Proposal for a Regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation){SEC(2008)1994} {SEC(2008)1995}
Date: 2008-06-10
Institutions: European Commission
Subjects: agricultural by-product, animal product, health control, health legislation, health risk, traceability

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COMMISSION OF THE EUROPEAN 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 animal by-products not intended for human 
consumption (Animal by-products Regulation) 

(presented by the Commission) 

{SEC(2008)1994} 
{SEC(2008)1995} 

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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  maintain  a  high  level  of  safety  along  the 
whole  production  and  distribution  chain,  from  "farm  to  fork".  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 consolidated and recast the various existing rules covering 
animal by-products (ABP). It  also  introduced stricter rules concerning the approval 
of  premises  handling  ABP,  the  channelling  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  Member  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  reflecting  the  experience  of  all  25  Member 
States in applying the legislation2. 

In addition, the Commission's Food and Veterinary 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 Member States and the findings of the FVO, 
the Commission report concludes that it has been challenging for all Member States 
and economic operators to ensure compliance with the provisions of the Regulation. 
Nonetheless, Member States' compliance has been generally satisfactory. The official 
controls  for  most  Category  1  and  2  materials  are  satisfactory  to  a  large  extent. 
However, more effort is needed to guarantee 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 controls. It also served as a basis for a wide 
debate with the Member States and with the 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. 

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OJ L 273, 10.10.2002, p. 1. 
COM (2005)521 final. 

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►  The interaction of the rules on ABP with other Community legislation should 

be clarified. 

►  A more risk-based approach for the categorisation 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  animal  health  in  the  Community  is  not 
compromised.  Operators  and  competent  authorities  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 progress 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  Council  at  the  end  of  2005,  Member  States 
indicated  their  broad  consensus  with  the  main  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  proposal,  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  public  health  (ABP  producers,  processors, 
traders  and  users,  and  consumer  organisations)  have  been  given  the  opportunity  to 
express their views on various occasions, via bilateral meetings or through an open 
consultation. 

Owing to the interaction between the rules on ABP and other Community legislation, 
the  Commission  set  up  an  Inter-Service  Steering  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. 

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The consultations were carried out in two steps: 

– 

– 

As  a  first  step,  a  general  consultation  on  the  issues  identified  and  possible 
options to resolve them was held. 

As  a  second  step,  once  the  potential  solutions  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  support  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  application  of  the  Regulation,  the  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  general  terms,  the  advice  obtained  suggests  that  the  key 
principle  of  the  Regulation,  which  is  the  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-products may be recovered and 
used safely for the production of, for instance, technical or industrial products under 
certain strict health conditions. 

4.2.2.  Methodology used 

Two main methodologies were used:  

(1) 

(2) 

analysis  of  the  report  data  submitted  by  the  competent  authorities  of  the 
25 Member States and  

analysis  of  data  collected  by  the  Commission's  Food  and  Veterinary  Office 
during 2004 to 2005. 

The data received and used is too extensive and varied to be summarised here.  

A copy of the Commission reports can be found at: 

http://ec.europa.eu/food/food/biosafety/animalbyproducts/index_en.htm 

http://ec.europa.eu/food/fvo/index_en.htm 

4.3. 

Impact Assessment 

The Commission carried out an in-house Impact Assessment (IA) as referred to in its 
work programme 2006. An assessment report is accessible on: 

http://ec.europa.eu/food/food/biosafety/animalbyproducts/index_en.htm 

The IA considered three main options: 

(a)  No action 

(b)  Self-regulation, guidance or co-regulation 

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(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  operators.  Self-regulation,  guidance  or  co-
regulation will not alleviate the burden resulting from disproportionate provisions in 
the legally binding text. 

In  line  with  the  findings  of  the  IA,  option  (c)  a  review  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  text.  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 the protection of animal and public health. 
Therefore, as the current Regulation, the proposal is based on Article 152(4)(b) of the 
Treaty. 

5.3. 

Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the 
exclusive competence of the Community. 

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The  objectives  of  the  proposal  cannot  be  sufficiently  achieved  by  Member  States’ 
actions. 

Risks  from  animal  by-products  may  seriously  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  does  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  Community.  It  should  be  ensured  that  imported 
consignments  meet  sanitary  standards  which  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  source  of  income  for  parts  of  the  farming 
population,  as  well  as  for  industries  which  process  certain  ABP.  To  ensure  the 
increase  productivity  and  stimulate 
rational  development 
competitiveness,  animal  health  and  public  health  rules  for  the  products  in  question 
are needed at Community level. 

this  sector, 

in 

5.4. 

Proportionality and simplification 

The proposal further simplifies the legislation, reducing the administrative burden for 
the  competent  authorities  (EU,  national  and  third  countries)  and  for  economic 
operators while preserving a high level of protection 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) adopted since the application 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,  cosmetic  products,  pharmaceutical  and  medical 
devices) will be clarified. Wherever the necessary level of protection allows such a 
solution, duplication of approval and channelling requirements should be avoided. 

The adoption of the proposal will lead to the repeal of the 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 proposal are to maintain a high level of food 
and feed safety and consumer protection, and at the same time to provide: 

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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 used, 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  gaps  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  insofar  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 materials for the production, develop safe 
manufacturing  processes  or  use  ABP  for  end  purposes  which  are  on  balance 
safe, ABP of all categories may be used. 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  classified  fall  under 
Category  2  and  may  not  be  used  in  feed  to  farmed  animals,  should  be 
maintained.  

Current  derogations  regarding  the  exceptional  burial  and  burning  on  site  in 
cases  of  disease  outbreaks  should  be  clarified  and  extended  to  situations  in 
which  recovery  operations  in  accordance  with  the  general  rules  of  the 
Regulation become practically very difficult, such as during natural disasters. 

7. 

OTHER INFORMATION 

7.1. 

Consistency with other policies and objectives of the Union 

The proposal is consistent with other Community policies, in particular the policy on 
the protection of the environment and of public health in relation to the use of animal 
by-products in feed, cosmetics, medicinal products and, medical devices. 

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7.2. 

Budgetary implication 

The  proposal  has  no  financial  implications  for  the  budget  of  the  European 
Community. 

7.3. 

Other 

The  proposal  is  in  line  with  the  Commission's  Lisbon  Strategy  commitment  to 
improve  the  acquis  communautaire,  addressing  possible  health  risks  by  adequate 
measures,  while  enhancing  competitiveness.  It  is  also  in  line  with  the  "Better 
Regulation" Programme of the Commission3. 

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Cf. COM (2006)689 final. 

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2008/0110 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down health rules as regards animal by-products not intended for human 
consumption (Animal by-products Regulation) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  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 European 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) 

(2) 

(3) 

Animal  by-products  not  intended  for  human  consumption  are  a  potential  source  of 
risks  to  public  and  animal  health.  Past  crises  related  to  outbreaks  of  foot-and-mouth 
disease,  the  spread  of  transmissible  spongiform  encephalopathies  such  as  bovine 
spongiform encephalopathy (BSE) and the occurrence of dioxins in feedingstuffs have 
shown the consequences of the improper use 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-economic  situation  of  the  farmers  and  of  the  industrial 
sectors  concerned  and  on  consumer  confidence  in  the  safety  of  products  of  animal 
origin.  Disease  outbreaks  can  also  have  negative  consequences  for  the  environment, 
not only due to the disposal problems posed, but also as regards biodiversity. 

Animal  by-products  arise  mainly  during  the  slaughter  of  animals  for  human 
consumption, and in the course of the disposal 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  needs  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.  

The  disposal  of  all  animal  by-products  is  not  a  realistic  option,  as  it  would  lead  to 
unsustainable costs and risks for the environment. Conversely, there is a clear interest 
for all citizens that provided the health risks are minimised, a wide range of animal by-
products  are  safely  used  for  various  applications  in  a  sustainable  manner.  A  wide 

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OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

range  of  animal  by-products  are  indeed  commonly  used  in  important  productive 
sectors, such as the pharmaceutical, feed and leather industries. 

New  technologies  have  widened  the  possible  use  of  animal  by-products  to  a  large 
number of productive sectors. However, the use of those new technologies might pose 
health risks that must also be minimised. 

Community health rules on animal by-products should be laid down in a coherent and 
comprehensive framework for their collection, handling, processing, disposal or use.  

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 those 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.  

Regulation  (EC)  No  1774/2002  of  the  European  Parliament  and  of  the  Council  of  3 
October  2002  laying  down  health  rules  concerning  animal  by-products  not  intended 
for  human  consumption7  lays  down  Community  rules  applicable  to  animal  by-
products. Based on scientific advice, that Regulation introduced a set of rules aimed at 
protecting  the  safety  of  the  food  and  feed  chain,  which  is  complementary  to 
Community legislation on food and feed. Those rules have significantly improved the 
level of protection in the Community against the risks posed by animal by-products. 

Regulation  (EC)  No  1774/2002  introduced  the  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 categories 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  products  are  derived  from  material  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 undergone veterinary inspection is to enter the 
feed chain. In addition, it lays down rules for processing standards which ensure the 
reduction of risks.  

Under Article 35(2) of Regulation (EC) No 1774/2002, the Commission is to submit a 
report  to  the  European  Parliament  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  legislative  proposals.  The  report  was  submitted  in 
October  20058 and emphasised that the principles of Regulation (EC) No 1774/2002 
should be maintained. In addition, it highlighted the areas where amendments to that 
Regulation  were  considered  necessary,  in  particular  clarifications  as  regards  the 
applicability of the rules to finished products, the relationship with other Community 
legislation  and  the  classification  of  certain  material.  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 support those conclusions. According to 

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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). 
COM (2005)521 final. 

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the FVO, improvements are necessary as regards 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  adopted  a  number  of  opinions  concerning 
animal  by-products.  Those  opinions  demonstrate  the  need  to  maintain  the  main 
principles  of  Regulation  (EC)  No  1774/2002;  in  particular  that  animal  by-products 
derived from animals shown not to be fit for 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 subsequent consultations carried out by the 
Commission  have  highlighted  that  the  rules  laid  down  in  Regulation  (EC)  No 
1774/2002  should  be  improved.  The  chief  objectives  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, should be clearly laid down. The provisions of 
this Regulation should permit the achievement 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  consumption  under  Community  legislation,  in 
particular where they do not comply with food hygiene legislation (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 purposes (animal by-products "by choice").  

(13) 

In addition, in order to prevent risks arising from wild animals, carcasses or parts of 
carcasses  of  such  animals  suspected  of  being  infected  with  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  hunting  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  provisions  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  material  from  vessels  operating  under  Community 
food hygiene legislation, except for material to which a disease risk is clearly attached.  

(15) 

It is appropriate to clarify in this Regulation which animals are to be classified as pet 
animals, so that by-products derived from such 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  and  of  the  Council  of  26  May  2003  on  the 
animal  health  requirements  applicable  to  the  non-commercial  movement  of  pet 
animals9 should be regarded as pet animals.  

(16)  For  the  sake  of  consistency  of  Community  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 prevention, 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). 

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to  Council  Directive  86/609/EEC  of  24  November  1986  on 

transmissible  spongiform  encephalopathies10  should  be  used  in  this  Regulation.  The 
the 
reference 
approximation  of  laws,  regulations  and  administrative  provisions  of  the  Member 
States  regarding  the  protection  of  animals  used  for  experimental  and  other  scientific 
purposes 11 should be clarified. 

(17)  For the sake of consistency of Community legislation, the definition of aquatic animal 
in  Article  3(1)(e)  of  Directive  2006/88/EC  of  24  October  2006  on  animal  health 
requirements for aquaculture animals and products thereof, and on the prevention and 
control of certain diseases in aquatic animals12 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  carrying  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 disposal of animal by-products which may not be 
used,  or  which  are  not  used  for  economic  reasons.  Member  States  should  commit 
adequate  resources  for  the  necessary  infrastructure  for  that  purpose  and  they  should 
ensure  its  smooth  operation.  The  scope  of  the  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 other and third countries provided that the 
objectives of this Regulation are met. 

(20) 

In  order  to  ensure  a  high  level  of  protection  of  public  and  animal  health,  Member 
States  should  continue  to  take  the  necessary  measures  to  prevent  the  dispatch  of 
animal by-products from restricted areas or establishments, in particular in the event of 
an outbreak of a disease listed in Council 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 disease14. 

(21)  Operations with animal by-products which give rise to a considerable degree of risk to 
public and animal health should only be carried out in establishments which have been 
approved  in  advance  for  such  operations  by  the  competent  authority.  This  condition 
should apply in particular to rendering plants and other plants 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 

11 

12 
13 

14 

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). 
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). 
OJ L 328, 24.11.2006, p.14. 
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). 
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 

12 

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(22) 

material  for  disposal  and  processing  arises  due  to  a  major  outbreak  of  disease, 
provided it is ensured that the temporary use under such amended conditions does not 
lead to the propagation of disease risks. 

In  addition,  such  approvals  should  not  be  necessary  for  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  public  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 particular, 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 registered under this Regulation. 

(23)  Plants and establishments should be approved 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 contained. The competent authority should carry out 
checks to verify compliance with these requirements. 

(24)  Plants and establishments whose operations 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  approvals  under  that  Community  legislation 
already take into account the objectives of this Regulation.  

(25)  Animal by-products should be classified into three categories which reflect the degree 
of  risk  that  they  pose  to  public  and  animal  health,  on  the  basis  of  risk  assessments. 
While  material  posing  a  high  risk  should  only  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 lead to the development of processes which 
eliminate or minimise the risks to public and animal health. Amendments to the lists of 
materials set out in this Regulation should be possible, in order to take account of such 
progress. Prior to any such amendments, and in accordance with the general principles 
of  Community  legislation  aimed  at  ensuring  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 material 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 mixture belonging to the highest risk category. 

(27)  Due  to  the  high  risk  to  public  health,  material  giving  rise  to  a  risk  of  transmissible 
spongiform  encephalopathy  (TSE)  should,  in  particular,  not  be  used  for  feed.  This 
restriction should apply to wild animals through which a communicable disease may 
be  transmitted.  The  restriction  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. 

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(28)  The use of certain substances and products 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 origin16 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  Directive  96/23/EC  of  29 
April  1996  on  measures  to  monitor  certain  substances  and  residues  thereof  in  live 
animals  and  animal  products18  lays  down  further  rules  on  the  monitoring  of  certain 
substances  and  residues  thereof  in  live  animals  and  animal  products.  Directive 
96/23/EC  also  lays  down  rules  which  apply  where  the  presence  of  residues  of 
authorised  substances  or  contaminants  exceeding  certain  permitted  levels  has  been 
established.  In  order  to  ensure  the  coherence  of  Community  legislation,  products  of 
animal  origin  in  which  substances  are  detected  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 appropriate, in view of the risk they pose to the food and feed 
chain.  

(29)  Manure and digestive tract content do not need to be disposed of, provided that proper 
treatment  ensures  that  diseases  are  not  transmitted  during  application  to  land.  By-
products  from  animals  that  die  on  farm  and  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  which  are  allowed  into  the  Community,  even 
though  they  do  not  comply  with  Community  legislation  upon  inspection  at  the 
Community  border  post,  and  to  products  which  do  not  comply  with  the  applicable 
requirements during checks carried 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 for certain feeding purposes. For any other animal by-products 
which are not listed under one of the three categories, the categorisation by default as 
Category  2  material  should  be  maintained  for  precautionary  reasons,  in  particular  to 
reinforce  the  general  exclusion  of  such  material  from  the  feed  chain  for  farmed 
animals. 

(31)  Other  legislation  which  has  entered  into  force  following  the  adoption  of  Regulation 
(EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 
laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the 
European  Food  Safety  Authority  and  laying  down  procedures  in  matters  of  food 
safety19, 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 

17 

18 

19 

20 

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). 
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). 
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). 
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). 
OJ L 139, 30.4.2004, p. 1; corrected version OJ L 226, 25.6.2004, p. 3. 

EN 

14 

   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  protecting  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  responsible  for  ensuring  compliance  with  this 
Regulation.  The  respective  basic  obligation  of  such  operators  to  ensure  compliance 
with this Regulation should be further clarified and specified as regards the means by 
which traceability is ensured, such as separate collection and channelling 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 competent authority. Own 
checks  should  be  carried  out  through  a  system  based  on  the  principles  of  hazard 
analysis and critical control points (HACCP) in plants processing animal by-products, 
such  as  rendering  plants,  in  plants  for  the  transformation  of  animal  by-products  into 
biogas  or  compost  and  in  plants  handling  more  than  one  category  of  animal  by-
products, such as plants storing raw material of two categories. Sampling of products 
to  check  compliance  with  Community  standards  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  fact  that  possible  risks  are  being  eliminated 
without the product being placed on the market. 

(33)  Animal  by-products  should  only  be  used  if  the  risks  to  public  and  animal  health  are 
minimised in the course of their processing and the placing on the market of products 
manufactured  on  the  basis  of  animal  by-products.  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  different  categories  should  be  clarified  in 
coherence with other Community legislation.  

(34)  Disposal of animal by-products and derived products should take place in accordance 
with environmental legislation regarding landfilling and waste incineration. In order to 
ensure  consistency,  incineration  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 waste22. Co-incineration of waste – either as a recovery or disposal 
operation – is subject to similar conditions regarding approval and operating as waste 
incineration,  in  particular  as  to  air  emission  limit  values,  wastewater  and  residue 
discharge,  control  and  monitoring  and  measurement  requirements.  Consequently, 
direct  co-incineration,  without  prior  processing,  of  all  three  categories  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  waste  disposal  operation.  However,  such  use 
should take place under conditions which ensure the protection of public and animal 
health, as well as the appropriate environmental standards.  

(36)  The  coherence  of  Community  legislation  requires  that  material  submitted  to  a 
detoxification  process  defined  in  accordance  with  Directive  2002/32/EC  of  the 

21 

22 

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). 
OJ L 332, 28.12.2000, p. 91. 

EN 

15 

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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  the  possibility  to  lay  down  parameters  for 
processing methods regarding time, temperature 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 from which the soft tissues or flesh have been removed, should 
be excluded from the scope of the Regulation. 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 arising to public and animal health. Guides to 
good  practice  at  Community  or  national  level  could  assist  in  the  dissemination  of 
knowledge regarding proper conditions under 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 authorise the preparation and application to land 
of  biodynamic  preparations,  on  the  basis  of  Category  2  and  Category  3  material,  as 
referred  to  in  Council  Regulation  (EC)  No  2092/91  of  24  June  1991  on  organic 
production  of  agricultural  products  and  indications  referring  thereto  on  agricultural 
products and foodstuffs24. 

(40)  Novel technologies which are being developed 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 Community. If a technological process has been 
developed by an individual, an application checked by the competent authority should 
be examined by the EFSA before such authorisation is granted, in order to ensure that 
an assessment of the risk reduction potential of the process is carried out.  

(41) 

It is appropriate to clarify the requirements applicable to the placing on the market of 
animal by-products and derived products intended for feeding purposes and of organic 
fertilizers and soil improvers, so as to ensure the protection of the food and feed chain. 
Only Category 3 material should be used for feeding purposes. Fertilisers 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 indigestible substance, should be added 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  fur25  lays  down  a 
general prohibition on the placing on the market and the importation and exportation 
of cat and dog fur and products containing such fur. However, that prohibition should 

23 

24 

25 

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). 
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). 
OJ L 343, 27.12.2007, p. 1. 

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16 

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not affect the obligation under this Regulation 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 and use of such material, the competent authority should 
be able to fix the conditions for such operations on a case-specific basis. Harmonised 
conditions should be laid down where action at a Community level is necessary. 

(44)  Regulation  (EC)  No  1774/2002  contains  detailed  provisions  which  allow,  by  way  of 
derogation, the feeding of Category 2 and Category 3 material to certain animals such 
as  zoo  animals.  Identical  provisions  should  be  laid  down  in  this  Regulation  and 
complemented  by  the  possibility  to  lay  down  detailed  rules  to  control  any  possible 
risks arising to public or animal health. 

(45)  Regulation  (EC)  No  1774/2002  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  for  the  preservation  of  those  species,  that  feeding  practice 
should continue to be permitted under this Regulation, in accordance with conditions 
laid down to prevent the spread of diseases. 

(46)  Burial and burning of unprocessed animal by-products, in  particular  of dead animals 
may  be  justified  in  specific  situations,  in  particular  in  remote  areas,  or  in  disease 
control situations requiring the emergency disposal of the animals killed as a measure 
to  control  an  outbreak  of  a  serious  transmissible  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  burial  and  burning  of  unprocessed  animal  by-
products  should  be  extended  to  areas  where  access  is  not  practically  possible  or 
presents a risk to the health and safety of the collection personnel. 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 place 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  this  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 order to ensure legal certainty, in particular 
regarding the suspension or permanent 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  may  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  order  to  ensure  traceability  and  cooperation 

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(52) 

between the competent authorities of Member States controlling the flow of material, 
the TRACES system introduced by Commission 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 Category 2 material and derived products from 
rendering operations, and Category 3 processed animal protein.  

In  order  to  facilitate  the  transportation  of  consignments  through  third  countries 
neighbouring  more  than  one  Member  State,  a  special  regime  for  the  dispatch  of 
consignments from the territory of one Member 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  trade  with  a  view  to  the  completion  of  the 
internal market27. 

(53)  For  the  sake  of  coherence  of  Community  legislation,  it  is  necessary  to  clarify  the 
relationship between the rules laid down in this Regulation and Community legislation 
on waste. In particular, consistency should be ensured with 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 environment, the export of animal by-products and derived 
products destined for disposal by incineration and by landfill should 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 adverse 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 disposal, and the amendment to this 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  Commission  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 Decision 94/904/EC establishing 
a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on 
hazardous waste31 are only imported, exported or dispatched 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 

27 

28 
29 
30 
31 

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). 
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). 
OJ L 190, 12.7.2006, p. 1. 
OJ L 39, 16.2.1993, p. 1. Corrigendum published at OJ L 74, 17.3.1994, p. 52. 
OJ L 272, 4.10.1997, p. 45. 
OJ  L  226,  6.9.2000,  p.  3.  Decision  as  last  amended  by  Council  Decision  2001/573/EC  (OJ  L  203, 
28.7.2001, p. 18). 

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(55)  The Commission should be able to carry out controls in Member States. Community 
controls  in  third  countries  should  be  carried  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  verification  of  compliance  with  feed  and  food  law, 
animal health and animal welfare rules32. 

(56)  The importation of animal by-products and 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 destined for uses outside the feed chain. 

(57)  Community  legislation  on  the  manufacture  of  derived  products  intended  for  use  as 
cosmetic products, medicinal products or medical 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 products33, Directive 2001/83/EC of the European Parliament and 
of  the  Council  of  6  November  2001  on  the  Community  code  relating  to  medicinal 
products  for  human  use34,  Directive  2001/82/EC  of  the  European  Parliament  and  of 
the  Council  of  6  November  2001  on  the  Community  code  relating  to  veterinary 
medicinal  products35,  Council  Directive  90/385/EEC  of  20  June  1990  on  the 
approximation of the laws of the Member States 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 Parliament 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 Regulation 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 should also be subject to the requirements of 
the specific Directives, insofar as they lay down rules controlling risks to public and 
animal  health.  Those  specific  Directives  already  regulate  starting  material  of  animal 
origin which may be used for the manufacture of the derived products referred to and 
impose  certain  conditions  to  ensure  the  protection  of  public  or  animal  health.  In 

32 

33 

34 

35 

36 

37 

38 

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). 
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). 
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). 
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). 
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). 
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). 
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 

19 

   EN 

 
                                                 
particular, Council Directive 76/768/EEC excludes 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 Directive 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  traceability,  operators  should  indicate  operations  using  such  raw 
material derived from animals to the competent authority, so that intervention by the 
authorities responsible for the protection of public and animal health is possible, in the 
event of any failure to comply with the rules laid down in this Regulation. 

(61)  Certain derived products do not enter the feed chain or are not applied to land which is 
grazed  by  farmed  animals  or  from  which  herbage  for  feed  is  cut.  Such  derived 
products  include  products  for  technical  uses,  such  as  treated  hides  for  leather 
production,  processed  wool  for  the  textile  industry,  bone  products  for  glue  and 
processed material destined for petfood. Operators 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 chain can be determined following which the 
resulting material no longer poses any significant risk.  

(63)  Under Regulation (EC) No 1774/2002, certain 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 the 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  Category  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  suitable  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 rules, criminal and other sanctions against operators which 
do  not  comply  with  those  rules  are  needed.  Therefore,  it  is  necessary  that  Member 
States lay down rules on penalties applicable to infringements 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  better  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 accordance with the principle of proportionality, 

39 

OJ L 105, 26.4.2003, p. 18. 

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20 

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as set out in that Article, this Regulation does not go beyond what is necessary in order 
to achieve those objectives. 

(67) 

In  order  to  enhance  legal  certainty  and  in  the  light  of  the  Commission’s  general 
objective to simplify Community legislation, a coherent framework 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 progress 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 implementation 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  implementing powers conferred on the Commission40. 
In  order  to  improve  coherence  and  clarity  of  Community  legislation,  the  technical 
rules concerning specific operations 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 Regulation41, should be laid down 
in separate implementing acts. Consultation and information of consumers and socio-
professional circles concerned with 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 group on the food chain and animal and plant 
health42. 

(69) 

In particular, the Commission should be empowered to adopt rules concerning the site 
and equipment of plants and establishments handling animal by-products, the handling 
and treatment of animal by-products, the categorisation of materials according to the 
risk  arising  from  them  to  public  and  animal  health,  measures  intended  to  ensure  the 
traceability  of  animal  by-products,  derogations  regarding  the  use  and  disposal  of 
animal  by-products,  conditions  for  the  placing  on  the  market  of  animal  by-products 
and derived products, conditions for the control for the dispatch of certain animal by-
products and derived products between Member States and conditions for the import 
and  transit  of  animal  by-products  and  derived  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-essential elements, they must be adopted 
in accordance with the regulatory procedure with 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 adoption of measures specifying the conditions for 
the dispatch of animal by-products from restricted holdings, plants or zones. 

40 

41 

42 

OJ  L  184,  17.7.1999,  p.  23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L  200,  22.7.2006, 
p. 11). 
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); Regulation (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). 
OJ L 275, 25.8.2004, p. 17. 

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21 

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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  public  health  rules  for  animal  by-products  and 
products derived thereof, in order: 

(a) 

to  prevent  and  minimise  risks  to  animal  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 consumption under Community legislation; or 

(b) 

that may be destined for human consumption under Community legislation, but 
pursuant  to  a  decision  by  an  operator  are  destined  for  purposes  other  than 
human consumption.  

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22 

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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 disease 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; 

animal  by-products  from  wild  game  and  from  wild  game  meat  referred  to  in 
Article 1(3)(e) of Regulation (EC) No 853/2004; 

oozytes, embryos and semen destined for breeding purposes;  

liquid milk, colostrum and products derived thereof which are obtained, kept, 
disposed of or used on the farm of origin;  

shells from shellfish with the soft tissue or flesh removed;  

catering waste, except if it  

(i) 

originates from means of transport operating internationally; 

(ii) 

is destined for feeding purposes; 

(b) 

(c) 

(d) 

(e) 

(f) 

(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 referred to in Article 22(a); and 

(g)  without  prejudice  to  Community  environmental  legislation,  material  disposed 
of  at  sea,  which  has  arisen  in  the  course  of  their  fishing  operations,  from 
vessels  complying  with  Regulations  (EC)  No  852/2004  and  No  853/2004, 
except  material  derived  from  on-board  evisceration  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) 

(b) 

cosmetic products as defined in Article 1(1) of Directive 76/768/EEC; 

active  implantable  medical  devices  as  defined  in  Article  1(2)(c)  of  Directive 
90/385/EEC; 

(c)  medical devices as defined in Article 1(2)(a) of Directive 93/42/EEC; 

EN 

23 

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(d) 

(e) 

in  vitro  diagnostic  medical  devices  as  defined  in  Article  1(2)(b)  of  Directive 
98/79/EC. 

veterinary  medicinal  products  as  defined  in  Article  1(2)  of  Directive 
2001/82/EC; 

(f)  medicinal products as defined in Article 1(2) of Directive 2001/83/EC. 

4. 

This  Regulation  shall  be  without  prejudice  to  Community  veterinary  legislation 
having as its objective the control and eradication of animal diseases. 

Article 3 
Definitions 

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

(1) 

(2) 

"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;  

"animal"  means  any  invertebrate  or  vertebrate  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; 

(4) 

(5) 

(6) 

(7) 

(b) 

equidae; 

"wild animal" means any animal not kept by humans;  

"pet animal" means any animal belonging to species normally nourished and kept by 
humans  for  purposes  other  than  farming  and  listed  in  Annex  I  to  Regulation  (EC) 
No 998/2003;  

"aquatic  animals"  means  aquatic  animals  as  defined  in  Article  3(1)(e)  of  Directive 
2006/88/EC; 

"competent  authority"  means  the  central  authority  of  a  Member  State  competent  to 
ensure compliance with the requirements of this Regulation or any authority to which 
that  competence  has  been  delegated;  it  also  includes,  where  appropriate,  the 
corresponding authority of a third country;  

EN 

24 

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(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

(20) 

(21) 

"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 Community or any other form 
of  supply  against  payment  or  free  of  charge to  such  a  third  party  or  storage  with  a 
view to supply to such a third party;  

"transit"  means  a  movement  through  the  Community  from  a  territory  of  a  third 
country to a territory of a third country, other than by sea or by air;  

"export" means a movement from the Community to a third country; 

"producer" means any person who produces animal by-products or derived products;  

"operator"  means  any  natural  or  legal  person  who  has  an  animal  by-product  or 
derived product under their actual control, including the producer; 

"transmissible  spongiform  encephalopathies  (TSEs)"  means  all 
transmissible 
spongiform  encephalopathies  as  defined  in  Article  3(1)(a)  of  Regulation  (EC)  No 
999/2001;  

"specified risk material" means specified risk material as defined in Article 3(1)(g) of 
Regulation (EC) No 999/2001; 

"derived  products"  means  any  product  obtained  from  one  or  more  treatments, 
transformations or steps of processing of animal by-products; 

"pressure  sterilisation"  means  the  processing  of  animal  by-products,  after  reduction 
in particle size to not more than 50 mm, to a core temperature of more than 133°C 
for at least 20 minutes without interruption at an absolute pressure of at least 3 bar; 

"products  of  animal  origin"  means  products  obtained  from  animals  and  products 
obtained from such products, including live animals where they are prepared for such 
use; 

"manure"  means  any  excrement  and/or  urine  of  farmed  animals,  with  or  without 
litter, or non-mineralised guano; 

"authorised  landfill"  means  a  landfill  for  which  a  permit  has  been  issued  in 
accordance with Directive 1999/31/EC; 

"approved  plant"  means  a  plant  approved  in  accordance  with  this  Regulation  for  a 
particular  operation  involving  the  handling  of  animal  by-products,  other  than  a 
fishing vessel; 

"establishment"  means  a  place  of  manufacture  of  derived  products  which  are 
regulated by other Community legislation; 

EN 

25 

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(22) 

(23) 

(24) 

(25) 

"organic  fertiliser"  and  "soil  improver"  means  materials  of  animal  origin  used  to 
maintain  or  improve  plant  nutrition  and  the  physical  and  chemical  properties  and 
biological activities of soils, either separately or together; they may include manure, 
digestive tract content, compost and digestion residues; 

"remote  area"  means  an  area  where  the  animal  population  is  so  small,  and  where 
disposal facilities are so far away that the arrangements necessary for the collection 
and  transport  of  animal  by-products  would  be  unacceptably  onerous  compared  to 
local disposal; 

"food" means food as defined in Article 2 of Regulation (EC) No 178/2002; 

"feed" means feed as defined in Article 3(4) of Regulation (EC) No 178/2002. 

Article 4 
National infrastructures and systems for the collection and disposal of animal by-products 

1. 

Member  States  shall  have  an  adequate  infrastructure  in  place  on  their  territory  that 
ensures that animal by-products are 

(a) 

collected, identified and transported without undue delay;  

(b)  disposed of in accordance with this Regulation. 

2. 

Member States shall  

(a) 

provide a system for the collection and disposal of animal by-products, which 
operates  efficiently  and  which  is  monitored  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 zones which are subject to restrictions  

(a) 

pursuant to Community veterinary legislation; or  

(b)  due to the presence of a serious transmissible disease  

(i) 

listed in Annex I to Directive 92/119/EEC; or  

EN 

26 

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(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,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 48(4). 

2. 

Paragraph  1  shall  not  apply  where  animal  by-products  and  derived  products  are 
dispatched under conditions to be adopted by the Commission to prevent the spread 
of diseases transmissible to humans or animals. 

Those  measures  designed  to  amend  non-essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 48(5). 

SECTION 3: APPROVAL OF PLANTS AND ESTABLISHMENTS 

Article 6 
Plants and establishments 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) 

(d) 

(e) 

(f) 

the incineration of animal by-products; 

for the disposal or recovery of animal by-products or derived products, which 
are waste, in co-incineration plants; 

the combustion of animal by-products and derived products; 

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 derived products of: 

(a) 

a particular category referred to in Articles 11, 12 or 13 ; or 

EN 

27 

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(b)  more than one category referred to in Articles 11, 12 or 13, indicating if such 

operations are carried out  

(i) 

(ii) 

permanently under conditions of strict separation which prevent any risks 
arising to public and animal health; or 

temporarily  under  conditions  which  prevent  contamination,  in  order  to 
accommodate for a lack of capacity for such products arising due to: 

– 

– 

a widespread outbreak of an epizootic disease; or  

other extraordinary and unforeseen 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 registration of plants and establishments 
approved or registered in accordance with: 

(i)  Regulation (EC) No 853/2004; or  

(ii)  Regulation (EC) No 183/2005; 

(b) 

(c) 

incineration plants and co-incineration plants which have a permit to operate in 
accordance with Directive 2000/76/EC; 

biogas and composting plants 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,  establishments  manufacturing  derived 

products referred to in Article 2(3); 

(e)  without  prejudice  to  Chapter  VI,  operators  who  import,  collect  or  channel 
animal by-products and derived products exclusively for the manufacture of the 
derived products referred 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  registered  by  the  competent  authority  upon  application  by  the 
operator.  

The application must contain the following information: 

(a) 

the category of animal by-products used; 

EN 

28 

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3. 

1. 

(b) 

the  nature  of  the  operations  performed  using  animal  by-products  or  derived 
products as starting material for which the application is made.  

Detailed rules for application for registration as provided for in paragraph 2 may be 
adopted in accordance with the procedure referred to in Article 48(3). 

Article 8 
Approval of plants 

The  competent  authority  shall  approve  a  plant  provided  that  the  operator  submits 
together with his application, evidence that: 

(a) 

(b) 

(c) 

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 down 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; 

it  handles  animal  by-products  and,  if  required  by  this  Regulation  or  by  rules 
adopted  in  accordance  with  this  Regulation,  derived  products  in  accordance 
with hygiene requirements laid down in accordance with Article 9; 

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 arising 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  following  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 only if it appears from a new official control of the plant, 
carried out within three months of granting conditional approval, that the plant meets 
the other applicable requirements.  

If  clear  progress  has  been  made  but  the  plant  still  does  not  meet  all  the  applicable 
requirements, the competent authority may prolong  conditional  approval. However, 
conditional approval shall not exceed a total of six months.  

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29 

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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 Section may be laid down by the Commission, on: 

(a) 

(b) 

the  requirements  applicable  to  the  incineration,  co-incineration  and  combustion  of 
animal by-products and derived products as referred to in Article 6(1)(c), (d) and (e); 

conditions for the handling, processing or storage of animal by-products or derived 
products in the same plant or establishment: 

(i)  where such operations are carried out separately; 

(ii)  where such operations are carried out temporarily; 

(c) 

standard transformation parameters for biogas and composting plants as referred to in 
Article 7(1)(c); 

(d) 

the site and equipment of plants and establishments requiring approval on: 

(i) 

(ii) 

general  hygiene  requirements  applicable  within  approved  plants  and 
establishments; 

technical  requirements  for  the  handling,  treatment,  transformation  and 
processing  of  animal  by-products  or  derived  products  within  approved  plants 
and establishments; 

(iii)  standards  for  treatment  of  waste  water  arising  from  the  premises  by  way  of 
filtration,  including  the  filter  pore  size  and  the  requirement  to  use  filters 
capable  of  effectively  removing  certain  pathogenic  agents  from  the  waste 
water. 

this  Regulation  by 
Those  measures  designed 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 48(4). 

to  amend  non-essential  elements  of 

SECTION 4: CATEGORISATION 

Article 10 
Categorisation of animal by-products and derived products 

1. 

Animal  by-products  shall  be  categorised  into  specific  categories  which  reflect  the 
level  of  risk  to  public  and  animal  health  arising  from  those  animal  by-products,  in 
accordance with the lists laid down in Articles 11, 12 or 13.  

EN 

30 

   EN 

 
2. 

Derived products shall be subject to the rules for the specific category of animal by-
products  from  which  they  have  been  derived,  unless  otherwise  specified  in  this 
Regulation, or in measures for the implementation of this Regulation adopted by the 
Commission.  

Those  measures  designed  to  amend  non-essential  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 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  presence  of  a  TSE  has  been  officially 
confirmed; 

(ii) 

animals killed in the context 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 being infected with diseases communicable to 

humans or animals;  

(b) 

the following material: 

(i) 

specified risk material;  

(ii) 

entire  bodies  or  parts  of  dead  animals  containing  specified  risk  material  
at the time of disposal; 

(c) 

(d) 

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;  

animal  material  collected  during  the  filtration  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 

31 

   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) 

(b) 

(c) 

(d) 

manure and digestive tract content;  

animal  material  collected  during  the  filtration  of  waste  water  required  by  Article 
8(1)(a), when such water is or has been in contact with Category 2 material;  

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;  

products  of  animal  origin  which  have  been  declared  unfit  for  human  consumption 
due to the potential presence of physical residues in those products; 

(e) 

products of animal origin, other than Category 1 material, that are:  

(i) 

imported or introduced from a third country and which fail to comply with the 
Community veterinary legislation for their importation or introduction into the 
Community  except  where  Community  legislation  allows  their  importation  or 
introduction subject to specific restrictions or their return to the third country; 
or 

(ii)  dispatched  to  another  Member  State  and  which  fail  to  comply  with 
requirements laid down or authorised by Community legislation except where 
they are returned with the authorisation of the competent authority responsible 
for the plant or establishment of origin.  

animals  and  parts  of  animals,  other  than  those  referred  to  in  Article  11  or  13,  that 
died other than by being slaughtered 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;  

mixtures of Category 2 material with Category 3 material; 

animal by-products other than Category 1 material or Category 3 material. 

(f) 

(g) 

(h) 

EN 

32 

   EN 

 
Article 13 
Category 3 material 

Category  3  material  shall  comprise  the  following  animal  by-products  or  any  material 
containing such by-products: 

(a) 

(b) 

carcasses  or  parts  of  animals  slaughtered  or,  in  the  case  of  game  and  farmed  fish, 
killed,  and  which  are  fit  for  human  consumption  in  accordance  with  Community 
legislation, but are not intended for human consumption for commercial reasons; 

the  following  parts  originating  either  from  animals  that  have  been  slaughtered  in  a 
slaughterhouse  and  were  considered  fit  for  slaughter  for  human  consumption 
following an ante-mortem inspection or from game killed for human consumption in 
accordance with Community legislation: 

(i) 

carcasses  or  parts  of  animals  which  are  rejected  as  unfit  for  human 
consumption  in  accordance  with  Community  legislation,  but  which  did  not 
show any signs of disease communicable to humans or animals; 

(ii)  heads of poultry; 

(iii)  hides and skins, including trimmings and splittings thereof; 

(iv) 

feet, including the phalanges and the tarsus and metatarsus bones, of: 

– 

– 

– 

animals other than ruminants,  

ruminants not requiring TSE testing, 

ruminants  which  have  been  tested  with  a  negative  result  in  accordance 
with Article 6(1) of Regulation (EC) No 999/2001;  

(v)  horns; 

(vi)  pig bristles;  

(vii)  feathers; 

(c) 

blood  of  animals  which  did  not  show  any  signs  of  disease  communicable  through 
that blood to humans or animals obtained from:  

(i) 

animals other than ruminants and ruminants not requiring TSE testing that have 
been slaughtered in a slaughterhouse, which were considered fit for slaughter 
for  human  consumption  following  an  ante-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 Regulation (EC) No 999/2001; 

EN 

33 

   EN 

 
(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

animal  by-products  derived  from  the  production  of  products  intended  for  human 
consumption, including degreased bones and greaves;  

products of animal origin, other than catering waste, which, after having been placed 
on  the  market  for  human  consumption  or  for  feeding  to  animals,  are  no  longer 
intended  for  such  consumption  or  such  feeding  for  commercial  reasons  or  due  to 
problems of manufacturing or packaging defects or other defects from which no risk 
to public or animal health arise;  

blood, placenta, wool, feathers, hair, horns, hoof cuts and milk originating from live 
animals that are not immediately destined for slaughter and did not show signs of any 
disease communicable through that product to humans or animals;  

aquatic animals, and parts of such animals, except sea mammals, which did not show 
any signs of diseases communicable to humans or animals;  

fresh  animal  by-products  from  aquatic  animals  originating  from  plants  or 
establishments manufacturing products for human consumption;  

the  following  material  originating  from  animals  which  did  not  show  any  signs  of 
disease communicable through that material to humans or animals: 

(i) 

shells, other than the shells referred to in Article 2(2)(e),  

(ii) 

the following originating from terrestrial animals: 

– 

– 

– 

hatchery by-products, 

eggs, 

egg by-products; 

(iii)  day-old chicks. 

terrestrial invertebrates other than species pathogenic to humans or animals; 

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); 

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 those referred to in point (c); 

(m) 

catering waste other than as referred to in Article 11(e). 

EN 

34 

   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  listed  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 elements of this Regulation shall be adopted 
in accordance with the regulatory procedure with scrutiny referred to in Article 48(4).  

CHAPTER II: 
OBLIGATIONS OF OPERATORS,  
OPERATION OF PLANTS AND  
ESTABLISHMENTS 

SECTION 1: 
GENERAL OBLIGATIONS OF OPERATORS 

1. 

2. 

3. 

Article 15 
Collection, identification as regards category and transportation 

Operators  shall  collect,  identify  and  transport  animal  by-products  without  undue 
delay under conditions which prevent risks arising to public and animal health.  

Operators  shall  ensure 
that  animal  by-products  and  derived  products  are 
accompanied during transportation by a commercial 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  subparagraph,  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  without  a  commercial 
document or health certificate. 

Commercial documents and health certificates accompanying animal by-products or 
derived  products  during  transportation  shall  include  information  on  the  quantity  of 
such products, and a description of the animal by-products or derived products and 
their marking, when such marking is required by this Regulation.  

EN 

35 

   EN 

 
4. 

The following measures may be laid down in accordance with the 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-products  and  derived  products  during 
transportation. 

5. 

Measures  for  the  implementation  of  this  Article  may  be  laid  down  by  the 
Commission on:  

(a) 

(b) 

(c) 

(d) 

cases where a health certificate is required having regard to the level of risk to 
public and animal health arising from certain derived products; 

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 products may take place without documents 
or certificates referred to in that paragraph; 

requirements  for  the  identification,  including  labelling,  and  for  the  separation 
of animal by-products during transportation;  

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  essential  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 16 
Records 

1. 

Any  person  consigning,  transporting  or  receiving  animal  by-products  or  derived 
products shall keep a record of consignments and related commercial documents or 
health certificates.  

However,  the  first  subparagraph  shall  not  apply  when  an  authorisation  to  transport 
manure  has  been  granted  in  accordance  with  the  second  subparagraph  of  Article 
15(2). 

2. 

Measures for the implementation of this Article may be adopted in accordance with 
the procedure referred to in Article 48(3), in particular on: 

(a) 

the format of records to be kept; 

EN 

36 

   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. 

2. 

3. 

Operators shall put in place, implement and maintain a permanent procedure of own 
checks in order to monitor compliance with this Regulation.  

Operators shall ensure that no material suspected or known 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.  

Plants  processing  animal  by-products,  plants  for  the  transformation  of  animal  by-
products  into  biogas  and  compost  and  plants  handling  more  than  one  category  of 
animal  by-products  shall  develop  the  procedure  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) 

(b) 

identify and control the critical control points in the plants;  

establish and implement methods for monitoring and checking critical control 
points;  

(c)  where  the  product  derived  from  the  processing  is  not  directly  disposed  of  on 
the same site by incineration, co-incineration, 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  standards,  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  tests  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 

37 

   EN 

 
4. 

Where  the  results  of  a  test  on  samples  taken  pursuant to paragraph 3(c) show non-
compliance  with  applicable  safety  requirements,  the  operator  of  the  plant  shall,  in 
addition to the requirements laid down in paragraph 2: 

(a) 

notify the competent authority immediately, 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) 

(d) 

increase the frequency of sampling and testing of production; 

instigate  appropriate  decontamination  and  cleansing  procedures  within  the 
plant. 

5. 

6. 

Batches found not to be in compliance with applicable safety requirements following 
checks  carried  out  in  accordance  with  paragraph  3(c)  shall  be  reprocessed  or 
disposed of under the supervision of the competent authority. 

Measures for the implementation of this Article may be adopted by the Commission, 
on: 

(a) 

(b) 

own checks and the maintenance of the HACCP system; 

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 methods for microbiological analyses. 

Those  measures  designed  to  amend  non  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance 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 shall 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 

38 

   EN 

 
(b) 

(c) 

the  feeding  of  farmed  animals  other  than  fur  animals  with  catering  waste  or 
feed material containing or derived from catering waste; 

the  feeding  of  farmed  animals  with  herbage,  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  processed  animal  protein  derived  from  the 
bodies or parts of bodies of farmed fish of the same species. 

2. 

Implementing rules to ensure the uniform application of the prohibitions laid down in 
paragraph 1 may be laid down by the Commission, and measures permitting: 

(a) 

(b) 

the  feeding  with  processed  animal  protein  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 

the  feeding  of  farmed  animals  with  herbage  from  land  to  which  organic 
fertilisers  or  soil  improvers  have  been  applied,  provided  that  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  essential  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 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 approved 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,  and  permanent  marking  of  the  resulting 
material; 

EN 

39 

   EN 

 
 
(b) 

in case the Category 1 material is a waste, disposed of or recovered 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,  and  permanent  marking  of  the  resulting 
material; 

in the case of Category 1 material other than material referred to in Article 11(a)(i) 
and  (ii),  disposed  of  by  processing  by  pressure  sterilisation  in  an  approved  plant, 
permanent marking of the resulting material and burial in an authorised landfill; 

in  the  case  of  Category  1  material  referred  to  in  Article  11(c),  submitted  to  a 
detoxification  process  defined  in  accordance  with  Article  8(2)  of  Directive 
2002/32/EC, and used in accordance with Article 21(c), (d) and (e); 

in the case of Category 1 material referred to in Article 11(e), disposed of by burial 
in an authorised landfill; 

used as a fuel for combustion; or 

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.  

(c) 

(d) 

(e) 

(f) 

(g) 

Article 20 
Disposal and use of Category 2 material 

Category 2 material shall be: 

(a) 

disposed of as a waste in an approved 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,  and  permanent  marking  of  the  resulting 
material; 

(b) 

in case the Category 2 material is a waste, disposed of or recovered 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,  and  permanent  marking  of  the  resulting 
material; 

(c) 

disposed of in an authorised landfill, following processing by pressure sterilisation in 
an approved plant and permanent marking of the resulting material;  

EN 

40 

   EN 

 
(d) 

permanently marked following processing in an approved plant: 

(i) 

(ii) 

in  the  case  of  resulting  proteinaceous  material,  by  pressure  sterilisation,  and 
used as an organic fertiliser or soil improver; or 

in the case of rendered fats, by pressure sterilisation, if the competent authority 
so requires, and further processed into fat derivatives in an approved plant, for 
use in organic fertilisers or soil improvers;  

(e) 

transformed in an approved or registered biogas or composting plant: 

(i) 

(ii) 

following  processing  by  pressure  sterilisation  and  permanent  marking  of  the 
resulting material; or 

in the case of manure, digestive tract content separated from the digestive tract, 
milk, milk-based products and colostrum, which the competent authority does 
not  consider  to  present  a  risk  for  the  spread  of  any  serious  transmissible 
disease, following or without prior processing; 

applied  to  land  without  processing,  in  the  case  of  manure,  digestive  tract  content 
separated from the digestive tract, milk, milk-based products and colostrums, which 
the  competent  authority  does  not  consider  to  present  a  risk  for  the  spread  of  any 
serious transmissible disease;  

in the case of material originating from aquatic animals, ensiled or composted in an 
approved or registered plant; 

used as a fuel for combustion; or 

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. 

(f) 

(g) 

(h) 

(i) 

Article 21 
Disposal and use of Category 3 material 

Category 3 material shall be: 

(a) 

(b) 

(c) 

disposed  of  as  a  waste  in  an  approved  or  registered  incineration  plant,  with  or 
without prior processing;  

in case the Category 3 material is a waste, disposed of or recovered in an approved or 
registered co-incineration plant, with or without prior processing; 

processed  in  an  approved  plant,  except  in  the  case  of  material  which  has  changed 
through  decomposition,  contamination  or  spoilage  so  as  to  present  an  unacceptable 
risk to public or animal health, and used:  

EN 

41 

   EN 

 
(i) 

as feed material for farmed animals or for the feeding to farmed animals other 
than  fur  animals,  and  placed  on  the  market  in  accordance  with  Article  24, 
except in the case of material referred to in Article 13(l) and (m); 

(ii) 

for the feeding to fur animals; or 

(iii)  for  the  manufacture  of  organic  fertilisers  or  soil  improvers,  which  shall  be 

placed on the market in accordance with Article 25. 

transformed in an approved or registered biogas or composting plant;  

in the case of material originating from aquatic animals, ensiled or composted in an 
approved or registered plant; 

in  the  case  of  shells  other  than  the  shells  referred  to  in  Article  2(2)(e),  used  under 
conditions which prevent risks arising to public and animal health; 

used as a fuel for combustion; or 

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. 

(d) 

(e) 

(f) 

(g) 

(h) 

Article 22 
Derogations 

By way of derogation to Articles 19, 20 and 21, animal by-products may be:  

(a) 

(b) 

(c) 

(d) 

(e) 

disposed  of  or  used  in  an  approved  plant,  in  accordance  with  alternative  methods 
which have been approved in accordance with Article 29(1) to (9); 

used for research and other specific purposes in accordance with Article 26; 

in the case of animal by-products referred to in Article 27, used for special feeding 
purposes in accordance with that Article; 

in the case of animal by-products referred to in Article 28, disposed of in accordance 
with that Article; 

in the case of Category 2 and Category 3 material and if authorised by the competent 
authority: 

(i) 

used for the preparation and application to land of bio-dynamic preparations as 
referred to in point 2.3 of Part A of Annex I to Regulation (EC) No 2092/91; 

(ii)  used for the feeding to pet animals; 

EN 

42 

   EN 

 
(f) 

in the case of Category 3 material referred 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 authority, 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,  temperature  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) 

(f) 

(g) 

the application to land of certain animal by-products, organic fertilisers and soil 
improvers; 

the use of certain animal by-products as feed material for farmed animals or for 
the feeding to farmed animals; 

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  essential  elements  of  this  Section,  by 
supplementing it, shall be adopted in accordance 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 animals  or derived products for 
use as feed material for farmed animals may only be placed on the market if: 

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(a) 

(b) 

they  are  or  are  derived  from  Category  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 material other than material referred to in 
Article 13(l) and (m); 

they  have  been  collected,  processed  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) 

(b) 

public and animal health conditions for the collection, processing and treatment 
of animal by-products and derived products referred to in paragraph 1; 

conditions  aimed  at  ensuring  traceability  and  preventing  cross-contamination 
which apply to the destination of material fit for human consumption to feeding 
purposes or to use as feed material. 

Those  measures  designed  to  amend  non  essential  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 25 
Placing on the market and use of organic fertilisers and soil improvers 

1. 

Organic  fertilisers  and  soil  improvers  may  be  placed  on  the  market  and  used 
provided 

(a) 

(b) 

(c) 

they are derived from Category 2 or Category 3 material; 

they  have  been  produced  in  accordance  with  the  conditions  for  pressure 
sterilisation  or  with  other  conditions  to  prevent  risks  arising  to  public  and 
animal  health,  in  accordance  with  the  requirements  of  Section  2  and  any 
measures which have been laid down in accordance with paragraph 2; 

in the case of organic fertilisers and 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. 

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44 

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Member States may adopt or maintain national rules imposing additional conditions 
for or restricting the use of organic fertilisers and soil improvers, provided that such 
rules are justified on grounds of the protection 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  conditions  for  the  production  and  use  of  organic 
fertilisers and soil improvers; 

(b) 

components for the marking of organic fertilisers or soil improvers; 

(c) 

(d) 

components to be mixed with organic fertilisers or soil improvers; 

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  essential  elements  of  this  Section,  by 
supplementing it, shall be adopted in accordance 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 animal by-products for research 
and other specific purposes 

1. 

2. 

The competent authority may, by way of derogation from Sections 1 and 2, authorise 
the  use  of  animal  by-products  and  derived  products  for  exhibitions,  and  for 
diagnostic,  educational  or  research  purposes  under  conditions  which  ensure  the 
control of risks to public and animal health.  

Such conditions shall include: 

(a) 

(b) 

the  prohibition  of  any  subsequent  use  of  the  animal  by-products  or  derived 
products for other purposes; 

the obligation to dispose of safely or to re-dispatch the animal by-products or 
derived products to their place of origin. 

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  registered  by  the  competent  authority  upon 
submission of the following information on: 

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45 

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3. 

4. 

(a) 

(b) 

the category of animal by-products used; 

the nature of the operations performed for which an application for registration 
is made using animal by-products or derived products as starting material. 

Measures for the implementation of this Article may be adopted in accordance with 
the procedure referred to in Article 48(3) as regards the submission of information, 
including a standard form. 

In  the  case  of  risks  to  public  and  animal  health  which  require  the  adoption  of 
measures for the whole territory of the Community, 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  essential  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 27 
Derogations regarding the collection 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  the  control  of  risks  to  public  and  animal 
health, the collection and use of: 

(a)  Category 2 material, provided that it comes from animals which were not killed 
or  did  not  die  as  a  result  of  the  presence  or  suspected  presence  of  a  disease 
communicable to humans or animals; 

(b)  Category 3 material for the feeding to: 

(i) 

zoo animals; 

(ii) 

circus animals; 

(iii)  reptiles and birds of prey other 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. 

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2. 

3. 

The competent authority may authorise, by way of derogation from Sections 1 and 2, 
and in accordance with conditions laid down pursuant to paragraph 3 of this Article, 
the feeding of the Category 1 material referred to in Article 11(b)(ii) to zoo animals 
and to endangered or protected species of necrophagous birds living in their natural 
habitat. 

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) 

(ii) 

the  species  of  necrophagous  birds  in  certain  Member  States  to  which 
such material may be fed;  

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  essential  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 28 
Derogations regarding the disposal of animal by-products 

1. 

The competent authority may, by way of derogation 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 remote areas by burning or burial on site or 
by  other  means  under  official  supervision  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 practically impossible or where access would 
only  be  possible  under  circumstances,  related  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 collection or where access would necessitate 
the use of disproportionate means of recovery;  

EN 

47 

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(d)  by  means  other  than  burning  or  burial  on  site,  under  official  supervision,  of 
Category  2  and  Category  3  materials  which  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 subparagraph 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 conditions which prevent the transmission 
of  risks  to  public  and  animal  health,  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 with point (d) of the first subparagraph 
of  paragraph  4,  if  transport  to  the  nearest  plant  approved  for  processing  or 
disposal of the animal by-products would increase the danger of propagation of 
health  risks  or  would  lead,  in  case  of  a  widespread  outbreak  of  an  epizootic 
disease, to a lack of capacity at such plants. 

The  size  of  the  remote  areas  in  a  particular  Member  State  referred  to  in  paragraph 
1(b) may not exceed a percentage of the size of the surface of its land territory.  

Member States shall make available to the Commission information on: 

(a) 

the  areas  that  they  categorise  as  remote  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 authorisations provided for in paragraph 1(c) and (d) 
with respect to Category 1 and Category 2 material. 

2. 

3. 

4. 

Measures for the implementation of this Article may be adopted by the Commission 
on: 

(a) 

conditions aimed at ensuring control of risks to public and animal health for the 
burning and burial on site;  

(b) 

the maximum percentage of the territory as referred to in paragraph 2; 

(c) 

the volume of animal by-products, in relation to the nature of activities and the 
species of origin, as referred to in paragraph 1(d); 

(d) 

the list of diseases referred to in paragraph 1(e). 

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Those  measures  designed  to  amend  non  essential  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 5: ALTERNATIVE METHODS FOR THE USE AND DISPOSAL OF ANIMAL 
BY-PRODUCTS AND DERIVED PRODUCTS 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Article 29 
Approval of alternative methods for use or disposal 

The procedure for approval of an alternative method of use or disposal of animal by-
products or derived products may be initiated either by the Commission or following 
an  application  by  a  Member  State  or  by  an  interested  party,  which  may  represent 
several interested parties. 

Interested  parties  shall  send  their  application  to  the  competent  authority  of  the 
Member State where they intend to use the alternative method.  

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 referred to in paragraph 10.  

The  competent  authority  shall  communicate  applications  from  Member  States  and 
interested  parties,  together  with  a  report  on  its  evaluation  to  the  European  Food 
Safety Authority (hereinafter referred to as "the Authority") and to the Commission. 

The  Commission  shall  communicate  applications,  together  with  a  report  on  its 
evaluation to the Authority. 

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.  

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.  

Where  applicants  submit  additional  information  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. 

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49 

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8. 

9. 

The  Authority  shall  forward  its  opinion  to  the  Commission,  the  applicant  and  the 
competent authority of the Member State concerned. 

Within three months of the receipt of the opinion of the Authority 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  for  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 authorisation of such an alternative method. 

Those  measures  designed  to  amend  non  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 

CHAPTER IV: 
OFFICIAL CONTROLS 

Article 30 
Official controls 

1. 

2. 

1. 

The  competent  authority  shall  at  regular  intervals  carry  out  official  controls  and 
supervision at approved or registered  plants and establishments  and at premises for 
which information has been provided in accordance with Article 40(3). 

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 

If the official controls and supervision carried out by the competent authority reveal 
that  one  or  more  of  the  requirements  of  this  Regulation  are  not  met,  it  shall  take 
appropriate action.  

The competent authority shall in particular  

(a) 

suspend  approvals  of  plants  and  establishments  approved  pursuant  to  this 
Regulation, if: 

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(i) 

(ii) 

the  conditions  for  approving  or  operating  the  plant  or  establishment  are 
no longer fulfilled;  

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  establishments  approved  pursuant  to  this 

Regulation, if: 

(i) 

(ii) 

the  conditions  for  approving  or  operating  the  plant  or  establishment  are 
no longer fulfilled; 

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 personal 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. 

1. 

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 information indicating 

(a) 

that the requirements of Community 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 

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  has  been  provided  in  accordance  with 
Article 40(3) within its territory.  

EN 

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It shall assign an official number to each approved or registered plant, establishment 
or user, and to each operator on which information has been provided in accordance 
with  Article  40(3)  which  identifies  the  plant,  establishment,  user  or  operator  with 
respect to the nature of its activities.  

Member  States  shall  indicate,  if  applicable,  an  official  number  which  has  been 
assigned  to  the  plant,  establishment,  user  or  operator  under  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  approved  plants  or  registered  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 Article may be laid down in accordance with 
the procedure referred to in Article 48(3), in particular on: 

(a) 

the format for the lists referred to in paragraph 1; 

(b) 

the procedure for making the lists referred 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,  Category  2  material  or 
meat  and  bone  meal  or  animal  fat  derived  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) 

(ii) 

if  the  material  or  derived  products  have  not  undergone  pressure 
sterilisation, it must undergo such treatment; or 

the material or derived products must 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  authority  of  the  place  of  origin  prior  to  the 
intended dispatch of a consignment. 

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52 

   EN 

 
2. 

3. 

4. 

5. 

6. 

The competent authority of the place of origin 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 products referred to in paragraph 1; 

(b)  meat and bone meal and animal fat derived from Category 2 material; 

(c) 

processed animal protein derived from Category 3 material.  

When informed  of the  dispatch, the  competent 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. 

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 place in accordance with 
an authorisation issued by the competent authority. 

When  animal  by-products  or  derived  products  are  sent  to  other  Member  States  via 
the territory of a third country, they shall be sent in means of transport which have 
been  sealed  in  the  Member  State  of  origin  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. 

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 requirements of Regulation (EC) No 1013/2006. 

Measures for the implementation of this Article may be adopted by the Commission 
on: 

(a) 

supplementary  conditions  for  the  dispatch  of  animal  by-products  or  derived 
products referred to in paragraph 3; 

(b)  models for the health certificates which have to accompany consignments sent 

in accordance with paragraph 4. 

Those  measures  designed  to  amend  non  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 48(4).  

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7. 

1. 

2. 

Derogations from paragraphs 1 to 4 may be granted by the Commission with respect 
to the dispatch of manure transported between two points located on the same farm 
or between farms located in the border regions of Member States sharing a common 
border. 

Those  measures  designed  to  amend  non  essential  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 34 
Community controls in Member States 

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  results  of  the  checks 
made. 

Measures for the implementation of this Article may be adopted in accordance with 
the  procedure  referred  to  in  Article  48(3),  in  particular  on  the  procedure  for  the 
cooperation with national authorities. 

CHAPTER V: 
IMPORT, TRANSIT AND EXPORT 

Article 35 
Import and transit of animal by-products 

1. 

Animal  by-products  or  derived  products  shall  be  imported  into,  or  sent  in  transit 
through, the Community in accordance with: 

(a) 

(b) 

the  relevant  requirements  of  this  Regulation  for  the  particular  animal  by-
product or derived product which are at least as strict as those applicable to the 
production  and  marketing  of  such  animal  by-products  or  derived  products 
within the Community; 

conditions  recognised  by  the  Commission  to  be  at  least  equivalent  to  the 
requirements  applicable  to  the  production  and  marketing  of  such  animal  by-
products or derived products under Community legislation; or 

EN 

54 

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(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,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 48(4).  

2. 

By way of derogation from paragraph 1, the importation and transit of: 

(a) 

(b) 

specified  risk  material  shall  take  place  only  in  accordance  with  Regulation 
(EC) No 999/2001;  

animal by-products or derived products mixed or contaminated with any of the 
waste  listed  as  hazardous  in  Decision  2000/532/EC  shall  take  place  only 
subject to the requirements of Regulation (EC) No 1013/2006; 

(c)  Category 1 material, Category 2 material 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  importation  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  take  place  in  accordance  with  national  measures  which 
ensure the control of risks to public and animal health, pending the adoption of 
harmonised conditions referred 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 referred 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  establishments  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  transportation  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  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 48(4). 

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Pending the adoption by the Commission of the 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 transit through the Community shall be drawn 
up in accordance with the procedure referred to in Article 48(3), taking into account 
in particular: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

the legislation of the third country;  

the  organisation  of  the  competent  authority  and  its  inspection  services  in  the 
third country, the powers  of  those  services, the supervision to which they are 
subject,  and  their  authority  to  monitor  effectively  the  application  of  their 
legislation;  

the actual health conditions applied to the production, manufacture, handling, 
storage and dispatch of products of animal origin intended for the Community;  

the  assurances  the  third  country  can  give  regarding  compliance  with  the 
relevant health conditions;  

experience of  marketing  the product from the third country and the results of 
import checks carried out;  

the result of any Community inspections in the third country;  

the  health  status  of  the  livestock,  other  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;  

the  regularity  and  speed  with  which  the  third  country  supplies  information 
about the existence of infectious 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; 

the regulations on the prevention 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 referred 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.  

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Article 36 
Implementing measures 

Measures for the implementation of Article 35 may be adopted by the Commission on: 

(a) 

(b) 

(c) 

(d) 

conditions for the importation and transit of Category 1 and Category 2 material and 
for products derived thereof; 

restrictions  regarding  public  or  animal  health  applicable  to  imported  Category  3 
material or products derived thereof which may  

(i) 

(ii) 

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; 

exclude  animal  by-products  or  derived  products  manufactured  in  certain 
establishments from importation or transit in order to protect public or animal 
health; 

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 establishments handling animal by-products or derived 
products from approval or registration as referred to in Article 35(3)(b); 

models for health certificates which shall 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  essential  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. 

2. 

3. 

The export of animal by-products and derived products destined for  incineration  or 
landfill shall be prohibited. 

The  export  of  animal  by-products  and  derived  products  for  use  in  a  biogas  or 
composting  plant  to  third  countries  which  are  not  members  of  the  OECD  shall  be 
prohibited. 

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. 

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Those  measures  designed  to  amend  non  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance 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 Category 3 material or 
products derived thereof in compliance with this Regulation. 

5. 

By way of derogation from paragraphs 3 and 4, the export of: 

(a) 

(b) 

specified  risk  material  shall  take  place  only  in  accordance  with  Regulation 
(EC) No 999/2001;  

animal by-products or derived products mixed or contaminated with any of the 
waste  listed  as  hazardous  in  Decision  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. 

2. 

3. 

Article  46  of  Regulation  (EC)  No  882/2004  shall  apply  mutatis  mutandis  to 
Community  controls  in  third  countries  carried  out  to  verify  compliance  with  this 
Regulation. 

Article 50(1)(a) of Regulation (EC) No 882/2004 shall apply mutatis mutandis to the 
phased introduction of the requirements of Article 35(3) of this Regulation. 

Article  52  of  Regulation  (EC)  No  882/2004  shall  apply  mutatis  mutandis  to  third-
country controls in Member States related 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 products referred to in Article 2(3) shall not 
be subject to Chapters II, III and IV. 

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However, in the case of derived products  

(a) 

(b) 

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  potential  risks  to  animal  health  in  accordance  with  the 
objectives of this Regulation; 

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 potential risks to public and animal 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) 

(b) 

to  the  derived  products  referred  to  in  Article  2(3)(a),  (b),  (c)  and  (d)  of  this 
Regulation, in the case of risks to animal health; 

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.  

1. 

2. 

3. 

Article 40 
Manufacture of derived products regulated by other Community legislation 

The  importation,  collection  and  channelling  of  animal  by-products  and  derived 
products  destined  for  establishments  for  the  manufacture  of  the  derived  products 
referred  to  in  Article  2(3)  and  the  manufacture  of  those  derived  products  shall  be 
carried  out  in  accordance  with  the  Community  legislation  referred  to  in  that 
paragraph.  

Unused  material  from  such  establishments  shall  be  disposed  of  in  accordance  with 
that legislation. 

However, this Regulation shall 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.  

Operators referred to in Article 7(1)(e) shall provide the following information to the 
competent  authority  responsible  for  official  controls  in  accordance  with  this 
Regulation: 

(a) 

(b) 

the category of animal by-products and derived products used; 

the  operations  using  animal  by-products  or  derived  products  as  starting 
material which are being performed in the establishment. 

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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 paragraph 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 products, 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 risks to public and animal health by: 

(i) 

safe sourcing in accordance with Article 42; 

(ii) 

safe  treatment  in  accordance  with  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  products  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  accordance  with  Article  46(2)(a),  when  such 
products no longer pose any significant risk to public or animal health.  

1. 

Safe sourcing shall include the use of the material: 

Article 42 
Safe sourcing 

(a) 

from which no unacceptable risks to public and animal health arise; 

(b)  which  has  been  collected  and  channelled  from  the  point  of  collection  to  the 
manufacturing  establishment  under  conditions  which  exclude  risks  arising  to 
public and animal health; or 

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(c)  which has been imported into the Community and channelled from the point of 
first entry to the manufacturing establishment under conditions which exclude 
risks arising to public and animal health. 

2. 

For  the  purpose  of  safe  sourcing,  operators  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 available to the competent authority upon request. 

The  operator  shall  also  transport  consignments  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 application of a manufacturing process to the material used which 
reduces  to  an  acceptable  level  risks  to  public  and  animal  health  arising  from  such  material 
used and from other substances arising from the manufacturing process. 

It shall be ensured that the derived product poses no unacceptable 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) 

(b) 

under conditions which pose no unacceptable risks to public and animal health; or 

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 the competent authority where they: 

(a) 

(b) 

handle material used in accordance with Article 41(1) and Article 42; 

treat material used in accordance with Article 41(1) and Article 43; or 

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(c) 

place  derived  products  on  the  market  in  accordance  with  Article  41(1)  and 
Article 44(b). 

Registration  shall  take  place  upon  receipt  by  the  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  petfood  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 referred to in Article 48(3), on: 

(a)  models  for  health  certificates  which  must  accompany  consignments  in 

accordance with the fourth subparagraph of Article 42(2); 

(b) 

a  harmonised  form  for  the  transmission  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 point in the manufacturing chain following 
which  no  public  or  animal  health  requirements  apply  to  the  placing  on  the 
market; 

(b) 

conditions  for  the  safe  sourcing  and  channelling  of  material  to  be  used  under 
conditions which exclude risks arising to public and animal health; 

(c) 

documentation as referred to in the 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 applicable to the end product; 

(f) 

conditions for the safe use of derived products which pose a risk to public or 
animal health. 

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Those  measures  designed  to  amend  non  essential  elements  of  this  Regulation,  by 
supplementing it, shall be adopted in accordance 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 Commission the text of any national legislation they 
adopt  in  areas  under  their  competence  which  directly  concern  the  proper  implementation  of 
this Regulation.  

Article 48 
Committee 

1. 

2. 

3. 

4. 

5. 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal  Health  established  by  Article  58(1)  of  Regulation  (EC)  No  178/2002, 
hereinafter referred to as "the Committee". 

Where  reference  is  made  to  this  paragraph,  Articles  3  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

Where  reference  is  made  to  this  paragraph,  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. 

Where  reference  is  made  to  this  paragraph,  Articles  5a(1)  to  (4),  and  Article 7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

Where  reference  is  made  to  this  paragraph,  Articles  5a(1)  to  (4)  and  (5)(b)  and 
Article  7  of  Decision  1999/468/EC  shall  apply,  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. 

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Article 49 
Penalties 

The Member States shall lay down the rules on penalties 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,  proportionate  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  effect  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 users approved or registered in accordance with Regulation (EC) 
No 1774/2002  before  [the  date  of  application  of  this  Regulation]  shall  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, fifteen 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 
The President 

For the Council 
The President 

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ANNEX 

CORRELATION TABLE 

Regulation (EC) No 1774/2002 

This Regulation 

Art. 1  

Art. 2 

Art. 3(1) 

Art. 3(2) 

Art. 3(3) 

Art. 4(1) 

Art. 4(2) 

Art. 4(3) 

Art. 4(4) 

Art. 5(1) 

Art. 5(2) 

Art. 5(3) 

Art. 5(4) 

Art. 6(1) 

Art. 6(2) 

Art. 6(3) 

Art. 7 

Art. 8 

Art. 9 

Art. 1, 2  

Art. 3 

./. 

Art. 35(3), fourth subparagraph 

Art. 4 

Art. 11 

Art. 19, 22, 23 

Art. 6(1)(a)  

Art. 35(2)(c), 37(3), 37(5)(a) 

Art. 12 

Art. 20, 22, 23 

Art. 6(1)(a) 

Art. 35(2)(c), 37(3) 

Art. 13 

Art. 21, 22, 23 

Art. 6(1)(a) 

Art. 15 

Art. 33 

Art. 16 

Art. 10, 11, 12, 13, 14, 15, 17, 18 

Art. 6, 7, 8, 9 

Art. 16  

Art. 19 

Art. 5 

Art. 24  

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Art. 20(1) 

Art. 20(2) 

Art. 20(3) 

Art. 21 

Art. 22 

Art. 23 

Art. 24 

Art. 25 

Art. 26 

Art. 27 

Art. 28 

Art. 29 

Art. 30 

Art. 31 

Art. 32 

Art. 33 

Art. 34 

Art. 35 

Art. 36 

Art. 37 

Art. 38 

Art. 41  

Art. 25 

Art. 41 

./. 

Art. 18 

Art. 26, 27 

Art. 28 

Art. 17 

Art. 30, 31, 32 

Art. 34 

Art. 35(1)(a), (c) 

Art. 35, 36 

Art. 35(1)(b)  

Art. 38(1) 

./. 

Art. 48 

./. 

Art. 47, 23(2) 

./.  

Art. 50 

Art. 52 

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