EN    EN EN 
SANCO/826/2008 (POOL/D1/2008/826/826SIA-EN.doc) 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 10.6.2008 
SEC(2008) 1995 
COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
Draft proposal for a Regulation of the European Parliament and the Council laying 
down health rules as regards animal by-p roducts not intended for human consumption 
(Animal by-products Regulation) 
  
SUMMARY OF THE IMPACT ASSESSMENT 
 
{COM(2008) 345 final} 
{SEC(2008) 1994}  
 
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
Draft proposal for a Regulation of the European Parliament and the Council laying 
down health rules as regards animal by-p roducts not intended for human consumption 
(Animal by-products Regulation) 
  
SUMMARY OF THE IMPACT ASSESSMENT  
1. P
OLICY CONTEXT AND CONSULTATION OF INTERESTED PARTIES  
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 a nd the Council describi ng the experience of 
all 25 Member Sates in applying the legi slation. In additi on, a general on-line 
consultation was carried out and a questionn aire on administrative costs sent to 
competent authorities, affected industries  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. 
                                                
 
1 OJ L 273, 10.10.2002, p. 1. 
 
EN 3   EN 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: 
• the lack of clarity  in the scope of the Regulation. Specifically it  is not clear 
when products are not longer considered as ABP, and so the requirements of the Regulation cease to apply, nor the 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). 
2. G
ENERAL OBJECTIVES  
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. 
3. 
OPERATIONAL OBJECTIVES  
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, 
 
EN 4   EN • 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 science as regards 
import of ABP. 
The aim of the initiative is in line w ith 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.  
4. OPTIONS CONSIDERED  
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 deliv ered (as further expl ained under chapter 
6). Although it was not possible to use the Standard Cost Model, an estimation of administrative costs has been carried out for some policy options as far as available data could be used. The following is a summ ary 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  
• The final option considered was a legisl ative revision of the current Regulation. 
 
EN 5   EN 5. CONCLUSION  
Following the impact analysis, the overall conclusion was that the best option to 
respond to the problems identified in the ev aluation was to carry out a legislative 
revision of the current Regulation. This legi slative review would solve the issues of 
different interpretations on the scope of the regulation and the derived problems as 
distortion of competition and different leve ls of protection against risks for public 
and animal health. It will also provide for a more risk-based categorisation of ABP, 
will clarify the derogations and would imply a reduction of administrative burden by eliminating double approvals for some types of premises.