Report from the Commission to the Council and the European Parliament on the measures taken by member states to ensure compliance with regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption
Date: 2005-10-21
Institutions: European Commission
Subjects: EU Member State, agricultural by-product, animal product, application of EU law, foodstuffs legislation, health control, health legislation, public health, report, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.10.2005 
COM(2005) 521 final 

. 

REPORT FROM THE COMMISSION TO THE COUNCIL AND 
THE EUROPEAN PARLIAMENT 

on the measures taken by member states to ensure compliance with regulation (EC) 
No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying 
down health rules concerning animal by-products not intended for human consumption 

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TABLE OF CONTENTS 

1. 

2. 

3. 

3.1. 

3.2. 

3.3. 

4. 

5. 

EXECUTIVE SUMMARY.......................................................................................... 4 

INTRODUCTION........................................................................................................ 5 

MEASURES TAKEN BY MEMBER STATES TO ENSURE COMPLIANCE 
WITH THE REGULATION........................................................................................ 7 

Measures taken by Member States to comply with the Regulation ............................. 7 

Derogations granted by Member States under Articles 23(2) and 24.......................... 8 

Overall situation on the measures taken by Member States to ensure compliance with 
the Regulation, as reflected in the FVO mission findings ........................................... 8 

MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED 
THROUGH COMITOLOGY PROCEDURE OR GUIDANCE ................................. 8 

ISSUES THAT CAN STILL BE SOLVED BY COMITOLOGY OR GUIDANCE 
OR CAN BE SOLVED ONLY BY CO-DECISION PROCEDURE.......................... 9 

5.1. 

Issues that can still be solved by Comitology or guidance .......................................... 9 

5.1.1.  Definitions for ABPs not yet covered .......................................................................... 9 

5.1.2.  Clarify EU veterinary and waste legislation applicable to ABPs ................................ 9 

5.1.3.  Technical products ....................................................................................................... 9 

5.1.4.  Alternatives methods for the processing, use and disposal of ABPs ......................... 10 

5.1.5.  Application on land of organic fertilisers and soil improvers.................................... 10 

5.1.6.  Transformation standards for ABPs in composting and biogas plants and heat 

treatment process for manure ..................................................................................... 10 

5.1.7.  Use of milk and milk-based products defined as Category 3 materials for direct 

feedingstuffs............................................................................................................... 11 

5.1.8.  Possibility to process ABPs from other sources on same site as a slaughterhouse.... 11 

5.1.9.  New import certificates for ABPs not yet covered .................................................... 11 

5.1.10.  Markers for ABPs intended for disposal as waste ..................................................... 11 

5.1.11.  Guidance to clarify issues that have arisen as a result of FVO missions................... 11 

5.1.12.  Implementing rules for prohibiting intra-species recycling (cannibalism) ................ 11 

5.2. 

Issues that can be solved only by Co-decision procedure.......................................... 12 

5.2.1.  Clarification of the scope of the Regulation and amendment of Article 1................. 12 

5.2.2.  Amendments of Articles 4, 5 and 6: clarification and need to insert new products .. 12 

5.2.3.  Amendments of Articles 17 and 18: exempt certain plants from the need for further 

approval under ABPs Regulation............................................................................... 12 

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6. 

7. 

SIMPLIFICATION .................................................................................................... 13 

CONCLUSION .......................................................................................................... 13 

ANNEX I 
ABBREVIATIONS AND TECHNICAL TERMS USED IN THE REPORT ........................ 15 

ANNEX II 
INFORMATION PROVIDED BY MEMBER STATES ON MEASURES TAKEN TO 
ENSURE COMPLIANCE WITH THE ABPs REGULATION .............................................. 17 

ANNEX III 
DEROGATION GRANTED BY MEMBER STATES UNDER ARTICLES 23(2) AND 24 23 

ANNEX IV 
MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH 
COMITOLOGY PROCEDURE OR GUIDANCE.................................................................. 24 

1. 

1.1. 

1.2. 

2. 

3. 

4. 

5. 

6. 

Transitional measures for Member States and Third Countries................................. 24 

Transitional measures for Member States.................................................................. 24 

Transitional measures for third Countries.................................................................. 25 

Commission Regulations amending Regulation (EC) No 1774/2002 ....................... 26 

Measures taken to implement Regulation (EC) No 1774/2002 ................................. 26 

Permanent general derogations granted. .................................................................... 27 

Permanent specific derogations granted on request from member States.................. 27 

Guidelines issued to clarify a certain number of issues. ............................................ 27 

ANNEX V 
LIST OF THE LEGISLATION REPEALED AND REPLACED BY REGULATION (EC) 
NO 1774/2002 .......................................................................................................................... 28 

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1. 

EXECUTIVE SUMMARY 

Article 35 of Regulation (EC) N° 1774/20021 of the European Parliament and of the 
Council of 3 October 2001 laying down health rules concerning animal by-products 
(ABPs) not intended for human consumption  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 is required to submit a report to 
the  European  Parliament  and  the  Council  accompanied,  if  necessary,  by  legislative 
proposals. 

All 25 Member States have submitted the required information. 

The present report addresses the following points: 

1. 

2. 

3. 

4. 

5. 

6. 

The  measures  taken  by  the  Member  States  to  ensure  compliance  with  the 
Regulation.  Overall,  Member  States  have  taken  the  necessary  administrative 
and control measures to ensure compliance. 

The main issues raised by the Member States that the Commission has already 
addressed  through  Comitology  or  guidelines,  including  implementing  and 
amending  measures  to  ensure  the  smooth  application  of  the  Regulation  and 
derogation and transitional measures to avoid the disruption of trade. 

The main issues raised by Member States that the Commission can still solve 
either through Comitology or by means of guidelines. 

The  main  issues  raised  by  Member  States  that  can  only  be  solved  by  Co-
decision  procedures.  In  particular,  Member  States  strongly suggest  redefining 
the scope of the Regulation. 

Possible further simplification of certain provisions of the Regulation. 

Finally,  the  report  concludes  that,  overall  Member  States  have  taken  the 
necessary  administrative  and  control  measures  to  ensure  compliance.  This 
conclusion  is  supported  by  the  findings  of  inspections  carried  out  by  the 
Commission’s Food and Veterinary Office. 

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OJ L 273 of 10.10.2002, p. 1. 

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2. 

INTRODUCTION 

Background 

Regulation (EC) No 1774/2002 of the European Parliament and of the Council lays 
down health rules for the collection, transport, storage, handling, processing and use 
or  disposal  of  all  ABPs  not  intended  for  human  consumption.  It  was  adopted  in 
response to various feed-borne crises (dioxin in 1999, classical swine fever in 2000 
and  foot  and  mouth  disease  in  2001,  EU-wide  Bovine  Spongiform  Encephalopathy 
(BSE) crisis in 2001).  

The  Regulation  is  an  Action  30  of  the  Commission’s  White  Paper  on  Food  Safety 
(2000).  It  has  revamped  the  Community’s  rules  on  ABPs,  ensuring  a  high  level  of 
protection of animal and public health throughout the EU.  

The overall situation surrounding the EU-wide feed-borne crises in 1999-2001 meant 
that  the  Regulation  had  to  be  applied  and  the  Commission  had  to  adopt  by 
Comitology  several  transitional  measures  (including  derogations  and  implementing 
measures)  rapidly  to  avoid  the  disruption  of  trade,  allowing  time  for  operators  and 
Member States administration systems to adapt. The Regulation entered into force on 
1 November 2002 and is directly applicable in all Member States since 1 May 2003.. 
Some of the measures introduced have resulted in difficulties of application. 

The  ABPs  Regulation  simplified  and  repealed  a  large  number  of  Community 
legislations,  which  were  adopted  in  the  past  in  reactions  to  crises,  creating  a  new 
single  legal  framework  for  the  ABPs  sector.  It  introduced  the  concept  of  three 
categories of ABPs, based on risk. It requires those categories of by-products to be 
processed, used or disposed of without undue delay in specified approved premises. 
Permitted  premises  must  operate  to  standards,  specified  where  appropriate,  that 
ensure  that  the  end  product  does  not  pose  a  risk  to  public  or  animal  health.  Where 
premises do not operate in accordance with the Regulation, the competent authority 
must act to prevent the premises continuing to receive ABPs or processed products, 
or  ensure  that  the  operator  takes  corrective  action.  The  Regulation  introduced 
incineration  and  co-incineration  as  outlets  for  ABPs  and,  for  certain  categories  of 
material,  permitted  composting  and  biogas  production.  It  also  provided  for 
alternative  outlets  to  be  permitted  where  appropriate  following  a  scientific  opinion 
and enabled Member States to exercise derogations to allow national practices such 
as the feeding of certain types of ABPs to birds of prey, necrophagous birds, packs of 
hounds,  zoo  animals,  etc.  It  also  tightened  the  traceability  and  record  keeping 
requirements,  requiring  dedicated  separation,  according  to  their  risk  status,  of  the 
collection, treatment and use of ABPs. 

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The  Community’s  scientific  advisory  body,  the  Scientific  Steering  Committee, 
replaced  by  the  European  Food  Safety  Authority  (EFSA)  since  2002  adopted  a 
number  of  opinions  in  relation  to  the  safety  of  ABPs,  including  animal  feed2.  The 
main conclusion of the scientific opinions was that ABPs derived from animals that 
are  not  fit  for  human  consumption  following health inspection should not enter the 
feed chain; they must be properly handled and disposed of following adequate pre-
treatment to prevent the possible spread of pathogens. On the basis of these opinions, 
the Regulation restricts the type of material that may be used for feeding to livestock 
or pets. It prohibits the recycling of certain ABPs into the feed chain, namely fallen 
stock and other condemned animal material. Only raw material derived from animals 
declared fit for human consumption is allowed for the production of feed. Thus only 
Category 3 material (or material which was fit for human consumption) may be used 
for  these  purposes,  after  suitable  processing  and  where  permitted  by  the  TSE 
Regulation No 999/20013. It also prohibits intra-species recycling (cannibalism) and 
the feeding of catering waste to livestock. This principle was strongly upheld by the 
European  Parliament  and  the  Council,  and  is  the  minimum  standard  that  Member 
States could support in the light of the recent EU-wide feed-borne crises. 

Progress: achievements 

Member  States  have  indicated  that  they  have  made  generally  good  progress  in 
applying  the  ABPs  Regulation.  There  is  broad  support  for  the  principles  of  the 
Regulation,  and  the  controls  outlined  above  are  proportionate  in  most  cases.  In 
particular,  the  increase  in  the  number  of  outlets  for  ABPs  and  the  potential  for 
increasing the amount of material recycled is welcome. The vast majority of ABPs 
produced including all risk materials are now being handled in accordance with the 
Regulation and consigned to the permitted outlets. This is confirmed by the findings 
of  the  inspections  carried  out  by  the  Commission’s  Food  and  Veterinary  Office 
(FVO)  in  Member  States  in  2004-2005.  Although  further  work  is  still  needed,  the 
increased focus on ABPs is thought to have helped to safeguard the integrity of the 
food and feed chains (by reducing the risk of illegal diversion of ABPs) and to have 
improved the standards of handling and treatment of ABPs at all stages. As such the 
application  of  the  Regulation  has  served  to  minimise  the  possibility  of  ABPs 
introducing  or  spreading  pathogens  to  humans  or  animals,  and  has  complemented 
other  legislation,  such  as  that  applying  to  the  environment,  food  hygiene,  and  TSE 
and  other  disease  control  measures.  Guidance  has  been  prepared  to  explain  the 
relationship between the ABPs and environment legislation, and between the ABPs 
and food hygiene legislation, facilitating a harmonious application. 

2 

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Opinions available on EFSA web site: 
http://www.efsa.eu.int/science/biohaz/biohaz_opinions/catindex_en.html 
OJ L 147, 31.5.2001, p. 1. 

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Issues 

The  Regulation  is  very  wide-ranging.  It  introduced  controls  on  some  material  and 
extended  the  controls  on  others,  as  well  as  bringing  new  types  of  outlet  within  its 
control. Thus there have been some difficulties in certain areas. Some of these have 
been  addressed  through  the  transitional  measures,  by  providing  time  to  enable  the 
relevant industry sector to adjust. But others have arisen because, during the original 
negotiations, not all of the numerous uses for ABPs had been identified. For some of 
these  uses  it  would  be  disproportionate  to  apply  the  full  controls  of  the  Regulation 
and Member States have indicated that a more appropriate level of control needs to 
be established. 

Why this report? 

Article 35 of the Regulation requires: 

–  Member  States  to  inform  the  Commission  of  the  national  measures  taken  to 
ensure  compliance  with  the  Regulation  within  a  year  following  its  entry  into 
force, and 

– 

on the basis of the information received, the Commission to submit a report to 
the  European  Parliament  and  the  Council  accompanied,  if  appropriate,  by 
legislative proposals. 

Member  States  have  submitted  the  necessary  information,  on  which  this  report  is 
based. 

The report is submitted  later  than required  under  Article  35  of  the  Regulation.  The 
extra time taken has enabled the Commission to take into account the situation in the 
new  Member  States  and  the  findings  of  the  FVO  inspections  in  providing  a  full 
picture of the compliance situation in Member States. 

3. 

MEASURES  TAKEN  BY  MEMBER  STATES  TO  ENSURE  COMPLIANCE 
WITH THE REGULATION 

3.1.  Measures taken by Member States to comply with the Regulation 

According to the areas of competence not determined by Community law or left to 
national  rules  by  the  Regulation,  Member  States  have  to  varying  degrees  taken  a 
series of measures to ensure compliance with the Regulation. The measures adopted 
can be broadly described as follows: 

–  Measures  to  allocate  and  define  the  competences  of  the  relevant  authorities 

involved in the implementation and enforcement of the Regulation; 

– 

– 

General implementation measures; 

Sectorial implementation measures; 

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–  Measures laying down sanctions; and 

– 

Guidance. 

The  information  provided  by  Member  States  on  the  measures  they  took  to  ensure 
compliance with the ABPs Regulation is given in Annex II of the report. 

3.2. 

Derogations granted by Member States under Articles 23(2) and 24 

–  Member  States  have  provided  derogation  under  Article  23  (2)  as  regards  the 
feeding of zoo, circus and fur animals, reptiles and birds of prey other than zoo 
or  circus  animals,  wild  animals  the  meat  of  which  is  not  for  human 
consumption, dogs from kennels and maggots for fishing bait. 

– 

Also Member States have given derogation under Article 24 of the Regulation 
as regards burial or burning under specific conditions and circumstances (dead 
pet animals, remote areas or in cases of disease outbreaks). 

For a full list of the derogations and explanations see Annex III. 

3.3. 

Overall situation on the measures taken by Member States to ensure compliance 
with the Regulation, as reflected in the FVO mission findings 

An interim report providing an overview of the 13 missions in the old Member States 
has been provided, for internal purpose, by the FVO in April 2005. The scope of the 
missions  was  to  evaluate  the  measures  put  in  place  to  give  effect  to  the  ABPs 
Regulation.  

Overall,  the  report  concludes  that  in  all  Member  States  adequate  arrangements  and 
sufficient infrastructures are in place to handle most of the ABPs in accordance with 
the  ABPs  Regulation.  However,  more  is  needed  to  guarantee  the  flow  of  all  ABPs 
within the allowed chains until their permitted use, separation or safe disposal in all 
Member States.  

In  particular,  adequate  staff  resources,  clear  definition  and  distribution  of 
responsibilities  amongst  the  competent  authorities  involved,  more  guidance  and 
training  for  and  co-operation  between  the  CA,  would  improve  the  effectiveness 
and/or uniformity of official control. 

4. 

MAIN  ISSUES  RAISED  BY  MEMBER  STATES  ALREADY  SOLVED 
THROUGH COMITOLOGY PROCEDURE OR GUIDANCE 

The  disposal  infrastructure  in  most  Member  States  was  already  suitably  developed 
and they easily phased in the new requirements by 1 May 2003. However, some of 
them were not going to be able to meet that deadline. Therefore, where appropriate 
and justifiable, Article 32 of the Regulation allowed a possible temporary relaxation 
of the measures. This was used to allow less developed industry sectors or those with 
specific problems in adapting time to acquire the necessary facilities. 

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At the  same time, the Commission  prepared permanent implementing  measures for 
the  various  Articles  as  well  as  reviewing  the  Annexes  and  general  and  specific 
derogations. 

A summary of legislative acts that the Commission has adopted until 1st September 
2005 under the Comitology procedure is given in Annex IV. 

5. 

ISSUES THAT CAN STILL BE SOLVED BY COMITOLOGY OR GUIDANCE 
OR CAN BE SOLVED ONLY BY CO-DECISION PROCEDURE 

5.1. 

Issues that can still be solved by Comitology or guidance 

Most  issues  raised  by  Member  States  can  be  solved  by  Comitology,  or  can  be 
clarified by updating current guidelines already published. The main issues are listed 
below. 

5.1.1.  Definitions for ABPs not yet covered 

There  is  a  need  to  clarify  the  definition  of  certain  ABPs  in  order  to  facilitate  a 
harmonised application of the Regulation. 

One example is the scope of the definition for “former foodstuffs” products of animal 
origin or containing them, which are no longer intended for human consumption for 
different reasons.  

5.1.2.  Clarify EU veterinary and waste legislation applicable to ABPs  

Member  States  and  operators  consider  it  important  to  avoid  duplication  and  any 
resulting  unnecessary  burden  due  to  the  concurrent  application  to  ABPs  of 
Community veterinary (under the responsibility of Health and Consumer protection 
Directorate General) and waste (under the responsability of the Directorate General 
for the Environment) legislation. Guidance has been issued which seeks to clarify the 
relationship between the two sets of controls. However, more legal clarity is needed. 
A  Commission  proposal,  which  is  intended  to  clarify  the  relationship  between 
Regulations  (EC)  No 1774/2002  and  259/93  in  respect  of  waste  shipments 
(COM(2003) 379  of  30  June  2003,  as  amended  by  COM(2004)  172)  is  currently 
subject to the Co-decision procedure, second reading. 

5.1.3.  Technical products 

• 

cosmetics, medicinal products, and medical devices 

The ABPs Regulation does not apply to finished products, such as cosmetic products, 
medicinal products, medical devices or in-vitro diagnostics. 

However, the ABPs Regulation has an important regulatory impact on these sectors, 
some  of  which  use  processed  ingredients/starting  materials and substances deriving 
from animals and animal-by products in producing the final product. Consequently, a 
more complete and satisfactory solution to simplify the application of the Regulation, 
making  it  more  appropriate  to  the  risk,  necessitates  changes  to  it,  through  Co-
decision procedure (see points 5.2.2 and 5.2.3). 

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Some  Member  States  and  EU  operators  have  expressed  concerns  about  the 
requirements  of  the  ABPs  Regulation  being  applied  to  the  importation  of  certain 
Category 3 starting materials which require only minor further handling (e.g. mixing, 
packaging or labelling) to make them suitable for placing on the market or use by the 
end  user  in  the  EU.  One  example,  are  “intermediate  products”  used  for  the 
manufacture of medical devices. A draft proposal laying down specific requirements 
for their importation is being finalised for adoption before the end of 2005. 

In addition, it has to be considered that these technical products, in many instances, 
use highly specialised materials and, for that purpose, it has been suggested to revise 
the list of third countries from which the importation of these materials is allowed.  

• 

Other technical products 

Other products having been processed in a way that they no longer pose a risk , such 
as fat derivatives for the production of fertilisers, could be excluded from the scope 
of  the  Regulation  (see  point  5.2  1)  or  subjected  to  limited  control  requirements  as 
above.  

5.1.4.  Alternatives methods for the processing, use and disposal of ABPs 

Technical amendments to a new Regulation allowing 5 new alternative methods for 
the  use/disposal  of  ABPs  (see  Annex  IV)  are  expected  to  accommodate  the  recent 
EFSA opinions (see also point 6). 

5.1.5.  Application on land of organic fertilisers and soil improvers 

Article  22(1)(c)  of  Regulation  (EC)  No  1774/2002  restricts  the  application  to 
pastureland  of  organic  fertiliser  or  soil  improvers,  other  than  manure.  A  scientific 
opinion has been issued by EFSA concerning the conditions under which Category 2 
and 3 materials can be applied to land, on the basis of which a draft proposal is being 
prepared. 

5.1.6.  Transformation  standards  for  ABPs  in  composting  and  biogas  plants  and  heat 

treatment process for manure 

Member  States  and  operators  have  raised  concerns  at  the  strictness  of  the 
transformation  standards  for  composting  and  biogas  plants  and  heat  treatment  for 
manure,  and  have  asked  the  Commission  to  allow  for  alternative  transformation 
parameters (time, temperature, and microbiological validation agents). 

Following  EFSA  opinions  on  the  issues,  the  Commission  will  lay  down  such 
alternative standards. 

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5.1.7.  Use  of  milk  and  milk-based  products  defined  as  Category  3  materials  for  direct 

feedingstuffs 

A new Regulation (EC) No 79/2005 has been adopted allowing the direct feeding to 
farmed  animals  of  dairy  products  produced  to  food  standards  (under  Council 
Directive  92/46/EEC4),  subject  to  animal  health  conditions  in  line  with  current 
scientific  opinions.  This  Regulation  could  be  amended  further  in  the  light  of  the 
EFSA opinion that is expected before end 2005.  

5.1.8.  Possibility to process ABPs from other sources on same site as a slaughterhouse 

Commission Regulation EC 808/2003 amending, Regulation No 1774/2002 permits 
the  operation  of  rendering  plants  adjacent  to  slaughterhouses,  subject  to  certain 
conditions. One of the conditions is that the ABPs to be processed in the rendering 
plant  must  originate  only  in  the  adjacent  slaughterhouse.  The  Commission  is 
considering introducing risk-based provisions to avoid the difficulties resulting from 
this condition. 

5.1.9.  New import certificates for ABPs not yet covered 

New certificates are being laid down in order to harmonise the import requirements 
for certain products wool, feathers, manure, composite products, etc) not yet covered 
by the Regulation..  

5.1.10.  Markers for ABPs intended for disposal as waste 

The  Regulation  requires  the  marking  of  ABPs  intended  for  disposal.  The 
Commission is still investigating the appropriate markers. A trial for this purpose is 
under  way.  Once  identified  and  validated,  the  markers  will  then  be  approved  by 
means of a Commission decision. 

5.1.11.  Guidance to clarify issues that have arisen as a result of FVO missions 

More questions have arisen as a result of the FVO missions in all Member States in 
2004-2005. An additional Commission guidance is being prepared with the view to 
facilitating further harmonious application of the Regulation. 

5.1.12.  Implementing rules for prohibiting intra-species recycling (cannibalism) 

Implementing rules for the prohibition of intra-species recycling (cannibalism) have 
only been laid down with regard to fish, because the use of processed animal protein 
other than fishmeal in the feeding of farmed animals has been prohibited by the BSE 
feed ban (Article 7 of Regulation (EC) No 999/2001 as amended). Progress has been 
made  in  the  development  of  methods  specifically  detecting  ruminant  proteins  in 
feedingstuffs, being one of the main conditions to review the BSE feed ban  

4 

OJ L 268, 14.9.1992, p. 1. 

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5.2. 

Issues that can be solved only by Co-decision procedure 

5.2.1.  Clarification of the scope of the Regulation and amendment of Article 1 

The Regulation is wide ranging. The provisions applicable to processed or finished 
products are not always clear. Thus a clarification in this respect is needed. 

Certain processed products, having been processed in a way that they no longer pose 
a risk, could be excluded from the scope of the Regulation or subject to a low level 
of  control.  For  example,  processed  ingredients  for  the  production  of  cosmetics, 
medical  devices  or  medicinal  products  are  not  to  be  considered  as  “animal  by-
products”.  Moreover,  the  ABPs  Regulation  clearly  does  not  apply  to  finished 
products, such as cosmetic products, medicinal products, medical devices or in-vitro 
diagnostics. (see point 5.1.3) 

For  ABPs  from  wild  animals  not  suspected  of  being  diseased,  it  should  be  further 
clarified  that,  in  accordance  with  the  objectives  of  the  Regulation,  the  ABPs 
produced  in  any  premises  used  for  processing  mammals  or  birds  for  human 
consumption,  are  covered  by  the  Regulation.  The  inclusion  in  the  scope  of  the 
Regulation of shellfish and other sea animals should also be better expressed.  

5.2.2.  Amendments of Articles 4, 5 and 6: clarification and need to insert new products 

As regards the categorisation of materials, a review exercise could be carried out to 
clarify  the  applicability  of  the  provisions  in  case  new  material  may  be  categorised 
under different entries. 

In  addition,  it  is  necessary  to  consider  the  possibility  of  including  in  the  different 
categories other products that, for the time being, cannot be classified properly.  

In this context the classification of ABPs that pose a very low risk as Category 2 (e.g. 
worms, insects, insect larvae, invertebrates intended for feeding to wild birds, use in 
pet-food  or  starting  material  used  for  cosmetic,  medical  devices  and  medicinal 
products like dead bees etc) should be re-visited. Such material may be classified as 
Category 3. 

5.2.3.  Amendments of Articles 17 and 18: exempt certain plants from the need for further 

approval under ABPs Regulation 

Certain premises already approved under food or other Community legislation must 
fulfil also the requirements set out in the ABPs Regulation. For those premises (e.g. 
producing tallow, eggs, gelatine etc.) for which Article 17 of the Regulation currently 
requires  an  approval,  there  should  be  no  need  to  be  re-approved  by  the  competent 
authority under the ABPs Regulation.  

Moreover  plants  producing  final  products  such  as  medical  devices,  cosmetic  and 
medicinal  product  shall  be  clearly  excluded  from  the  approval  obligation  under  the 
ABP regulation 

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As  well,  for  pet-food  and  technical  establishments  receiving  processed  animal 
proteins(PAPs),  for  which  Article  18  of  the  Regulation  currently  requires  an 
approval, there should be no need for re-approval by the competent authority under 
the  ABPs  Regulation  considering  that  PAPs  no  longer  pose  a  risk  to  animal  and 
public health  and are  already  approved under other Community legislation meeting 
the objectives of the ABPs legislation. 

Also,  many  products  destined  for  technical  products  are  produced  in  controlled 
laboratories,  university, research  and hospital  laboratories  or  in  the  medical  device, 
cosmetic  or  pharmaceutical  plants  themselves.  For  these  premises  approval  as 
described in the current regulation may not be necessary or appropriate. 

6. 

SIMPLIFICATION 

The  Regulation,  a  new  legal  framework  covering  the  whole  sector,  from  “farm-to-
table”  under  the  Commission  White  Paper  on  Food  Safety,  has  simplified  and 
repealed the previous 19 legislative acts (see list in Annex V). 

It has replaced the rules in various Commission Decisions, which lay down rules on 
animal and public health for the processing, disposal, placing on the market and use 
of products of animal origin not intended for human consumption.  

The  actions  highlighted  in  paragraphs  5.1  and  5.2  will  be  guided  by  the  same 
simplification  principle.  In  addition,  particular  attention  will  be  given  to  the 
following two areas: 

– 

– 

clarification of the scope of the Regulation  

approval  procedure  for  alternative  methods  for  the  processing,  uses  and 
disposal of ABPs 

7. 

CONCLUSION 

Member  States  and  operators  have  indicated  that  they  have  made  generally  good 
progress in applying the ABPs Regulation. There is broad support for the principles 
of the Regulation, and the controls are proportionate in most cases. In particular, the 
increase  in  the  number  of  outlets  for  ABPs  and  the  potential  for  increasing  the 
amount  of  material  recycled  is  welcome.  The  vast  majority  of  ABPs  produced 
including all risk materials are now being handled in accordance with the Regulation 
and consigned to the permitted outlets. 

According  to  the  Food  and  Veterinary  Office  inspections,  the  official  controls  of 
most  Category  1  and  2  materials  are  satisfactory  to  a  large  extent.  In  all  Member 
States  adequate  measures  (arrangements  and  infrastructures)  are  in  place  to  ensure 
the proper handling of most of the ABPs in accordance with the ABPs Regulation. In 
particular,  there  are  adequate  systems  in  place  to  ensure  the  proper  disposal  of  the 
risk materials (Category 1 and 2 materials). 

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However, more work is needed to guarantee the flow of all ABPs within the allowed 
chains until their permitted use, separation or safe disposal in all Member States. In 
particular,  adequate  staff  resources,  a  clear  definition  and  distribution  of 
responsibilities  amongst  the  competent  authorities  involved,  more  guidance  and 
training for and co-operation between the competent authorities, would improve the 
effectiveness and/or harmonisation of official controls. 

The  ABPs  Regulation  covers  a  wide  range  of  fields  and,  in  particular,  further 
clarification  of  the  scope  of  the  Regulation  would  help  to  achieve  full  compliance, 
enhancing common understanding by all operators involved and help to address the 
real risks that derive from animal by-products. This harmonisation of the rules will 
increase the competitiveness of operators in the light of the Lisbon strategy. 

While the changes proposed under points 5.1 and 5.2 reflect the main issues raised 
by Member States and stakeholders until now, it can be expected that on the basis of 
more  experience  gained  over  the  next  few  years,  it  might  be  necessary  to 
accommodate unforeseen issues and/ or emerging policy. 

The  Commission  is  considering  the  necessary  legislative  proposals  to  address  the 
issues referred to under point 5.2 via the co-decision procedure involving the Council 
and  the  European  Parliament.  The  Commission  continues  to  address  the  issues 
referred to under point 5.1 by Comitology. 

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ANNEX I 

ABBREVIATIONS AND TECHNICAL TERMS USED IN THE REPORT 

ABPs 

Animal  By-Products  (part  of  animal  that  is  not  intended 
for human consumption) 

ABP Regulation 

Regulation No 1774/2002 of the European Parliament and 
the  Council  laying  down  health  rules  concerning  animal 
by-products not intended for human consumption 

BSE 

Category 1 

Category 2  

Category 3 

Comitology 

known 

Bovine  Spongiform  Encephalopathy  is  one  of  a  group  of 
diseases 
spongiform 
encephalopathies, or TSEs, which are caused by the build-
up  of  abnormal  prion  proteins  in  the  brain  and  central 
nervous system 

transmissible 

as 

High-risk  animal  by-products  referred  to  in  Article  4  of 
the ABP Regulation (e.g. animals infected with TSE) 

Medium risk animal by-products referred to in Article 5 of 
the ABP Regulation (e.g. dead on-farm poultry and other 
ABPs that are neither Category 1 nor Category 3) 

Low or non-risk animal by-products referred to in Article 
6 of the ABP Regulation (safe ABPs from animals "fit for 
human consumption") 

Legislative  procedure  requiring  approval  of  measures  to 
be  taken  by  the  Commission  by  a  regulatory  committee 
composed of the representatives of the Member States and 
chaired by the representative of the Commission 

Competent 
(CA) 

authority 

The  authority  of  a  Member  State  responsible  for  the 
implementation and enforcement of the ABPs Regulation 

EFSA 

FVO 

European  Food  Safety  Authority:  Independent  European 
body  that  provides  assistance  and  scientific  advice 
concerning  risk  assessment  and  risk  analysis  to  the 
Commission,  European  Parliament  and  the  Member 
States 

Food and Veterinary Office – Directorate F of DG Health 
and  Cosumer  Protection  (SANCO)  located  in  Grange 
the 
for 
(Ireland) 
implementation  of  Community  food  safety  legislation  in 
the Member States and in third countries 

verification 

responsible 

of 

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Intra-species  recycling 
(cannibalism) 

Feeding of a species with processed animal protein derived 
from the bodies or parts of bodies of animals of the same 
species (e.g. pig protein given to pig) 

Processed 
protein 

animal 

Parts  of  animals  that  are  processed  e.g.  fish  meal,  meat 
and bone meal, bloodmeal 

TSE 

Transmissible  Spongiform  Encephalopathies:  family  of 
diseases including BSE, Chronic Wasting Disease, Scrapie 
and Creutzfeldt-Jakob Disease 

White  paper  on  Food 
Safety 

Policy paper developed by DG SANCO in 1999, following 
a  number  of  food  crises,  to  develop  a  new  food  safety 
strategy 

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ANNEX II 

INFORMATION PROVIDED BY MEMBER STATES ON MEASURES TAKEN TO 
ENSURE COMPLIANCE WITH THE ABPs REGULATION 

Member State 

1. 

Belgium 

2. 

Czech Republic 

3. 

Denmark 

4. 

Germany 

Measures  taken  to  ensure  compliance  with 
the ABPs Regulation 

Belgium  has  drawn  up  a  convention  to  define 
the  competence  of  each  authority  involved  in 
the  enforcement  and  implementation  of  the 
Regulation.  In  Belgium  6  different  authorities 
are  responsible  for  cover  the  scope  of  the 
Regulation. 

to 

reference 

From 1 May 2004, after the EC accession, the 
Regulation  is  in  force  in  the  Czech  Republic. 
The 
this  Regulation  was 
in  Decree  N°  295/2003;  An 
mentioned 
amendment  to  Act  on  veterinary  care  is  being 
prepared  currently  and  a  reference  to  the 
enforcement of Regulation (EC) No 1774/2002 
shall be included in this amendment 

Since 2003, a number of Orders, circulars and 
guidance notes have been issued to give effect 
to the ABPs Regulation. Violation of the ABPs 
rules  has  been  made  punishable  by  Order  no. 
355 of 19. May 2003, which also identifies the 
competent authority for ABPs 

(Gesetz 

An  Act  implementing  Community  provisions 
on  the  processing  and  disposal  of  ABPs  not 
intended  for  human  consumption  has  been 
adopted 
Durchführung 
gemeinschaftlicher  Vorschriften  über  die 
Verarbeitung  und  Beseitigung  von  nicht  für 
den  menschlichen  Verzehr 
bestimmten 
tierischen  Nebenprodukten  vom  25  Januar 
2004)  

zur 

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5. 

Estonia 

6. 

Greece 

7. 

Spain 

8. 

France 

9. 

Ireland 

10. 

Italy 

The  Infectious  Animal  Disease  Control  Act 
lays  down  the  general  rules  for  processing 
ABPs.  The  Regulation  of  the  Minister  of 
Agriculture  N0  52/2004  “approving  procedure 
for  ABPs  plants”  lays  down  the  procedure  for 
handling  the  approval  documentation.  Estonia 
(and  Cyprus)  was  granted  under  Commission 
to 
Decision  2004/467/EC, 
31.12.2004  the  derogation  to  allow  burial  of 
ABPs 

from  1.5.2004 

“Pending  the  promulgation  of  the  Presidential 
Decree, which had already taken its final form 
since  2003,  at  the  Official  Journal  of  the 
Government, we use the competent authorities 
for 
the  approval,  supervision  and  posing 
sanctions  from  the  Presidential  Decree  243  of 
1993  with  the  demand  from  the  producers, 
enterprises  and  activities  involved  with  ABPs 
to  fulfill  all  the  requirements  of  the  ABPs 
Regulation.” 

lays  down 

in  particular 

The Royal Decree 1429/2003 of 21 November 
2003 
for 
the  arrangements 
the  Regulation.  The  Decree 
implementing 
the  allocation  of 
to 
refers 
responsibilities among the various government 
bodies  specific  to  the  Spanish  legal  order  (the 
General State Administration, the Autonomous 
Regions, the local authorities). 

The  measures  adopted  by  France  can  be 
grouped  into  four  categories:  implementation 
measures  at  national  level  of  broad  character; 
specific  implementation  measures  for  some 
sectors;  measures  adopted  in  accordance  with 
derogations; 
Article 
administrative or penal sanctions, as set in the 
different national texts. 

providing 

23(2), 

The  national  implementing  rules  giving  effect 
to the Regulation in Ireland are set down in the 
European  Communities  (ABPs)  Regulations  – 
Statutory Instrument 248 of 2003.  

of  Health 

The  Ministry 
issued 
implementation guidelines of the Regulation to 
ensure  a  uniform  and  correct  implementation 
throughout the national territory. This has been 
made  in  co-operation  with  the  Regions  and 

has 

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Autonomous  Provinces,  with  the  Ministry  of 
Environment  and  with 
the  Ministry  of 
Agricultural  and  Forest  Policies.  In  addition, 
the legislative Decree N. 63 of 17 March 2005 
concerning 
has 
sanctions/measures to be applied in relation to 
the sanitary rules on ABPs. 

published 

been 

11. 

Cyprus 

12. 

Latvia 

13. 

Lithuania 

The  Regulation  has  been  introduced  into  the 
national  legislation  under  the  implementation 
of EC Legislation in the Veterinary Sector Law 
of  2004  N°  149(1).  Cyprus  (and  Estonia)  was 
granted 
Decision 
2004/467/EC, from 1.5.2004 to 31.12.2004 the 
derogation to allow burial of ABPs. Cyprus has 
obtained  an  extension  of  this  derogation  until 
31 October 2005. 

Commission 

under 

The Regulation is directly applicable since the 
date  of  accession.  General  requirements  have 
been  laid  down  in  the  Law  on  Veterinary 
Medicine (1 July, 2001). 

Responsibility  in  case  of  failure  to  meet  these 
requirements is laid down in the Penal Law and 
in the Code of Administrative Misdemeanor. 

Requirements  laid  down  in  regulations,  which 
are  not  directly  applicable  have  been 
transposed  into  Regulations  of  the  Cabinet  of 
Ministers  No  606  of  20 July,  2004  on 
veterinary  and  hygiene  requirements  to  the 
chain  of  ABPs  not  fit  for  human  consumption 
(27 July, 2004). 

introduced 

The  Regulation  has  been 
into 
Lithuanian  legislation  by  Order  N°  B1-996  of 
the  Director  of  the  State  Food  and  Veterinary 
Service  of  23  December  2003.  From  1  May 
2004,  all  EC  Regulations  are  directly 
incorporated  into  the  national  legislation  in 
national 
the 
accordance  with 
provisions 
(Resolution  N°  1180  of  18 
September 2003). 

relevant 

14. 

Luxembourg 

The implementation provisions have concerned 
mainly 
the  repartition  of  competence.  A 
number of national rules are in place regarding 
that  could  be 
the  categories  of  material 
disposed of by incineration or landfill. Several 

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15. 

Hungary 

16. 

Malta 

17. 

The Netherlands 

18. 

Austria 

circulars  and  other  instructions  have  been 
issued  regarding  removal,  identification  and 
disposal. 

The Regulation is directly applicable since the 
date  of  accession.  However,  a  new  national 
legislation  to  enforce  it  is  being  drafted  and 
will  be  in  place  at  the  end  of  2005  and  the 
existing Ministerial decree will be repealed. 

Malta  has  published  in  the  national  official 
“gazette” on 18 January 2005 a draft regulation 
applying  the  ABPs  Regulation  opened  for  4 
weeks’  comment  period.  Draft  national 
legislation  on  waste  has  been 
in 
November 2004 for consultation and will enter 
into force shortly (FVO mission). This sets out 
a  system  of  registration  for  hauliers  of  ABPs, 
among others, and  the requirements they must 
fulfill. 

issued 

National  provisions  have  been  made  in  a 
implementing  Regulation: 
specific  national 
“implementation  of  EU  Regulation  on  ABPs 
not  intended  for  human  consumption”  and  the 
“Regulation on inspection and trade of ABPs” 
applicable since 9 September 2003. 

and 

After  its  publication  in  the  European  Official 
Journal,  the  Regulation  and  the  associated 
implementing 
transitional  measures 
provisions  were  made  known  to  the  relevant 
authorities  and  the  industry  in  Austria  by 
means  of  Erlässe  (official  circulars)  and  by 
the  official  veterinary 
announcements 
bulletin 
the 
(AVN),  pointing  out 
provisions in question are directly applicable.  

that 

in 

Animal 

Materials 

The 
Act 
(Tiermaterialiengesetz)  that  came  into  force  1 
January  2004  deals  with  the  procedures  for 
the  responsibility  of  competent 
approval, 
authorities  for  control,  an  obligation  for 
owners/producers  of  ABP/fallen  stock  to  hand 
over  ABP  to  approved  plants  and  repeals 
previous national legislation in this field. 

In 
addition, 
legislation 
the  food 
provides  for 
establishments  for  proper  collection,  storage 

complementary 
the  obligation  for 

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19. 

Poland 

20. 

Portugal 

21. 

Slovenia 

and hand over of ABP. 

The  ABPs  regulation  and  related  transitional 
measures  are  legally  binding  and  directly 
applicable  in  Poland  by  the  date  of  accession. 
The  act  of  protection  of  animal  health  and 
control of infectious diseases of animals of 11 
March  2004  provides  for  official  supervision 
and  approval  of  plants  dealing  with  ABPs. 
Moreover, the Act provides for penal sanctions 
for  business  operators 
to  meet 
veterinary requirements. 

failing 

Portugal  has  published  the  following  legal 
texts: Dispatch n° 8137/2003 of 9 May, which 
defines  a  system  for  the  collection  of  fallen 
stock.  Decree-law  N°  244/2003  of  7  October 
requires  all  operators  of 
2003,  which 
incubation 
slaughterhouses,  cutting  plants, 
centres and egg product industries to present a 
plan  for  the  disposal  of  Category  2  and  3  of 
ABPs.  Dispatch  n°  9134/2005  of  26  April 
2005, which defines competence of the various 
competent  authorities  with  regard 
the 
classification,  separation  marking,  weighing, 
sealing  and  expedition,  where  appropriate,  of 
Category  1,  2  and  3  ABPs,  at  slaughterhouses 
and cutting plants. 

to 

into 

force 

in 
entered 
The  Regulation 
accordance  with  the  Slovenian  legal  order,  on 
the  day  of  accession.  Imposing  of  sanctions 
and  the  competence  of  services  are  governed 
by  sectoral  acts  such  as  Veterinary  Practice 
Act,  Environmental  Protection  Act,  etc. 
rules  have  been 
Several 
adopted 
in  particular 
repartition of competences and the concept and 
conditions of public utility service. 

implementation 
in  2004  concerning 

22. 

23. 

Slovak Republic 

The Regulation has been implemented as it is. 

Finland 

Finland has undertaken a series of measures to 
implement  the  Regulation:  National  Statutes 
to 
have  been  established 
Regulation  (EC)  No 1774/2002,  application 
guides  have  been  published  to  clarify  the 
legislation  and  lectures  have  been  given  in 
to  authorities, 
different  part  of  Finland 
operators and people working in the agriculture 

to  give  effect 

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24. 

Sweden 

25. 

United Kingdom 

sector. 

An  adjustment  of  the  Swedish  Regulation  to 
rules in the ABPs Regulation was made at the 
1st  of  October  2003.  The  necessary  national 
implementing  rules  to  ensure  i.e.  sanction 
possibilities  are  set  down  in  the  Swedish  Act 
(1992:1683) and the appointment of competent 
authority  of  ABPs  in  the  Swedish  Ordinance 
(1998:134). Both entered into force at the 1st of 
January 2004. 

Four Regulations have been issued in England, 
Scotland,  Wales  and  Northern  Ireland.  These 
Regulations provide for the administration and 
Enforcement of the Regulation in the different 
parts of the United Kingdom. 

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ANNEX III 

DEROGATION GRANTED BY MEMBER STATES UNDER ARTICLES 23(2) 
AND 24 

– 

– 

Article 23 (2) of the Regulation provides that Member States may authorise the use 
of  Category  2  ABPs  that  come  from  animals  which  are  not  suspected  of  a  disease 
communicable  to  humans  or  animals  and  Category  3  ABPs  for  the  feeding  of  zoo, 
circus  and  fur  animals,  reptiles  and  birds  of  prey  other  than  zoo  or  circus  animals, 
wild  animals  the  meat  of  which  is  not  for  human  consumption,  dogs  from  kennels 
and maggots for fishing bait. 

16 Member States have granted and/or have laid down in the national provisions the 
possibility of granting the derogations under Article 23 (2) of the Regulation. 

These  are:  Belgium,  the  Czech  Republic,  Denmark,  Spain,  France,  Ireland,  Italy, 
Latvia,  Hungary,  Malta,  the  Netherlands,  Portugal,  Slovenia,  Finland,  Sweden  and 
the United Kingdom. 

Article  24  of  the  Regulation  provides  that  Member  States  may  decide  to  grant  a 
derogation in regard to the possibility to dispose of the ABPs as waste by burial or 
burning under specific conditions and circumstances (dead pet animals, remote areas 
or in cases of disease outbreaks). 

17 Member States have granted and/or have laid down in the national provisions the 
possibility of granting the derogation under Article 24. 

These are: Belgium, the Czech Republic, Germany, Estonia, Greece, Spain, Ireland, 
Italy,  Latvia,  Hungary,  Malta,  the  Netherlands,  Austria,  Slovenia,  Finland,  Sweden 
and United Kingdom.  

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ANNEX IV 

MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH 
COMITOLOGY PROCEDURE OR GUIDANCE 

1. 

Transitional measures for Member States and Third Countries 

Member  States  are  acquainted  with  the  local  conditions  of  the  industry  and  were 
asked  to  assess  the  likely  effects  of  the  Regulation  on  the  industry  and  to  submit 
appropriate  requests  for  transitional  measures.  Interested  Member  States  submitted 
requests, and the following transitional measures have been granted. 

1.1. 

Transitional measures for Member States 

•  Feeding  catering  waste  (swill  feeding)  to  animals  (Austria  and  Germany). 

Commission Decision 2003/328/EC (Expiry date: 31/10/2006). 

•  Feeding used cooking oil to animals (Ireland and United Kingdom). Commission 

Decision 2003/320/EC (Expired on 31/10/2004). 

•  Total separation between plants handling Category 1, 2 and 3 materials (Finland 
and  France).  Commission  Decision  2003/325/EC  (Expired  for  France  on 
30/04/2004 and expiry date for Finland: 31/10/2005). 

•  Separation of oleo-chemical plants (Belgium, Germany, Italy, Netherlands, Spain, 
Sweden and United Kingdom). Commission Decision 2003/326/EC. (Expiry date: 
31/10/2005). 

•  Separation  of  intermediate  plants  (France  and  Italy).  Commission  Decision 

2003/323/EC. (Expired on 30/04/2004). 

•  Low-capacity 

incinerators/co-incinerators 

(Finland  and  United  Kingdom). 

Commission Decision 2003/327/EC. (Expired on 31/12/2004). 

•  Manure  processing  standards  (Belgium,  France,  Finland  and  Netherlands). 
Commission  Decision  2003/329/EC  as  amended  by  Commission  Decision 
2005/14/EC  (Expiry  date:  31/12/2005  pending  a  scientific  opinion  by  the  EFSA 
adopted on 07/09/2005) 

•  Composting  standards  (all  Member  States).  Commission  Regulation  (EC) 
No 809/2003  as  amended  by  Commission  Regulation  (EC)  No  12/2005  (Expiry 
date:  31/12/2005  pending  a  scientific  opinion  by  the  EFSA  adopted  on 
07/09/2005) 

•  Biogas standards (all Member States) Commission Regulation (EC) No 810/2003 
as  amended  by  Commission  Regulation  (EC)  No  12/2005  (Expiry  date: 
31/12/2005 pending a scientific opinion by the EFSA adopted on 07/09/2005) 

•  Processing  standards  for  mammalian  blood  (Germany,  Italy,  Spain  and  United 

Kingdom). Commission Decision 2003/321/EC (Expired on 31/12/2004). 

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•  Collection  of  wastewater  (Austria,  Denmark,  France,  Finland,  Italy,  Ireland, 
Portugal,  Spain,  Sweden,  Estonia  and  Hungary).  Commission  Decision 
2003/334/EC and Commission Decision 2004/468/EC (Expired on 30/04/2005). 

•  The possibility of on-site burning or burial of ABPs (Estonia and Cyprus: for the 
latter an extension of the transitional measures has been granted until 1.11.2005 in 
order to allow extra time to the industry to comply with the requirements of the 
Regulation).  Commission  Decision  2004/467/EC  (Expired  on  01/01/2005)  and 
Commission Decision 2005/62/EC (Cyprus). 

•  Separation  of  Category  1  and  2  processing  plants  and  the  inclusion  of  ABPs 
establishments  in  the  list  of  establishments  in  transition  in  Latvia.  Commission 
Decision  2004/464/EC  and  Commission  Decision  2004/476/EC.  (Expired  on 
31/12/2004). 

•  Collection,  transport  and  disposal  of  former  foodstuffs.  Commission  Regulation 

813/2003/EC (Expiry date: 31/12/2005). 

1.2. 

Transitional measures for third Countries 

General  transitional  arrangements  were  granted  to  third  countries  postponing  the 
application  of  the  import  provisions  of  the  Regulation  allowing  adequate  time  for 
them to adjust to the new requirements and to allow the Commission time to update 
the rules on importation in Annexes VII and VIII and the model of health certificates 
in Annex X. 

In addition, the following specific transitional measures were granted: 

•  Import of gelatine produced from vertebrae bones from Japan and United States to 
Netherlands, France and United Kingdom intended for making photo films in the 
EU (Commission Decision 407/2004: to be reviewed as appropriate in the light of 
new scientific advice). 

•  Import and placing on the market of certain materials of animal origin classified 
as  Categories  1  and  2  intended  for  technical  purposes  (all  third  countries) 
(Commission Regulation 878/2004/EC: to be reviewed as appropriate in the light 
of new scientific advice). 

•  Separation  of  Category  1,  2  and  3  intermediate  plants  and  the  separation  of 
Category  1,  2  and  3  processing  plants  (Australia,  Canada,  China  and  USA) 
(Commission Regulation 780/2004/EC – expiry date: 31/10/2005). 

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2. 

Commission Regulations amending Regulation (EC) No 1774/2002 

Five  Commission  Regulations  have  been  introduced  amending  the  Annexes  to  the 
Regulation: 

•  Regulation (EC) No 808/2003 has amended Article 12(3) to allow the incineration 
of  specified  risk  material  and  bodies  of  animals  in  low-capacity  incinerators  in 
line with the SSC opinion and has introduced some other technical amendments to 
the Annexes, in line with the wording of the Articles.  

•  Regulations (EC) No 668/2004 and No 416/2005 have introduced some technical 
amendments  to  bring  the  Annexes  in  line  with  the  text  of  the  Articles  and  have 
updated the model of health certificates and introduced new models for the import 
of  certain  products  that  may  be  used  as  feed  material,  pet-food,  dogchew  and 
technical products. The list of third countries has been updated in accordance. 

•  Regulation  (EC)  No  92/2005  has  amended  the  Regulation  as  regards  biogas 

transformation and processing of rendered fats. 

•  Regulation  (EC)  No  93/2005  has  amended  Annexes  II  and  V  of  the  Regulation 

(see point 3). 

3. 

Measures taken to implement Regulation (EC) No 1774/2002 

Measures  have  been  introduced  implementing  the  various  Articles.  The  following 
implementing Regulations have been introduced: 

•  Use  of  milk,  milk-based  products  and  milk-derived  products  (Regulation  (EC) 
No 79/2005). The Regulation allows the direct feeding to farmed animals of dairy 
products  produced  to  food  standards  subject  to  animal  health  conditions  in  line 
with current scientific opinions, waiting for the opinion of EFSA 

•  Means of use or disposal of ABPs (Regulation (EC) No 92/2005). The Regulation 
provides for the possibility to dispose of ABPs by five other alternative methods. 

•  Processing of ABPs of fish origin and a commercial document for the transport of 
ABP (Regulation (EC) No 93/2005). The Regulation establishes a specific method 
for the processing of ABPs of fish origin and lays down a harmonised model of 
commercial document for the transport of ABPs. 

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4. 

Permanent general derogations granted.  

The following derogations have been granted: 

•  Derogation from the intra-species recycling ban for fish with regard to the feeding 
of fish with processed animal protein derived from the bodies or parts of bodies of 
animals of the same species (Article 22(2) of the basic regulation). In addition it 
was necessary to provide transitional arrangements to allow adequate time so that 
the industry can adjust to the new requirements as regards the feeding of fish with 
processed animal protein derived from the bodies or parts of bodies of animals of 
the same species. (Regulation (EC) No 811/2003). 

•  Detailed  requirements  of  how  burial  and  burning  should  be  carried  out  in 
accordance  with  Article  24(1)  of  the  basic  regulation.  (Regulation  (EC) 
No 811/2003). 

5. 

Permanent specific derogations granted on request from member States 

Implementing measures have been introduced to allow the continual feeding of: 

•  Fur  animals  with  processed  animal  protein  derived  from  the  bodies  or  part  of 
bodies  of  animal  of  the  same  species  (Finland,  Estonia).  Commission  Decision 
2003/324/EC. 

•  Endangered  or  protected  species  of  necrophagous  birds  with  dead  ruminants 
containing  specified  risk  material  (Article  23(2)  (Italy,  France,  Spain,  Portugal, 
Greece  and  Cyprus).  Commission  Decision  2003/322/EC,  as  amended  by 
Commission Decision 2004/455/EC. 

6. 

Guidelines issued to clarify a certain number of issues. 

Two guideline documents have been issued (see Annex II): 

•  “Guidance  on  applying  the  new  ABPs  Regulation  (EC)  No  1774/2002”  in  the 
form  of  questions  and  answers  clarifying  the  main  concerns  raised  by  Member 
States and stakeholders. 

•  “Guidance  note  on  the  application  to  ABPs  of  community  legislation  regarding 

animal and public health and waste”. 

A full list of legislation, plus guidance notes and other information relating to animal 
by-products, are available on the ABP web site of the Directorate General for Health 
and Consumer Protection, and may be accessed via: 

http://europa.eu.int/comm/food/food/biosafety/animalbyproducts/index_en.htm 

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ANNEX V 

LIST OF THE LEGISLATION REPEALED AND REPLACED BY REGULATION 
(EC) NO 1774/2002 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Commission Decision 89/18/EEC of 22 December 1988 concerning the conditions of 
importation  from  third  countries  of  fresh  meat  for  purposes  other  than  human 
consumption, OJ L 8, 11.1.1989, p. 17. 

Council  Directive  90/667/EEC  of  27  November  1990  laying  down  the  veterinary 
rules for the disposal and processing of animal waste, for its placing on the market 
and  for  the  prevention  of  pathogens  in  feedingstuffs  of  animal  or  fish  origin, 
OJ L 363, 27.12.1990, P.51 

Commission Decision 92/187/EEC of 28 February 1992 laying down the conditions 
which  have  to  be  complied  with  for  importation  of  certain  raw  materials  for  the 
pharmaceutical  processing  industry,  coming  from  certain  third  countries,  which  do 
not  appear  on  the  list  established  by  Council  Decision  79/542/EEC,  OJ  L  87, 
2.4.1992, p. 20. 

Commission  Decision  92/183/EEC  of  3  March  1992  laying  down  the  general 
conditions  to  be  complied  with  for  the  import  of  certain  raw  materials  for  the 
pharmaceutical  processing  industry,  coming  from  third  countries,  which  appear  on 
the list established by Council Decision 79/542/EEC, OJ L 87, 2.4.1992, p. 20. 

Commission  Decision  94/143/EC  of  1  March  1994  laying  down  the  animal  health 
requirements  and  the  veterinary  certification  for  the  importation  of  serum  from 
equidae from third countries, OJ L 62, 5.3.1994, p. 41. 

Commission  Decision  94/309/EC  of  27  April  1994  laying  down  the  animal  health 
requirements and the veterinary certification for the importation from third countries 
of  certain  pet-foods  and  certain  untanned  edible  products  for  pets,  containing  low-
risk animal materials, as last amended by Decision 97/199/EC; OJ L 137, 1.6.1994, 
p. 62.  

Commission  Decision  94/344/EC  of  27  April  1994  laying  down  the  animal  health 
requirements and the veterinary certification for the importation from third countries 
of  processed  animal  protein  including  products  containing  this  protein  intended  for 
animal consumption, OJ L 154, 21.6.1994, p. 45.  

Commission  Decision  94/435/EC  of  10  June  1994  laying  down  the  animal  health 
requirements and the veterinary certification for the importation of pig bristles from 
third countries, OJ L 180, 14.7.1994, p. 40. 

Commission Decision 94/446/EC of 14 June 1994 laying down the requirements for 
the  importation  from  third  countries  of  bones  and  bone  products,  horns  and  horn 
products  and  hooves  and  hoof  products,  excluding  meals  thereof,  for  further 
processing  not  intended  for  human  or  animal  consumption,  as  last  amended  by 
Decision 97/197/EC,OJ L 183, 19.7.1994, p. 46.  

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10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

the 
Commission  Decision  94/860/EC  of  20  December  1994 
requirements  for  the  import  from  third  countries  of  apiculture  products  for  use  in 
apiculture, OJ L 352, 31.12.1994, p. 69. 

laying  down 

Commission  Decision  95/341/EC  of  27  July  1995  concerning  animal  health 
conditions  and  the  veterinary  certification  for  imports  of  milk  and  milk-based 
products not intended for human consumption from third countries5, as amended by 
Decision 96/106/EC, OJ L 352, 31.12.1994, p. 69. 

Commission  Decision  95/348/EC  of  22  June  1995  laying  down  the  veterinary  and 
animal health rules applicable in the United Kingdom and Ireland to the treatment of 
certain types of waste intended to be marketed locally as feedstuffs for certain animal 
categories, OJ L 200, 24.8.1995, p. 42. 

Commission  Decision  96/500/EC  of  22  July  1996  laying  down  the  animal  health 
requirements  and  the  certification  or  official  declaration  for  the  import  of  game 
trophies of birds and ungulates not having undergone a complete taxidermy treatment 
from third countries, OJ L 203, 13.8.1996, p. 13. 

Commission  Decision  97/168/EC  of  29  November  1996  laying  down  the  animal 
health  requirements  and  the  certification  or  official  declaration  for  the  import  of 
hides and skins of ungulates from third countries, OJ L 67, 7.3.1997, p. 19. 

Commission Decision 97/198/EC of 25 March 1997 laying down the animal health 
requirements  and  the  veterinary  certification  for  the  import  of  processed  animal 
protein from certain third countries which use alternative heat treatment systems and 
amending Decision 94/344/EC, OJ L 084 , 26.03.1997, p. 36 

Commission Decision 97/735/EC of 21 October 1997 concerning certain protection 
measures  with  regard  to  trade  in  certain  types  of  mammalian  waste  OJ  L  294, 
28.10.1997, p. 7. 

Commission  Decision  99/534/EC  of  19  July  1999  on  measures  applying  to  the 
processing  of  certain  animal  waste  to  protect  against  transmissible  spongiform 
encephalopathies, OJ L 204, 4.8.1999, p.37. 

Commission  Decision  2001/25/EC  of  27  December  2002  prohibiting  the  use  of 
certain animal by-products in animal feed, OJ L 6, 11.1.2001, p. 16. 

Commission  Decision  92/562/EEC  of  17  November  1992  on  the  approval  of 
alternative  heat  treatment  systems  for  processing  high-risk  material,  OJ  L  359, 
9.12.1992, p. 23. 

5 

OJ L 200, 24.8.1995, p. 42. 

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