destination. However, these Member States may allow other languages, 
accompanied, if necessary, by an official translation. 
(e) If for reasons of identification of the items of 
the consignment, additional sheets of paper are attached 
to the certificate, these sheets of paper shall also be 
considered as forming part of the original of the 
certificate by the application of the signature and stamp 
of the certifying official veterinarian, in each of the sheets of paper. (f) When the certificate, including additional 
schedules referred to in d), comprises more than one 
page, each page shall be numbered -( page number ) of 
(total number of pages )– on its bottom and shall bear the 
code number of the certificate that has been designated 
by the competent authority on its top. 
(g) The original of the certificate must be 
completed and signed by an official veterinarian. In 
doing so, the competent authorities of the exporting 
country shall ensure that the principles of certification 
equivalent to those laid down in Council Directive 96/93/EC are followed. 
(h) The colour of the signature shall be different to 
that of the printing. The same rule applies to stamps other than those embossed or watermark. 
(i) The original of the certificate must accompany 
the consignment at the EU border inspection post.  
(j) If health certificates are used for consignments 
in transit, box No I.5 (“Consignee”) of the relevant 
health certificate shall be completed with the name and 
address of the border inspection post through which the 
consignment is intended to leave the European Union. 
  
EN 192   EN CHAPTER 1 
Health certificate 
For processed animal protein not intended for human consumption, including mixtures and 
products other than petfood containing such protein, for dispatch to or for transit2 through 
the European Union 
COUNTRY Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Nature of commodity Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
  
EN 193   EN  
COUNTRY Processed animal protein not intended for human 
consumption including mixtures and products other than 
petfood containing such protein 
 II.a. Certificate reference number II.b. 
II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 (1a) 
and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular Annex XIV, Section II, 
Chapter I, and Annex XVIII, Section I, thereof and certify that:   
II.1. the processed animal protein or product described above contains exclusively processed animal protein not intended 
for human consumption that; 
(a) has been prepared and stored in an establishment or plant approved, validated and supervised by the 
competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009(2), and 
(b) has been prepared exclusively with the following animal by-products: 
(2) either  [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-
mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation, but which did not show any signs of disease communicable 
to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings a nd splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals, other than ruminants; 
(iv)  pig bristles; (v)  feathers; ] 
(
2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals, obtained from animals other than ruminants that have been slaughtered in a 
slaughterhouse after having been considered fit for slaughter for human consumption following an 
ante-mortem inspection in accordance with Union legislation] 
 (2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing 
or packaging defects or other defects from which no risk to public or animal health arise;] 
 (2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live 
animals that did not show signs of any disease communicable through that product to humans or 
animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs 
of diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic an imals originating from establishments or plants 
manufacturing products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease  
EN 194   EN COUNTRY Processed animal protein not intended for human 
consumption including mixtures and products other than 
petfood containing such protein 
 II.a. Certificate reference number II.b. 
communicable through that material to humans or animals:  
(i) shells from shellfish with soft tissue or flesh; 
(ii) the following originating from terrestrial animals: 
– hatchery by-products,  
– eggs, 
– egg by-products, including egg shells, 
(iii) day-old chicks killed for commercial reasons;] 
(2) and/or [ — aquatic and terrestrial invertebrates other than species pathogenic to humans or animals;] 
(2) and/or [ — animals and parts thereof of the zoological order of Rodentia and Lagomorpha, except Category 
material as referred to in Article 8(a)(iii), (iv) and (v) and Category  2 material as referred to in 
Article 9(a) to (g) of Regulation (EC) No 1069/2009;] 
and 
(c) has been subjected to the following processing standard : (2) either [heating 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 produced by saturated steam, with a particle size prior to 
processing of not more than 50 millimetres; ] 
(2) or [in the case of non-mammalian protein other th an fishmeal, the processing method 1-2-3-4-5-7 as set 
out in Annex VII, Section III, of  Regulation (EC) No …/…; ] 
(2) or [in the case of fishmeal the processi ng method 1-2-3-4-5-6-7……………………… as set out in 
Annex VII, Section III, of Regulation (EC) No …/…;] 
(2) or [in the case of porcine blood, the processing method 1-2-3-4-5-7………as set out in Annex VII, 
Section III to Regulation (EC) No …/ …, where in case of method 7 a heat treatment of at least 80 °C 
has been applied throughout its substance;] 
II.2. the competent authority examined a random sample immediately prior to dispatch and found it to comply with the 
following standards (
3): 
Salmonella: Absence in 25 g:  n = 5, c = 0, m = 0, M = 0 
Enterobacteriaceae:   n = 5, c = 2, m = 10, M = 300 in 1g; 
II.3. the end product : 
(2) either [ was packed in new or sterilised bags, ] 
(2) or [ was transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected before use,] 
which bear labels indicating “NOT FOR HUMAN CONSUMPTION” 
II.4. the end product was stored in enclosed storage; 
II.5. the product has undergone all precautions to avoid recontamination with pathogenic agents after treatment;  
EN 195   EN COUNTRY Processed animal protein not intended for human 
consumption including mixtures and products other than 
petfood containing such protein 
 II.a. Certificate reference number II.b. 
II.6. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation 
(EC) No 999/2001(4) or mechanically separated meat obtained from bones of bovine, ovine or caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas injected into 
the cranial cavity or killed by the same method or slaughtere d by laceration of central nervous tissue by means of an 
elongated rod-shaped instrument intr oduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation (EC) 
No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;] 
Notes 
Part I: 
— Box reference I.6: Person responsible fo r the consignment in EU: this box is to be filled in only if it is a certificate 
for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be  filled in only if it is a certificate for transit commodity. 
The products in transit can only be stored in free zones, free warehouses and custom warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name 
(ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.05; 05.06; 05.07 or 23.01 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b)  OJ L …, …, p. 
(2) Delete as appropriate.  
(3) Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in 
all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of 
bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be between m and M, the sample still being 
considered acceptable if the bacterial count of the other samples is m or less. 
(4) OJ L 147, 31.5.2001.  
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU : This certificate is only for veterinary purposes and has  
EN 196   EN COUNTRY Processed animal protein not intended for human 
consumption including mixtures and products other than 
petfood containing such protein 
 II.a. Certificate reference number II.b. 
to accompany the consignment until it r eaches the border inspection post.  
Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 197   EN CHAPTER 2 
Health certificate 
For milk, milk products, colostrum and colostrum products not intended for human 
consumption for dispatch to or transit through  (2) the European Union 
COUNTRY:  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the load in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Name Approval number Custom warehouse
Address
Name Approval number
Address
Postal code
I.13. Place of loading I.14. Date of departureI.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Further process Technical use Other
I.26. For transit through EU to 3rd Country I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Species Approval number of establishments Net weight Batch number
Manufacturing plantPart I : Details of dispatched consignment I.2.a
  
EN 198   EN  COUNTRY Milk, milk products, colostrum and colostrum 
products not for human consumption  
 II. Health information II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
  I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009, and in particular Article 10 thereof, and Regulation (EU) No …/.., and in particular … 
Annex … thereto, and certify that the milk(2), the milk products(2) colostrum(2) or the colostrum 
products(2) referred to in box I.28 comply with the following conditions:  
II.1. they were produced and derived in ………………………..……… ( insert name of exporting  country )(3), 
……………….……… ( insert name of region )(3), which is listed in the Annex to Decision 2004/438/EC, 
and which has been free from foot-and-mouth disease (FMD) and rinderpest for 12 months immediately 
prior to export and has not practiced vaccination against rinderpest during that period; 
II.2. they were produced from raw milk or colostrum derived from animals which at the time of milking did 
not show clinical signs of any disease transmissible through milk or colostrum to humans or animals, and 
which had been kept for at least 30 days prior to production on holdings that were not subject to official restrictions due to foot-and-mouth disease or rinderpest; 
II.3. they are milk or milk products that: 
(2)either  [have undergone one of the treatments or combinations thereof described in point II. 4] 
(2)or [comprise whey to be fed to animals of species sus ceptible to foot-and-mouth disease, and that whey was 
collected from milk subjected to one of the treatments described in point II. 4 and  
(2)either [the whey was collected at least 16 hours  after clotting and has a pH below 6;] 
(2)(4)or [the whey has been produced at least 21 days before the shipping and during that period no 
cases of FMD have been detected in the exporting country;] 
(2)(4)or [the whey has been produced on ../../.., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection 
Post of the European Union;]] 
II.4. they have been subject to one of the following treatments: 
(2)either  [High Temperature Short Time pasteurisation at 72°C for at least 15 seconds, or an equivalent 
pasteurisation achieving a negative reaction to a phospha tase test in bovine milk, in combination with: 
(2)either  [a subsequent second High Temperature Shor t Time pasteurisation at 72°C for at least 
15 seconds or an equivalent pasteurisation which itself achieves a negative reaction to a phosphatase test in bovine milk;] 
(2)or [a subsequent drying process that in the case of milk intended for feeding is combined with 
additional heating to 72°C or higher;] 
(2)or [a subsequent process by which the pH is reduced and kept for at least one hour at a level 
below 6;] 
(2)(4)or [the condition that the milk/milk product has been produced at least 21 days before the 
shipping and during that period no cases of FMD have been detected in the exporting country;] 
(2)(4)or [the milk/milk product has been produced on .../../…., this date, in consideration of the 
foreseen voyage duration, being at least 21 days before the consignment is presented to a 
Border Inspection Post of the European Union;] 
(2)or [sterilisation at a level of at least F 03;]]  
(2)or [Ultra High Temperature treatment at 132°C for at least one second in combination with: 
(2)either [a subsequent drying process that in the case of milk intended for feeding is combined with 
additional heating to 72°C or higher,] 
(2)or [a subsequent process by which the pH is reduced and kept for at least one hour at a level below 6;] 
(2)(4)or [the condition that the milk/milk product has been produced at least 21 days before the 
shipping and during that period no cases of FMD has been detected in the exporting 
country;] 
(2)(4)or [the milk/milk product has been produced on .../../…., this date, in consideration of the 
foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspection Post of the European Union;]] 
II.5. they are colostrum or colostrum products of bovine animals that have been subject to High Temperature 
Short Time pasteurisation at 72°C for at least 15 seconds, or an equivalent pasteurisation achieving a  
EN 199   EN  COUNTRY Milk, milk products, colostrum and colostrum 
products not for human consumption  
 II. Health information II.a. Certificate reference number II.b. 
negative reaction to a phosphatase test  in bovine milk, in combination with: 
(2)(4)either [the condition that the colostrum or colostrum products have been pr oduced at least 21 days 
before the shipping and in this period no cases of FMD have been detected in the exporting 
country; ] 
(2)(4)or [the colostrum or colostrum products have been produced on .../../…., this date, in consideration of the foreseen voyage duration, being at least 21 days before the consignment is presented to a Border Inspecti on Post of the European Union;]   
and have been obtained from animals subject to regular veterinary inspections to ensure that they come from 
holdings on which all bovine herds are: 
(2)(4)either [recognised as officially tuberculosis and brucellosis free(5),] 
(2)(4)or [not restricted under the national legislation of the third country of origin regarding 
eradication of tuberculosis and brucellosis, ] 
and (2)(4) either [recognised as official enzootic-bovine-leukosis free(5);] 
(2)(4)or [included in an official system for the control of enzootic bovine leukosis and there has been no evidence as result of clinical and laboratory testing of this disease in the herd during the past two years;] 
II.6. every precaution was taken to avoid contamination of the milk/milk product/colostrum/colostrum product 
after processing; 
II.7. the milk/milk product/colostrum/colostrum product was packed: 
(2)either  [in new containers,] 
(2)or [in vehicles or bulk containers disinfected prior to loading using a product approved by the 
competent authority,] 
and the containers are marked so as to indicate the nature of the milk/milk product/colostrum and bear labels 
indicating that the product is Category 3 material and not intended for human consumption; 
II.8. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001(6)  or mechanically separated meat obtained from bones of bovine, ovine 
or caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped in strument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.9.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requ irements for the la st three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least   
EN 200   EN  COUNTRY Milk, milk products, colostrum and colostrum 
products not for human consumption  
 II. Health information II.a. Certificate reference number II.b. 
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requir ements set out in points (i) and (ii).] 
 
Notes 
Part I: 
● Box reference I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate 
for transit commodity. 
● Box reference I.12: Place of destinatio n: this box is to be filled in on ly if it is a certificate for transit 
commodity. 
● Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) 
or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the Border 
Inspection Post of the European Union. 
● Box reference I.19: use the appropriate Harmonised System (HS) code of the World Customs 
Organisation: 23.09.10, 23.09.90, 35.01, 35.02 or 35.04. 
● Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must be 
included. 
● Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
● Box reference I.28: “Manufacturing plant”: provide the registration number of treatment or processing 
establishment.  
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate. 
(3) For completion if the authorisation to import into the European Union is restricted to certain regions of the 
third country concerned. 
(4) this condition applies only to third countries liste d in column "A" of Annex I to Decision 2004/438/EC 
(5) Officially tuberculosis and brucellosis free herd  as laid down in Annex A to Council Directive 
64/432/EEC; and officially enzootic-bovine-leukosis free herd as laid down in part II of Annex D to 
Council Directive 64/432/EEC 
– The signature and the seal must be in a different colour from that of the printing. 
– Note for the importer: this certificate is only for veterinary purposes and must accompany the 
consignment until it reaches the Border Inspection Post of the European Union.  
EN 201   EN  COUNTRY Milk, milk products, colostrum and colostrum 
products not for human consumption  
 II. Health information II.a. Certificate reference number II.b. 
(6) OJ L 147, 31.5.2001.  
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 202   EN CHAPTER 3(A) 
Health certificate 
For canned petfood intended for dispatch to or for transit2 through the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
23.09.10
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 203   EN  COUNTRY      Canned Petfood 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009] (1a) and in particular Articles 8 and 10 thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVII, Chapter II and Annex XVIII, Section II, thereof and certify that the petfood 
described above: 
II.1. has been prepared and stored in an establishment or plant approved and supervised by the competent 
authority in accordance with Article 24  of Regulation (EC) No 1069/2009; 
II.2. has been prepared exclusively with the following animal by-products : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of 
animals killed, and which are fit for human consum ption in accordance with Union legislation, 
but are not intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been 
slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption 
following an ante-mortem inspection or bodies and the following parts of animals from game 
killed for human consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human 
consumption in accordance with Union legislation , but which did not show any signs of 
disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings a nd splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals, other than ruminants;  
 (iv)  pig bristles; (v)  feathers; ] 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from animals other than ruminants that have been slaughtered in a 
slaughterhouse after having been considered fit for slaughter for human consumption following 
an ante-mortem inspection in accor dance with Union legislation;] 
 (2) and/or [ — animal by-products arising from the production of products intended for human 
consumption, including degreased bone, greaves and centrifuge or separator sludge from milk 
processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal  origin, or feeding stuffs containing animal by-
products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;] 
(2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live 
animals that did not show signs of any disease communicable through that product to humans 
or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any 
signs of diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments 
manufacturing products for human consumption;]  
EN 204   EN  COUNTRY      Canned Petfood 
  II.a. Certificate reference number II.b. 
(2) and/or [ - the following material originating from animals which did not show any signs of 
disease communicable through that material to humans or animals:  
(i) shells from shellfish with soft tissue or flesh; 
(ii) the following originating from terrestrial animals: 
– hatchery by-products,  
– eggs, 
– egg by-products, including egg shells, 
(iii) day-old chicks killed for commercial reasons;] 
 
(2) and/or [ — animal-by products from aquatic and terrestrial invertebrates other than species   
pathogenic to humans or animals;] 
(2) and/or [ — material from animals which have been treated with certain substances which are 
prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in 
accordance with Article 35(1)(a)(ii) of Regulation (EC) No 1069/2009]. 
II.3. has been subjected to heat treatment to a minimum Fc value of 3 in hermetically sealed containers; 
II.4. was analysed by a random sampling of at least five containers from each processed batch by laboratory 
diagnostic methods to ensure adequate heat treatment of the whole consignment as foreseen under 
point II.3; 
II.5. has undergone all precautions to avoid contamination with pathogenic agents after treatment. 
II.6. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.8.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele,  
EN 205   EN  COUNTRY      Canned Petfood 
  II.a. Certificate reference number II.b. 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006(1d), the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last seven years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destinatio n: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be given. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ … (1c)  OJ L 147. 31.5.1001, p.1. (1d)  OJ L 94, 1.4.2006, p.28. (2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: This certificate is only for veterinary Formatted:  Polish 
EN 206   EN  COUNTRY      Canned Petfood 
  II.a. Certificate reference number II.b. 
purposes and has to accompany the consignment until it reaches the border inspection post.  
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 207   EN CHAPTER 3(B) 
Health certificate 
For processed petfood other than canned petfood, intended for dispatch to or for transit2 
through the European Union  
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
23.09.10
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 208   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Articles 8 and 10 thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVII, Chapter II and Annex XVIII, Section II thereof and certify that the petfood 
described above : 
II.1. has been prepared and stored in a plant approved and supervised by the competent authority in accordance 
with Article 24 of Regulation (EC) No 1069/2009; 
II.2. has been prepared exclusively with the following animal by-products : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of 
animals killed, and which are fit for human consum ption in accordance with Union legislation, 
but are not intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been 
slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption 
following an ante-mortem inspection or bodies and the following parts of animals from game 
killed for human consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human 
consumption in accordance with Union legislation , but which did not show any signs of 
disease communicable to humans or animals; 
(ii)  heads of poultry; (iii)  hides and skins, including trimmings a nd splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals, other than ruminants; 
 (iv)  pig bristles; 
(v)  feathers; ] 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from animals other than ruminants that have been slaughtered in a slaughterhouse after having been considered fit for slaughter for human consumption following 
an ante-mortem inspection in accor dance with Union legislation;] 
 (2) and/or [ — animal by-products arising from the production of products intended for human 
consumption, including degreased bone, greaves and centrifuge or separator sludge from milk 
processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of 
manufacturing or packaging defects or other defects form which no risk to public or animal 
health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal  origin, or feeding stuffs containing animal by-
products or derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises;] 
(2) and/or [ — blood, placenta, wool, feathers, hair, ho rns, hoof cuts and raw milk originating from live 
animals that did not show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any 
signs of diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments 
manufacturing products for human consumption;]  
EN 209   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
(2) and/or [ - the following material originating from animals which did not show any signs of 
disease communicable through that material to humans or animals:  
(i) shells from shellfish with soft tissue or flesh; 
(ii) the following originating from terrestrial animals: 
– hatchery by-products,  
– eggs, 
– egg by-products, including egg shells, 
(iii) day-old chicks killed for commercial reasons;] 
 
(2) and/or [ — animal-by products from aquatic and terrestrial invertebrates other than species   
pathogenic to humans or animals;] 
 
(2) and/or [ — material from animals which have been treated with certain substances which are 
prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in 
accordance with Article 35(1)(a)(ii) of Regulation (EC) No 1069/2009]. 
II.3.  
(2) either [was subjected to a heat treatment of at least 90 °C throughout its substance;] 
(2) or  [was produced as regards ingredients of animal origin using exclusively products which had been 
(a) in the case of animal by-products or derived products from meat or meat products subjected to a 
heat treatment of at least 90° C throughout its substance; 
(b) in the case of milk and milk based products, 
   (i) if they are from third countries or parts of third countries listed in column B of Annex I to 
Decision 2004/438/EC(3) submitted to a pasteurisation treatment sufficient to produce a negative 
phosphatase test, 
   (ii) with a pH reduced to less than 6 from third countries or parts of third countries listed in column C 
of Annex I to Decision 2004/438/EC, first submitted to a pasteurisation treatment sufficient to 
produce a negative phosphatase test 
   (iii) if they are from third countries or parts of third countries listed in column C of Annex I to 
Decision 2004/438/EC, submitted to a sterilisation process or a double heat treatment where each treatment was sufficient to produce a negative phosphatase test on its own 
   (iv) if they are from third countries or parts of third countries listed in column C of Annex I to 
Decision 2004/438/EC where there has been an outbreak of foot-and-mouth disease in the last 12 
months or where vaccination against foot-and-mouth disease has been carried out in the last 12 
months submitted to 
either —  a sterilisation process whereby an Fc va lue equal or greater than 3 is achieved 
or 
—  an initial heat treatment with a heating effect at least equal to that achieved by a 
pasteurisation process of at least 72° C for at least 15 seconds and sufficient to produce a  
EN 210   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
negative reaction to a phosphatase test, followed by 
either 
—  a second heat treatment with a heating effect at least equal to that achieved by the initial 
heat treatment, and which would be sufficient to produce a negative reaction to a 
phosphatase test, followed, in the case of dr ied milk, or dried milk-based products by a 
drying process 
or 
—  an acidification process such that the pH has been maintained at less than 6 for at least one 
hour; 
(c) in the case of gelatine, produced using a process that ensures that unprocessed Category 3 
material is subjected to a treatment with acid or alkali, followed by one or more rinses with 
subsequent adjustment of the pH and subsequent, if necessary repeated, extraction by heat, 
followed by purification by means of filtration and sterilisation; 
(d) in the case of hydrolysed protein produced using a production process involving appropriate 
measures to minimise contamination of raw Category 3 material, and, in the case of hydrolysed 
protein entirely or partly derived from ruminant hides and skins produced in a processing plant 
dedicated only to hydrolysed protein production, using only material with a molecular weight 
below 10000 Dalton and a process involving the preparation of raw Category 3 material by 
brining, liming and intensive washing followed by  
  (i) exposure of the material to a pH of more than 11 for more than three hours at a 
  temperature of more than 80° C and subsequently by heat treatment at more than 
  140° C for 30 minutes at more than 3,6 bar; or 
  (ii) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11,  
  followed by heat treatment at 140° C for 30 minutes at 3 bar; 
(e) in the case of egg products submitted to any of the processing methods 1 to 5 or 7, as referred to 
in Section III of Annex VII to Regulation (EC) No  …/…; or treated in acco rdance with Chapter II 
of Section X of Annex III to Regulation (EC) No 853/2004 (4); 
(f) in the case of collagen submitte d to 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, the use of preservatives other than those permitted by Union 
legislation being prohibited; 
(g) in the case of blood products, produced using any of the processing methods 1 to 5 or 7, as 
referred to in Section III of Annex VII to Regulation (EC) No …/…; 
(h) in the case of mammalian processed animal protein submitted to any of the processing methods 1 
to 5 or 7 and, in the case of porcine blood, submitted to any of the processing methods 1 to 5 or 7 
provided that in the case of method 7 a heat treatment throughout its substance at a minimum 
temperature of 80 ° C has been applied; 
(i) in the case of non-mammalian processed protein with the exclusion of fishmeal submitted to any 
of the processing methods 1 to 5 or 7 as referred to in Section III of Annex VII to Regulation (EC) 
No …/…; 
(k) in the case of fishmeal submitted to any of the processing methods or to a method and parameters 
which ensure that the products complies with the microbiological standards set in Section I of 
Annex XIV to Regulation (EC) No …/…;  
EN 211   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
(l) in the case of rendered fat, including fish oils, submitted to processing methods 1 to 5 or 7 (and 
method 6 in the case of fish oil) as referred to  in Section III of Annex VII to Regulation (EC) No 
…/… or produced in accordance with Chapter II of Section XII of Annex III to Regulation (EC) 
No 853/2004(4); rendered fats from ruminant animals must be purified in such a way that the 
maximum level of remaining total insoluble impurities does not excess 0.15% in weight; 
(m) in the case of dicalcium phosphate produced by a process that 
(i) ensures that all Category 3 bone-material is finely crushed and degreased with hot water and 
treated with dilute hydrochloric acid (at a minimum concentration of 4% and a pH of less than 
1,5) over a period of at least two days; 
(ii) following the procedure under (i), applie s a treatment of the obtained phosphoric liquor 
with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7; and 
(iii) finally, air dries the precipitate of dicalcium phosphate with inlet temperature of 65° C to 
325° C and end temperature between 30° C and 65° C; 
(n) in the case of tricalcium phosphate produced by a process that ensures 
(i) that all Category 3 bone-material is finely  crushed and degreased in counter-flow with hot 
water (bone chips less than 14 mm); 
(ii) continuous cooking with steam at 145° C during 30 minutes at 4 bar; 
(iii) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by 
centrifugation; and  
(iv) granulation of the tricalcium phosphate after drying in a fluid bed with air at 200° C]; 
(n) in the case of flavouring innards, produced according to a treatment method and parameters, 
which ensure that the product co mplies with the microbiological standards referred to under point 
II.4. 
(2) or  [was subject to a treatment such as drying or fermentation, which has been authorised by the competent 
 authority;] 
(2) or  [in the case of aquatic and terrestrial invertebrates other than species pathogenic to humans or animals, 
be  subject to a treatment which has been authorised by the competent authority and which ensures 
that the  petfood poses no unacceptable risks to public and animal health;] 
II.4. was analysed by a random sampling of at least five samples from each processed batch taken during or after 
storage at the processing plant and complies with the following standards (5): 
Salmonella:   absence in 25g: n = 5, c = 0, m = 0, M = 0, 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram; 
II.5. has undergone all precautions to avoid contamination with pathogenic agents after treatment; 
II.6. was packed in new packaging, which, if the petfood is not dispatched in ready-to-sell packages on which it 
is clearly indicated that the content is destined for feeding to pets only, bear labels indicating “NOT FOR 
HUMAN CONSUMPTION “; 
II.7. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to  
EN 212   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cav ity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.8.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a  
EN 213   EN  COUNTRY   Processed petfood other than canned 
petfood 
  II.a. Certificate reference number II.b. 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wago ns or container and lorries), flight number (aircraft) 
or name (ship); information is to be provid ed in the event of un loading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be 
given. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
Part II: (1a)  OJ L 300, 14.11.2009, p.1.  (1b)  OJ … (2) Delete as appropriate. (3)  OJ L 226, 25.06.2004, p. 22.  (4) OJ L 139, 30.4.2004, p. 55. Corrected by OJ L 226, 25.6.2004, p. 22.  (5) Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number 
of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be between m and M, the sample still being 
considered acceptable if the bacterial count of the other samples is m or less 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: This certificate is only  for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post 
— Note for the person responsible for the consignment in EU: This certificate is only  for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post.
 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 214   EN  
EN 215   EN CHAPTER 3(C) 
Health certificate 
For dogchews intended for dispatch to or for transit2 through the European Union  
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
42.05.00
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 216   EN  COUNTRY       Dogchews 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009, (1a) and in particular Article 10, and Regulation (EU) No …/…(1b), and in particular Annex 
XVII, Chapter II and Annex XVIII, Section II thereo f, and certify that the dogchews described above : 
II.1. have been prepared exclusively with the following animal by-products : 
(2) either  [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of 
animals killed, and which are fit for human consum ption in accordance with Union legislation, 
but are not intended for human consumption for commercial reasons; ] 
(2) and/or  [ —carcasses and the following parts originating either from animals that have been 
slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption 
following an ante-mortem inspection or bodies and the following parts of animals from game 
killed for human consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human 
consumption in accordance with Union legislation , but which did not show any signs of 
disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings a nd splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals other than ruminants; 
 (iv)  pig bristles; (v)  feathers; ] 
 (2) and/or [ 
— blood of animals which did not show any signs of disease communicable through 
blood to humans or animals obtained from animals other than ruminants that have been 
slaughtered in a slaughterhouse after having been considered fit for slaughter for human 
consumption following an ante-mortem inspection in accordance with Union legislation;] 
 (2) and/or [ — animal by-products arising from the production of products intended for human 
consumption, including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — animal-by products from aquatic animals or iginating from plants or establishments 
manufacturing products for human consumption;] 
(2) and/or [ — material from animals which have been treated with certain substances which are 
prohibited pursuant to Directive 96/22/EC, the import of the material being permitted in accordance with Article 35(1)(a)(ii) of Regulation (EC) No 1069/2009]. 
II.2. have been subjected  
(2) either [in the case of dogchews made from hides and skins of ungulates or from fish, to a treatment 
sufficient to destroy pathogenic organisms (including salmonella); and the dogchews are dry]; 
(2) and/or [in the case of dogchews made from animal by-products other than hides and skins of ungulates 
or from fish, to a heat treatment of at least 90°C throughout their substance;] 
II.3. were examined by random sampling of at least five samples from each processed batch taken 
during or after storage at the processing plant and complies with the following standards (3): 
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0, 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram;  
EN 217   EN  COUNTRY       Dogchews 
  II.a. Certificate reference number II.b. 
II.4. have undergone all precautions to avoid contam ination with pathogenic agents after treatment; 
II.5. were packed in new packaging; 
II.6. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.7.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii).]  
EN 218   EN  COUNTRY       Dogchews 
  II.a. Certificate reference number II.b. 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only 
if it is a certificate for transit commodity; it may be filled in if the certificate is for import 
commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for 
transit commodity. The products in transit can only  be stored in free zones, free warehouses 
and custom warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight 
number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if 
applicable) should be given. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b)   
(2) Delete as appropriate. 
(3) Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria ; the result is considered satisfactory if the 
number of bacteria in all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if 
the number of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be between m and M, the 
sample still being considered acceptable if the b acterial count of the other samples is m or less 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: This certificate is only for 
veterinary purposes and has to accompany the consignment until it reaches the border 
inspection post .  
EN 219   EN  COUNTRY       Dogchews 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 220   EN CHAPTER 3(D) 
Health certificate 
For raw petfood for direct sale or animal by-products to be fed to fur animals, intended for 
dispatch to or for transit2 through the European Union  
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Nature of commodity Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 221   EN  COUNTRY  Raw petfood for direct sale or animal by 
products to be fed to fur animals 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009  (1a) and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVII, Chapter II and Annex XVIII, Section II thereof, and certify that the raw petfood or animal by-
product described above : 
II.1. consist of animal by-products that satisfy the health re quirements below; 
II.2. consist of animal by-products: 
(a) derived from meat which satisfies the relevant animal and public health requirements laid down in : 
—  Commission Regulation (EU) No 206/2010(2) and provided the animals from which the meat is 
derived come from a territory or part of a te rritory ……(ISO code) as listed in that Regulation 
which has been free of foot and mouth disease, rinderpest, classical swine fever, African swine 
fever and swine vesicular disease for the last 12 months and where no vaccination has taken place during that time (only as relevant for the susceptible species), 
—  and/or Commission Regulation (EC) No 798/2008(3), and provided the animals from which the 
meat is derived come from a territory or part of a territory ……(ISO code) as listed in that 
Decision which has been free from Newcastle disease and Avian Influenza for the last 12 months, 
—  and/or Commission Regulation (EC) No 119/2009(4), and provided the animals from which the 
meat is derived come from a territory or part of a territory ……(ISO code) as listed which has been free from foot and mouth disease, rinderpest, classical swine fever, African swine fever, 
swine vesicular disease, Newcastle disease and Avian Influenza for the last 12 months and 
where no vaccination has taken place during that time (only as relevant for the susceptible 
species), 
(b) derived from animals that, at the slaughterhouse, have passed the ante-mortem health inspection 
during the 24 hours before the slaughter and have shown no evidence of the diseases referred in the 
Decisions above for which the animals are susceptible, and 
(c) derived from animals that have been treated in the slaughterhouse before and at the time of slaughter 
or killing in accordance with the relevant provisions of Council Regulation (EC) No 1099/2009 on 
the protection of animals at the time of killing; 
II.3. consist only of the fo llowing animal by-products: 
(a) parts of slaughtered animals, which were fit for human consumption in accordance with Union 
legislation, but are not intended for human consumption for commercial reasons, and 
(b) parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected 
by any signs of diseases communicable to humans or animals and derive from carcasses that are fit 
for human consumption in accord ance with Union legislation; 
II.4. have been obtained and prepared without contact with other material not complying with the conditions 
required in the Decisions above, and it has been handled so as to avoid contamination with pathogenic 
agents; 
II.5. have been packed in final packaging which bear labels indicating “RAW PETFOOD - NOT FOR HUMAN 
CONSUMPTION” or “ANIMAL BY-PRODUCTS FOR FEED FOR FUR ANIMALS - NOT FOR 
HUMAN CONSUMPTION” and then in leak-proof and officially sealed boxes/containers or in new 
packaging preventing any leakage and officially sealed boxes/containers which bear labels indicating 
“RAW PETFOOD - NOT FOR HUMAN CONSUMPTION” or “ANIMAL BY-PRODUCTS FOR FEED  
EN 222   EN  COUNTRY  Raw petfood for direct sale or animal by 
products to be fed to fur animals 
  II.a. Certificate reference number II.b. 
FOR FUR ANIMALS - NOT FOR HUMAN CONSUMPTION”, the name and the address of the 
establishment of destination; 
II.6. in the case of raw petfood: 
(a) have been prepared and stored in a plant approved and supervised by the competent authority in 
accordance with Article 24 of Regulation (EC) No 1069/2009 and 
(b) were examined by random sampling of at least five samples from each batch taken during storage 
(before dispatch) and complies with the following standards (6): 
Salmonella:  absence in 25 g: n=5, c=0, m=0, M=0 
Enterobacteriacae: n=5, c=2, m=10, M=5000 in 1 gram; 
II.7. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.8.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No   
EN 223   EN  COUNTRY  Raw petfood for direct sale or animal by 
products to be fed to fur animals 
  II.a. Certificate reference number II.b. 
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii).] 
Notes 
Part I: 
—  Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity.  
—  Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
—  Box reference I.15: Registration number (railway wagons  or container and lorries), flight number (aircraft) 
or name (ship); information is to be provid ed in the event of un loading and reloading.  
—  Box reference I.19: use the appropriate HS code: 05.11.91; 05.11.99 or 23.09.90.  
—  Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be 
given. 
—  Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate.  
—  Box reference I.28: Nature of commodity: select raw petfood or animal by-product.  
Part II: 
(1) Delete as appropriate. 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b)  
(2) OJ L 73, 20.3.2010, p.1. 
(3) OJ L 226, 23.8.2008, p.1.  
(4) OJ L 39, 10.2.2009, p.12. 
(5) OJ L 303, 18.11.2009, p.1. 
(6) Where: 
n = number of samples to be tested;  
EN 224   EN  COUNTRY  Raw petfood for direct sale or animal by 
products to be fed to fur animals 
  II.a. Certificate reference number II.b. 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all samples does not exceed m; 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the 
number of bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be between m and M, the sample still 
being considered acceptable if the bacterial count of the other samples is m or less 
—  The signature and the stamp must be in a different colour to that of the printing.  
—  Note for the person responsible for the consignment in EU: This certificate is only  for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post.  
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 225   EN  
CHAPTER 3(E) 
Health certificate 
For flavouring innards for use in the manufacture of petfood, intended for dispatch to or for 
transit2 through the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Nature of commodity Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
  
EN 226   EN  COUNTRY  Flavouring innards for use in the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009(1a) and in particular Article 8 and 10 thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVII, Chapter III and Annex XVIII,  Section II thereof and certify that the flavouring 
innards products described above : 
II.1. consist of animal by-products that sa tisfy the animal health requirement below; 
II.2. have been prepared including the following animal by-products which are exclusively : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human 
consumption in accordance with Union legislation , but which did not show any signs of 
disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)            hides and skins, including trimmings and splitting, thereof horns and feet, including the   
                   phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals  
                   other than ruminants;  
(iv)  pig bristles; 
(v)  feathers; ] 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from the animals other than ruminants that have been slaughtered in a 
slaughterhouse after having been considered fit for slaughter for human consumption following an 
ante-mortem inspection in accordance with Union legislation]; 
 (2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects from which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;] 
(2) and/or [— blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live 
animals that did not show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [— aquatic animals, and parts of such animals, except sea mammals, which did not show any signs 
of diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments  
EN 227   EN  COUNTRY  Flavouring innards for use in the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
manufacturing products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i) shells from shellfish with soft tissue or flesh; 
(ii) the following originating from terrestrial animals: 
— hatchery by-products,  
— eggs, 
— egg by-products, including egg shells, 
(iii) day-old chicks killed for commercial reasons;]  (2) and/or [— animal-by products from aquatic and terrestrial invertebrates other than species 
pathogenic to humans or animals;] 
(2) and/or [- material from animals which have been treated with certain substances which are prohibited 
pursuant to Directive 96/22/EC, the import of the ma terial being permitted in accordance with Article 
35(1)(a)(ii) of Regulation (EC) No 1069/2009] 
II.3. have been subjected to processing in accordance with Annex XVII, Chapter III of Regulation (EC) No 
…/…, in order to kill pathogenic agents; 
II.4. have been examined by the competent authority taking a random sample immediately prior to dispatch 
and found it to comply with the following standards (3): 
Salmonella:absence in 25g: n = 5, c = 0, m = 0, M = 0, 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram; 
II.5. the end product was : 
(2) either [ packed in new or sterilised bags, ] 
(2) or [ transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected with a disinfectant approved by the competent authority before use, ] 
and which bear labels indicating “NOT FOR HUMAN CONSUMPTION”; 
II.6. the end product was stored in enclosed storage; 
II.7. the product has undergone all precautions to avoid contamination with pathogenic agents after 
treatment; 
II.8. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped in strument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or  
EN 228   EN  COUNTRY  Flavouring innards for use in the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
caprine animals;] 
II.9.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requ irements for the la st three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destin ed to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requir ements set out in points (i) and (ii).] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.04 or 05.11.91.  
EN 229   EN  COUNTRY  Flavouring innards for use in the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be given. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
— Box reference I.28: define the innard product. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b)  
 (2) Delete as appropriate. 
(3) Where: 
n = number of samples to be tested; 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all samples does not exceed m; 
M = maximum value for the number of bacteria; the resu lt is considered unsatisfactory if the number of 
bacteria in one or more samples is M or more; and 
c = number of samples the bacterial count of which may be between m and M, the sample still being 
considered acceptable if the bacterial count of the other samples is m or less 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: This certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post  
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 230   EN CHAPTER 3(F) 
Health certificate 
For animal by-products for the manufacture of petfood, intended for dispatch to or for transit 
through 2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Further process Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
 
  
EN 231   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II.1. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009(1a) and Regulation (EU) No …/… and certify that the animal by-products described above : 
II.1.1. consist of animal by-products that sa tisfy the animal health requirements below; 
II.1.2. have been obtained in  the territory of: ………………….…………(2) from animals: 
(3) either [(a) that have remained in this territory sin ce birth or for at least the last three months before 
slaughter; ] 
(3) or [(b) killed in the wild in this territory(4); ] 
II.1.3. have been obtained from animals: 
(3) either [(a) coming from holdings : 
(i) where, for the following diseases for which the animals are susceptible, there has been 
neither case/outbreak of rinderpest, swine vesicular disease, Newcastle disease or highly 
pathogenic avian influenza during the prior 30 days, nor of classical or African swine 
fever during the prior 40 days; nor in the holdin gs situated in their vicinity within 10 km, 
during the prior 30 days, and 
(ii) where there has been neither case/outbreak of foot and mouth disease during the prior 60 
days, nor in the holdings situated in their vi cinity within 25 km, during the prior 30 days, 
and 
(b) which : 
(i) were not killed to eradic ate any epizootic disease, 
(ii) have remained in their holdings of origin for at least forty days before departure and which 
have been transported directly to the slaughterhouse without contact with other animals 
which did not comply with the same health conditions, 
(iii) at the slaughterhouse, have passed the ante-mortem health inspection during the 24 hours 
before the slaughter and have shown no evidence of the diseases referred to above for which the animals are susceptible, and 
(iv) have been treated in the slaughterhouse before and at the time of slaughter or killing in 
accordance with the relevant provisions of Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing
(1c); ] 
(3) or [(a) captured and killed in the wild in an area : 
(i) in which within 25 km there has been no case/outbreak of any of the following diseases 
for which the animals are susceptible: foot and mouth disease, rinderpest, Newcastle 
disease or highly pathogenic avian influenza during the prior 30 days , nor of classical or 
African swine fever during the prior 40 days and 
(ii) that is situated at a distance that exceeds 20 km from the borders separating another 
territory of a country or part thereof, which is not authorised at these dates for exporting 
this material to the European Union, and 
(b) which after killing were transported within 12 hours for chilling either to a collection centre and immediately afterwards to a game establishment, or directly to a game establishment; ]  
EN 232   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
II.1.4. have been obtained in an establishment around which, within a radius of 10 km, there has been no 
case/outbreak of diseases referred to in point II.1.3 for which the animals are susceptible during the 
prior 30 days or, in the event of a case of disease, the preparation of raw material for exportation to the 
European Union has been authorised only after removal of all meat, and the total cleaning and 
disinfection of the establishment under the control of an official veterinarian; 
II.1.5. have been obtained and prepared without contact with other material not complying with the 
conditions required above, and it has been handled so as to avoid contamination with pathogenic 
agents; 
II.1.6. have been packed in new packaging preventing any leakage and in officially sealed containers bearing 
the label indicating “RAW MATERIAL ONLY FOR THE MANUFACTURE OF PETFOOD” and the 
name and address of the EU es tablishment of destination; 
II.1.7. consist only of the following animal by-products : 
(2) either [- carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ -carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-
mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human 
consumption in accordance with Union legislation , but which did not show any signs of 
disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals other than ruminants; 
 (iv)  pig bristles; (v)  feathers; ] 
(2) and/or [ - animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing;] 
(2) and/or [ - products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ - aquatic animals, and parts of such animals, except sea mammals, which did not show any signs 
of diseases communicable to humans or animals;] 
(2) and/or [ - animal by-products from aquatic animals originating from plants or establishments 
manufacturing products for human consumption;] 
(2) and/or [ - the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells form shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
–  hatchery by-products,  
–  eggs, 
–  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;]  
EN 233   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
(2) and/or [ — animal-by products from aquatic or terrestrial invertebrates, other than species 
pathogenic to humans or animals;] 
(2) and/or [- material from animals which have been treated with certain substances which are prohibited 
pursuant to Directive 96/22/EC, the import of the material being permitted in accordance with Article 
35(1)(a)(ii) of Regulation (EC) No 1069/2009] 
II.1.8. have been deep-frozen at the plant of origin or have been preserved in accordance with EU legislation 
in such a way that they will not spoil between di spatch and delivery to the plant of destination; 
II.1.9. in the case of raw material derived from animals which have been treated with certain substances 
prohibited in accordance with Directive 96/22/EC for the manufacture of petfood, the import being 
permitted in accordance with Article 35(1)(a)(ii) of Regulation (EC) No 1069/2009: 
(a) it has been marked in the third country before entry into the territory of the Union by a cross 
of liquefied charcoal or activated carbon on each outer side of each frozen block, or, when 
the raw material is transported in pallets which are not divided into separate consignments during transport to the petfood plant of destinat ion, on each outer side of each pallet, in a 
way that the marking covers at least 70 % of the diagonal length of the frozen block and be 
of at least 10 cm width,
 
(b) in case of material which is not frozen, the ra w material has been marked in the third country 
before entry into the territory of the Union by spraying it with liquefied charcoal or by 
applying charcoal powder in a way that the charcoal is clearly visible on the material, and 
(c) in the case the animal by-products are made up of raw material which has been treated as 
referred to above and other non-treated raw material, all the raw materials have been marked 
as laid down in point (a) and (b) above. 
(3) (6) [ II.2. Specific requirements 
(3) (7) II.2.1. The by-products in this consignment come from animals that have been kept in the territory mentioned 
under (II.1.2), where vaccination programmes against foot-and-mouth disease are being regularly carried out and officially controlled in domestic bovine animals. 
(3) (8) II.2.2. The by-products in this consignment consists only of animal by-products derived from trimmed offal 
of domestic ruminants, which have maturated at an am bient temperature of more than +2°C for at least 
three hours, or in the case of masseter muscles of bovine animals and de-boned meat of domestic 
animals, for at least 24 hours. ] 
II.3. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.4.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a  
EN 234   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii).] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.11.91 or 05.11.99. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate.  
EN 235   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
— Box reference I.28: Manufacturing plant: provide the veterinary control number of the approved 
establishment. 
Part II : 
(*) Excluding raw blood, raw milk, hides and skins, hooves and horn, pig bristles and feathers (see 
relevant specific certificates for the import of these products). 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b) OJ 
(1c) OJ L 303, 18.11.2009, p.1. 
 (2) The name and ISO code number of the exporting country as laid down in: 
— part 1 of Annex II of Commission Regulation (EC) No 206/2010; 
— the Annex to Commission Regulation (EC) No 798/2008, and;  
— the Annex to Regulation (EC) No 119/2009. 
In addition the ISO code of regionalisation in this Annex (where applicable fo r the susceptible species 
concerned) should be included. 
(3) Delete as appropriate. 
(4) Only for countries from where game meat intended for human consumption of the same animal species 
is authorised for importation into the European Union. 
(5) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
(6) Supplementary guarantees to be provided when the material of domestic ruminants originated in the 
territory of a South American or South African country or part thereof from where only maturated and 
de-boned fresh meat of domestic ruminants for human consumption is permitted for exportation to the European Union. In the case of offal only trimmed offal of domestic ruminants which must be 
exclusively offal from which the bones, cartilage, trachea and main bronchi, lymphatic glands, 
adhering connective tissue, fat and mucus have b een completely removed is permitted. The whole 
masseter muscles of bovine animals, incised in accordance with paragraph 41(a) of Chapter VIII of 
Annex I to Council Directive 64 /433/EEC, are also permitted. 
(
7) Only for certain South American countries. 
(8) Only for certain South American and South African countries. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.   
EN 236   EN  COUNTRY   Animal by-products for the manufacture of 
petfood 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 237   EN CHAPTER 4(A) 
Health certificate 
For the import of blood and blood products from equidae to be used outside the feed chain, 
for dispatch to or for transit2 through the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
30.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Manufacturing plantPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
 
  
EN 238   EN  COUNTRY Blood and blood products from equidae for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009(1) and in particular Article 8(c) and Article 10 thereof, and Regulation (EU) No …/…(2), and 
in particular Chapter IV of Annex XVII thereto, and certify that the blood or blood products of equidae 
described above : 
II.1. consist of blood or blood products from equidae that satisfy the health requirements below; 
II.2. consist exclusively of blood or blood products of equidae not intended for human nor animal 
consumption; 
II.3. come from a third country, territory or part thereo f listed in row no. 3 of the table in Chapter II of 
Section II of Annex XVIII to Regulation (EU) No …/… where the following diseases are compulsorily 
notifiable: African horse sickness, dourine, glanders ( Burkholderia mallei) , equine encephalomyelitis 
(all types including VEE), equine infectious anaemia, vesicular stomatitis, rabies, anthrax; 
II.4. have been derived from blood which was collected under the supervision of a veterinarian, from 
equidae, which on inspection at the time of collection were free from clinical signs of infectious 
disease:  
(3) either  [in slaughterhouses approved in accordance with Regulation (EC) No 853/2004(3), ] 
(3) or [in slaughterhouses approved and supervised by the competent authority of the country of export,] 
(3) or [ in facilities approved and supervised by the competent authority of the country of export for the 
purpose of collecting blood from equidae for the production of blood products for  purposes other than 
feeding for farmed animals. ] 
II.5. have been derived from blood which was collected from equidae  
II.5.1. which on inspection on the date of blood collection did not show clinical signs of any of the 
compulsorily notifiable diseases liste d in Annex A to Directive 90/426/EEC(4), and of Equine 
influenza, Equine piroplasmosis, Equine rhinopneumonitis and Equine viral arteritis  listed in 
point 4 of Article 1.2.3. of the Terrestrial Animal Health Code of the World Organisation for Animal 
Health (OIE), 2008 Edition; 
II.5.2. which have been kept for at least 30 days prior to the date of and during blood collection on holdings 
under veterinary supervision which were not subject to a prohibition order pursuant to Article 4(5) or 
restrictions for African horse sickness in accordance with Article 5 of Directive 90/426/EEC; 
II.5.3. which had no contact with equidae from a holding which was subject to a prohibition order for animal 
health reasons pursuant to Article 4(5) of Directive 90/426/EEC. 
II.5.4. have been derived from blood which was collected from equidae for which the period for the 
prohibition order referred to in points II.5.2. an d II.5.3 has been determined as followed: 
(3) either [ where not all the animals of species susceptible to the disease located on the holding have been 
slaughtered and the premises disinfected the period of prohibition has been:  
- six months in the case of glanders ( Burkholderia mallei) , beginning on the date on which the 
equidae infected with the disease are slaughtered; 
- six months in the case of equine encephalomyelitis of any type, including Venezuelan equine 
encephalomyelitis, beginning on the date on which the equidae infected with the disease are 
slaughtered; 
- in the case of equine infectious anaemia, until the date on which, the infected animals having 
been slaughtered, and the remaining animals have shown a negative reaction to two Coggins tests carried out three months apart;  
EN 239   EN  COUNTRY Blood and blood products from equidae for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
- during six months from the date of the last recorded case of vesicular stomatitis; 
- during one month from the date of the last recorded case of rabies; 
- during 15 days from the date of the last recorded case of anthrax.] 
(3) or [ if all the animals of species susceptible to the disease located on the holding have been  slaughtered 
and the premises disinfected, the period of prohibition shall be 30 days, beginning on the date on 
which the animals were slaughtered and the premises disinfected, except in the case of anthrax, where 
the period of prohibition shall 15 days]  
 
II.6. blood products must come from a establishment or plant approved or registered by the competent 
authority of the third country meeting the specific conditions set out in Article 23 or 24 of Regulation 
(EC) No 1069/2009. 
II.7. blood products have been produced from blood which fulfils the conditions referred in II.4. and II.5 
and  
(3) either  [has been produced from blood collected from equidae which have been kept for a period of at least 
three months, or since birth if less than three months old, prior to the date of collection on holdings 
under veterinary supervision in the country of collection which during that period and the period of 
blood collection has been free of:  
 (a) African horse sickness for two years 
 (b) Venezuelan equine encephalomyelitis for a period of at least two years; 
 (c) glanders 
(2) either [for a period of three years; ] 
(2) or [ for a period of six  months where the animals have passed the post-mortem 
inspection for glanders in the slaughterhouse  referred to in paragraph 1, including a 
careful examination of mucous membranes from the trachea, larynx, nasal cavities 
and sinuses and their ramifications, after sp litting the head in the median plane and 
excising the nasal septum;] 
 (d) vesicular stomatitis for six months;] 
(3) or [has been subjected to at least one of the following treatments, followed by an effectiveness check, for 
the inactivation of possible causative pathogens for African horse sickness, equine encephalomyelitis 
of all types including Venezuelan equine encephalomyelitis, equine infectious anaemia, vesicular 
stomatitis and glanders ( Burkholderia mallei ): 
(2) either [ heat treatment at a temperature of 65°C for at least three hours]] 
(2) or [ irradiation at 25 kGy by gamma rays]] 
(2) or [ change in pH to pH 5 for two hours]] 
(2) or [ heat treatment of at least 80°C throughout their substance]] 
II.8. all precautions have been taken to avoid contamination of the blood and blood products with 
pathogenic agents during production, handling and packaging; 
II.9. blood and blood products were packed in sealed impermeable containers clearly labelled "NOT FOR 
HUMAN OR ANIMAL CONSUMPTION" and bearing the approval number of the establishment of 
collection;  
EN 240   EN  COUNTRY Blood and blood products from equidae for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
II.10. the products were stored in enclosed storage; 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) must 
be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the veterinary control number of the registered 
establishment of collection. 
Part II: 
(1) OJ L 300, 14.11.2009, p. 1 
(2) OJ … 
(3)  Delete as appropriate 
(4) OJ No. L 139, 30.04.2004, p. 55 
(5) OJ L 224, 18.8.1990, p. 42  
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and must accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 241   EN CHAPTER 4(B) 
Health certificate 
For blood products not intended for human consumption that could be used as feed material, 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 242   EN  COUNTRY    Blood products that could be used as 
feed  
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and Regulation (EC) No …/… (1b) and certify that the blood products described above : 
II.1. consist of blood products that satisfy the health requirements below; 
II.2. consist exclusively of blood products not intended for human consumption; 
II.3. have been prepared and stored in a plant, approved, validated and supervised by the competent 
authority in accordance w ith Article 24 of Regulation (EC) No 1069/2009; 
II.4. have been prepared exclusively with the following animal by-products : 
(2) either [ blood of slaughtered animals, which is fit for human consumption in accordance with Union 
legislation, but is not intended for human consumption for commercial reasons; ] 
(2) and/or [ blood of slaughtered animals, which is rejected as unfit for human consumption but is not affected by 
any signs of diseases communicable to humans or animals, derived from carcasses that are fit for 
human consumption in accordance with Union legislation; ] 
(2) and/or [ blood of slaughtered animals, which is rejected as unfit for human consumption but is not affected by 
any signs of diseases communicable to humans or animals, derived from carcasses that are fit for 
human consumption in accordance with Union legislation; ] 
II.5. have been submitted  
(2) either [ to processing in accordance with processing method ……….. (3) as set out in Annex VII, Section III  
of Regulation (EU) No  …/…] 
(2) or [ to a method and parameters which ensure that the product complies with the microbiological 
standards set in Annex XIV, Section I to Regulation (EU) …/…, ]  
 in order to kill pathogenic agents; II.6. have been examined under the responsibility of the competent authority taking a random sample 
immediately prior to dispatch and found it to comply with the following standards (4): 
Salmonella:  absence in 25g: n = 5, c = 0, m = 0, M = 0, 
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 gram; 
II.7. the end product was : (
2) either [ packed in new or sterilised bags, ] 
(2) or [ transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected with a disinfectant approved by the competent authority before use, ] and which bear labels 
indicating “NOT FOR HUMAN CONSUMPTION”; 
II.8. the end product was stored in enclosed storage; 
II.9. the product has undergone all precautions to avoid contamination with pathogenic agents after 
treatment; 
II.10.  
EN 243   EN  COUNTRY    Blood products that could be used as 
feed  
  II.a. Certificate reference number II.b. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.11.91 or 05.11.99. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
 (2) Delete as appropriate. 
(3) Insert method 1 to 5 or 7 as applicable. 
(4) Where: 
n = number of samples to be tested, 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all samples does not exceed m, 
M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number 
of bacteria in one or more samples is M or more, and 
c = number of samples the bacterial count of which may be between m and M, the sample still 
being considered acceptable if  the bacterial count of the other samples is m or less.  
EN 244   EN  COUNTRY    Blood products that could be used as 
feed  
  II.a. Certificate reference number II.b. 
—  The signature and the stamp must be in a different colour to that of the printing. 
—  Note for the person responsible for the consignment in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 245   EN CHAPTER 4(C) 
Health certificate 
For untreated blood products, excluding of equidae, for the manufacture of derived products 
for uses outside the feed chain, intended for dispatch to or for transit through2 the European 
Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
30.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 246   EN  COUNTRY Untreated blood products, excluding of equidae, for derived 
products 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) 
No 1069/2009 (1a), and in particular Article 8(c) and (d ) and Article 10 thereof, and Regulation 
(EU) No …/… (1b), and  in particular Annex XVIII, Section II thereof, and certify that: 
II.1. the blood products described above consist of blood products that satisfy the health requirements 
below; 
II.2. they consist exclusively of blood products not intended for human or animal consumption; II.3. they have been prepared and stored in a plant supervised by the competent authority or in the 
establishment of collection
(2), exclusively with the following animal by-products: 
(2)either [ - blood of slaughtered animals, which is fit for human consumption in accordance with Union 
legislation, but is not intended for human consumption for commercial reasons; ] 
(2) and/or [ - blood of slaughtered animals, which is rejected as unfit for human consumption but is not 
affected by any signs of diseases communicable to humans or animals, derived from carcasses 
that are fit for human consumption in accordance with Union legislation; ] 
(2)and/or [ - blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, 
after undergoing ante-mortem inspection, and were f it, as a result of such inspection, for slaughter 
for human consumption in accordance with Union legislation; ] 
(2)and/or [ - blood and blood products originating from live animals that did not show signs of any disease 
communicable through that product to humans or animals;] 
II.4. the blood from which such products are manufactured has been collected: 
(2)either [ in slaughterhouses approved in  accordance with Union legislation, ] 
(2)or [ in slaughterhouses approved and supervised by the competent authority of the third country, ] 
(2)or [ from live animals in facilities approved and su pervised by the competent authority of the third 
country. ] 
(2)[II.5. in the case of blood products derived from animals belonging to the taxa Artiodactyla, 
Perissodactyla and Proboscidea, including their crossbreds, the products come: 
II.5.1. from a country where no case of rinderpest, pe ste des petits ruminants and Rift Valley fever has 
been recorded for 12 months and in which vaccination has not been carried out against those 
diseases for at least 12 months. 
(2)[II.5.2. either [ from the territory of a country or region with code …. (3) where no case of foot-and-mouth 
disease has been recorded for 12 months and in which vaccination has not been carried out against 
this disease for at least 12 months ] 
(2)[II.5.2. or [ from the territory of a country or region with code …. (3) where no case of foot-and-mouth 
disease has been recorded for 12 months and in which vaccination programmes against foot-and-
mouth disease are being officially carried out and controlled in domestic ruminant animals for at 
least 12 months(4) ] ] 
(2)[II.5.3. In addition, in case of animals other than Suidae and Tayassuidae:  
(2)either [ in the country or region of origin no cas e of vesicular stomatitis and bluetongue(2) (including 
the presence of seropositive animals) has been recorded for 12 months and in which vaccination  
EN 247   EN  COUNTRY Untreated blood products, excluding of equidae, for derived 
products 
  II.a. Certificate reference number II.b. 
has not been carried out against those diseases for at least 12 months, ] 
(2)or [ in the country or region of origin vesicular stomatitis and bluetongue(2) seropositive animals are 
present(4) ] 
(2)[II.5.4. In addition, in ca se of Suidae and Tayassuidae: 
[II.5.4.1. [ in the country or  region of origin no case of swine ve sicular disease, classical swine fever and 
African swine fever has been recorded for at least 12 months and vaccination has not been carried 
out against those diseases for at least 12 months in the susceptible species ] 
(2)[II.5.4.2. either [ in the country or region of origin no  case of vesicular stomatitis (including the presence of 
seropositive animals) has been recorded for 12 months and in which vaccination has not been 
carried out against this disease for at least 12 months, ] 
(2)[II.5.4.2. o [ in the country or region of origin vesicular stomatitis seropositive animals are present(4) ] ] 
(2)[II.6. in the case of blood products derived from poultry or other avian species the animals and the 
products come from the territory of a country or region with code …. (5)] 
 which has been free from Newcastle disease and highly pathogenic avian influenza as defined in 
the Terrestrial Animal Health Code of the OIE 
 which for at least 12 months has not carried out vaccination against avian influenza 
 where the animals from which the products derive have not been vaccinated against Newcastle 
disease with vaccines prepared from a Newcastle disease master strain showing a higher 
pathogenicity than lentogenic virus strains. ] 
II.7. the products were: 
(2) either [ packed in new or sterilised bags or bottles, ] 
(2) or [ transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected with a disinfectant approved by the competent authority before use, ] 
 the outer packaging or containers bear labels indicating “NOT FOR HUMAN OR ANIMAL 
CONSUMPTION”; 
II.8. the products were stored in enclosed storage; 
II.9. the products have undergone all precautions to avoid contamination with pathogenic agents 
during transport; 
II.10. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;]  
EN 248   EN  COUNTRY Untreated blood products, excluding of equidae, for derived 
products 
  II.a. Certificate reference number II.b. 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the cons ignment in the European Union: this box is to 
be filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is 
for import commodity. 
— Box reference I.12: Place of destin ation: this box is to be filled in only if it is a certificate for 
transit commodity. The products in transit can only be stored in free zones, free warehouses and 
custom warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
 (2) Delete as appropriate. 
(3) Code of the territory as it appears in Part 1 of Annex II to Decision 79/542/EEC. 
(4) In this case following the border check provided for in Directive 97/78/EC, and in accordance 
with the conditions laid down in Article 8(4) of that Directive, the products must be transported 
directly to the plant of destination. 
(5) Code of the territory as it appears in Part 1 of Annex II to Decision 2006/696/EC. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in the European Union: this certificate is only 
for veterinary purposes and has to accompany the consignment until it reaches the border 
inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 249   EN CHAPTER 4(D) 
Health certificate 
For treated blood products, excluding of equidae, for the manufacture of derived products for 
uses outside the feed chain, intended for dispatch to or for transit through2 the European 
Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
30.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 250   EN  COUNTRY Treated blood products, excluding of equidae, for products 
other than feeding to farmed animals 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 8(c) and 8(d) and Article 10 and Regulation (EU) No …/… (1b), 
and  in particular Annex XVIII, Section II  thereof, and certify that: 
II.1. the blood products described above consist of blood products that satisfy the requirements below; II.2. they consist exclusively of blood products not intended for human or animal consumption; II.3. they have been prepared and stored in a plant supervised by the competent authority exclusively with 
the following animal by-products: 
(2) either [ — blood of slaughtered animals, which is fit for human consumption in accordance with Union 
legislation, but is not intended for human consumption for commercial reasons; ] 
(2) and/or [ — blood of slaughtered animals, which is rejected as unfit for human consumption but is not 
affected by any signs of diseases communicable to humans or animals, derived from carcasses that are 
fit for human consumption in accordance with Union legislation; ] 
(2) and/or [ — blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, 
after undergoing ante-mortem inspection, and were fit,  as a result of such inspection, for slaughter for 
human consumption in accordance with Union legislation; ] 
(2) and/or [ — blood and blood products originating from live animals that did not show clinical signs of any 
disease communicable through these products to humans or animals. ] 
II.4. the blood from which such products are manufactured has been collected: 
(2) either [ in slaughterhouses approved in  accordance with Un ion legislation, ] 
(2) or [ in slaughterhouses approved and supervised by the competent authority of the third country, ] 
(2) or [ from live animals in facilities approved and su pervised by the competent authority of the third 
country. ] 
(2) [II.5. In case of blood products derived from Arti odactyla, Perissodactyla and Proboscidea including their 
crossbreeds, other than Suidae and Tayassuidae, the products have undergone one of the following 
treatments, guaranteeing the absence of pathogens of foot-and-mouth disease, vesicular stomatitis, 
rinderpest, peste des petits ruminants, Rift Valley fever and bluetongue: 
(2) either [ heat treatment at a temperature of 65°C for at least three hours, followed by an effectiveness check, ] 
(2) or [ irradiation at 25 kGy by gamma rays, followed by an effectiveness check, ] 
(2) or [ change in pH to pH 5 for two hours, followed by an effectiveness check, ] 
(2) or [ heat treatment of at least 80°C throughout their substance, followed by an effectiveness check]] 
(2) [II.6. In the case of bloo d products derived from Suidae, Tayassuida e, poultry and other avian species, the 
products have undergone one of the following treatments guaranteeing the absence of pathogens of the 
following diseases: foot-and-mouth disease, vesicular stomatitis, swine vesicular disease, classical swine fever, African swine fever, Newcastle disease and highly pathogenic avian influenza as 
appropriate to the species; 
(2) either [ heat treatment at a temperature of 65°C for at least three hours, followed by an effectiveness check, ]  
EN 251   EN  COUNTRY Treated blood products, excluding of equidae, for products 
other than feeding to farmed animals 
  II.a. Certificate reference number II.b. 
(2) or [ irradiation at 25 kGy by gamma rays, followed by an effectiveness check, ] 
(2) or [ heat treatment of at least 80°C for Suidae/Tayassuidae (2) and at least 70°C for poultry and other 
avian species(2) throughout their substan ce, followed by an effectiveness check ] ] 
(2) [II.7. In the case of blood products derived from species other than  listed under II.5. or II.6. the products 
have undergone of the following tr eatment (please specify):…………………. ] 
II.8. The products were : 
(2) either [ packed in new or sterilised bags or bottles, ] 
(2) or [ transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected with a disinfectant approved by the competent authority before use, ] and 
  [the outer packaging or containers bear labels indicating “NOT FOR HUMAN OR ANIMAL 
CONSUMPTION”]; 
II.9. the products were stored in enclosed storage; 
II.10. the products have undergone all precautions to avoid contamination with pathogenic agents after 
treatment; 
II.11. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in the European Union: this box is to be 
filled in only if it is a certificate for transit commodity; it may be filled in if the certificate is for import 
commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included.  
EN 252   EN  COUNTRY Treated blood products, excluding of equidae, for products 
other than feeding to farmed animals 
  II.a. Certificate reference number II.b. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
Part II: 
(1a) OJ 
(1b) OJ 
 (2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in the European Union: this certificate is only for 
veterinary purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 253   EN CHAPTER 5(A) 
Health certificate 
For fresh or chilled hides and skins of ungulates, intended for dispatch to or for transit 
through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight
(Scientific name)Part I : Details of dispatched consignment I.2.a
 
  
EN 254   EN  COUNTRY   Fresh or chilled hides and skins of ungulates 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 thereof, and Regulation (EU) No …/… (1b), and in particular 
Annex XVIII, Section II  thereof, and certify that the hides and skins described above : 
II.1. have been obtained from animals that (2): 
(a) were slaughtered and their carcasses are fit for human consumption in accordance with Union 
legislation or  
(b) were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were 
considered fit, as a result of such inspection, for slaughter for human consumption in 
accordance with Union legislation; 
II.2. originate from a country or, in the case of region alisation in accordance with Union legislation, from a 
part of a country from which imports of all categories of fresh meat of the corresponding species are authorised and which : 
(a) for at least 12 months before dispatch, has been free from the following diseases 
(3): 
[— classical swine fever, and African swine fever, ] 
[— rinderpest, ] 
and 
(b) has been free for at least 12 months before dispatch from foot-and-mouth disease and where, for 
12 months before dispatch, no vaccination has been carried out against foot-and-mouth disease (3); 
II.3. have been obtained from : 
[ animals that have remained in the territory of the country of origin for at least three months before being 
slaughtered or since birth in the case of animals less that three months old; ] 
[ in the case of hides and skins from bi-ungulates, animals that come from holdings in which there has 
been no outbreak of foot-and-mouth disease in the previous 30 days, and around which within a radius of 
10 km there has been no case of foot-and-mouth disease for 30 days; ] 
[ in the case of hides and skins from swine, animals that come from holdings in which there has been no 
outbreak of swine vesicular disease in the previous 30 days, or of classical or African swine fever in the previous 40 days, and around which within a radius of 10 km there has been no case of these diseases for 
30 days; ] 
[ animals that have shown no evidence of [ foot-and-mouth disease ], [ rinderpest ], [ classical swine 
fever ], [ African swine fever ] or [ swine vesicula r disease ](3) during ante-mor tem health inspection at 
the slaughterhouse during the 24 hours before slaughter; ] 
II.4. have undergone all precautions to avoid recontamination with pathogenic agents; 
II.5. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous  
EN 255   EN  COUNTRY   Fresh or chilled hides and skins of ungulates 
  II.a. Certificate reference number II.b. 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 41.01; 41.02 or 41.03. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be given. 
— Box reference I.26 a nd I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1a)  OJ L 300, 14.11.2009, p.1.  
(1b)  OJ 
 (2) Delete as appropriate. 
(3) Delete diseases not applicable to the species concerned. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: This certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 256   EN CHAPTER 5(B) 
Health certificate 
For treated hides and skins of ungulates, intended for dispatch to or for transit through2 the 
European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight
(Scientific name)Part I : Details of dispatched consignment I.2.a
 
  
EN 257   EN  COUNTRY     Treated hides and skins of 
ungulates 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1) and in particular Article 10 ther eof, and Regulation (EU) No …/… (1b), and in particular 
Annex XVIII, Section II  thereof, and certify that the hides and skins described above : 
II.1. have been obtained from animals that (2): 
(a) were slaughtered and their carcasses are fit for human consumption in accordance with Union 
legislation or  
(b) were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were 
considered fit, as a result of such inspection, for slaughter for human consumption in accordance 
with Union legislation or  
(c) did not show any clinical signs of any disease communicable to humans or animals through the 
hide or skin, and were not killed to eradicate any epizootic disease; 
(2)either  [II.2 come from animals originate from a th ird country or, in the case of regionalisation in 
accordance with Union legislation, from a part of a third country listed in part 1 of Annex II to Decision 
79/542/EEC(3) from which imports of fresh meat of the corresponding species are authorised and have 
been: 
(2)either [ dried; ] 
(2)or [ dry-salted or wet-salted for at least 14 days prior to dispatch; ] 
(2)or [dry-salted or wet-salted on the following date …………………….… and according to the declaration of 
the transporter, the hides and skins will be transporte d by ship and the duration of transport will be such 
that they will have undergone a minimum of 14 days of salting before they reach the EC border 
inspection post ] 
(2)or [ salted for seven days in sea salt with the addition of 2% of sodium carbonate; ] 
(2)or [salted in sea salt with the addition of 2% of sodium carbonate on the following date 
…………………….… and according to the declaration of th e transporter, the hides and skins will be 
transported by ship and the duration of transport w ill be such that they will have undergone a minimum 
of 7 days of salting before they reach the EC border inspection post ]] 
(2)or [II.2. come from animals originate from a thir d country or, in the case of regionalisation in 
accordance with Union legislation, from a part of a third country listed in part 1 of Annex II to Decision 79/542/EEC from which imports of fresh meat of the corresponding species are NOT authorised and have 
been:: 
(2)either [ salted for seven days in sea salt with  the addition of 2% of sodium carbonate; ]  
(2)or [salted in sea salt with the addition of 2% of sodium carbonate on the following date 
…………………….… and according to the declaration of th e transporter, the hides and skins will be 
transported by ship and the duration of transport w ill be such that they will have undergone a minimum 
of 7 days of salting before they reach the EC border inspection post ] 
(2)or [ dried for 42 days at a temperature of at least 20°C; ] 
II.3. the consignment has not been in contact with other animal products or with live animals presenting a risk 
of spreading a serious transmissible disease. 
II.4.  
EN 258   EN  COUNTRY     Treated hides and skins of 
ungulates 
  II.a. Certificate reference number II.b. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destinatio n: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship) and information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 41.01; 41.02 or 41.03. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be given. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
Part II: 
(1a)  OJ L 300, 14.11.2009, p.1.  
(1b)  OJ 
 (2) Delete as appropriate. 
(3) OJ L 146, 14.6.1979, p. 15. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: This certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 259   EN  COUNTRY     Treated hides and skins of 
ungulates 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 260   EN CHAPTER 5(C) 
Official declaration 
For treated hides and skins of ruminants and of equidae that are intended for dispatch to or 
for transit through2 the European Union and have been kept separate for 21 days or will 
undergo transport for 21 uninterrupted days before importation 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Manufacturing plant Net weight
(Scientific name)Part I : Details of dispatched consignment I.2.a
  
EN 261   EN  COUNTRY  Treated hides and skins of Ruminants and of Equidae 
that have been kept separate for 21 days or will undergo 
transport for 21 uninterrupted days before importation 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Declaration 
I, the undersigned declare that the hides and skins described above : II.1. have been obtained from animals that 
(1) : 
(a) were slaughtered and their carcasses are fit for human consumption in accordance with Union 
legislation or  
(b) were slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were 
considered fit, as a result of such inspection, for slaughter for human consumption in accordance 
with Union legislation or  
(c) did not show any clinical signs of any disease communicable to humans or animals through the 
hide or skin, and were not killed to eradicate any epizootic disease; 
II.2. have been: 
(1) either [ dried; ] 
(1) or [ dry-salted or wet-salted for at least 14 days prior to dispatch; ] 
(1) or [ salted for seven days in sea salt with the addition of 2% of sodium carbonate; ] 
II.3. have not been in contact with other animal products or with live animals presenting a risk or spreading a 
serious transmissible disease; 
(1) either [ II.4. have been kept separate immediately before dispatch for 21 days under official supervision 
after the treatment described under point (II.2). ] 
(1) or [ II.4. following the declaration of the transporter,  the duration of the transp ort period is foreseen to 
be at least 21 days. ] 
II.4. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity.  
EN 262   EN  COUNTRY  Treated hides and skins of Ruminants and of Equidae 
that have been kept separate for 21 days or will undergo 
transport for 21 uninterrupted days before importation 
  II.a. Certificate reference number II.b. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 41.01; 41.02 or 41.03. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be given. 
— Box reference I.26 a nd I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: This declaration is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 263   EN CHAPTER 6(A) 
Health certificate 
For treated game trophies of birds and ungulates, being solely bones, horns, hooves, claws, 
antlers, teeth, hides or skins, for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.22. Number of packages
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Species (Scientific name) Nature of commodity Number of packagesI.21.Part I : Details of dispatched consignment I.2.a
I.10. 
 
  
EN 264   EN  COUNTRY  Treated game trophies of birds and ungulates, being 
solely bones, horns, hooves, claws, antlers, teeth, hides or skins 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) 
No 1069/2009 (1a) and Regulation (EU) No …/…(1b), and in particular Annex XVIII, Section II 
thereof, and certify that the game trophies described above : 
II.1. have been packaged, immediately after treatment, without being in contact with other products of 
animal origin likely to contaminate them, in individual, transparent and closed packages so as to 
avoid any subsequent contamination; 
(2) either[II.2. in the case of game trophie s consisting solely of hides or skin : 
(2) either [have been dried. ] 
(2) or [ have been dry-salted or wet-salted for a minimum of 14 days before dispatch. ] 
(2) or [ were dry-salted or wet-salted on …………………………..… (date) and, according to the 
declaration of the transporter, will be transported by ship and the duration of the transport will be 
such that they will have undergone a minimum of 14 days salting before they reach the EC border 
inspection post. ] ] 
(2) or [II.2. in the case of game trophies consisting sole ly of bone, horns, hooves, claws, antlers or teeth : 
(a) have been immersed in boiling water for an appropriate time so as to ensure that any 
matter other than bone, horns, hooves, claws, antlers or teeth is removed, and 
(b) have been disinfected with a product authoris ed by the competent authority, in particular 
with hydrogen peroxide where parts consisting of bone are concerned. ] 
II.3. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped in strument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consig nment in EU: this box is to be filled in only if 
it is a certificate for transit commodity; it may be filled in if the certificate is for import 
commodity. 
— Box reference I.12: Place of destinat ion: this box is to be filled in  only if it is a certificate for 
transit commodity. The products in transit can only be stored in free zones, free warehouses and 
custom warehouses.  
EN 265   EN  COUNTRY  Treated game trophies of birds and ungulates, being 
solely bones, horns, hooves, claws, antlers, teeth, hides or skins 
  II.a. Certificate reference number II.b. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.19: use the appropriate HS code: 05.05; 05.06; 05.07 or 97.05. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
— Box reference I.28: for nature of commodity, specify choosing one or more possibilities among 
the following: [ bones ], [ horns ], [ hooves ], [ claw s ], [ antlers ], [ teeth ], [ hides ] or [ skins ] 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
 (2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 266   EN CHAPTER 6(B) 
Health certificate 
For game trophies of birds and ungulates consisting of entire parts not having been treated, 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.22. Number of packages
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Species (Scientific name) Number of packagesI.21.Part I : Details of dispatched consignment I.2.a
I.10. 
 
  
EN 267   EN  COUNTRY  Game trophies of birds and ungulates consisting of 
entire parts not having been treated 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) 
No 1069/2009 (1a) and Regulation (EU) No …/…(1b), and in particular Annex XVIII, Section II 
thereof, and certify that the game trophies described above : 
(2) either [II.1. with respect to game trophies  of cloven-hoofed animals, excluding swine : 
(a) ……………..… (region) has been free from foot-and-mouth disease and rinderpest for the 
previous 12 months, and during the same period, no vaccination against any of those diseases 
has taken place, and 
(b) the game trophies described above : 
(i) were obtained from animals which were kill ed in the territory of that region, which is 
authorised for export of fresh meat of the corresponding susceptible domestic species 
and where, during the last 60 days, there have been no animal health restrictions 
because of outbreaks of diseases to which the game animals are susceptible, and 
(ii) originated from animals that were killed at a distance of at least 20 km from the borders 
of another third country or part of a third country not authorised to export untreated 
game trophies of cloven-hoofed animals other than swine to the Union; ] 
(2) or [II.1. with respect to game trophies of wild swine : 
(a) ………………… (region) during the last 12 mont hs was free from classical swine fever, 
African swine fever, swine vescicular disease, foot-and-mouth disease and porcine 
enteroviral encephalmiyelitis (Teschen disease) and no vaccinations have been carried out 
against any of those diseases during the last 12 months, and 
(b) the game trophies described above : 
(i) were obtained from animals which were kille d in that territory, which is authorised for 
export of fresh meat of the corresponding susceptible domestic species and where, 
during the last 60 days, there have been no animal health restrictions because of outbreaks of diseases to which the swine are susceptible, and 
(ii) originated from animals that were killed at  a distance of at least 20 km from the borders 
of another third country or part of a third country not authorised to export untreated game trophies of wild swine to the Union; ] 
(2) or [II.1. with respect to game trophies of solipeds, the game trophies described above were obtained from 
wild solipeds that were killed in the territory  of the exporting country mentioned above; ] 
(2) or [II.1. with respect to game trophies of game birds : 
(a) …………………………… (region) is free from highly pathogenic avian influenza and 
Newcastle disease, and 
(b) the game trophies described above were obtained from wild game birds that were killed in 
that region and where during the last 30 days there have been no animal health restrictions because of outbreaks of disease to wh ich the wild birds are susceptible; ] 
II.2. The game trophies described above have been packaged without being in contact with other 
products of animal origin likely to contaminat e them, in individual, transparent and closed 
packages so as to avoid any subsequent contamination.  
EN 268   EN  COUNTRY  Game trophies of birds and ungulates consisting of 
entire parts not having been treated 
  II.a. Certificate reference number II.b. 
II.3. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consig nment in EU: this box is to be filled in only if 
it is a certificate for transit commodity; it may be filled in if the certificate is for import 
commodity. 
— Box reference I.12: Place of destin ation: this box is to be filled in only if it is a certificate for 
transit commodity. The products in transit can only be stored in free zones, free warehouses and 
custom warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.05; 05.06 or 05.07. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
 (2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 269   EN  COUNTRY  Game trophies of birds and ungulates consisting of 
entire parts not having been treated 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 270   EN  
CHAPTER 7 (A) 
Health certificate 
For pig bristles from third countries or regions thereof that are free from African swine fever, 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
05.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Manufacturing plant Number of packages Net weightPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 271   EN  COUNTRY  Pig bristles from third countries or regions thereof that 
are free from African swine fever 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) 
No 1069/2009 (1a) , and in particular Article 10(b)(iv)  thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVIII Section II thereof, and certify that : 
II.1. the pig bristles described above have been obtained from pigs originating, and slaughtered in a 
slaughterhouse, in the country of origin; 
II.2. the pigs, from which the pig bristles have been obtained, did not show during inspection, carried out at 
the time of slaughtering, signs of diseases communicable to humans or animals and were not killed to 
eradicate any epizootic disease; 
II.3. the country of origin or, in case of regionalisation according to Union legislation, the region of origin, has 
been free from African swine fever for at least 12 months; 
II.4. the pig bristles are dry and securely enclosed in packaging. 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be included. 
— Box reference I.26 a nd I.27: fill in according to whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide th e veterinary control number of the registered 
establishment. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
 (2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: this certificate is on ly for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post.  
EN 272   EN  COUNTRY  Pig bristles from third countries or regions thereof that 
are free from African swine fever 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 273   EN CHAPTER 7 (B) 
Health certificate 
For pig bristles from third countries or regions thereof that are not free from African swine 
fever, intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
05.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Manufacturing plant Number of packages Net weightPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
 
  
EN 274   EN  COUNTRY  Pig bristles from third countries or regions thereof that 
are not free from African swine fever 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10(b)(iv) thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVIII, Section II thereof, and certify that : 
II.1. the pig bristles described above have been obtained from pigs originating, and slaughtered in a 
slaughterhouse, in the country of origin; 
II.2. the pigs from which the pig bristles have been obtained did not show during inspection, carried out at 
the time of slaughtering, signs of diseases communi cable to humans or animals and were not killed to 
eradicate any epizootic disease; 
II.3. the pig bristles mentioned above have been : 
(2) either [ boiled; ] 
(2) or [ dyed; ] 
(2) or [ bleached; ] 
II.4. the pig bristles are dry and securely enclosed in packaging. 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the veterinary control number of the registered 
establishment. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1.  
(1b) OJ 
(2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing.  
EN 275   EN  COUNTRY  Pig bristles from third countries or regions thereof that 
are not free from African swine fever 
  II.a. Certificate reference number II.b. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 276   EN CHAPTER 8 
Health certificate 
For animal by-products to be used for purposes outside the feed chain or for trade samples2, 
intended for dispatch to or for transit through2 the European Community 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 277   EN COUNTRY  Animal by-products for the manufacture of derived products 
for uses outside the feed chain, or for trade samples(2) 
 
 II.a. Certificate reference number II.b.  Part II: Certification 
 
 
 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) 
No 1069/2009 (1) and certify that the animal by-products described above : 
II.1. are trade samples which consist of animal by-products intended for particular studies or analyses as 
 referred to in Annex I No. 47 of Regulation (EC) No 1069/2009, that are bearing the label "TRADE 
 SAMPLE NOT FOR HUMAN CONSUMPTION"; or  
II.2.  that satisfy the animal health requirements below; II.2.1. have been obtained in  the territory of:………………….…………
(2) from animals: 
(3) either [(a) that have remained in this territory sin ce birth or for at least the last three months before 
slaughter; ] 
(3) or [(b) killed in the wild in this territory(4)] 
II..3. have been obtained from animals: 
(3) either [(a) coming from holdings : 
(i) where, for the following diseases for which the animals are susceptible, there has been 
neither case/outbreak of rinderpest, swine vesicular disease, Newcastle disease or 
highly pathogenic avian influenza during the prior 30 days, nor of classical or African 
swine fever during the prior 40 days; nor in the holdings situated in their vicinity 
within 10 km, during the prior 30 days, and 
(ii) where there has been neither case/outbreak of foot and mouth disease during the prior 
60 days, nor in the holdings situated in thei r vicinity within 25 km, during the prior 30 
days, and 
 (b) which : 
(i) were not killed to eradicate any epizootic disease, 
(ii) have remained in their holdings of origin for at least forty days before departure and 
which have been transported directly to the slaughterhouse without contact with other 
animals which did not comply with the same health conditions, 
(iii) at the slaughterhouse, have passed the ante-mortem health inspection during the 24 
hours before the slaughter and have shown no evidence of the diseases referred to 
above for which the animals are susceptible, and 
(iv) have been treated in the slaughterhouse before and at the time of slaughter or killing in 
accordance with the relevant provisions of Council Regulation (EC) 1099/2009 on the protection of animals at the time of killing] 
(3) or [(a) captured and killed in the wild in an area : 
(i) in which within 25 km there has been no case/outbreak of any of the following 
diseases for which the animals are susceptible: foot and mouth disease, rinderpest, 
Newcastle disease or highly pathogenic avian influenza during the prior 30 days nor of 
classical or African swine fever during the prior 40 days and 
(ii) that is situated at a distance that exce eds 20 km from the borders separating another  
EN 278   EN territory of a country or part thereof, wh ich is not authorised at these dates for 
exporting this material to the European Community, and 
(b) which after killing were transported within 12 hours for chilling either to a collection centre and 
immediately afterwards to a game establishment, or directly to a game establishment] 
II.2.2. have been obtained in an establishment around which, within a radius of 10 km, there has been no 
case/outbreak of diseases referred to in point II.1.3 for which the animals are susceptible during the prior 
30 days or, in the event of a case of disease, the preparation of raw material for exportation to the 
European Community has been authorised only after removal of all meat, and the total cleaning and 
disinfection of the establishment under the control of an official veterinarian; 
II.2.3.. have been obtained and prepared without contact  with other material not complying with the conditions 
required above, and it has been handled so as to avoid contamination with pathogenic agents; 
II.2.4. have been packed in new packaging preventing any leakage and in officially sealed containers bearing the 
label indicating “ANIMAL BY-PRODUCTS ONLY FOR THE MANUFACTURE OF DERIVED  
PRODUCTS FOR USES OUTSIDE THE FEED CHAIN” and the name and address of the EU 
establishment indicate in the authorisation of compet ent authority in the Member State of destination; 
II.2.5. consist only of the following animal by-products : 
(3) either [ -parts of slaughtered animals, which are fit for human consumption in accordance with Community 
legislation, but are not intended for human consumption for commercial reasons ] 
(3) and/or [ -parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by 
any signs of diseases communicable to humans or animals and derive from carcasses that are fit for human 
consumption in accordance with Community legislation ] 
(3) and/or [ -animal by-products derived from the production of products intended for human consumption, including 
degreased bones and greaves ] 
(3) and/or [ -products of animal origin, other than catering waste (5), which, after having been placed on the market 
for human consumption or for feeding to animals, are no longer intended for such consumption or such 
feeding for commercial reasons or due to problems of  manufacturing or packaging defects or other defects 
from which no risk to public or animal health arise] 
(3) and/or [ - aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals] 
(3) and/or [ - fresh animal by-products from aquatic animals originating from plants or establishments manufacturing 
products for human consumption] 
(3) and/or [ - shells, hatchery by-products and cracked egg by-products originating from animals which did not show 
clinical signs of any disease communicable through that product to humans or animals;] 
(3) and/or [ - fur originating from animals that did not show clinical signs of any disease communicable through that 
product to humans or animals] 
II.1.8. have been deep-frozen at the plant of origin or have been preserved in accordance with EU legislation in 
such a way that they will not spoil between disp atch and delivery to the plant of destination. 
(3) (6) [ II.2.6. Specific requirements 
(3)(7) II.2.6.1. The by-products in this consignment come fr om animals that have been obtained in the territory 
mentioned under (II.1.2), where vaccination programmes against foot-and-mouth disease are 
being regularly carried out and officially controlled in domestic bovine animals. 
(3)(8) II.2.6.2. The by-products in this consignment consists of animal by-products derived from offal or de-
boned meat. ] 
II.2.7. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to  
EN 279   EN Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by la ceration of central nervous 
tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.2.8.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last three years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and capri ne animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined  to a Member State listed in the Annex to the 
Regulation (EC) No 546/2006, the ovine and caprine animals from which these products are 
derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
y Box reference I.6: Person re sponsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
y Box reference I.11: In case of consignments for the particular technological studies or analyses: indicate 
name and address of establishment only.  
EN 280   EN y Box reference I.12:Place of destinatio n: this box is to be filled in:  
-  products for the the manufacture of derived products for uses outside the feed chain: only if it is a 
certificate for transit commodity. The products in transit can only be stored in free zones, free 
warehouses and custom warehouses; 
-  products for the particular technological studies or analyses: the EU plant indicated in authorisation of 
competent authority. 
y Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) 
or name (ship); information is to be provided in case of unloading and reloading. 
y Box reference I.19: use the appropriate HS code: 05.11.91; 05.11.99 or 30.01. 
y Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be 
included. 
y Box reference I.26: not relevant 
y Box reference I.27: fill in acco rding to an import certificate. 
y Box reference I.28:  
-  products for the manufacture of derived products for uses outside the feed chain: Manufacturing plant: 
provide the veterinary control number of the approved establishment; 
-  products for the particular technological studies or analyses: the EU plant indicated in authorisation of 
competent authority. 
 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate. 
(2) The name and ISO code number of the exporting country as laid down in: 
part 1 of Annex II of Commission Regulation (EC) No 206/2010; the Annex to Regulation (EC) No 798/2008, and;  
the Annex to Regulation (EC) No 119/2009. 
In addition the ISO code of regionalisation in this Annex (where applicable for the susceptible species 
concerned) should be included. 
(3) Delete as appropriate. 
(4) Only for countries from where game meat intended for human consumption of the same animal species is 
authorised for importation into the European Community. 
(5) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centra l kitchens and household kitchens. 
(6) Supplementary guarantees to be provided when th e material of domestic ruminants originated in the 
territory of a South American or South African country or part thereof from where only maturated and de-
boned fresh meat of domestic ruminants for human consumption is permitted for exportation to the 
European Community. In the case of offal only trimmed offal of domestic ruminants which must be exclusively offal from which the bones, cartilage, trachea and main bronchi, lymphatic glands adhering 
connective tissue, fat and mucus have been completely removed is permitted. The whole masseter muscles 
of bovine animals, incised in accordance with paragraph 41(a) of Chapter VIII of Annex I to Council  
EN 281   EN Directive 64/433/EEC, are also permitted. 
(7) Only for certain South American countries. 
(8) Only for certain South American and South African countries. 
y The signature and the stamp must be in a different colour to that of the printing. 
y Note for the person responsible for the consignment in  EU: this certificate is only for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capitals):     Qualification and title: 
 D a t e :       S i g n a t u r e :   Stamp: 
 
  
EN 282   EN CHAPTER 9 
Health certificate 
For fish oil not intended for human consumption to be used as feed material or for purposes 
outside the feed chain, intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. I.8. 
  
EN 283   EN  COUNTRY Fish oil to be used as feed material or for purposes outside the 
feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify  that the fish oil described above : 
II.1. consists of fish oil that satis fy the health requirements below; 
II.2. contains exclusively fish oil not intended for human consumption; II.3. has been prepared and stored in a dedicated fish plant approved, validated and supervised by the 
competent authority in accordance with Artic le 24 of Regulation (EC) No 1069/2009; 
II.4. has been prepared exclusively with the following animal by-products : 
(2) and/or [ - products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ - aquatic animals, and parts of such animals, except sea mammals, which did not show any signs 
of diseases communicable to humans or animals;] 
(2) and/or [ - animal-by products from aquatic animals originating from plants or establishments 
manufacturing products for human consumption;] 
II.5. the fish oil: 
(a) has been subjected to processing in accordance w ith Annex XIV, Section II, Chapter III of Regulation 
…/… , in order to kill pathogenic agents, 
(b) has not been in contact with other types of oils including rendered fats from other animal species, and 
(2) either [(c) is packaged in new containers or in containers that have been cleaned and all precautions taken 
to prevent their contamination, ] 
(2) or [(c) where bulk transport is intended, the pipe, pumps and bulk tanks and any other bulk container 
or bulk road tanker used in the transportation of the product from the manufacturing plant either 
directly on to the ship or into shore tanks or direct to plants have been inspected and found to be clean 
before use, ] 
 and which bear labels indicating “NOT FOR HUMAN CONSUMPTION”.  
Notes 
Part I:  
— Box reference I.6: Person responsible for the consignmen t in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to  be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading.  
EN 284   EN  COUNTRY Fish oil to be used as feed material or for purposes outside the 
feed chain 
  II.a. Certificate reference number II.b. 
— Box reference I.19: use the appropriate HS code: 15.04 or 15.18. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill  in according to whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the registration number of the treatment/processing 
establishment. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1.  
(2) Delete as appropriate 
(3) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the bord er inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 285   EN CHAPTER 10(A) 
Health certificate 
For rendered fats not intended for human consumption to be used as feed material, intended 
for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. I.8. 
  
EN 286   EN  COUNTRY Rendered fats not intended for human consumption to be used 
as feed material 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 th ereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify that the rendered fats described above : 
II.1. consist of rendered fats that sa tisfy the health requirements below; 
II.2. consist of rendered fats no t intended for human consumption; 
II.3. have been prepared and stored in a plant approved, validated and supervised by the competent 
authority in accordance with Article 24 of Regu lation (EC) No 1069/2009 or in accordance with 
Article 4(2) of Regulation (EC) No 853/2004(2) , in order to kill pathogenic agents; 
II.4. have been prepared exclusively with the following animal by-products : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation , but which did not show any signs of disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of: 
–  animals, other than ruminants requiring TSE testing; and 
–  ruminants which have been tested with a negative result in accordance with Article 6(1) of 
Regulation  (EC) No 999/2001; 
(iv)  pig bristles; (v)  feathers; ] 
 (2) and/or [
— blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from the following animals that have been slaughtered in a slaughterhouse 
after having been considered fit for slaughter for human consumption following an ante-mortem 
inspection in accordance with Union legislation: 
(i)  animals other than ruminants requiring TSE testing; and  
(ii)  ruminants which have been tested with a negative result in accordance with Article 6(1) of 
Regulation  (EC) No 999/2001;] 
(2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [— petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health  
EN 287   EN  COUNTRY Rendered fats not intended for human consumption to be used 
as feed material 
  II.a. Certificate reference number II.b. 
arises;] 
(2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof  cuts and raw milk originating from live animals 
that did not show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating form plants or establishments manufacturing 
products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
–  hatchery by-products,  
–  eggs, 
–  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
II.5. (2) either [in the case of material of porcine origin, come from a country or part of a territory free from 
foot-and-mouth disease for the previous 24 months and free from classical swine fever and African 
swine fever for the previous 12 months; ] 
(2) and/or [ —in the case of material of poultry origin, come from a country or part of a territory free from 
Newcastle disease and avian influenza for the previous 6 months ;] 
(2) and/or [ —in the case of material of ruminant origin, come from a country or part of a territory free from foot-
and-mouth disease for the previous 24 months and free from Rinderpest for the previous 12 months ;] 
(2) and/or [ — where there has been an outbreak of one of the abovementioned diseases during the relevant 
period mentioned above, have been subjected to a heat treatment for at least 70°C for 30 minutes or at 
least 90°C for at least 15 minutes, and  
 details of the critical control points are recorded and maintained so that the owner, operator or their 
representative and, as necessary, the competent authority can monitor the operation of the plant; the 
information must include the particle size, critical temperature and, as appropriate, the absolute time, 
pressure profile, raw material feed-rate and fat recycling rate. ] 
II.6. if derived from ruminant animals were purified in such way that the maximum levels of remaining 
total insoluble impurities does not exceed 0.15 % in weight; 
II.7. the rendered fats : 
(a) have been subjected to processing in accordance with Annex XIV, Section II, Chapter III of 
Regulation (EC) No …/… , or treatment in accord ance with Section XII of Annex III to Regulation 
(EC) No 853/2004, in order to kill pathogenic agents, and 
(4) either [(b) are packaged in new containers or in containers that have been cleaned and all precautions 
taken to prevent their contamination, ] 
(4) or [(b) where bulk transport is intended, the pipe, pumps and bulk tanks and any other bulk container  
EN 288   EN  COUNTRY Rendered fats not intended for human consumption to be used 
as feed material 
  II.a. Certificate reference number II.b. 
or bulk road tanker used in the transportation of the product from the manufacturing plant either 
directly on to the ship or into shore tanks or direct to plants have been inspected and found to be clean 
before use, ] 
and which bear labels indicating “NOT FOR HUMAN CONSUMPTION”; 
II.7. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.8.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which  
EN 289   EN  COUNTRY Rendered fats not intended for human consumption to be used 
as feed material 
  II.a. Certificate reference number II.b. 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 15.02; 15.03; 15.04; 15.05; 15.06; 15.16.10; 15.17 or 
15.18. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the registration number of the treatment/processing 
establishment. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b) [   ] 
(2)  
(3) Delete as appropriate 
(5) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 290   EN  COUNTRY Rendered fats not intended for human consumption to be used 
as feed material 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 291   EN CHAPTER 10(B) 
Health certificate 
For rendered fats not intended for human consumption to be used for certain purposes  
outside the feed chain, intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. I.8. 
  
EN 292   EN  COUNTRY Rendered fats not intended for human consumption for uses 
outside the feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Articles 8, 9 and 10 thereof, and Regulation (EU) No …/…(1b), and in 
particular Annex XVIII, Section II thereof, and certify that the rendered fats described above : 
II.1. consist of rendered fats not intended for human consumption that satisfy the health requirements 
below; 
II.2. have been prepared exclusively with the following animal by-products: 
II.2.1. in the case of materials des tined for the production of biodiesel,  animal by-products referred to in 
Articles 8, 9 and 10 of Regulation (EC) No 1069/2009;  
II.2.2.  in the case of materials destined for other purposes: 
(2) either [ — animal by-products which have been derived from animals which have been submitted to illegal 
treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC; ] 
(2) either [ — animal by-products containing residues of other substances and environmental contaminants listed 
in Group B(3) of Annex I to Directive 96/23/EC, if such residues exceed the permitted levels laid 
down by Union legislation or, in the absence th ereof, by legislation of the Member State of 
importation; ] 
(2) either [ — animal by-products containing residues of authorised substances or contaminants exceeding the 
permitted levels referred to in Article 15(3) of Directive 96/23/EC; ] 
(2) and/or  [ — products of animal origin which have been declared unfit for human consumption due to the 
presence of foreign bodies in those products;] 
(2) and/or  [ — animals and parts of animals, other than those referred to in Articles 8 and 10 of Regulation (EC) 
No 1069/2009, that died other than being slaughtered or killed for human consumption, including animals killed for disease control purposes;] 
(2) and/or  [— carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not intended for human consumption for commercial reasons; ] 
(2) and/or [— carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation , but which did not show any signs of disease communicable 
to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of: 
–  animals, other than ruminants requiring TSE testing; and 
–  ruminants which have been tested with a negative result in accordance with Article 6(1) of 
Regulation  (EC) No 999/2001; 
(iv)  pig bristles; 
(v)  feathers; ]  
EN 293   EN  COUNTRY Rendered fats not intended for human consumption for uses 
outside the feed chain 
  II.a. Certificate reference number II.b. 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from the following animals that have been slaughtered in a slaughterhouse 
after having been considered fit for slaughter for human consumption following an ante-mortem 
inspection in accordance with Union legislation: 
(i)  animals other than ruminants requiring TSE testing; and  (ii)  ruminants which have been tested with a negative result in accordance with Article 6(1) of 
Regulation  (EC) No 999/2001;] 
(2) and/or [— animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [— petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;] 
(2) and/or [— blood, placenta, wool, feathers, hair, horns, hoof  cuts and raw milk originating from live animals 
that did not show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments manufacturing 
products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
–  hatchery by-products,  
–  eggs, 
–  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
 
II.3. the rendered fats : (a) have been subjected to processing in accordance with method ………. as laid down in Annex VII, 
Section III of Regulation (EC) No …/… , in order to kill pathogenic agents, and 
(b)  have been permanently marked before shipment  to the European Union with glyceroltriheptanoate 
(GTH), so that a homogenous minimum concentration of at least 250 mg GTH per kilogram fat is 
achieved; and 
(c)  in the case of rendered fats of ruminant origin, insoluble impurities in excess of 0.15% in weight have 
been removed; and  
EN 294   EN  COUNTRY Rendered fats not intended for human consumption for uses 
outside the feed chain 
  II.a. Certificate reference number II.b. 
(d) have been transported under conditions which prevent their contamination, and 
(e)  and which bear labels on the packaging or container indicating “NOT FOR HUMAN OR ANIMAL 
CONSUMPTION”; 
II.4. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.5.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requi rements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which            complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which  
EN 295   EN  COUNTRY Rendered fats not intended for human consumption for uses 
outside the feed chain 
  II.a. Certificate reference number II.b. 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 15.02; 15.03; 15.04; 15.05; 15.06; 15.16.10; 15.17 or 
15.18. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the registration number of the treatment/processing 
establishment. 
Part II: 
(1a) OJ L 300, 14.11.2009, p.1. 
(1b) [   ] 
(2)  
(3) Delete as appropriate 
(5) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 296   EN  COUNTRY Rendered fats not intended for human consumption for uses 
outside the feed chain 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 297   EN CHAPTER 11 
Health certificate 
For gelatine and collagen not intended for human consumption to be used as feed material or 
for purposes outside the feed chain, intended for dispatch to or for transit through2 the 
European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. I.8. 
  
EN 298   EN  COUNTRY  Gelatine and collagen not intended for human 
consumption to be used as feed material or for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 th ereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify that the gelatine/collagen(2) described above : 
II.1. consists of gelatine/collagen(2) that satisfy the health requirements below; 
II.2. consist exclusively of gelatine/collagen(2) not intended for human consumption; 
II.3. has been prepared and stored in a plant approved, validated and supervised by the competent authority 
in accordance with Article 24 of Regulation (EC) No  1069/2009, in order to kill pathogenic agents; 
II.4. has been prepared exclusively with the following animal by-products : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation , but which did not show any signs of disease communicable 
to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals other than ruminants; 
(iv)  pig bristles; (v)  feathers; ] 
(2) and/or [
— animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems 
of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments manufacturing 
products for human consumption;] 
II.5. the gelatine/collagen(2) : 
 (a) was wrapped, packaged, stored and transported under satisfactory hygiene conditions, and in 
particular wrapping and packaging took place in a dedicated room, and only preservatives permitted  
EN 299   EN  COUNTRY  Gelatine and collagen not intended for human 
consumption to be used as feed material or for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
under Union legislation were used. 
 Wrappings and packages containing gelatine/collagen(2) carry the words 
“GELATINE/COLLAGEN(2) SUITABLE FOR ANIMAL CONSUMPTION”, and 
(2) either [(b) in the case of gelatine, has been produced by a process that ensuring that unprocessed 
Category 3 material is subjected to a treatment w ith acid or alkali, followed by one or more rinses, 
involving pH adjustment, extraction by heating one or several times in succession, followed by 
purification by means of filtration and sterilisa tion, in order to kill pathogenic agents. ] 
(2) or [(b) in the case of collagen, has been produced by a process that 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, in order to kill pathogenic agents. ] 
II.6. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.7.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products 
are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie   
EN 300   EN  COUNTRY  Gelatine and collagen not intended for human 
consumption to be used as feed material or for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 35.03 or 35.04. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Nature of commodity: select gelatine or collagen. 
   Manufacturing plant: provide the registration number of treatment/processing 
  establishment. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate 
(3) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 301   EN  COUNTRY  Gelatine and collagen not intended for human 
consumption to be used as feed material or for purposes outside 
the feed chain 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 302   EN CHAPTER 12 
Health certificate 
For hydrolysed protein, dicalcium phosphate and tricalcium phosphate not intended for 
human consumption to be used as feed material or for uses outside the feed chain, intended 
for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. I.8. 
  
EN 303   EN  COUNTRY  Hydrolysed protein, dicalcium phosphate and 
tricalcium phosphate to be used as feed material or outside the 
feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 (1a) 
and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular Annex XVIII, 
Section II thereof, and certify that the hydrolysed protein/dicalcium phosphate/tricalcium phosphate(2) 
described above : 
II.1. consists of hydrolysed protein/dicalcium phosphate/tricalcium phosphate(2) that satisfy the health 
requirements below; 
II.2. consists exclusively of hydrolysed protein/dicalcium phosphate/tricalcium phosphate(2)not intended for 
human consumption; 
II.3. has been prepared and stored in a plant approved, validated and supervised by the competent authority 
in accordance with Article 24 of Regulation (EC) No  1069/2009, in order to kill pathogenic agents; 
II.4. has been prepared exclusively with the following animal by-products : 
(2) either [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation , but which did not show any signs of disease communicable 
to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals, other than ruminants; 
(iv)  pig bristles; 
(v)  feathers; ] 
 (2) and/or [
— blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from animals other than ruminants that have been slaughtered in a 
slaughterhouse after having been considered fit for slaughter for human consumption following an 
ante-mortem inspection in accordance with Union legislation;] 
 (2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;] 
(2) and/or [— blood, placenta, wool, feathers, hair, horns, hoof  cuts and raw milk originating from live animals 
that did not show signs of any disease communicable through that product to humans or animals;]  
EN 304   EN  COUNTRY  Hydrolysed protein, dicalcium phosphate and 
tricalcium phosphate to be used as feed material or outside the 
feed chain 
  II.a. Certificate reference number II.b. 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments manufacturing 
products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
—  hatchery by-products,  
—  eggs, 
—  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
 
II.5. the hydrolysed protein/dicalcium phosphate/tricalcium phosphate(2): 
(a) was wrapped and packaged in packaging which bear labels indicating “NOT FOR HUMAN 
CONSUMPTION” and stored and transported under satisfactory hygiene conditions, and in particular 
wrapping and packaging took place in a dedicated room, and only preservatives permitted under Union legislation were used, and 
(2)either [(b) in the case of hydrolysed protein, has been produced by a process involving appropriate 
measures to minimise contamination of raw Category 3 material.  
 In the case of hydrolysed proteins entirely or partly derived from ruminants hides and skins, has been 
produced in a processing plant dedicated only to hydrolysed proteins production, using a process involving the preparation of the raw Category 3 ma terial by brining, liming and intensive washing 
followed by : 
(i) exposure of the material to a pH of more than 11 for more than 3 hours at temperature of 
more than 80 C and subsequently by heat treatment at more than 140°C for 30 minutes at 
more than 3.6 bar; and 
(ii) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by 
heat treatment at 140°C for 30 minutes at 3 bar. ] 
(2)or [(b) in the case of dicalcium phosphate, has been produced by a process that: 
(i) ensures that all Category 3 bone-material is finely crushed and degreased with hot water 
and treated with dilute hydrochloric acid (at a minimum concentration of 4% and a pH of 
less than 1,5) over a period of at least two days, 
(ii) followed by treatment of the obtained phosphoric liquor with lime, resulting in a 
precipitate of dicalcium phosphate at pH 4 to 7, and 
(iii) finally air-dries this precipitate for 15 mi nutes, with inlet temperature of 270° to 325°C 
and end temperature between 60° and 65°C. ]  
EN 305   EN  COUNTRY  Hydrolysed protein, dicalcium phosphate and 
tricalcium phosphate to be used as feed material or outside the 
feed chain 
  II.a. Certificate reference number II.b. 
(2)or [(b) in the case of tricalcium phosphate, has been produced by a process ensuring : 
(i) that all Category 3 bone-material is finely  crushed and degreased in counter-flow with hot 
water (bone chips less than 14 mm), 
(ii) continuous cooking with steam at 145°C during 30 minutes at 4 bars, 
(iii) separation of the protein broth from the hydroxyapatite (tricalcium phosphate) by 
centrifugation, and 
(iv) granulation of the tricalcium phosphate after drying in a fluid bed with air at 200°C. ] 
II.6. 
(2) either [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals; and 
  the animals from which this product is derived have not been slaughtered after stunning by means of gas 
injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous 
tissue by means of an elongated rod-shaped inst rument introduced into the cranial cavity;] 
(2) or [the product does not contain and is not derived from specified risk material as defined in Annex V to 
Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or 
caprine animals;] 
II.7.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk 
products of ovine or caprine origin, the ovine and caprine animals from which these 
products are derived have been kept continuously since birth or for the last three years on a 
holding where no official movement restriction is imposed due to a suspicion of TSE and 
which has satisfied the following requir ements for the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk 
products of ovine or caprine origin, and destined to a Member State listed in the Annex to 
the Regulation (EC) No 546/2006, the ovine and caprine animals from which these products are derived have been kept continuously since birth or for the last seven years on a holding 
where no official movement restriction is imposed due to a suspicion of TSE and which has 
satisfied the following requirements for the last seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case:  
EN 306   EN  COUNTRY  Hydrolysed protein, dicalcium phosphate and 
tricalcium phosphate to be used as feed material or outside the 
feed chain 
  II.a. Certificate reference number II.b. 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignmen t in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be  provided in case of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 28.35 or 35.04. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in according to  whether it is a transit or an import certificate. 
— Box reference I.28: Nature of commodity: specify if hydrolysed protein, dicalcium phosphate or
  tricalcium phosphate. 
   Manufacturing plant: provide the registration number of treatment/processing 
  establishment. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate 
(3) Catering waste means all waste food, including used cooking oils, originating in restaurants, catering 
facilities and kitchens, including centr al kitchens and household kitchens. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post.  
EN 307   EN  COUNTRY  Hydrolysed protein, dicalcium phosphate and 
tricalcium phosphate to be used as feed material or outside the 
feed chain 
  II.a. Certificate reference number II.b. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 308   EN CHAPTER 13 
Health certificate 
For apiculture by-products intended exclusively for use in apiculture, intended for dispatch to 
or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Nature of commodity Manufacturing plant Net weight
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 309   EN  COUNTRY       Apiculture by-products 
intended exclusively for use in apiculture  
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 ther eof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify that  the apiculture by-pro ducts described above : 
II.1. come from an area where the diseases mentioned below are officially notifiable and which is not 
subject to any restrictions associated with: 
(a) American foul brood (Paenibacillus larvae larvae), 
(b) Acariosis (Acarapis woodi (Rennie)), (c) Small hive beetle (Aethina tumida), and (d) Tropilaelaps mites (Tropilaelaps spp); 
II.1. have been 
(2) either [subjected to a temperature of -12°C or lower for at least 24 hours; ] 
(2) or [in the case of wax refined or processed in accordance with processing method 1-2-3-4-5-7(2 as set out 
in Annex VII Section III of Regulation (EU) No …/…. ] 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.19: use the appropriate HS code: 05.11.99 and specify the commodity as listed under 
note Box reference I.28. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be given. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
— Box reference I.28: Nature of commodity: means honey, beeswax, royal jelly, propolis or pollen used 
in bee-keeping; 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate.  
EN 310   EN  COUNTRY       Apiculture by-products 
intended exclusively for use in apiculture  
  II.a. Certificate reference number II.b. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: This certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 311   EN CHAPTER 14(A) 
Health certificate 
For fat derivatives not intended for human consumption to be used outside the feed chain, 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
15.16.10
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
 
  
EN 312   EN  COUNTRY     For fat derivatives to be used for purposes  
                                                                                     outside the feed chain 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify that the fat derivatives described above : 
II.1. consist of fat derivatives that sa tisfy the health requirements below; 
II.2. consist of fat derivatives intended for purposes outside the feed chain, other than in cosmetics, 
pharmaceuticals and medical devices; 
II.3. have been prepared and stored in a plant approved, validated and supervised by the competent 
authority in accordance with Article 24 of Regulati on (EC) No 1069/2009, in order to kill pathogenic 
agents; 
II.4. have been prepared from rendered fats exclusively produced the following materials: 
II.4.1.  the following Category 1 and Category 2 materials: 
(2) either [ — animal by-products which have been derived from animals which have been submitted to illegal 
treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC; ] 
(2) either [ — animal by-products containing residues of other substances and environmental contaminants listed 
in Group B(3) of Annex I to Directive 96/23/EC, if  such residues exceed the permitted levels laid 
down by Union legislation or, in the absence th ereof, by legislation of the Member State of 
importation; ] 
(2) either [ — animal by-products containing residues of authorised substances or contaminants exceeding the 
permitted levels referred to in Ar ticle 15(3) of Directive 96/23/EC; ] 
(2) and/or  [ — products of animal origin which have been declared unfit for human consumption due to the 
presence of foreign bodies in those products;] 
(2) and/or  [ — animals and parts of animals, other than those referred to in Articles 8 and 10 of Regulation (EC) 
No 1069/2009, that died other than being slaughtered or killed for human consumption, including 
animals killed for disease control purposes;] 
II.4.2.  Category 3 materials: 
(2) and/or  [ — carcasses and parts of animals slaughtered or, in the case of game, bodies or parts of animals 
killed, and which are fit for human consumption in accordance with Union legislation, but are not 
intended for human consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts originating either from animals that have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection or bodies and the following parts of animals from game killed for human 
consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in 
accordance with Union legislation , but which did not show any signs of disease communicable 
to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting, thereof horns and feet, including the 
phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of: 
–  animals, other than ruminants requiring TSE testing; and  
EN 313   EN  COUNTRY     For fat derivatives to be used for purposes  
                                                                                     outside the feed chain 
  II.a. Certificate reference number II.b. 
–  ruminants which have been tested with a negative result in accordance with Article 6(1) of 
Regulation  (EC) No 999/2001; 
(iv)  pig bristles; 
(v)  feathers; ] 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from the following animals that have been slaughtered in a slaughterhouse 
after having been considered fit for slaughter for human consumption following an ante-mortem 
inspection in accordance w ith Union legislation: 
(i)  animals other than ruminants requiring TSE testing; and  
(ii)  ruminants which have been tested with a ne gative result in accordan ce with Article 6(1) of 
Regulation  (EC) No 999/2001;] 
(2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems 
of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;] 
(2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals 
that did not show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of 
diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments manufacturing 
products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
–  hatchery by-products,  
–  eggs, 
–  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
II.5. in case of fat derivatives produced from an imal by-products referred to in point II.4.1: 
(a)   have been produced using the following methods : 
(2) either [ transesterification or hydrolysis at least 200°C, under corresponding appropriate 
  pressure, for 20 minutes (glycerol, fatty acids and esters), and ] 
(2) or   [ saponification with NaOH 12M (glycerol and soap):  
EN 314   EN  COUNTRY     For fat derivatives to be used for purposes  
                                                                                     outside the feed chain 
  II.a. Certificate reference number II.b. 
    (2) either [ in a batch process at 95°C for three hours, and ] 
    (2) or [ in a continuous process at 140°C, 2 bars (2000 hPa)   
   for eight minutes;] ] 
(2) or   [ hydrogenation at 160°C at 12 bars (12000 hPa) pressure for 20 minutes;] 
(b)   are packaged in new containers or in containers that have been cleaned, and all 
  precautions are taken to prevent its contamination which bear labels indicating 
  “NOT FOR HUMAN OR ANIMAL CONSUMPTION” 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is 
a certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) 
should be included. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the registration number of treatment/processing 
establishment. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: this certificate is only for veterinary 
purposes and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 315   EN CHAPTER 14 (B) 
Health certificate 
For fat derivatives not intended for human consumption to be used as feed or outside the feed 
chain, intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
15.16.10
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 316   EN COUNTRY     For fat derivatives to be used as feed or outside  
                                                                         the feed chain 
 II.a. Certificate reference number II.b. 
II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 (1a) 
and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular Annex XVIII, Section II 
thereof, and certify that the fa t derivatives described above : 
II.1. consist of fat derivatives that satisfy the health requirements below; II.2. consist of fat derivatives not intended for human nor animal consumption; II.3. have been prepared and stored in a plant approved, validated and supervised by the competent authority in 
accordance with Article 24 of Regulation (EC) No 1069/2009, in order to kill pathogenic agents; 
II.4. have been prepared from rendered fats exclusively produced from the following Category 3 materials: 
(2) either [
— carcasses and parts of animals slaughtered or, in the ca se of game, bodies or parts of animals killed, and 
which are fit for human consumption in accordance with  Union legislation, but are not intended for human 
consumption for commercial reasons; ] 
(2) and/or [ — carcasses and the following parts or iginating either from animals th at have been slaughtered in a 
slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection 
or bodies and the following parts of animals from game killed for human consumption in accordance with Union 
legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in accordance 
with Union legislation , but which did not show any signs of disease communicable to humans or animals; 
(ii)  heads of poultry; 
(iii)  hides and skins, including trimmings and splitting,  thereof horns and feet, including the phalanges and the 
carpus and metacarpus bones, tarsus and metatarsus bones, of animals, other than ruminants; 
(iv)  pig bristles; 
(v)  feathers; ] 
 (2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to humans or animals 
obtained from animals other than ruminants that have been slaughtered in a slaughterhouse after having been 
considered fit for slaughter for human consumption following an ante-mortem inspection in accordance with 
Union legislation;] 
 (2) and/or [ — animal by-products arising from the production of products intended for human consumption, including 
degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer intend for 
human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other 
defects form which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or derived 
products, which are no longer intended for feeding for co mmercial reasons or due to problems of manufacturing or 
packaging defects or other defects from which no risk to public or animal health arises;] 
(2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live animals that did not 
show signs of any disease communicable through that product to humans or animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of diseases 
communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating fro m plants or establishments manufacturing products 
for human consumption;]  
EN 317   EN COUNTRY     For fat derivatives to be used as feed or outside  
                                                                         the feed chain 
 II.a. Certificate reference number II.b. 
(2) and/or [ — the following material originating from animals which did not show any signs of disease communicable 
through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
—  hatchery by-products,  
—  eggs, 
—  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
 
II.5. are packaged in new containers or in which bear labels indicating "NOT FOR HUMAN CONSUMPTION”, that 
have been cleaned, and all precautions are taken to prevent its contamination; 
II.6.  the product does not contain and is not derived from specified risk material as defined in Annex V to Regulation 
(EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals; 
II.7.  the animals from which this product is derived have not been slaughtered after stunning by means of gas injected 
into the cranial cavity or killed by the same method or sl aughtered by laceration of central nervous tissue by means 
of an elongated rod-shaped instrument introduced into the cranial cavity; and 
II.8.  the product does not contain and is not derived from bovine, ovine or caprine materials other than those derived from 
animals born, continuously reared and slaughtered in a countr y or region classified as posing a negligible BSE risk 
by a decision in accordance with Article 5(2) of Regulation (EC) No 999/2001 
II.9.  in addition as regards TSE: 
 (2)either  [in case of animal by-products intended for feeding ruminants and containing milk  or milk products of 
ovine or caprine origin, the ovine and caprine animals from which these products are derived have been 
kept continuously since birth or for the last three years on a holding where no official movement restriction is imposed due to a suspicion of TSE an d which has satisfied the fo llowing requirements for 
the last three years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No  
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least  
                       one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii); 
(2)or [in case of animal by-products intended for feeding ruminants or containing milk or milk products of 
ovine or caprine origin, and destined to a Member St ate listed in the Annex to the Regulation (EC) No 
546/2006, the ovine and caprine animals from which these products are derived have been kept 
continuously since birth or for the last seven years on a holding where no official movement restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last 
seven years: 
                      (i)   it has been subject to regular official veterinary checks 
                      (ii)   no classical scrapie case, as defined in point 2(g) of Annex I to Regulation (EC) No   
EN 318   EN COUNTRY     For fat derivatives to be used as feed or outside  
                                                                         the feed chain 
 II.a. Certificate reference number II.b. 
           999/2001, has been diagnosed or, following the confirmation of a classical scrapie  
           case: 
                                -      all animals in which classical scrapie was confirmed have been killed and  
                      destroyed, and 
                                -          all goats and sheep on the holding have been killed and destroyed, except for  
                       breeding rams of the ARR/ARR genotype and breeding ewes carrying at least                         one ARR allele and no VRQ allele, 
                      (iii)   ovine and caprine animals, with the exception of sheep of the ARR/ARR prion  
           genotype, are introduced into the holding only if they come from a holding which 
           complies with the requirements set out in points (i) and (ii).] 
 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a certificate 
for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to be  filled in only if it is a certificate for transit commodity. 
The products in transit can only be stored in free zones, free warehouses and custom warehouses. 
— Box reference I.15: Registration number (railway wagons or  container and lorries), flight number (aircraft) or 
name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should be 
included. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
— Box reference I.28: Manufacturing plant: provide the registration number of treatment/processing establishment. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in EU: this certificate is only for veterinary purposes and has 
to accompany the consignment until it reaches the border inspection post. 
Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp:  
EN 319   EN CHAPTER 15 
Health certificate 
For egg products not intended for human consumption that could be used as feed material, 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
35.02
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species (Scientific name) Nature of commodity Manufacturing plant Number of packages Net weight Batch numberPart I : Details of dispatched consignment I.2.a
I.17.I.10. 
  
EN 320   EN  COUNTRY    Egg products not intended for human consumption 
     that could be used as feed  
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 10 thereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, and certify that the egg products described above : 
II.1. consist of egg products that sa tisfy the health requirements below; 
II.2. consist exclusively of egg products not intended for human consumption; II.3. have been prepared and stored in a plant, approved, validated and supervised by the competent authority 
in accordance with Article 24 of Regulation (EC) No 1069/2009 or Article 4(2) of Regulation (EC) No 
853/2004 
(2), in order to kill pathogenic agents; 
II.4. have been prepared (derived) exclusively with the following animal by-products: 
(2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no longer 
intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects form which no risk to public or animal health arise;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i)  shells from shellfish with soft tissue or flesh; 
(ii)  the following originating from terrestrial animals: 
—  hatchery by-products,  
—  eggs, 
—  egg by-products, including egg shells, 
(iii)  day-old chicks killed for commercial reasons;] 
II.5. have been subjected to processing : 
(3) either [ in accordance with processing method ……….. (4) as set out in Annex VII, Section III of Regulation 
(EC) No  …/… ;] 
(3) or [ in accordance to a method and parameters which ensure that the products complies with the 
microbiological standards set in Annex XIV, Section I to Regulation …/…;]  
(3) or [ treated in accordance with S ection X, Chapters I to III of Annex III to Regulation (EC) No 853/2004; ] 
II.6. have been examined by the competent authority taking a random sample immediately prior to dispatch 
and found it to comply with the following standards (5): 
Salmonella :  absence in 25g: n = 5, c = 0, m = 0, M = 0, 
Enterobacteriaceae:  n = 5, c = 2, m = 10, M = 300 in 1 gram; 
II.7. meet Union standards on residues of substances  that are harmful or might alter the organoleptic 
characteristics of the product or make its use as feed dangerous or harmful to animal health;  
EN 321   EN  COUNTRY    Egg products not intended for human consumption 
     that could be used as feed  
  II.a. Certificate reference number II.b. 
II.8. the end product was : 
(3) either [ packed in new or sterilized bags, ] 
(3) or [ transported in bulk in containers or other means of transport that were thoroughly cleaned and 
disinfected with a disinfectant approved by the competent authority before use, ] 
 and which bear labels indicating “NOT FOR HUMAN CONSUMPTION”; 
II.9. the end product was stored in enclosed storage; 
II.10. the product has undergone all precautions to avoid co ntamination with pathogenic agents after treatment. 
  
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destinatio n: this box is to be filled in only if it is a certificate for transit 
commodity. The products in transit can only be stored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wa gons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in case of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should 
be included. 
— Box reference I.26 and I.27: fill in  according to whether it is a transit or an import certificate. 
Part II: 
(1) OJ L 300, 14.11.2009, p.1.  
(2) OJ L 212, 22.07.1989, p. 89. 
(3) Delete as appropriate 
(4) Insert method 1 to 5 or 7 as applicable. 
(5) Where: 
n = number of samples to be tested, 
m = threshold value for the number of bacteria; the result is considered satisfactory if the number of 
bacteria in all samples does not exceed m, 
M = maximum value for the number of bacteria; the re sult is considered unsatisfactory if the number 
of bacteria in one or more samples is M or more, and  
EN 322   EN  COUNTRY    Egg products not intended for human consumption 
     that could be used as feed  
  II.a. Certificate reference number II.b. 
c = number of samples the bacterial count of which may be between m and M, the sample still 
being considered acceptable if the bacterial count of the other samples is m or less. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignment in  EU: this certificate is on ly for veterinary purposes 
and has to accompany the consignment until it reaches the border inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 323   EN CHAPTER 16 
Model Declaration 
Declaration by the importer 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, orga nic fertilisers or soil improvers for dispatch 
to the European Union 
Note for the importer: This declaration is only for veterinary purposes and has to accompany 
the consignment until it reaches the border inspection post. 
I, the undersigned, declare that the following products (1): 
(a) bones and bone products (excluding bone meal); 
(b) horns and horn products (excluding horn meal); 
(c) hooves and hoof products (excluding hoof meal); 
are intended to be imported by me into the Union, and I declare that these products will not be 
diverted at any stage for any use in food, feed  material, organic fertilizers or soil improvers 
and will be conveyed directly for the purpose of further processing or treatment to: 
 Name:_______________________ Address:____________________________________ 
Furthermore, I declare that the product does not contain and is not derived from specified risk 
material as defined in Annex V to Regulation (EC) No 999/2001 or mechanically separated meat obtained from bones of bovine, ovine or caprine animals. The importer: 
Name: ________________________ Address: ___________________________________ 
Done at _______________ on _______________  
  (place)   (date)  
Signature __________________________________________________ 
Reference number as indicated on the common veterinary entry document (CVED) provided 
for in Annex III to Commission Regulation (EC) 136/2004 : 
 _____________________________________________________ 
Official stamp of the border inspection post of entry into the EC 
(2) 
Signature: ____________________________________________________________ 
  (Signature of the official veterina rian of the border inspection post)  (2)  
Name: ___________________________________   (Name in capital letters) 
___________________ 
(1) Delete as appropriate 
(2) The signature and the stamp must be in a different colour to that of the printing.  
EN 324   EN CHAPTER 17 
Health certificate 
For processed manure, derived products from processed manure and guano from bats 
intended for dispatch to or for transit through2 the European Union 
COUNTRY  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval number Name Approval number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval number of establishments
Species Nature of commodity Manufacturing plant Net weight
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
 
  
EN 325   EN  COUNTRY    Processed manure, derived products from processed 
manure products and guano from bats 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 
1069/2009 (1a) and in particular Article 9 thereof, and Regulation (EU) No …/…(1b), and in particular 
Annex XVIII, Section II thereof, an d certify that the processed manure, the derived products from 
processed manure and the guano from bats described above: 
II.1. come from a plant for the manufacture of products for purposes other than feeding to farmed animals, a 
biogas plant or a composting plant approved by the competent authority of the third country meeting the 
special conditions laid down in Regulation (EC) No 1069/2009 and in Regulation (EU) No …/…; 
II.2.(2) have been subjected to: 
[a heat treatment process of at least 70 °C for at least 60 minutes] or 
[an equivalent treatment validated and authorized by the importing Member State in accordance with the 
specific conditions laid down in Regulation (EC) No 1069/2009 and in Regulation (EU) No …/… as 
follows: 
 .............................................................................................................................. ....................................  
 .............................................................................................................................. ....................................  
 .............................................................................................................................. .................................... ] 
II.3. are: 
(a) free from Salmonella (no salm onella in 25 g treated product); 
(b) free from Escherichia coli or from enterobacteriacea (based on the aerobic count: less than 
  1000 cfu per gram of treated product); and 
(c) have been subjected to reduction in spore-forming bacteria and toxic formation. 
II.4. are securely enclosed in: 
(a) well-sealed and insulated containers, or 
(b) properly sealed packs (plastic bags or ‘big bags’). 
Notes 
Part I: 
— Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only if it is a 
certificate for transit commodity; it may be filled in if the certificate is for import commodity. 
— Box reference I.12: Place of destination: this box is to  be filled in only if it is a certificate for transit 
commodity. The products in transit can only be st ored in free zones, free warehouses and custom 
warehouses. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.23: for bulk containers, the container number and the seal number (if applicable) should  
EN 326   EN  COUNTRY    Processed manure, derived products from processed 
manure products and guano from bats 
  II.a. Certificate reference number II.b. 
be given. 
— Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
— Box reference I.31: Nature of commodity: enter if processed manure or if processed manure products. 
 
Part II: 
(1) OJ L 300, 14.11.2009, p.1. 
(2) Delete as appropriate. 
— The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person responsible for the consignmen t in EU: This certificate is only for veterinary 
purposes and has to accompany the consignmen t until it reaches the bo rder inspection post. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 327   EN CHAPTER 18 
Health certificate 
For horns and horn products, excluding horn meal, and hooves and hoof products, 
excluding hoof meal, intended for the production of organic fertilizers or soil 
improvers intended for dispatch to or for transit through (2) the European Union  
  
EN 328   EN COUNTRY:  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the load in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Name Approval number Custom warehouse
Address
Name Approval number
Address
Postal code
I.13. Place of loading I.14. Date of departureI.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Animal feedingstuff Further process Technical use Other
I.26. For transit through EU to 3rd Country I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Species Approval number of establishments Net weight Batch number
Manufacturing plantPart I : Details of dispatched consignment I.2.a
  
EN 329   EN  
 COUNTRY Horns and horn 
 products  and hooves and 
 hoof products intended to 
 produce  organic 
 fertilizers or soil 
 improvers  
 II. Health information II.a. Certificate reference 
number II.b. 
 Part II: Certification 
 
 
 
 Part II: Certification 
II. Health attestation 
 I, the undersigned official veterinarian, declare that I have read and understood Regulation 
(EC) No 1069/2009 (1), and Regulation (EU) No …/…, and in particular Chapter II of Section 
II of Annex XVIII thereof,  and certify that the horns and horn products, excluding horn meal 
and hooves and hoof products, excluding hoof meal (2) described above: 
(2)either [originate from animals that were slaughtered in a slaughterhouse, after undergoing ante-mortem 
 inspection, and were fit, as a result of such inspection, for slaughter for human consumption] 
(2)or [ originate from animals that did not show clinical signs of any disease communicable through 
that product to humans or animals]   
II.2. horns must have undergone a heat treatment for one hour at a core temperature of at least 80 
°C  
II.3. horns must be removed without opening the cranial cavity. II.4. at any stage of processing, storage or transport every precaution shall be taken to avoid cross-
contamination. 
II.5.  the horns and horn products, excluding horn meal and hooves and hoof products, excluding 
hoof meal were packed: 
 
(2)either  [ in new packaging or containers]  
 
(2)or [in vehicles or bulk containers disinfected prior to loading using a product approved  
 by the competent authority]  
 and  [the packaging or containers are marked so as to indicate the type of the animal by-product (3) 
and bear labels indicating ‘NOT FOR HUMAN AND ANIMAL CONSUMPTION’ and   the name and address of the EU establishment of destination]. 
Notes 
Part I: 
– Box reference I.6: Person responsible for the consignment in EU: this box is to be filled in only 
if it is a certificate for transit commodity; it may be filled in if the certificate is for import 
commodity. 
– Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for 
transit commodity. The products in transit must only be stored in free zones, free warehouses and custom warehouses. 
–
 Box reference I.15: Registration number (railway wagons or container and lorries), flight 
number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
–
 Box reference I.23: for bulk containers, the container number and the seal number (if 
applicable) must be given. 
– Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. 
– Box reference I.28: Nature of commodity  
EN 330   EN  COUNTRY Horns and horn 
 products  and hooves and 
 hoof products intended to 
 produce  organic 
 fertilizers or soil 
 improvers  
 II. Health information II.a. Certificate reference 
number II.b. 
Part II: 
(1) OJ L 300, 14.11.2009, p. 1. 
(2) Delete as appropriate. 
(3)  Type of product : horns, horn products, hooves, hoof products. 
– The signature and the stamp must be in a different colour to that of the printing. 
– Note for the person responsible for the consignment in EU: this certificate is only for 
veterinary purposes and must accompany the consignment until it reaches the border inspection post.  
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
 
  
EN 331   EN CHAPTER 19 
Health certificate 
For gelatine not intended for human consumption to be used by the photographic industry, 
intended for dispatch to the European Union 
COUNTRY:  Veterinary certificate to EU
I.1. Consignor I.2. Certificate reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee 
Name
Address
Postal code
Tel.N°
I.7.Country of origin  ISO code I.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin
Name Approval number
Address
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification: I.17. No.(s) of CITES 
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
3503
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use
I.27. For import or admission into EU
I.28. Identification of the commodities
Species (Scientific name) Approval number of establishments Net weight Batch number
manufacturing plantI.26.Part I : Details of dispatched consignment I.2.a
I.6.
I.12.
  
EN 332   EN  COUNTRY    Gelatine not intended for human consumption to be 
     used by the photographic industry 
  II.a. Certificate reference number II.b. 
 Part II: Certification 
 
 
 
 Health attestation 
 I, the undersigned official, declare that I have read and understood Regulation (EC) No 1069/2009 (1a) and 
in particular Articles 8 and 10 thereof, and Regulation (EU) No …/…(1b), and in particular Annex XVIII, 
Section II thereof, and certify that the photographic gelatine described above: 
II.1. consists exclusively of photographic gelatine for photographic uses and is not intended for any other 
purpose; 
II.2. has been prepared and stored in a plant registered and supervised by the competent authority in 
accordance with Article 23 of Regulation (EC) No 1069/2009, which do not produce gelatine for food, 
feed or other uses intended for dispatch to the European Union; 
II.3. has been prepared with Category 3 animal by-pro ducts and/or bovine vertebral column classified as 
Category 1 material; 
II.4. has been wrapped, packag ed, stored and transported unde r satisfactory hygiene conditions. 
II.5. has been produced by a process ensuring that the raw material is: 
(a) treated by pressure sterilisation as defined in Artic le 3 no. 19 of Regulation (EC) No …1069/2009 or  
(b) subjected to: 
(i) treatment with acid for at least two days, wa shing with water and treatment with an alkaline 
solution for at least 20 days; the pH must be adjusted and the material purified by means of 
filtration and sterilised at 138-140 ˚C for 4 seconds; or 
(ii) treatment with alkali for at least two days , washing with water and treatment with an acid 
solution for 10-12 hours; the pH must be adjusted and the material purified by means of 
filtration and sterilised at 138-140 ˚C for 4 seconds. 
II.6. has been wrapped and packaged in wrappings and packages carrying the words “PHOTOGRAPHIC 
GELATINE FOR THE PHOTOGRAPHIC INDUSTRY ONLY”; 
Notes 
Part I: 
— Box reference I.5: The intended destination of the photographic gelatine can only be the Czech Republic, 
Luxembourg, the Netherlands or the United Kingdom. 
— Box reference I.9: Country of destination: only ap plicable for the Czech Republic, Luxemburg, United 
Kingdom or the Netherlands. 
— Box reference I.15: Registration number (railway wagons or container and lorries), flight number 
(aircraft) or name (ship); information is to be provided in the event of unloading and reloading. 
— Box reference I.23: Identification of container/seal number: only where applicable. 
Part II : 
(1) OJ L 300, 14.11.2009, p.1. 
(re Pressure sterilisation (method 1) is also referred to in Annex VII Section III of  Regulation (EC) No /… as 
follows:  
EN 333   EN  COUNTRY    Gelatine not intended for human consumption to be 
     used by the photographic industry 
  II.a. Certificate reference number II.b. 
“Reduction 
1. 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 eq uipment, 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. 
 Time, temperature and pressure 
2. After reduction the animal by-products 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 produced by saturated 
steam; the heat treatment may be applied as the sole  process or as a pre- or post-process sterilisation 
phase. 
3. The processing may be carried out in batch or continuous systems.” 
—  The signature and the stamp must be in a different colour to that of the printing. 
— Note for the person respon sible for the load in EU: th is certificate is only for veterinary purposes and has 
to accompany the consignment until it reaches the factory of destination from the border inspection post.. 
 Official veterinarian  
 Name (in capital letters): Qualification and title: 
 Date: Signature: 
 Stamp: 
  
EN 334   EN CHAPTER 20 
Model declaration 
Declaration for the import from third countries and for the transit through the European 
veterinary medicinal products, Union of intermediate products to be used for the manufacture of medicinal products, medical devices, in vitro diagnostics and laboratory reagents 
COUNTRY Model declaration
I.1. Consignor I.2. Document reference number 
Name
I.3. Central Competent Authority
Address
I.4. Local Competent Authority
Tel.N°
I.5. Consignee I.6. Person responsible for the consignment in EU 
Name Name
Address Address
Postal code Postal code
Tel.N° Tel.N°
I.7.Country of origin  ISO co dI.8. Region of origin Code I.9. Country of destination  ISO code I.10. Region of destination Code
I.11. Place of origin I.12. Place of destination
Custom warehouse
Name Approval/Registration number Name Approval/Registration number
Address Address
Postal code
I.13. Place of loading I.14. Date of departure
I.15. Means of transport I.16. Entry BIP in EU 
Aeroplane Ship Railway wagon
Road vehicle Other
Identification:
Documentary references:
I.18. Description of commodity I.19. Commodity code (HS code)
I.20.Quantity
I.21 Temperature of product I.22. Number of packages
Ambient Chilled Frozen
I.23. Identification of container/Seal number I.24.Type of packaging
I.25. Commodities certified for:
Technical use Other
I.26. For transit to 3rd Country vis-à-vis EU I.27. For import or admission into EU
3rd country  ISO code
I.28. Identification of the commodities
Approval/Registration number of establishments
Species Manufacturing plant Net weight Batch number
(Scientific name)Part I : Details of dispatched consignment I.2.a
I.17.
  
EN 335   EN  
 COUNTRY Intermediate products  
 II. Declaration  II.a. Reference number II.b. 
 Part II: Certification 
 
 
 
 I, the undersigned, declare that the intermediate product re ferred to above are intended to be imported by me into 
the Union and satisfy the definition provided for in Annex I point 27 of Regulation (EU) No …/…, and in 
particular that: 
(1) it is intended for the manufacture of medicinal products, veterinary medicinal products, medical devices, 
active implantable medical devices, in vitro diag nostic medical devices or laboratory reagents; 
(2) its design, transformation and manufacturing stages have been sufficiently completed in order to qualify the material directly or as a component of a product intended for that purpose, except for the fact that it requires further handling or transformation such as mixing, coating, assembling, packaging or labelling 
to make it suitable for placing on the market or put ting into service as medicinal products, veterinary 
medicinal products, active implantable medical device, medical devices or in vitro diagnostic medical device in accordance with the Union legislation
(1) applicable to those products  or as laboratory reagents; 
(3) it has been derived from the following material which may have originated from animals which have 
been submitted to illegal   
treatment as defined in Article 1(2)(d) of Directiv e 96/22/EC or Article 2(b) of Directive 96/23/EC(2): 
(a) carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Union legislation, but are 
not intended for human consumption for commercial reasons, 
(b) carcases and the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an 
ante-mortem inspection or bodies and the following parts of animals from game killed for 
human consumption in accordance with Union legislation: 
(i)  carcasses or bodies and parts of animals which are rejected as unfit for human consumption in  accordance with Union legislation , but which did not show any signs of disease communicable to 
humans or animals; 
(ii)  heads of poultry; 
(iii)            hides and skins, including trimmings and splitting, thereof horns and feet, including the   
                   phalanges and the carpus and metacarpus bones, tarsus and metatarsus bones, of animals  
                   other than ruminants;  
(iv)  pig bristles; 
(v)  feathers; ] 
 
(2) and/or [ — blood of animals which did not show any signs of disease communicable through blood to 
humans or animals obtained from animals other than ruminants that have been slaughtered in a 
slaughterhouse after having been considered fit for slaughter for human consumption following an 
ante-mortem inspection in accordance with Union legislation]; 
 (2) and/or [ — animal by-products arising from the production of products intended for human consumption, 
including degreased bone, greaves and centrifuge or separator sludge from milk processing; ] 
(2) and/or [ — products of animal origin, or foodstuffs containing products of animal origin, which are no 
longer intend for human consumption for commercial reasons or due to problems of manufacturing or 
packaging defects or other defects from which no risk to public or animal health arise;] 
(2) and/or [ — petfood and feeding stuffs of animal origin, or feeding stuffs containing animal by-products or 
derived products, which are no longer intended for feeding for commercial reasons or due to problems 
of manufacturing or packaging defects or other defects from which no risk to public or animal health 
arises;]  
EN 336   EN  COUNTRY Intermediate products  
 II. Declaration  II.a. Reference number II.b. 
(2) and/or [ — blood, placenta, wool, feathers, hair, horns, hoof cuts and raw milk originating from live 
animals that did not show signs of any disease communicable through that product to humans or 
animals;] 
(2) and/or [ — aquatic animals, and parts of such animals, except sea mammals, which did not show any signs 
of diseases communicable to humans or animals;] 
(2) and/or [ — animal-by products from aquatic animals originating from plants or establishments 
manufacturing products for human consumption;] 
(2) and/or [ — the following material originating from animals which did not show any signs of disease 
communicable through that material to humans or animals:  
(i) shells from shellfish with soft tissue or flesh; (ii) the following originating from terrestrial animals: 
— hatchery by-products,  
— eggs, 
— egg by-products, including egg shells, 
(iii) day-old chicks killed for commercial reasons;]  
(2) and/or [— animal-by products from aquatic and terrestrial invertebrates other than species 
pathogenic to humans or animals;] 
(2) and/or   [ — animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except  
                   Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to   
                    in Article 9(a) to (g) of Regulation (EC) No 1069/2009;]  
(2) and/or [ — products derived from or generated by: 
                                       — aquatic animals, and parts of such animals, except sea mammals, which did not show  
                                            any signs of disease communicable to humans or animals, 
 
                                      — aquatic and terrestrial invertebrates other than species pathogenic to humans or animal s, 
                                       — animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except  
                                           Ca tegory 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2   
                                           material as referred to in Article 9(a) to (g) of Regulation (EC) No 1069/2009;] 
(2) and/or [ — animal by-products other than Ca tegory 1 material or Category 3 material, as referred to in  
                               Article 9(g) of Regulation (EC) No 1069/2009, which: 
 
                                      — do not carry any risk of transmission of diseases communicable to humans or animals,  
 
                                      — are transported under conditions which exclude the transmission of such risks,;] 
 
(4) their outer packaging is labelled ‘FOR MEDICINAL PRODUCTS / VETERINARY MEDICINAL 
PRODUCTS / MEDICAL DEVICES/ ACTIVE IMPLANTABLE MEDICAL DEVICES / IN VITRO 
DIAGNOSTIC MEDICAL DEVICES/ LABORATORY REAGENTS ONLY’ and they are not intended 
to be diverted at any stage within the Union for any other use; 
(5) the consignment will be transported directly to the pl ace of destination as indicated under point I.12. of 
this declaration that is  
                              - an establishment or plant for the production of medicinal products, veterinary medicinal 
                                 products, medical devices, in vitro diagnostics or laboratory reagents, which has been   
EN 337   EN  COUNTRY Intermediate products  
 II. Declaration  II.a. Reference number II.b. 
                                 registered in accordance with Article 23 of Regulation (EC) No 1069/2009; 
                              - an establishment or plant which has been approved in accordance with Article 24(1)(h), from 
                                 where they shall only be dispatched to an establishment or plant referred to in the preceding  
                                 subpoint of (5). 
Notes 
(1) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on 
the Union code relating to veterinary medicinal products, Directive 2001/83/EC of the 
European Parliament and of the Council of 6 November 2001 on the Union code relating to medicinal products for human use, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices, as appropriate. 
 
(2) Delete as appropriate 
 
 The importer 
 Name (in capital letters): Address: 
 Date: Signature: 
  
EN 338   EN ANNEX XX  
OFFICIAL CONTROLS 
SECTION I  
OFFICIAL CONTROLS REGARDING THE ANIMAL BY-PRODUCTS CHAIN  
As referred to in Article 4(3) of the Animal By-products Regulation, the competent authority 
must take the necessary measures to control the entire chain of collection, transport, use and 
disposal of animal by-products and derived products. Such controls shall be carried out in accordance with the principles laid down in Ar ticle 3 of Regulation (EC) No 882/2004. Such 
controls shall include checks on the keeping of required records and documents and, when this Regulation requires it or the competent authority considers it necessary, the application of seals. 
When the competent authority applies a seal to a consignment of animal by-products or 
derived  products, it must inform the competent authority of the place of destination. 
SECTION II  
OFFICIAL CONTROLS IN PROCESSING PLANTS 
CHAPTER I 
Supervision of the production 
1. The competent authority shall supervise processing plants to ensure compliance with 
the requirements of the Animal By-products Regulation and with this Regulation. It 
shall in particular: 
(a) check: 
(i) the general conditions of hygiene of the premises, equipment and staff;  
(ii) the efficacy of the own checks carried out by the plant, in accordance 
with Article 28 of the Animal By-products Regulation, such checks 
shall include an examination of the results and if necessary, the taking of samples;  
(iii) the effective implementation of the permanent written procedure based 
on the hazard analysis and critical control points (HACCP) principles in accordance with Article 29(1) of the Animal By-products Regulation; such checks shall include an examination of the results and if necessary, the taking of samples; 
(iv) the standards of the products after processing. The analyses and tests 
must be carried out in accordan ce with scientifi cally-recognised 
methods (in particular, those laid down in Union legislation or, where  
EN 339   EN none exist, recognised international standards or, in their absence, 
national standards); and  
(v) the storage conditions;  
(b) take any samples required for laboratory tests; and  
(c) make any other checks it considers necessary to ensure compliance with the 
Animal by-products Regulation and with this Regulation.  
2. To allow it to carry out its responsibilities under paragraph 1, the competent authority 
must have free access at all times to all parts of the processing plant and to records, 
commercial documents and health certificates. 
CHAPTER II 
Validation procedures 
1. Prior to issuing an approval, 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:  
(a) description of the process by a process flow diagram;  
(b) identification of critical control points (CCPs) including the material process 
rate for continuous systems;  
(c) compliance with the specific proces s requirements laid down by this 
Regulation; and  
(d) achievement of the following requirements:  
(i) particle size for batch-pressure and continuous processes, defined by 
the mincer hole or the anvil gap size, and  
(ii) temperature, pressure, processing time and, in the case of continuous 
processing systems, the material processing rate, as specified in 
paragraphs 2 and 3.  
2. In the case of a batch pressure system:  
(a) the temperature must be monitored with a permanent thermocouple and it must 
be plotted against real time;  
(b) the pressure stage must be monitored with a permanent pressure gauge. 
Pressure must be plotted against real time;  
(c) the processing time must be shown by time/temperature and time/pressure 
diagrams.  
At least once a year the thermocouple and the pressure gauge must be calibrated.   
EN 340   EN 3. In the case of a continuous pressure system:  
(a) the temperature and the pressure must be monitored with thermocouples, or an 
infrared temperature gun, and pressure gauges used at defined positions 
throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it. The temperature and pressure must be plotted against real time;  
(i) feed screw revolutions per minute (rev./min.),  
(ii) electric power (amps at given voltage),  
(b) measurement of the minimum transit time inside the whole relevant part of the 
continuous system where the temperature and pressure comply with the 
required conditions, must be provided to the competent authorities, using insoluble markers, such as manganese dioxide, or a method which offers 
equivalent guarantees. Accurate measurement and control of the material process rate is essential and must be measured during the validation test in 
relation to a CCP that can be continuously monitored such as:  
(iii) evaporation/condensation rate, or   
(iv) number of pump strokes per unit time.  
All measuring and monitoring equipment must be calibrated at least once a 
year.  
4. The competent authority must repeat the checks on the  validation procedures when it 
considers it necessary, and in any case each time any significant alterations are made 
to the process, such as modifications of the machinery or changes of raw materials.  
CHAPTER II І 
Lists of registered and approved establishments, plants and operators 
1. Access to lists of registered and approved establishments, plants and operators 
In order to assist Member States in making up-to-date lists of registered and approved 
establishments, plants and operators available to other Member States and to the public, the Commission shall provide a website which shall contain links to the national websites provided by each Member State, as referred to in paragraph 2(a). 
2. Format for national websites 
(a) Each Member State shall provide the Commission with a linking address to a 
single national website containing the master list of all registered and approved establishments, plants and operators on its territory (‘master list’). 
(b) Each master list shall consist of one sheet and shall be completed in one or 
more official languages of the Union.  
EN 341   EN 3. The layout, including the relevant informatio n and codes, of master lists shall follow 
the technical specifications which are published by the Commission on its website.   
EN 342   EN  
SECTION III 
SPECIFIC REQUIREMENTS 
CHAPTER I 
Official controls regarding marking of derived products 
The competent authority shall carry out a performance check of the monitoring and recording 
system referred to in point 2 of Section V of Annex XI of this Regulation to ascertain 
compliance with this Regulation and may, where necessary, request the testing of additional 
samples in accordance with the method referred to in the second paragraph of the same point. 
 
CHAPTER II 
Official controls in low-capacity incineration plants 
The competent authority must inspect the low-capacity incineration plant for incineration of 
the Category 1 materials referred to Article 8(b)(i) of the Animal By-products Regulation 
before approval, and at least once a year to monitor compliance with the Animal By-products 
Regulation and with this Regulation. 
 
CHAPTER III 
Official controls in remote areas 
In the case of disposal of animal by-products in remote areas in accordance with Article 
19(1)(b) of the Animal By-products Regulation , the competent authority shall monitor 
regularly the areas categorised as remote areas to ensure that those areas and the disposal operations are properly controlled. 
 
CHAPTER IV 
Official controls in registered farms for the feeding of fur animals  
EN 343   EN 1. The competent authority shall take the necessary measures to control: 
(a) the appropriate composition, processing and use of the feed containing meat  
and bone meal or other products which have been processed in accordance with 
Section III of Annex VII and which are derived from the bodies or parts of bodies of animals of the same species; and 
(b) that the animals that are fed with the feed referred to in point (a), including: 
(i) strict supervision of the health status of those animals; 
(ii) appropriate TSE surveillance invol ving regular sampling and laboratory 
examination for TSEs. 
2. The samples referred to in point 1(b)(ii) shall include samples taken from animals 
showing neurological symptoms and from older breeding animals. 
CHAPTER V 
Official controls regarding collection centres 
1.  The competent authority shall  
(a) include collection centres into the list drawn up in accordance with Article 47 
of the Animal By-products Regulation; 
(b) assign an official number to each collection centre; 
(c) update the list and make it availa ble together with the list drawn up in 
accordance with Article 47 of the Animal By-products Regulation; and 
2. The competent authority shall carry out official controls at collection centres in order 
to verify compliance with this Regulation. 
CHAPTER VI 
Official controls regarding the feeding of necrophagous birds with Category 1 material 
The competent authority shall supervise the health status of the farmed  animals in the region 
where the feeding takes place, and shall carry out an appropriate TSE surveillance involving 
regular sampling and laboratory examination fo r TSEs. The samples shall include samples 
taken from animals showing neurological symptoms and from older breeding animals. 
CHAPTER VII 
Official controls regarding the applicatio n of certain organic fertilisers and soil 
improvers  
EN 344   EN The competent authority shall carry out controls along the entire chain of production and use 
of organic fertilisers and soil improvers subject to the restrictions referred to in Chapter III of 
Annex IV. Those controls shall include checks on the mixing with a component referred to in 
point 2 of Chapter I of Section II of Annex XV, and checks on the stocks of such products 
kept on farm and the records kept in accordance with the Animal By-products Regulation and 
with this Regulation. 
CHAPTER VIII 
Official controls regarding approved photographic factories 
The competent authority shall carry out documentary checks in approved photographic 
factories referred to in table 3 in point 1 of Chapter XII of Section II of Annex XVIII on the channelling chain from the border inspection posts of first entry to the approved photographic 
factories for the purpose of reconciliation of the quantities of products imported, used and disposed of.  
CHAPTER IX 
Time period for the decision on certain consignments dispatched to other Member 
States  
The competent authority shall take its decision on certain consignments dispatched from 
another Member State, as referred to in Article 48(1) of the Animal By-products Regulation, 
within 20 calendar days from the receipt of an application which is submitted in the official 
language of the competent authority. 
CHAPTER X 
Standard format for applications for certain authorisations  
in intra-Community trade 
Operators shall submit applications for the authorisation of the dispatch of animal by-products 
referred to in Article 48(1) of the Animal By-products Regulation in accordance with the following format:  
EN 345   EN APPLICATION FOR THE AUTHORISATION OF THE DISPATCH OF  
ANIMAL BY-PRODUCTS TO ANOTHER MEMBER STATE 
(ARTICLE 48 OF THE ANIMAL BY-PRODUCTS REGULATION) 
Name and address of consignor  (applicant) 
 Approval or registration number, issued 
by (competent authority) 
 
Name and address of consignee 
 Approval or registration number, issued 
by (competent authority) 
 
Animal by-products(1) 
 Category 1 material 
 Category 2 material 
 Meat-and-bone meal derived from 
Category 1 material 
 Animal fat derived from Category 1 
material 
 Meat-and-bone meal derived from 
Category 2 material 
 Animal fat derived from Category 2 
material Intended use(1) 
 Disposal 
 Processing 
 Combustion 
 Application to land 
 Transformation into biogas 
 Composting 
 Petfood 
 For feeding to(2): 
_________________________ 
 For the manufacture of the following 
derived products(3): 
_________________________ 
 
In case of meat-and-bone meal and animal 
fat: 
The materials have been processed according 
to the following method(4): ___ Species of origin: 
I, the undersigned, declare that the above information is factually correct. 
____________________________________________  
EN 346   EN (Signature: name, date, contact details: telephone, fax (if applicable), e-mail) 
Decision by the competent authority of the Member State of destination(5): 
The dispatch of the consignment is: 
 refused. 
 accepted. 
 accepted subject to the application of pressure sterilisation (method 1) to the materials. 
 accepted subject to the following conditions for the dispatch(3): 
 
  _____________ 
(Date, stamp and signature of the competent authority) 
Notes: 
Complete the document in BLOCK capitals. (1) Tick as appropriate. (2) Specify in accordance with Article 18 of Regulation (EC) No 1069/2009. 
(3) Specify. 
(4) Specify one of the processing me thods referred to in Section III of Annex VII of Regulation (EU) No … 
(5) For the competent authority: tick as appropriate.