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-products not intended for human consumption (Animal by-products Regulation) - Summary of the impact assessment {COM(2008) 345 final} {SEC(2008) 1994}
Date: 2008-06-10
Institutions: European Commission
Subjects: agricultural by-product, animal product, health control, health legislation, health risk, impact study, traceability

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

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

SUMMARY OF THE IMPACT ASSESSMENT 

{COM(2008) 345 final} 
{SEC(2008) 1994} 

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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-products not intended for human consumption 
(Animal by-products Regulation) 

SUMMARY OF THE IMPACT ASSESSMENT 

1. 

POLICY CONTEXT AND CONSULTATION OF INTERESTED PARTIES 

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

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

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

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OJ L 273, 10.10.2002, p. 1. 

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

• 

• 

• 

• 

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

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

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

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

2. 

GENERAL OBJECTIVES 

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

3. 

OPERATIONAL OBJECTIVES 

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

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

• 

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

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• 

• 

• 

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

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

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

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.  

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

• 

• 

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

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

• 

The final option considered was a legislative revision of the current Regulation. 

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5. 

CONCLUSION 

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

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