Commission staff working document - Impact assessment accompanying the draft 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) {COM(2008)345 final} {SEC(2008)1995}
Date: 2008-06-10
Institutions: European Commission
Subjects: agricultural by-product, animal product, health control, health legislation, health risk, impact study, traceability

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SANCO/826/2008 (POOL/D1/2008/826/826IA-EN.doc) 

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.6.2008 
SEC(2008) 1994 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

accompanying the 

Draft 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) 

{COM(2008)345 final} 
{SEC(2008)1995} 

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   EN 

 
 
 
 
 
 
TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

2.7. 

2.8. 

2.9. 

EXECUTIVE SUMMARY.......................................................................................... 5 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES... 8 

Overview ...................................................................................................................... 8 

Consultation of competent authorities ......................................................................... 8 

Consultation of stakeholders and of consumer organisations ...................................... 8 

Consultation of international partners.......................................................................... 9 

Inter-Service Steering Group (ISSG) ........................................................................... 9 

The European Food Safety Authority (EFSA)........................................................... 10 

Other opportunities used for consultation .................................................................. 10 

General on-line consultation ...................................................................................... 10 

Consultation on administrative burden to competent authorities of MS and the 
industry....................................................................................................................... 10 

2.10.  Opinion of the Impact Assessment Board.................................................................. 11 

3. 

3.1. 

3.2. 

PROBLEM IDENTIFICATION................................................................................ 12 

Background ................................................................................................................ 12 

The issues / problems that require actions ................................................................. 17 

3.2.1.  Policy issue 1: The scope of the Regulation is not sufficiently clear.................... 17 

3.2.2.  Policy Issue 2 – Categorization of ABPs: Categorization of some materials is 

disproportionate compared to the risk................................................................... 20 

3.2.3.  Policy issue 3- Duplication of approvals for some type of premises .................... 21 

3.2.4.  Policy issues 4 - Derogations of the Regulation do not consider certain specific 

situations. .................................................................................................................. 22 

3.3. 

3.4. 

4. 

5. 

PERSPECTIVES (POSSIBLE EVOLUTION OF THE ISSUE / PROBLEM) ........ 24 

Subsidiarity test.......................................................................................................... 25 

OBJECTIVES ............................................................................................................ 26 

KEY POLICY OPTIONS .......................................................................................... 27 

5.1. 

Policy issue 1-Clarifying the scope............................................................................ 27 

5.1.1.  Policy issue 1 (a) - Determination of the end of the ABP life-cycle...................... 27 

5.1.2.  Policy issue 1 (b)- Coverage of ABP from wild animals ....................................... 28 

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5.2. 

5.3. 

5.4. 

6. 

6.1. 

6.2. 

Policy issue 2 - Categorising new products ............................................................... 29 

Policy issue 3-Clarifying the approvals / registrations and controls.......................... 29 

Policy issue 4-Clarifying the derogations .................................................................. 29 

ANALYSIS OF IMPACTS........................................................................................ 30 

GENERAL REMARKS............................................................................................. 30 

ANALYSIS OF IMPACTS........................................................................................ 32 

6.2.1.  Policy issue 1-Clarifying the Scope of the Regulation........................................... 32 

6.2.2.  Policy issue 2 categorising new products ............................................................... 45 

6.2.3.  Policy issue 3 Clarifying the approvals / registration and controls ..................... 47 

6.2.4.  Policy issue 4 - Clarifying the derogations............................................................. 53 

7. 

COMPARING THE OPTIONS. ................................................................................ 56 

7.1. 

Policy issue 1-Clarifying the scope of the Regulation ............................................... 56 

7.1.1.  Determination of the end of the ABP life-cycle. .................................................... 56 

7.1.2.  Coverage of wild animals......................................................................................... 57 

7.2. 

7.3. 

7.4. 

7.5. 

8. 

8.1. 

8.2. 

8.3. 

Policy issue 2- Categorising new products ................................................................ 58 

Policy issue 3. - Clarifying the approvals/registration and controls .......................... 59 

Policy issue 3-Clarifying the derogations .................................................................. 60 

Conclusion.................................................................................................................. 60 

MONITORING AND EVALUATION ..................................................................... 61 

Community................................................................................................................. 61 

Member States............................................................................................................ 61 

Communication and Consultation with stakeholders................................................. 62 

ANNEX I-A ............................................................................................................................. 63 

ANNEX I-B.............................................................................................................................. 66 

ANNEX II ................................................................................................................................ 71 

ANNEX III............................................................................................................................... 74 

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ANNEX IV............................................................................................................................... 75 

ANNEX V ................................................................................................................................ 87 

ANNEX VI............................................................................................................................... 88 

ANNEX VII ............................................................................................................................. 93 

ANNEX VIII ............................................................................................................................ 97 

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1. 

EXECUTIVE SUMMARY 

The  item  is  part  of  the  Commission  agenda  planning  /work  programme  (reference 
2005/SANCO/058). 

In response to a number of crises affecting the safety of public and animal health as 
regards products of animal origin - in particular linked to Transmissible Spongiform 
Encephalopathy  (TSE),  dioxin,  Classical  Swine  Fever  (CSF)  and  Foot  and  Mouth 
Disease (FMD) - the Community has adopted a series of measures to protect public 
and  animal  health,  from  "farm  to  fork".  Among  several  pieces  of  legislation 
concerning  animal  and  public  health,  Regulation  (EC)  No  1774/2002  laying  down 
health  rules  concerning  animal  by-products  (ABP)  not  intended  for  human 
consumption1  consolidated,  simplified  and  replaced  19  previous  legal  acts.  It 
introduced stricter rules concerning the approval of certain premises, the channelling 
and  traceability  of  certain  products  and  the  implementation  of  several  processing 
parameters for strictly risk-related categories of ABP, in order to guarantee the safety 
of final products intended for feed or technical uses. 

Since the entry into force of the Regulation a continuous process of communication 
and  consultation  with  stakeholders  has  been  initiated  and  maintained  by  the 
Commission in order to identify possible issues or areas where problems could arise 
(see Annex I and Annex II) including inspections of the Food and Veterinary Office 
to monitor the implementation of the ABP rules by competent authorities of Member 
States.  Based  on  the  information  submitted  by  Member  States  and  the  outcome  of 
FVO  inspections,  the  Commission,  on  24  October  2005,  submitted  a  report, 
COM (2005) 521,  to  the  European  Parliament  and  the  Council  describing  the 
experience of all 25 Member Sates in applying the legislation. In addition, a general 
on-line consultation was carried out and a questionnaire on administrative costs sent 
to competent authorities, affected industries and stakeholders, including third country 
partners,  in  order  to  gather  data  on  the  possible  impacts  of  this  initiative  on 
administrative  burden.  An  Inter-service  Steering  Group  comprising  several 
Directorates-General  was  created  in  order  to  guide  work  and  provide  specialized 
input  for  this  Impact  Assessment.  This  group  has  met  three  times  during  the 
development of this impact assessment. 

The legislation is working well and generally meets its overall objectives. However, 
the consultations have identified areas where changes need to be considered in order 
to  update  the  current  legislation  and  to  provide  legal  certainty,  simplify  it  and  thus 
reduce administrative burden. In particular, the need emerged to clarify certain issues 
and to ensure flexibility to take account of emerging scientific knowledge about risks 
associated to the possible uses of ABP. Consequently a revision is being considered, 
which does however not envisage any changes to the basic principles and structure of 
the  way  the  use,  processing,  disposal,  traceability  and  channelling  of  ABP  not 
intended for human consumption are regulated in the European Union. Whilst there 
are a number of issues that need to be addressed, the areas which could have major 
impacts, and which are the focus of this impact assessment, are: 

1 

OJ L 273, 10.10.2002, p. 1. 

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• 

• 

• 

• 

the  lack  of  clarity  in  the  scope  of  the  Regulation.  Specifically  it  is  not  clear 
when  products  are  not  longer  considered  as  ABP,  and  so  the  requirements  of 
the Regulation cease to apply, nor the extent to which ABP from wild game is 
covered; 

the categorization of ABP is not always proportionate to the risk they pose, 

some of the premises that fall into the scope of this Regulation have to undergo 
a  double  approval  (under  the  ABP  legislation  and  under  other  sector 
legislation) 

and the fact that current Regulation does not consider some important issues as 
regards derogations (impact of ABP for research, natural disasters). 

Therefore, the general objectives of this initiative remain the same as for the current 
legislation,  i.e.  to  protect  human  and  animal  health  and  ensure  food  safety,  to 
reinforce consumers' confidence in the safety of the food and feed chain, to facilitate 
smooth functioning of the internal market, and to increase competitiveness of the EU 
industries affected by this Regulation. 

Specific objectives were identified and these are to review the Regulation on ABP in 
order  to  adjust  the  regulatory  framework  to  the  risks  posed  by  animal  by-products, 
improve legal clarity and adapt requirements to progress in science and technology. 

To  achieve  these  specific  objectives,  operational  objectives  were  established 
focusing on the problems identified as: 

• 

• 

• 

• 

for the scope of the Regulation: adjusting the regulatory framework to the risks 
posed by animal by-products by determining to which processed products the 
rules  apply,  thereby  preventing  gaps  or  overlapping  of  legislation  and 
reinforcing consumers' confidence, 

for categorising new products: adjusting the regulatory framework to the risks 
posed by new animal by-products and improving legal clarity, 

for clarifying approvals/ registrations and controls: improving legal clarity and 
avoiding any unnecessary burdens, 

for clarifying the derogations: adjusting the regulatory framework to the risks 
posed by animal by-products and contributing to progress in science as regards 
import of ABP. 

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The  aim  of  the  initiative  is  in  line  with  the  Commission's  strategic  objectives  and 
better  regulation  principles,  namely  to  improve  and  make  the  measures  more 
effective and efficient, reducing unnecessary burden for operators as far as protection 
of public and animal health and food safety are not undermined.  

To  address  the  problems  identified  during  the  process,  different  options  were 
considered except deregulation as the current legislation has proven to be an efficient 
tool to achieve a high level of protection against public and animal health risks.  

The social, economic and environmental impacts of all options were analyzed during 
the impact assessment process. The analysis has remained mainly qualitative due to 
the  limited  data  that  the  questionnaire  delivered  (as  further  explained  under 
chapter 6).  Although  it  was  not  possible  to  use  the  Standard  Cost  Model,  an 
estimation of administrative costs has been carried out for some policy options as far 
as available data could be used. The following is a summary of the conclusions from 
the analyses carried out: 

• 

• 

• 

The no-change option, which is based on continuing with the current situation 
for  all  the  issues  was  considered  not  adequate  as  it  would  not  solve  the 
problems  that  currently  exist  as  regards  the  level  of  protection  of  public  and 
animal health, the distortion of competition and the functioning of the internal 
market .  

The  use  of  non/soft  regulatory  tools  was  also  considered  for  clarifying  the 
scope  of  the  Regulation  while  for  the  rest  of  the  identified  issues  the  use  of 
these  tools  was  considered  not  relevant,  .  The  results  of  the  impact  analyses 
concluded that the use of non-regulatory tools would not solve the problem of 
legal uncertainty when interpreting the scope of the ABP Regulation  

Following the impact analysis, the overall conclusion was that the best option 
to  respond  to  the  problems  identified  in  the  evaluation  was  to  carry  out  a 
legislative  revision  of  the  current  Regulation.  This  legislative  review  would 
solve the issues of different interpretations on the scope of the regulation and 
the  derived  problems  as  distortion  of  competition  and  different  levels  of 
protection against risks for public and animal health. It will also provide for a 
more risk-based categorisation of ABP, will clarify the derogations and would 
imply a reduction of administrative burden by eliminating double approvals for 
some types of premises.  

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2. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

2.1. 

Overview  

The  item  is  part  of  the  Commission  agenda  planning  /  work  programme  (reference 
2005/SANCO/058). 

A number of stakeholders, experts, competent authorities of the Member States and 
international  trading  partners  have  been  consulted,  bilaterally  or  collectively.  More 
than 36 European Associations with an interest related to the food chain and animal 
and  public  health  (ABP  producers,  processors,  traders,  users,  and  consumers)  have 
been  given  the  opportunity  on  a  number  of  occasions  to  express  their  views  in 
accordance  with  the  Commission’s  minimum  standards  for  consultation.  An  Inter-
Service  Steering  Group  was  established.  In  summary,  the  reactions  towards  the 
proposal were positive. The need for legal certainty and for improving the risk-based 
approach of the requirements was highlighted.  

The  Impact  Assessment  (IA)  follows  the  structure  given  in  the  Commission’s  IA 
guidelines  SEC(2005)791  of  15  June  2005.  It  aims  to  consider  the  environmental, 
economic  and  social  aspects  of  policies  on  ABP  in  an  integrated  and  proportionate 
way. 

2.2. 

Consultation of competent authorities 

Article 35 of the ABP 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,  on  24  October  2005,  submitted  a  report, 
COM  (2005)  521,  to  the  European  Parliament  and  the  Council  describing  the 
experience of all 25 Member States in applying the legislation2. The report also takes 
into account the findings of the Commission's Food and Veterinary Office, gathered 
during inspections carried out in 2004 and 2005 to assess the level of compliance in 
all 25 Member States. 

From  December  2005  to  September  2006,  six  working  groups  and  one  specialized 
meeting  were  held  with  Member  States’  experts,  in  the  framework  of  the  Standing 
Committee  on  the  Food  Chain  and  Animal  Health  to  discuss  the  issues  to  be 
reviewed. Also, over a two-day meeting of the Council Working Party of Veterinary 
Experts  (Public  Health)  on  10  and  11  November  2005,  Member  States  have 
examined  the  Commission’s  report.  The  outcome  of  that  meeting  supported  the 
Commission’s intention to review the legislation concerned. 

2.3. 

Consultation of stakeholders and of consumer organisations 

The  consultation  of  stakeholders  and  consumer  organizations  targeted  the  sectors 
likely  to  be  affected  by/or  involved  in  policy  implementation.  A  list  of  the 
stakeholders and consumer organizations consulted can be found in Annex I-A. 

2 

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

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– 

A  three-stage  consultation  was  held  via  the  working  group  of  the  Advisory 
Group  on  the  Food  Chain  and  Animal  and  Plant  Health.  The  1st  stage 
(20 February  2006)  sought  to  ascertain  stakeholders’  perceptions  about  the 
nature  of  the  issues  identified  in  the  Commission  report  and  to  collect  views 
about  the  possible  options  to  solve  them.  The  2nd  stage  (7  September  2006) 
aimed  to  sound  out  stakeholders  on  the  likely  acceptability  of  the  preferred 
option(s). The 3rd stage (20 April – 18 June 2007) collected views on possible 
impacts of the options. Copies of the minutes are available at  

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

– 

Ad  hoc  bilateral  meetings  were  held  with  the  representatives  of  the  specific 
sectors  likely  to  be  affected,  including  key  associations  (see  summary  of 
chronology of main exchanges at Annex I-B).  

The  stakeholders  largely  agreed  with  the  need  to  review  the  areas  identified  in  the 
Commission report, particularly those that relate to clarification of the rules and the 
introduction  of  a  level  of  flexibility.  Whilst  consumer  organisations  were  also 
consulted, no specific comments were received from them.  

2.4. 

Consultation of international partners 

From  2002  to  2006  several  bilateral  discussions have  been held with major  trading 
partners  (USA,  Canada,  Japan,  Australia,  New  Zealand,  Switzerland,  etc),  the 
outcome  of  which  has  fed  into  the  review  process.  Details  (dates  and  broad  issues 
discussed) are given at Annex II. 

In  line  with  Article  5(6)  of  the  SPS  Agreement,  16  notifications  to  the  WTO/SPS 
have been made as regards implementing and amending measures. The Commission 
report  has  also  been  notified,  with  the  view  to  obtaining  early  comments  from 
international trading partners. 

The outcome of the bilateral discussions and responses to the notifications have been 
considered and as appropriate taken into account in relation to import provisions. 

All trading partners consider that the review would be a step in the right direction. 

2.5. 

Inter-Service Steering Group (ISSG) 

Given  the  crosscutting  nature  of  the  issues  concerned,  the  Commission  set  up  an 
ISSG to provide specialized inputs and to bring a wider perspective to the process.  

Three meetings of the ISSG were held (20 February, 13 September 2006 and 5 June 
2007) in order to obtain other services’ views about the issues identified, the possible 
options and likely impacts. 

The services concerned were: AGRI, ENTR, ENV, FISH, RELEX, RTD, SG, SJ and 
TRADE. As far as possible, the comments expressed by the various DGs represented 
at the three meetings have been taken into account in this document. 

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2.6. 

The European Food Safety Authority (EFSA) 

A  number  of  changes  being  proposed  arise  from  new  scientific  advice.  These 
changes relate mainly to the use of Category 1 and/or 2 materials for the production 
of technical / industrial products (biogas, bio-diesel, photo gelatine, fertilizers / soil 
improvers). The Commission has consulted EFSA concerning aspects of the review 
that are relevant to its work. A list of opinions is given in Annex III.  

2.7. 

Other opportunities used for consultation 

Views  were  also  collected  during  three  workshops  –  in  Greece  (May 2006),  Italy 
(June 2006)  and  Poland  (July 2006)  –  and  one  Conference  in  Brussels  (September 
2006)  organized  by  the  Commission  as  part  of  the  “better  training  for  safer  food” 
initiative, involving the competent authorities of the Member States and of the third 
countries trading partners and operators. 

The  workshops  and  conference  highlighted  a  number  of  local,  regional,  third 
countries  and  sector  specific  concerns,  which  have  been  considered  in  completing 
this report. A report of the workshops and conference is available at: 

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

2.8. 

General on-line consultation 

A general consultation addressed to the general public, stakeholders, Member States 
and  third  countries  has  been  carried  out  from  20 April  to  18 June  2007  via  an 
Interactive Policy Making online at the following Commission website: 

http://ec.europa.eu/yourvoice/ipm/forms/dispatch?form=animalbyproducts 

The statistics and a summary of the main findings of this consultation are available in 
Annex IV. The outcome of this consultation has been used as part of the analysis of 
impacts. 

2.9. 

Consultation on administrative burden to competent authorities of MS and the 
industry 

A questionnaire was sent to Member States and third countries competent authorities 
and interested stakeholders in order to gather data concerning the expected potential 
impact  of  the  review  on  administrative  burden  for  enterprises,  the  voluntary  sector 
and public authorities. The addressees had the possibility to respond from 20 April to 
18 June  2007.  Where  possible,  the  results  of  this  consultation  have  been  used  to 
analyse  the  impacts  of  the  different  proposed  options.  However,  it  should  be  noted 
that  the  quality  of  responses  was  mixed  and  it  was  difficult  to  get  any  clear  and 
consistent  information  on  costs.  The  questionnaire  and  a  summary  of  the  answers 
received can be found in Annex V. 

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2.10.  Opinion of the Impact Assessment Board 

This  document  has  taken  into  account  the  recommendations  of  the  Impact 
Assessment Board as far as possible. As a consequence of the opinion of the Impact 
Assessment  Board,  some  changes  have  been  introduced  in  this  document,  in 
particular  the  changes  related  to  information  obligations  for  businesses  and  public 
authorities have been listed in order to clarify simplification benefits, though to give 
exact estimations of these costs for all the affected industrial sectors was not possible 
due to time constraints as this item is a priority of the Commission Legislative Work 
Programme  for  2007.  Though  the  EU  Standard  Cost  Method  has  not  been  used 
considerable effort to calculate the costs and to get data from Competent Authorities 
and  the  industrial  sectors  affected  has  been  carried  out  and  assumptions  have  been 
made  when  no  data  was  available.  As  explained  under  chapter  6,  to  make 
extrapolations on these costs from one industrial sector to others is difficult as these 
costs highly depend on the industrial sectors considered and the type and number of 
ABP they use as raw material.  

To  address  the  question  of  whether  divergence  in  implementation  has  led  to  costs 
differences which hamper the functioning of the internal market qualitative analyses 
of the situation has been carried out, though, as for the issue of monetisation of the 
simplification  benefits,  data  submitted  by  the  Member  States  and  the  industrial 
sectors has not enough quality to make precise indications. Though it was clear that 
considerable differences between costs of registration in different Member States, it 
has not been possible to find out whether these divergences are due to the different 
interpretations of the Regulation by the Member States or to other factors such as the 
type of premises and the different items considered for the calculations of this costs.  

To  include  further  quantification  of  the  problems  identified,  further  effort  has  been 
made to collect data on the industrial sector affected. Data on the size, employment 
and  turn  over  of  the  affected  industrial  sectors  was  available,  but  the  estimation  of 
compliance  costs  for  all  the  affected  industrial  sectors  was  not  possible  for  the 
reasons  already  mentioned  though  some  indication  of  theses  costs  for  the 
biochemical industry are given under chapter 6. 

As  regards  the  procedure  and  presentation  of  the  document,  the  benefits  of  the 
selected  options  have  been  further  explained  and  data  sources  have  been  clarified. 
Further  quantification  of  the  problem  definition  has  been  included  as  regards  the 
number of entities and employment for some of the affected industrial sectors.  

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3. 

PROBLEM IDENTIFICATION 

3.1. 

Background 

In response to a number of crises affecting the safety of public and animal health as 
regards products of animal origin in particular linked to - Transmissible Spongiform 
Encephalopathy  (TSE),  dioxin,  Classical  Swine  Fever  (CSF)  and  Foot  and  Mouth 
Disease (FMD) - the Community has adopted a series of measures to protect public 
and  animal  health,  from  "farm  to  fork".  Among  several  pieces  of  legislation 
concerning  animal  and  public  health,  Regulation  (EC)  No  1774/2002  laying  down 
health  rules  concerning  animal  by-products  (ABP)  not  intended  for  human 
consumption3  consolidated,  simplified  and  replaced  19  previous  legal  acts.  It 
introduced stricter rules concerning the approval of certain premises, the channelling 
and  traceability  of  certain  products  and  the  implementation  of  several  processing 
parameters for strictly risk-related categories of ABP, in order to guarantee the safety 
of final products intended for feed or technical uses. 

– 

The ABP legislation is complex and covers a very broad range of products and 
industries. The following background information about the current legislation 
helps to understand the problem identification.  

– 

Scope of the ABP Regulation. 

The  ABP  Regulation  lays  down  a  general  framework  for  a  wide  range  of 
stakeholders and industrial sectors such as producers of feeding stuffs, petfood 
and  technical  products  (organic  fertilizers,  biogas  /  bio-fuel,  compost,  game 
trophies,  cosmetics,  medicinal  products,  medical  devices/laboratory  reagents, 
photo  gelatine,  etc)  and  for  waste  operations  (incineration,  co-incineration 
plants).  The  Regulation  covers  ABP  handled  within  the  Community  (placing 
on  the  market  and  intra-Community  trade),  transited  through  as  well  as 
imported into the Community from third countries, and affects small, medium 
and large operators in EU and third countries. 

– 

Categorisation of ABP 

The  Regulation  classifies  ABP  into  3  categories;  with  Category  1  material 
being  of  the  highest  risk  and  Category  3  comprising  materials  of  low  or 
negligible risk. Materials that are not Category 1 or 3 are, by default, placed in 
Category  2.  The  categories  are  described  in  the  box  below,  along  with 
examples of which ABP falls within which category, allowed uses and means 
of disposal.  

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Category 1 ABP:  

Allowed uses: 

Category 2 ABP:  

Allowed uses: 

Category 3 ABP:  

Allowed uses:  

Animals infected or suspected of being 
infected with transmissible spongiform 
encephalitis (TSE). ABP from animals 
treated  with  hormones; 
laboratory 
animals; pet animals 

Use 
not 
compulsory 
possible) 

allowed, 

destruction 
(generation  of  energy 

Fallen  stock;  animals  killed  due  to  an 
epizootic  disease  (other  than  TSEs); 
manure;  by  default  any  ABP  not 
categorised as 1 or 3 

technical  uses 

Certain 
fertilizers  or 
oleochemical products. 

as 
for  production  of 

such 

ABP  from  animals  fit  for  human 
consumption 

Feeding  purposes  and  any  technical 
use 

– 

Extent of the industry  

It  is  important  to  understand  the  extent  and  scope  of  the  industries  that  are 
affected by the ABP regulation (Diagram 1 highlights some of these industries 
and  the  ABPs  with  which  they  are  linked).  The  scope  of  the  Regulation  is 
cross-cutting, covering a wide range of industrial sectors. Animal by-products 
are being used or handled by operators in the field of feed for farmed and pet 
animals, of technical products (production organic fertilizers, biogas / bio-fuel, 
compost,  game  trophies,  cosmetic,  medicinal  products,  medical  devices/lab 
reagents,  photo  gelatine,  etc)  and  of  waste  disposal  /  recycling  operations 
(incineration, co-incineration, landfill, etc). As a consequence impacts of each 
policy  issue  can  vary  substantially  depending  on  the  type  of  industry 
considered. Further information is given in Annex VI, not only on the variety 
of industries operating on the basis of ABP but also with details of the size and 
importance of some of these industries. For example,  

EN 

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Gelatine Manufacturers of Europe - 10 European companies with a total of 
22  production  plants.  This  accounts  for  45  %  of  the  worldwide  gelatine 
production. Gelatine is produced mainly from bones and some parts of hides 
and  skins  of  bovine,  porcine  and  fish.  It  is  used  for  food,  feed  and  for 
technical purposes (e. g. photo and cinema films, x-ray-films). 

European  Fat  Processors  and  Renderers  Association  companies  process 
about 15.5 million metric tons ABP per year. It has 483 production units with 
almost 17000 employees. Raw material comprises mainly of whole carcasses 
and of any ABP derived during slaughter. Products are meat, bone meal and 
tallow. 

UECBV  –  European  Slaughterhouses  and  meat  Traders  Association 
represents  stakeholders  for  livestock  markets,  livestock  traders  and  meat 
traders, slaughterhouses, cutting plants and meat preparation plants, importers 
and exporters in the 25 Member States and other European countries. UECBV 
represents  some  15,000  firms  of  all  sizes  and  230,000  jobs.  These 
stakeholders  are  main  generators  of  ABP:  ABP  from  live  animals  (manure, 
milk,  eggs,  etc.),  ABP  derived  during  slaughtering  (specified  risk  materials, 
meat  not  fit  for  human  consumption,  etc.)  and  during  further  processing 
(unusable  cuts  or  other  parts  in  meat  cutting  plants  or  during  meat 
preparation), 

European  Oleochemicals  &  Allied  Products  Group  has  17  members  who 
produce  fatty  acids.  With  around  500  mio  euro/year  turnover  the  industry 
represents  10.000  jobs  in  Europe.  Oleochemicals,  such  as  glycerine,  are 
produced mainly from tallow.  

FEDIAF – petfood industry represents the interests of 19 national pet food 
industry associations and with this  the interests  of around 450 European pet 
food  producing  companies.  In  2005,  products  worth  8.5 Milliard  Euro  were 
sold.  This  industry  employs  directly  21.000  and  indirectly  another  30.000 
people.  Raw  material  for  petfood  production  are  e.  g.  meat,  livers,  kidneys, 
milk products, hides and skins and a large further variety of ABP. 

EFPIA  –  European  Federation  of  Pharmaceutical  Industries  and 
Associations 

EFPIA represents the pharmaceutical industry operating in Europe through its 
direct  of  30  national  associations  and  46  leading  pharmaceutical  companies 
and  2.100  companies  committed.  Such  products  derive  mainly  from  blood 
products, but also from enzymes (derived e. g. from stomach or intestines) or 
organs used for medical devices (cardiac valves obtained from hearts, lenses 
of eyes, parts of the medium or internal ear, etc.).  

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The  European  vaccine  industry  (data  submitted  by  EVM  –  European 
Vaccine  Manufacturers)  is  the  largest  supplier  of  vaccines  in  the  world, 
producing  approximately  80%  of  vaccines  used  worldwide.  It  is  the  largest 
supplier  to  UNICEF  of  vital  paediatric  vaccines,  including  polio  vaccines. 
ABP used for vaccine production is mainly blood serum, but also pathogens 
or parts thereof (bacteria, viruses, etc.). 

Veterinary products industry: More than 50.000 fulltime jobs in Europe are 
dependent  on  the  animal  health  industry  with  about  15,000  being  in 
production,  marketing,  sales,  research  and  development.  European  sales  of 
animal  health  care  related  products  amounted  to  $5.3 billion  US  in  2005. 
Such  products  derive  mainly  from  blood  products,  but  also  from  enzymes 
(derived e. g. from stomach or intestines) or medical devices (cardiac valves, 
parts of eyes or ears, etc.). 

EDMA – European Diagnostic Manufacturers Association brings together 
20  National  Associations  in  European  countries  and  29  of  the  major 
companies engaged in research, development, manufacture or distribution of 
in-vitro-diagnostic  products.  Through  its  affiliated  National  Associations, 
EDMA  represents  in  total  more  than  500  companies  (or  over  700  legal 
entities)  across  the  EU.  The  market  for  in-vitro  diagnostic  products  has  a 
value  of  around  9  billion  €  per  year  (2005  figures).  The  main  ABP  used  is 
blood serum. 

Confederation  of  National  Associations  of  Tanners  and  Dressers  of  the 
European  Community  represents  companies  with  more  than  3.000  plants 
(mainly small and medium enterprises). More than 50.000 direct jobs depend 
on the leather industry that accounts a 8.000 Million Euro turnover/year. This 
hides  and  skins  used  as  raw  materials  represent  typically  50-60%  of  leather 
production costs 

European  Cosmetics  Industry:  The  value  of  output  of  the  EU  cosmetics 
industry is estimated at around €35 billi on (in 2004) and the industry employs 
over 150,000 Europeans directly. Cosmetics are being produced mainly using 
tallow  and  derived  products,  e.  g.  glycerine,  but  also  enzymes,  acids, 
hormones  or  colours  derived  from  various  animal  tissues  (skin,  intestines, 
hair, insects, etc.). 

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Diagram 1:  Sectors / industries covered by the Regulation 

SLAUGHTERHOUSE

FARM

RESTAURANT

Ante mortem 
inspection

..

..

SLAUGHTER

..

Bones

CUTTING

Fats trimmed  
from carcases

Post mortem
inspection

Meat and offal

Hides and skins

Blood

Fats

Defatted
bones for
gelatine

Fats

Greaves

Meat 
Meat products
Processed 
Animal Proteins

Leather

Gelatine
Collagen
Hydrol.
Proteins

Blood 
products
(incl. 
serum)

Human food
Animal feed* 
Petfood
Pharmaceutical
Cosmetic
Technical

Human food
Animal feed *
Petfood
Pharmaceutical
Cosmetic
Technical

Human food
Animal feed *
Petfood
Pharmaceutical
Cosmetic
Technical

Human food
Animal feed 
Petfood
Pharmaceutical
Cosmetic
Technical

8
Catering waste

Fallen stock

Animals unfit for
H. consumption

Parts unfit for 
H. consumption

Rendering 
Technical

Animals positive to
BSE rapid test

BSE Specified Risk 
Material

Destruction

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3.2. 

The issues / problems that require actions 

The current Regulation entered into force on 1 November 2002 (and applied as from 
1 May 2003) and lays down strict rules, covering almost everything being a (dead) 
animal  or  having  been  derived  from  animals  and  not  intended  for  human 
consumption. The Commission report of 2005 (see section 2.2) concluded that it has 
been  challenging  for  all  Member  States  and  economic  operators  to  apply  the  rules 
laid down by this Regulation. However, compliance has been generally satisfactory 
and  the  basic  principles  of  the  Regulation  have  proven  to  deliver  a  significant 
contribution towards achieving the objectives of a high level of protection of public 
and animal health now achieved in the Community and should be preserved. In order 
to contribute to the achievement of these objectives, the Commission has, since the 
entry into force of this Regulation, already carried out a number of actions including 
the  drafting  of  guidelines  and  issuing  legislation  by  means  of  Comitology  (the 
complete list can be found in Annex VIII).  

Even  though  the  legislation  is  working  well  and  generally  meets  its  overall 
objectives, the subsequent consultations have identified areas where changes need to 
be considered in order to update the current legislation and to provide legal certainty, 
as well as simplify and reduce administrative burden. What has been identified is that 
the products and the industries concerned are wider ranging than foreseeable by the 
legislators at the time of adoption of the Regulation. In addition, further information 
on  the  risks  posed  by  certain  ABP  material,  and  the  effectiveness  of  treatment 
standards  in  producing  a  'safe'  product,  has  become  available  in  the  years  since 
adoption  of  the  legislation.  Therefore,  it  is  an  appropriate  time  to  look  again  at 
certain  aspects  of  the  legislation.  The  intention  being  to  focus  on  ensuring  that  the 
current rules are 'risk-proportionate' i.e. they allow trade and competitiveness of the 
EU industries that deal with ABP without reducing the level of protection for public 
and animal health. 

Whilst  there  are  a  number  of  issues  that  are  likely  to  be  addressed  in  any  revision, 
there are a few where it has been identified that there might be significant impacts. 
These are set out below and are the subject of this impact assessment.  

3.2.1.  Policy issue 1: The scope of the Regulation is not sufficiently clear 

The  scope  of  the  Regulation  is  very  wide  ranging,  covering  –  with  only  a  few 
exceptions - any animal by-product (i.e. entire bodies, parts of animals and products 
of  animal  origin)  which  is  not  intended  for  human  consumption.  With  such  a  wide 
scope we need to examine whether the rules are always proportionate to the risk and 
consideration needs to be given to providing more focus. Specifically in two areas; 
uncertainty as to when the legislation ceases to apply to ABPs (end of the "life cycle" 
of  an  ABP)  and  difficulties  that  have  arisen  due  to  exceptions  from  the  scope  for 
ABP from wild animals). 

Policy Issue 1(a) - For certain ABP it is not clear at which stage of their processing 
the legislation ceases to apply 

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Summary 

Although the regulation is clear about when materials become an ABP, i.e. when the 
"ABP life-cycle" starts, it is less clear about when they stop being an ABP, i.e. the 
life-cycle  stops  and  the  Regulation  does  not  apply  any  more.  This  means  that, 
technically, products such as leather and clothing made from wool are still subject to 
the ABP regulation. Whilst for these types of products Member States have adopted 
a pragmatic approach and not applied the regulation (as there are no obvious risks for 
public or animal health associated), there are other ABP products where the situation 
is  not  so  clear.  For  companies  who  deal  with  such  products  and  for  the  Member 
States  authorities that must ensure proper enforcement, the legal  uncertainty  due to 
the lack of a clear definition of the end of the ABP life-cycle can be a major problem, 
either due to inconsistent enforcement that may lead to health risks and/or distortion 
of competition or having to apply stringent and disproportionate rules when there is a 
negligible risk to health from the products in question. 

Background 

The  Regulation  classifies  certain  materials  as  animal  by-products  and  lays  down 
rules for their handling, channelling and final use. These rules also apply for products 
containing  ABP  in  addition  to  other  materials.  The  Regulation,  however,  does  not 
define the point as from which no further controls of the ABP are needed (the "end 
point of the life cycle"). It was certainly not the intention of the legislators to subject 
highly  processed  products  to  controls,  such  as  leather  shoes  (produced  from  hides 
and skins), paints (produced with certain milk products) or lubricants (produced from 
tallow).  These  products  pose  a  negligible  risk  to  public  or  animal  health  and 
application of the requirements of the ABP Regulation is disproportionate.  

Whilst  there  would  potentially  be  unnecessary  costs  to  operators  and  competent 
authorities  in  applying  the  Regulation  to  highly  processed  products,  in  reality 
Member  States  have  adopted  a  pragmatic  approach,  acknowledging  that  such 
products  were  not  the  target  of  the  legislation  and,  consequently,  applying  and 
interpreting the Regulation as not extending to these products. 

A higher degree of legal certainty would however avoid different interpretations and 
a  difference  in  the  level  of  protection  throughout  Member  States.  Not  least  as 
because  the  range  of  products  and  industries  that  fall  under  the  ABP  Regulation  is 
often  not  clear  cut  as  it  is  with  products  such  as  shoes  and  wool  clothing.  For 
example, it is possible to treat tallow to the extent that there is a negligible risk (i.e. 
the  ABP  life-cycle  is  'finished')  –  but  the  degree  of  treatment  required  will  be 
dependent on whether the tallow is derived  from  Category  1,  2  or 3 materials. The 
current ABP Regulation allows the use of Category 3 tallow for production of feed 
and  any  technical  product  including  cosmetics,  medicinal  products  and  medical 
devices. Category 1 and 2 tallow and any product derived thereof, are in principle not 
allowed for such purposes. This poses problems for the tallow derivatives industry, 
in  particular  as  regards  a  wide  range  of  items  produced  for  industrial  purposes 
(lubricants, plastics and rubber components, paints, etc).  

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In  the  pharmaceutical  industry,  highly  processed  ABPs  which  pose  negligible  risk 
are often used, but the companies handling them must anyhow follow the provisions 
of the ABP Regulation as regards authorization procedures, which are in addition to 
the  already  stringent  authorization  procedures  foreseen  by  the  pharmaceutical 
legislation.  

Policy  Issues  1(b)  -  It  is  not  clear  whether  ABP  from  wild  game  are  subject  to  the 
requirements of the Regulation. 

Summary 

The ABP Regulation excludes from its scope bodies and parts of wild game which 
die in nature (either due to natural reasons or through hunting), as long as the wild 
animals are not suspected of being infected with a communicable disease. However, 
this  means  there  is  uncertainty  as  to  whether  ABP  from  establishments  that  handle 
hunted  wild  game  for  the  placing  on  the  market  of  wild  game  meat  and  other 
foodstuffs  (be  these  in  EU  or  third  country)  fall  under  the  ABP  Regulation.  In  this 
regard,  it  must  be  considered  that  these  establishments  are  indeed  covered  by  the 
recently  revised  food  hygiene  legislation.  The  major  problem  relates  to  import  of 
wild  game  from  outside  of  the  EU  and  the  fact  that  game  handling  establishments 
outside of the EU may not be subject to similar hygiene conditions. 

Background 

Although  a  problem  of  much  less  magnitude  than  the  previous  one,  current 
provisions  as  regards  ABP  from  wild  animals  have  led  to  some  difficulties  of 
interpretation: the ABP Regulation includes in its scope bodies and parts of farmed 
game  which  are  slaughtered  for  human  consumption.  However,  it  excludes  entire 
bodies  or  parts  of  wild  animals  if  they  are  not  suspected  of  being  infected  with 
diseases communicable to humans or animals (with the exception of certain fish and 
ABP used to produce game trophies).  

The intention of the legislator was to avoid requiring collection and disposal of wild 
game, which die in nature for natural reasons or through hunting for non-commercial 
purposes. However, this general exclusion from the scope does not clarify, whether 
ABP  derived  from  handing  wild  game  in  game  handling  establishments  or  ABP 
derived  from  wild  game  supplied  to  the  local  market  by  hunters  are  subject  to  the 
requirements  of  the  ABP  Regulation.  These  ABP  could  pose  non-negligible  risk  to 
public and/ or animal health. Risks could arise, for example, if these ABP are derived 
from  animals  infected  with  classical  swine  fever,  foot-and  mouth  disease  or 
tuberculosis,  and  are  then  brought  into  contact  with  susceptible  individuals.  Such 
diseases  are  absent  or  rare  in  most  parts  of  the  Community  but  are  common  in  a 
certain number of third countries. The lack of clarity of current provisions also has an 
impact on our import rules. 

Furthermore,  it  must  be  considered  that  wild  game  handling  establishments  are 
covered  by  the  recently  revised  food  hygiene  legislation.  This  legislation,  in 
particular Regulation (EC) No 853/2004, contains provisions on the handling of wild 
game,  which  obliges  operators  to  ensure  hygienic  conditions  and  in  particular  to 
prevent contamination of meat from other animal material present.  

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ABP  derived  from  wild  animals  may  be  of  economic  interest  e.g.  for  the  pet  food 
industry  but  any  industry  using  ABP  could  also  use  this  source.  Currently,  certain 
Member  States  and  parts  of  the  industry  are  acting  on  their  own  responsibility  and 
subject such ABP to adequate safety requirements. 

Nevertheless, in order to ensure that these obligations are being met in a consistent 
way in the EU and in relation to imports, it is preferable to clarify to which extent the 
rules on ABP are applicable to game-handling operations. Therefore, it is necessary 
to  clarify  the  scope  of  the  Regulation  as  regards  ABP  derived  from  wild  animals, 
with the aim to ensure legal certainty by harmonising requirements for their control, 
and in the interest of uniform and adequate protection of human and animal health. 
By  clarifying  the  provisions  applicable  to  certain  commercial  hunting  operations, 
consistency with Community food hygiene legislation should also be ensured, while 
any duplication will be avoided. 

3.2.2.  Policy  Issue  2  –  Categorization  of  ABPs:  Categorization  of  some  materials  is 

disproportionate compared to the risk 

Summary 

The Regulation  needs to take account of scientific evidence that has emerged as to 
the risks of certain ABP. More specifically, the current categorization system is not 
always risk proportionate for certain ABPs, with this having significant implications 
for the industries that use these products. 

Background 

Under  the  current  rules,  ABP  are  classified  in  accordance  with  the  risk  they  pose. 
This may be inadequate in two ways: 

• 

Some of the material is not listed in the category corresponding to the risk 

The  risk  attached  to  ABP  is  in  some  cases  decided  by  reference  to  other 
Community  legislation  which  is  based  on  the  assessment  of  risks  to  public 
health  (such  as  the  legislation  on  TSEs)  and  to  the  safety  of  the  feed  chain 
(such as legislation on residues). In some cases, this other legislation has been 
changed since the entry into application of the ABP Regulation to reflect new 
scientific knowledge (e.g. ruminants below a certain age limit do not have to be 
tested for BSE and therefore, the classification of the ruminant blood does no 
longer adequately reflect the risk assessment behind BSE rules).  

• 

Some  of  the  material  is  not  listed  at  all  and  therefore  by  default  fall  into 
category 2 

ABP rules establish that any ABP not been defined as Category 1 or Category 
3  material  falls  immediately  by  default  under  category  2.  The  aim  of  this 
provision  is  the  protection  against  any  possible  unidentified  risks  that  may 
arise.  However,  the  Regulation  only  allows  a  very  limited  use  of  category  2 
ABP. Since entry into application of the Regulation, more scientific evidence 
has become available on possible uses of some animal by-products and on the 
risks attached to them (see box below) 

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Examples of ABP for which the categorisation is considered as not being 
risk adequate. 

Casein,  a  by-product  derived  from  milk  processing  and  used  for  the 
production  of  white  paints  does  not  fall  under  any  of  the  ABP  listed  as 
Category 1 or 3 and falls also by default under Category 2. As such, its use 
for  technical  purposes  is  limited,  which  poses  great  difficulties  to  the  paint 
industry. 

Insects  are  used  in  the  cosmetic  industry  (as  they  provide  pigments  for 
lipsticks, etc), for pet food and for fish-feed. These ABP fall into Category 2 
also by default and are therefore not allowed for those purposes (in order to 
allow  for  continued  use  of  these  materials,  a  transitional  measure  has  been 
adopted under the ABP Regulation (Regulation (EC) No 878/2004)).  

Current legislation contains no simple facility for updating the categorisation of ABP 
other than via the adoption of transitional measures which do not result in a coherent 
legal  framework.  Hence,  the  legislation  is  not  flexible  enough  to  keep  up  with 
advancements  in  scientific  knowledge  and  technology.  This  means  that  the 
legislation  is  not  always  risk-proportionate  and  may  to  some  extent  impose 
unnecessary burdens on the manufacturing industries using these products, .or indeed 
preventing use of ABP which are safe and of economic value.  

3.2.3.  Policy issue 3- Duplication of approvals for some type of premises 

Summary 

Experience  has  shown  that  the  relationship  between  the  ABP  Regulation  and  other 
Community  sector legislation  is  not  always clear and in some cases at other places 
they  are  overlapping.  As  a  consequence,  there  are  legal  uncertainties  how  the 
requirements  laid  down  in  different  legal  acts  are  supposed  to  apply  to  certain 
operators.  Also,  certain  operators  have  to  be  approved  twice  by  the  relevant 
authorities for similar objectives. 

Background 

The Regulation requires that all premises handling ABP must be approved and meet 
the requirements of the ABP Regulation, even if they have also to be approved under 
other  Community  sector  legislation.  As  a  result,  certain  premises  that  are  already 
approved  under  food/feed  legislation  (e.g.  for  the  production  of  tallow,  eggs, 
gelatine,  etc)  or  under  technical  sector  legislation  (e.g.  on  cosmetics,  medicinal 
products and medical devices) must also be approved under the ABP Regulation.  

These different sets of rules may result in a duplication of administrative burden for 
operators  as  well  as  different  ways  of  application  of  the  legislation,  since  different 
competent  authorities  might  develop  different  ways  of  resolving  overlaps  in  the 
rules.  However,  as  long  as  food  safety  and  animal  and  public  health  protection  are 
guaranteed  by  the  sector  legislation,  this  duplication  for  operators  as  well  as  for 
competent authorities should be avoided.  

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Example of types of premises undergoing double approvals 

Establishments producing gelatine or collagen for human consumption may decide 
to deliver their end products also for uses outside the food chain, which fall under 
the  ABP  rules (e.g.  photographic gelatine). Since  they are already approved under 
food  hygiene  legislation  and  comply  with  the  relevant  production  standards,  it 
should be considered whether a separate approval under ABP rules is necessary for 
such plants.  

Petfood  plants  may  already  be  approved  under  Regulation  (EC)  No 183/2005  on 
feed  hygiene  for  other  manufacturing  operations.  In  this  respect,  they  have  to 
comply with comprehensive requirements as regards hygienic production conditions 
and  the  monitoring  of  risks  to  public  and  animal  health  during  their  operation. 
Insofar  as  the  objectives  of  these  rules  coincide  with  the  objectives  of  the  ABP 
Regulation, it would not seem proportionate to require such plants to be approved 
again under ABP rules. 

3.2.4.  Policy  issues  4  -  Derogations  of  the  Regulation  do  not  consider  certain  specific 

situations.  

Summary 

The strict rules of the Regulation on  derogations  need to  take into account  specific 
circumstances.  The  import  of  a  wide  range  of  ABP  is  sometimes  necessary  for 
research purposes. Under emergency situations, disposal of ABP through the normal 
channels is not practically feasible. The current rules do not provide for risk-adequate 
solutions to these problems. 

Background 

– 

Import of ABP for research 

Current  provisions  allow  the  use  in  the  Community  of  all  Categories  of  ABP 
for  research  and  scientific  purposes  under  Member  States  responsibility. 
However,  the  importation  of  Category  1  and  2  materials  for  such  purposes  is 
not  allowed  even  if  their  use  is  strictly  limited  to  research/scientific  purposes 
(for  example:  materials  derived  from  experimental  animals  are  classified  as 
Category 1 material and as such their import is prohibited).  

Certain stakeholders are constantly developing new possibilities to use certain 
ABP classified as Category 1 for testing and research/scientific purposes. The 
current  restriction  on  imports  undermines  such  development  of  new  products 
and  related  technologies  and  therefore  the  competitiveness  of  EU  enterprises 
engaged in research.  

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Example of ABP used for research purposes: 

Research institutes have in the past been engaged in projects which required 
the use of material from non-farmed animals belonging to species or breeding 
lines  not  present  in  Europe,  such  as  for  example  non  human  primates  or 
certain  genetically  modified  mice.  Due  to  such  animals  being  classified  as 
Category  1  material,  import  of  the  derived  by-products  is  not  permitted. 
Similar considerations would apply to by-products from animals or materials 
with  BSE  or  other  disease  risk  which  are  used  for  the  purpose  of  tests  in 
Community reference laboratories.  

– 

Disposal in natural disasters 

In  certain  situations  the  requirements  for  incineration  and  landfill  of  animal 
carcases, in particular of fallen stock, cannot be applied. The current legislation 
provides  for  derogation  in  three  scenarios,  namely  in  the  case  of  (i)  dead  pet 
animals,  (ii)  remote  areas  with  low  animal  density  population  and  (iii)  major 
outbreaks of highly contagious animal diseases, such as FMD. The derogations 
have  been  put  in  place  in  order  to  avoid  the  risk  of  spreading  diseases  or  in 
view of the lack of disposal capacity for a large number of animals which die. 

While  under  the  respective  contingency  plans  efforts  are  necessary  to  ensure 
sufficient capacity for the rendering of dead animals in the context of disease 
control  measures,  the  available  rendering  or  incinerator  capacity  within  a 
region or country could quickly be overwhelmed and become a limiting factor 
in the control of a disease, as observed in the case of 1997 CSF and 2001 FMD 
epidemics.  

Similar considerations need to be applied for certain scenarios such as; 

• 

• 

areas  where  access  is  practically  not  possible  (eg:  due  to  geographical 
conditions)  or  present  a  risk  to  health  and  safety  of  those  charged  with 
the operation, and where there is a unacceptable discrepancy between the 
requirements  for  occupational  safety  and  the  potential  risks  to  animal 
health, and  

areas where there is a natural disaster, to which it is equally argued that 
the  derogation  should  be  extended.  Examples  of  this  situation  are 
provided in the text box below: 

EN 

23 

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During  the  fires  in  Galicia  (Spain)  in  2006,  a  total  of  130  carcasses  of 
animals had to be brought to the nearest accessible mountain paths where 
a  lorry  could  drive  at  a  total  cost  of  33 000  €.  To  this  cost  the  normal 
costs  for  transport  to  and  destruction  in  the  rendering  plant  have  to  be 
added. 

In summary, the costs for recovery and disposal, under the conditions of 
the disaster are five times higher that the costs for the same procedures 
under normal circumstances. 

Similar  considerations  apply  to  exceptional  circumstances  such  as 
extreme  heat  or  floods.  As  an  example,  during  the  extreme  heat  in 
France in  the summer  of 2003, the  amount of poultry, fish and porcine 
cadavers which had to be collected rose by 40% as opposed to the same 
period  in  previous  years  (in  total:  around  12.000  tonnes  more).  The 
additional disposal costs for this quantity of material can be estimated at 
3 000 000 €. 

3.3. 

PERSPECTIVES (POSSIBLE EVOLUTION OF THE ISSUE / PROBLEM) 

Although  a  precise  evolution  of  the  problem  for  all  different  operators  and 
stakeholders  involved  cannot  be  predicted,  from  a  general  point  of  view,  it  can  be 
stated  that  a  lack  of  legal  clarity  and  consequential  different  interpretations  with 
respect  to  the  scope  and  the  rules  of  the  Regulation  could  lead  to  public  and/or 
animal  health  risks  and  different  levels  of  protection  across  the  Community,  and 
distortion of competition for operators.  

Insofar  as  the  risk-proportionality  of  the  rules  on  animal  by-products  needs  to  be 
improved  and  the  rules  need  to  be  adapted  to  possible  progress  in  science  and 
technology,  the  competitiveness  of  various  industries  in  the  European  Union  could 
be undermined as industries outside the EU are not subjected to these requirements. 
As a consequence manufacturers could move outside the EU with negative impacts 
on  employment  and  the  economy.  Advance  in  medical  research  could  be  also 
negatively affected by the prohibition on imports o ABP for these purposes. 

Unnecessary  administrative  burden  would  be  imposed  on  EU  industries  and 
competent  authorities  as  well  as  inconsistencies  would  persist  with  other  EU 
legislation. 

Different  interpretations  of  the  scope  of  the  Regulation  will  lead  to  potential 
distortion of competition that hampers the functioning of the internal market and to 
different  levels  of  protection  against  public  and  animal  health  threats  between 
Member States. 

EN 

24 

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3.4. 

Subsidiarity test  

The project refers to a revision of Regulation 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.  Article  152  (2)  of  the  Treaty 
provides  a  legal  basis  for  the  EU  legislative  measures  on  ABP  as  the  primary 
objective  of  the  Regulation  is  the  protection  of  public  and  animal  health.  The 
subsidiarity principle applies insofar as the proposal does not fall under the exclusive 
competence of the Community.  

Necessity-test 

Significant risks of the spread of diseases to which animals may be exposed and of 
endangering animal and human health through animal feeding stuffs, were witnessed 
in  recent  years  in  relation  to  BSE,  FMD,  CSF  and  dioxin.  Such  health  risks  were 
identified  across  the  Community  and  had  significant  impact  on  intra-Community 
trade  (such  as  market  failures  due  to  changes  in  consumption  patterns).  For  this 
reason particular requirements are needed at Community level as regards the placing 
on the market of certain ABP, particularly in regions with a poor health status. This 
would also ensure that products imported from or exported to third countries are of a 
hygiene  standard  which  is  at  least  equivalent  to  the  minimum  hygiene  standard 
applied in the Community. 

The current revision, even though not intending to introduce any changes to the basic 
principles  and  structure  of  the  way  ABPs  are  handled,  has  to  be  done  at  the 
Community level as only this way certain issues can be effectively clarified, as well 
as sufficient flexibility to take account of emerging scientific knowledge about risks 
associated to the possible uses of ABP can be ensured. 

Added-value test  

ABP are included in the list of products in Annex I to the Treaty4. Their placing on 
the  market  constitutes  an  important  source  of  income  for  part  of  the  farming 
population  and  other  concerned  sectors.  To  ensure  a  smooth  functioning  of  the 
internal  market,  rational  development  in  this  sector,  increase  productivity  and 
stimulate competitiveness, animal health and public health rules for the products in 
question are needed at Community level. 

Boundary test 

Crises that have occurred in the past show that in the case of a disease outbreak and 
in the absence of a fully harmonised approach, Member States may be subjected to 
internal  pressure,  that  may  eventually  prevent  the  adoption  of  the  best  measures  to 
control the disease, if they are not bound by Community legislation. This may finally 
lead  to  the  spread  of  disease  and  additional  costs  and  losses  for  the  farming,  agro- 
and food-industries as well as for the Member States' and the Community’s budgets.  

4 

Annex I to the Treaty establishing the European Community, List referred to in Article 32 of the Treaty 
(list of products subject to the provisions governing CAP). 

EN 

25 

   EN 

 
                                                 
In  addition,  in  the  absence  of  a  harmonised  approach,  measures  restricting  trade 
would  be  taken  at  national  level,  disrupting  the  functioning  of  the  internal  market. 
This  would  also  have  a  serious  impact  on  EU  exports  as  the  credibility  of  EU 
measures  would  be  jeopardized.  Member  states  will  have  to  face  third  country 
restrictions to exports themselves, meaning severe trade restrictions as a consequence 
of animal health problems losing power to negotiate at international level. 

In light of these different elements, EU action is justified as it is clear that Member 
States  can  not  achieve  this  satisfactorily  and  that  the  EU  can  do  it  better  and  more 
efficiently. 

4. 

OBJECTIVES 

The aim of the review is in line with the Commission's strategic objectives and better 
regulation principles5, namely to improve and make the measures more effective and 
efficient, reducing unnecessary burden for operators as far as protection of public and 
animal health and food safety are not undermined.  

Therefore, the general objective is to review the Regulation on ABP in order to: 

• 

• 

• 

better  ensure  the  safety  of  the  food  and  feed  chain  and  reinforce  consumers' 
confidence 

facilitate smooth functioning of the internal market, 

increase competitiveness of the EU industries affected by this Regulation 

In  order  to  achieve  the  general  objectives,  the  following  specific  objectives  have 
been established. 

• 

• 

• 

adjust the regulatory framework to the risks posed by animal by-products  

improve legal clarity and,  

adapt requirements to progress in science and technology;  

5 

Communication  from  the  Commission  -  Action  plan:  "Simplifying  and  improving  the  regulatory 
environment"; COM(2002) 278 final. 
Communication from the President in agreement with Vice-President Wallstrom - "Strategic objectives 
2005 – 2009, Europe 2010: A partnership for European Renewal, Prosperity, Solidarity and Security"; 
COM(2005) 12 final. 
- 
Communication 
"Communication to the Spring European Council: Working together for growth and jobs – A new start 
for the Lisbon Strategy", COM(2005) 24 final. 
Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  European 
Economic and Social Committee and the Committee of the Region – Proposal for a joint declaration by 
the Council, the European Parliament and the Commission on the European Union Development Policy 
– "The European Consensus", COM(2005) 0311 final. 

in  agreement  with  Vice-President  Verheugen 

from  President  Barroso 

EN 

26 

   EN 

 
                                                 
 
 
 
The operational objectives focusing on the problems identified are: 

• 

• 

• 

• 

for the scope of the Regulation: adjusting the regulatory framework to the risks 
posed by animal by-products by determining to which processed products the 
rules apply, thereby reinforcing consumers' confidence 

for categorising new products: adjusting the regulatory framework to the risks 
posed by animal by-products and improving legal clarity 

for clarifying approvals/ registrations and controls: improving legal clarity and 
avoiding any unnecessary burdens 

for clarifying the derogations: adjusting the regulatory framework to the risks 
posed by animal by-products and improving legal clarity, also to contribute to 
progress in science as regards import of ABP 

5. 

KEY POLICY OPTIONS  

As  already  explained  under  chapter  3.2,  the  basic  principles  of  Regulation  (EC) 
No 1774/2002 have proven to deliver a key contribution towards achieving a higher 
level  of  public  an  animal  health  in  the  Community  and  towards  preventing  food 
safety and animal health crises such as those which have occurred in the past (BSE, 
CSF, FMD). The high level of protection against public and animal health risks must 
be  maintained  and  thus  deregulation  has  not  been  considered,  as  it  is  not  an 
appropriate approach to this very sensitive issue.  

To  address  the  problems  identified  and  described  under  chapter  2,  different  policy 
options have been considered and were the subject of an impact assessment. Due to 
the  different  nature  of  the  problems  identified  and  the  different  range  of  operators 
affected by each specific issue it was considered more adequate to tackle each issue 
separately. 

The  "Do-nothing"  approach  has  been  considered  for  all  options  as  well  as  the 
"legislative  review"  option.  Alternatives  to  the  regulatory  approach  have  also  been 
analyzed  for  some  of  the  issues  but  for  not  for  the  problems  that  are  related  to 
legislative  interaction,  clarifying  derogations  or  re-categorization  as  they  were 
considered not relevant due to the reasons explained later in this section. 

5.1. 

Policy issue 1-Clarifying the scope 

5.1.1.  Policy issue 1 (a) - Determination of the end of the ABP life-cycle 

Option (a): 

Do-nothing 

Option (b): 

Co-regulation 

Commission  and  stakeholders  could  set  a  common  framework  for  the  adoption  of 
standards based on which the end-point in the manufacturing chain where the rules of 
the Regulation cease to apply will be established.  

EN 

27 

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Option (c): 

Legislative review 

Two possible sub-options have been identified: 

– 

– 

Exemption of finished products from the Regulation: Finished products which 
have  been  processed  to  a  certain  extent  could  be  exempted  from  the 
Regulation.  

Introduction  of  a  legal  basis  for  the  determination  of  the  end  of  the  ABP  life 
cycle.  Reduction  of  controls  to  products  manufactured  on  ABP  basis  when 
technical  and  scientific  considerations  allow  concluding  that  this  entails  no 
inadequate risks to public and animal health.  

5.1.2.  Policy issue 1 (b)- Coverage of ABP from wild animals 

Option (a): 

Do-nothing 

Option (b): 

Alternatives to legislative tools 

• 

Self Regulation: 

Stakeholders  concerned  (such  as  hunters  associations  and  producers  of  game 
meat)  could  identify  for  which  type  of  premises  it  is  necessary  to  apply  the 
controls of the Regulation. 

• 

Co-regulation: 

Commission and stakeholders could set a common framework for the adoption 
of  standards  to  establish  which  type  of  premises  must  be  subjected  to  the 
controls of the Regulation.  

• 

Guidance: 

Guidance  drawn  up  by  the  Commission,  as  appropriate  following  scientific 
advice and/ or consultation with the authorities responsible for enforcement in 
Member  States,  could  be  produced  to  give  orientation  when  establishments 
obtaining/processing  ABP  from  wild  animals  should  be  subjected  to  the 
requirements of this Regulation. 

Option (c): 

Legislative review 

To  extend  the  scope  to  cover  all  ABP  from  wild  animals  which  are  handled  to  be 
placed on the market and allow the competent authority to define conditions to apply 
to establishments handling such ABP;  

EN 

28 

   EN 

 
 
 
 
5.2. 

Policy issue 2 - Categorising new products 

Option (a): 

Do-nothing 

Option (b): 

Alternatives to legislative tools 

Alternatives to the pure regulatory approach have been considered to be not relevant 
as the issue relates to the strict categorization of the current Regulation and it is not 
open to modification by non-legal instruments. 

Option (c): 

Legislative review 

To reclassify products which pose a low risk for public and /or animal health based 
on scientific assessment in order to facilitate their use.  

5.3. 

Policy issue 3-Clarifying the approvals / registrations and controls 

Option (a): 

Do-nothing 

Option (b): 

Alternatives to regulatory tools 

As this policy issue relates to the need to clarify interaction of different Community 
legislation  non-regulatory  tools  have  been  considered  to  be  not  relevant  and  thus 
their impacts are not been analyzed in this document.  

Option (c): 

Legislative review 

To  remove  duplicated  approvals  and  rely  on  the  provisions  already  introduced  by 
other  Community  sector  legislation,  but  maintain  certain  requirements  in  order  to 
ensure traceability of these ABP. 

5.4. 

Policy issue 4-Clarifying the derogations 

Option (a): 

Do-nothing 

Option (b): 

Alternatives to regulatory tools 

Alternatives  to  regulatory  tools  have  been  considered  not  relevant  for  this  policy 
issue as it relates to clarifying the derogations of the Regulation and so their impacts 
are not assessed in this document.  

Option (c): 

Legislative review 

Extending the derogations to: 

– 

– 

Allow  the  imports  of  animal  by-products  for  research  purposes  in  line  with 
other EU legislation such as legislation on TSE and  

Extend the possibility to bury and burn carcases of animals in areas (i) affected 
by  natural  disasters,  (ii)  where  access  is  not  practically  possible  or  present  a 
risk to health and safety. 

EN 

29 

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6. 

ANALYSIS OF IMPACTS 

6.1. 

GENERAL REMARKS 

This Impact Assessment combines quantitative and qualitative approaches to ensure 
that adequate consideration is given to a broad range of direct and indirect as well as 
social, environmental and economic impacts.  

The  quantitative  analysis  is  based  on  the  results  of  the  consultation,  including  data 
supplied  by  Member  States  competent  authorities,  third  countries  competent 
authorities and industries and other stakeholders affected.  

Consultation  on  administrative  costs.  Data 
encountered 

limitations  and  difficulties 

The  stakeholder  consultation  carried  out  by  DG  SANCO  delivered  only  limited 
information  on  financial  impacts.  Generally  stakeholders  (both  industry  and 
competent authorities) claimed that estimation was very difficult or even impossible 
for  them  for  different  reasons  mentioned  below  (not  all  of  these  are  applicable  to 
every  submission).  Based  on 
the 
proportionality principle, the assessment of the options has not been carried out using 
the  Standard  Cost  Model.  Consequently,  in  order  to  quantify  the  impacts, 
calculations for concrete options have been based on assumptions where appropriate.  

limitations  and  according 

these  data 

to 

As covering quantitative impacts on all industries affected by this proposal was not 
possible due to lack of accurate data from all of them, some examples of industries 
have been used to illustrate these analyses. 

• 

• 

The costs to comply with the Regulation are perceived by stakeholders as much 
higher  than  administrative  costs,  and  therefore  some  of  them  focused  their 
answers  on  assessing  compliance  costs.  (eg:  Cost  for  slaughterhouses  and 
renderers  of  the  implementation  of  ABP  Regulation  were  assessed  to  be 
54 mio. Euro/year in a single MS according to data submitted by UECBV). In 
addition,  ABP  requirements  overlap  with  other  requirements  (sectoral  rules, 
Good Manufacturing Practices, environmental legislation etc.) and often is it is 
difficult  to  estimate  whether  or  not  a  given  cost  occurs  only  as  a  result  of 
obligation resulting from ABP rules. 

Even when stakeholders can provide some estimation of overall administrative 
costs imposed on them by current Regulation it is difficult for them to assess 
how an eventual change of legislation would affect these costs. The impact of 
the proposal not only depends on the type of industry considered, but also on 
the type and category of ABP that they use or process. For example, one single 
pharmaceutical  plant  can  use  more  then  80  different  ABP,  depending  on  the 
range of products they produce, while others may only use a few ABP. 

EN 

30 

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• 

• 

• 

• 

• 

As  it  was  possible  not  to  provide  certain  information  in  the  questionnaire, 
many stakeholders provided only partial data. 

Some  of  the  industrial  sectors  affected  by  this  Regulation  are  mainly 
dominated  by SME. In  most  cases  these companies do not dispose of precise 
calculations about costs of these options. 

There are environmental issues related to the use or disposal of ABP. Although 
this  proposal  will  not  introduce  changes  or  requirements  on  environmental 
conditions for the use, processing or disposal of ABP, some of the issues could 
have  indirect  environmental  impacts  but  these  are  difficult  to  predict  and  are 
not  considered  to  be  of  major  importance.  It  has  to  be  noted  that  the 
environmental issues related to ABP are regulated by environmental legislation 
of the EU. 

Data  submitted  by  the  competent  authorities  give  an  idea  of  the  costs  for  the 
administration related with some of the policy issues (ex: costs of registration 
and inspections of the premises). But costs vary a lot between Member States 
and even between regions as explained later. 

As  the  scope  of  the  Regulation  leaves  room  for  interpretation,  administrative 
costs of this proposal vary between sectors under the responsibility of different 
competent authorities. Also it was difficult to obtain disaggregated data on the 
type  of  premises  to  be  registered/  or  inspected  yearly.  The  lack  of 
disaggregated  data  makes  it  difficult  to  assess  the  reduction  of  administrative 
burden as a consequence of elimination of double approvals as it is not possible 
to establish the exact number of premises affected by this proposal. In addition, 
the costs of registration and inspection vary significantly depending on the type 
of  premises  and  on  the  Member  State.  e.g.:  registration  cost  per  dossier  vary 
between 16000 € and 75 €. The lack of disaggregate data makes impossible to 
compare between type of premises but in general approval of technical plants 
(including  petfood  plants)  is  more  time  demanding  and  in  general  costs  of 
authorisation  are  higher  than  for  other  types  of  premises  as  co-incineration 
plants.  More  detailed  examination  and  discussion  of  the  responses  with 
Member  States  which  had  submitted  estimations  also  showed  that  different 
bases  had  been  used  for  calculations,  which  makes  comparisons  even  more 
difficult. Some authorities have introduced internal systems of cost calculation 
throughout  the  various  steps  of  their  control  actions  that  facilitate  the 
submission of data, whereas others supplied rough estimates. In one particular 
case,  these  estimates  referred  to  the  mere  costs  of  visits  necessary  prior  to 
granting  an  approval  which  were  being  billed  to  operators,  while  general 
running costs, such as staff salaries, were not being broken down and therefore 
not included in the estimate on a proportionate basis.  

EN 

31 

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• 

• 

As  a  further  consequence  of  the  difficulties  referred  to  above,  it  is  also  very 
difficult  to  assess  whether  differences  in  interpretation  actually  have  a 
significant effect on the proper functioning of the internal market. A Member 
State  may  for  instance  interpret  the  absence  of  provisions  on  suspension  of 
approvals in case of shortcomings in intermediate and storage plants as a lack 
of  legal  basis  to  intervene  –  and  this  might  be  seen  as  reducing  compliance 
costs  for  operators  since  they  might  not  have  to  seek  insure  coverage  for 
periods  of  non-delivery  to  their  customers.  However,  it  is  actually  more 
probable  that  the  overall  majority  of  competent  authorities  would  take  a 
different  view  and  intervene  based  on  other  provisions  of  administrative  law, 
thus  interpreting  the  express  references  to  suspension  of  approvals  in 
provisions such as Article 17 (3) of the Regulation as an illustrative reference 
(in  the  particular  case,  a  clarification  in  the  course  of  the  review  is  however 
intended). 

It  is  equally  difficult  to  generalise  potential  effects  of  the  various  options  on 
employment. On the one hand, many sectors operate with technical equipment 
which does not always require a large amount of manpower to be operational. 
On the other hand, changes to the possible uses of animal by-products, such as 
following  a  risk-based  re-categorisation  of  certain  materials,  may  also  have 
different effects on affected sectors. While more material may e.g. be available 
to  manufacturing  sectors,  less  material  would  need  to  be  disposed  of,  with 
potential effects on employment, which are difficult to quantify. 

6.2. 

ANALYSIS OF IMPACTS  

6.2.1.  Policy issue 1-Clarifying the Scope of the Regulation 

– 

Policy issue 1 (a) - Determination of the end of the ABP life-cycle 

Option (a):  Do-nothing  

Social Impacts 

To do nothing will preserve the current uncertainties regarding the question to 
which  extent  products  which  have  been  processed  on  the  basis  of  ABP  are 
subjected  to  the  requirements  of  the  Regulation.  As  a  result,  the  sectors 
concerned will comply to a different extent with these requirements. This could 
lead  to  public  and/or  animal  health  risks  and  different  levels  of  protection 
throughout the Community.  

EN 

32 

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Economic impacts 

Sectors complying with the requirements face certain compliance costs, e.g. for 
the  setting  up  of  measures  guaranteeing  traceability  and  hygiene,  as  well  as 
continuous  monitoring  and  documentation.  If  these  requirements  are  being 
imposed  in  one  part  of  the  Community,  while  they  are  not  required  in  other 
parts of the Community, competitive disadvantages are being created with a 
potential  effect  on  the  economic  development  of  the  establishments  affected. 
As  regards  the  choice  of  locations  for  new  establishments,  the  level  of 
enforcement  of  the  rules  of  the  Regulation  could  be  a  decisive  factor  for 
economic  operators,  with  potential  effects  on  the  distribution  of  economic 
development  and  employment  between  different  regions.  The  box  below 
provides an example of how been under the scope of the ABP Regulation can 
affect a certain industry. While it is clear that some industries need to be under 
the scope of the ABP Regulation, to prevent risks for public or animal health 
and  ensure  the  safety  of  the  food  chain,  the  do-nothing  option  would  not 
prevent  industries  facing  different  compliance  and  administrative  costs 
between Member States. 

The  following  data  illustrate  the  economic  and  social  impacts  that 
current  Regulation  on  ABP  had  for  manufacturers  of  diagnostic  tools 
destined  to  examine  samples  e.g.  of  human  or  animal  blood  or  tissues, 
with the aim of detecting the presence of diseases or in conjunction with 
therapeutic measures (source: EDMA) 

• 

• 

• 

• 

• 

• 

10-15% increase in cost (Germany), 

problems  with  non-  EU  suppliers  no  longer  willing  to  supply 
materials due to small volume and problems of complying, 

revalidation of new suppliers (time + costs associated), 

review  and  cessation  of  "small-quantity"  products 
manufacturers, 

lines  by 

relocation by EU manufacturers outside the EU, 

loss of employment (estimated up to 5000 employees in Germany) 

EN 

33 

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Option (b):  Co-regulation  

Social Impacts 

Co-regulation  would  not  result  either  in  resolving  the  legal  uncertainties 
regarding the application of the Regulation along the processing chain of ABP 
due  to  the  wide-range  nature  of  the  issue  and  industries  involved.  It  also 
implies difficulties for the Commission to establish a consensus between all the 
affected operators. This means that a harmonised interpretation of the scope of 
the ABP Regulation will not be achieved by this option, and as a consequence 
different  levels  of  protection  against  public  and  animal  health  risks  in  the 
Community would continue. 

Economic impacts 

The  sectors  participating  in  the  co-regulation  would  in  addition  not  be 
compelled  to  come  to  horizontal  agreements  which  would  result  in  the  same 
type  of  rules  for  the  use  of  ABP  by  several  sectors  concerned.  As  a 
consequence, similar differences regarding the competitive situation as for 
option (a) could arise. 

Option (c):  Legislative review 

Difficulties  for  determining  the  impact  of  option  (c)  on  administrative  and 
compliance costs: 

• 

• 

• 

• 

Both types of costs vary a lot between Member States and also between 
industries  and  plants  depending  on  the  type,  category,  quantity  and 
variety of ABP they use (e.g: a single pharmaceutical plant can use more 
than 80 types of ABP while a leather plant may use only 3 or 4).  

This option will affect plants using only exempted ABP, so to calculate 
this  costs  it  would  be  necessary  to  know,  for  each  plant/industry,  the 
complete list of ABP they use and the costs of carrying out the tasks that 
the  modification  will  remove.  As  a  consequence  it  was  not  possible  to 
calculate the impact on administrative and compliance costs.  

It can be said that not all the plants/industries producing highly processed 
products  will  be  affected  by  the  Regulation,  so  the  costs  have  been 
calculated  for  different  percentages  of  plants  affected  taking  as  an 
example  the  biochemical  industry  to  give  an  idea  of  the  possible 
economic impacts that the proposal could have. 

The biochemical industry was used as an example because the best data 
available are from it. This may be because they are particularly interested 
in the proposal, as it will have a major impact on them and also because 
they  are  larger  and  more  technology-based  companies  than  in  other 
industrial sectors, so for them to assess the costs is not so difficult. 

EN 

34 

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• 

In  addition,  ABP  requirements  overlap  with  other  requirements  (sector 
rules, Good Manufacturing Practices, environmental legislation, etc.) and 
often it is difficult to estimate whether or not a given cost occurs only as 
a  result  of  obligation  resulting  from  ABP  rules  and  whether  this  tasks 
will continue to be carried out despite the exemption of the ABP they use 
from the scope of the Regulation. 

Economic impacts 

Direct impacts: 

A  legislative  review  which  clarifies  the  scope  of  the  Regulation  will  address 
the  issue  of  legal  uncertainty  through  varying  interpretations.  It  will  also 
provide  for  a  comparable  competitive  framework  for  the  operators  concerned 
and  result  in  a  stable  framework  for  investments  and  the  creation  of  new 
employment.  

This  option  will  have  a  positive  impact  on  EU  companies  having  premises, 
importing and commercialising their products in several/all Member States as 
they will affect the same requirements for all their processing plants.  

The main economic advantages of this option for the industries affected will be 
the  decrease  in  compliance  costs  related  to  the  collection,  handling,  storage, 
disposal  and  processing  requirements  and  the  obligation  to  have  a  system  of 
own  checks  established  under  the  ABP  Regulation.  For  example  the  annual 
costs of having established a system of own checks were estimated in 193800 € 
for a biochemical plant.  

This option would also have positive impacts also in third country enterprises 
exporting highly processed products if they use ABP exempted from the scope 
of  the  Regulation.  As  an  example,  the  following  are  the  costs  estimated  by  a 
USA pharmaceutical plant with an annual turnover of more than 250 million €. 

• 

• 

• 

771  applications  for  USDA  1774/2002  related  inspections  for  exporting 
their products to the EU. The annual costs for approval of ABP (40) for 
export to the EU were estimated to be  82 500 €,  including tasks carried 
out by external staff. 

Cost  for  carrying  out  own  checks  related  to  ABP  obligations  were 
estimated to be 38 900 € annually 

Cost for identification and labelling 122 200€ (2038 sh ipment per year to 
the EU) 

The  economic  and  social  dimension  of  the  industrial  sectors  affected  by  this 
option is illustrated in Annex VI. 

This  option  would  have  also  indirect  economic  impacts  on  industries 
producing certain ABP as their demand for certain uses will increase due to the 
fact that they will not be subjected to the set of requirements laid down by the 
Regulation.  

EN 

35 

   EN 

 
 
 
 
 
 
 
 
 
An  example  of  this  situation  would  be  the  fat  processing  and  rendering 
industry. As illustrated in the graph below the main outlet of animal fats was 
energy production. If the demand of oleo-chemical industries for the products 
increases,  probably  their  price  will  also  increase,  having  positive  benefits  for 
the fat processors and renderers (industries producing these ABP) but negative 
for  the  rest  of  the  industries  using  these  products  for  other  purposes.  At  this 
stage however it is very difficult to make forecast about this as ABP compete 
with other raw materials used for similar purposes in the market, nevertheless 
even  though price of some components might  rise (while  others will fall), on 
average the price of final products are likely to decrease. 

Graph 1 Evolution between 2005 and 2006. Main outlets of animal fats (Source 
EFPRA) 

734

728

651

652

693 701

2005

2006

800

700

600

500

400

300

200

100

0

218

188

191 173

82

60

Food

Others

33

Chim ist
industry

Energy

Oleochim ical
& soap

Pet food

Feed

Social impacts 

This  option  will  furthermore  allow  operators  and  control  authorities  to  focus  their 
resources  on  the  control  of  those  risks  which  have  potentially  the  greatest  negative 
consequences for public and animal health.  

As  processed  products  will  be  excluded  only  when  scientific  evidence  shows  that 
they  do  not  pose  any  risk  for  animal  or  public  health,  the  high  level  of  protection 
against these risks in the community will continue to apply.  

Environmental impacts of all options: 

None  of  the  options  referred  to  would  have  direct  environmental  impacts,  since 
changes  to  environmental  requirements  applicable  to  the  disposal,  handling  and 
processing of ABP are not being considered for this policy issue.  

EN 

36 

   EN 

 
 
 
 
 
Indirect  environmental  impacts  are  difficult  to  assess  due  to  the  different  uses  of 
ABP  and  the  variety  of  raw  materials  competing  with  them  in  the  market  for  the 
same uses.  

For example, on one hand, as illustrated in graph 1, the largest share of fats outlets in 
the  EU  are  used  for  renewable  energy  production  (biomass  incineration,  tallow 
combustion,  bio-diesel  and  biogas)  helping  to  save  fossil  energy  and  greenhouse 
emissions. If demand of fats for other uses increases, this might reduce the energetic 
valorisation of these products.  

On  the  other  hand,  the  EU  oleo-chemical  industry  uses  palm  oil  as  a  substitute  of 
animal  fats  when  those  are  not  sufficiently  available  on  the  market.  Production  of 
palm oil is done in virgin areas of tropical rain forest and an increased demand can 
have negative impacts on the environment, though the quantity of palm oil demanded 
by  the  biochemical  industry  is  not  assessed  to  be  enough  to  cause  major 
environmental  impacts  it  is  an  example  that  illustrates  the  complexity  of  the 
environmental issues related to the use of ABP. 

Impacts on administrative burden: 

Option  (a)  and  Option  (b)  would  not  imply  a  change  in  the  administrative  burden, 
however might result in generation of other compliance costs. 

Option  (c)  will  have  as  a  consequence  reduction  on  administrative  burden  for 
operators  and  competent  authorities  of  Member  States.  Approximately  75 %  of  the 
Competent  authorities  and  affected  industries  assessed  that  option  (c)  will  imply 
decrease  on  administrative  costs  for  them,  though  the  exact  amount  was  not 
calculated due to the difficulties already explained under this chapter. 

Reduction on administrative burden for operators: 

Under option (c), premises using only ABP exempted would be completely out of the 
scope  of  the  ABP  Regulation  while  those  premises  using  any  ABP  included  under 
the scope would have to apply all the requirements and would not be affected by the 
proposal.  

Reduction on administrative burden for operators will arise from the fact that these 
types  of  premises  using  only  exempted  ABP  will  not  have  to  comply  with  the 
following requirements: 

• 

• 

• 

Submit application for approval of the premises,  

Undergo  inspections  carried  out  by  competent  authorities  to  demonstrate  that 
they comply with the requirements set out in the Regulation  

Issuing  the  required  documentation  for  transportation  of  ABP.  Reduction  on 
compliance costs would arise from the fact the premises using only exempted 
ABP  will  not  have  to  bear  the  costs  related  to  the  laboratory  testing  and  the 
certification and permits for imports. 

EN 

37 

   EN 

 
The  following  example  illustrates  how  the  reduction  of  administrative  and 
compliance  cots  depends  on  which  category  of  an  ABP  (wool)  would  be  excluded 
from the scope of the Regulation.  

Impacts on costs for operators 

WOOL 

It is estimated that imports of wool with different degree of processing 
into the EU are divided as follows (source INTERLAINE): 

EU-25 WOOL IMPORTS SHARES

s
e
g
a
t
n
e
c
r
e
P

100%

80%

60%

40%

20%

0%

2000  

2001  

2002  

2003  

Years

2004  

2005  

2006

 CLEAN GREASY WOOL

SCOURED WOOLS CARBONIZED WOOLS

(Explanatory  note:  Greasy  wool:  wool  shorn  from  the  sheep  and  packaged  usually 
into bales on the farm of origin. It still contains the grease (fat) and impurities of non-
animal origin. Scoured wool: wool washed in hot water and detergent to remove the 
non-wool  contaminants  and  then  dried.  Carbonised  wool:  wool  which  has  been 
subjected  a  chemical  process  to  remove  material  of  plant  origin  from  wool  using 
some sort of acid. Usually it follows the scouring process). 

If  the  end  of  the  ABP  life-cycle  of  wool  would  be  determined  as  to 
cover only greasy wool, a considerable percentage (currently over 50 % 
and  increasing)  of  the  annual  imported  volume  could  be  classified  as 
being no longer ABP. This represents over 100.000 tons of wool every 
year. 

Reduction  on  administrative  burden  for  operators  further  processing 
such  wool  will  arise  from  the  fact  that  they  will  not  have  to  comply 
with the requirements laid down in the ABP Regulation as long as they 
are dealing with only exempted material. 

EN 

38 

   EN 

 
The  following  is  an  example  of  compliance  and  administrative  costs  faced  by  a 
biochemical plant using ABP. To calculate the reduction of costs it was considered 
that  the  plant  is  only  using  exempted  ABP.  It  is  not  possible  however  to  give  an 
estimation  of  the  exact  impact  because  of  the  lack  of  data  on  the  exact  number  of 
establishments of each industry and the type of ABP they use (if they are using any). 
It  has  to  be  noted,  that  these  assumptions  and  calculations  are  based  on  data 
submitted by a single company and only focused on the number of companies active 
in  the  biochemical  sector  while  this  proposal  potentially  affects  a  wide  range  of 
industries. 

Table 2. An estimate of current administrative costs for a plant active in the biochemical 
industry  using  ABP  (source:  answers  to  the  questionnaire  on  administrative  costs  by 
industries): 

Information 
Obligation 

Required 
actions 

Regulatory 
Origin 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€)/year 

Gain approval 
for an 
establishment 
by competent 
authority 

Submit a 
request and 
supporting 
documentation 
for approval 

Laboratory 
testing 

Labelling 

Sample, 
perform and 
document lab 
test  

Label must be 
attached to 
products 

Materials 
must be 
imported with 
proper 
documentation 

Apply for 
import 
certificates, 
permits 

TOTAL 

Art 18 

190 

150-200  Once,  prior 

production 
handling 

to 
or 

1 

28500-
38000 
(once) 

Art 25 

190 

32/month  continuous 

120 

72960 

Annex II 
Chapter 1 

190 

580/year 

continuous 

300 

110200 

Art 29 

190 

210 

continuous 

200/year 

39900 

251560-
261060 

None  of  these  tasks  would  have  to  be  carried  out  by  this  plant,  if  they  use  only 
products that are out of the ABP regulation requirements so the reduction of costs for 
this  operator  could  be  estimated  prior  to  production  28.500-38.500  €  and  annually 
223.060 €

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
Although the exact number of affected premises is not known, and the costs showed 
above  are  only  data  from  a  single  company,  if  we  assume  that  all  of  all  of  the 
estimated biochemical companies (28.600 as explained under chapter 6.3.3) only use 
exempted ABP and that the costs are similar across the sector, the total reduction of 
costs would be approximately 2.63,416- 2.245,116 million €. If we assume that only 
1%  of  them  would  be  affected  by  the  proposal,  the  reduction  of  costs  would  be 
approximately  21-22  million  €.  But  even  assuming  that  only  1%  of  the  premises 
would be affected by the modification, these costs are probably overestimated, as not 
all the industries face such a high compliance and administrative costs.  

Reduction of administrative burden for competent authorities: 

The reduction of administrative burden for competent authorities arises from the fact 
that  they  will  not  have  to  approve  the  establishments  and  carry  out  inspections  to 
check  whether  the  requirements  of  the  APB  regulation  are  being  complied  with  in 
these types of premises and also they will not have to authorise them under the ABP 
Regulation. 

Table  3.  An  estimate  of  these  costs  for  the  competent  authorities  in  relation  to  one 
approved  establishment  is  the  following  (source:  answers  to  the  questionnaire  for 
competent authorities on administrative costs): 

Information 
Obligation 

Required 
actions 

Evaluate the 
submitted 
request and 
documentation 

Perform and 
document 
official controls 

Keep updated 
and transmit list 
of approved 
plants (for all) 

Approve 
entity 

Official 
controls 

List of 
plants 

TOTAL 

Regulatory 
Origin (Art 
of Reg 
(EC) 
1774/2002) 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€) 

Art 18 

60 

10-30 

Once,  prior 
production 
handling 

to 
or 

1 

600-
1800 

Art 26 

60 

5-15 

1-2 

Art 26 

60 

30 

Not defined 

1-2 

300-
900 

Not 
defined 

1800 

2700-
4500 

None  of  these  tasks  would  have  to  be  carried  out  for  by  competent  authorities  for 
plants  using  only  exempted  ABP,  and  so  the  reduction  of  costs  would  be 
  and  annually  300-900 € /  concerning  each 
approximately  once  600-1800 €
establishment.  Difference  in  the  cost  associated  with  managing  the  list  of 
establishments would be negligible. 

EN 

40 

   EN 

 
 
 
 
 
 
 
Based  on  the  assumptions  explained  in  the  calculation  of  costs  for  operators,  the 
reduction  for  competent  authorities  would  approximately  be  23.22-38.7 million €  if 
all the plants would be affected by the proposal, and 0,23-0,38 million € if only 1 % 
are affected, but same considerations about the over estimation on costs explained in 
the calculations for the industry apply here.  

Impacts on SME 

A significant percentage of industries affected are SMEs. Though the impacts will be 
positive it was also not possible to quantify for the reasons already explained. 

Comparison of the two legislative review sub-options: 

(1)  Exemption of processed finished products from the Regulation 

Due to the wide range of materials covered by the Regulation, this sub-option 
would  require  to  determine  under  which  technical  conditions  products  fall 
outside  the  rules.  These  technical  conditions  are  likely  to  require  adaptation 
over  time  due  to  evolution  in  science  and  technology.  Therefore,  this  option 
would not provide for a flexible basis to adapt to newly emerging health risks. 

Exempting  processed  animal  fat  for  use  as  a  fuel  or  for  technical  purposes 
from the scope of the Regulation would remove the controls of the Regulation 
over processing establishments. However, in case scientific evidence were to 
become available which would suggest that certain risks to public health are 
not  being  eliminated  by  the  processing  standards  imposed,  it  would  not  be 
possible to impose further treatment steps for the elimination of such risks. 

(2) 

Introduction  of  a  legal  basis  for  the  determination  of  the  end  of  the  ABP  life 
cycle. 

This  sub-option  would  allow  introducing  rules  which  would  be  more 
proportionate  to  the  risks  arising  from  specific  products  maintaining  a  high 
level of protection of public and animal health across the EU.  

By  providing  for  a  legal  basis  for  the  adoption  of  technical  standards  via 
implementing  rules,  this  option  would  allow  to  react  to  progress  in  science, 
such as new assessments carried out by the European Food Safety Authority or 
to newly emerging risks.  

EN 

41 

   EN 

 
 
 
 
 
In  the  example  cited  above,  a  legal  basis  for  the  adoption  of  technical 
standards  would  enable  the  legislator  to  adopt  additional  standards  which 
would eliminate the new risk in question as regards animal fat for use in fuel. 
At the same time, it could very well be the case that the standards for animal 
fat  for  technical  applications  would  not  have  to  be  adapted  if  the  risk  in 
question is being eliminated by other treatment steps already in place (such 
as  a  chemical  treatment  or  the  addition  of  an  additive  to  make  the  product 
made out of animal fat usable in a particular technical product). 

– 

Policy issue 1 (b) - Coverage of wild animals 

Option (a):  Do-nothing 

Social  impacts  (public  and  animal  health):  Doing  nothing  would  leave 
potential risks from animal by-products arising in establishments handling wild 
game meat for human consumption uncontrolled. Wild animals are a potential 
source  of  animal  diseases  including  zoonoses  (e.g.:  avian  influenza)  and  thus 
ABP  products  should  be  adequately  controlled  in  order  to  prevent  negative 
impacts  for  public,  animal  health  and  also  the  economy.  Thus,  an  adequate 
level  of  protection  against  public  and  animal  health  risks  across  the 
Community would not be ensured. 

Possible economic impacts linked to the risks arising from ABP 

Through importation of ABP from game animal diseases could be introduced 
into  the  EU  which  could  have  an  enormous  financial  and  socio-economic 
impact. Example of such diseases are the Classical Swine Fever epidemic in 
the  Netherlands  (1997-1998)  and  the  Foot-and-Mouth  epidemic  in  the  UK 
(2001). 

Implications were the following: 

Community  financial  contribution  during  the  epidemic  of  Classical 
Swine Fever – The Netherlands, 1997-1998 

The  EU  paid  a  total  of  80.5  million  €  from  the  “Veterinary  Fund”  and  an 
additional 570 million € was spent for exceptional market support measures to 
the Member States affected by CSF under the 1997 and 1998 budget. (Source: 
Court of Auditors SPECIAL REPORT No 1/2000 on classical swine fever). 

EN 

42 

   EN 

 
 
 
 
Community  financial  contribution  during  epidemic  a  Foot-and-Mouth 
Disease epidemic – 2001 

Overall, for the 2001 crisis alone the total expenditure declared by all affected 
Member States (France, Ireland, Netherlands, and the UK) for compensation 
for slaughter and destruction of animals as well as disinfecting of farms and 
equipment was about 2,693.4 million €, of  which 1,616 million € was claimed 
for  Community  reimbursement.  Following  the  decision  to  reimburse  losses 
related to the FMD crisis of 2001, the EU paid a total of 465.6 million € to 
Member  States  from  the  EU  “Veterinary  Fund”.  No  exceptional  market 
support  measures  have  been  implemented  with  respect  to  the  FMD  crises. 
(Court of Auditors, SPECIAL REPORT No8/2004 on FMD) 

Option (b):  Co-regulation or guidance 

Social impacts (public and animal health) and economic impacts:  

• 

• 

Self-regulation  would  not  result  in  a  coherent  level  of  protection  and 
legal  certainty  across  the  Community  because  operators  are  not  well 
organised  and  the  sector  does  not  seem  to  be  well  structured  and 
organised  to  put  in  place  an  effective  self-regulation  framework.  In 
addition,  rules  adopted  by  the  sectors  concerned  would  not  bind  the 
control  authorities  and  could  lead  to  checks  being  performed  to  a 
different  extent  throughout  Member  States.  As  a  consequence,  risks  for 
public and animal health posed by ABP from wild animals will continue 
to be uncontrolled as well as the inconsistencies with the Food Hygiene 
legislation  and  the  competitive  situation  of  operators  could  vary  across 
the Community.  

Co-regulation  between  the  sectors  concerned,  in  particular  hunters  and 
game  meat  processors,  and  the  legislators,  could  introduce  clear  rules 
which  would  ensure  sufficient  protection  against  public  and  animal 
health  risks.  This  would  also  result  in  a  common  framework  for 
competition, in particular regarding investments and the creation of new 
labour. However, since the problem is also linked to the potential import 
of  public  and  animal  health  risks  from  ABP  from  outside  the 
Community, it is difficult to conceive in which way stakeholders outside 
the Community could participate to the process and be obliged to follow 
the  rules  introduced.  This  means  that  the  risks  that  public  or  animal 
health threats are being introduced in the Community through the imports 
of these products will continue. 

• 

Guidance  issued  by  the  Commission  would  result  in  the  same  adverse 
effects as those mentioned before with respect to self-regulation.  

EN 

43 

   EN 

 
 
 
 
Option (c) Legislative review 

– 

To  extend  the  scope  to  cover  all  ABP  from  wild  animals  handled  to  be 
placed  on  the  market  and  allow  the  competent  authority  to  define 
conditions to apply to establishments handling such ABP.  

Social impacts: 

Extension of the scope to ABP from wild animals which are intended to be placed on 
the  market  would  increase  the  level  of  protection  for  public  and  animal  health 
and  ensure  that  game  handling  establishments  within  the  Community  collect  and 
dispose  of  ABP  arising  during  their  operations  in  a  safe  way,  in  line  with  the 
principles  of  the  current  food  safety  and  hygiene  legislation.  As  regards  imported 
ABP, the extension of the scope will also result in a higher level of protection.  

The option could slightly raise compliance costs for some of these premises as they 
will have to adapt procedures for handling and disposing ABP. But it has to be noted 
that  being  under  the  scope  of  the  ABP  Regulation  could  have  also  economic 
advantages  as  these  establishments  would  be  able  to  commercialise  these  products 
for example for the petfood industry. 

Environmental impacts of all options: 

Option (a) implies accepting animal health risks arising from the fact that ABP from 
wild  animals  are  not  covered  under  the  Regulation.  ABP  are  a  source  of  animal 
diseases  also  affecting  the  wildlife.  In  consequence,  leaving  out  of  the  scope  ABP 
from wild game could have negative environmental consequences. A higher level of 
protection  of  animal  health  and  thus  the  wildlife  will  arise  from  option  (c)  by 
imposing  the  disposal  or  use  of  ABP  in  accordance  with  the  rules  laid  down  in 
veterinary legislation, uncontrolled disposal of ABP would be indirectly prevented. 

Impacts on administrative burden of all options: 

Option (a) and option (b) will not have impacts on administrative burden. 

Option  (c)  will  lead  to  some  additional  burden  for  economic  operators  affected 
(establishments handling ABP in the EU and also the same type of establishments in 
third countries exporting wild game to the EU).  

However, since some of the requirements are already applied under the food hygiene 
legislation  (authorisation,  inspection)  and  this  legislative  review  does  not  intend  to 
duplicate  them  it  can  be  estimated  that  there  will  be  no  adverse  effects  on  the 
economic development of the sector or employment. This also implies that option (c) 
will not imply significant administrative costs for the Competent Authorities as they 
are already carrying out these requirements under the Food Hygiene legislation.  

Option (c) could also have impacts for some third country establishments exporting 
products.  Though  they  would  face  some  additional  compliance  costs  the  advantage 
for them would be facing the same requirements to export to any EU Member State. 

EN 

44 

   EN 

 
 
The extension will also not result in adverse effects for the importance of hunting as 
a  social  activity,  since  it  does  not  impose  additional  burden  on  hunters  supplying 
wild  game  meat  to  game  handling  establishments  in  line  with  the  food  hygiene 
legislation.  Although  it  was  not  possible  to  obtain  the  exact  number  of  theses 
establishments for all Member States there are approximately 452 establishments in 
14  of  them.  It  has  to  be  noted  that  there  are  significant  differences  on  this  number 
depending on the Member State considered. 

6.2.2.  Policy issue 2 categorising new products 

Option (a): 

Do-nothing 

Option (a) will not provide for a risk-adequate categorisation of certain ABP which 
pose  a  low  risk.  Maintaining  the  default  categorisation  means  to  exclude  a  wide 
range  of  ABP  from  certain  industrial  uses  when  this  ABP  do  not  pose  any  risk  for 
public or animal health and are valuable materials.  

Option (b):  Alternatives to regulatory tools 

Alternatives to regulatory tools have not been considered as they will not address the 
problem  since  the  strict  categorisation  which  is  one  of  the  core  elements  of  the 
current  Regulation  is  not  open  to  modification  or  interpretation  by  non-legal 
instruments. 

Option (c): 

Legislative review 

– 

To reclassify products which pose a low risk for public and /or animal health 
based on scientific assessment in order to facilitate their use.  

Social and economic impacts 

Option (c) will allow resolving the problem.  On the basis of scientific advice ABP 
may  be  re-classified  and  their  potential  uses,  whether  for  feeding  purposes  or  for 
technical  applications,  may  be  determined  on  a  case-by-case  basis.  This  would 
ensure a high level of protection of animal and public health, while eliminating 
adverse effects on the economic development of the sectors using certain animal by-
products.  

Some ABP are high quality raw materials and they should be allowed for the widest 
possible applications as long as they do not pose risks for animal and public health. 
Allowing the technical use of certain ABP would increase market chances for many 
companies which would then be able to process such ABP into safe and high quality 
finished  products,  resulting  in  increased  competitiveness  and  reduced  operating 
costs.  Additionally,  the  quantity  of  ABP  which  have  to  be  disposed  by  using  high 
cost rendering processes will be reduced. 

EN 

45 

   EN 

 
Environmental impacts of all options: 

No environmental impacts are foreseen for option (a) and (b). 

Positive  environmental  impacts  may  arise  from  the  fact  that  certain  category  1  and 
category 2 ABP will be recycled as a raw material instead of been destroyed and thus 
a more sustainable use of these resources will be achieved. 

Impacts on administrative burden: 

Option (a) and option (b) will not imply any change on administrative burden.  

Option  (c)  could  have  negligible  impact  on  administrative  burden  as  similar 
administrative requirements will apply for these ABP even if they fall into a different 
category.  

The  main  economic  impact  for  the  industries  using  these  ABP  is  that  they  will  be 
able to use also categories 1 and 2 ABP and this means a higher quantity of available 
raw materials. Industrial sectors affected could replace some raw materials for these 
ABP  that  are  cheaper  and  to  save  in  production  costs.  This  economic  impact  will 
depend on the share of the production costs that these ABP represent for them. 

The re-categorization of ABP will have as a consequential impact on the price of raw 
materials  used  as  a  substitute  but  this  is  difficult  to  assess  as  it  will  vary  for  each 
specific ABP and will depend on the market situation. 

The  following  are  some  examples  of  the  importance  of  the  use  of  ABP  for  certain 
industrial sectors.  

Under the current Regulation, blood from animals other than ruminants which have 
been  declared  fit  for  slaughter  is  categorised  as  Category  3  (Article 6 (1) (d))  and 
may be used for a number of purposes. By contrast, blood from ruminants to which 
no TSE or other disease risk is attached is classified in a different sub-category of 
Category 3 (Article 6 (1) (k)) and as such excluded from certain uses, such as use in 
petfood.  However,  Regulation  (EC)  No 999/2001  does  not  require  calves  below  a 
certain  age  limit  to  be  tested  for  BSE.  Therefore,  if  it  were  possible  to  reclassify 
blood  from  such  calves  under  the  subcategory  for  animals  other  than  ruminants 
(Article  6  (1)  (d)),  such  blood  could  be  used  for  petfood.  This  option  could  be 
beneficial for slaughterhouses specialised on slaughtering calves, as well as regards 
raw material prices for petfood ingredients. However, due to a wide range of other 
products  available  on  the  market  which  may  be  used  in  petfood,  such  as  material 
from hormone-treated animals, meat-and-bone meal and animal fat, it is difficult to 
quantify the precise economic impact of such re-categorization. 

EN 

46 

   EN 

 
 
6.2.3.  Policy issue 3 Clarifying the approvals / registration and controls 

Option (a): 

Do-nothing 

Social and economic impacts:  

This option means accepting the overlapping between EU legislation and to continue 
requiring  double  approval  for  some  premises  with  the  consequent  social  and 
economic  impacts of  the  unnecessary  burden imposed to operators  that undermines 
competitiveness of the industries affected. 

Option (b): 

Alternatives to regulatory tools 

Alternative to regulatory tools have not been considered as they will not address the 
problem  since  the  issue  related  to  the  double  approval  that  some  premises  are 
undergoing because of the interaction of different EU legislation. 

Legislative review: To remove duplicated approvals and rely on the 
Option (c): 
provisions  already  introduced  by  other  Community  sector  legislation,  but  maintain 
certain requirements in order to ensure traceability of these ABP 

The social and economic impacts of this option will arise from the reduction on the 
administrative burden as it is related to eliminating duplication of approvals. 

Social impacts 

This option would ensure that the establishments concerned remain under the control 
of the veterinary authorities. In that way, intervention in case of risks to public and 
animal  health  would  remain  a  possibility.  In  order  to  ensure  traceability,  minimal 
requirements,  such  as  a  registration  requiring  information  of  the  veterinary 
authorities about the use of ABP in certain establishments would be sufficient.  

Impacts on administrative burden 

This  option  would  remove  additional  administrative  burden  (such  as  costs  for  the 
submission of application) from operators of establishments manufacturing products 
under other Community legislation, without lowering the level of protection against 
human  and  animal  health  risk.  In  that  way,  the  competitiveness  of  such  operators 
would  be  enhanced,  with  a  potentially  beneficial  effect  on  the  creation  of 
employment.  

Furthermore,  it  would  reduce  administrative  workload  for  authorities  issuing 
approvals.  However,  since  risks  to  public  and  animal  health  also  arise  in  such 
establishments  and  ABP  are  being  delivered  to  them,  the  complete  removal  of 
controls by the authorities responsible for the application of the ABP Regulation (in 
many cases veterinary authorities) could create gaps in ensuring traceability of ABP 
and prevent the authorities from acquiring the necessary knowledge of the potential 
risks  linked  to  individual  establishments.  Similarly,  they  would  not  be  able  to 
intervene in case of shortcomings. 

EN 

47 

   EN 

 
In the case of a plant manufacturing cosmetic products which is using animal fat 
as  a  starting  material,  an  additional  approval  under  the  ABP  Regulation  would  be 
considered  as  unnecessary.  The  provisions  of  the  Community  legislation  on 
cosmetics  which  determine  the  starting  material  to  be  used  for  the  production  of 
cosmetics  can  be  considered  as  sufficient  for  the  control  of  risks  to  public  and 
animal  health.  However,  if  the  veterinary  authorities  were  unaware  of  the  use  of 
such  materials,  they  would  not  be  able  to  intervene  in  case  it  would  appear  that  a 
plant  manufacturing  cosmetics  would  not  sufficiently  process  the  material  used  to 
eliminate  public  and  animal  health  risks.  Similarly,  if  it  was  to  appear  that 
consignments of animal fats were on the market which posed such risks, e.g. due to 
fraud or other malpractice, they would not be able to take measures to ensure that 
the cosmetic manufacturer in question does not use such material for the purposes 
of his production. 

The following is an example of administrative costs related to the approval faced by 
a biochemical plant using ABP. It is not possible however to give an estimation of 
the exact impact because of the lack of disaggregated data on each type of premises 
authorised  by  Member  States.  It  has  to  be  noted,  that  these  assumptions  and 
calculations  are  based on data submitted by a single company and only focused on 
the  number  of  companies  active  in  the  biochemical  sector  while  this  proposal 
potentially affects a wide range of industries.  

EN 

48 

   EN 

 
 
Table  4.  An  estimate  of  current  administrative  costs  for  a  company  active  in  the 
biochemical industry using ABP (source: answers to the questionnaire for industries on 
administrative costs): 

Information 
Obligation 

Required 
actions 

Regulatory 
Origin 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€)/year 

Gain approval 
for an 
establishment 
by competent 
authority 

Submit a 
request and 
supporting 
documentation 
for approval 

Laboratory 
testing 

Labelling 

Sample, 
perform and 
document lab 
test  

Label must be 
attached to 
products 

Materials 
must be 
imported with 
proper 
documentation 

Apply for 
import 
certificates, 
permits 

TOTAL 

Art 18 

190 

150-200  Once, prior to 
production or 
handling 

1 

28500-
38000 
(once) 

Art 25 

190 

32/month  continuous 

120 

72960 

Annex II 
Chapter 1 

190 

580/year 

continuous 

300 

110200 

Art 29 

190 

210 

continuous 

200/year 

39900 

251560-
261060 

Table 5. An estimate of costs according to the proposal for the same company  

Information 
Obligation 

Required 
actions 

Regulatory 
Origin 

Labelling 

Annex II 
Chapter 1 

Label must be 
attached to 
products 
during 
transport 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€)/year 

190 

580/year 

continuous 

300 

110200 

Materials 
must be 
imported with 
proper 
documentation 

Apply for 
import 
certificates, 
permits 

Art 29 

190 

210 

continuous 

200/year 

39900 

EN 

49 

   EN 

 
 
 
 
 
 
 
 
The impact of change could therefore represent for this given company a reduction of 
EUR 28.500-38.000  in  the  cost  required  prior  to  approval  and  around  EUR 72.960 
annually  (or  even  more  depending  also  on  volume  of  actual  production),  in  total 
101.460-110.960 €.  Is  also  possible  that  some   of  the  companies  using  highly 
processed materials as their starting material for production could still further benefit 
from  provisions  determining  the  end  of  ABP  life-cycle  and  thereby  reduce 
administrative costs even further as explained under chapter 6.3.3. 

The  number  of  affected  plants  is  estimated  in  the  in-vitro-diagnostic  industry  more 
than  500  companies,  in  the  medicinal  and  veterinary  medicinal  industry  46  leading 
companies and 2.100 committed companies and in the cosmetics sector around 3600 
companies with around 6000 production establishments. 

If  we  assume  that  costs  are  similar  across  the  sector  and  that  this  companies  have 
only one establishment each, the approximated number of companies affected by the 
proposal would be 8600 and the approximated costs reduced by the proposal would 
be  872,556-954,256  million  €.  But  even  assuming  that  only  1%  of  the  premises 
would be affected by the modification, these costs are probably overestimated, as not 
all the industries face such a high compliance and administrative costs. 

The reduction of administrative burden for competent authorities arises from the fact 
that  they  will  not  have  to  approve  the  establishments  and  carry  out  inspections  to 
check  whether  the  requirements  of  the  APB  regulation  are  being  complied  with  in 
these types of premises and also they will not have to authorise them under the ABP 
Regulation. 

The estimate of these costs for the approval of a biochemical plant is the following. 
Similar  consideration  on  the  difficulties  to  calculate  the  overall  costs  explained  for 
the industries apply to the administrative costs for competent authorities: 

EN 

50 

   EN 

 
Table 6. An estimate of the current administrative costs for the competent authorities in 
relation  to  one  approved  establishment  is  the  following:  (source:  answers  to  the 
questionnaire for industries on administrative costs): 

Information 
Obligation 

Required 
actions 

Evaluate the 
submitted 
request and 
documentation 

Perform and 
document 
official controls 

Keep updated 
and transmit list 
of approved 
plants 

Approve 
entity 

Official 
controls 

List of 
plants 

Total 

Regulatory 
Origin (Art 
of Reg 
(EC) 
1774/2002) 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€) 

Art 18 

60 

10-30 

Once,  prior 
production 
handling 

to 
or 

1 

600-
1800 

Art 26 

60 

5-15 

1-2 

Art 26 

60 

30 

Not defined 

1-2 

300-
900 

Not 
defined 

1800 

2700-
4500 

Table 7. An estimate of the administrative costs for the competent authorities according 
to this proposal for one approved establishment would be: 

Information 
Obligation 

Required 
actions 

and 

Perform 
document 
official controls 

Keep  updated 
and transmit list 
of 
approved 
plants 

Official 
controls 

List of 
plants 

TOTAL 

Regulatory 
Origin (Art 
of Reg 
(EC) 
1774/2002) 

Average 
cost per 
hour (€) 

Hours 
spent on 
this task 

Frequency/Year 

Total 
number 
of 
activities 

Total 
cost 
(€) 

Art 26 

60 

5-15 

1-2 

1-2 

300-
900 

Art 26 

60 

30 

Not defined 

Not 
defined 

1800 

2200-
2700 

EN 

51 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
According to the proposal only the costs associated with the official controls and the 
management  of  list  of  registered  plants  would  still  occur  due  to  the  obligation  to 
register and  control these  establishments by the veterinary authority.  Depending on 
later  implementing  provisions  and/or  practical  arrangements  between  different 
sectoral  national  authorities  that  cost  could  vary  somewhat  but  in  any  case  is 
expected  to  be  similar  to  or  less  than  the  current  management  of  list  of  approved 
plants. According to all this the reduction on administrative costs for the competent 
authorities would be 500-1800 €. 

If you assume that the number of plants affected by the proposal would be also 8600, 
and that costs for carrying out these tasks are similar between competent authorities 
the approximate reduction of the costs for the competent authorities of this proposal 
would be 4.3 million € to 15.48 million €. 

However,  as  it  has  been  noted  before,  these  costs  not  only  vary  between  Member 
Sates, but as between regions and types of premises to be inspected / approved.  

As an example, the following table illustrates the average input of hours needed and 
the  related  average  costs  incurred  by  regional  administrations  in  Germany  (for  an 
average establishment, costs indicated do not include payments for external advice).  

The  efforts  necessary  for  granting  approvals  and  carrying  out  inspections  vary 
between different types of plants or establishments. Therefore, since the distribution 
of  establishments  varies  between  regions,  the  figures  indicated  may  also  differ  for 
this reason.  

Table  8.  Average  input  of  hours  needed  and  the  related  average  costs  incurred  by 
regional  administrations  in  Germany  (source:  answers  to  the  questionnaire  for 
industries on administrative costs): 

Land (region) 

Hours needed for 
granting an 
approval 

Costs for granting 
an approval (€) 

Hours normally 
necessary for 
carrying out 
inspections 

Costs for carrying 
out inspections 
(€) 

Baden-
Württemberg 

Bavaria 

Berlin 

Bremen 

Hessen 

Lower Saxony 

Rhineland-
Palatinate 

Saxony-Anhalt 

35 

10 

16 

10 

4 

10 

11 

5 

EN 

2000 

550 

770 

600 

300 

700 

600 

250 

52 

5 

12 

3 

2 

10 

5 

15 

2 

280 

720 

160 

130 

700 

350 

870 

100 

   EN 

 
 
Comparing the costs assessed by competent authorities for authorising plants and for 
carrying  out  inspections  it  was  found  that  normally  the  authorisation  costs  are 
approximately  three  times  the  inspection  costs.  Removing  the  duplication  of 
approvals  will  allow  competent  authorities  to  allocate  more  financial  resources  on 
inspections, and as a consequence prevent public and animal health problems. 

Environmental impacts of all options 

None  of  them  will  have  environmental  impacts  since  no  changes  to  the 
environmental obligations of such establishments are being considered.  

6.2.4.  Policy issue 4 - Clarifying the derogations 

Option (a): 

Do-nothing 

Do-nothing  would  lead  to  continuation  of  the  current  difficulties  for  researchers 
(universities,  pharmaceutical  industry,  etc.)  to  get  certain  materials  necessary  for 
their studies since importation  of  ABP  of  Categories  1 and 2 for research purposes 
would continue not to be allowed. 

With regard to burial and burning of animal carcasses, the current difficulties arising 
in  the  case  of  natural  disasters  or  where  access  to  dead  animals  is  practically 
impossible  would  remain.  Consequently,  the  disproportional  situation  between 
requirements  and  risks  would  remain  and  even  public  health  risks  could  be  put  at 
stake  if  animal  carcasses  would  always  be  required  to  be  collected  for  disposal 
(dangerous collection circumstances). 

Option (b): 

Alternatives to regulatory tools 

Options  (b)  will  not  remedy  the  problems  identified  since  derogations  to  the  legal 
requirements  are  exemptions  from  the  strict  rules  of  the  requirements  of  the 
Regulation which may only be used under specific circumstances defined by law. 

Option (c): 

Legislative review 

Extending the derogations to 

– 

– 

Allow  the  imports  of  ABP  for  research  purposes  in  line  with  other  EU 
legislation such as legislation on TSE and 

Extend the possibility to bury and burn carcases of animals in areas (i) affected 
by  natural  disasters,  (ii)  where  access  is  not  practically  possible  or  present  a 
risk to health and safety. 

EN 

53 

   EN 

 
Social Impacts 

To extend derogations to allow the imports of ABP for research purposes would not 
have any negative impacts on public and animal health as the sale of these products 
is  restricted  to  professional  end  users  only  working  in  academic,  medical, 
governmental  and  health  care  institutions.  These  products  are  not  intended  for 
general consumer use. 

Their channelling to the actual researchers would be subject to import authorization 
ensuring that they would be used for the purposes foreseen. 

– 

Imports of ABP for research purposes 

Research .in the medical field is of major importance to a large number of companies 
producing  vaccines  or  medicines  to  cure  disease.  Some  of  these  Community  based 
companies are world-leading in their field. Improvement of their research activities 
could  result  in  the  development  of  new  products,  ensuring  or  improving  health  of 
humans and animals throughout the Community and worldwide. 

Vaccine  production  is  a  small  but  critical  part  of  the  pharmaceutical  marketplace. 
Europe is a major supplier of these materials to the rest of the world. Continuation of 
the difficult situation with regard to research possibilities due  to import restrictions 
of  materials  needed  and  reduction  in  vaccine  production  in  Europe  could  have 
catastrophic impact on healthcare worldwide and result in significant job losses.  

– 

Burial and burning of carcases 

Extending  the  derogation  possibilities  on  burial  and  burning  of  animal  carcasses 
could  lead  to  a  better  acceptance  of  Community  rules  by  the  public  as  they  would 
possibly accept this as better adjusting rules to necessities. 

Economic impacts 

– 

Imports of ABP for research 

Option  (c)  would  bring  the  provisions  of  the  ABP  Regulation  in  line  with  other 
Community legislation, such as Directive 97/78 on import checks and the Regulation 
999/2001  concerning  TSE.  It  would  also  contribute  to  the  competitiveness  of 
research and subsequent innovations in technology carried out in Europe. This could 
result  in  investments  and  in  the  creation  of  employment  once  the  results  of  such 
research are being commercialized. It could also result in beneficial consequences for 
human and animal health in the Community and worldwide, leading to reduction of 
costs for healthcare. This option will have also positive economic impacts for third 
country companies exporting products needed for research to the EU. 

EN 

54 

   EN 

 
Research is an essential part for the improvement of existing and the development of 
new medicinal products. Biotech medicines, for example, account for 10 to 15% of 
the  current  pharmaceutical  market  (42  billion  Euros  in  2002)  and  comprise  the 
highest  growth  segment  of  the  market.  More  than  one  fifth  of  the  new  medicines 
launched  each  year  are  now  biotechnology  derived.  Development  of  this  market, 
however, is only possible if research is possible. Currently, more than 60 companies 
are active in this area in Europe. 

The situation is similar for the development of human and animal vaccines. In 2002, 
European companies produced about 80% of the vaccines produced globally. 50% of 
these were exported to the USA, and about 30% were used in Europe. About 12,000 
people in Europe work for vaccine manufacturers. Research and development spend 
for  this  segment  was  $1.5  billion  Euro  in  2002,  with  two  thirds  of  all  research  on 
vaccines occurring within the EU. The total market for vaccines worldwide in 2002 
was 6.3 billion Euros. 

– 

Burial and burning of carcases 

With  regard  to  the  burial and burning of animal  carcasses,  this  option  would  allow 
competent  authorities  to  take  more  risk-proportionate  measures  under  exceptional 
circumstances where the normal disposal system cannot be relied on due to the large 
amount of animal carcasses or the difficulties with respect to recovery. By allowing 
for  swift  disposal  on  site  and  thus  avoiding  delays,  it  would  also  serve  to  contain 
disease-risks  arising  from  the  decomposition  of  animals  for  other  animals  and 
humans.  

Environmental impacts 

No  negative  effects  on  the  environment  are  envisaged  by  extending  the  derogation 
possibilities to importation of Category 1 and 2 ABP for research purposes.  

Negative effects on the environment of this option arising from extended burial and 
burning possibilities would have to be prevented by complementary measures which 
ensure  the  protection  of  air,  soil  and  ground  water  and  previous  studies  of  their 
situation  and  characteristics.  Such  measures  could  follow  the  rules  applicable  to 
disposal under the current disposal derogations. 

Impacts on administrative burden 

Option (c) will lead to some additional burden for researchers and authorities when 
applying  for  derogation  and  when  deciding  on  it.  However,  procedures  will  be 
automatic in the case of institutions or companies importing on a regular basis, which 
diminishes burden. 

In  the  case  of  burial  and  burning  of  animal  carcasses,  less  compliance  costs  will 
result  from  the  fact  that  there  transport  of  the  carcasses  will  not  be  carried  out. 
However,  the  evaluation  of  the  situation  of  the  soil,  water  and  air  may  result  in  a 
slight increase of costs for administrations when applying these derogations.  

EN 

55 

   EN 

 
 
7. 

COMPARING THE OPTIONS. 

7.1. 

Policy issue 1-Clarifying the scope of the Regulation 

7.1.1.  Determination of the end of the ABP life-cycle. 

Options 

Option 1-Do 
nothing 

Option 2-
Coregulation 

Option3-Legislative Review 

Type of 
impacts 

Social 

Economic  

- 

- 

- 

level 
protection 

[different 
of 
against risks] 

- 

level 
protection 

[different 
of 
against risks] 

+ 

[distortion 
competition] 

of 

- 

[distortion 
competition] 

of 

+ 

[limited  use  of 
ABP] 

- 

[limited  use  of 
ABP] 

(1) 

(2) 

[harmonised 
level 
pf 
protection 
but 
flexible] 

not 

[prevent 
distortion  of 
competition] 

[more  use  of 
ABP] 

++  [harmonised 

level 
pf 
protection  and 
flexible] 

[prevent 
distortion 
competition] 

of 

[more  use  of 
ABP] 

+ 

+ 

± 

+ 

± 

Environmental 

± 

± 

The preferred option 

Since  the  introduction  of  a  legal  basis  for the determination of the end of the  ABP 
life cycle solution allows for a risk-based determination of the end point for the many 
different  kinds  of  material  covered  by  the  rules,  it  appears  to  provide  for  the  best 
possible solution to the problem as it will imply reduction of administrative burden 
for  operators  and  competent  authorities,  decrease  of  compliance  costs  for  operators 
while ensuring legal certainty and maintaining a high level protection of public and 
animal health across the Community. 

EN 

56 

   EN 

 
 
 
7.1.2.  Coverage of wild animals 

Options 

Type of 
impacts 

Social 

Economic  

Environmental 

Option A 
Do nothing 

Option B 
Alternatives to 
Regulatory tools 

Option C 
Legislative Review 

- 

- 

- 

risk 

of 
(continuation 
of 
increased 
introducing  epizootic 
disease into free areas 
the  Community 
of 
endangering 
public 
and/ or animal health) 

of 
risks  of 
introduction 
potential 

(continuation 
increased 
disease 
and 
economic 
consequences  due  to 
the  disease  itself  and 
to control measures.) 

a 
on 
(depending 
possibly 
introduced 
disease  and  measures 
to  be  taken,  negative 
environmental 
impacts could occur.) 

= - - (same  as  Option  A, 
with 
however, 
slightly 
better 
control possibilities.) 

+ 

(decreased  risk  for 
public  and  human 
health) 

= - - (same  as  Option  A, 
however, 
with 
better 
slightly 
control possibilities.) 

- / + (Negative  impacts  on 
some  establishments 
due  to  necessity  to 
comply  with  ABP 
Positive 
rules. 
impacts 
on 
commercialising 
possibilities) 

- 

+ 

(same  as  Option  A, 
however, 
with 
better 
slightly 
control possibilities.) 

(Better  protection  of 
health of wildlife and 
of the soil/ water due 
to 
of 
prohibition 
uncontrolled 
disposal)  

The preferred option 

From the conclusions of the analysis of impacts the preferred option will be option 
(c) although it may imply some costs for the game-handling establishments as option 
(a)  and  option  (b)  will  not  provide  with  the  necessary  level  of  protection  against 
public  and  animal  health  risks  and  will  not  solve  the  inconsistencies  that  currently 
exist with the Food hygiene legislation.  

EN 

57 

   EN 

 
 
 
 
7.2. 

Policy issue 2- Categorising new products 

Options 

Type of 
impacts 

Social 

Economic  

Option A 
Do nothing 

Option B 
Alternatives to 
Regulatory tools 

Option C 
Legislative Review 

- 

- 

due 

negative 
(Possibly 
to 
impacts 
reduced  valorisation 
possibilities 
and 
consequently 
employment) 

Not 
(the 
relevant 
Regulation does not leave 
room 
for 
guidelines/interpretations) 

(Maintaining 
the 
situation  of  not  being 
able 
valorise 
certain ABP) 

to 

Not 
(the 
relevant 
Regulation does not leave 
room 
for 
guidelines/interpretations) 

+ 

+ 

Environmental 

=  

Not 
(the 
relevant 
Regulation does not leave 
room 
for 
guidelines/interpretations)  

+ 

increased 

(Possibly 
employment 
possibilities)  

to 
ABP, 
market 

(Improved 
possibilities 
valorise 
increased 
chances, 
competitiveness  and 
decreased  operating 
costs.)  

valorisation 
(Better 
and 
recycling 
possibilities  of  ABP 
reduced 
while 
quantities 
be 
to 
disposed of) 

The preferred option 

In  light  of  the  conclusions  of  the  analysis  of  impacts  the  preferred  option  will  be 
option (c) as option (a) and option (b) will not address the problem that this default 
categorization poses for the industries using these ABP. 

EN 

58 

   EN 

 
 
 
 
7.3. 

Policy issue 3. - Clarifying the approvals/registration and controls 

Options 

Type of 
impacts 

Social 

Economic  

Option A 
Do nothing 

Option B 
Alternatives to 
Regulatory tools 

Option C 
Legislative Review 

- 

- 

(continuing  with  the 
administrative  burden 
the 
imposed 
operators 
and 
competent authorities) 

to 

(continuing  with  the 
administrative  burden 
the 
imposed 
operators 
and 
competent authorities) 

to 

(Not possible due to legal 
requirements) 

+ 

(Not possible due to legal 
requirements) 

+ 

(will 
remove 
administrative burden 
for  operators 
and 
competent 
authorities) 

remove 
(will 
administrative burden 
for  operators 
and 
competent 
authorities) 

Environmental 

= 

(Not possible due to legal 
requirements) 

= 

The preferred option 

As  the  problem  relates  to  interaction  of  different  EU  legislation  and  taking  into 
account  the  conclusions  of  the  impact  section,  the  preferred  option  would  be 
option (c). 

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7.4. 

Policy issue 3-Clarifying the derogations 

Options 

Type of 
impacts 

Social 

Option A 
Do nothing 

Option B 
Alternatives to 
Regulatory tools 

Option C 
Legislative Review 

- 

(continuation 
possibilities 
endangering 
health)  

of 
for 
human 

= 

(Not  possible  due  to 
legal requirements) 

Economic  

- 

= 

(Not  possible  due  to 
legal requirements) 

of 
(acceleration 
impacts  from  reduced 
research  possibilities 
and  on 
on  basic 
in 
applied 
universities 
and 
companies) 

research 

Environmental 

± 

± 

+  (probably 

of 
improvement 
animal 
human 
and 
following 
health 
results  of 
research. 
Improvement  of  risk-
proportionate measures 
and 
of 
protection 
public health)  

+  (better  possibilities  for 
research, 
therefore 
investments  and  more 
employment;  probably 
of 
improvement 
animal 
human 
and 
health, 
therefore 
reduced  health  care 
costs 

+  (or  ± 

if 

adequate 

complementary 
protection  measures 
are adopted.) 

The preferred option 

According  to  the  conclusions  of  the  analysis  of  impacts  option  (c)  would  be  the 
preferred option. 

7.5. 

Conclusion 

Taking into account all analyses of impacts, the preferred option for all policy issues 
is the option of the legislative review.  

This  conclusion  also  results  from  the  actions  taken  by  the  Commission  since  the 
adoption and implementation of the ABP Regulation. The difficulties identified have 
been addressed where necessary and where possible by way of legislative measures 
taken  by  the  Commission  following  Comitology  procedures  as  well  as  by  non-
legislative tools. A list of these measures and tools is given in Annex 6. Some issues, 
however, could not be solved this way since they relate to rules fixed by the Articles 
of the Regulations, which can only be amended by co-decision procedures.  

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8. 

MONITORING AND EVALUATION 

Monitoring  and  evaluating  the  economic,  social  and  environmental  effects  of  EU 
policies is a core element accompanying  the  political process. In the  area  of  public 
and animal health, monitoring and assessing the implementation and effectiveness of 
action taken are shared between the Community and Member States.  

8.1. 

Community 

In accordance with Article 211 of the EC Treaty, it is the duty of the Commission to 
ensure proper application of Community legislation. In the field of public and animal 
health, the Commission services, in particular the Food and Veterinary Office (FVO) 
collect  information  which  serves  to  evaluate  to  which  extent  measures  taken  have 
been  implemented.  The  information  also  helps  to  identify  to  which  extent  the 
measures  taken  at  Community  level  effectively  address  the  risks  which  were 
identified as requiring action.  

The FVO has carried out a series of inspections in the area of ABP in all 25 Member 
States  in  2004-2005  in  order  to  gather  information  related  to  the  proper 
implementation of the Regulation. Similar inspections can be envisaged as a way of 
follow-up in the near to long term. 

the  Commission  collects 

the  proper 
Furthermore, 
implementation of the rules and possible new risks by way of its rapid alert systems 
(in particular the RAPEX system for consumer products and the RASSF system for 
food and feed). 

information 

regarding 

In the animal health area, the Community has in place a well functioning system to 
gather information on the animal health situation in the Community, with particular 
reference to major animal diseases. 

8.2.  Member States 

Member States are obliged to ensure proper implementation and enforcement of the 
Regulation.  This  has  implications  for  both  central  and  local  administrative  systems 
and  financial  resources  for  carrying  out  official  controls  by  means  of  regular 
inspections  and  supervision  at  plants  approved  in  accordance  with  the  Regulation 
(pet food plants, processing plants, biogas/composting plants, etc). 

In  certain  areas,  the  Regulation  requires  that  Member  States  shall  report  to  the 
Commission and to other Member States on the way they have make use of certain 
derogations and provide information on national measures taken which are related to 
the Regulation. 

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8.3. 

Communication and Consultation with stakeholders 

The  Commission  will  also  continue  to  monitor  the  improvements  made  by  this 
review  of  the  Regulation  or  possible  new  problems  arising  through  frequent 
meetings,  bilateral  exchanges  of  views,  with  the  industry  and  other  stakeholders 
concerned by the proposal, including consumers associations. The Commission will 
continue to collect views from Member States' authorities by regular meetings of the 
Standing  Committee  on  the  Food  Chain  and  Animal  Health  and  from  other 
stakeholders by way of consultations of the Advisory Group on the Food Chain and 
Animal and Plant Health. 

The Commission will also consider the possibility of carrying out a special study to 
collect  information  on  the  effects  of  the  proposed  review  of  the  legislation.  This 
study  could  be  based  on  contacts  with  a  wide  range  of  different  stakeholders  and 
cover the aspects identified as requiring modifications now, as well as any potentially 
new  problems.  A  feasible  timing  for  such  an  exercise  is  probably  2-3  years  after 
entry into force of the reviewed legislation. 

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ANNEX I-A 

LIST OF THE STAKEHOLDERS CONSULTED ON THE IMPACT ASSESSMENT 

I. 

Stakeholders consulted through the Advisory Group 

1 

2 

3 

4 

5 

6 

7 

8 

AIPCE-CEP – Association des Industries do Poisson de l'U.E. (fish) 

AVEC – Poultry processors and poultry trade association (poultry) 

BEUC – Bureau européen des Consommateurs (consumers)  

CEFIC – European Chemical Industry Council (chemical industry) 

CELCAA  –  European  Liaison  Committee  for  the  Agri-Food  Trade  (agric. 
Products trade) 

CIAA  –  Confederation  of  the  food  and  drink  industries  of  the  EU  (agric. 
product industry) 

CLITRAVI – Centre de Liason des Industries Transformatrices de Viandes de 
L'U.E. (meat processors) 

COPA-COGECA – (farmers)  
Committee  of  Professional  Agricultural  Organisations  in  the  European  Union 
(COPA)  and  General  Confederation  of  Agricultural  Co-operatives  in  the 
European Union (COGECA)  

9 

ECSLA – European Cold Storage and Logistics Association (cold stores) 

10  EDA – European Dairy Association (milk) 

11  EFPRA – European Fat Processors and Renderers Association (renderers) 

12  EMRA – European Modern Restaurant Association (modern restaurants) 

13  EUROCOMMERCE – Retail wholesale and international trade representation 

to the European Union (retailers) 

14  EUROPABIO – European association for bioindustries (bioindustries) 

15 

FEDIAF  –  Fédération  Européenne  de  l'Industrie  des  Aliments  pour  Animaux 
Familiers (petfood) 

16 

FEFAC – Fédération Européenne des Fabricants d'Aliments Composés (feed) 

17 

FESASS  –  Féderation  Européenne  pour  la  Santé  Animale  et  la  Securité 
Sanitaire (animal health) 

18 

FVE – Federation of Veterinarians of Europe (veterinarians) 

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19  HOTREC – Trade association of hotels, restaurants and cafes in the European 

Union 

20 

IFAH – International Federation for Animal Health (animal health industry) 

21 

IFOAM – International Federation of Organic Agriculture Movements (organic 
agriculture) 

22  UAPME – SME – Union Européenne de l'Artisanat et des petites et moyennes 

entreprises 

23  UECBV – Union Européenne du Commerce du Bétail Vivant (meat trade) 

24  UGAL – Union of groups of independent retailers of Europe (retailers) 

II. 

Other ABP sector representatives consulted 

25  APAG  –  European  Oleochemicals  and  Allied  Products  Group  (oleochemical 

industry) 

26 

Fachverband  Biogas  e.  V.  –  German  Biogas  Association  (as  coordinator  for 
other European organisations) 

27  CIBC  –  Confédération  Internationale  de  la  Boucherie  et  de  la  Charcuterie 

(butchers) 

28  CCTA – European collagen industry (collagen) 

29  COTANCE – Confederation of National Associations of Tanners and Dressers 

of the European Community (leather industry) 

30  DEMETER-International  e.V.  –  Organisation  for  products  of  certified 

biodynamic production (biodynamic producers) 

31  EAPA – European Animal Protein Association (protein processors) 

32  EBB – European Biodiesel Board (biodiesel producers) 

33  ECN – European Compost Network (compost producers) 

34  EDFA – European Down and Feather Association (feathers) 

35  EDMA – European Diagnostic Manufacturers Association (in-vitro diagnostics 

industry) 

36  EuLA – European Lime Association (lime)  

37 

FACE  –  Federation  of  Associations  for  Hunting  &  Conservation  of  the  E.U. 
(hunters) 

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38 

39 

FEAD  –  European  Federation  of  Waste  Management  and  Environmental 
Services (waste management) 

FEICA  –  Fédération  Européenne  des  Industries  de  Colles  et  Adhésifs 
(adhesives manufacturers) 

40  GME – Gelatine Manufacturers of Europe (gelatine) 

41 

ISIA – International Serum Industry Association (serum) 

42  VOD – Verband organischer Düngemittel (organic fertilisers) 

43 

INTERLAINE  –  Umbrella  organization  for  European  associations  of  raw 
materials  suppliers,  processors,  spinners  and  weavers  of  wool  and  wool 
textiles. 

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ANNEX I-B 

SUMMARY OF CHRONOLOGY OF MAIN EXCHANGES WITH REPRESENTATIVES OF THE 
SPECIFIC SECTORS LIKELY TO BE AFFECTED BY THE REVIEW 

Bilateral or multilateral meetings have been held with the following industry associations, 
during which specific aspects related to Regulation (EC) No 1774/2002 have been raised and 
further discussed (sometimes alongside with issues which may have been considered by way 
of  comitology  amendments).  The  following  list  gives  a  non-conclusive  overview  over  these 
meetings: 

18 November 2002 

18 December 2002 

17 January 2003 

12 February 2003 

20 February 2002 

5 March 2003 

25 March 2003 

28 March 2003 

ca.  45  international  industry  organisations: 
explanation  of  the  ABP  Regulation  and 
discussion of specific aspects 

GME:  importation  of  bones  derived  from 
animals treated with growth hormones and/ or 
containing specified risk materials (SRM) for 
gelatine production; processing conditions for 
from 
dicalcium 
gelatine production) 

(by-product 

phosphate 

FEFAC: connection of the ABP Regulation to 
the feed ban 

importation 

for 
APAG: 
in 
pharmaceutical 
oleochemical  plants;  separation  requirement 
for Category 2 and 3 ABP 

purposes;  HACCP 

tallow 

of 

devices 

correlation 
Medical 
between legislation from DG ENTR and ABP 
rules 

industry: 

Photographic  industry  (Kodak):  Importation 
and  use  of  gelatine  produced  from  animals 
treated  with 
for 
growth 
photographic purposes 

hormones 

WR²:  Discussion  of  alkali  hydrolysis  as  an 
alternative treatment method 

European  dairy  association, 
International 
butchers association, GME, APAG, UECBV; 
Argentina  and  other  organisations  and  third 
participants): 
(in 
countries 
clarification of ABP issues 

total 

160 

EN 

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8 April 2003 

1 July 2003 

4 July 2003 

23 July 2003 

28 July 2003 

30 July 2003 

2 September 2003  

7 October 2003 

13 October 2003 

17 October 2003 

6 November 2003 

industry:  Transport 

Milk 
foodstuffs;  use  of 
(Category 2) for petfood production 

former 
of 
contaminated  milk 

industry 

(Fuji,  Kodak): 
Photographic 
Importation  and  use  of  gelatine  produced 
from  animals  treated  with  growth  hormones 
for photographic purposes 

EFPRA: Processing conditions for production 
of hydrolysed proteins from feather meal 

WR²  (alkali  hydrolysis  industry):  Discussion 
of  alkali  hydrolysis  as  an  alternative 
treatment method 

Cotance:  application  of  food,  feed  and  ABP 
rules  on  handling  and  treating  of  hides  and 
skins 

SARIA  (rendering  industry):  Discussion  of 
an  alternative 
for 
production of biodiesel 

treatment  of 

tallow 

Photographic  industry  (Kodak):  Importation 
and  use  of  gelatine  produced  from  animals 
for 
growth 
treated  with 
photographic purposes 

hormones 

GME: import requirements for gelatine 

Industry producing adhesives: Possibilities to 
mark  raw  materials  for  adhesive  production, 
in particular as regards milk products 

APAG:  use  of  tallow  for  biofuel  production; 
possibilities  for  marking  of  tallow;  labelling 
requirements 
import 
certificates for fat derivatives 

tallow 

tanks; 

for 

EFPRA:  Discussion  of  combustion  of  tallow 
in a thermal boiler as an alternative treatment 
method; marking of ABP 

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25 November 2003 

9 January 2004 

22-23 Jan. 2004 

19 March 2004 

30 May 2005 

26 August 2005 

24 October 2005 

22 November 2005 

29 November 2005 

13 January 2006 

23 January 2006 

24 February 2006 

Applicability 

Milk  industry:  Use  of  milk  for  feeding 
purposes; 
of  marking 
requirements  for  milk  products  (casein) 
derived  from  animals  treated  with  growth 
petfood 
hormones 
production  

intended 

and 

for 

EFPRA: Marking of ABP; use of hydrolysed 
feather meal 

FEDIAF: use of blood products (plasma) 

Demeter  (organic  industry):  possibilities  to 
use Category 2 and 3 materials for production 
of their products 

UECBV 
legislation) 

(overlap  with 

environmental 

Fur  trade  industry  (import  requirements  for 
importation  of  hides  and  skins  from  fur 
animals) 

SITFA  (feather  industry):  requirements  on 
importation and transportation of feathers 

UECBV  (clarification  of  certain  terms,  e.  g. 
"fertilisers"  or  "tallow"  ,  under  ABP  and 
under waste legislation; use of residues from 
biogas  and  composting;  marking  of  ABP; 
need to simplify the ABP rules) 

APAG  (Presentation  and  discussion  of  a 
study on the effect of oleochemical treatment 
of tallow on prion activity) 

Cotance (use of hides and skins from "cohort 
animals") 

FEDIAF  (labelling  of  processed  petfood; 
commercial  document 
ready-to-sell 
products;  approval  of  plants  only  processing 
pre-treated ABP) 

for 

Photographic industry (use of gelatine by this 
industry) 

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16 March 2006 

20 March 2006 

22 June 2006 

28 June 2006 

29 June 2006 

27 July 2006 

10 August 2006 

5 September 2006 

7 September 2006 

20 September 2006 

20 September 2006 

EULA  (Lime  Association):  Discussion  of  an 
application for a method allowing production 
of lime from ABP 

Working Group of the Advisory Group on the 
Food  Chain,  Animal  and  Plant  Health 
(Commission  presentation  of  the  intended 
scope 
- 
Present:  Advisory  Group  Members  with  an 
interest 
in  ABP,  additional  stakeholders 
concerned) 

exercise 

review 

the 

of 

(treatment 

EULA 
the 
production of lime; approval requirements for 
lime producing plants) 

requirements 

for 

EFPRA 
legislation) 

(overlap  with 

environmental 

European  Dairy  Association  (overlap  with 
food and feed hygiene legislation, duplication 
of approvals under such legislation and ABP 
rules) 

EAPA 

EFPRA, 
for 

(treatment 
FEDIAF, 
requirements 
blood; 
differentiation between blood meal and blood 
products) 

porcine 

EDMA  (interlink  with  ENTR 
legislation 
regarding  the  manufacture  of  products  for 
diagnostic purposes) 

EDMA (follow-up meeting of 10/08/2006) 

Working Group of the Advisory Group on the 
Food  Chain,  Animal  and  Plant  Health 
(presentation of a draft proposal for review of 
the Regulation) 

EFPRA, 

FEFAC, 

UECBV, 
Cotance 
(classification of ruminant blood; materials to 
be  used  in  Category  3  processing  plants; 
requirements  for  dairy  products  in  ABP  and 
in fed and food legislation; etc.) 

Conference on animal by-products, as part of 
the "Better Training for Safer Food" initiative 
(provided  an  opportunity  to  collect  views  of 
Member  States,  third  countries  and  certain 
industry sectors – UECBV (slaughterhouses), 

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21 September 2006 

9 October 2006 

19 October 2006 

25 October 2006 

9 November 2006 

22 November 2006 

8 December 2006 

22 February 2007 

27 March 2007 

19 April 2007  

23 April 2007  

1 June 2007  

EFPRA  (renderers),  COTANCE  –  leather, 
FEFAC – animal feed) 

COTANCE  (request  for  clarifications  with 
respect to classification of hides and skins) 

VOD  (import  and  labelling  conditions  for 
hornmeal, bonemeal and bloodmeal for use in 
fertilisers) 

EFPRA (see 28 June 2006) 

UECBV  (simplification  of  legislation,  risk-
based  approach  for  categorisation  of  animal 
by-products) 

ISIA  (concerns  about  importation  of  serum 
and  other  products  in  particular  from  third 
countries 
treating  animals  with  growth 
hormones) 

informal  discussion  with  EFPRA, 
(basis:  draft 

Joint 
UECBV  and  COTANCE 
proposal) 

Deutscher  Bauernverband  (German  Farmers 
Association):  Swill  feeding;  catering  waste; 
use  of  ABP  in  composting  and  biogas 
production;  manure  handling;  risks  from 
sewage sludge 

FACE  (handling  of  pheasant  chicks  being 
reared  and  then  released  in  the  wild  for 
hunting; handling of "damaged game") 

(possibilities 

MIV 
feed  milk; 
categorisation  of  milk  containing  prohibited 
substances; quality management) 

to 

ISIA  (categorisation  of  serum;  impacts  of 
Regulation (EC) No 2007/2006) 

CWT  (company  producing  hydrocarbon  – 
oil):  Discussion  of  an  application  for  a 
method  allowing  production  of  industrial  oil 
from ABP 

FACE 
assessment) 

(questionnaire 

to 

the 

impact 

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ANNEX II 

SUMMARY OF CHRONOLOGY OF MAIN EXCHANGES WITH INTERNATIONAL PARTNERS LIKELY 
TO BE AFFECTED BY THE REVIEW 

Bilateral  or  multilateral  meting  have  been  held  with  the  following  third  countries,  during 
which specific aspects related to Regulation (EC) No 1774/2002 were being raised and further 
discussed  (sometimes  alongside  with  issues  which  were  considered  by  way  of  comitology 
amendments): 

8 November 2002 

18 November 2002 

19 November 2002 

10 February 2003 

12 February 2003 

19 February 2003 

19 February 2003 

23 April 2003 

15 September 2003 

25 November 2003 

USA: Import certificates for gelatine 

third  countries: 
Representatives  of  63 
explanation  of  the  ABP  Regulation  and 
discussion of specific aspects 

USA: marking of pet food; long list of issues, 
e.  g;  blood  from  ruminants;  applicability  of 
the  ABP  Regulation  on  technical  products; 
use of used cooking oils 

long 

Canada: 
e.  g. 
list  of 
categorisation of heads and feet from poultry; 
hydrolysed proteins for use in pet food; use of 
grieves derived from gelatine production 

issues, 

importation 

APAG: 
for 
in 
pharmaceutical 
oleochemical  plants;  separation  requirement 
for Category 2 and 3 ABP 

purposes;  HACCP 

tallow 

of 

China: sourcing of materials, e. g. for lanolin 
production or for cosmetic products 

USA:  marking  of  ABP;  ban  on  international 
catering waste 

USA: Importation of collagen produced from 
bovine  hides  for  production  of  sausage 
casings  

USA  and  photographic  industry:  Discussion 
of  possibilities  to  import  gelatine  derived 
from  animals  which  have  been  treated  with 
growth hormones for photographic purposes 

Canada: Listing of establishments; request for 
certain  import  derogations  from  the  ABP 
Regulation 

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3-4 December 2003 

10 December 2003 

10 December 2003 

15 January 2004 

17 March 2004 

30 March 2004  

23 June 2004 

12 July 2004 

USA:  Transitional  measures  and  derogations 
for importation of ABP, e. g. hides and skins 
and pet food 

Canada:  Certification  requirements;  marking 
of  pet 
transit 
requirements; etc. 

food;  game 

trophies; 

New  Zealand: 
imports 

technical  conditions  on 

USA: long list if issues. E. g. import rules for 
finished  products  such  as  paints,  lubricants, 
finished laboratory reagents; used cooking oil 
for  use  in  animal  feed  or  for  technical 
purposes;  use  of  dead  in  transit  poultry  for 
processing  of  (Category  3)  processed  animal 
protein 

USA:  recommendations 
regulations for trading in animal products 

to  refine  health 

call): 

(conference 

USA 
photographic 
gelatine;  certificates  for  raw  ABP;  import  of 
treatment 
bones  for  gelatine  production; 
requirements 
tallow; 
derogation for tallow and for hides 

for  birdseed  with 

(conference  call):  blood  derived 
laboratory  use;  certification 

USA 
products  for 
requirements for dairy products 

USA  (conference  call):  importation  of  blood 
products;  lists  of  approved  plants;  health 
certification requirements 

11 November 2004 

USA: import certificates 

20 June 2005 

7 July 2005 

USA:  Derogation  for  separation  of  plants; 
risk  assessment  for  tallow  and  gelatine; 
approval  of  marking  substances;  importation 
of  certain  intermediate  products;  exportation 
of  milk  replacers;  raw  milk  for  research 
purposes;  blood 
lagomorphs  and 
from 
rodentia 

USA:  Export  of  gelatine  capsules  from  USA 
to EU 

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22 March 2006 

04 December 2006 

16 January 2007 

Australia:  discussion  of  a  list  of  points 
submitted by Australia  

Japan: Swill feeding 

Australia,  New  Zealand,  USA,  Canada: 
review of the ABP Regulation; importation of 
intermediate  products;  questions  on  how  to 
covered  by 
trade  with  products  not 
Regulation  (EC)  No  2007/2006;  clarification 
request on Category 2 ABP of low risk 

20 January 2007  

New Zealand: Categorisation of certain ABP 

In addition to these meetings a very intense exchange of letters and e-mails has taken place 
with  several  third  countries  where  the  Commission  has  tried  to  clarify  uncertainties  and  to 
provide help by issuing guidance notes or, where this was not possible by amending existing 
legislation or by adopting transitional measures, derogations or implementing legislation. 

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ANNEX III 

OPINIONS OF THE EUROPEAN FOOD SAFETY AUTHORITY (EFSA) RELATING TO THE 
ABP REGULATION 

Opinion  of  the  Panel  on  Biological  Hazards  of  the  European  Food  Safety  Authority  on  the 
process  of  "High  Pressure  Hydrolysis  Biogas"  (HPHB)  as  method  for  safe  disposal  of 
category  1  Animal  by-Products  (ABP)  not  intended  for  human  consumption.  (Question  N° 
EFSA-Q-2003-028). 

Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority 
on  the  safety  vis-à-vis  biological  risk  including  TSEs  of  the  "application  on  pastureland  of 
organic fertilisers and soil improvers". (Question N° EFSA-Q-2003-090). 

Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority 
on  the  safety  vis-à-vis  biological  risk  including  TSEs  of  the  "application  on  pastureland  of 
organic fertilisers and soil improvers" (Question N° EFSA-Q-2003-090). 

Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority 
on  the  “Assessment  of  the  human  and  animal  BSE  risk  posed  by  tallow  with  respect  to 
residual BSE risk” (Question N° EFSA-Q-2003-099). 

Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority 
on  the  “Quantitative  assessment  of  the  human  BSE  risk  posed  by  gelatine  with  respect  to 
residual BSE risk” (Question N° EFSA-Q-2003-099) 

Opinion of the Scientific Panel BIOHAZ on the “Quantitative assessment of the residual BSE 
risk  posed  by  di-calcium  phosphate  (DCP)  and  tri-calcium  phosphate  (TCP)  from  bovine 
bones used as an animal feed additive or as fertiliser” (Question N° EFSA-Q-2003-099). 

Opinion  of  the  Panel  on  Biological  Hazards  of  the  European  Food  Safety  Authority  on 
“Combustion of Tallow in a Thermal Boiler” process for safe disposal of animal by-products 
as method for safe disposal of category 1 Animal by-Products (ABP) not intended for human 
consumption (Question N° EFSA-Q-2003 –234). 

Opinion  of  the  Panel  on  Biological  Hazards  of  the  European  Food  Safety  Authority  on 
“Biodiesel Process” as a method for safe disposal of  category  1 Animal by-Products  (ABP) 
(Question N° EFSA-Q-2004-028). 

Opinion  of  the  BIOHAZ  Panel  on  the  "safety  of  collagen  and  a  processing  method  for  the 
production of collagen" (Question N° EFSA-Q-2004-085). 

Opinion of the BIOHAZ Panel on the "BSE risk from cohort animals: bovine hides and skins 
for technical purposes" (Question N° EFSA-Q-2005-292). 

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ANNEX IV 

STATISTICS OF THE ONLINE QUESTIONNAIRE6 

Date open: 2007-04-24 

End date: 2007-06-19 

There are 114 responses 

Reply as an individual or on behalf of an 
organisation, institution or company 

Organisation, institution, company 

Individual 

Number of responses 

% of responses 

107 

17 

(86.3%) 

(13.7%) 

Type  of  organisation, 
company 

institution  or 

Number of responses 

% of responses 

Organization representing the private sector 

Private company 

National authority 

National NGO  

Other contributor 

Regional or local authority 

International NGO 

International 
institution/think tank 

organization 

Academic 

42 

38 

8 

8 

7 

3 

1 

0 

(39.3%) 

(35.5%) 

(7.5%) 

(7.5%) 

(6.5%) 

(2.8%) 

(0.9%) 

(0%) 

6 

Note: questions were optional for the participants to answer and some have chosen not to answer all of 
them. Therefore the number of responses given to any particular question varies and does not add up to 
the number of all the people answering the questionnaire (124). Similarly, the % of responses refers to 
the number of responses in relation to all the people answering the questionnaire and does not add up to 
100%. 

EN 

75 

   EN 

 
 
 
                                                 
Country of residence 

Number of responses 

% of responses 

UK-United Kingdom  

BE-Belgium 

NL-Netherlands 

DE-Germany 

Other non-European country 

FI-Finland 

DK-Denmark 

CZ-Czech Republic 

EL-Greece 

IE-Ireland 

IT-Italy 

EE-Estonia 

FR-France  

PT-Portugal 

SK-Slovakia 

Other European countries 

53 

20 

14 

11 

6 

5 

3 

2 

2 

2 

2 

1 

1 

1 

1 

0 

(42.7%) 

(16.1%) 

(11.3%) 

(8.9%) 

(4.8%) 

(4%) 

(2.4%) 

(1.6%) 

(1.6%) 

(1.6%) 

(1.6%) 

(0.8%) 

(0.8%) 

(0.8%) 

(0.8%) 

(0%) 

EN 

76 

   EN 

 
 
 
RESULTS FROM THE ON_LINE CONSULTATION 

A. 

Determination of the end of the ABP life-cycle 

Option (a): Do-nothing 

Number of responses 

% Responses 

Strongly disagree  

Disagree 

Agree 

Other 

Strongly agree 

37 

18 

14 

14 

11 

(29.8%) 

(14.5%) 

(11.3%) 

(11.3%) 

(8.9%) 

Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Agree 

Disagree 

Other 

Strongly agree 

Strongly disagree  

36 

30 

11 

7 

6 

(29%) 

(24.2%) 

(8.9%) 

(5.6%) 

(4.8%) 

Option (c): Legislative review 

i.  Exemption  of  finished  products 

from the Regulation 

Number of responses 

% Responses 

Agree 

Disagree 

Other 

Strongly agree 

Strongly disagree 

EN 

39 

20 

14 

8 

5 

77 

(31.5%) 

(16.1%) 

(11.3%) 

(6.5%) 

(4%) 

   EN 

 
 
 
 
Option (c): Legislative review 

ii.  Introduction  of  a  legal  basis  for 
determining  the  end  of  the  ABP 
life cycle 

Strongly agree 

Agree 

Disagree 

Other 

Strongly disagree  

Number of responses 

% Responses 

40 

28 

8 

8 

4 

(32.3%) 

(22.6%) 

(6.5%) 

(6.5%) 

(3.2%) 

B. 

Coverage of wild animals 

Option (a): Do-nothing 

Number of responses 

% Responses 

Strongly agree 

Disagree 

Agree 

Strongly disagree  

Other 

23 

21 

18 

17 

12 

(18.5%) 

(16.9%) 

(14.5%) 

(13.7%) 

(9.7%) 

Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Agree 

Disagree 

Other 

Strongly disagree  

Strongly agree 

49 

17 

11 

9 

2 

(39.5%) 

(13.7%) 

(8.9%) 

(7.3%) 

(1.6%) 

EN 

78 

   EN 

 
 
 
 
Option (c): Legislative review 

i.  To  extend  the  scope  to  cover  all 
wild  animals,  but  apply  only 
minimal  Community  controls  in 
line with the Hygiene legislation 

Disagree 

Strongly disagree 

Agree 

Other 

Strongly agree 

Number of responses 

% Responses 

30 

25 

16 

13 

2 

(24.2%) 

(20.2%) 

(12.9%) 

(10.5%) 

(1.6%) 

ii.  To  extend  the  scope  to  cover  all 
wild  animals,  but  allow 
the 
competent  authority  to  issue  a 
general authorisation 

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly disagree  

Strongly agree 

41 

23 

13 

6 

4 

(33.1%) 

(18.5%) 

(10.5%) 

(4.8%) 

(3.2%) 

iii.  To  extend  the  scope  to  cover  all 
wild  animals,  but  apply  only 
minimal  Community  controls  in 
line  with  the  Hygiene  legislation 
the  competent 
and 
authority 
issue  a  general 
to 
authorisation 

to  allow 

Strongly disagree  

Disagree 

Agree 

Other 

Strongly agree 

EN 

Number of responses 

% Responses 

23 

23 

18 

15 

3 

79 

(18.5%) 

(18.5%) 

(14.5%) 

(12.1%) 

(2.4%) 

   EN 

 
 
 
 
CATEGORISING NEW PRODUCTS AND TECHNICAL USE OF ALL THREE 
CATEGORIES OF ABP 

A. 

Categorising new ABP 

Option (a): Do-nothing 

Number of responses 

% Responses 

Disagree 

Strongly disagree 

Agree 

Strongly agree 

Other 

34 

28 

7 

4 

4 

(27.4%) 

(22.6%) 

(5.6%) 

(3.2%) 

(3.2%) 

Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly disagree 

Strongly agree 

34 

17 

13 

6 

2 

(27.4%) 

(13.7%) 

(10.5%) 

(4.8%) 

(1.6%) 

Option (c): Legislative review 

i.  To 

categorise 

newly 

the 

intrinsically low risk products 

Number of responses 

% Responses 

Disagree 

Agree 

Strongly agree 

Other 

Strongly disagree 

EN 

29 

28 

10 

5 

1 

80 

(23.4%) 

(22.6%) 

(8.1%) 

(4%) 

(0.8%) 

   EN 

 
 
 
 
ii.  To  maintain  current  default 
categorization,  but  create  basis 
for  proportional  measures  to  be 
introduced  on  a  case-by-case 
basis 

Number of responses 

% Responses 

Disagree 

Agree 

Strongly disagree 

Other 

Strongly agree 

40 

24 

4 

4 

0 

(32.3%) 

(19.4%) 

(3.2%) 

(3.2%) 

(0%) 

iii.  To  categorise  newly  intrinsically 
low risk products and to create a 
legal  basis  to  categorise  further 
products 
proportional 
measures  to  be  introduced  on  a 
case-by-case basis 

and 

Agree 

Strongly agree 

Disagree 

Other 

Strongly disagree 

Number of responses 

% Responses 

47 

23 

5 

4 

0 

(37.9%) 

(18.5%) 

(4%) 

(3.2%) 

(0%) 

B. 

Technical use of all three Categories of ABP 

Option (a): Do-nothing 

Number of responses 

% Responses 

Disagree 

Strongly disagree 

Agree 

Other 

Strongly agree 

EN 

35 

17 

11 

7 

4 

81 

(28.2%) 

(13.7%) 

(8.9%) 

(5.6%) 

(3.2%) 

   EN 

 
 
 
 
Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly disagree  

Strongly agree  

34 

16 

13 

5 

1 

(27.4%) 

(12.9%) 

(10.5%) 

(4%) 

(0.8%) 

Option (c): Legislative review 

i.  Extending the list of products per 
category  and  their  possible  uses 
in the Regulation 

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly agree 

Strongly disagree 

40 

20 

9 

5 

2 

(32.3%) 

(16.1%) 

(7.3%) 

(4%) 

(1.6%) 

ii.  Introduction  of  the  possibility  to 
use  any  animal  by-product  for 
technical  uses  on  a  risk  based 
approach 

Number of responses 

% Responses 

Agree 

Strongly agree  

Other 

Strongly disagree  

Disagree 

39 

37 

3 

0 

0 

(31.5%) 

(29.8%) 

(2.4%) 

(0%) 

(0%) 

EN 

82 

   EN 

 
 
 
 
CLARIFYING THE APPROVALS / REGISTRATIONS AND CONTROLS 

Option (a): Do-nothing 

Number of responses 

% Responses 

Strongly disagree 

Disagree 

Agree 

Strongly agree 

Other 

36 

22 

11 

3 

2 

(29%) 

(17.7%) 

(8.9%) 

(2.4%) 

(1.6%) 

Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Disagree 

Agree 

Strongly disagree  

Other 

Strongly agree  

Option (c): Legislative review 

i.  To  remove  duplicated  approvals 
and  rely  fully  on  the  provisions 
already 
introduced  by  other 
Community sector legislation 

Disagree 

Agree 

Other 

Strongly agree  

Strongly disagree  

40 

13 

8 

8 

1 

(32.3%) 

(10.5%) 

(6.5%) 

(6.5%) 

(0.8%) 

Number of responses 

% Responses 

28 

14 

11 

9 

3 

83 

(22.6%) 

(11.3%) 

(8.9%) 

(7.3%) 

(2.4%) 

   EN 

EN 

 
 
 
 
ii.  To  remove  duplicated  approvals, 
rely  on  the  provisions  already 
introduced  by  other  Community 
legislation,  but  require 
sector 
registration 
specific 
businesses 

for 

Disagree 

Agree 

Strongly agree  

Strongly disagree  

Other 

Number of responses 

% Responses 

30 

16 

9 

7 

6 

(24.2%) 

(12.9%) 

(7.3%) 

(5.6%) 

(4.8%) 

iii.  To  remove  duplicated  approvals, 
rely  on  the  provisions  already 
introduced  by  other  Community 
legislation,  and  require 
sector 
registration in all cases 

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly disagree  

Strongly agree  

32 

15 

10 

6 

4 

(25.8%) 

(12.1%) 

(8.1%) 

(4.8%) 

(3.2%) 

iv.  To  remove  duplicated  approvals, 
rely  on  the  provisions  already 
introduced  by  other  Community 
sector 
require 
legislation, 
registration  in  all  cases  and  to 
legal  basis  allowing 
create  a 
additional 
introduction 
requirements 

of 

Agree 

Strongly agree  

Disagree 

Other 

Strongly disagree  

EN 

Number of responses 

% Responses 

23 

14 

12 

12 

8 

84 

(18.5%) 

(11.3%) 

(9.7%) 

(9.7%) 

(6.5%) 

   EN 

 
 
 
 
CLARIFYING THE DEROGATIONS 

Option (a): Do-nothing 

Number of responses 

% Responses 

Strongly disagree  

Disagree 

Agree 

Strongly agree  

Other 

30 

25 

14 

5 

3 

(24.2%) 

(20.2%) 

(11.3%) 

(4%) 

(2.4%) 

Option 
regulation or guidance 

(b):  Self-regulation, 

co-

Number of responses 

% Responses 

Disagree 

Agree 

Other 

Strongly disagree 

Strongly agree 

Option (c): Legislative review 

i.  Extending 

the  derogation  by 
allowing  Member  States 
to 
authorise the importation and use 
all  three  Categories  of  ABP  for 
research purposes 

Agree 

Strongly agree 

Other 

Disagree 

Strongly disagree 

31 

16 

10 

6 

4 

(25%) 

(12.9%) 

(8.1%) 

(4.8%) 

(3.2%) 

Number of responses 

% Responses 

31 

25 

12 

5 

0 

85 

(25%) 

(20.2%) 

(9.7%) 

(4%) 

(0%) 

   EN 

EN 

 
 
 
 
ii.  Extending 

the  derogation 

to 
provide  for  burial  or  burning  in 
more  areas  affected  by  special 
circumstances 

Agree 

Other 

Strongly agree  

Strongly disagree  

Disagree 

Number of responses 

% Responses 

29 

21 

13 

4 

3 

(23.4%) 

(16.9%) 

(10.5%) 

(3.2%) 

(2.4%) 

EN 

86 

   EN 

 
 
ANNEX V 

QUESTIONNAIRE SENT TO COMPETENT AUTHORITIES OF MEMBER STATES 
AND STAKEHOLDERS AND NUMBER OF ANSWERES RECEIVED 

Type of organisation, institution or company 

Number of responses 

Competent Authorities from Member States 

Competent Authorities from third countries  

Organization representing the private sector 

Private company 

NGO  

Other contributor 

Total 

16 

1 

7 

10  

0 

0 

34 

EN 

87 

   EN 

 
 
ANNEX VI 

Examples of the economic and social dimension of the industries affected by the review 

EFPRA – European Fat Processors and Renderers Association 

EFPRA members process about 15,5 million metric tons (mMT) of animal by-products (raw 
materials)  per  year.  Of  this  about  5,5  mMT  are  Category  1  and  2  and  about  10  mMT  are 
Category 3 and food grade material. 

The production of rendered products is as follows: 

Cat. 1 and 2 (combined) 

Cat. 3 and Food grade (Combined) 

Total 

* 

Processed Animal Protein 

Protein Meal/PAP* 

Rendered Fat 

1.32 mMT 

2.42 mMT 

3.75 mMT 

0.92 mMT 

1.68 mMT 

2.6 mMT 

Confederation  of  National  Associations  of  Tanners  and  Dressers  of  the  European 
Community  

This  confederation  represents  companies  with  more  than  3.000  plants  (mainly  small  and 
medium  enterprises).  More  than  50.000  direct  jobs  depend  on  the  leather  industry  that 
accounts a 8.000 Million Euro turnover/year. This hides and skins represent typically 50-60% 
of leather production costs 

Cotance – Leather industry 

Hides and skins  (HS)  make up 50  %  of the  costs of the whole leather production chain. Of 
raw  HS  only  20 %  are  used  for  leather  production  (the  rest  are  heir,  splits,  etc.).  The  other 
80 %  enter  into  the  food  chain  (e.  g;  gelatine,  collagen,  hydrolised  proteins),  feed  and 
technical products (e. g. fertilisers). 

FEDIAF – petfood industry 

FEDIAF  represents  the  interests  of  19  national  pet  food  industry  associations.  In  all,  it 
represents  the  views  and  interests  of  around  450  European  pet  food  producing  companies. 
FEDIAF members provide a range of products to help ensure long, healthy and active lives of 
millions of pets in Europe, which are cared for in around 55 million pet keeping households. 

FEDIAF members process 5.000.000 ton of raw materials (not only ABP) per year. Yearly, 
they  use  about  2.750.000  ton  of  by-products  from  European  agriculture.  In  2005,  products 
worth  8.5 billion  Euro  were  sold  with  a  yearly  growth  rate  of  3 %.  This  industry  employs 
directly 21.000 people and indirectly another 30.000 people.  

EN 

88 

   EN 

 
 
As an example, one big company imports from 30 third countries to 160 locations within the 
EU15; this company has 30.000 associates. Each day, this company processes in just one of 
the plants 380 to raw materials (ABP, tallow, cereals, vitamins, etc.) while having about 70 
lorries of packaging materials. 

GME – Gelatine Manufacturers of Europe 

GME represents 10 European companies with a total of 22 production plants in Europe. They 
produce  110.000  ton  gelatine  per  year,  which  is 45  %  of  the  world  production.  Worldwide, 
apart  from  Europe,  Japan,  USA  and  China  are  the  main  producers.  All  producers  of  bone 
gelatine in Europe are members of GME. 

Photographic industry (Kodak) 

Kodak produces all over the world but everywhere to the same standard. In Europe, they have 
2  production  plants  (FR  and  UK),  where  they  employ  about  6000  people  and  produce 
products worth 1 billion €. Most of the products  produced in Europe are also sold in Europe. 

Products  of  Kodak  are  in  particular  photo  imaging  products  (photo  films),  motion  pictures 
(cinema), x-ray-films and medical devices. Kodak does not produce for the food industry.  

Associations representing the use of Serum: 

1. 

EDMA – European Diagnostic Manufacturers Association  

EDMA membership brings together 20 National Associations in European countries 
and 29  of the  major companies engaged in  the  research, development,  manufacture 
or distribution of IVD products. Through its affiliated National Associations, EDMA 
represents  in  total  more  than  500  companies  (or  over  700  legal  entities)  across 
Europe. 

http://www.edma-ivd.be/ 

2. 

IFAH - International Federation for Animal Health 

The  International  Federation  for  Animal  Health  (IFAH)  is  an  organisation 
representing manufacturers of veterinary medicines, vaccines and other animal health 
products in both developed and developing countries across five continents. 

http://www.ifahsec.org/default.htm 

3. 

EFPIA – European Federation of Pharmaceutical Industries and Associations 

EFPIA  represents  the  pharmaceutical  industry  operating  in  Europe.  Through  its 
direct of 30 national associations and 46 leading pharmaceutical companies, EFPIA 
is  the  voice  on  the  EU  scene  of  2,100  companies  committed  to  researching, 
developing  and  bringing  to  patients  new  medicines  that  improve  health  and  the 
quality of life around the world. 

http://www.efpia.org/Content/Default.asp 

EN 

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4. 

EVM – European Vaccine Manufacturers 

EVM  is  a  specialised  group  within  EFPIA,  the  professional  association  of  the 
European pharmaceutical industry. EVM brings together 8 company members. The 
group was established in 1991 in order to promote a favourable climate for expanded 
vaccine protection and improved vaccine coverage in Europe, and to help sustain the 
innovative research and development capability of vaccine manufacturers in Europe 

EVM members: 

• 

• 

• 

• 

• 

• 

• 

Baxter - Austria  

Berna A Crucell Company - Switzerland and Spain  

GlaxoSmithKline Biologicals - Belgium  

Novartis Vaccines - Italy and Germany  

Sanofi Pasteur - France  

Sanofi Pasteur MSD - France  

Solvay Pharmaceuticals - The Netherlands  

•  Wyeth Vaccines - Belgium  

The European vaccine industry: 

• 

• 

• 

• 

• 

is the largest supplier of vaccines in the world, producing approximately 80% 
of vaccines used worldwide.  

is  the  largest  supplier  to  UNICEF  of  vital  paediatric  vaccines,including  polio 
vaccines  

has  developed  vaccines  specifically  designed  for  the  needs  of  developing 
countries  (e.g.,  combined  paediatric  vaccines  against  diphtheria,  tetanus, 
pertussis, hepatitis B, and invasive Hib disease)  

is working in collaboration with the public sector in joint R&D activities and in 
clinical trials partnerships to develop vaccines against diseases that particularly 
burden developing countries (e.g., denguefever, leishmaniasis, rotavirus, HIV, 
malaria and tuberculosis, among others)  

contributes  significantly  to  Research  &  Development  with  over  half  of  all 
global vaccine R&D being carried out in Europe by EVM member companies  

EN 

90 

   EN 

 
• 

• 

has  production  facilities  not  only  in  Europe  but  across  the  globe  through 
international collaboration and joint ventures  

submits  its  novel  products  to  a  centralised  procedure  to  obtain  EU  licensing 
(e.g.  all  hepatitis  B  vaccines,  hepatitis  B-containing  combination  vaccines,  as 
well as the pneumococcal conjugate vaccines, among others). 

http://www.evm-vaccines.org/ 

5. 

ISIA – International Serum Industry Association 

Use of serum: 

Animal serum (a blood-derived ABP) is used extensively in 

1. 

2. 

3. 

4. 

Life science research 

Production of human and animal vaccines 

Production of biopharmaceuticals 

Production of diagnostic products 

The use of serum in research is critical in the development of future diagnostic and 
biologically  based  therapeutic  products,  a  high  growth  segment  of  the  healthcare 
industry 

Animal Health Sector: 

More  than  50,000  full  time  jobs  in  Europe  are  dependent  on  the  animal  health 
industry  with  ~15,000  being  in  production,  marketing,  sales,  research  and 
development. European sales of animal health care related products amounted to $5.3 
billion US in 2005. 

Diagnostic Manufacturing: 

Serum is used in the manufacturing of antibodies and antigens for use in diagnostic 
tests, as well as a component or diluent in the test kits themselves. These diagnostic 
tests provide critical health care information allowing the potential for global health 
care savings. 

The  European  market  for  in  vitro  diagnostics  was  7.8  billion  Euros  in  2004.  Over 
550  companies  all  over  Europe  serve  this  market.  Several  of  these  companies 
compete globally, and are market leaders on a worldwide basis. 

Reduction in diagnostic test manufacturing in Europe could have significant impact 
on the healthcare, financial and employment sectors. 

EN 

91 

   EN 

 
Biopharmaceuticals: 

Biopharmaceuticals  are  defined  as  pharmaceuticals  manufactured  by  biotechnology 
methods,  with  the  products  having  biological  sources  usually  involving  live 
organisms or their active components. Biotech medicines account for 10 to 15% of 
the  current  pharmaceutical  market  (42 billion Euros  in  2002)  and  comprise  the 
highest  growth  segment  of  the  market.  More  than  one  fifth  of  the  new  medicines 
launched  each  year  are  now  biotechnology  derived.  Biotech  medicines  have  been 
developed for a wide range of rare and chronic diseases and will continue to provide 
new breakthroughs in the years to come. More than 60 companies are active in this 
area in Europe. 

Given  the  uses  of  serum  described  above  in  both  research  and  production  it  is 
apparent  that  the  inability  to  use  this  material  would  significantly  impact  this 
segment and result in job losses, healthcare concerns and financial woe. 

Human vaccines: 

In  2002,  European  companies  produced  3.5 billion  vaccines  doses,  which  are  80 % 
of  the  vaccines  produced  globally!  50%  of  these  were  exported  to  the  USA,  and 
about  30 of  these  doses  were  used  in  Europe.  2.8  billion  doses  were  used  for 
humanitarian  purposes.  About  12,000  people 
in  Europe  work  for  vaccine 
manufacturers.  Research  and  development  spend  for  this  segment  was  $1.5  billion 
Euros in 2002, with two thirds of all research on vaccines occurring within the EU. 
The total market for vaccines worldwide in 2002 was 6.3 billion Euros. 

Vaccine  production  is  a  small  but  critical  part  of  the  pharmaceutical  marketplace. 
Europe is a major supplier of these materials to the rest of the world. Reduction in 
vaccine  production  in  Europe  could  have  catastrophic  impact  on  healthcare 
worldwide and result in significant job losses.  

In  summary,  serum  is  a  critical  component  in  use  in  all  of  the  segments  detailed 
above.  It  is  essential  for  the  wellbeing  of  these  industries  in  Europe  that  this 
important intermediate be responsibly imported through clear channels in a way that 
maintains total traceability 

EN 

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ANNEX VII 

List of legislation concerning ABP introduced since October 2002 

1. 

Transitional measures for Member States and Third Countries 

1.1. 

Transitional measures for Member States 

• 

• 

• 

• 

• 

• 

• 

Collection,  transport,  treatment,  use  and  disposal  of  former  foodstuffs  (all 
Member  States).  Commission  Regulation 
(expiry: 
31/7/2009) 

(EC)  No 197/2006 

The  possibility  of  on-site  burning  or  burial  of  ABP  (Estonia  and  Cyprus). 
Commission  Decision  2004/467/EC  (Expired  on  01/01/2005).  Commission 
Decision  2005/62/EC  as  amended  by  Decision  2005/869/EC  extended  the 
transitional measures for Cyprus (expired on 1/1/2007). 

Separation  of  Category  1  and  2  processing  plants  and  the  inclusion  of  ABP 
establishments in the list of establishments in transition in Latvia. Commission 
Decisions 2004/464/EC and 2004/476/EC (expired on 31/12/2004). 

Collection, 
Regulation 813/2003/EC (expired on 31/12/2005). 

transport  and  disposal  of  former  foodstuffs.  Commission 

Biogas  standards  (all  Member  States).  Commission  Regulation  (EC) 
No 810/2003  as  amended  by  Regulation  (EC)  No 12/2005  and  by  (EC) 
No 209/2006 & by (EC) 185/2007 (expiry: 30 June 2008) 

Composting  standards  (all  Member  States).  Commission  Regulation  (EC) 
No 809/2003  as  amended  by  Regulations  (EC)  No  12/2005  and  by  (EC) 
No 209/2006) & by (EC) 185/2007 (expiry: 30 June 2008) 

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

•  Manure  processing  standards  (Belgium,  France,  Finland  and  Netherlands). 
Commission Decision 2003/329/EC as amended by Decision 2005/14/EC and 
by Decision 2006/129/EC (expired on 31/12/2006) 

• 

• 

• 

Feeding  catering  waste  (swill  feeding)  to  animals  (Austria  and  Germany). 
Commission Decision 2003/328/EC (expired on 31/10/2006). 

Low-capacity  incinerators/co-incinerators  (Finland  and  United  Kingdom). 
Commission Decision 2003/327/EC (expired on 31/12/2004). 

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

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• 

• 

• 

• 

Total  separation  between  plants  handling  Category  1,  2  and  3  materials 
(Finland  and  France).  Commission  Decision  2003/325/EC  (expired  on 
30/04/2004 for FR and on 31/10/2005 for FIN). 

Separation  of  intermediate  plants  (France  and  Italy).  Commission  Decision 
2003/323/EC (expired on 30/04/2004). 

Processing standards for mammalian blood (Germany, Italy, Spain and United 
Kingdom). Commission Decision 2003/321/EC (expired on 31/12/2004). 

Feeding  used  cooking  oil  to  animals  (Ireland  and  United  Kingdom). 
Commission Decision 2003/320/EC (expired on 31/10/2004). 

1.2. 

Transitional measures for third countries 

General  transitional  arrangements  were  granted  to  third  countries  postponing  the 
application of the import provisions and allowing adequate time for them to adjust to 
the new requirements and for the Commission to update the import rules. In addition, 
the following specific transitional measures were granted: 

• 

• 

• 

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  as  amended  by  Regulation 
(EC) No 1877/2006 (no expiry date) 

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 (expired on 31/10/2005). 

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 2004/407/EC as amended by Decision 
2006/311/EC (no expiry date) 

2. 

Amending Regulations 

Eight Regulations have been introduced amending the Articles and/or Annexes: 

• 

• 

• 

Regulation  (EC)  No 829/2007  has  amended  certain  Annexes  relating  to 
production standards and has brought all import certificates into line with the 
requirements of the TRACES system. 

Importation and transit of certain intermediate products derived from Category 
3 material intended for technical uses  in medical devices, in vitro diagnostics 
and  laboratory  reagents  and  amending  the  ABP  Regulation.  Commission 
Regulation (EC) No 2007/2006. 

Regulation  (EC)  No 208/2006  amending  Annexes VI  and  VIII  as  regards 
processing  standards  for  biogas  and  composting  plants  and  requirements  for 
manure 

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• 

• 

• 

• 

• 

Regulation (EC) No 416/2005 amending Annex XI as regards the importation 
from Japan of certain animal by-products intended for technical purposes 

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

Regulation  (EC)  No 92/2005  has  amended  the  Regulation  as  regards  biogas 
transformation and processing of rendered fats. 

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 
accordingly. 

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. 

3. 

Implementing Regulations 

Six implementing Regulations have been introduced: 

• 

• 

• 

• 

Importation and transit of certain intermediate products derived from Category 
3 material intended for technical uses  in medical devices, in vitro  diagnostics 
and  laboratory  reagents  and  amending  the  ABP  Regulation.  Commission 
Regulation (EC) 2007/2006. 

Listing  of  approved  plants  in  Member  States.  Regulation  (EC) 1192/2006 
provides  for  ways  of  updating,  and  communicating  to  the  Commission  and 
other Member States, the list of approved establishments 

Control  measures  as  regards  fertilisers  and  soil  improvers.  Regulation  (EC) 
No 181/2006 allows the use of organic fertilisers and soil improvers other than 
manure under certain conditions and amends Annex I 

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

•  Means of use or disposal of ABP. Regulation (EC) No 92/2005 as amended by 
Regulations  (EC)  No 2067/2005  &  (EC)  No  1678/2006  provides  for  the 
possibility to dispose of ABP by other alternative methods or recycle them in 
other ways. 

• 

Use of milk, milk-based products and milk-derived products. Regulation (EC) 
No 79/2005  allows  the  direct  feeding  to  farmed  animals  with  dairy  products 
produced to food standards 

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4. 

Permanent general derogations 

Two permanent / general derogations have been granted: 

• 

• 

Derogation  from  the  intra-species  recycling  ban  for  fish  (Article  22(2). 
Regulation (EC) No 811/2003. 

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

5. 

Permanent specific derogations granted on request from member States 

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

• 

• 

Feeding  of  endangered  /  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 Decisions 2004/455/EC & 2005/830/EC. 

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. 

6. 

Guidelines issued to clarify a number of issues 

Five guidelines have been issued: 

• 

• 

• 

• 

• 

Guidance  note:  Interpretation  of  Regulation  1774/2002/EC  -  questions  from 
FVO missions (April 2006) 

Guidelines  for  applications  for  new  alternative  methods  of  disposal  or  use  of 
ABP (April 2006) 

Frequently asked Questions and Answers on ABP (6 May 2004) 

Guidance  on  applying  the  new  ABP  Regulation  in  the  form  of  questions  and 
answers  clarifying 
the  main  concerns  raised  by  Member  States  and 
stakeholders (April 2004)  

Guidance note on the application to ABP of Community legislation regarding 
animal and public health and waste (March 2004, updated in March 2007)  

A full list of ABP legislation can be found at:  

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

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List of other Community legislation and policy changes taken into account 

ANNEX VIII 

Articulation with other Community legislation 

TSE 

• 

Current provisions contains a number of TSE-related elements, including - 

– 

– 

– 

– 

– 

– 

– 

Classification  as  Category  1  of  tissues  such  as  SRM  and  BSE  positive  / 
suspects and animals killed in the context TSE eradication. 

General  requirement  for  mammalian  materials  intended  for  the  production  of 
processed animal protein to be pressure-cooked. 

Ban on the landfill of TSE suspects/positive even after pressure-cooking. 

Burial or burning of fallen stock only allowed in remote areas (excluding BSE 
positive). 

Prohibition on intra-species recycling ("cannibalism"). 

Requirement  to  filter  tallow  to  maximum  0,15 %  in  weight  to  remove  the 
protein fraction. 

Prohibition  on  the  application  to  pastureland  of  organic  fertilisers  and  soil 
improvers. 

• 

• 

• 

Being  a  general  legal  framework,  the  ABP  Regulation  ensures  that  TSE  risk 
materials are disposed of properly; thus, complementing the TSE Regulation. Subject 
to the TSE feed ban, it foresees the possibility to use processed animal protein of all 
species  in  feed,  provided  that  only  safe  material  is  used  and  mammalian  derived 
protein  has  been  treated  using  the  highest  processing  standard  (pressure-cooking) 
capable to inactivate the TSE agent. 

The proposal suggests no policy changes that would affect the above elements. 

However,  as  stipulated  in  the  TSE  road  map,  provided  the  positive  trend  continues 
and  scientific  conditions  are  in  place,  it  might  be  envisaged  in  long  term  to  adapt 
some of the above provisions to the improving BSE trend. 

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Waste legislation 

There is a concomitant review of waste legislation (shipment and framework). 

• 

Waste shipment Regulation 

The  co-legislators  have  recently  adopted  Regulation  (EC)  No 1013/2006  on  waste 
shipment, revamping the relevant Community legislation. 

The new Regulation excludes ABP that are controlled by the ABP Regulation. But in 
Article 59(1)  it  requires  the  Commission  to  complete  a  review  of  the  relationship 
between it and the ABP Regulation. If necessary, this review shall be accompanied 
by appropriate proposals with a view to achieving an equivalent level of procedures 
and control regime for the shipment of ABP. 

The  opportunity  is  taken  to  propose  some  changes  to  ensure  such  equivalency,  in 
particular as regards ABP that become waste when mixed with or contaminated by 
hazardous waste. 

• 

Waste Framework legislation 

The  Commission  has  also  proposed  a  review  of  the  basic  waste  framework  law.  A 
proposal for a Directive of the European Parliament and of the Council on waste is at 
initial stage of co-decision. 

It is proposed to exclude from the scope of the waste framework law ABP that are 
regulated  by  the  ABP  Regulation,  except  when  ABP  are  foreseen  for  incineration, 
landfill or use in biogas or composting plant. 

This  is  viewed  by  interests  as  a  further  step  in  the  right  direction,  avoiding 
duplication and improving the procedural arrangements in applying Community law. 

• 

Waste incineration 

The Commission has initiated a study on the incineration of tallow and its impact on 
the tallow burning industry. 

The study has been finalised at the end of  the  year  2006,  and  might  result  in  a  co-
decision review of the relevant Community provisions. 

Cosmetics, medicinal products and medical devices 

• 

Approval of plants 

Separate  Community  legislation  governs  the  manufacturing  and  placing  on  the 
market and export of cosmetics, medicinal products and medical devices (including 
laboratory reagents). 

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Current provisions only apply to cosmetics, medicinal products and medical devices 
(including laboratory reagents) as far as concern the source and starting materials of 
animal origin that are used in the manufacture of such products. It requires that such 
starting  materials  must  derive  from  "Category  3  materials"  i.e.  materials  from 
animals fit for human consumption following veterinary checks. 

When  such  starting  materials  are  to  be  imported  into  the  EU,  they  must  meet 
equivalent conditions set out in the Regulation, ensuring their safety vis-à-vis animal 
and public health. 

Sector legislation has been adapted to reflect these basic conditions. 

– 

It is proposed to recognise that in most cases such sector legislation achieves 
the objectives of the ABP Regulation; hence, should be relied on, excluding the 
sector  establishments  from  the  need  for  further  approval  under  the  ABP 
Regulation,  unless  new  risks  arise  or  a  comparison  of  specific  provisions  of 
sector legislation with ABP rules shows that no equivalent degree of protection 
is being ensured. 

• 

Intermediate products 

– 

Use of category 3 material 

Current  provisions  require  intermediate  products  to  be  ‘derived  from 
Category 3 material’. This poses severe problems for the industry, which uses 
many  intermediate  products  are  derived  from  animals  not  intended  for 
slaughter  for  human  consumption,  sometimes  raised  specifically  for  the 
purpose of producing intermediate products from their tissues, and sometimes 
under  laboratory  conditions.  These  include  dogs,  mice,  rats,  snakes,  insects, 
worms and many other species, whose by-products are classified as Category 1 
or  2  because  they  are  not  intended  for  human  consumption  and  are  not 
slaughtered in a slaughterhouse. As such they cannot be used. 

– 

It  is  proposed  to  adapt  the  provisions,  avoiding  disruption  of  trade  in 
/importation  of  intermediate  products  derived  from  such  animal  species  kept 
for non-food purpose. 

– 

Hormone derived materials 

Also,  in  some  countries,  particularly  Australia  and  the  NAFTA  countries, 
growth  hormones  are  regularly  used  on  farmed  animals  intended  for  human 
consumption. 

Community  law  does  not  allow  such  animals  to  enter  the  human  food  chain. 
However, it does not seem necessary to prevent the use of tissues derived from 
such animals to produce intermediate products. Nevertheless, these animals can 
only be classed as Category 1 and therefore intermediate products derived from 
is prohibited by the Regulation. 

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Restricting  the  sourcing  to  only  those  animals  that  have  not  been  fed  with 
growth  hormones  could,  according  to  industry  sources,  cut  off  supplies  of  a 
large  number  of  vital  intermediate  products.  For  instance,  it  is  estimated  that 
more  than  70%  of  biopharmaceutical  and  diagnostic  products  currently 
produced within the Community are derived from or use intermediate products 
sourced in Australia and North America. The vast majority, if not all, of these 
would  have  been  fed  with  growth  hormones  and  would  automatically  be 
classified as Category 1. 

– 

It  is  proposed  to  adapt  the  provisions,  avoiding  disruption  of  trade  in 
/importation  of  intermediate  products  derived  from  animals  fed  growth 
hormones. 

– 

Countries from which intermediate products may be imported 

Current provisions require intermediate products to come from only listed third 
countries. However, that list concerns countries where the importation of fresh 
meat /products of animal origin intended for food is allowed. 

The  listing  would  seem  inappropriate  given  that  some  of  the  products 
concerned  are  not  derived  from  meat  producing  species  (dogs,  mice,  rats, 
snakes and many other species). 

It  is  proposed  to  readjust  the  listing  accordingly,  also  reducing  the  level  of 
burden resulting from control and inspections at Border Inspection Posts. 

Estimates of the potential impact on industry 

– 

– 

According  to  the  industry,  sales  of  in-vitro  diagnostic  products  in  the  EU  are 
worth some 9.4 billion Euros and the industry employs around 100,000 people. 
As an example the industry estimates a 10-15% increase in costs in Germany 
as a result of the application of current interim measures, leading to a number 
of negative impacts on the industry, including an estimated 5000 jobs lost (see 
enclosed the industry's economic impact data). 

Other policy 

The proposal also takes into account recent law changes in the field of food/feed hygiene and 
animal nutrition. Being a framework law, the ABP Regulation ensures that by-products from 
food  production  are  properly  handled  and  used  or  disposed  of;  so  as  to  avoid  any  direct  or 
indirect source of contamination for food. The ABP Regulation complements the general rules 
for  the  handling  of  by-products  from  food  production  in  food  establishments,  set  down  in 
Regulation (EC) No 852/2004, which, in particular, provides for its disposal in a hygienic and 
environmental friendly way. In addition, rules related to certain food activities have already 
been more specifically addressed in the ABP legislation to cover certain practices, such as the 
possible use of hides and skins for gelatine or collagen production, or the direct use of certain 
dairy products for feed purposes. The proposal suggests no policy changes that would affect 
the above elements. It might, however, adapt some of the provisions to improve basing of the 
rules on possible risk while ensuring the current high level of public and animal health. 

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