EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 10.6.2008 
COM(2008) 345 final 
2008/0110 (COD)   
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
laying down health rules as regards an imal by-products not intended for human 
consumption (Animal by-products Regulation) 
 
(presented by the Commission) 
 
{SEC(2008)1994} {SEC(2008)1995}  
EN 2   EN EXPLANATORY MEMORANDUM  
1. BACKGROUND 
In response to several crises linked to products of animal origin which threatened the 
safety of public and animal health (TSE , dioxin, FMD), the Community introduced a 
comprehensive legislative framework to ma intain a high level of safety along the 
whole production and distribut ion chain, from "farm to fo rk". In this context, 
Regulation (EC) No 1774/2002 laying down health rules concerning animal by-
products not intended for human consumption1 (hereinafter: "the Regulation ") was 
adopted. The Regulation conso lidated and recast the vari ous existing rules covering 
animal by-products (ABP). It also introdu ced stricter rules concerning the approval 
of premises handling ABP, the channelli ng and traceability of certain products and 
the implementation of processing standards which ensure that products produced on the basis of ABP are safe, if they are intended for feed or for technical uses. The Regulation applied as of 1 May 2003. 
2. THE
 COMMISSION  REPORT 
Article 35 of the Regulation requires Memb er States to inform the Commission of 
the measures taken to ensure compliance with the Regulation. On the basis of the 
information received, the Commission submitted a report to the European Parliament and the Council on 24 October 2005 reflectin g the experience of all 25 Member 
States in applying the legislation
2. 
In addition, the Commission's Food and Vete rinary Office (FVO) carried out a round 
of inspections in all 25 Member States  throughout 2004 and 2005 to assess the level 
of compliance of the Member States.  
On the basis of information supplied by Memb er States and the fi ndings of the FVO, 
the Commission report concludes that it ha s been challenging for all Member States 
and economic operators to ensure complian ce with the provisions of the Regulation. 
Nonetheless, Member States' compliance has been generally satisfactory. The official 
controls for most Category 1 and 2 materi als are satisfactory to a large extent. 
However, more effort is needed to guaran tee the necessary traceability of the flow of 
materials based on ABP throughout the various production chains. The report 
recommended a number of measures which could improve the uniform application of 
the law and the effectiveness of official cont rols. It also served as a basis for a wide 
debate with the Member States and with th e wide range of stakeholders affected by 
the rules on ABP.  
3. THE  ISSUE 
The following major issues emerged from consultations on the report as meriting 
reconsideration:  
► The basic framework of safeguards applicable to all ABP should be 
maintained. 
► The scope of the rules on ABP should be adjusted. 
                                                 
1 OJ L 273, 10.10.2002, p. 1. 
2 COM (2005)521 final.  
EN 3   EN ► The interaction of the rules on ABP w ith other Community legislation should 
be clarified. 
► A more risk-based approach for the categ orisation of ABP, as  well as controls, 
should be introduced. 
These major issues should be addressed in a way which ensures that the level of  
protection against risks to public and an imal health in the Community is not 
compromised. Operators and competent author ities remain responsible for ensuring 
that ABP are only being sent to outlets authorised by the law. Adjustments to the rules may only be made insofar as progr ess in science and technology allows.  
4. CONSULTATION
 AND  IMPACT  ASSESSMENT 
4.1. Consultation of interested parties 
4.1.1. Consultation method, sectors targeted 
Upon presentation of the report to the C ouncil at the end of 2005, Member States 
indicated their broad consensus with the ma in areas identified as requiring review. 
Further technical questions were brought  to the Commission’ s attention during 
discussions and are considered in the present context. 
In preparing the current pr oposal, a number of interested parties (stakeholders, 
technical experts and competent authorities of the Member States, and international 
trading partners) have been consulted. More than 36 European associations with an 
interest in the food chain, animal and pub lic health (ABP pr oducers, processors, 
traders and users, and consumer organisati ons) have been given the opportunity to 
express their views on various  occasions, via bilateral me etings or through an open 
consultation. 
Owing to the interaction between the rule s on ABP and other Co mmunity legislation, 
the Commission set up an Inter-Service St eering Group (ISSG), which met twice 
between February and September 2006. 
Six working groups with Member States experts were held between July 2006 and 
December 2006, in order to discuss the major issues related to the review.  
EN 4   EN The consultations were car ried out in two steps: 
– As a first step, a general consultati on on the issues iden tified and possible 
options to resolv e them was held. 
– As a second step, once the potential solu tions were identified, stakeholders 
were asked to provide information on the likely impact of the policy options identified. 
4.1.2. Responses and follow-up 
Generally, interested parties agree that  the issues which have emerged from 
consultations reflect the major areas which merit reconsideration In particular, the 
majority of participants in the open consultation s upport the conclusion that the 
Regulation should be amended in order for the necessary adjustments to the rules to be made. 
4.2. Collection and use of expertise 
4.2.1. Scientific opinions 
Since the entry into applic ation of the Regulation, th e Community's scientific 
advisory body (the Scientific Steering Committee, which has been replaced by the 
European Food Safety Authority since 2002)  has adopted a number of opinions in 
relation to ABP. These scientific opinions advised on the capacity to contain risks via 
treatment standards. In ge neral terms, the advice obtained suggests that the key 
principle of the Regulation, which is th e exclusion of ABP derived from animals 
unfit for human consumption from the feed chain, should be maintained.  
The conclusions also suggest  that certain unsafe by-produ cts may be recovered and 
used safely for the production of, for inst ance, technical or industrial products under 
certain strict health conditions. 
4.2.2. Methodology used 
Two main methodologies were used:  
(1) analysis of the report data submitt ed by the competent authorities of the 
25 Member States and  
(2) analysis of data collected by the Commission's Food and Veterinary Office 
during 2004 to 2005. 
The data received and used is too extens ive and varied to be summarised here.  
A copy of the Commission reports can be found at: http://ec.europa.eu/food/food/bi osafety/animalbyproducts/index_en.htm 
http://ec.europa.eu/ food/fvo/index_en.htm
 
4.3. Impact Assessment 
The Commission carried out an in-house Imp act Assessment (IA) as referred to in its 
work programme 2006. An assessm ent report is accessible on: 
http://ec.europa.eu/food/food/bi osafety/animalbyproducts/index_en.htm 
The IA considered three main options: (a) No action (b) Self-regulation, guidance or co-regulation  
EN 5   EN (c) Review of the legislation. 
The IA concludes that to “no action” is likely to lead to trade disruption and severe 
negative socio-economic costs for opera tors. Self-regulati on, guidance or co-
regulation will not alleviate the burden resulting from disproportionate provisions in the legally binding text. 
In line with the findi ngs of the IA, option (c) a revi ew of the legislation, is the 
solution which is most suitable to the existing problems. 
5. LEGAL
 ELEMENTS  OF THE  PROPOSAL 
5.1. Summary of the proposed action(s) 
The proposal takes into account the results of the review carried out on Regulation 
and re-enacts the reviewed provisions, as well as the remaining part of the enacting 
provisions, in a single te xt. The provisions laid down in the Annexes to the 
Regulation, as well as provisions laid  down in separate Community acts 
implementing or derogating from that Regulation, such as Regulations (EC) 
No 811/2003, 79/2005, 92/2005 or 181/2006, will be re-enacted in an implementing 
Regulation, under the comitology procedure. This  will be prepared in parallel, so as 
to enter into application simultaneously with the current proposal. 
5.2. Legal basis 
The primary objective of the Regulation is th e protection of animal  and public health. 
Therefore, as the current Regulation, the pr oposal is based on Article 152(4)(b) of the 
Treaty. 
5.3. Subsidiarity principle 
The subsidiarity principle applies insofar as the propos al does not fall under the 
exclusive competence of the Community.  
EN 6   EN The objectives of the proposal cannot be sufficiently achieved by Member States’ 
actions. 
Risks from animal by-products may serious ly endanger the safety of the food and 
feed chain, as well as the health status  of livestock throughout the Community. 
Experience in recent years with bovine  spongiforme encephalopathy (BSE), foot-
and-mouth disease (FMD), classical swine fever (CSF) and dioxin has shown that a 
response at Member State level alone doe s not sufficiently contain major health 
threats, not least because of the close interconnection of the economic sectors throughout the Common Market.  
In addition, ABP and products manufactured  on the basis of ABP are being imported 
from third countries into the Communit y. It should be ensured that imported 
consignments meet sanitary standards wh ich are at least equivalent to those 
applicable within the Community.  
The objectives of the proposal can be better achieved by the Community. 
ABP are included in the list of products in  Annex I to the Treaty. Their placing on 
the market constitutes an important sour ce of income for parts of the farming 
population, as well as for industries which process certain ABP. To ensure the 
rational development in this sector , increase productivity and stimulate 
competitiveness, animal health and public health rules for the products in question are needed at Community level. 
5.4. Proportionality and simplification 
The proposal further simplifies the legisla tion, reducing the admi nistrative burden for 
the competent authorities (EU, nationa l and third countries) and for economic 
operators while preserving a high level of pr otection of the public  and animal health. 
It aims to allow for the consolidation of all the implementing measures and 
derogations (to date 14 acts in total) adopt ed since the applica tion of the Regulation 
on the basis of a single text. 
The interaction between the rules on animal by-products and other Community sector 
legislation (food, feed, waste, cosme tic products, pharmaceutical and medical 
devices) will be clarified. Wherever the n ecessary level of protection allows such a 
solution, duplication of a pproval and channelling requi rements should be avoided. 
The adoption of the proposal will lead to  the repeal of th e current Regulation. 
6. SCOPE
 OF THE  PROPOSAL 
In the light of the practical and scientific  experience gained and the outcome of the 
consultation, the main elements of the propos al are to maintain a high level of food 
and feed safety and consumer protecti on, and at the same time to provide:  
EN 7   EN i. Clarification 
 An end point in the life-cycle  of ABP is being introduced so as to clarify the 
point from which ABP cease to be covered by the requirements of the Regulation along the manufacturing chain. This point can be fixed at various 
stages, depending on the nature of ABP us ed, the characteristics of a treatment 
process or the intended end use of the product manufactured on ABP basis.  
 With respect to legal uncertainties regarding the scope  of the rules on ABP 
from wild game, potential sanitary ga ps are being closed by introducing 
parallel provisions to the legislation on food hygiene.  
 With regard to the interaction with other Community legislation , the approval 
of establishments and the performance of  official controls, duplication between 
requirements is being avoided insofa r as the objectives  protected by one 
legislative framework can be considered  to be covered sufficiently by another 
legislative framework.  
ii. A more risk-based approach  
 The primary responsibility of operators  to ensure that the requirements of the 
Regulation are met, in line with the approach adopted in Community legislation on food and feed hygiene, is being reinforced. This should allow the 
competent authorities to focus resources  on verifying compliance of operators 
with this obligation.  
 In particular regarding the manufacture of products based on ABP without 
direct relevance to the safety of the (food and) feed chain  (other than those 
produced as feed to farmed animals or as organic fertilisers), operators are entrusted with increased responsibility for the placing on the market of safe 
products. Provided they use safe raw ma terials for the production, develop safe 
manufacturing processes or use ABP fo r end purposes which are on balance 
safe, ABP of all categories may be use d. Further details regarding this option 
may be laid down by way of implementing rules. 
 New products, which have been proven  to pose only limited risks, should be 
introduced into the classification of ABP . At the same time, the precautionary 
provision, whereby any ABP which are not expressly cla ssified fall under 
Category 2 and may not be used in f eed to farmed animals, should be 
maintained.  
 Current derogations regarding the exceptional burial and burning on site  in 
cases of disease outbreaks should be clar ified and extended to situations in 
which recovery operations in accordan ce with the general rules of the 
Regulation become practically very difficu lt, such as during natural disasters. 
7. OTHER
 INFORMATION 
7.1. Consistency with other policie s and objectives of the Union 
The proposal is consistent with other Commun ity policies, in part icular the policy on 
the protection of the environment and of public  health in relation to the use of animal 
by-products in feed, cosmetics, medi cinal products and, medical devices.  
EN 8   EN 7.2. Budgetary implication 
The proposal has no financial implicati ons for the budget of the European 
Community. 
7.3. Other 
The proposal is in line with the Co mmission's Lisbon Strategy commitment to 
improve the acquis communautaire, addressi ng possible health risks by adequate 
measures, while enhancing competitiveness.  It is also in lin e with the "Better 
Regulation" Programme  of the Commission3. 
                                                 
3 Cf. COM (2006)689 final.  
EN 9   EN 2008/0110 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
laying down health rules as regards an imal by-products not intended for human 
consumption (Animal by-products Regulation) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty establishing th e European Community, and in particular 
Article 152(4)(b) thereof, 
Having regard to the proposal from the Commission4, 
Having regard to the opinion of the Eu ropean Economic and Social Committee5, 
Having regard to the opinion of  the Committee of the Regions6, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty, 
Whereas: (1) Animal by-products not intended for human consumption are a potential source of 
risks to public and animal health. Past cris es related to outbreaks of foot-and-mouth 
disease, the spread of transmissible spongiform en cephalopathies such as bovine 
spongiform encephalopathy (BSE) and the occu rrence of dioxins in feedingstuffs have 
shown the consequences of the improper us e of certain animal by-products for public 
and animal health, the safety  of the food and feed chain and consumer confidence. In 
addition, such crises may also  have a wider adverse impact  on society as a whole, by 
their impact on the socio-ec onomic situation of the farm ers and of the industrial 
sectors concerned and on consumer confiden ce in the safety of products of animal 
origin. Disease outbreaks can also have ne gative consequences for the environment, 
not only due to the disposal problems posed, but also as regards biodiversity. 
(2) Animal by-products arise mainly durin g the slaughter of animals for human 
consumption, and in the course of the dispos al of dead animals and of disease control 
measures. Regardless of their source, they pose a potential risk to animal and public 
health and the environment. This risk need s to be adequately controlled, either by 
channelling such products towards safe means of disposal or by using them for different purposes, provided that strict conditions are applied which minimise the 
health risks involved.  
(3) The disposal of all animal by-products is  not a realistic option, as it would lead to 
unsustainable costs and risks for the environm ent. Conversely, there is a clear interest 
for all citizens that provided the health ri sks are minimised, a wide  range of animal by-
products are safely used for various appli cations in a sustainable manner. A wide 
                                                
 
4 OJ C […], […], p. […]. 
5 OJ C […], […], p. […]. 
6 OJ C […], […], p. […].  
EN 10   EN range of animal by-products are indeed commonly used in important productive 
sectors, such as the pharmaceutical , feed and leat her industries. 
(4) New technologies have widened the possi ble use of animal by-products to a large 
number of productive sectors. However, th e use of those new technologies might pose 
health risks that must also be minimised. 
(5) Community health rules on animal by-products should be laid down in a coherent and 
comprehensive framework for their collecti on, handling, processing, di sposal or use.  
(6) Those general rules should be proportionate  to the risk to public and animal health 
which animal by-products pose at different stages of their handling along the chain 
from collection to their use or disposal. The rules should also take into account the 
risks for the environment posed during t hose operations. The Community framework 
should include health rules on the placing on the market , intra-Community trade and 
importation of animal by-products, where appropriate.  
(7) Regulation (EC) No 1774/2002 of the Europe an Parliament and of the Council of 3 
October 2002 laying down health rules c oncerning animal by-products not intended 
for human consumption7 lays down Community rules applicable to animal by-
products. Based on scientific advice, that Re gulation introduced a set of rules aimed at 
protecting the safety of the food and f eed chain, which is complementary to 
Community legislation on f ood and feed. Those rules have  significantly improved the 
level of protection in the Community agai nst the risks posed by animal by-products. 
(8) Regulation (EC) No 1774/2002 introduced th e classification of animal by-products 
into three categories according to the degree of risk involved. It requires operators to 
keep animal by-products of different categorie s separate from each other if they wish 
to make use of animal by-products which do not pose a significant risk to public or 
animal health, in particular if such produc ts are derived from ma terial fit for human 
consumption. That Regulation also introduced the principle that high risk material 
should not be fed to farmed animals, and that  material derived from animals is not to 
be fed to animals of the species from which it is derived. Pursuant to that Regulation, 
only material from animals which have under gone veterinary inspec tion is to enter the 
feed chain. In addition, it lays down rules for processing  standards which ensure the 
reduction of risks.  
(9) Under Article 35(2) of Regulation (EC) No 1774/2002, the Commission is to submit a 
report to the European Parl iament and to the Council on  the measures taken by the 
Member States to ensure compliance with  that Regulation. The report is to be 
accompanied, if appropriate, by legislativ e proposals. The report was submitted in 
October 20058 and emphasised that the princi ples of Regulation (EC) No 1774/2002 
should be maintained. In addition, it highlight ed the areas where amendments to that 
Regulation were considered necessary, in pa rticular clarifications as regards the 
applicability of the rules to finished products, the re lationship with other Community 
legislation and the classification of certain ma terial. The findings of a series of fact-
finding missions carried out in the Member States by the Food and Veterinary Office 
of the Commission (FVO) in 2004 and 2005 su pport those conclusions. According to 
                                                 
7 OJ L, 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 
1432/2007 (OJ L 320, 6.12.2007, p. 13). 
8 COM (2005)521 final.  
EN 11   EN the FVO, improvements are necessary as regard s the traceability of the flow of animal 
by-products and the effectiveness and harmonisation of official controls. 
(10) The Scientific Steering Committee, which was succeeded by the European Food 
Safety Authority (EFSA) in 2002, has a dopted a number of opinions concerning 
animal by-products. Those opinions demonstrate the need to maintain the main principles of Regulation (E C) No 1774/2002; in particular that animal by-products 
derived from animals shown not to be fit fo r human consumption as a result of a health 
inspection, should not enter the feed chain.  However, those animal by-products may 
be recovered and used for the production of technical or industrial products under 
specified health conditions. 
(11) The conclusions of the Presidency of the Council on the Commission report which 
were adopted in December 2005, and the subse quent consultations carried out by the 
Commission have highlighted that the ru les laid down in Regulation (EC) No 
1774/2002 should be improved. The chief object ives of the rules on animal by-
products, namely the control of risks to public  and animal health and the protection of 
the safety of the food and feed chain, s hould be clearly laid down. The provisions of 
this Regulation should permit the ach ievement of those objectives. 
(12) The rules on animal by-products laid down in this Regulation should apply to products 
that may not be used for human cons umption under Community legislation, in 
particular where they do not  comply with food hygiene le gislation (animal by-products 
"by law"). Those rules should, however, also  apply to products which do comply with 
certain rules regarding their possible use for human consumption, even if they are 
eventually destined for other purpose s (animal by-products "by choice").  
(13) In addition, in or der to prevent risks arising from w ild animals, carcasses or parts of 
carcasses of such animals susp ected of being infected wi th a transmissible disease 
should be subject to the rules laid down in  this Regulation. This inclusion should not 
imply an obligation to collect and dispose of bodies of wild animals that have died or 
that are hunted in their natural habitat. If good hun ting practices are observed, 
intestines and other body parts of wild game may be disposed  of safely on site. Animal 
by-products from hunted game should only be  subject to the pr ovisions of this 
Regulation insofar as food hygiene legislation applies to the placing on the market of 
such game and involves operations carried out by game-handling establishments.  
(14) The rules laid down in this Regulation should apply to  animal by-products derived 
from aquatic animals, other than materi al from vessels operating under Community 
food hygiene legislation, except fo r material to which a disease risk is clearly attached.  
(15) It is appropriate to clarify in this Regul ation which animals are to  be classified as pet 
animals, so that by-products derived from su ch animals should not be used in feed for 
farmed animals. In particular, the species listed in Annex I to Regulation (EC) No 998/2003 of the European Parliament a nd of the Council of 26 May 2003 on the 
animal health requirements applicable to the non-commercial movement of pet 
animals
9 should be regarded as pet animals.  
(16) For the sake of consistency of Commun ity legislation, the definitions set out in 
Regulation (EC) No 999/2001 of the European  Parliament and of the Council of 
22 May 2001 laying down rules for the preven tion, control and eradication of certain 
                                                 
9 OJ L 146, 13.6.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 245/2007, 
(OJ L 73, 13.3.2007, p. 9).  
EN 12   EN transmissible spongiform encephalopathies10 should be used in this Regulation. The 
reference to Council Directive 86/609/EEC of 24 November 1986 on the 
approximation of laws, regulations and admi nistrative provisions of the Member 
States regarding the protection of animals us ed for experimental and other scientific 
purposes 11 should be clarified. 
(17) For the sake of consiste ncy of Community legislation, th e definition of aquatic animal 
in Article 3(1)(e) of Dir ective 2006/88/EC of 24 Oct ober 2006 on anim al health 
requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseas es in aquatic animals
12 should be used in this Regulation. 
(18) Council Directive 1999/ 31/EC of 26 April 1999 on the landfill of waste13 specifies the 
conditions for the issuing of a permit for a landfill. This Regulation should provide for 
the disposal of animal by-products on landfills for which such a permit has been issued.  
(19) The primary responsibility for carryi ng out operations in accordance with this 
Regulation should rest with operators. At the same time, the public interest in 
preventing risks to public and animal health requires that  a collection and disposal 
system is in place to ensure the safe dis posal of animal by-products which may not be 
used, or which are not used for economi c reasons. Member States should commit 
adequate resources for the necessary infras tructure for that purpose and they should 
ensure its smooth operation. The scope of th e collection and disposal system should 
take into account the actual amount of  animal by-products which accrue in the 
particular Member State. It should also reflect, on a precautionary basis, the need for extended disposal capacities in the event of major outbreaks of transmissible diseases 
or of temporary technical failures in an existing disposal facility. Member States 
should be permitted to cooperate with each ot her and third countries provided that the 
objectives of this Regulation are met. 
(20) In order to ensure a hi gh level of protection of public and animal health, Member 
States should continue to ta ke the necessary measures to prevent the dispatch of 
animal by-products from restricted areas or es tablishments, in partic ular in the event of 
an outbreak of a disease listed in Counc il Directive 92/119/EEC of 17 December 1992 
introducing general Community measures for the control of certain animal diseases 
and specific measures relating to swine vesicular disease
14. 
(21) Operations with animal by-products which gi ve rise to a considerable degree of risk to 
public and animal health should only be carrie d out in establishments which have been 
approved in advance for such  operations by the competen t authority. This condition 
should apply in particular to rendering plants and other pl ants handling and processing 
untreated animal by-products. It should be permitted that animal by-products of more 
than one category are handled in the same establishment provided cross-contamination 
is prevented. It should further be permitted to amend these conditions if the amount of 
                                                 
10 OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1275/2007, 
(OJ L 284, 30.10.2007, p. 8). 
11 OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament 
and of the Council (OJ L 230, 16.9.2003, p. 32). 
12 OJ L 328, 24.11.2006, p.14. 
13 OJ L 182, 16.7.1999, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
14 OJ L 62, 15.3.1993, p. 69. Directive as last amended by Commission Directive 2007/729/EC (OJ L 294, 
13.11.2007, p. 26).  
EN 13   EN material for disposal and processing aris es due to a major outbreak of disease, 
provided it is ensured that the temporar y use under such amended conditions does not 
lead to the propagation of disease risks. 
(22) In addition, such approv als should not be necessary fo r plants and establishments 
which process or handle certain safe materials,  such as products processed to an extent 
that they no longer pose a risk to publ ic and animal health. Such plants and 
establishments should be registered so as to permit official control of the flow of 
material and ensure their traceability. In pa rticular, plants which have been approved 
or registered under Regulation (EC) No 183/ 2005 of the European Parliament and of 
the Council of 12 January 2005 laying down requirements for feed hygiene15 should 
only be required to be regi stered under this Regulation. 
(23) Plants and establishments should be a pproved following the submission of information 
to the competent authority which demonstrates that the requirements for the infrastructure and operation of the plant or establishment in accordance with this Regulation will be met, so that any risks to  public and animal health arising from the 
process used will be adequately containe d. The competent aut hority should carry out 
checks to verify compliance with these requirements. 
(24) Plants and establishments whose operati ons have already been approved in accordance 
with Community legislation on food and feed  hygiene should not be required to be 
approved under this Regulation, as approva ls under that Community legislation 
already take into account the objectives of this Regulation.  
(25) Animal by-products should be classified in to three categories which reflect the degree 
of risk that they pose to public and animal health, on th e basis of risk assessments. 
While material posing a high risk should onl y be used for purposes outside the feed 
chain, the use of material posing a lower risk should be permitted under safe 
conditions.  
(26) Progress in science and technology may l ead to the development of processes which 
eliminate or minimise the risks to public a nd animal health. Amendments to the lists of 
materials set out in this Regul ation should be possible, in or der to take account of such 
progress. Prior to any such amendments, and in accordance with the general principles 
of Community legislation aimed at ensuri ng a high level of protection of public and 
animal health, a risk assessment should be carried out by the appropriate scientific institution, such as the EFSA, the European Medicines Agency or the Scientific Committee for Consumer Products, depending on the type of materi al for which risks 
are to be assessed. However, it should be clear that once materials of different 
categories are mixed, the mixture should be handled in accordance with the standards 
laid down for the proportion of the mixtur e belonging to the hi ghest risk category. 
(27) Due to the high risk to pub lic health, material giving rise  to a risk of transmissible 
spongiform encephalopathy (TSE) should, in pa rticular, not be used for feed. This 
restriction should apply to wild animal s through which a communicable disease may 
be transmitted. The restricti on on the feeding of material  giving rise to a TSE risk 
should be without prejudice to  the feeding rules laid down in Regulation (EC) No 
999/2001. 
                                                
 
15 OJ L 35, 8.2.2005, p. 1.  
EN 14   EN (28) The use of certain substances and produc ts is illegal under Council Regulation (EEC) 
No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of  veterinary medicinal products in food 
stuffs of animal origin
16 and Council Directive 96/22/EC  of 29 April 1996 concerning 
the prohibition on the use in stockfarming of  certain substances having a hormonal or 
thyrostatic action and of ß-agonists17. In addition, Council Dir ective 96/23/EC of 29 
April 1996 on measures to monitor certain su bstances and residues thereof in live 
animals and animal products18 lays down further rules on the monitoring of certain 
substances and residues thereof in liv e animals and animal products. Directive 
96/23/EC also lays down rules which a pply where the presence of residues of 
authorised substances or contaminants exceeding certain permitted levels has been established. In order to ensu re the coherence of Community legislation, products of 
animal origin in which substances are de tected in breach of Regulation (EEC) No 
2377/90 and Directives 96/22/EC and 96/23/EC should be classified as Category 1 or 
Category 2 material, as appropria te, in view of the risk th ey pose to the food and feed 
chain.  
(29) Manure and digestive tract co ntent do not need to be disp osed of, provided that proper 
treatment ensures that diseases are not tr ansmitted during application to land. By-
products from animals that die on farm a nd animals killed for the eradication of 
diseases except TSEs, should not be used in the feed chain. This restriction should also 
apply to imported animal by-products whic h are allowed into the Community, even 
though they do not comply with Commun ity legislation upon inspection at the 
Community border post, and to products wh ich do not comply with the applicable 
requirements during checks carri ed out within the Community. 
(30) Since the date of entry into force of  Regulation (EC) No 1774/2002, the classification 
of certain animal by-products by default as  Category 2 material limits their possible 
uses severely, while not necessarily being proportionate to the risks involved. Accordingly those animal by-products should be  reclassified as Category 3 material, 
so as to allow their use fo r certain feeding purposes. Fo r any other animal by-products 
which are not listed under one of the three ca tegories, the categoris ation by default as 
Category 2 material should be maintained for precautionary reasons, in particular to 
reinforce the general exclusion of such ma terial from the feed chain for farmed 
animals. 
(31) Other legislation which has entered in to force following the adoption of Regulation 
(EC) No 178/2002 of the European Parlia ment and of the Council of 28 January 2002 
laying down the general principles and requ irements of food law, establishing the 
European Food Safety Authority and layi ng down procedures in matters of food 
safety
19, namely Regulation (EC) No 852/2004 of the European Parliament and of the 
Council of 29 April 2004 on the hygiene of foodstuffs20 and Regulation (EC) No 
                                                 
16 OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1353/2007 
(OJ L 303, 21.11.2007, p. 6). 
17 OJ L 125, 23.5.1996, p. 3. Directive as amended by Directive No 2003/74/EC of the European 
Parliament and the Council (OJ L 262, 14.10.2003, p. 17). 
18 OJ L 125, 23.5.1996, p. 10. Directive as last amended by Directive 2006/104/EC (OJ L 363, 
20.12.2006, p. 352). 
19 OJ L 31, 1.2.2002. p. 1. Regulation as amended by Commission Regulation (EC) No 575/2006 (OJ L 
100, 8.4.2006, p. 3). 
20 OJ L 139, 30.4.2004, p. 1; corrected version OJ L 226, 25.6.2004, p. 3.  
EN 15   EN 853/2004 of the European Parliament and of  the Council of 29 April 2004 laying down 
specific hygiene rules for food of animal origin21, and to which Regulation (EC) No 
1774/2002 is complementary, places the primary duty of complying with Community legislation, aimed at prot ecting public and animal health, on the food business 
operators. In line with that  legislation, operators carrying out activities under this 
Regulation should also be primarily respons ible for ensuring compliance with this 
Regulation. The respective basic obligation of such operators to ensure compliance 
with this Regulation should be further clar ified and specified as regards the means by 
which traceability is ensured, such as sepa rate collection and cha nnelling of animal by-
products. 
(32) A system of own checks is necessary to ensure that within  a plant or establishment, the 
requirements of this Regulation are fulfilled. The proper performance of own checks is also of indicative importance for checks carried out by the comp etent authority. Own 
checks should be carried out through a system based on the principles of hazard analysis and critical contro l points (HACCP) in plants processing animal by-products, 
such as rendering plants, in plants for th e transformation of animal by-products into 
biogas or compost and in plants handli ng more than one cat egory of animal by-
products, such as plants storing raw materi al of two categories. Sampling of products 
to check compliance with Community stan dards such as microbiological criteria 
should not be compulsory for products which are to be incinerated, co-incinerated or 
disposed of on the same site, due to the f act that possible risks are being eliminated 
without the product being placed on the market. 
(33) Animal by-products should onl y be used if the ri sks to public and animal health are 
minimised in the course of their processi ng and the placing on the market of products 
manufactured on the basis of animal by-produc ts. If this option is not available, the 
animal by-products should be disposed of under safe conditions. The options available 
for the use of animal by-products of the di fferent categories s hould be clarified in 
coherence with other Community legislation.  
(34) Disposal of animal by-products and deri ved products should take place in accordance 
with environmental legislation regarding landf illing and waste incineration. In order to 
ensure consistency, incinera tion should take place in accordance with Directive 
2000/76/EC of the European Parliament and of the Council of 4 December 2000 on 
the incineration of waste
22. Co-incineration of waste – eith er as a recovery or disposal 
operation – is subject to similar conditions regarding approval an d operating as waste 
incineration, in particular as to air em ission limit values, wastewater and residue 
discharge, control and m onitoring and measurement requirements. Consequently, 
direct co-incineration, without prior proces sing, of all three cat egories of materials 
should be permitted. 
(35) The use of animal by-products or derived products as a fuel in the combustion process 
should be authorised and it is not a wast e disposal operation. However, such use 
should take place under conditions which ensu re the protection of public and animal 
health, as well as the appropria te environmental standards.  
(36) The coherence of Community legislation requires that material submitted to a 
detoxification process defined in accord ance with Directive 2002/32/EC of the 
                                                 
21 OJ L 139, 30.4.2004, p. 26; corrected version OJ L 226, 25.6.2004, p. 22. Regulation as last amended 
by Commission Regulation (EC) No 1243/2007 (OJ L 281, 25.10.2007, p. 8). 
22 OJ L 332, 28.12.2000, p. 91.  
EN 16   EN European Parliament and of the Council of  7 May 2002 on undesirable substances in 
animal feed23 may also be used for feeding purposes.  
(37) This Regulation should provide for th e possibility to lay down parameters for 
processing methods regarding time, temperat ure and pressure for animal by-products, 
in particular for the methods currently referred to as methods 2 to 7 under the 
Regulation (EC) No 1774/2002.  
(38) Shells from shellfish fr om which the soft tissues or flesh have been removed, should 
be excluded from the scope of the Regulati on. Due to the various practices regarding 
the removal of such soft tissue or flesh from shells in the Community, it should be 
possible to use shells from which the entire soft tissue or flesh has not been removed, 
provided such use does not lead to a risk aris ing to public and animal health. Guides to 
good practice at Community or national level could assist in the dissemination of 
knowledge regarding proper conditions unde r which such use would be possible. 
(39) In view of the limited risk  to public or animal  health arising from such products, the 
competent authority should be able to author ise the preparation and application to land 
of biodynamic preparations, on  the basis of Category 2 a nd Category 3 material, as 
referred to in Council Regulation (EC) No 2092/91 of 24 June 1991 on organic 
production of agricultural pr oducts and indications referr ing thereto on agricultural 
products and foodstuffs24. 
(40) Novel technologies which are being deve loped offer advantageous ways of generating 
energy on the basis of animal by-products or of  providing for the safe disposal of such 
products. In order to take account of the related progress in science and technology, 
such technologies should be authorised as alternative methods for the disposal or use 
of animal by-products throughout the Commun ity. If a technologica l process has been 
developed by an individual, an application checked by th e competent au thority should 
be examined by the EFSA before such authoris ation is granted, in order to ensure that 
an assessment of the risk reduction pote ntial of the proce ss is carried out.  
(41) It is appropriate to clarify the requiremen ts applicable to the pl acing on the market of 
animal by-products and derived products in tended for feeding purposes and of organic 
fertilizers and soil improvers, so as to ensure the protecti on of the food and feed chain. 
Only Category 3 material should be used for feeding purposes. Fe rtilisers produced on 
the basis of animal by-products may affect the safety of the feed and food chain. 
Where they have been manufactured from proteineacous material, a component, such 
as an inorganic or an indigest ible substance, should be a dded in order to prevent their 
direct use for feeding purposes. 
(42) Regulation (EC) No 1523/ 2007 of the European Parliament and of the Council of 11 
December 2007 banning the placing on the market and the import to, or export from the Community of cat and dog fur and products containing such fur
25 lays down a 
general prohibition on the pl acing on the market and the importation and exportation 
of cat and dog fur and products containing such  fur. However, that prohibition should 
                                                 
23 OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2006/77/EC (OJ L 271, 
30.9.2006, p. 53). 
24 OJ L 198, 22.7.1991, p. 1. Regulation as last amended by Commission Regulation (EC) No 1319/2007 
(OJ L 293, 10.11.2007, p. 3). 
25 OJ L 343, 27.12.2007, p. 1.  
EN 17   EN not affect the obligation under this Regulati on to dispose of animal by-products from 
cats and dogs, including fur.  
(43) The promotion of science and research requires the use of animal by-products of all 
categories, sometimes in quantities below the scale of commercial exchanges. In order to facilitate the importation an d use of such material, th e competent au thority should 
be able to fix the conditions for such operations on a case-specific basis. Harmonised conditions should be laid down where acti on at a Community level is necessary. 
(44) Regulation (EC) No 1774/2002 contains de tailed provisions whic h allow, by way of 
derogation, the feeding of Category 2 and Cate gory 3 material to certain animals such 
as zoo animals. Identical provisions shoul d be laid down in this Regulation and 
complemented by the possibility to lay dow n detailed rules to control any possible 
risks arising to public or animal health. 
(45) Regulation (EC) No 1 774/2002 allows for the feeding of Category 1 material to 
endangered species of necrophagous birds living in their natural habitat. In order to 
provide an adequate tool fo r the preservation of those sp ecies, that feeding practice 
should continue to be permitted under this Regulation, in accordance with conditions 
laid down to prevent th e spread of diseases. 
(46) Burial and burning of unpr ocessed animal by-products, in particular of dead animals 
may be justified in specific situations, in particular in remote areas, or in disease 
control situations requi ring the emergency disposal of th e animals killed as a measure 
to control an outbreak of a serious transm issible disease. The available rendering or 
incinerator capacity within a region or Member State could otherwise be a limiting 
factor in the control of a disease.  
(47) The current derogation concerning bur ial and burning of unprocessed animal by-
products should be extended to areas wher e access is not practically possible or 
presents a risk to the health and safety of the collection personne l. Experience gained 
with the application of Regulation (EC)  No 1774/2002 has shown that under such 
exceptional circumstances, disposal by burial or burning on site can be justified so as 
to ensure the swift disposal of animals and to avoid the propagation of disease risks. 
The overall size of remote areas in a Member  State should be limited, so as to ensure 
that the general obligation to have in pl ace a proper disposal system which complies 
with the rules laid down in this Regulation is fulfilled. 
(48) Establishments which handle only small quantities of animal by-products which do not 
pose a risk to public and animal health should be allowed to dispose of such by-
products by means other than disposal in  accordance with th is Regulation, under 
official supervision. 
(49) The possible courses of action which the competent authority can  take when carrying 
out official controls should be specified in or der to ensure legal certainty, in particular 
regarding the suspension or perm anent interruption of operations. 
(50) The obligation of Member States to put in place a sufficient disposal infrastructure 
entails financial and other commitments. In order to ensure that Member States may 
control the quantity of material which ma y be introduced for disposal into their 
territory, the competent authority should authorise the dispatch of such material to its territory.  
(51) Pressure sterilisation and auxiliary transport conditions may be imposed so as to 
ensure the control of possible risks. In or der to ensure traceability and cooperation  
EN 18   EN between the competent authorities of Member States controlling the flow of material, 
the TRACES system introduced by Comm ission Decision 2004/292/EC of 30 March 
2004 on the introduction of the Traces system26 should be used to provide information 
on the dispatch of all Category 1 and Cate gory 2 material and derived products from 
rendering operations, and Category 3 processed animal protein.  
(52) In order to facilitate the transporta tion of consignments through third countries 
neighbouring more than one Member State, a special regime for the dispatch of 
consignments from the territory of one Memb er State to another through the territory 
of a third country should be introduced in  order to ensure, in particular, that 
consignments re-entering the Community territory are subject to veterinary checks in accordance with Council Directive 89/662/EC of 11 December 1989 concerning veterinary checks in intra-Community trad e with a view to the completion of the 
internal market
27. 
(53) For the sake of coherence of Community legislation, it is nece ssary to clarify the 
relationship between the rules laid down in  this Regulation and Community legislation 
on waste. In particular, cons istency should be ensured w ith the prohibitions on waste 
exports laid down in Regulation (EC) No 1013/2006 of the European Parliament and 
of the Council of 14 June 2006 on shipments of waste28. In order to prevent potentially 
detrimental effects for the e nvironment, the export of an imal by-products and derived 
products destined for disposal by incinera tion and by landfill shoul d be prohibited. It 
should also be prevented that animal by- products and derived products are exported 
with the objective to use them in a biogas or composting plant to third countries which 
are not members of the OECD, in order to prevent potentially a dverse environmental 
impacts and risks to public and animal health. When applying the provisions to 
derogate from the export ban in Article 37, the Commission shall fully respect in its 
decisions the Basel Convention on the control of transboundary movements of 
hazardous waste and their dispos al, and the amendment to th is Convention in Decision 
III/1 of the Conference of the Parties, as ratified by the European Community by 
Council Decisions 93/98/EEC29 and 97/640/EC30, respectively, and implemented by 
Regulation (EC) No 1013/2006. 
(54) In addition, it should be ensured that animal by-products mixed or contaminated with 
hazardous waste, as listed in Commi ssion Decision 2000/532/EC of 3 May 2000 
replacing Decision 94/3/EC establishing a list  of wastes pursuant to Article 1(a) of 
Council Directive 75/442/EEC on waste and Council Decisi on 94/904/EC establishing 
a list of hazardous waste pursuant to Artic le 1(4) of Council Di rective 91/689/EEC on 
hazardous waste31 are only imported, exported or disp atched between Member States 
in accordance with Regulation (EC) No 1013/ 2006. It is also necessary to lay down 
rules concerning the dispatch of such  material within a Member State. 
                                                 
26 OJ L 94, 31.3.2004, p. 63. Decision as last amended by Decision 2005/515/EC (OJ L 187, 19.7.2005, 
p. 29). 
27 OJ L 395, 30.12.1989, p. 13. Directive as last amended by Directive 2004/41/EC of the European 
Parliament and of the Council (OJ L 157, 30.4.2004, p.33; corrected version OJ L 195, 2.6.2004, p. 12). 
28 OJ L 190, 12.7.2006, p. 1. 
29 OJ L 39, 16.2.1993, p. 1. Corrigendum published at OJ L 74, 17.3.1994, p. 52. 
30 OJ L 272, 4.10.1997, p. 45. 
31 OJ L 226, 6.9.2000, p. 3. Decision as last am ended by Council Decision 2001/573/EC (OJ L 203, 
28.7.2001, p. 18).  
EN 19   EN (55) The Commission should be able to carry out controls in Memb er States. Community 
controls in third countries should be carri ed out in accordance with Regulation (EC) 
No 882/2004 of the European Parliament and the Council of 29 April 2004 on official 
controls performed to ensure the verifica tion of compliance with feed and food law, 
animal health and animal welfare rules32. 
(56) The importation of animal by-products a nd derived products into the Community and 
the transit of such material should take place in accordance with  rules which are at 
least as strict as those applicable within the Community. Alternatively, the rules applicable to animal by-products and derived products in third countries may be recognised to be equivalent to the rules laid down in Community legislation. Due to 
the potential risk arising from them, a simplified set of import rules should be 
applicable to products which are destin ed for uses outside the feed chain. 
(57) Community legislation on the manufacture of derived products intended for use as 
cosmetic products, medicinal products or me dical devices comprises a comprehensive 
framework for the placing on the market  of such products: Council Directive 
76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products
33, Directive 2001/83/EC of th e European Parliament and 
of the Council of 6 November 2001 on th e Community code relating to medicinal 
products for human use34, Directive 2001/82/EC of the European Parliament and of 
the Council of 6 November 2001 on the Co mmunity code relati ng to veterinary 
medicinal products35, Council Directive 90/385/ EEC of 20 June 1990 on the 
approximation of the laws of the Member St ates relating to active implantable medical 
devices36, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices37 
and Directive 98/79/EC of the European Pa rliament and of the Council of 27 October 
1998 on in vitro  diagnostic medical devices38("the specific Directives"). However, the 
specific Directives on cosmetic products and medical devices do not provide for 
protection against risks to animal health. In  such cases, this Regul ation should apply to 
these risks and safeguard measures in accordance with Regulation (EC) No 178/2002 
should be possible.  
(58) Animal by-products or derived products that  are supplied as material or ingredients for 
the manufacture of such derived products shou ld also be subject to the requirements of 
the specific Directives, insofar as they la y down rules controlling risks to public and 
animal health. Those specific Directives al ready regulate starting material of animal 
origin which may be used for the manufactur e of the derived products referred to and 
impose certain conditions to ensure the prot ection of public or animal health. In 
                                                 
32 OJ L 165, 30.4.2004, corrected version OJ L 191, 28.5.2004, p. 1. Regulation as last amended by 
Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). 
33 OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive (EC) No 2007/67/EC 
(OJ L 305, 23.11.2007, p. 22). 
34 OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 
10.12.2007, p. 121). 
35 OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 
36 OJ L 189, 20.7.1990, p. 17. Directive as last amended by Directive 2007/47/EC of the European 
Parliament and of the Council (OJ L 247, 21.9.2007, p. 21). 
37 OJ L 169, 12.7.1993, p. 1. Directive as last amended by Directive 2007/47/EC of the European 
Parliament and of the Council (OJ L 247, 21.9.2007, p. 21). 
38 OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 
31.10.2003, p. 1).  
EN 20   EN particular, Council Directive 76/768/EEC ex cludes Category 1 material and Category 
2 material as part of the composition of a cosmetic product and obliges manufacturers 
to apply good manufacturing practices. Commission Dir ective 2003/32/EC of 23 April 
200339 introduces detailed specifications with respect to medical devices manufactured 
utilising tissues of animal origin. 
(59) However, where those conditions have not yet been laid down in the specific 
Directives or where they do not cover certain  risks to public and animal health, this 
Regulation should apply.  
(60) In order to ensure trac eability, operators s hould indicate operations using such raw 
material derived from animals to the competent authority, so that intervention by the authorities responsible for the protection of pub lic and animal health is possible, in the 
event of any failure to comply with th e rules laid down in this Regulation. 
(61) Certain derived products do not enter the f eed chain or are not applied to land which is 
grazed by farmed animals or from which he rbage for feed is cut. Such derived 
products include products for technical us es, such as treated hides for leather 
production, processed wool for the text ile industry, bone produc ts for glue and 
processed material destined for petfood. Oper ators should be permitted to place such 
products on the market provided that they  are either derived from raw material 
requiring no treatment or the treatment or the end use of the treated material ensure adequate risk control.  
(62) Community rules may also provide that  no requirements apply to the placing on the 
market of such products when it is justified due to the absence of risk, in particular 
when an end point in the manufacturing ch ain can be determined following which the 
resulting material no longer poses any significant risk.  
(63) Under Regulation (EC) No 1774/2002, certa in products, notably guano, certain hides 
to which particular forms of treatment such  as tanning have been applied, and certain 
game trophies, have been exempted from th e requirements of that Regulation. Similar 
exemptions should be provided for by implementing measures, such as in the case of oleochemical products. However, in order to maintain an adequate level of protection 
of the feed chain, operators handling Ca tegory 1 and Category 2 material for the 
manufacture of petfood should continue to be required to obtain approval. 
(64) The dissemination and use of guides to good practice at Community and national level 
by the economic sectors concerned by the Regulation can serve as a useful tool to enhance knowledge about and develop su itable practical instruments for the 
application of this Regulation. 
(65) Certain failures to comply with the rules laid down in Regulation (EC) No 1774/2002 
have been revealed in a number of Member  States. Accordingly, in addition to the 
strict enforcement of those ru les, criminal and other sanc tions against operators which 
do not comply with those rules are needed. Therefore, it is necessary that Member 
States lay down rules on pena lties applicable to infri ngements of this Regulation. 
(66) Since the objectives of the action to be taken cannot be  sufficiently achieved by the 
Member States and can therefore be be tter achieved at Community level, the 
Community may adopt measures, in accordance with the principle of  subsidiarity as 
set out in Article 5 of the Treaty. In accord ance with the principle of proportionality, 
                                                
 
39 OJ L 105, 26.4.2003, p. 18.  
EN 21   EN as set out in that Ar ticle, this Regulation does not go beyond what is  necessary in order 
to achieve those objectives. 
(67) In order to enhance le gal certainty and in the light  of the Commission’s general 
objective to simplify Community legislation, a coherent fr amework of rules should be 
laid down in this Regulation, taking into  account the rules laid down in Regulation 
(EC) No 1774/2002, as well as the experience gained and pr ogress made since the date 
of entry into force of that  Regulation. Regulation (EC) No 1774/2002 should therefore 
be repealed and replaced by this Regulation. 
(68) The measures necessary for the implemen tation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implem enting powers conferred on the Commission
40. 
In order to improve coherence and clarity of Community legisla tion, the technical 
rules concerning specific ope rations involving animal by- products, which are currently 
laid down in the Annexes to Regulation (EC) No 1774/2002, as well as in implementing measures adopted on  the basis of that Regulation
41, should be laid down 
in separate implementing acts. Consultation and information of consumers and socio-professional circles concerned w ith issues related to this Regulation should be carried 
out in accordance with Commission Decision 2004/613/EC of 6 August 2004 
concerning the creation of an advisory gr oup on the food chain and animal and plant 
health
42. 
(69) In particular, the Commi ssion should be empowered to adopt rules concerning the site 
and equipment of plants a nd establishments handling animal by-products, the handling 
and treatment of animal by-products, the categ orisation of materials according to the 
risk arising from them to public and animal  health, measures intended to ensure the 
traceability of animal by-products, derogati ons regarding the use and disposal of 
animal by-products, conditions for the plac ing on the market of animal by-products 
and derived products, conditions for the contro l for the dispatch of  certain animal by-
products and derived products between Memb er States and conditions for the import 
and transit of animal by-products and deri ved products. Since those measures are of 
general scope and are designed to amend non- essential elements of this Regulation, 
inter alia  by supplementing it with new non-essen tial elements, they must be adopted 
in accordance with the regulatory procedure w ith scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 
(70) On grounds of efficiency, the normal time-limits for the regulatory procedure with 
scrutiny should be curtailed for the adopti on of measures specifying the conditions for 
the dispatch of animal by-products from  restricted holdings, plants or zones. 
                                                 
40 OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, 
p. 11). 
41 Regulation (EC) No 811/2003 on intra-species recycling (OJ L 117, 13.5.2003, p. 14); Decision 
2003/322/EC on the feeding of necrophagous birds (OJ L 117, 13.5.2003, p. 32; Decision as last amended by Decision 2005/830/EC (OJ L 311, 26.11.2005, p. 40); Decision 2003/324/EC on intra-
species recycling for fur animals (OJ L 117, 13 .5.2003, p. 37, Decision adapted by Decision 
2004/434/EC, OJ L 189, 27.5.2004, p. 43); Regulation (EC) No 92/2005 on alternative methods of disposal or use (OJ L 19, 21.1.2005, p. 27; Regulation as last amended by Regulation (EC) 
No 1576/2007, OJ L 340, 22.12.2007, p. 89); Regul ation (EC) No 181/2006 on organic fertilisers and 
soil improvers (OJ L 29, 2.2.2006, p. 31); Regulation (EC) No 1192/2006 on lists of approved plants (OJ L 215, 5.8.2006, p. 10); Regulation No 2007/2006 on Category 3 intermediate products (OJ L 379, 
28.12.2006, p. 98). 
42 OJ L 275, 25.8.2004, p. 17.  
EN 22   EN HAVE ADOPTED THIS REGULATION: 
CHAPTER I 
COMMON PROVISIONS 
SECTION 1: 
SUBJECT -MATTER , SCOPE , DEFINITIONS , INFRASTRUCTURE  
Article 1 
Subject-matter 
This Regulation lays down animal and publi c health rules for animal by-products and 
products derived thereof, in order: 
(a) to prevent and minimise risks to anim al and public health arising from those 
products; and 
(b) to protect the safety of the food and feed chain. 
Article 2 
Scope 
1. This Regulation shall apply to animal by-products and products derived thereof  
(a) which are excluded from human consum ption under Community legislation; or 
(b) that may be destined for human c onsumption under Community legislation, but 
pursuant to a decision by an operator ar e destined for purposes other than 
human consumption.   
EN 23   EN 2. This Regulation shall not apply to the following animal by-products and products 
derived thereof: 
(a) entire bodies or parts of wild animals: 
(i) which are not suspected of being infected with a di sease communicable 
to humans or animals, except for aquatic animals landed for commercial purposes; 
(ii) in the case of wild terrestrial animals, which are not collected after 
killing, in accordance with good hunting practice; 
(b) animal by-products from wild game a nd from wild game meat referred to in 
Article 1(3)(e) of Regulation (EC) No 853/2004; 
(c) oozytes, embryos and semen destined for breeding purposes;  
(d) liquid milk, colostrum and products de rived thereof which are obtained, kept, 
disposed of or used on the farm of origin;  
(e) shells from shellfish with the soft tissue or flesh removed;  
(f) catering waste, except if it  
(i) originates from means of tran sport operating internationally; 
(ii) is destined for feeding purposes; (iii) is destined for use in a biogas plant, for composting or for the 
manufacture of derived products which are intended for use by way of 
alternative methods as referre d to in Article 22(a); and 
(g) without prejudice to Community environm ental legislation, material disposed 
of at sea, which has arisen in the c ourse of their fishing operations, from 
vessels complying with Regulatio ns (EC) No 852/2004 and No 853/2004, 
except material derived from on-board ev isceration of fish showing signs of 
disease, including parasites. 
3. This Regulation shall not apply to the following derived products, subject to the 
special regime set out in Chapter VI: 
(a) cosmetic products as defined in Article 1(1) of Directive 76/768/EEC; 
(b) active implantable medical devices as defined in Article 1(2)(c) of Directive 
90/385/EEC; 
(c) medical devices as defined in Ar ticle 1(2)(a) of Di rective 93/42/EEC;  
EN 24   EN (d) in vitro  diagnostic medical devices as define d in Article 1(2)(b) of Directive 
98/79/EC. 
(e) veterinary medicinal products as de fined in Article 1(2) of Directive 
2001/82/EC; 
(f) medicinal products as defined in Article 1(2) of Directive 2001/83/EC. 
4. This Regulation shall be without prejud ice to Community vete rinary legislation 
having as its objective th e control and eradication of animal diseases. 
Article 3 
Definitions 
For the purposes of this Regulation, th e following definitions shall apply: 
(1) "animal by-products" means entire bodies or  parts of animals of dead animals or 
products of animal origin referred to in Articles 11, 12 and 13, including oozytes, 
embryos and semen;  
(2) "animal" means any invertebrate or vert ebrate animal (including fish, reptiles and 
amphibians);  
(3) "farmed animal" means: 
(a) any animal that is kept, fattened or bred by humans and used for the production 
of food, wool, fur, feathers, hides and skins or any other product of animal 
origin or for other farming purposes; 
(b) equidae; 
(4) "wild animal" means any animal not kept by humans;  (5) "pet animal" means any animal belonging to species normally nourished and kept by 
humans for purposes other than farming a nd listed in Annex I to Regulation (EC) 
No 998/2003;  
(6) "aquatic animals" means aquatic animals as  defined in Article 3(1)(e) of Directive 
2006/88/EC; 
(7) "competent authority" means the central authority of a Member State competent to 
ensure compliance with the re quirements of this Regulation or any authority to which 
that competence has been delegated; it  also includes, wh ere appropriate, the 
corresponding authority of a third country;   
EN 25   EN (8) "placing on the market" means any operation the purpose of which is to sell animal 
by-products or derived products to a third party in the Co mmunity or any other form 
of supply against payment or free of charge to such a third part y or storage with a 
view to supply to such a third party;  
(9) "transit" means a movement through the Community from a territory of a third 
country to a territory of  a third country, other th an by sea or by air;  
(10) "export" means a movement from  the Community to a third country; 
(11) "producer" means any person who produces  animal by-products or derived products;  
(12) "operator" means any natural or lega l person who has an animal by-product or 
derived product under their actual control, including the producer; 
(13) "transmissible spongiform encephalopa thies (TSEs)" means all transmissible 
spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 
999/2001;  
(14) "specified risk material" means specified risk material as  defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001; 
(15) "derived products" means any product obtained from one or more treatments, 
transformations or steps of pr ocessing of animal by-products; 
(16) "pressure sterilisation"  means the processing of animal by-products, after reduction 
in particle size to not more  than 50 mm, to a core te mperature of more than 133°C 
for at least 20 minutes without interruption at  an absolute pressure of at least 3 bar; 
(17) "products of animal origin" means pr oducts obtained from animals and products 
obtained from such products, including live an imals where they are prepared for such 
use; 
(18) "manure" means any excrement and/or ur ine of farmed animals, with or without 
litter, or non-mineralised guano; 
(19) "authorised landfill" means a landfill for which a permit has been issued in 
accordance with Directive 1999/31/EC; 
(20) "approved plant" means a plant approved in accordance with this Regulation for a 
particular operation involving the hand ling of animal by-products, other than a 
fishing vessel; 
(21) "establishment" means a place of ma nufacture of derived products which are 
regulated by other Community legislation;  
EN 26   EN (22) "organic fertiliser" and "soil improver" means materials of animal origin used to 
maintain or improve plant nutrition and th e physical and chemical properties and 
biological activities of soils, either separately or togeth er; they may include manure, 
digestive tract content, com post and digestion residues; 
(23) "remote area" means an area where the animal population is so small, and where 
disposal facilities are so fa r away that the arrangements necessary for the collection 
and transport of animal by-products woul d be unacceptably onerous compared to 
local disposal; 
(24) "food" means food as defined in Ar ticle 2 of Regulation (EC) No 178/2002; 
(25) "feed" means feed as defined in Ar ticle 3(4) of Regulation (EC) No 178/2002. 
Article 4 
National infrastructures and systems for the co llection and disposal of animal by-products 
1. Member States shall have an adequate infr astructure in place on their territory that 
ensures that animal by-products are 
(a) collected, identified and tran sported without undue delay;  
(b) disposed of in accordance with this Regulation. 
2. Member States shall  
(a) provide a system for the collection a nd disposal of animal by-products, which 
operates efficiently and which is m onitored continuously by the competent 
authority; 
(b) commit adequate resources for the operation of such a system. 
3. Member States may fulfil their obligations  under this Article in cooperation with 
other Member States and third countries. 
SECTION 2: ANIMAL HEALTH RESTRICTIONS  
Article 5 
General animal health restrictions  
1. Without prejudice to Article 2(4), animal by-products and derived products shall not 
be dispatched from holdings, plants or z ones which are subject to restrictions  
(a) pursuant to Community vete rinary legislation; or  
(b) due to the presence of a serious transmissible disease  
(i) listed in Annex I to Di rective 92/119/EEC; or   
EN 27   EN (ii) set out in a list laid down by the Commission. 
The measures referred to in point (b)(ii) designed to amend non-essential elements of 
this Regulation, by supplementing it, sha ll be adopted in accordance with the 
regulatory procedure with scruti ny referred to in Article 48(4). 
2. Paragraph 1 shall not apply where anim al by-products and de rived products are 
dispatched under conditions to be adopted by the Commi ssion to prevent the spread 
of diseases transmissible to humans or animals. 
Those measures designed to amend non-esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(5). 
SECTION 3: APPROVAL OF PLANTS AND ESTABLISHMENTS  
Article 6 
Plants and establishmen ts requiring approval 
1. Plants and establishments handling animal  by-products and derived products shall be 
approved by the competent authority. 
Such approval shall specify for which of  the following operations it is granted: 
(a) the handling, storage or processing of animal  by-products and derived 
products; 
(b) the transformation of animal by-products into biogas or compost; 
(c) the incineration of animal by-products; (d) for the disposal or recovery of an imal by-products or derived products, which 
are waste, in co-incineration plants; 
(e) the combustion of animal by-products and derived products; (f) the handling or manufacture of petfood as referred to in the third subparagraph 
of Article 45. 
2. The approval referred to in paragraph 1 shall specify if the plant or establishment is 
approved for operations with animal by-products and deri ved products of: 
(a) a particular category referred to  in Articles 11, 12 or 13 ; or  
EN 28   EN (b) more than one category referred to in  Articles 11, 12 or 13, indicating if such 
operations are carried out  
(i) permanently under conditions of stri ct separation which prevent any risks 
arising to public and animal health; or 
(ii) temporarily under conditions which prevent contaminati on, in order to 
accommodate for a lack of capacity fo r such products arising due to: 
– a widespread outbreak of an epizootic disease; or  
– other extraordinary and unf oreseen circumstances . 
Article 7 
Exemptions from the requirement for approval 
1. By way of derogation from Article 6( 1), no approval shall be required for: 
(a) operations covered by the approval or re gistration of plants and establishments 
approved or registered in accordance with: 
(i) Regulation (EC) No 853/2004; or  (ii) Regulation (EC) No 183/2005; 
(b) incineration plants and co -incineration plants which ha ve a permit to operate in 
accordance with Directive 2000/76/EC; 
(c) biogas and composting plan ts in which animal by-products or derived products 
are transformed in accordance with the standard parameters laid down pursuant 
to Article 9(c) ; 
(d) without prejudice to Chapter VI, es tablishments manufacturing derived 
products referred to in Article 2(3); 
(e) without prejudice to Chapter VI, oper ators who import, collect or channel 
animal by-products and derived products exclusively for the manufacture of the 
derived products referre d to in Article 2(3); 
(f) plants and establishments subject to Section 2 of Chapter VI, except plants 
referred to in Article 6(1)(f). 
2. Plants and establishments exempt from approval in accordance with paragraph 1(a), 
(b) and (c) shall be regist ered by the competent aut hority upon application by the 
operator.  
The application must contain the following information: 
(a) the category of animal by-products used;  
EN 29   EN (b) the nature of the operations perfor med using animal by-products or derived 
products as starting material for which the application is made.  
3. Detailed rules for application for registra tion as provided for in paragraph 2 may be 
adopted in accordance with the proc edure referred to in Article 48(3). 
Article 8 
Approval of plants 
1. The competent authority shall approve a plant provided that the operator submits 
together with his appl ication, evidence that: 
(a) it is designed and constructed in compliance with this Regulation and has in 
place adequate controls to prevent risks arising to public and animal health and 
which comply with any measures laid dow n in accordance with paragraph 3 for 
the site and equipment, in particular for the treatment of waste water arising 
from the premises by way of filtration; 
(b) it handles animal by-produc ts and, if required by this  Regulation or by rules 
adopted in accordance with this Regulat ion, derived products in accordance 
with hygiene requirements laid down in accordance with Article 9; 
(c) if required by measures adopted in accordance with paragraph 3, the operator 
has carried out a validation of the process to be used in the plant, in order to 
verify its capacity to prevent risks ar ising to public and animal health; and 
(d) the operator has put in place a system of own checks in the plant as referred to 
in Article 17. 
2. The plant shall only be approved follo wing an on-site visit by the competent 
authority.  
The competent authority may grant conditional approval if it appears that the plant 
meets all the requirements referred to  in paragraph 1(a) and (b).  
It shall grant full approval onl y if it appears from a new offi cial control of the plant, 
carried out within three months of granti ng conditional approval, that the plant meets 
the other applicable requirements.  
If clear progress has been made but the pl ant still does not meet all the applicable 
requirements, the competent authority ma y prolong conditional approval. However, 
conditional approval shall not ex ceed a total of six months.   
EN 30   EN 3. Measures for the implementation of the validations to be carried out by the operator 
in accordance with paragraph 1(c) may be laid down in accordance with the 
procedure referred to in Article 48(3). 
Article 9 
Implementing measures 
Measures for the implementation of this S ection may be laid down by the Commission, on: 
(a) the requirements applicable to the inci neration, co-incinerat ion and combustion of 
animal by-products and derived pr oducts as referred to in Ar ticle 6(1)(c), (d) and (e); 
(b) conditions for the handling, processing or storage of animal by-products or derived 
products in the same pl ant or establishment: 
(i) where such operations are carried out separately; (ii) where such operations ar e carried out temporarily; 
(c) standard transformation parameters for bi ogas and composting plants as referred to in 
Article 7(1)(c); 
(d) the site and equipment of plants a nd establishments re quiring approval on: 
(i) general hygiene requir ements applicable within approved plants and 
establishments; 
(ii) technical requirements for the handling, treatment, transformation and 
processing of animal by-products or de rived products within approved plants 
and establishments; 
(iii) standards for treatment of waste wa ter arising from the premises by way of 
filtration, including the filte r pore size and the requirement to use filters 
capable of effectively re moving certain pathogenic agents from the waste 
water. 
Those measures designed to amend non-es sential elements of this Regulation by 
supplementing it, shall be adopted in accordance  with the regulatory procedure with scrutiny 
referred to in Article 48(4). 
SECTION 4: CATEGORISATION  
Article 10 
Categorisation of animal by-products and derived products 
1. Animal by-products shall be categorised into specific categorie s which reflect the 
level of risk to public and animal health  arising from those animal by-products, in 
accordance with the lis ts laid down in Articles 11, 12 or 13.   
EN 31   EN 2. Derived products shall be subject to the rules for the specific category of animal by-
products from which they have been deri ved, unless otherwise specified in this 
Regulation, or in measures for the impleme ntation of this Regul ation adopted by the 
Commission.  
Those measures designed to amend non-esse ntial elements of this Regulation by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 
Article 11 
Category 1 material 
Category 1 material shall comprise the following animal by-products or any material 
containing such by-products: 
(a) entire bodies and all body parts, including hides and skins, of the following animals: 
(i) animals suspected of being infected  by a TSE in accordance with Regulation 
(EC) No 999/2001 or in which the presen ce of a TSE has been officially 
confirmed; 
(ii) animals killed in the cont ext of TSE eradication measures; 
(iii) animals other than farmed and wild animals, including in particular pet 
animals, zoo animals and circus animals; 
(iv) animals used for experiments as defined by Article 2(d) of Directive 
86/609/EEC;  
(v) wild animals, when suspected of bei ng infected with diseases communicable to 
humans or animals;  
(b) the following material: 
(i) specified risk material;  (ii) entire bodies or parts of dead anim als containing specified risk material  
at the time of disposal; 
(c) products of animal origin derived from animals which have been submitted to illegal 
treatment as defined in Article 1(2)(d) of  Directive 96/22/EC and Article 2(b) of 
Directive 96/23/EC;  
(d) animal material collected during the f iltration of waste water required by Article 
8(1)(a), when such water is or has been  in contact with Category 1 material; 
(e) catering waste from means of transport operating internationally;   
EN 32   EN (f) mixtures of Category 1 material with either Category 2 material or Category 3 
material or both. 
Article 12 
Category 2 material 
Category 2 material shall comprise the following animal by-products or any material 
containing such by-products: 
(a) manure and digestive tract content;  (b) animal material collected during the f iltration of waste water required by Article 
8(1)(a), when such water is or has been  in contact with Category 2 material;  
(c) products of animal origin containing residues of authorised substances or 
contaminants exceeding the permitted levels  as referred to in Article 15(3) of 
Directive 96/23/EC;  
(d) products of animal origin which have been declared unfit for human consumption 
due to the potential presence of phys ical residues in those products; 
(e) products of animal origin, other th an Category 1 material, that are:  
(i) imported or introduced from a third c ountry and which fail to comply with the 
Community veterinary legislation for th eir importation or in troduction into the 
Community except where Community legi slation allows their importation or 
introduction subject to specific restrictions  or their return to the third country; 
or 
(ii) dispatched to another Member St ate and which fail to comply with 
requirements laid down or authorised by Community legislation except where 
they are returned with the authorisati on of the competent authority responsible 
for the plant or establishment of origin.  
(f) animals and parts of animals, other than those referred to in Ar ticle 11 or 13, that 
died other than by being sla ughtered for human consumption or, in the case of game, 
that died other than by being killed for human consumption, including animals killed for disease control purposes, and foeti and embryos of ruminants and pigs and dead-in-shell chicken;  
(g) mixtures of Category 2 mate rial with Category 3 material; 
(h) animal by-products other than Category  1 material or Category 3 material.  
EN 33   EN Article 13 
Category 3 material 
Category 3 material shall comprise the following animal by-products or any material 
containing such by-products: 
(a) carcasses or parts of animals slaughtered or, in the case of game and farmed fish, 
killed, and which are fit for human c onsumption in accordance with Community 
legislation, but are not intended for hu man consumption for commercial reasons; 
(b) the following parts originating either from  animals that have been slaughtered in a 
slaughterhouse and were considered f it for slaughter for human consumption 
following an ante-mortem inspection or from  game killed for human consumption in 
accordance with Community legislation: 
(i) carcasses or parts of animals wh ich are rejected as unfit for human 
consumption in accordance with Commun ity legislation, but which did not 
show any signs of disease communicable to humans or animals; 
(ii) heads of poultry; (iii) hides and skins, including tr immings and splittings thereof; 
(iv) feet, including the phalanges and th e tarsus and metatarsus bones, of: 
– animals other than ruminants,  
– ruminants not requiring TSE testing, 
– ruminants which have been tested w ith a negative result in accordance 
with Article 6(1) of Re gulation (EC) No 999/2001;  
(v) horns; (vi) pig bristles;  (vii) feathers; 
(c) blood of animals which di d not show any signs of di sease communicable through 
that blood to humans or animals obtained from:  
(i) animals other than ruminants and rumi nants not requiring TSE testing that have 
been slaughtered in a sla ughterhouse, which were cons idered fit for slaughter 
for human consumption following an an te-mortem inspection in accordance 
with Community legislation; or  
(ii) ruminants which have been tested with a negative result in accordance with 
Article 6(1) of Regul ation (EC) No 999/2001;  
EN 34   EN (d) animal by-products derived from the production of products intended for human 
consumption, including degreas ed bones and greaves;  
(e) products of animal origin, other than catering waste, wh ich, after having been placed 
on the market for human consumption or for feeding to animals, are no longer 
intended for such consumption or such f eeding for commercial reasons or due to 
problems of manufacturing or packaging def ects or other defects from which no risk 
to public or animal health arise;  
(f) blood, placenta, wool, feathe rs, hair, horns, hoof cuts and milk originating from live 
animals that are not immediately destined fo r slaughter and did not show signs of any 
disease communicable through that pr oduct to humans or animals;  
(g) aquatic animals, and parts of such anim als, except sea mammals, which did not show 
any signs of diseases communicable to humans or animals;  
(h) fresh animal by-products from aquati c animals originating from plants or 
establishments manufacturing products for human consumption;  
(i) the following material originating from animals which did not show any signs of 
disease communicable through that ma terial to humans or animals: 
(i) shells, other than the shells re ferred to in Article 2(2)(e),  
(ii) the following originating from terrestrial animals: 
– hatchery by-products, 
– eggs, 
– egg by-products; 
(iii) day-old chicks. 
(j) terrestrial invertebrates other than sp ecies pathogenic to humans or animals; 
(k) dead animals and parts thereof of the zoological orders of Rodentia  and Lagomorpha , 
except Category 1 material or Category 2 material as referred to in Article 12(a) to 
(g); 
(l) hides and skins, hooves, feathers, wool, horns, hair and fur originating from dead 
animals that did not show any signs of disease communicable through that product to 
humans or animals other than t hose referred to in point (c); 
(m) catering waste other than as referred to in Article 11(e).  
EN 35   EN Article 14 
Changes of categories 
Articles 11, 12 and 13 may be amended by the Commission in order to  take into account 
progress in science as regards the assessment of  the level of risk, provided such progress can 
be identified on the basis of a risk assessment carried out by the appropriate scientific institution. However, no animal by-products li sted in those Articles may be removed from 
those lists and only changes of categorisation of  such products may be made or additional 
animal by-products may be added to those lists. 
Those measures designed to amend non essential el ements of this Regulation shall be adopted 
in accordance with the regulatory procedure wi th scrutiny referred to in Article 48(4).  
CHAPTER II: 
OBLIGATIONS OF OPERATORS,  
OPERATION OF PLANTS AND  
ESTABLISHMENTS 
SECTION 1: 
GENERAL OBLIGATIONS OF OPERATORS  
Article 15 
Collection, identification as re gards category and transportation 
1. Operators shall collect, identify and transport animal by-products without undue 
delay under conditions which prevent risks arising to public and animal health.  
2. Operators shall ensure that animal  by-products and derived products are 
accompanied during transportation by a comm ercial document and, when required by 
this Regulation or by a measure adopted in  accordance with paragraph 5, by a health 
certificate.  
By way of derogation from the first s ubparagraph, the competent authority may 
authorise the transport of manure between two points located on the same farm or 
between farms and users within the same  Member State wit hout a commercial 
document or health certificate. 
3. Commercial documents and health certif icates accompanying animal by-products or 
derived products during transportation shall include information on the quantity of such products, and a descrip tion of the animal by-products  or derived products and 
their marking, when such marking is required by this Regulation.   
EN 36   EN 4. The following measures may be laid down in  accordance with th e procedure referred 
to in Article 48(3): 
(a) models for commercial documents and health certificates which are required to 
accompany animal by-products during transportation;  
(b) models for health certificates and the conditions subject to which they are 
required to accompany animal by-pr oducts and derived products during 
transportation. 
5. Measures for the implementation of this Article may be laid down by the 
Commission on:  
(a) cases where a health certificate is require d having regard to the level of risk to 
public and animal health arising from certain derived products; 
(b) cases where, by way of derogation from  paragraph 2 and having regard to the 
low level of risk to public and animal health arising from certain derived products, transportation of derived produc ts may take place without documents 
or certificates referred to  in that paragraph; 
(c) requirements for the identification, in cluding labelling, and for the separation 
of animal by-products during transportation;  
(d) conditions to prevent risks to public and animal health arising during the 
collection and transportation of animal  by-products, including conditions for 
the safe transportation of those products with respect  to containers, vehicles 
and packaging material. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
Article 16 
Records 
1. Any person consigning, transporting or receiving animal by-products or derived 
products shall keep a record of consignm ents and related commercial documents or 
health certificates.  
However, the first subparagraph shall not a pply when an authorisation to transport 
manure has been granted in accordance w ith the second subpa ragraph of Article 
15(2). 
2. Measures for the implementation of this Ar ticle may be adopted in accordance with 
the procedure referred to in Ar ticle 48(3), in particular on: 
(a) the format of records to be kept;  
EN 37   EN (b) the period of time during which records must be kept. 
SECTION 2: OPERATION OF PLANTS AND ESTABLISHMENTS  
Article 17 
Own checks of plants and establishments 
1. Operators shall put in place, implement a nd maintain a permanent procedure of own 
checks in order to monitor comp liance with this Regulation.  
2. Operators shall ensure that no material suspected or know n not to comply  with this 
Regulation leaves the plant, unless destined  for disposal, before  being reprocessed 
under the supervision of the competent authority and re-sampled officially in 
accordance with Articles 11 and 12 of Regulation (EC) No 882/2004.  
3. Plants processing animal by-products, pl ants for the transformation of animal by-
products into biogas and compost and plan ts handling more than one category of 
animal by-products shall develop the proc edure referred to in paragraph 1 in 
accordance with the principles of the system  of hazard analysis and critical control 
points (HACCP).  
Operators of such plants shall in particular: (a) identify and control the critic al control points in the plants;  
(b) establish and implement methods for monitoring and checking critical control 
points;  
(c) where the product derived from the pro cessing is not directly disposed of on 
the same site by incineration, co-inciner ation, combustion or by an alternative 
method of disposal authorised pursuant to  Article 22(a), take representative 
samples to check compliance: 
(i) of each processed batch with the st andards, in particular as regards 
processing methods and microbiological  safety of the end product, which 
have been laid down in measures which have been adopted in accordance with paragraph 6 of this Article, 
(ii) with the maximum permitted levels of physical and chemical residues 
laid down in Community legislation;  
(d) record the results of the checks and test s referred to in points (b) and (c), as 
applicable, and keep them for a period of  at least two years for presentation to 
the competent authorities; 
(e) put in place a system ensuring the traceability of each batch dispatched.  
EN 38   EN 4. Where the results of a test on samples ta ken pursuant to paragraph 3(c) show non-
compliance with applicable safety requirement s, the operator of the plant shall, in 
addition to the requirements laid down in paragraph 2: 
(a) notify the competent authority immediat ely, providing full details on the nature 
of the sample and on the batch from which it was taken;  
(b) establish the causes of non-compliance;  (c) increase the frequency of sa mpling and testing of production; 
(d) instigate appropriate decontaminati on and cleansing procedures within the 
plant. 
5. Batches found not to be in compliance with  applicable safety requirements following 
checks carried out in accord ance with paragraph 3(c) shall be reprocessed or 
disposed of under the supervision of the competent authority. 
6. Measures for the implementation of this Article may be adopte d by the Commission, 
on: 
(a) own checks and the maintenance of the HACCP system; (b) requirements specifying the modalities of the actions to be taken by the 
operator in accordance with paragraphs 2 and 3, in particular as regards sampling methods and reference met hods for microbiological analyses. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
CHAPTER III: 
DISPOSAL AND USE 
OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS 
SECTION 1: 
RESTRICTIONS ON USE  
Article 18 
Restrictions on use 
1. The following uses of animal by-products and derived products sh all be prohibited: 
(a) the feeding of terrestrial animals of a species with processed animal protein 
derived from the bodies or parts of bodies  of animals of the same species;   
EN 39   EN (b) the feeding of farmed animals other than fur animals with catering waste or 
feed material containing or derived from catering waste; 
(c) the feeding of farmed animals with he rbage, either directly by grazing or by 
feeding with cut herbage, from land to which organic fertilisers or soil 
improvers, other than manure, have been applied; 
(d) the feeding of farmed fish with pr ocessed animal protein derived from the 
bodies or parts of bodies of farm ed fish of the same species. 
2. Implementing rules to ensure the uniform a pplication of the prohi bitions laid down in 
paragraph 1 may be laid down by the Commission, and measures permitting: 
(a) the feeding with processed animal pr otein derived from bodies or parts of 
bodies of animals of the same species to fur animals, by way of derogation from paragraph 1(a); and 
(b) the feeding of farmed animals with  herbage from land to which organic 
fertilisers or soil improvers have been  applied, provided th at the grazing or 
cutting takes place after the lapse of a waiting period which ensures adequate control of risks to public and animal health, by derogation from paragraph 1(c). 
 Those measures designed to amend non e ssential elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
SECTION 2: 
DISPOSAL AND USE  
Article 19 
Disposal and use of Category 1 material 
Category 1 material shall be  
(a) disposed of as a waste in an appr oved or registered incineration plant:  
(i) directly without prior processing; or 
(ii) following processing in an approved plant, if the competent authority so 
requires by pressure sterilisation, a nd permanent marking of the resulting 
material;  
EN 40   EN (b) in case the Category 1 material is a waste, disposed of or recove red in an approved or 
registered co-incineration plant; 
(i) directly without prior processing; or 
(ii) following processing in an approved plant, if the competent authority so 
requires by pressure sterilisation, a nd permanent marking of the resulting 
material; 
(c) in the case of Category 1 ma terial other than material referred to in Article 11(a)(i) 
and (ii), disposed of by processing by pre ssure sterilisation in an approved plant, 
permanent marking of the resulting materi al and burial in an authorised landfill; 
(d) in the case of Category 1 material referred to in Article 11(c), submitted to a 
detoxification process defined in accordan ce with Article 8(2) of Directive 
2002/32/EC, and used in accordance w ith Article 21(c), (d) and (e); 
(e) in the case of Category 1 material referred to in Article 11(e), disposed of by burial 
in an authorised landfill; 
(f) used as a fuel for combustion; or (g) used for the manufacture of  derived products referred to in Chapter VI and placed on 
the market in accordance with the special  regime set out in that Chapter.  
Article 20 
Disposal and use of Category 2 material 
Category 2 material shall be: 
(a) disposed of as a waste in an a pproved or registered incineration plant 
(i) directly without prior processing; or 
(ii) following processing in an approved plant, if the competent authority so 
requires by pressure sterilisation, a nd permanent marking of the resulting 
material; 
(b) in case the Category 2 material is a waste, disposed of or recove red in an approved or 
registered co-incineration plant 
(i) directly without prior processing; or 
(ii) following processing in an approved plant, if the competent authority so 
requires by pressure sterilisation, a nd permanent marking of the resulting 
material; 
(c) disposed of in an authorised landfill, following processing by pressure sterilisation in 
an approved plant and permanent mark ing of the resulting material;   
EN 41   EN (d) permanently marked following processing in an approved plant: 
(i) in the case of resultin g proteinaceous material, by pressure sterilisation, and 
used as an organic fertil iser or soil improver; or 
(ii) in the case of rendered fats, by pressu re sterilisation, if th e competent authority 
so requires, and further pro cessed into fat derivatives in an approved plant, for 
use in organic fertilisers or soil improvers;  
(e) transformed in an approved or re gistered biogas or composting plant: 
(i) following processing by pressure ster ilisation and permanent marking of the 
resulting material; or 
(ii) in the case of manure, digestive tract content separated from the digestive tract, 
milk, milk-based products and colostru m, which the competent authority does 
not consider to present a risk for th e spread of any serious transmissible 
disease, following or without prior processing; 
(f) applied to land without pr ocessing, in the case of ma nure, digestive tract content 
separated from the digestive tract, milk, m ilk-based products and colostrums, which 
the competent authority does not  consider to present a ri sk for the spread of any 
serious transmissible disease;  
(g) in the case of material originating from aquatic animals, ensiled or composted in an 
approved or registered plant; 
(h) used as a fuel for combustion; or (i) used for the manufacture of derived products referred to  in Chapter VI and placed on 
the market in accordance with the speci al regime set out in that Chapter. 
Article 21 
Disposal and use of Category 3 material 
Category 3 material shall be: (a) disposed of as a waste in an approved or registered incineration plant, with or 
without prior processing;  
(b) in case the Category 3 material is a waste, disposed of or recove red in an approved or 
registered co-incineration plant, with or without prior processing; 
(c) processed in an approved plant, except in the case of material which has changed 
through decomposition, contaminat ion or spoilage so as to  present an unacceptable 
risk to public or anim al health, and used:   
EN 42   EN (i) as feed material for farmed animals or for the feeding to farmed animals other 
than fur animals, and placed on the ma rket in accordance with Article 24, 
except in the case of material referr ed to in Article 13(l) and (m); 
(ii) for the feeding to fur animals; or 
(iii) for the manufacture of organic fert ilisers or soil improvers, which shall be 
placed on the market in accordance with Article 25. 
(d) transformed in an approved or re gistered biogas or composting plant;  
(e) in the case of material originating from aquatic animals, ensiled or composted in an 
approved or registered plant; 
(f) in the case of shells  other than the shells referred to in Article 2( 2)(e), used under 
conditions which prevent risks aris ing to public and animal health; 
(g) used as a fuel for combustion; or (h) used for the manufacture of  derived products referred to in Chapter VI and placed on 
the market in accordance with the speci al regime set out in that Chapter. 
Article 22 
Derogations 
By way of derogation to Articles 19, 20 and 21, animal by-products may be:  
(a) disposed of or used in an approved plan t, in accordance with  alternative methods 
which have been approved in accordance with Article 29(1) to (9); 
(b) used for research and other specific purposes in accordance with Article 26; 
(c) in the case of animal by-products referre d to in Article 27, used  for special feeding 
purposes in accordance with that Article; 
(d) in the case of animal by-products referred to in Article 28, disposed of in accordance 
with that Article; 
(e) in the case of Category 2 and Category 3 material and if authorised by the competent 
authority: 
(i) used for the preparation and applicati on to land of bio-dynami c preparations as 
referred to in point 2.3 of Part A of Annex I to Regulati on (EC) No 2092/91; 
(ii) used for the feeding to pet animals;  
EN 43   EN (f) in the case of Category 3 material refe rred to in Article 13(f ) and other animal by-
products which are removed in the course of surgical intervention on  live animals, if 
authorised by the competent au thority, disposed of on farm. 
Article 23 
Implementing measures 
1. Measures for the implementation of this Section may be laid down by the 
Commission, on: 
(a) processing methods for animal by-products  other than pressure  sterilisation, in 
particular as regards the time, temper ature and pressure parameters to be 
applied for those processing methods; 
(b) parameters for the transformation of animal by-products into biogas or 
compost; 
(c) ensilage of material originating from aquatic animals; (d) permanent marking of animal by-products; (e) the application to land of certain anim al by-products, organic fertilisers and soil 
improvers; 
(f) the use of certain animal  by-products as feed material for farmed animals or for 
the feeding to farmed animals; 
(g) the level of risk to public or animal health with respect to certain material 
which is considered as unacceptable as referred to in Article 21(c). 
Those measures designed to amend non e ssential elements of this Section, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
2. Pending the adoption of rules in accordance with points (b) and (c) of the first 
subparagraph of paragraph 1, Member States  may adopt or maintain national rules 
for the transformation of animal by-products referred to in Article 13(m) and for the 
ensilage of material originating from aquatic animals. 
SECTION 3: PLACING ON THE MARKET  
Article 24 
Placing animal by-products on the market for feeding purposes  
1. Animal by-products destined for feeding to farmed anim als or derived products for 
use as feed material for farmed animal s may only be placed on the market if:  
EN 44   EN (a) they are or are derived from Cate gory 3 material; however, in the case of 
material destined for feeding to farmed  animals other than fur animals, they 
are, or are derived from, Category 3 materi al other than material referred to in 
Article 13(l) and (m); 
(b) they have been collected, processe d or transformed, as applicable, in 
accordance with the conditions for pressure  sterilisation or other conditions to 
prevent risks arising to public and animal  health in accordance with Section 2 
and any measures which have been laid down in accordance with paragraph 2 of this Article; 
(c) they come from approved or registered plants or establishments, as applicable 
for the animal by-product or derived product. 
2. Measures for the implementation of this Article may be laid down by the 
Commission on: 
(a) public and animal health conditions fo r the collection, processing and treatment 
of animal by-products and derived pr oducts referred to in paragraph 1; 
(b) conditions aimed at ensuring traceabili ty and preventing cross-contamination 
which apply to the destination of materi al fit for human consumption to feeding 
purposes or to use as feed material. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
Article 25 
Placing on the market and use of or ganic fertilisers and soil improvers 
1. Organic fertilisers and soil improvers ma y be placed on the market and used 
provided 
(a) they are derived from Cate gory 2 or Category 3 material; 
(b) they have been produced in accordance with the conditions for pressure 
sterilisation or with othe r conditions to prevent risks arising to public and 
animal health, in accordance with th e requirements of Section 2 and any 
measures which have been laid down in accordance with paragraph 2; 
(c) in the case of organic fertilisers a nd soil improvers derived from proteineacous 
material, they have been mixed with a component excluding the subsequent use of the mixture for feeding purposes; and 
(d) they come from approved or registered plants or establishments, as applicable.  
EN 45   EN Member States may adopt or maintain na tional rules imposing additional conditions 
for or restricting the use of organic fertilisers and soil impr overs, provided that such 
rules are justified on grounds of the pr otection of public and animal health. 
2. Measures for the implementation of this Article may be laid down by the 
Commission on: 
(a) public and animal health condition s for the production and use of organic 
fertilisers and soil improvers; 
(b) components for the marking of or ganic fertilisers or soil improvers; 
(c) components to be mixed with organic fertilisers or soil improvers; (d) supplementary conditions, such as the substances or methods to be used for 
marking and the minimum proportions to be observed when preparing the 
mixture, in order to exclude the use of  such fertilisers or soil improvers for 
feeding purposes. 
Those measures designed to amend non e ssential elements of this Section, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
SECTION 4: DEROGATIONS REGARDING THE USE AND DISPOSAL OF ANIMAL BY -
PRODUCTS AND DERIVED PRODUCTS  
Article 26 
Derogations regarding the use of an imal by-products for research 
and other specific purposes 
1. The competent authority may, by way of de rogation from Sections 1 and 2, authorise 
the use of animal by-products and deri ved products for exhibitions, and for 
diagnostic, educational or research pur poses under conditions which ensure the 
control of risks to public  and animal health.  
Such conditions shall include: (a) the prohibition of any subsequent us e of the animal by-products or derived 
products for other purposes; 
(b) the obligation to dispose of safely or  to re-dispatch the animal by-products or 
derived products to their place of origin. 
2. Operators of plants and establishments  performing operations with respect to 
Category 1 and Category 2 material and users performing such operations in 
accordance with paragraph 1 shall be re gistered by the competent authority upon 
submission of the following information on:  
EN 46   EN (a) the category of animal by-products used; 
(b) the nature of the operations performed for which an application for registration 
is made using animal by-products or de rived products as starting material. 
3. Measures for the implementation of this Ar ticle may be adopted in accordance with 
the procedure referred to in Article 48(3 ) as regards the submission of information, 
including a standard form. 
4. In the case of risks to public and anim al health which require the adoption of 
measures for the whole territory of the Commu nity, in particular in the case of newly 
emerging risks, harmonised conditions for the importation and use of the animal by-products and derived products referred to in paragraph 1 may be adopted by the 
Commission. Such conditions may include requirements regarding the storage, 
packaging, identification, transportation and disposal. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
Article 27 
Derogations regarding the collectio n and use of animal by-products  
for special feeding purposes 
1. The competent authority may, by way of derogation from Sections 1 and 2, 
authorise, under conditions which ensure th e control of risks to  public and animal 
health, the collection and use of: 
(a) Category 2 material, provided that it co mes from animals which were not killed 
or did not die as a result of the presence or suspected presence of a disease communicable to humans or animals; 
(b) Category 3 material for the feeding to: 
(i) zoo animals; 
(ii) circus animals; (iii) reptiles and birds of prey ot her than zoo or circus animals; 
(iv) fur animals; (v) wild animals the meat of which is not destined for human consumption; (vi) dogs from recognised kennels or packs of hounds; (vii) maggots for fishing bait.  
EN 47   EN 2. The competent authority may authorise, by way of derogation from Sections 1 and 2, 
and in accordance with conditions laid down pur suant to paragraph 3 of this Article, 
the feeding of the Category 1 material refe rred to in Article 11(b)(ii) to zoo animals 
and to endangered or protected species of necrophagous birds livi ng in their natural 
habitat. 
3. Measures for the implementation of this Article may be adopted  by the Commission 
on the conditions under which: 
(a) the collection and use as referred to in paragraph 1 may be authorised with 
respect to channelling, storage and use of Category 2 material and Category 3 
material for feeding, including in the case of newly emerging risks; 
(b) the feeding of Category 1 material as referred to in paragraph 2 may be 
authorised, including: 
(i) the species of necrophagous birds in  certain Member States to which 
such material may be fed;  
(ii) the measures which are necessary to  ensure that access of  other species to 
the material fed is being prevented. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
Article 28 
Derogations regarding the dis posal of animal by-products 
1. The competent authority may, by way of de rogation from Sections 1 and 2, authorise 
the disposal:  
(a) by burial of dead pet animals; (b) of Category 1 material referred to in  Article 11(a)(v) and 11(b)(ii), Category 2 
material and Category 3 material in remo te areas by burning or burial on site or 
by other means under official supervisi on which prevent the transmission of 
risks to public and animal health; 
(c) by burning or burial on site or by other means under official supervision 
preventing the transmission of risks to public and animal health of Category 1 material referred to in Article 11(b)(ii), Category 2 material, and Category 3 material in areas where access is prac tically impossible or where access would 
only be possible under circumstances, re lated to geographical or climatic 
reasons or due to a natural disaster, which present risks to the health and safety 
of the personnel carrying out the colle ction or where access would necessitate 
the use of disproportionate  means of recovery;   
EN 48   EN (d) by means other than burning or buria l on site, under offici al supervision, of 
Category 2 and Category 3 materials wh ich do not pose a risk to public and 
animal health and which arise at the premises of operators handling no more than a volume of such animal by-products  arising per week, which is set in 
accordance with point (c) of the first s ubparagraph of paragraph 4, in relation 
to the nature of the activities carried out and the species of origin of the animal 
by-products concerned; 
(e) by burning or burial on site, under condi tions which prevent the transmission 
of risks to public and animal healt h, of animal by-products other than 
Category 1 material referred to in Article 11(a)(i) in the event of an outbreak of 
a notifiable disease listed in accordance w ith point (d) of th e first subparagraph 
of paragraph 4, if transpor t to the nearest plant a pproved for processing or 
disposal of the animal by-products would increase the danger of propagation of 
health risks or would lea d, in case of a widespread outbreak of an epizootic 
disease, to a lack of capacity at such plants. 
2. The size of the remote areas in a particul ar Member State referred to in paragraph 
1(b) may not exceed a percentage of the size of the surface of its land territory.  
3. Member States shall make available to the Commission information on: 
(a) the areas that they categorise as re mote areas for the purpose of applying 
paragraph 1(b) and the reasons for that  categorisation, and updated information 
concerning any change to such categorisation; 
(b) the use they make of the authorisati ons provided for in paragraph 1(c) and (d) 
with respect to Category 1 and Category 2 material. 
4. Measures for the implementation of this Article may be adopted  by the Commission 
on: 
(a) conditions aimed at ensuring control of ri sks to public and an imal health for the 
burning and burial on site;  
(b) the maximum percentage of the territ ory as referred to  in paragraph 2; 
(c) the volume of animal by-products, in rela tion to the nature of activities and the 
species of origin, as referr ed to in paragraph 1(d); 
(d) the list of diseases refe rred to in paragraph 1(e).  
EN 49   EN Those measures designed to amend non e ssential elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
SECTION 5: ALTERNATIVE METHODS FOR THE USE AND DISPOSAL OF ANIMAL 
BY-PRODUCTS AND DERIVED PRODUCTS  
Article 29 
Approval of alternative me thods for use or disposal 
1. The procedure for approval of an alternat ive method of use or disposal of animal by-
products or derived products may be init iated either by the Commission or following 
an application by a Member State or by an  interested party, which may represent 
several interested parties. 
2. Interested parties shall send their applic ation to the competent authority of the 
Member State where they intend to use the alternative method.  
3. The competent authority shall evaluate within a period of two months following 
receipt of a complete application, whether the application complies with the standard 
format for applications re ferred to in paragraph 10 .  
The competent authority shall communicate applications from Member States and 
interested parties, together with a re port on its evaluation to the European Food 
Safety Authority (hereinafter  referred to as "the Aut hority") and to the Commission. 
4. The Commission shall communicate applic ations, together with a report on its 
evaluation to the Authority. 
5. The Authority shall assess, within six months following receipt of a complete 
application, whether the method submitted ensures that risks to public or animal health are reduced to a degree which is at least equivalent to the processing methods 
laid down in accordance with Article 23(1) (a) and issue an opinion on the submitted 
application.  
6. In duly justified cases where the Authority requests additional information from 
applicants, the period provided for in  paragraph 5 may be suspended.  
After consulting the applicant, the Authority shall lay down a period within which 
that information may be provided to it and inform the Commission of the additional period needed.  
7. Where applicants submit additional inform ation on their own initiative, they shall 
send it to the Authority. 
In that case the period provided for in  paragraph 5 shall not be extended by an 
additional period.  
EN 50   EN 8. The Authority shall forward its opinion to the Commission, the applicant and the 
competent authority of the Member State concerned. 
9. Within three months of the receipt of th e opinion of the Author ity and taking account 
of that opinion, the Commission shall inform  the applicant of the proposed measure 
in accordance with paragraph 11.  
10. A standard format for applications fo r alternative methods may be adopted in 
accordance with the procedure referred to in Article 48(2). 
11. The following measures may be  adopted by the Commission: 
(a) measures authorising an alternative method of use or disposal of animal by-
products or derived products; 
(b) measures rejecting the authorisat ion of such an alternative method. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 
CHAPTER IV: 
OFFICIAL CONTROLS 
Article 30 
Official controls 
1. The competent authority shall at regular intervals carry out official controls and 
supervision at approved or re gistered plants and establishments and at premises for 
which information has been provided in accordance with Article 40(3). 
2. The competent authority shall take into account adherence to Community and 
national guides to good practice, when carrying out its official controls. 
Article 31 
Suspensions, withdrawals and prohibitions on operations 
1. If the official controls and supervision carried out by the competent authority reveal 
that one or more of the requirements of th is Regulation are not met, it shall take 
appropriate action.  
The competent authority shall in particular  (a) suspend approvals of plants and es tablishments approved pursuant to this 
Regulation, if:  
EN 51   EN (i) the conditions for approving or operating the plant or establishment are 
no longer fulfilled;  
(ii) the operator can be expected to  remedy the deficiencies within a 
reasonable period of time; 
(iii) the potential risks to public and animal health do not  require action in 
accordance with point (b); 
(b) withdraw approvals of plants and es tablishments approved pursuant to this 
Regulation, if: 
(i) the conditions for approving or ope rating the plant or establishment are 
no longer fulfilled; 
(ii) the operator cannot be expected to remedy the deficiencies within a 
reasonable period of time  
– for reasons relating to the infrastructure of the plant 
– for reasons relating to the persona l capacity of the operator or the 
staff under his supervision, or  
– because of serious risks to public and animal health requiring major 
adjustments to the operation of the plant or establishment before the operator may apply for re-approval.  
2. The competent authority shall temporarily or  permanently prohibit a registered plant, 
establishment or user or an  operator of premises on which information has been 
provided in accordance with Article 40(3), from carrying out operations under this 
Regulation, as appropriate, following receipt of inform ation indicating 
(a) that the requirements of Comm unity legislation are not met; or 
(b) potential risks to public or animal health arising from such operations. 
Article 32 
Lists of approved or registered plants, establishments and users 
1. Each Member State shall draw up a list of  plants, establishments and users which 
have been approved or registered in accordance with this Regulation and of 
establishments on which information ha s been provided in accordance with 
Article 40(3) within its territory.   
EN 52   EN It shall assign an official number to each ap proved or registered plant, establishment 
or user, and to each operator on which info rmation has been provided in accordance 
with Article 40(3) which identifies the plan t, establishment, user or operator with 
respect to the nature of its activities.  
Member States shall indicate,  if applicable, an offici al number which has been 
assigned to the plant, establishment, user or operator unde r other Community 
legislation.  
Member States shall make the lists of  approved or registered plants and 
establishments available to the Commission and other Member States.  
Member States shall keep the lists of appr oved plants or regist ered plants and the 
lists of operators upon which information has been provided up-to-date and make 
them available to other Member States and to the public.  
2. Measures for the implementation of this Ar ticle may be laid down in accordance with 
the procedure referred to in Ar ticle 48(3), in particular on: 
(a) the format for the lists referred to in paragraph 1; (b) the procedure for making the lists re ferred to in paragraph 1 available. 
Article 33 
Controls for dispatch of animal by -products to other Member States 
1. Where an operator intends to dispatch Category 1 material, Ca tegory 2 material or 
meat and bone meal or animal fat deri ved from Category 1 material to another 
Member State, the competent authority of  the Member State of destination shall 
decide upon application by the operator:  
(a) to refuse receipt of the consignment ; (b) to accept the consignment unconditionally; or (c) to make receipt of the consignment subject to the following conditions: 
(i) if the material or derived pr oducts have not undergone pressure 
sterilisation, it must unde rgo such treatment; or 
(ii) the material or derived products mu st comply with any conditions for the 
dispatch of the consignment which are justified for the protection of 
animal and public health in order to  ensure that material and derived 
products are handled in accordance with this Regulation. 
Operators shall inform the competent author ity of the place of origin prior to the 
intended dispatch of a consignment.  
EN 53   EN 2. The competent authority of the place of or igin shall inform the competent authority 
of the place of destination, by means of  the TRACES system in accordance with 
Decision 2004/292/EC, of the dispatch of each consignment sent to other Member 
States, of  
(a) material or derived product s referred to in paragraph 1; 
(b) meat and bone meal and animal fat derived from Category 2 material; (c) processed animal protein de rived from Categor y 3 material.  
When informed of the dispatch, the compet ent authority of the place of destination 
shall inform the competent authority of the place of origin of the arrival of each 
consignment by means of the TRACES system. 
3. Animal by-products, meat and bone meal and animal fat referred to in paragraph 1 of 
this Article shall be conveyed directly to  the plant of destination, which must have 
been approved or registered in accordance with Articles 6, 7 and 8 or, in the case of manure, to the farm where the application to  land is to take pl ace in accordance with 
an authorisation issued by the competent authority. 
4. When  animal by-products or derived products are sent to other Member States via 
the territory of a third countr y, they shall be sent in m eans of transport which have 
been sealed in the Member State of orig in and shall be accompanied by a health 
certificate.  
Consignments shall re-enter  the Community only via a border inspection post, in 
accordance with Article 6 of Directive 89/662/EEC. 
5. By way of derogation from paragraphs  1 to 4, animal by- products or derived 
products referred to therein which have been  mixed or contaminated with any of the 
waste listed as hazardous in Decision 2000/ 532/EC shall be sent to other Member 
States only subject to the require ments of Regulation (EC) No 1013/2006. 
6. Measures for the implementation of this Article may be adopted  by the Commission 
on: 
(a) supplementary conditions for the disp atch of animal by-products or derived 
products referred to in paragraph 3; 
(b) models for the health certificates wh ich have to accompany consignments sent 
in accordance with paragraph 4. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).   
EN 54   EN 7. Derogations from paragraphs 1 to 4 may be granted by the Commission with respect 
to the dispatch of manure transported betw een two points located on the same farm 
or between farms located in the border re gions of Member Stat es sharing a common 
border. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
Article 34 
Community controls in Member States 
1. Experts from the Commission may make on- the-spot checks, in cooperation with the 
competent authorities of Member States, in  so far as is necessary for the uniform 
application of this Regulation.  
The Member State on whose territory checks are made shall provide the experts with 
all the assistance necessary for carrying out their duties.  
The Commission shall inform the competent authority of the resu lts of the checks 
made. 
2. Measures for the implementation of this Ar ticle may be adopted in accordance with 
the procedure referred to in Article 48(3) , in particular on the procedure for the 
cooperation with nati onal authorities. 
CHAPTER V: 
IMPORT, TRANSIT AND EXPORT 
Article 35 
Import and transit of animal by-products 
1. Animal by-products or derived products sha ll be imported into, or sent in transit 
through, the Community in accordance with: 
(a) the relevant requirements of this Regulation for the particular animal by-
product or derived product which are at leas t as strict as those applicable to the 
production and marketing of such anim al by-products or derived products 
within the Community; 
(b) conditions recognised by the Commissi on to be at least equivalent to the 
requirements applicable to the producti on and marketing of such animal by-
products or derived products unde r Community legislation; or  
EN 55   EN (c) in the case of derived products referred to in Chapter VI or material for their 
manufacture, in accordance with the special regime set out in that Chapter. 
The measures provided for in point (b), designed to amend non essential elements of 
this Regulation, by supplementing it, sha ll be adopted in accordance with the 
regulatory procedure with scrutiny referred to in Article 48(4).  
2. By way of derogation from paragrap h 1, the importation and transit of: 
(a) specified risk material shall take  place only in accordance with Regulation 
(EC) No 999/2001;  
(b) animal by-products or derived products mixed or contaminated with any of the 
waste listed as hazardous in Decisi on 2000/532/EC shall take place only 
subject to the requirements of  Regulation (EC) No 1013/2006; 
(c) Category 1 material, Category 2 materi al and products derived thereof, which 
are not intended for the manufacture of derived products referred to in Chapter 
VI, shall only take place provided that  rules for their im portation have been 
adopted in accordance with Article 36(a); 
(d) animal by-products and derived products  destined for the purposes referred to 
in Article 26(1) shall ta ke place in accordance with national measures which 
ensure the control of risks to public a nd animal health, pending the adoption of 
harmonised conditions referre d to in Article 26(4). 
3. In case of the importation and transit of Category 3 material and products derived 
thereof, the relevant requirements as referr ed to in point (a) of  the first subparagraph 
of paragraph 1 shall be adopted by the Commission. 
Those requirements may specify that consignments: 
(a) must come from a third country or part  of a third country listed in accordance 
with paragraph 4; 
(b) must come from plants or establ ishments approved or registered by the 
competent authority of the third country of origin and listed  by that authority 
for that purpose; 
(c) shall be accompanied during transpor tation to the point of entry into the 
Community where the veterinary checks take place by documentation such as a 
commercial document, a declaration or a health certificate which correspond to 
a model laid down in accordance with Article 36(d). 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  
EN 56   EN Pending the adoption by the Commission of th e requirements referred to in point (a) 
and point (c) of the second subparagraph, the Member States shall specify those 
requirements in national measures. 
4. Lists of third countries or parts of third countries from which animal by-products or 
derived products may be imported or tran sit through the Community shall be drawn 
up in accordance with the procedure referred to in Article 48(3), taking into account in particular: 
(a) the legislation of the third country;  (b) the organisation of the competent aut hority and its inspection services in the 
third country, the powers of those servic es, the supervision to which they are 
subject, and their authority to monitor effectively the application of their legislation;  
(c) the actual health conditions applie d to the production, manufacture, handling, 
storage and dispatch of products of anim al origin intended for the Community;  
(d) the assurances the th ird country can give rega rding compliance with the 
relevant health conditions;  
(e) experience of marketing the product from the third country and the results of 
import checks carried out;  
(f) the result of any Community inspections in the third country;  (g) the health status of the livestock, ot her domestic animals and wildlife in the 
third country, having particular regard to exotic animal diseases and any 
aspects of the general health  situation in the country which might pose a risk to 
public or animal health in the Community;  
(h) the regularity and speed with which the third country supplies information 
about the existence of infec tious or contagious animal diseases in its territory, 
in particular the diseases listed in the Terrestrial Animal Health Code and the 
Aquatic Animal Health Code of the World Organisation for Animal Health; 
(i) the regulations on the prev ention and control of  infectious or contagious animal 
diseases in force in the third country and their implementation, including rules 
on imports from other third countries. 
The lists of plants and establishments refe rred to in paragraph 3 must be kept up-to-
date and communicated to the Commission and the Member States and made available to the public.   
EN 57   EN Article 36 
Implementing measures 
Measures for the implementation of Artic le 35 may be adopted by the Commission on: 
(a) conditions for the importation and transit of Category 1 and Category 2 material and 
for products derived thereof; 
(b) restrictions regarding p ublic or animal health applicable to imported Category 3 
material or products derived thereof which may  
(i) be laid down by reference to Community lists of third countries or parts of 
third countries drawn up in accordance with Article 35(4) or for other public or animal health purposes; 
(ii) exclude animal by-products or deri ved products manufactured in certain 
establishments from importation or trans it in order to protect public or animal 
health; 
(c) conditions for the manufacture of animal by- products or derived products in plants or 
establishments in third countries; such conditions may include the modalities for 
controls of such plants or  establishments by the competent authority concerned and 
may exempt certain plants or establishmen ts handling animal by-products or derived 
products from approval or registration as  referred to in Article 35(3)(b); 
(d) models for health certificates which sh all accompany consignments and state that the 
animal by-products or derived products concerned have been collected or manufactured in accordance with the requirements of this Regulation. 
Those measures designed to amend non esse ntial elements of this Regulation, by 
supplementing it, shall be adopted in accordance  with the regulatory procedure with scrutiny 
referred to in Article 48(4). 
Article 37 
Export 
1. The export of animal by-products and deri ved products destined for incineration or 
landfill shall be prohibited. 
2. The export of animal by-products and de rived products for use in a biogas or 
composting plant to third countries which are not members of the OECD shall be 
prohibited. 
3. Category 1 material, Category 2 material and products derived thereof shall only be 
exported for purposes other than those referred  to in paragraphs 1 and 2 provided that 
rules for their export have been adopted by the Commission.  
EN 58   EN Those measures designed to amend non e ssential elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 
4. Article 12 of Regulation (EC) No 178/ 2002 concerning food and feed exported from 
the Community shall apply mutatis mutandis  to the export of Ca tegory 3 material or 
products derived thereof in compliance with this Regulation. 
5. By way of derogation from para graphs 3 and 4, the export of: 
(a) specified risk material shall take  place only in accordance with Regulation 
(EC) No 999/2001;  
(b) animal by-products or derived products mixed or contaminated with any of the 
waste listed as hazardous in Decisi on 2000/532/EC shall take place only 
subject to the requirements of Regulation (EC) No 1013/2006. 
Article 38 
Application of Regulation (EC) No 882/ 2004 for the purposes of certain controls 
1. Article 46 of Regulation (EC) No 882/2004 shall apply mutatis mutandis  to 
Community controls in third countries carri ed out to verify compliance with this 
Regulation. 
2. Article 50(1)(a) of Regulati on (EC) No 882/2004 shall apply mutatis mutandis to the 
phased introduction of the requirements of Article 35( 3) of this Regulation. 
3. Article 52 of Regulation (EC) No 882/2004 shall apply mutatis mutandis to third-
country controls in Member States rela ted to operations under this Regulation. 
CHAPTER VI 
SPECIAL REGIME 
SECTION 1: DERIVED PRODUCTS REGULATED BY CERTAIN OTHER COMMUNITY 
LEGISLATION  
Article 39 
Placing on the market of derived products  
regulated by other Community legislation 
1. The placing on the market of the derived produc ts referred to in Ar ticle 2(3) shall not 
be subject to Chapters II, III and IV.  
EN 59   EN However, in the case of derived products  
(a) referred to in Article 2(3)(a), (b), (c ) and (d), those Chapters shall apply where 
the Community legislation referred to in Article 2(3) does not provide for 
conditions controlling potent ial risks to animal health  in accordance with the 
objectives of this Regulation; 
(b) referred to in Article 2(3)(e) and (f), those Chapters shall apply where the 
Community legislation referred to in  Article 2(3) does not provide for 
conditions controlling potent ial risks to public and anim al health in accordance 
with the objectives of this Regulation. 
2. Articles 53 and 54 of Regulation (EC) No  178/2002 concerning emergency measures 
shall apply mutatis mutandis   
(a) to the derived products referred to in Ar ticle 2(3)(a), (b), (c) and (d) of this 
Regulation, in the case of risks to animal health; 
(b) to the derived products referred to in Article 2(3)(e) and (f) of this Regulation, 
in the case of risks to public and animal health.  
Article 40 
Manufacture of derived products regula ted by other Commu nity legislation 
1. The importation, collection and channell ing of animal by-products and derived 
products destined for establishments fo r the manufacture of the derived products 
referred to in Article 2(3) and the manuf acture of those derived products shall be 
carried out in accordance with the Commun ity legislation referred to in that 
paragraph.  
Unused material from such establishments shall be disposed of in accordance with 
that legislation. 
2. However, this Regulation sh all apply where the Community legislation referred to in 
Article 2(3) does not provide for conditions  controlling potential risks to public and 
animal health in accordance with the objectives of this Regulation.  
3. Operators referred to in Article 7(1)(e) sh all provide the following information to the 
competent authority responsible for offici al controls in accordance with this 
Regulation: 
(a) the category of animal by-pr oducts and derived products used; 
(b) the operations using animal by-produc ts or derived products as starting 
material which are being performed in the establishment.  
EN 60   EN 4. Measures may be adopted in accordance with the procedure referred to in 
Article 48(3) for the implementation of this Article as regards the transmission of the information referred to in pa ragraph 3 of this Article. 
SECTION 2: PLACING ON THE MARKET OF OTHER DERIVED PRODUCTS  
Article 41 
Placing on the market of other derived products 
 outside the feed chain 
1. Operators may place on the market derived pr oducts, other than the products referred 
to in Article 2(3), provided:  
(a) those products are  
(i) not intended for use as feed material  for the feeding to farmed animals or 
for application to land from which such animals are to be fed, or 
(ii) intended for feeding to fur animals; and  
(b) they ensure the control of risk s to public and an imal health by: 
(i) safe sourcing in accordance with Article 42; (ii) safe treatment in accordance w ith Article 43, where safe sourcing does 
not ensure sufficient control; or 
(iii) verifying that the products are only used for safe end uses in accordance 
with Article 44 where safe treatment does not ensure sufficient control. 
2. Operators may also place the derived produc ts referred to in paragraph 1 on the 
market without restrictions, subject to determination by the Commission of an end 
point in the manufacturing chain in accordan ce with Article 46(2)(a), when such 
products no longer pose any si gnificant risk to public or animal health.  
Article 42 
Safe sourcing 
1. Safe sourcing shall include the use of the material: 
(a) from which no unacceptable risks to  public and animal health arise; 
(b) which has been collected and channelle d from the point of collection to the 
manufacturing establishmen t under conditions which exclude risks arising to 
public and animal health; or  
EN 61   EN (c) which has been imported into the Community and channelled from the point of 
first entry to the manufacturing establis hment under conditions which exclude 
risks arising to public and animal health. 
2. For the purpose of safe sourcing, opera tors shall provide documentation of the 
requirements of paragraph 1, including, where necessary, proof of the safety of bio-
security measures taken in order to exclude  risks arising to public and animal health 
from starting material. 
Such documentation shall be kept availabl e to the competent authority upon request. 
The operator shall also transport consignm ents of material from the point of 
collection to the manufacturing establishment or, in the case of a point of collection in a third country, to the point of  first entry into the Community. 
The consignments shall be accompanied by a health certificate corresponding to a 
model laid down in accordance with Article 46(1)(a). 
Article 43 
Safe treatment 
Safe treatment shall include appl ication of a manufacturing proce ss to the material used which 
reduces to an acceptable level risks to public an d animal health arising from such material 
used and from other substances aris ing from the manufacturing process. 
It shall be ensured that the derived product poses no unacceptabl e risks to public and animal 
health, in particular by way of  testing of the end product. 
Article 44 
Safe end uses 
Safe end uses shall include uses of derived products: 
(a) under conditions which pose no unacceptabl e risks to public and animal health; or 
(b) which pose a risk to public and animal  health, for specific purposes provided that 
such use is justified by objectives set out in Community legislation, in particular for 
the protection of public and animal health. 
Article 45 
Registration of operators 
Operators shall be registered by th e competent authority where they: 
(a) handle material used in accordance with Article 41(1) and Article 42; 
(b) treat material used in accordance with Article 41(1) and Article 43; or  
EN 62   EN (c) place derived products on the market in accordance with Article 41(1) and 
Article 44(b). 
Registration shall take place upon receipt by th e competent authority of the information 
referred to in Article 7(2). 
However, operators handling animal by-products other than Category 3 material, or products 
derived thereof for the manufacture of pe tfood shall be approved in accordance with 
Articles 6, 7 and 8. 
Article 46 
Implementing measures 
1. Measures for the implementation of Articles 42 and 45 may be adopted in 
accordance with the procedure referr ed to in Article 48(3), on: 
(a) models for health certificates which must accompany consignments in 
accordance with the fourth s ubparagraph of Article 42(2); 
(b) a harmonised form for the transmissi on of information in order to obtain 
registration as referred to in Article 45. 
2. Measures for the implementation of this Section may be adopted  by the Commission, 
on: 
(a) conditions which determine an end poi nt in the manufacturing chain following 
which no public or animal health re quirements apply to the placing on the 
market; 
(b) conditions for the safe sourcing and ch annelling of material to be used under 
conditions which exclude risks aris ing to public and animal health; 
(c) documentation as referred to in th e second subparagraph of Article 42(2); 
(d) parameters for the manufacturing process as referred to in the first 
subparagraph of Article  43, in particular as regards the application of physical 
or chemical treatments to the material used; 
(e) testing requirements app licable to the end product; 
(f) conditions for the safe use of derived products which pose a ri sk to public or 
animal health.  
EN 63   EN Those measures designed to amend non e ssential elements of this Regulation, by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 
CHAPTER VII 
GENERAL AND FINAL PROVISIONS 
Article 47 
National legislation 
Member States shall communicate to the Commissi on the text of any national legislation they 
adopt in areas under their competence which dir ectly concern the proper implementation of 
this Regulation.  
Article 48 
Committee 
1. The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health established by Articl e 58(1) of Regulation (EC) No 178/2002, 
hereinafter referred to  as "the Committee". 
2. Where reference is made to this pa ragraph, Articles 3 and 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 
3. Where reference is made to this pa ragraph, Articles 5 and 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 
4. Where reference is made to this paragraph,  Articles 5a(1) to (4 ), and Article 7 of 
Decision 1999/468/EC shall apply, having re gard to the provisions of Article 8 
thereof. 
5. Where reference is made to this paragraph, Articles 5a(1) to (4) and (5)(b) and 
Article 7 of Decision 1999/468/EC shall appl y, having regard to the provisions of 
Article 8 thereof. 
The time limits laid down in Article 5a(3 ) (c), (4) (b) and (4) (e) of Decision 
1999/468/EC shall be two months, one month and two months respectively.  
EN 64   EN Article 49 
Penalties 
The Member States shall lay down the rules on pe nalties applicable to infringements of this 
Regulation and shall take all measures necessary  to ensure that they are implemented. The 
penalties provided for must be effective, prop ortionate and dissuasive. The Member States 
shall notify those provisions to the Commission by […] at the latest and shall notify it without 
delay of any subsequent amendment affecting them. 
Article 50 
Repeal 
Regulation (EC) No 1774/2002 is repealed with eff ect from [the date of  application of this 
Regulation].  
References to Regulation (EC) No 1774/2002 shall be construed as references to this 
Regulation and shall be read in accordance with the correlation table laid down in the Annex.  
Article 51 
Transitional measure 
Plants, establishments and user s approved or registered in a ccordance with Regulation (EC) 
No 1774/2002 before [the date of application of  this Regulation] shal l be deemed to be 
approved or registered, as required, in accordance with this Regulation. 
Article 52 
Entry into force 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall apply from [the first day of the month, fift een months after the date of 
its entry into force]. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
For the European Parliament For the Council 
The President The President  
EN 65   EN ANNEX  
CORRELATION TABLE 
Regulation (EC) No 177 4/2002 This Regulation 
Art. 1  Art. 1, 2  
Art. 2 Art. 3 
Art. 3(1) ./. 
Art. 3(2) Art. 35(3), fourth subparagraph 
Art. 3(3) Art. 4 
Art. 4(1) Art. 11 
Art. 4(2) Art. 19, 22, 23 
Art. 4(3) Art. 6(1)(a)  
Art. 4(4) Art. 35(2)(c), 37(3), 37(5)(a) 
Art. 5(1) Art. 12 
Art. 5(2) Art. 20, 22, 23 
Art. 5(3) Art. 6(1)(a) 
Art. 5(4) Art. 35(2)(c), 37(3) 
Art. 6(1) Art. 13 
Art. 6(2) Art. 21, 22, 23 
Art. 6(3) Art. 6(1)(a) 
Art. 7 Art. 15 
Art. 8 Art. 33 
Art. 9 Art. 16 
Art. 10, 11, 12, 13, 14, 15, 17, 18 Art. 6, 7, 8, 9 
Art. 16  Art. 5 
Art. 19 Art. 24   
EN 66   EN Art. 20(1) Art. 41  
Art. 20(2) Art. 25 
Art. 20(3) Art. 41 
Art. 21 ./. 
Art. 22 Art. 18 
Art. 23 Art. 26, 27 
Art. 24 Art. 28 
Art. 25 Art. 17 
Art. 26 Art. 30, 31, 32 
Art. 27 Art. 34 
Art. 28 Art. 35(1)(a), (c) 
Art. 29 Art. 35, 36 
Art. 30 Art. 35(1)(b)  
Art. 31 Art. 38(1) 
Art. 32 ./. 
Art. 33 Art. 48 
Art. 34 ./. 
Art. 35 Art. 47, 23(2) 
Art. 36 ./.  
Art. 37 Art. 50 
Art. 38 Art. 52