EN    EN EN 
SANCO/826/2008 (POOL/D1/2008/826/826IA-EN.doc) 
 
EN    EN  COMMISSION OF THE E UROPEAN 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-p roducts not intended for human consumption 
(Animal by-products Regulation) 
 
{COM(2008)345 final} 
{SEC(2008)1995} 
 
EN 2   EN TABLE OF CONTENTS 
1. EXECUTIVE SUMMARY.......................................................................................... 5 
2. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES... 8 2.1. Overview.................................................................................................................. .... 8 
2.2. Consultation of competent authorities ......................................................................... 8 2.3. Consultation of stakeholders and of consumer organisations...................................... 8 
2.4. Consultation of international partners.......................................................................... 9 2.5. Inter-Service Steering Group (ISSG)........................................................................... 9 2.6. The European Food Safety Authority (EFSA)........................................................... 10 2.7. Other opportunities used for consultation.................................................................. 10 2.8. General on-line consultation ...................................................................................... 10 2.9. Consultation on administrative burden to competent authorities of MS and the 
industry....................................................................................................................... 10 
2.10. Opinion of the Impact Assessment Board.................................................................. 11 3. PROBLEM IDENTIFICATION................................................................................ 12 3.1. Background ................................................................................................................ 12 
3.2. The issues / problems that require actions ................................................................. 17 
3.2.1.  Policy issue 1: The scope of the Re gulation 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 a pprovals for some type of premises .................... 21 
3.2.4.  Policy issues 4 - Derogations of the Re gulation do not consider certain specific 
situations. .................................................................................................................. 22 
3.3. PERSPECTIVES (POSSIBLE EVOLUT ION OF THE ISSUE / PROBLEM) ........ 24 
3.4. Subsidiarity test......................................................................................................... . 25 
4. OBJECTIVES ............................................................................................................ 26 5. 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 
 
EN 3   EN 5.2. Policy issue 2 - Categorising new products ............................................................... 29 
5.3. Policy issue 3-Clarifying the approv als / registrations and controls.......................... 29 
5.4. Policy issue 4-Clarifying the derogations .................................................................. 29 6. ANALYSIS OF IMPACTS........................................................................................ 30 6.1. GENERAL REMARKS............................................................................................. 30 6.2. 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 e nd of the ABP life-cycle. .................................................... 56 
7.1.2.  Coverage of wild animals ......................................................................................... 57 
7.2. Policy issue 2- Categor ising new products ................................................................ 58 
7.3. Policy issue 3. - Clarifying the appr ovals/registration and controls .......................... 59 
7.4. Policy issue 3-Clarifying the derogations .................................................................. 60 7.5. Conclusion................................................................................................................ .. 60 
8. MONITORING AND EVALUATION ..................................................................... 61 
8.1. Community................................................................................................................. 61 
8.2. Member States............................................................................................................ 6 1 
8.3. Communication and Consultation with stakeholders................................................. 62 
ANNEX I-A ...................................................................................................................... ....... 63 
ANNEX I-B...................................................................................................................... ........ 66 
ANNEX II ....................................................................................................................... ......... 71 
ANNEX III...................................................................................................................... ......... 74 
 
EN 4   EN ANNEX IV....................................................................................................................... ........ 75 
ANNEX V ........................................................................................................................ ........ 87 
ANNEX VI....................................................................................................................... ........ 88 
ANNEX VII ...................................................................................................................... ....... 93 
ANNEX VIII..................................................................................................................... ....... 97 
 
EN 5   EN 1. EXECUTIVE  SUMMARY 
The item is part of the Commission age nda 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 pa rticular 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-pr oducts (ABP) not in tended for human 
consumption
1 consolidated, simplified and repl aced 19 previous legal acts. It 
introduced stricter rules concerning the appr oval of certain premises, the channelling 
and traceability of certain pr oducts and the implementation of several processing 
parameters for strictly risk-related categories of ABP, in order to guarantee the safety of final products intended fo r feed or technical uses. 
Since the entry into force of the Regula tion a continuous process of communication 
and consultation with stakeholders has been initiated and maintained by the 
Commission in order to identi fy possible issues or areas where problems could arise 
(see Annex I and Annex II) including inspectio ns 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 appl ying the legislation. In addition, a general 
on-line consultation was carried out and a questionnaire on administrative costs sent 
to competent authorities, affected industri es and stakeholders, in cluding third country 
partners, in order to gath er data on the possible impacts of this initiative on 
administrative burden. An Inter-serv ice Steering Group comprising several 
Directorates-General was created in orde r 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 genera lly 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 pr ovide legal certainty, simplify it and thus 
reduce administrative burden. In particular, th e need emerged to clarify certain issues 
and to ensure flexibility to  take account of emerging sc ientific knowledge about risks 
associated to the possible uses of ABP. C onsequently 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, tr aceability and channelling of ABP not 
intended for human consumption are regulat ed 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. 
 
EN 6   EN • the lack of clarity  in the scope of the Regulati on. 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 exte nt 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 th e scope of this Regulation have to undergo 
a double approval (under the ABP legi slation 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 an imal 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 thes e are to review the Regulation on ABP in 
order to adjust the regula tory framework to the risk s posed by animal by-products, 
improve legal clarity and adapt requiremen ts 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: adjusti ng the regulatory framework to the risks 
posed by animal by-products and contributi ng to progress in sc ience as regards 
import of ABP. 
 
EN 7   EN 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 imp acts 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 follo wing 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 regard s the level of protection of public and 
animal health, the distortion of competi tion and the functioning of the internal 
market .  
• The use of non/soft regulatory tools wa s 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 overa ll 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 Regul ation. This legislative review would 
solve the issues of different interpreta tions on the scope of the regulation and 
the derived problems as distortion of competition and different levels of 
protection against risks for public and anim al health. It will also provide for a 
more risk-based categorisation of ABP, will clarify the derogations and would imply a reduction of administrative bu rden by eliminating double approvals for 
some types of premises.  
 
EN 8   EN 2. PROCEDURAL  ISSUES  AND  CONSULTATION  OF INTERESTED  PARTIES 
2.1. Overview  
The item is part of the Commission age nda planning / work programme (reference 
2005/SANCO/058). 
A number of stakeholders, experts, compet ent authorities of the Member States and 
international trading partners have been consulted, bilaterally or collectively. More 
than 36 European Associations with an inte rest 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 Ju ne 2005. It aims to consid er 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 Regulat ion requires Member States to inform the Commission 
of the measures taken to ensure complian ce 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 Par liament and the Council describing the 
experience of all 25 Member States in applying the legislation
2. The report also takes 
into account the findings of the Commissi on'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’ e xperts, in the framew ork 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 N ovember 2005, Member States have 
examined the Commission’s report. The outcome of that meeting supported the 
Commission’s intention to revi ew the legislation concerned. 
2.3. Consultation of stakeholders and of consumer organisations 
The consultation of stakeholders and cons umer 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  
 
EN 9   EN – A three-stage consultation was held vi a 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’ per ceptions about the 
nature of the issues identified in the Commission report and to collect views about the possible options to solve them. The 2
nd stage (7 September 2006) 
aimed to sound out stakeholders on the likely acceptability of the preferred option(s). The 3
rd 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/bi osafety/animalbyproducts/index_en.htm  
– Ad hoc  bilateral meetings were held with the representatives of the specific 
sectors likely to be aff ected, including key associ ations (see summary of 
chronology of main exchanges at Annex I-B).  
The stakeholders largely agreed with the n eed 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. Wh ilst consumer organisations were also 
consulted, no specific comments were received from them.  
2.4. Consultation of international partners 
From 2002 to 2006 several bilate ral discussions have been held with major trading 
partners (USA, Canada, Japan, Australi a, New Zealand, Switzerland, etc), the 
outcome of which has fed into the review process. Details (dat es and broad issues 
discussed) are given at Annex II. 
In line with Article 5(6) of the SPS Agr eement, 16 notifications to the WTO/SPS 
have been made as regards implementi ng and amending measur es. 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 notif ications have been 
considered and as appropriate taken into  account in relation to import provisions. 
All trading partners consider that the revi ew would be a step in the right direction. 
2.5. Inter-Service Steering Group (ISSG) 
Given the crosscutting nature of the is sues concerned, the Commission set up an 
ISSG to provide specialized inputs and to br ing 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’ view s 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 vari ous DGs represented 
at the three meetings have been ta ken into account in this document. 
 
EN 10   EN 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 Cate gory 1 and/or 2 materials for the production 
of technical / industrial products (biogas, bio-diesel, photo gelatine, fertilizers / soil 
improvers). The Commission has consulted EF SA 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 collecte d during three workshops – in Greece (May 2006), Italy 
(June 2006) and Poland (July 2006) – and one  Conference in Brussels (September 
2006) organized by the Commi ssion as part of the “bette r training for safer food” 
initiative, involving the competent authoritie s 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, wh ich have been considered in completing 
this report. A report of the works hops and conference is available at: 
http://ec.europa.eu/food/food/bi osafety/animalbyproducts/index_en.htm  
2.8. General on-line consultation 
A general consultation addre ssed to the general public, st akeholders, 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/fo rms/dispatch?form=animalbyproducts  
The statistics and a summary of the main findi ngs of this consulta tion are available in 
Annex IV. The outcome of this consultation ha s been used as part of the analysis of 
impacts. 
2.9. Consultation on administrative burden to competent authorit ies 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 conc erning the expected potential 
impact of the review on administrative bur den for enterprises, the voluntary sector 
and public authorities. The addressees had the possibility to re spond from 20 April to 
18 June 2007. Where possible, the results of this consultation have been used to 
analyse the impacts of the different propos ed 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 ques tionnaire and a summary of the answers 
received can be found in Annex V. 
 
EN 11   EN 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 inform ation obligations for businesses and public 
authorities have been listed in order to clarify simplification benefits, though to give 
exact estimations of these co sts for all the affected indus trial 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 b een 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 industr ial 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 diverg ence in implementation has led to costs 
differences which hamper the functioning of the internal market qualitative analyses 
of the situation has been carried out, t hough, 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 pr ecise indications. T hough it was clear that 
considerable differences between costs of registration in differe nt Member States, it 
has not been possible to find out whether th ese 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 differe nt items considered for the calculations of this costs.  
To include further quantification of the pr oblems 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 i ndustrial 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 so urces have been clarified. 
Further quantification of the problem definition has been included as regards the number of entities and employ ment for some of the aff ected industrial sectors.  
 
EN 12   EN 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-pr oducts (ABP) not in tended for human 
consumption
3 consolidated, simplified and repl aced 19 previous legal acts. It 
introduced stricter rules concerning the appr oval of certain premises, the channelling 
and traceability of certain pr oducts and the implementation of several processing 
parameters for strictly risk-related categories of ABP, in order to guarantee the safety of final products intended fo r feed or technical uses. 
– The ABP legislation is comp lex and covers a very br oad range of products and 
industries. The following background info rmation about the current legislation 
helps to understand the problem identification.  
– Scope of the ABP Regulation. 
 The ABP Regulation lays down a gene ral framework for a wide range of 
stakeholders and industrial sectors such as producers of feeding stuffs, petfood 
and technical products (organic fertilizer s, biogas / bio-fuel, compost, game 
trophies, cosmetics, medici nal products, medical devices/laboratory reagents, 
photo gelatine, etc) and for waste opera tions (incinerati on, co-incineration 
plants). The Regulation covers ABP ha ndled within the Community (placing 
on the market and intra-Community tr ade), 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 Categor y 3 comprising materials of low or 
negligible risk. Materials that are not Cate gory 1 or 3 are, by default, placed in 
Category 2. The categories are desc ribed in the box below, along with 
examples of which ABP falls within which category, allowed uses and means 
of disposal.  
                                                
 
3 OJ L 273, 10.10.2002, p. 1. 
 
EN 13   EN Category 1 ABP :  Animals infected or suspected of being 
infected with transmissible spongiform 
encephalitis (TSE). ABP from animals 
treated with hormones; laboratory 
animals; pet animals 
Allowed uses: Use not allowed, destruction 
compulsory (generation of energy 
possible) 
Category 2 ABP :  Fallen stock; animals killed due to an 
epizootic disease (other than TSEs); 
manure; by default any ABP not 
categorised as 1 or 3 
Allowed uses: Certain technical uses such as 
fertilizers or for production of 
oleochemical products. 
Category 3 ABP :  ABP from animals fit for human 
consumption 
Allowed uses:  Feeding purposes and any technical 
use 
 
– Extent of the industry  
 It is important to understand the exte nt 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 li nked). The scope of the Regulation is 
cross-cutting, covering a wi de range of industrial se ctors. Animal by-products 
are being used or handled by operators in the field of feed for farmed and pet 
animals, of technical produc ts (production organic fert ilizers, biogas / bio-fuel, 
compost, game trophies, cosmetic, me dicinal products, medical devices/lab 
reagents, photo gelatine, et c) and of waste disposal  / recycling operations 
(incineration, co-incineration, landfill, etc). As a consequence impacts of each 
policy issue can vary substantiall y depending on the type of industry 
considered. Further information is give n 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 14   EN Gelatine Manufacturers of Europe -  10 European companies with a total of 
22 production plants. This accounts fo r 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 a nd cinema films, x-ray-films). 
European Fat Processors and Renderers Association  companies process 
about 15.5 million metric tons ABP per y ear. It has 483 production units with 
almost 17000 employees. Raw material co mprises mainly of  whole carcasses 
and of any ABP derived during slaughter . Products are meat, bone meal and 
tallow. 
UECBV – European Slaughterhouse s and meat Traders Association  
represents stakeholders for livestock markets, livestock traders and meat 
traders, slaughterhouses, cutting plants a nd 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 sl aughtering (specified risk materials, 
meat not fit for human consumption, etc.) and during further processing 
(unusable cuts or other parts in m eat 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. Oleo chemicals, such as glycerine, are 
produced mainly from tallow.  
FEDIAF – petfood industry  represents the interest s of 19 national pet food 
industry associations and with this the interests of around 450 European pet 
food producing companies. In 2005, produc ts worth 8.5 Milliard Euro were 
sold. This industry employs direct ly 21.000 and indirectly another 30.000 
people. Raw material for petfood produc tion 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 indus try 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 (cardi ac valves obtained from hearts, lenses 
of eyes, parts of the medium  or internal ear, etc.).  
 
EN 15   EN The European vaccine industry  (data submitted by EVM – European 
Vaccine Manufacturers) is the largest s upplier 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 main ly 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 a nd 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 intestin es) or medical devices (cardiac valves, 
parts of eyes or ears, etc.).  
EDMA – European Diagnosti c Manufacturers Association brings together 
20 National Associations in European  countries and 29 of the major 
companies engaged in research, devel opment, manufacture or distribution of 
in-vitro-diagnostic produc ts. Through its affiliated  National Associations, 
EDMA represents in to tal 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 Associatio ns of Tanners and Dressers of the 
European Community  represents companies w ith 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. Cosmetic s are being produced mainly using 
tallow and derived products, e. g. gly cerine, but also enzymes, acids, 
hormones or colours derived from vari ous animal tissues (skin, intestines, 
hair, insects, etc.).  
 
 
EN 16   EN Diagram 1: Sectors / industries covered by the Regulation 
 
..8
..
..SLAUGHTERHOUSE
Ante mortem 
inspection
SLAUGHTER
Post mortem
inspection
Bones Hides and skins Blood
FatsDefatted
bones for
gelatine
Human food
Animal feed* 
Petfood
Pharmaceutical
Cosmetic
TechnicalFats Greaves
Human food
Animal feed *
Petfood
Pharmaceutical
Cosmetic
TechnicalFats trimmed  
from carcasesMeat and offalCUTTING
Human food
Animal feed *
Petfood
Pharmaceutical
Cosmetic
TechnicalMeat 
Meat products
Processed 
Animal ProteinsLeatherGelatine
Collagen
Hydrol.
ProteinsBlood 
products
(incl. 
serum)
Human food
Animal feed 
Petfood
Pharmaceutical
Cosmetic
TechnicalAnimals unfit fo r
H. consumption
Animals positive to
BSE rapid testParts unfit for 
H. consumption
BSE Specified Risk 
MaterialRendering 
Technical
DestructionRESTAURANT Catering waste
Fallen stockFARM
 
 
EN 17   EN 3.2. The issues / problems that require actions 
The current Regulation entered into for ce on 1 November 2002 (and applied as from 
1 May 2003) and lays down strict rules, covering almost everyt hing 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 a nd economic operators to apply the rules 
laid down by this Regulation. However, compliance has been generally satisfactory 
and the basic principles of the Regulati on 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 Comm unity and should be preserved. In order 
to contribute to the achievement of thes e objectives, the Commission has, since the 
entry into force of this Re gulation, already carried out a number of actions including 
the drafting of guidelines and issuing le gislation 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 th e 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 tim e to look again at 
certain aspects of the legislation. The inte ntion being to focus on ensuring that the 
current rules are 'risk-proportionate' i.e. th ey allow trade and competitiveness of the 
EU industries that deal with  ABP without reducing the le vel of protection for public 
and animal health. 
Whilst there are a number of i ssues that are likely to be  addressed in any revision, 
there are a few where it has been identifie d that there might be significant impacts. 
These are set out below and are the s ubject of this impact assessment.  
3.2.1.  Policy issue 1: The scope of the Re gulation 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. enti re 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 providi ng 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 no t clear at which stage of their processing 
the legislation ceases to apply  
 
EN 18   EN 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 le ather 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 (a s there are no obvious risks for 
public or animal health associated), ther e 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 materi als as animal by-products and lays down 
rules for their handling, channelling and fina l use. These rules also apply for products 
containing ABP in addition to other mate rials. 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 m ilk products) or lubri cants (produced from 
tallow). These products pose a negligible risk to public or animal health and application of the requirements of th e ABP Regulation is disproportionate.  
Whilst there would potentially be unnecessa ry costs to operators and competent 
authorities in applying the Regulation to highly processed products, in reality 
Member States have adopted a pragma tic approach, acknowledging that such 
products were not the target of the le gislation and, conse quently, applying and 
interpreting the Regulation as not extending to these products. 
A higher degree of legal certa inty would however avoid di fferent interpretations and 
a difference in the level of protection throughout Member States. Not least as 
because the range of products and industr ies 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 ex tent 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 derive d 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, medi cinal products and medical 
devices. Category 1 and 2 tallow  and any product derived ther eof, are in principle not 
allowed for such purposes. This  poses problems for the ta llow derivati ves industry, 
in particular as regards a wide range of items produced for industrial purposes 
(lubricants, plastics and rubbe r components, paints, etc).  
 
EN 19   EN In the pharmaceutical industry, highly pro cessed ABPs which pose negligible risk 
are often used, but the companies handling them must anyhow follow the provisions 
of the ABP Regulation as regards authorizat ion procedures, which are in addition to 
the already stringent authorization pro cedures foreseen by the pharmaceutical 
legislation.  
Policy Issues 1(b) - It is not clear whether ABP from w ild 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 count ry) fall under the ABP Regulation. In this 
regard, it must be considered that thes e 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 subj ect to similar hygiene conditions. 
Background 
Although a problem of much less magnit ude than the previous one, current 
provisions as regards ABP fr om 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 c onsumption. However, it excludes entire 
bodies or parts of wild anim als if they are not suspecte d 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 avoi d requiring collection a nd 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 lo cal 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 ar ise, 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 c ontact with susceptible individuals. Such 
diseases are absent or rare in most pa rts 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 re vised food hygiene legislati on. This legisl ation, in 
particular Regulation (EC) No 853/2004, cont ains 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.  
 
EN 20   EN ABP derived from wild animals may be of  economic interest e.g. for the pet food 
industry but any industry using ABP could al so 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 thes e 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 adequa te protection of human and animal health. 
By clarifying the provisions applicable to certain commercial hunting operations, 
consistency with Community food hygiene le gislation 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 scie ntific evidence that has emerged as to 
the risks of certain ABP. More specificall y, 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 applicati on of the ABP Regulation to reflect new 
scientific knowledge (e.g. ruminants below a certai n age limit do not have to be 
tested for BSE and therefore, the cla ssification of the ruminant blood does no 
longer adequately refl ect 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 defa ult under category 2. The aim of this 
provision is the protecti on against any possible unide ntified risks that may 
arise. However, the Regulation only a llows a very limited use of category 2 
ABP. Since entry into app lication 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) 
 
EN 21   EN  Examples of ABP for which the categor isation 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 Cate gory 2. As such, its use 
for technical purposes is limited, which poses great difficulties to the paint 
industry. 
Insects  are used in the cosmetic industr y (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 a llowed for those purposes (in order to 
allow for continued use of these materi als, a transitional measure has been 
adopted under the ABP Regulation (Regulation (EC) No 878/2004)).  
 
Current legislation contains no simple f acility 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 en ough to keep up with 
advancements in scientific knowledge and technology. This means that the 
legislation is not always risk-proportio nate and may to some extent impose 
unnecessary burdens on the ma nufacturing 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 approv als for some type of premises 
Summary Experience has shown that the relations hip 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 lega l 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 re sult, 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 differe nt ways of resolving overlaps in the 
rules. However, as long as food safety and animal and public health protection are 
guaranteed by the sector legi slation, this duplication for operators as well as for 
competent authorities should be avoided.  
 
EN 22   EN Example of types of premis es undergoing double approvals 
Establishments producing gelatine or coll agen 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 rule s is necessary for 
such plants.  
Petfood plants may already be approve d under Regulation (EC) No 183/2005 on 
feed hygiene for other manufacturing operati ons. In this respect, they have to 
comply with comprehensive requirements  as regards hygienic production conditions 
and the monitoring of risks to public a nd 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 Regulat ion on derogations need to take into account specific 
circumstances. The import of a wide ra nge of ABP is sometimes necessary for 
research purposes. Under em ergency situations, disposal  of ABP through the normal 
channels is not practically feasible. The cu rrent 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 c onstantly developing new po ssibilities 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 th e competitiveness of EU enterprises 
engaged in research.  
 
EN 23   EN 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 an imals 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 de rived 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 di seases, such as FM D. The derogations 
have been put in place in order to avoid the risk of spreading diseases or in 
view of the lack of dispos al capacity for a large number of animals which die. 
 While under the respective contingency pl ans efforts are necessary to ensure 
sufficient capacity for the rendering of dead animals in the context of disease 
control measures, the available renderi ng or incinerator capacity within a 
region or country could quickly be ov erwhelmed and become a limiting factor 
in the control of a disease, as obser ved 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 no t 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 24   EN During the fires in Galicia (Spain) in 2006, a total of 130 carcasses of 
animals had to be brought to the n earest 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 destructio n 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 exam ple, during the extreme heat in 
France in the summer of 2003, the am ount 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 probl em for all different operators and 
stakeholders involved cannot be predicted, from a general point of view, it can be 
stated that a lack of lega l clarity and conseq uential 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 th e rules on animal by-products needs to be 
improved and the rules need to be adap ted to possible progr ess 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 administrativ e burden would be imposed on EU industries and 
competent authorities as well as incons istencies 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 pub lic and animal health threats between 
Member States. 
 
EN 25   EN 3.4. Subsidiarity test  
The project refers to a revision of Regul ation 1774/2002 of the European Parliament 
and of the Council of 3 October 2002 layi ng down health rules concerning animal 
by-products not intended for human cons umption. Article 152 (2) of the Treaty 
provides a legal basis for the EU legisl ative measures on ABP as the primary 
objective of the Regulation is the protec tion of public and animal health. The 
subsidiarity principle applies insofar as th e 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 thr ough 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 ha d significant impact on intra-Community 
trade (such as market failures due to ch anges 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 fr om or exported to third countries are of a 
hygiene standard which is at least equi valent to the minimum hygiene standard 
applied in the Community. 
The current revision, even though not intendi ng to introduce any changes to the basic 
principles and structure of the way AB Ps are handled, has to be done at the 
Community level as only this way certain issu es can be effectively clarified, as well 
as sufficient flexibility to take account of emerging scie ntific 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 sour ce 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 a nd 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 appro ach, 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 le gislation. This may finally 
lead to the spread of dis ease and additional costs and lo sses for the farming, agro- 
and food-industries as well as for the Memb er States' and the Community’s budgets.  
                                                
 
4 Annex I to the Treaty establis hing the European Community, List referred to in Article 32 of the Treaty  
(list of products subject to the provisions governing CAP). 
 
EN 26   EN In addition, in the absence of a harmoni sed approach, measures restricting trade 
would be taken at national level, disruptin g 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 trad e restrictions as a consequence 
of animal health problems losing power to negotiate at international level. 
In light of these different elements, EU actio n 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 th e Commission's strategic objectives and better 
regulation principles
5, namely to improve and make the measures more effective and 
efficient, reducing unnecessary burden for opera tors as far as protection of public and 
animal health and food safety are not undermined.  
Therefore, the general objective  is to review the Regul ation on ABP in order to: 
• better ensure the safety of the food and feed chain and reinforce consumers' 
confidence 
• facilitate smooth functioni ng of the internal market, 
• increase competitiveness of the EU industries affected by this Regulation 
In order to achieve the ge neral 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 progre ss 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 from President Barroso in agreement with Vice-Pr esident Verheugen - 
"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 – Prop osal 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. 
 
EN 27   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 reinforc ing 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: adjusti ng 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, th e basic principles of Regulation (EC) 
No 1774/2002 have proven to deliver a ke y contribution toward s 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 identi fied and the different range of operators 
affected by each specific issue it was consider ed more adequate to tackle each issue 
separately. 
The "Do-nothing" approach has been cons idered for all options as well as the 
"legislative review" option. Alte rnatives 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 derogati ons or re-categoriza tion as they were 
considered not relevant due to the re asons 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 28   EN Option (c): Legislative review  
Two possible sub-options have been identified: 
– Exemption of finished products from th e Regulation: Finished products which 
have been processed to a certain ex tent could be exempted from the 
Regulation.  
– Introduction of a legal basis for the dete rmination of the end of the ABP life 
cycle.  Reduction of controls to products manufactured on ABP basis when 
technical and scientific c onsiderations allow concl uding 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 hunt ers 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 mu st be subjected to the 
controls of the Regulation.  
• Guidance: 
 Guidance drawn up by the Commission, as  appropriate follo wing scientific 
advice and/ or consultati on with the authorities res ponsible for enforcement in 
Member States, could be produced to gi ve orientation when establishments 
obtaining/processing ABP from wild an imals 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 29   EN 5.2. Policy issue 2 - Categorising new products 
Option (a): Do-nothing  
Option (b): Alternatives to legislative tools  
Alternatives to the pure regulat ory approach have been considered to be not relevant 
as the issue relates to the st rict categorization of the cu rrent 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 orde r to facilitate their use.  
5.3. Policy issue 3-Clarifying the appr ovals / 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 tool s 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 ma intain certain require ments 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 derogati ons 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 carca ses 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 30   EN 6. ANALYSIS  OF IMPACTS 
6.1. GENERAL REMARKS 
This Impact Assessment combines quantitati ve and qualitative approaches to ensure 
that adequate consideration is given to a br oad range of direct and indirect as well as 
social, environmental and economic impacts.  
The quantitative analysis is based on the re sults of the consulta tion, including data 
supplied by Member States competent au thorities, third c ountries competent 
authorities and industries and ot her stakeholders affected.  
Consultation on administrative cost s. Data limitations and difficulties 
encountered 
The stakeholder consultation carried out  by DG SANCO delivered only limited 
information on financial impacts. Gene rally stakeholders (both industry and 
competent authorities) claimed that estima tion was very difficult or even impossible 
for them for different reasons mentioned be low (not all of these are applicable to 
every submission). Based on these data  limitations and according to the 
proportionality principle, the assessment of the options has not been carried out using 
the Standard Cost Model. Consequentl y, in order to quantify the impacts, 
calculations for concrete opti ons have been based on assumptions where appropriate.  
As covering quantitative impacts on all indus tries 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 Regulati on 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 accord ing 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 so me estimation of overall administrative 
costs imposed on them by curr ent Regulation it is difficult for them to assess 
how an eventual change of legislation w ould 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 31   EN • As it was possible not to provide certa in information in the questionnaire, 
many stakeholders provided only partial data. 
• Some of the industrial sectors aff ected by this Regulation are mainly 
dominated by SME. In most cases thes e companies do not dispose of precise 
calculations about costs of these options. 
• There are environmental issu es related to the use or disposal of ABP. Although 
this proposal will not introduce cha nges or requirements on environmental 
conditions for the use, processing or dispos al 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 importa nce. It has to be noted that the 
environmental issues related to ABP ar e 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 co sts vary a lot between Member States 
and even between regions as explained later. 
• As the scope of the Regulation leaves room for interpreta tion, administrative 
costs of this proposal vary between sect ors 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 a nd inspection vary signifi cantly 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 a nd discussion of th e 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 c ontrol actions that facilitate the 
submission of data, whereas others supplie d 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 sta ff salaries, were not being broken down and therefore 
not included in the estimate on a proportionate basis.  
 
EN 32   EN • As a further consequence of the difficul ties referred to above, it is also very 
difficult to assess whether differences in interpretation actually have a significant effect on the pr oper functioning of the internal market. A Member 
State may for instance interpret the ab sence of provisions on suspension of 
approvals in case of shortcomings in inte rmediate 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 custom ers. However, it is actually more 
probable that the overall ma jority of competent authorities would take a 
different view and intervene based on ot her provisions of administrative law, 
thus interpreting the express referenc es 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 pot ential effects of the various options on 
employment. On the one hand, many sect ors operate with technical equipment 
which does not always require a large amount of manpower to  be operational. 
On the other hand, changes to the possibl e 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 mate rial 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 exte nt with these requirements. This could 
lead to public and/or animal health ri sks and different levels of protection 
throughout the Community.  
 
EN 33   EN  Economic impacts 
 Sectors complying with the requirements  face certain compliance costs, e.g. for 
the setting up of measures  guaranteeing tracea bility 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 Regulat ion could be a decisive factor for 
economic operators, with potential eff ects on the distribution of economic 
development and employment between  different regions. The box below 
provides an example of how been unde r the scope of the ABP Regulation can 
affect a certain industry. While it is clea r that some industries need to be under 
the scope of the ABP Regulation, to prev ent 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 supplie rs 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 lines by 
manufacturers, 
• relocation by EU manuf acturers outside the EU, 
• loss of employment (estimated up to 5000 employees in Germany) 
 
 
EN 34   EN  Option (b): Co-regulation  
 Social Impacts 
 Co-regulation would not re sult either in resolving the legal uncertainties 
regarding the appli cation of the Regulation along the processing chain of ABP 
due to the wide-range natu re of the issue and indus tries involved. It also 
implies difficulties for the Commission to  establish a consensus between all the 
affected operators. This means that a ha rmonised 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 betw een Member States and also between 
industries and plants depending on  the type, category, quantity and 
variety of ABP they use (e.g: a sing le pharmaceutical plant can use more 
than 80 types of ABP while a leat her 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 becau se they are particularly interested 
in the proposal, as it will have a ma jor impact on them and also because 
they are larger and more technolo gy-based companies than in other 
industrial sectors, so for them to assess the costs is not so difficult. 
 
EN 35   EN • In addition, ABP requirements overlap  with other requirements (sector 
rules, Good Manufacturing Practices, e nvironmental legislation, etc.) and 
often it is difficult to estimate whethe r 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 despit e 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 interpretati ons. It will also 
provide for a comparable competitive framework for the operators concerned and result in a stable framework fo r investments and the creation of new 
employment.  
 This option will have a positive imp act on EU companies having premises, 
importing and commercialising their products  in several/all Member States as 
they will affect the same requireme nts for all their processing plants.  
 The main economic advantages of this option for the industries affected will be 
the decrease in compliance costs relate d 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 im pacts also in third country enterprises 
exporting highly processed products if th ey 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 identificati on 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 36   EN  An example of this situation would be the fat processing and rendering 
industry. As illustrated in the graph belo w 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 (indus tries producing these ABP) but negative 
for the rest of the industries using th ese products for other purposes. At this 
stage however it is very difficult to ma ke forecast about this as ABP compete 
with other raw materials used for simila r purposes in the ma rket, nevertheless 
even though price of some components mi ght rise (while others will fall), on 
average the price of final pr oducts are likely to decrease. 
 Graph 1 Evolution between 2005 and 2006. Main outlets of  animal fats (Source 
EFPRA) 
 
728734
652651
188218693701
33191173
8260
0100200300400500600700800
Energy Oleochimical
& soapPet food Feed Chimist
industryFood Others2005 2006
 
Social impacts 
This option will furthermore allow operators  and control authorities to focus their 
resources on the control of those risks wh ich 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 fo r 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 woul d have direct environmental impacts , since 
changes to environmental requirements a pplicable to the disposal, handling and 
processing of ABP are not being cons idered for this policy issue.  
 
EN 37   EN Indirect environmental impacts  are difficult to assess due to the different uses of 
ABP and the variety of raw materials comp eting with them in the market for the 
same uses.  
For example, on one hand, as illustrated in gr aph 1, the largest share of fats outlets in 
the EU are used for renewable energy production (biomass incineration, tallow 
combustion, bio-diesel and biogas) helpi ng to save fossil en ergy 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 sufficien tly available on the market. Production of 
palm oil is done in virgin areas of tropica l 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 rela ted to the use of ABP. 
Impacts on administrative burden: 
Option (a) and Option (b) woul d not imply a change in the administrative burden, 
however might result in generati on of other compliance costs. 
Option (c) will have as a consequence reduction on administrative burden for 
operators and competent authorities of Me mber States. Approximately 75 % of the 
Competent authorities and affected indus tries assessed that option (c) will imply 
decrease on administrative costs fo r them, though the exact amount was not 
calculated due to the difficulties al ready explained unde r this chapter. 
Reduction on administrative burden for operators:
 
Under option (c), premises using only ABP ex empted would be completely out of the 
scope of the ABP Regulation while thos e premises using any ABP included under 
the scope would have to appl y all the requirements and wo uld 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 comp etent authorities to demonstrate that 
they comply with the requiremen ts set out in the Regulation  
• Issuing the required documentation for transportation of ABP. Reduction on 
compliance costs would arise from the f act 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 38   EN The following example illustrates how the reduction of administrative and 
compliance cots depends on which categor y 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 de gree of processing 
into the EU are divided as follows (source INTERLAINE): 
EU-25 WOOL IMPORTS SHARES
0%20%40%60%80%100%
2000  2001  2002  2003  2004  2005  2006YearsPercentages
 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 c ontains 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 considerab le percentage (currently over 50 % 
and increasing) of the annual imported volume could be classified as 
being no longer ABP. This represen ts over 100.000 tons of wool every 
year. 
Reduction on administrative burden for operators further processing 
such wool will arise from the fact th at 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 39   EN The following is an example of complian ce and administrative costs faced by a 
biochemical plant using ABP. To calculat e the reduction of cost s 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 assump tions 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 pro posal potentially affe cts 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 Art 18 190 150-200 Once, prior to 
production or 
handling 1 28500-
38000 
(once) 
Laboratory 
testing Sample, 
perform and 
document lab 
test  Art 25 190 32/month continuous 120 72960 
Labelling Label must be 
attached to 
products Annex II 
Chapter 1 190 580/year continuous 300 110200 
Materials 
must be 
imported with 
proper 
documentation Apply for 
import 
certificates, 
permits Art 29 190 210 continuous 200/year 39900 
TOTAL       251560-
261060 
 
None of these tasks would have to be ca rried 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 pr ior to production 28.50 0-38.500 € and annually 
223.060 €  
 
EN 40   EN Although the exact number of affected prem ises 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 modi fication, these costs are prob ably overestim ated, as not 
all the industries face such a high co mpliance and administrative costs.  
Reduction of administrative bur den for competent authorities:
 
The reduction of administrative burden for co mpetent authorities arises from the fact 
that they will not have to approve the es tablishments and carry out inspections to 
check whether the requirements of the AP B 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 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 
(€) 
Approve 
entity Evaluate the 
submitted 
request and 
documentation Art 18 60 10-30 Once, prior to 
production or 
handling 1 600-
1800 
Official 
controls Perform and 
document 
official controls Art 26 60 5-15 1-2 1-2 300-
900 
List of 
plants Keep updated 
and transmit list 
of approved 
plants (for all) Art 26 60 30 Not defined Not 
defined 1800 
TOTAL       2700-
4500 
None of these tasks would have to be car ried out for by competent authorities for 
plants using only exempted ABP, and so the reduction of costs would be 
approximately once 600-1800 €  and annually 300-900 € / concerning each 
establishment. Difference in the cost associated with managing the list of 
establishments would be negligible. 
 
EN 41   EN Based on the assumptions explained in th e calculation of costs for operators, the 
reduction for competent authorities woul d approximately be 23.22-38.7 million € if 
all the plants would be a ffected 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 legisl ative review sub-options:  
(1) Exemption of processed finish ed products from the Regulation 
 Due to the wide range of materials c overed by the Regulation, this sub-option 
would require to determine under which technical conditions products fall 
outside the rules. These technical cond itions 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 th at certain risks to public health are 
not being eliminated by the processi ng standards imposed, it would not be 
possible to impose further treatment step s for the elimination of such risks. 
 
(2) Introduction of a legal bas is for the determination of  the end of the ABP life 
cycle. 
 This sub-option would allow intr oducing rules which would be more 
proportionate to the risks arising from  specific products maintaining a high 
level of protection of public a nd animal health across the EU.  
 By providing for a legal basis for th e adoption of technical standards via 
implementing rules, this option would a llow to react to progress in science, 
such as new assessments carried out by the European Food Safety Authority or 
to newly emerging risks.  
 
EN 42   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 applicati ons 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) - Cove rage of wild animals 
 Option (a): Do-nothing  
 Social impacts (public and animal health) : Doing nothing would leave 
potential risks from animal by-products ar ising in establishments handling wild 
game meat for human consumption uncont rolled. Wild animals are a potential 
source of animal diseases  including zoonoses (e.g.: avian influenza) and thus 
ABP products should be adequately cont rolled in order to prevent negative 
impacts for public, animal health and also the economy. Thus, an adequate 
level of protection against public a nd 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 an imal diseases could be introduced 
into the EU which could have an e normous 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 dur ing 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 43   EN Community financial contribution during epidemic a Foot-and-Mouth 
Disease epidemic – 2001 
Overall, for the 2001 crisis alone the tota l expenditure declared by all affected 
Member States (France, Ireland, Neth erlands, and the UK) for compensation 
for slaughter and destruction of animal s as well as disinfecting of farms and 
equipment was about 2,693.4 million €, of  which 1,616 million € was claimed 
for Community reimbursement. Followi ng 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 implemente d 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 ani mal 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 eff ective self-regulation framework. In 
addition, rules adopted by the sect ors concerned would not bind the 
control authorities and could lead  to checks being performed to a 
different extent throughout Member St ates. As a consequence, risks for 
public and animal health posed by AB P from wild animals will continue 
to be uncontrolled as well as the in consistencies with the Food Hygiene 
legislation and the competitive situation of operators could vary across the Community.  
• Co-regulation  between the sectors concerne d, in particular hunters and 
game meat processors, and the legisl ators, could introduce clear rules 
which would ensure sufficient prot ection 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 ri sks 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 44   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 an imals 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 establishm ents within the Community collect and 
dispose of ABP arising duri ng their operations in a safe way, in line with the 
principles of the current food safety a nd 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 co sts 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 risk s arising from the fact that ABP from 
wild animals are not covered under the Re gulation. 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 envi ronmental 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, uncont rolled disposal of ABP woul d 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 al so 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, insp ection) and this legislativ e 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 empl oyment. This also implies that option (c) 
will not imply significant administrative costs for the Competent Authorities as they are already carrying out these requiremen ts under the Food Hygiene legislation.  
Option (c) could also have impacts for so me third country establishments exporting 
products. Though they would face some add itional compliance costs the advantage 
for them would be facing the same require ments to export to any EU Member State. 
 
EN 45   EN The extension will also not result in adverse effects fo r 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 ther e 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-adequa te 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 regulat ory 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 modi fication 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 us es, whether for feedi ng purposes or for 
technical applications, may be determin ed on a case-by-case basis. This would 
ensure a high level of protectio n 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 fo r animal and public health. 
Allowing the technical use of  certain ABP would increase market chances for many 
companies which would then be able to pr ocess such ABP into safe and high quality 
finished products, resulti ng in increased competitiv eness and reduced operating 
costs. Additionally, the quantity of ABP whic h have to be disposed by using high 
cost rendering processes will be reduced. 
 
EN 46   EN Environmental impacts of all options: 
No environmental impacts are fo reseen 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 mate rial 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 thes e ABP even if they fall into a different 
category.  
The main economic impact for the industrie s 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 cost s 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 im portance of the use of ABP for certain 
industrial sectors.  
Under the current Regulation, blood from an imals other than ruminants which have 
been declared fit for slaughter is categor ised 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 ex cluded 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. Ther efore, if it were possible to reclassify 
blood from such calves under the subcateg ory 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 imp act of such re -categorization. 
 
 
EN 47   EN 6.2.3.  Policy issue 3 Clarifying the approv als / 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 interactio n of different EU legislation. 
Option (c): Legislative review : To remove duplicated approvals and rely on the 
provisions already introduced by other Co mmunity 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 duplica tion 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 re quiring 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 admini strative burden (such as costs for the 
submission of application) from operators of establishments manufacturing products 
under other Community legislat ion, without lowering the le vel of protection against 
human and animal health risk. In that way, the competitiveness of such operators would be enhanced, with a potentially beneficial e ffect on the creation of 
employment.  
Furthermore, it would reduce administra tive 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 th e ABP Regulation (in 
many cases veterinary authorities) could create gaps in ensuring traceability of ABP and prevent the authorities fr om 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 48   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 provision s of the Community legislation on 
cosmetics which determine the starting mate rial to be used for the production of 
cosmetics can be considered as sufficien t 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 suffi ciently process the material used to 
eliminate public and animal health risk s. Similarly, if it was to appear that 
consignments of animal fats were on the ma rket 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 administrativ e 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 di saggregated data on each type of premises 
authorised by Member States. It has to  be noted, that th ese assumptions and 
calculations are based on data submitted by a single company and only focused on the number of companies active in the bi ochemical sector while this proposal 
potentially affects a wide range of industries.  
 
EN 49   EN Table 4. An estimate of current administra tive 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 Art 18 190 150-200 Once, prior to 
production or 
handling 1 28500-
38000 
(once) 
Laboratory 
testing Sample, 
perform and 
document lab 
test  Art 25 190 32/month continuous 120 72960 
Labelling Label must be 
attached to 
products Annex II 
Chapter 1 190 580/year continuous 300 110200 
Materials 
must be 
imported with 
proper 
documentation Apply for 
import 
certificates, 
permits Art 29 190 210 continuous 200/year 39900 
TOTAL       251560-
261060 
Table 5. An estimate of costs according to the proposal for the same company  
Information 
Obligation Required 
actions Regulatory 
Origin Average 
cost per 
hour (€) Hours 
spent on 
this task Frequency/Year Total 
number 
of 
activities Total 
cost 
(€)/year 
Labelling Label must be 
attached to 
products 
during 
transport Annex II 
Chapter 1 190 580/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 50   EN The impact of change could therefore repr esent 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 materi al for production could still further benefit 
from provisions determining the end of  ABP life-cycle and thereby reduce 
administrative costs even furthe r as explained under chapter 6.3.3. 
The number of affected plants  is estimated in the in-v itro-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 pr oduction establishments. 
If we assume that costs are similar across the sector and that this companies have 
only one establishment each, the approximate d number of companies affected by the 
proposal would be 8600 and the approximate d 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, thes e costs are probably ove restimated, as not 
all the industries face such a high co mpliance and administrative costs. 
The reduction of administrative burden for co mpetent authorities arises from the fact 
that they will not have to approve the es tablishments and carry out inspections to 
check whether the requirements of the AP B 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 approva l of a biochemical pl ant is the following. 
Similar consideration on the difficulties to  calculate the overal l costs explained for 
the industries apply to th e administrative costs fo r competent authorities: 
 
EN 51   EN Table 6. An estimate of the current administra tive 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 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 
(€) 
Approve 
entity Evaluate the 
submitted 
request and 
documentation Art 18 60 10-30 Once, prior to 
production or 
handling 1 600-
1800 
Official 
controls Perform and 
document 
official controls Art 26 60 5-15 1-2 1-2 300-
900 
List of 
plants Keep updated 
and transmit list 
of approved 
plants Art 26 60 30 Not defined Not 
defined 1800 
Total       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 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 
(€) 
Official 
controls Perform and 
document 
official controls Art 26 60 5-15 1-2 1-2 300-
900 
List of 
plants Keep updated 
and transmit list 
of approved 
plants Art 26 60 30 Not defined Not 
defined 1800 
TOTAL       2200-
2700 
 
 
EN 52   EN According to the proposal only the costs associ ated with the official controls and the 
management of list of regist ered plants would still occu r due to the obligation to 
register and control these establishments  by the veterinary authority. Depending on 
later implementing provisions and/or prac tical 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 reducti on 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 co mpetent authorities 
the approximate reduction of the costs for th e competent authoritie s of this proposal 
would be 4.3 million € to 15.48 million €. 
However, as it has been noted before, th ese 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 illustra tes the average input of hours needed and 
the related average costs incurred by region al administrations in Germany (for an 
average establishment, costs indicated do not include paymen ts for external advice).  
The efforts necessary for granting approva ls and carrying out inspections vary 
between different types of plants or estab lishments. 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 a nd the related average costs incurred by 
regional administrations in Germany (s ource: 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 35 2000 5 280 
Bavaria 10 550 12 720 
Berlin 16 770 3 160 
Bremen 10 600 2 130 
Hessen 4 300 10 700 
Lower Saxony 10 700 5 350 
Rhineland-
Palatinate 11 600 15 870 
Saxony-Anhalt 5 250 2 100 
 
 
EN 53   EN Comparing the costs assessed by competent au thorities for authorising plants and for 
carrying out inspections it was found that normally the author isation costs are 
approximately three times the inspecti on costs. Removing the duplication of 
approvals will allow competent authorities to allocate more financial resources on 
inspections, and as a consequence preven t 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 es tablishments are being considered.  
6.2.4.  Policy issue 4 - Clarif ying 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 importa tion of ABP of Categories 1 and 2 for research purposes 
would continue not to be allowed. 
With regard to burial and bur ning of animal carcasses, the current difficulties arising 
in the case of natural disasters or wher e access to dead animals is practically 
impossible would remain. Consequently, the disproportional situation between 
requirements and risks would remain and ev en 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 id entified since derogations to the legal 
requirements are exemptions from the st rict rules of the requirements of the 
Regulation which may only be used under sp ecific 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 carca ses 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 54   EN Social Impacts 
To extend derogations to allow the imports  of ABP for research  purposes would not 
have any negative impacts on public and anim al health as the sa le of these products 
is restricted to professional end us ers only working in academic, medical, 
governmental and health care instituti ons. 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 majo r importance to a large number of companies 
producing vaccines or medicines to cure di sease. 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 th e Community and worldwide. 
Vaccine production is a small but critical  part of the pharmaceutical marketplace. 
Europe is a major supplier of these material s to the rest of the world. Continuation of 
the difficult situation with regard to rese arch possibilities due to import restrictions 
of materials needed and reduction in v accine 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 bur ial and burning of animal carcasses 
could lead to a better acceptance of Co mmunity 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 co ntribute to the competitiveness of 
research and subsequent innova tions 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 al so 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 55   EN Research is an essential part for the impr ovement 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. Mo re 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 po ssible. Currently, more than 60 companies 
are active in this area in Europe . 
The situation is similar for the developmen t 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 tota l 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 ta ke more risk-proportionate measures under exceptional 
circumstances where the normal disposal sy stem 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 a nd thus avoiding delays, it w ould also serve to contain 
disease-risks arising from the decompos ition of animals for other animals and 
humans.  
Environmental impacts 
No negative effects on the environment ar e envisaged by exte nding the derogation 
possibilities to importation of Category 1 and 2 ABP for research purposes.  
Negative effects on the environment of th is option arising from extended burial and 
burning possibilities would ha ve to be prevented by comp lementary measures which 
ensure the protection of ai r, soil and ground water and pr evious studies of their 
situation and characteristics. Such measures could follow the rules applicable to disposal under the curren t disposal derogations. 
Impacts on administrative burden 
Option (c) will lead to some additional bur den 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 bur ning of animal carcasses, less compliance costs will 
result from the fact that there transpor t 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 administra tions when applying these derogations.  
 
EN 56   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. 
Option3-Legislative Review  Options 
Type of  
impacts Option 1-Do 
nothing Option 2-
Coregulation 
(1) (2) 
Social - [different level 
of protection 
against risks] - [different level 
of protection 
against risks] + [harmonised 
level pf 
protection 
but not 
flexible] ++ [harmonised 
level pf 
protection and 
flexible] 
Economic  - [distortion of 
competition] 
- [limited use of 
ABP] - [distortion of 
competition] 
- [limited use of 
ABP] + [prevent 
distortion of 
competition] 
+ [more use of 
ABP] + [prevent 
distortion of 
competition] 
+ [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 de termination 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, de crease of compliance costs for operators 
while ensuring legal certainty and maintain ing a high level prot ection of public and 
animal health across the Community. 
 
EN 57   EN 7.1.2.  Coverage of wild animals 
 Options 
Type of  
impacts Option A 
Do nothing Option B 
Alternatives to 
Regulatory tools Option C 
Legislative Review 
Social - (continuation of 
increased risk of 
introducing epizootic 
disease into free areas 
of the Community 
endangering public 
and/ or animal health) = - - (same as Option A, 
however, with 
slightly better 
control possibilities.) + (decreased risk for 
public and human 
health) 
Economic  - (continuation of 
increased risks of 
disease introduction 
and potential 
economic 
consequences due to 
the disease itself and 
to control measures.)  = - - (same as Option A, 
however, with 
slightly better 
control possibilities.) - / + (Negative impacts on 
some establishments 
due to necessity to 
comply with ABP 
rules. Positive 
impacts on 
commercialising 
possibilities) 
Environmental - (depending on a 
possibly introduced 
disease and measures 
to be taken, negative 
environmental 
impacts could occur.) - (same as Option A, 
however, with 
slightly better 
control possibilities.) + (Better protection of 
health of wildlife and 
of the soil/ water due 
to prohibition of 
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 th e 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 58   EN 7.2. Policy issue 2- Categorising new products 
 Options 
Type of  
impacts Option A 
Do nothing Option B 
Alternatives to 
Regulatory tools Option C 
Legislative Review 
Social - (Possibly negative 
impacts due to 
reduced valorisation 
possibilities and 
consequently 
employment) Not relevant (the 
Regulation does not leave 
room for 
guidelines/interpretations) + (Possibly increased 
employment 
possibilities)  
Economic  - (Maintaining the 
situation of not being 
able to valorise 
certain ABP) Not relevant (the 
Regulation does not leave 
room for 
guidelines/interpretations)  + (Improved 
possibilities to 
valorise ABP, 
increased market 
chances, 
competitiveness and 
decreased operating 
costs.)  
Environmental =  Not relevant (the 
Regulation does not leave 
room for 
guidelines/interpretations)   + (Better valorisation 
and recycling 
possibilities of ABP 
while reduced 
quantities to be 
disposed of)  
 
The preferred option 
In light of the conclusions of the analys is of impacts the pref erred 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 59   EN 7.3. Policy issue 3. - Clarifying the a pprovals/registration and controls 
 Options 
Type of  
impacts Option A 
Do nothing Option B 
Alternatives to 
Regulatory tools Option C 
Legislative Review 
Social - (continuing with the 
administrative burden 
imposed to the 
operators and 
competent authorities) (Not possible due to legal 
requirements) + (will remove 
administrative burden 
for operators and 
competent 
authorities) 
Economic  - (continuing with the 
administrative burden 
imposed to the 
operators and 
competent authorities) (Not possible due to legal 
requirements) + (will remove 
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 se ction, the preferred option would be 
option (c). 
 
EN 60   EN 7.4. Policy issue 3-Clarifying the derogations 
 Options 
Type of  
impacts Option A 
Do nothing Option B 
Alternatives to 
Regulatory tools Option C 
Legislative Review 
Social - (continuation of 
possibilities for 
endangering human 
health)  = (Not possible due to 
legal requirements) + (probably 
improvement of 
human and animal 
health following 
results of research. 
Improvement of risk-
proportionate measures 
and protection of 
public health)  
Economic  - (acceleration of 
impacts from reduced 
research possibilities 
on basic and on 
applied research in 
universities and 
companies) = (Not possible due to 
legal requirements) + (better possibilities for 
research, therefore 
investments and more 
employment; probably 
improvement of 
human and animal 
health, therefore 
reduced health care 
costs 
Environmental ± ± + (or ± if adequate 
complementary 
protection measures 
are adopted.)  
 
The preferred option 
According to the conclusions of the anal ysis 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 Regul ation. The difficulties identified have 
been addressed where necessary and where possible by way of legislative measures 
taken by the Commission following Comito logy procedures as well as by non-
legislative tools. A list of these m easures and tools is given in Annex 6 . Some issues, 
however, could not be solved th is way since they relate to rules fixed by the Articles 
of the Regulations, which can only be amended by co-decision procedures.  
 
EN 61   EN 8. MONITORING  AND  EVALUATION 
Monitoring and evaluating the economic, so cial and environmental effects of EU 
policies is a core element ac companying the political process. In the area of public 
and animal health, monitoring and assessing the implementation and effectiveness of 
action taken are shared between th e Community and Member States.  
8.1. Community 
In accordance with Article 211 of the EC Treat y, it is the duty of the Commission to 
ensure proper application of Community legi slation. In the field of public and animal 
health, the Commission services, in partic ular the Food and Vete rinary Office (FVO) 
collect information which serves to evalua te to which extent measures taken have 
been implemented. The information also he lps to identify to which extent the 
measures taken at Community level eff ectively 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 in spections can be envisaged as a way of 
follow-up in the near to long term. 
Furthermore, the Commission collects information regarding the proper 
implementation of the rules and possible ne w risks by way of its rapid alert systems 
(in particular the RAPEX system for cons umer products and the RASSF system for 
food and feed). 
In the animal health area, the Community  has in place a well functioning system to 
gather information on the animal health s ituation in the Community, with particular 
reference to major animal diseases. 
8.2. Member States 
Member States are obliged to ensure pr oper 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 th at Member States shall report to the 
Commission and to other Member States on the way they have ma ke use of certain 
derogations and provide information on nati onal measures taken which are related to 
the Regulation. 
 
EN 62   EN 8.3. Communication and Consulta tion 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 cons umers associations. The Commission will 
continue to collect views fr om 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 po ssibility 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 wi de range of different stakeholders and 
cover the aspects identified as requiring m odifications 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. 
 
EN 63   EN ANNEX I-A  
LIST OF THE STAKEHOLDERS CONSULTED ON THE IMPACT ASSESSMENT  
I. Stakeholders consulted through the Advisory Group  
1 AIPCE-CEP – Association des Industr ies do Poisson de l'U.E. (fish) 
2 AVEC – Poultry processors and pou ltry trade association (poultry) 
3 BEUC – Bureau européen de s Consommateurs (consumers)  
4 CEFIC – European Chemical I ndustry Council (chemical industry) 
5 CELCAA – European Liaison Committee for the Agri-Food Trade (agric. 
Products trade) 
6 CIAA – Confederation of the food and drink industries of the EU (agric. 
product industry) 
7 CLITRAVI – Centre de Liason des Indus tries Transformatrices de Viandes de 
L'U.E. (meat processors) 
8 COPA-COGECA – (farmers)  
Committee of Professional Agricultural Or ganisations 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 Asso ciation (renderers) 
12 EMRA – European Modern Restaurant  Association (modern restaurants) 
13 EUROCOMMERCE – Retail wholesale a nd 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 Fa bricants d'Aliments Composés (feed) 
17 FESASS – Féderation Européenne pour  la Santé Animale et la Securité 
Sanitaire (animal health) 
18 FVE – Federation of Veterinari ans of Europe (veterinarians) 
 
EN 64   EN 19 HOTREC – Trade association of hotels, restaurants and cafes in the European 
Union 
20 IFAH – International Federation for Anim al Health (animal health industry) 
21 IFOAM – International Fe deration of Organic Agricu lture Movements (organic 
agriculture) 
22 UAPME – SME – Union Européenne de l' Artisanat et des petites et moyennes 
entreprises 
23 UECBV – Union Européenne du Comme rce 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 (a s coordinator for 
other European organisations) 
27 CIBC – Confédération Intern ationale de la Boucherie et de la Charcuterie 
(butchers) 
28 CCTA – European collag en industry (collagen) 
29 COTANCE – Confederation of National A ssociations of Tanners and Dressers 
of the European Commun ity (leather industry) 
30 DEMETER-International e.V. – Organi sation for products of certified 
biodynamic production (biodynamic producers) 
31 EAPA – European Animal Protein Association (prote in processors) 
32 EBB – European Biodiesel Bo ard (biodiesel producers) 
33 ECN – European Compost Network (compost producers) 34 EDFA – European Down and Feather Association (feathers) 
35 EDMA – European Diagnos tic Manufacturers Associa tion (in-vitro diagnostics 
industry) 
36 EuLA – European Lime Association (lime)  
37 FACE – Federation of Associations fo r Hunting & Conservation of the E.U. 
(hunters) 
 
EN 65   EN 38 FEAD – European Federation of Wa ste Management and Environmental 
Services (waste management) 
39 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 Dünge mittel (organic fertilisers) 
43 INTERLAINE – Umbrella organization for European associations of raw 
materials suppliers, processors, spinne rs and weavers of wool and wool 
textiles. 
 
EN 66   EN 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 re lated to Regulation (EC) No 1774/2002 have been raised and 
further discussed (sometimes alongside with is sues which may have been considered by way 
of comitology amendments). The following list gives a non-conclusive overview over these 
meetings: 
18 November 2002 ca. 45 internat ional industry organisations: 
explanation of the ABP Regulation and discussion of specific aspects 
18 December 2002 GME: importation of bones derived from 
animals treated with growth hormones and/ or containing specified risk materials (SRM) for gelatine production; processing conditions for dicalcium phosphate (by-product from gelatine production) 
17 January 2003 FEFAC: connecti on of the ABP Regulation to 
the feed ban 
12 February 2003 APAG: importation of tallow for 
pharmaceutical purposes; HACCP in oleochemical plants; separation requirement for Category 2 and 3 ABP 
20 February 2002 Medical devices industry: correlation 
between legislation fr om DG ENTR and ABP 
rules 
5 March 2003 Photographic industry (Kodak): Importation 
and use of gelatine produced from animals treated with growth hormones for photographic purposes 
25 March 2003 WR²: Discussion of alkali hydrolysis as an 
alternative treatment method 
28 March 2003 European dairy association, International 
butchers association, GME, APAG, UECBV; Argentina and other or ganisations and third 
countries (in total 160 participants): clarification of ABP issues 
 
EN 67   EN 8 April 2003 Milk industry : Transport of former 
foodstuffs; use of contaminated milk (Category 2) for petfood production 
1 July 2003 Photographic industry (Fuji, Kodak): 
Importation and use of gelatine produced from animals treated with growth hormones for photographic purposes 
4 July 2003 EFPRA: Processing conditions for production 
of hydrolysed proteins from feather meal 
23 July 2003 WR² (alkali hydrol ysis industry): Discussion 
of alkali hydrolysis as an alternative treatment method 
28 July 2003 Cotance: applic ation of food, feed and ABP 
rules on handling and treating of hides and skins 
30 July 2003 SARIA (rendering industry): Discussion of 
an alternative treatm ent of tallow for 
production of biodiesel 
2 September 2003  Photographic industry (Kodak): Importation 
and use of gelatine produced from animals treated with growth hormones for photographic purposes 
7 October 2003 GME: import requirements for gelatine 
13 October 2003 Industry producing adhesives: Possibilities to 
mark raw materials for adhesive production, 
in particular as regards milk products 
17 October 2003 APAG: use of ta llow for biofuel production; 
possibilities for marking of tallow; labelling requirements for tallow tanks; import certificates for fat derivatives 
6 November 2003 EFPRA: Discussion of combustion of tallow 
in a thermal boiler as an alternative treatment method; marking of ABP 
 
EN 68   EN 25 November 2003 Milk industry: Use of milk for feeding 
purposes; Applicability of marking requirements for milk products (casein) derived from animals treated with growth hormones and intended for petfood production  
9 January 2004 EFPRA: Marking of ABP; use of hydrolysed 
feather meal 
22-23 Jan. 2004 FEDIAF: use of blood products (plasma) 19 March 2004 Demeter (organic industry): possibilities to 
use Category 2 and 3 materials for production of their products 
30 May 2005 UECBV (overlap with environmental 
legislation) 
26 August 2005 Fur trade industry (import requirements for 
importation of hides and skins from fur animals) 
24 October 2005 SITFA (feather industry): requirements on 
importation and transportation of feathers 
22 November 2005 UECBV (clarificati on of certain terms, e. g. 
"fertilisers" or "ta llow" , under ABP and 
under waste legislation; use of residues from biogas and composting; marking of ABP; need to simplify the ABP rules) 
29 November 2005 APAG (Present ation and discussion of a 
study on the effect of oleochemical treatment 
of tallow on prion activity) 
13 January 2006 Cotance (use of hides and skins from "cohort 
animals") 
23 January 2006 FEDIAF (labelling of processed petfood; 
commercial document for ready-to-sell products; approval of pl ants only processing 
pre-treated ABP) 
24 February 2006 Photographic industry (use of gelatine by this 
industry) 
 
EN 69   EN 16 March 2006 EULA (Lime Asso ciation): Discussion of an 
application for a method allowing production of lime from ABP 
20 March 2006 Working Group of the Advisory Group on the 
Food Chain, Animal and Plant Health (Commission presentation of the intended scope of the review exercise - Present:
 Advisory Group Members with an 
interest in ABP, additional stakeholders concerned) 
22 June 2006 EULA (treatment requirements for the 
production of lime; approval requirements for lime producing plants) 
28 June 2006 EFPRA (overlap with environmental 
legislation) 
29 June 2006 European Dairy A ssociation (overlap with 
food and feed hygiene legislation, duplication of approvals under such  legislation and ABP 
rules) 
27 July 2006 FEDIAF, EFPRA, EAPA (treatment 
requirements for porcine blood; differentiation between blood meal and blood products) 
10 August 2006 EDMA (interlink with ENTR legislation 
regarding the manufacture of products for 
diagnostic purposes) 
5 September 2006 EDMA (follow-up meeting of 10/08/2006) 7 September 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) 
20 September 2006 UECBV, E FPRA, FEFAC, Cotance 
(classification of rumina nt blood; materials to 
be used in Category 3 processing plants; requirements for dairy products in ABP and in fed and food legislation; etc.) 
20 September 2006 Conference on animal by-products, as part of 
the "Better Training fo r Safer Food" initiative 
(provided an opportunity to collect views of Member States, third countries and certain industry sectors – UECBV (slaughterhouses), 
 
EN 70   EN EFPRA (renderers), COTANCE – leather, 
FEFAC – animal feed) 
21 September 2006 COTANCE (request for clarifications with 
respect to classificati on of hides and skins) 
9 October 2006 VOD (import and labelling conditions for 
hornmeal, bonemeal and bloodmeal for use in fertilisers) 
19 October 2006 EFPRA (see 28 June 2006) 25 October 2006 UECBV (simplifi cation of legislation, risk-
based approach for categorisation of animal by-products) 
9 November 2006 ISIA (concerns  about importation of serum 
and other products in particular from third countries treating animals with growth hormones) 
22 November 2006 Joint informal discussion with EFPRA, 
UECBV and COTANCE (basis: draft proposal) 
8 December 2006 Deutscher Bauernverband (German Farmers 
Association): Swill feeding; catering waste; use of ABP in composting and biogas production; manure handling; risks from sewage sludge 
22 February 2007 FACE (handling of pheasant chicks being 
reared and then released in the wild for 
hunting; handling of "damaged game") 
27 March 2007 MIV (possibilities to feed milk; 
categorisation of milk  containing prohibited 
substances; quality management) 
19 April 2007  ISIA (categoris ation of serum; impacts of 
Regulation (EC) No 2007/2006) 
23 April 2007  CWT (company producing hydrocarbon – 
oil): Discussion of an application for a method allowing production of industrial oil from ABP 
1 June 2007  FACE (questionnaire to the impact 
assessment) 
 
 
EN 71   EN ANNEX II  
SUMMARY OF CHRONOLOGY OF MAIN EXCHANGES WITH INTERNATIONAL PARTNERS LIKELY 
TO BE AFFECTED BY THE REVIEW  
Bilateral or multilateral meting have been he ld with the following third countries, during 
which specific aspects related to Regulation (E C) No 1774/2002 were being raised and further 
discussed (sometimes alongside with issues wh ich were considered by way of comitology 
amendments): 
8 November 2002 USA: Import certificates for gelatine 18 November 2002 Representatives of 63 third countries: 
explanation of the ABP Regulation and discussion of specific aspects 
19 November 2002 USA: marking of pet food; long list of issues, 
e. g; blood from rumina nts; applicability of 
the ABP Regulation on technical products; use of used cooking oils 
10 February 2003 Canada: long list of issues, e. g. 
categorisation of heads and feet from poultry; hydrolysed proteins for use in pet food; use of grieves derived from gelatine production 
12 February 2003 APAG: importation of tallow for 
pharmaceutical purposes; HACCP in oleochemical plants; separation requirement for Category 2 and 3 ABP 
19 February 2003 China: sourcing of materials, e. g. for lanolin 
production or for cosmetic products 
19 February 2003 USA: marking of  ABP; ban on international 
catering waste 
23 April 2003 USA: Importation of collagen produced from 
bovine hides for production of sausage casings  
15 September 2003 USA and photogr aphic industry: Discussion 
of possibilities to import gelatine derived from animals which have been treated with growth hormones for photographic purposes 
25 November 2003 Canada: Listing of establishments; request for 
certain import deroga tions from the ABP 
Regulation 
 
EN 72   EN 3-4 December 2003 USA: Transitional measures and derogations 
for importation of ABP, e. g. hides and skins and pet food 
10 December 2003 Canada: Certification requirements; marking 
of pet food; game trophies; transit requirements; etc. 
10 December 2003 New Zealand: technical conditions on 
imports 
15 January 2004 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 
17 March 2004 USA: recommenda tions to refine health 
regulations for trading in animal products 
30 March 2004  USA (conference call): photographic 
gelatine; certificates for raw ABP; import of 
bones for gelatine production; treatment requirements for birdseed with tallow; derogation for tallow and for hides 
23 June 2004 USA (conference call): blood derived 
products for laboratory  use; certification 
requirements for dairy products 
12 July 2004 USA (conference ca ll): importation of blood 
products; lists of appr oved plants; health 
certification requirements 
11 November 2004 USA: import certificates 20 June 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 from lagomorphs and 
rodentia 
7 July 2005 USA: Export of gelatine capsules from USA 
to EU 
 
EN 73   EN 22 March 2006 Australia: disc ussion of a list of points 
submitted by Australia  
04 December 2006 Japan: Swill feeding 16 January 2007 Australia, New Zealand, USA, Canada: 
review of the ABP Regu lation; importation of 
intermediate products; questions on how to trade with products not covered by 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 ex change of letters and e-mails has taken place 
with several third countries where the Commissi on has tried to clarify uncertainties and to 
provide help by issuing guidance notes or, wher e this was not possible by amending existing 
legislation or by adopting transitional measur es, derogations or im plementing legislation. 
 
EN 74   EN ANNEX III  
OPINIONS OF THE EUROPEAN FOOD SAFETY AUTHORITY (EFSA)  RELATING TO THE 
ABP R EGULATION  
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 inte nded for human consumption. (Question N° 
EFSA-Q-2003-028). 
Opinion of the Scientific Panel on Biological Ha zards 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 improve rs". (Question N° EFSA-Q-2003-090). 
Opinion of the Scientific Panel on Biological Ha zards 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 improve rs" (Question N° EFSA-Q-2003-090). 
Opinion of the Scientific Panel on Biological Ha zards of the European Food Safety Authority 
on the “Assessment of the human and animal BS E risk posed by tallow with respect to 
residual BSE risk” (Question N° EFSA-Q-2003-099). 
Opinion of the Scientific Panel on Biological Ha zards 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) an d 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” pro cess for safe disposal of animal by-products 
as method for safe disposal of category 1 An imal 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 met hod for safe disposal of catego ry 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" (Que stion N° EFSA-Q-2004-085). 
Opinion of the BIOHAZ Panel on the "BSE risk from cohort animals: bovine hides and skins 
for technical purposes" (Que stion N° EFSA-Q-2005-292). 
 
EN 75   EN 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 Number of responses % of responses 
Organisation, institution, company 107 (86.3%) 
Individual 17 (13.7%) 
 
Type of organisation, institution or 
company Number of responses % of responses 
Organization representing the private sector 42 (39.3%) 
Private company 38 (35.5%) 
National authority 8 (7.5%) 
National NGO  8 (7.5%) 
Other contributor 7 (6.5%) 
Regional or local authority 3 (2.8%) 
International NGO 1 (0.9%) 
International organization Academic 
institution/think tank 0 (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 76   EN  
Country of residence Number of responses % of responses 
UK-United Kingdom  53 (42.7%) 
BE-Belgium 20 (16.1%) 
NL-Netherlands 14 (11.3%) 
DE-Germany 11 (8.9%) 
Other non-European country 6 (4.8%) 
FI-Finland 5 (4%) 
DK-Denmark 3 (2.4%) 
CZ-Czech Republic 2 (1.6%) 
EL-Greece 2 (1.6%) 
IE-Ireland 2 (1.6%) 
IT-Italy 2 (1.6%) 
EE-Estonia 1 (0.8%) 
FR-France  1 (0.8%) 
PT-Portugal 1 (0.8%) 
SK-Slovakia 1 (0.8%) 
Other European countries 0 (0%) 
 
 
EN 77   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  37 (29.8%) 
Disagree 18 (14.5%) 
Agree 14 (11.3%) 
Other 14 (11.3%) 
Strongly agree 11 (8.9%) 
 
Option (b): Self-regulation, co-
regulation or guidance Number of responses % Responses 
Agree 36 (29%) 
Disagree 30 (24.2%) 
Other 11 (8.9%) 
Strongly agree 7 (5.6%) 
Strongly disagree  6 (4.8%) 
 
Option (c): Legislative review 
i. Exemption of finished products 
from the Regulation Number of responses % Responses 
Agree 39 (31.5%) 
Disagree 20 (16.1%) 
Other 14 (11.3%) 
Strongly agree 8 (6.5%) 
Strongly disagree 5 (4%) 
 
 
EN 78   EN Option (c): Legislative review 
ii. Introduction of a legal basis for 
determining the end of the ABP 
life cycle Number of responses % Responses 
Strongly agree 40 (32.3%) 
Agree 28 (22.6%) 
Disagree 8 (6.5%) 
Other 8 (6.5%) 
Strongly disagree  4 (3.2%) 
 
B. Coverage of wild animals 
Option (a): Do-nothing Number of responses % Responses 
Strongly agree 23 (18.5%) 
Disagree 21 (16.9%) 
Agree 18 (14.5%) 
Strongly disagree  17 (13.7%) 
Other 12 (9.7%) 
 
Option (b): Self-regulation, co-
regulation or guidance Number of responses % Responses 
Agree 49 (39.5%) 
Disagree 17 (13.7%) 
Other 11 (8.9%) 
Strongly disagree  9 (7.3%) 
Strongly agree 2 (1.6%) 
 
 
EN 79   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 Number of responses % Responses 
Disagree 30 (24.2%) 
Strongly disagree 25 (20.2%) 
Agree 16 (12.9%) 
Other 13 (10.5%) 
Strongly agree 2 (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 41 (33.1%) 
Agree 23 (18.5%) 
Other 13 (10.5%) 
Strongly disagree  6 (4.8%) 
Strongly agree 4 (3.2%) 
 
iii. To extend the scope to cover all 
wild animals, but apply only minimal Community controls in 
line with the Hygiene legislation 
and to allow the competent authority to issue a general 
authorisation Number of responses % Responses 
Strongly disagree  23 (18.5%) 
Disagree 23 (18.5%) 
Agree 18 (14.5%) 
Other 15 (12.1%) 
Strongly agree 3 (2.4%) 
 
 
EN 80   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 34 (27.4%) 
Strongly disagree 28 (22.6%) 
Agree 7 (5.6%) 
Strongly agree 4 (3.2%) 
Other 4 (3.2%) 
 
Option (b): Self-regulation, co-
regulation or guidance Number of responses % Responses 
Disagree 34 (27.4%) 
Agree 17 (13.7%) 
Other 13 (10.5%) 
Strongly disagree 6 (4.8%) 
Strongly agree 2 (1.6%) 
 
Option (c): Legislative review 
i. To categorise newly the 
intrinsically low risk products Number of responses % Responses 
Disagree 29 (23.4%) 
Agree 28 (22.6%) 
Strongly agree 10 (8.1%) 
Other 5 (4%) 
Strongly disagree 1 (0.8%) 
 
 
EN 81   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 40 (32.3%) 
Agree 24 (19.4%) 
Strongly disagree 4 (3.2%) 
Other 4 (3.2%) 
Strongly agree 0 (0%) 
 
iii. To categorise newly intrinsically 
low risk products and to create a legal basis to categorise further 
products and proportional 
measures to be introduced on a case-by-case basis Number of responses % Responses 
Agree 47 (37.9%) 
Strongly agree 23 (18.5%) 
Disagree 5 (4%) 
Other 4 (3.2%) 
Strongly disagree 0 (0%) 
 
B. Technical use of all three Categories of ABP 
Option (a): Do-nothing  Number of responses % Responses 
Disagree 35 (28.2%) 
Strongly disagree 17 (13.7%) 
Agree 11 (8.9%) 
Other 7 (5.6%) 
Strongly agree 4 (3.2%) 
 
 
EN 82   EN Option (b): Self-regulation, co-
regulation or guidance  Number of responses % Responses 
Disagree 34 (27.4%) 
Agree 16 (12.9%) 
Other 13 (10.5%) 
Strongly disagree  5 (4%) 
Strongly agree  1 (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 40 (32.3%) 
Agree 20 (16.1%) 
Other 9 (7.3%) 
Strongly agree 5 (4%) 
Strongly disagree 2 (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 39 (31.5%) 
Strongly agree  37 (29.8%) 
Other 3 (2.4%) 
Strongly disagree  0 (0%) 
Disagree 0 (0%) 
 
 
EN 83   EN CLARIFYING THE APPROVALS / REGISTRATIONS AND CONTROLS  
Option (a): Do-nothing Number of responses % Responses 
Strongly disagree 36 (29%) 
Disagree 22 (17.7%) 
Agree 11 (8.9%) 
Strongly agree 3 (2.4%) 
Other 2 (1.6%) 
 
Option (b): Self-regulation, co-
regulation or guidance Number of responses % Responses 
Disagree 40 (32.3%) 
Agree 13 (10.5%) 
Strongly disagree  8 (6.5%) 
Other 8 (6.5%) 
Strongly agree  1 (0.8%) 
 
Option (c): Legislative review 
i. To remove duplicated approvals 
and rely fully on the provisions already introduced by other 
Community sector legislation Number of responses % Responses 
Disagree 28 (22.6%) 
Agree 14 (11.3%) 
Other 11 (8.9%) 
Strongly agree  9 (7.3%) 
Strongly disagree  3 (2.4%) 
 
 
EN 84   EN ii. To remove duplicated approvals, 
rely on the provisions already 
introduced by other Community 
sector legislation, but require registration for specific 
businesses Number of responses % Responses 
Disagree 30 (24.2%) 
Agree 16 (12.9%) 
Strongly agree  9 (7.3%) 
Strongly disagree  7 (5.6%) 
Other 6 (4.8%) 
 
iii. To remove duplicated approvals, 
rely on the provisions already 
introduced by other Community 
sector legislation, and require registration in all cases Number of responses % Responses 
Disagree 32 (25.8%) 
Agree 15 (12.1%) 
Other 10 (8.1%) 
Strongly disagree  6 (4.8%) 
Strongly agree  4 (3.2%) 
 
iv. To remove duplicated approvals, 
rely on the provisions already 
introduced by other Community sector legislation, require 
registration in all cases and to 
create a legal basis allowing introduction of additional 
requirements Number of responses % Responses 
Agree 23 (18.5%) 
Strongly agree  14 (11.3%) 
Disagree 12 (9.7%) 
Other 12 (9.7%) 
Strongly disagree  8 (6.5%) 
 
 
EN 85   EN CLARIFYING THE DEROGATIONS  
Option (a): Do-nothing  Number of responses % Responses 
Strongly disagree  30 (24.2%) 
Disagree 25 (20.2%) 
Agree 14 (11.3%) 
Strongly agree  5 (4%) 
Other 3 (2.4%) 
 
Option (b): Self-regulation, co-
regulation or guidance  Number of responses % Responses 
Disagree 31 (25%) 
Agree 16 (12.9%) 
Other 10 (8.1%) 
Strongly disagree 6 (4.8%) 
Strongly agree 4 (3.2%) 
 
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 Number of responses % Responses 
Agree 31 (25%) 
Strongly agree 25 (20.2%) 
Other 12 (9.7%) 
Disagree 5 (4%) 
Strongly disagree 0 (0%) 
 
 
EN 86   EN ii. Extending the derogation to 
provide for burial or burning in 
more areas affected by special 
circumstances Number of responses % Responses 
Agree 29 (23.4%) 
Other 21 (16.9%) 
Strongly agree  13 (10.5%) 
Strongly disagree  4 (3.2%) 
Disagree 3 (2.4%) 
 
 
EN 87   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 16 
Competent Authorities from third countries  1 
Organization representing the private sector 7 
Private company 10  
NGO  0 
Other contributor 0 
Total 34 
 
 
EN 88   EN ANNEX VI  
Examples of the economic and social dimensio n 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 mM T are Category 1 and 2 and about 10 mMT are 
Category 3 and food grade material. 
The production of rendered products is as follows:  Protein Meal/PAP
* Rendered Fat 
Cat. 1 and 2 (combined) 1.32 mMT 0.92 mMT Cat. 3 and Food grade (Combined) 2.42 mMT 1.68 mMT Total 3.75 mMT 2.6 mMT 
* Processed Animal Protein 
Confederation of National Associations of Tanners and Dressers of the European 
Community   
This confederation represents companies w ith 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 co sts 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 nationa l pet food industry associations. In all, it 
represents the views and inte rests 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 mate rials (not only ABP)  per year. Yearly, 
they use about 2.750.000 ton of by-products from  European agricultu re. 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 indir ectly another 30.000 people.  
 
EN 89   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 da y, this company processes in just one of 
the plants 380 to raw materials (ABP, tallow, ce reals, 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 ar e 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 im aging 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 Diagnosti c Manufacturers Association   
EDMA membership  brings together 20 National Asso ciations in European countries 
and 29 of the major companie s 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 Fed eration for Animal Health  
The International Federation for Animal  Health (IFAH) is an organisation 
representing manufacturers of veterinary me dicines, 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 Ph armaceutical 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 th at improve health and the 
quality of life around the world. 
http://www.efpia.org/Content/Default.asp  
 
EN 90   EN 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 covera ge in Europe, and to help sustain the 
innovative research and development capabili ty 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 supp lier of vaccines in the worl d, producing approximately 80% 
of vaccines used worldwide.  
• is the largest supplier to UNICEF of v ital paediatric vaccin es,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 pub lic sector in joint R&D activities and in 
clinical trials partnerships to develop v accines against diseases that particularly 
burden developing countries (e.g., denguefeve r, 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 91   EN • has production facilities not only in Europe but across the globe through 
international collaboration and joint ventures  
• submits its novel products to a centralis ed procedure to obtain EU licensing 
(e.g. all hepatitis B vaccines, hepatitis B-containing combination vaccines, as 
well as the pneumococcal conjuga te vaccines, among others). 
http://www.evm-vaccines.org/  
5. ISIA – International Serum Industry Association  
Use of serum: 
Animal serum (a blood-derived AB P) is used extensively in 
1. Life science research 2. Production of human and animal vaccines 3. Production of biopharmaceuticals 4. Production of diagnostic products The use of serum in research is critical in the development of future diagnostic and 
biologically based therapeuti c 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 an tibodies 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 informa tion allowing the potent ial 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 92   EN Biopharmaceuticals: 
Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology 
methods, with the products having biol ogical sources usually involving live 
organisms or their active components. Biot ech 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. Mo re than one fifth of the new medicines 
launched each year are now biotechnology de rived. Biotech medi cines have been 
developed for a wide range of rare and chr onic diseases and will continue to provide 
new breakthroughs in the years to come. Mo re 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 peopl e 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 materi als to the rest of the world. Reduction in 
vaccine production in Europe could ha ve 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 industr ies in Europe that this 
important intermediate be responsibly impor ted through clear channels in a way that 
maintains total traceability 
 
EN 93   EN ANNEX VII  
List of legislation concerning ABP introduced since October 2002 
1. Transitional measures for Mem ber States and Third Countries 
1.1. Transitional measures for Member States 
• Collection, transport, treatment, use a nd disposal of former foodstuffs (all 
Member States). Commission Regul ation (EC) No 197/2006 (expiry: 
31/7/2009 ) 
• The possibility of on-site burning or burial of ABP (Estonia and Cyprus). 
Commission Decision 2004/467/EC (E xpired on 01/01/2005). Commission 
Decision 2005/62/EC as amended by Decision 2005/869/EC extended the 
transitional measures for C yprus (expired on 1/1/2007). 
• Separation of Category 1 and 2 processi ng 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, transport and disposal  of former foodstuffs. Commission 
Regulation 813/2003/EC (e xpired on 31/12/2005). 
• Biogas standards (all Member St ates). 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). Commissi on 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 a nd 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 (e xpired on 31/12/2006) 
• Feeding catering waste (swill feedi ng) 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). 
 
EN 94   EN • Total separation between plants ha ndling Category 1, 2 and 3 materials 
(Finland and France). Commissi on 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 20 03/321/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 gr anted to third countries postponing the 
application of the import provis ions and allowing adequate ti me for them to adjust to 
the new requirements and for the Commissi on to update the import rules. In addition, 
the following specific transiti onal measures were granted: 
• Import and placing on the market of certain materials of animal origin 
classified as Categories 1 and 2 inte nded 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 Un ited Kingdom intended for making photo 
films in the EU. Commission Decisi on 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 ame nded certain Annexes relating to 
production standards and has brought all im port certificates into line with the 
requirements of the TRACES system. 
• Importation and transit of certain inte rmediate products derived from Category 
3 material intended for technical uses in medical devices, in vitro diagnostics 
and laboratory reagents and amendi ng 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 co mposting plants and requirements for 
manure 
 
EN 95   EN • Regulation (EC) No 416/2005 amending A nnex XI as regards the importation 
from Japan of certain animal by-produc ts intended for technical purposes 
• Regulation (EC) No 93/2005 has amended Annexes II and V of the Regulation  
• Regulation (EC) No 92/2005 has amende d 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 pr oducts that may be used as  feed material, pet-food, 
dogchew and technical products. The list of third countrie s 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 opi nion and has introduced some other 
technical amendments to the Annexes. 
3. Implementing Regulations 
Six implementing Regulations have been introduced: 
• Importation and transit of certain inte rmediate products derived from Category 
3 material intended for technical uses in medical devices, in vitro diagnostics 
and laboratory reagents and amendi ng the ABP Regulation. Commission 
Regulation (EC) 2007/2006. 
• Listing of approved plants in Me mber 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 fertilis ers and soil improvers. Regulation (EC) 
No 181/2006 allows the use of organic fertilisers and soil improvers other than manure under certain conditi ons and amends Annex I 
• Processing of ABP of fi sh 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 m odel 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 al ternative 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 
 
EN 96   EN 4. Permanent general derogations 
Two permanent / general derogations have been granted: 
• Derogation from the intra-species r ecycling 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 gran ted on request from member States 
Two measures have been introduced to allow the continual feeding of: 
• Feeding of endangered / protected sp ecies of necrophagous birds with dead 
ruminants containing specified risk mate rial (Article 23(2) (Italy, France, 
Spain, Portugal, Greece and Cyprus).  Commission Decision 2003/322/EC, as 
amended by Commission Decisi ons 2004/455/EC & 2005/830/EC. 
• Fur animals with processed animal prot ein 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 cl arify a number of issues 
Five guidelines have been issued: 
• Guidance note: Interpretation of Re gulation 1774/2002/EC - questions from 
FVO missions (April 2006) 
• Guidelines for applications for new alte rnative 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 concer ns raised by Member States and 
stakeholders (April 2004)  
• Guidance note on the application to AB P 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/b iosafety/animalbyproducts/index_en.htm 
 
EN 97   EN ANNEX VIII  
List of other Community legislation and policy changes taken into account 
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 mate rials intended for the production of 
processed animal protein to be pressure-cooked. 
– Ban on the landfill of TSE suspects/po sitive even after pressure-cooking. 
– Burial or burning of fallen stock only al lowed 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 pastur eland 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 possibili ty 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 highe st processing standa rd (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 ro ad map, provided the positive trend continues 
and scientific conditions are in place, it might be envisa ged in long term to adapt 
some of the above provisions to the improving BSE trend. 
 
EN 98   EN Waste legislation 
There is a concomitant review of wast e legislation (shipment and framework). 
• Waste shipment Regulation 
The co-legislators have recently adopt ed 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 Regulat ion. If necessary, this re view shall be accompanied 
by appropriate proposals with a view to ach ieving 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 wa ste 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 Par liament 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 wh en ABP are foreseen for incineration, 
landfill or use in biogas or composting plant. 
This is viewed by interests as a furthe r step in the right direction, avoiding 
duplication and improving the procedural a rrangements 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 pro ducts and medical devices 
• Approval of plants 
Separate Community legislation govern s the manufacturing and placing on the 
market and export of cosmetics, medicinal products and medical devices (including 
laboratory reagents). 
 
EN 99   EN Current provisions only apply to cosmetics,  medicinal products and medical devices 
(including laboratory reagents) as far as c oncern the source and starting materials of 
animal origin that are used in the manufact ure of such products. It requires that such 
starting materials must derive from "Cat egory 3 materials" i.e. materials from 
animals fit for human consumpti on following veterinary checks. 
When such starting materials are to be imported into the EU, they must meet 
equivalent conditions set out in the Regulat ion, ensuring their safety vis-à-vis animal 
and public health. 
Sector legislation has been adapte d 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 risk s 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 intermedia te 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, some times 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-pr oducts 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 provisi ons, 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 anim als 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 pr oducts. Nevertheless, these animals can 
only be classed as Category 1 and theref ore intermediate pro ducts derived from 
is prohibited by the Regulation. 
 
EN 100   EN  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 derive d 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 provisi ons, 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 co me 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 insp ections at Border Inspection Posts. 
– Estimates of the potential impact on industry 
 According to the industry, sales of in-v itro diagnostic produ cts in the EU are 
worth some 9.4 billion Euros and th e 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, includ ing 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 AB P 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 pro duction in food establishments, set down in 
Regulation (EC) No 852/2004, which, in particular, provides for its dispos al in a hygienic and 
environmental friendly way. In addition, rules re lated to certain food ac tivities have already 
been more specifically addressed in the ABP legisl ation 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 en suring the current high level of  public and animal health.