Source: EURLEX
Language: en
Format: md

**EN**

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

# **EN EN**

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}**

# **EN 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-products 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 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
consumption [1] 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.

1 OJ L 273, 10.10.2002, p. 1.

# EN 2 EN

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.** **G** **ENERAL 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,

# EN 3 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: 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.

# EN 4 EN

**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.

# EN 5 EN