Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 COM(2007) 194 final — 2007/0064 (COD)
Date: 2007-09-26
Institutions: European Economic and Social Committee
Subjects: European Medicines Agency, European standard, animal product, foodstuff, human nutrition, veterinary drug

15.1.2008

EN

Official Journal of the European Union

C 10/51

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the
European Parliament and of the Council laying down Community procedures for the establishment
of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing
Regulation (EEC) No 2377/90’

COM(2007) 194 final — 2007/0064 (COD)

(2008/C 10/13)

On 22 May 2007, the Council decided to consult the European Economic and Social Committee, under
Articles 37 and 152(4)(b) of the Treaty establishing the European Community, on the abovementioned
proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 4 July 2007. The rapporteur was Mr Coupeau.

At its 438th plenary session, held on 26 and 27 September 2007 (meeting of 26 September 2007), the
European Economic and Social Committee adopted the following opinion by 151 votes with 6 abstentions.

1. Conclusions and recommendations

The European Economic and Social Committee notes the

1.1
steps taken by the European Commission.

The Committee would

pharmacological
1.2
substance intended for food-producing animals to be submitted
to the European Medicines Agency (EMEA) and the Maximum
Residue Limits (MRLs) to be assessed by the Committee for
Medicinal Products for Veterinary Use (CVMP).

any

like

1.3
Any company producing pharmacological products for
animals should be authorised by the EMEA and have had its
MRLs assessed by the CVMP.

1.4
In order to prevent any hindrance to the movement of
products within the European Community, these authorisations
will be valid throughout all the EU Member States.

b) simplify the existing legislation by enhancing readability of

the provisions on established MRLs for the end-users;

c) provide clear references for the control of residues of phar-
macologically active substances in foodstuffs to improve
consumer health protection and the functioning of
the
Single Market;

d) clarify the Community procedures establishing Maximum
Residue Limits (MRLs) by ensuring consistency with interna-
tional standards.

3. Current situation

The current legal framework for MRLs has led to particu-

3.1
lar problems:

1.5
The procedure for placing products on the market
should be simplified, whilst maintaining a high level of
consumer protection.

a) Availability of veterinary medicines has decreased to an
that creates adverse effects for public and animal

extent
health and animal welfare.

1.6
Simplifying European documents and making them more
readable would benefit all Europeans. Access to such documents
would help everyone to discover and understand Europe's
contribution to their daily lives.

2. Aim of the proposal

The aim is to continue to limit consumer exposure to

2.1
pharmacologically active substances.

b) International standards supported by the EU cannot be
included in Community legislation without a new scientific
assessment by the European Medicines Agency.

c) Member States' supervisory bodies have no points of refer-
ence, in particular for substances detected in foodstuffs from
third countries.

d) The current legislation is difficult to understand.

2.2 Whilst maintaining a high level of consumer protection,
the proposal should also help to simplify legislation.

4. Proposed measures

In order to achieve the desired aim, specific objectives

2.3
should be borne in mind:

a) improve availability of veterinary medicinal products for
food-producing animals in order to ensure animal health and
welfare and avoid illegal use of substances;

4.1

The main changes proposed are as follows:

a) make the assessment of possibilities for extrapolation a
compulsory part of
the overall scientific assessment and
create a legal basis for the Commission to lay down the prin-
ciples for applying extrapolation;

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Official Journal of the European Union

15.1.2008

b) introduce an obligation to adapt Community legislation to
include Maximum Residue Limits (MRLs) set by Codex with
the support of the EU;

c) create a specific legal framework to set maximum residue
limits for pharmacologically active substances not intended
to be authorised as veterinary medicines in particular for
control purposes and for imported foodstuffs.

The Commission has taken care to consult the parties
to determine what changes might be

in order

4.2
concerned,
needed.

5. Recommendations

The European Economic and Social Committee notes the

5.1
steps taken by the European Commission.

The Committee would

5.2
pharmacological
substance intended for food-producing animals to be submitted
to the European Medicines Agency (EMEA) and the Maximum
Residue Limits (MRLs) to be assessed by the Committee for
Medicinal Products for Veterinary Use (CVMP).

any

like

Any company producing pharmacological products for
5.3
animals should be authorised by the EMEA and have had its
MRLs assessed by the CVMP.

5.4
In order to prevent any hindrance to the movement of
products within the European Community, these authorisations
will be valid throughout Europe.

5.5
The procedure for placing products on the market
should be simplified, whilst maintaining a high level of
consumer protection.

5.6
Developments in scientific knowledge will help to deter-
mine whether products are innocuous and how long to wait
between administering the medicine to an animal and slaugh-
tering it for consumption.

Brussels, 26 September 2007.

Developments in scientific knowledge should enable the

5.7
Council to set a maximum residue limit.

Request

for procedures:

the current procedure has
5.8
proved its worth and managing requests for authorisation
should still form part of it.

The classification of pharmacologically active substances

5.9
should thus take account of the following:

a) a maximum residue limit

b) the absence of a maximum residue limit

c) a ban on administering substances.

The EMEA should consult the reference laboratories, in

5.10
order to determine the process for analysing residues.

5.11
European Union must not be hindered.

The movement of foodstuffs of animal origin in the

5.12
Simplifying European documents and making them
more readable would benefit all Europeans. Access to such
documents would help everyone to discover and understand
Europe's contribution to their daily lives.

5.13 Meat products from outside the Community treated
with medicines not licensed in the EU should be subject to a
scientific study proving that these products are innocuous, be
submitted to the EMEA, and then have their MRLs validated by
the Committee,
in order to ensure that consumers are fully
protected.

The

Commission

5.14
issues
surrounding the availability of medicinal substances for certain
species, such as goats, rabbits, etc., which laboratories choose
not to develop because they are not profitable.

consider

should

the

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS