Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta-agonists COM(2007) 292 final — 2007/0102 (COD)
Date: 2007-09-26
Institutions: European Economic and Social Committee
Subjects: domestic animal, hormone, market approval, veterinary drug

15.1.2008

EN

Official Journal of the European Union

C 10/57

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the
European Parliament and of the Council amending Council Directive 96/22/EC concerning the
prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic
action and of beta-agonists’

COM(2007) 292 final — 2007/0102 (COD)

(2008/C 10/15)

On 2 July 2007, the Council decided to consult the European Economic and Social Committee, under
Article 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 6 September 2007. The rapporteur was
Mr Jírovec.

At its 438th plenary session, held on 26 and 27 September 2007 (meeting of 26 September 2007), the
Economic and Social Committee adopted the following opinion by 152 votes to 1 with 3 abstentions.

1. Conclusions

— Stilbenes, stilbene derivatives, their salts and esters

The European Economic and Social Committee takes

1.1
note of the measures proposed by the European Commission.

1.2
The Committee welcomes the simplification and clarifica-
tion of this legislation, which applies both to the general public
and to companies providing pharmaceutical products
for
animals.

The proposal for a directive upholds the principle of
1.3
proportionality, as it lays down only limited changes on the
basis of the most recent scientific data and expert opinions.

1.4
The proposed directive also addresses
third-country imports of food-producing animals.

the issue of

The proposal for a directive does not contravene WTO

1.5
commitments.

1.6
The future unavailability of Oestradiol 17ß and its ester-
like derivates will have a negligible impact on farming and
animal welfare.

1.7

There is no need to set maximum residue limits.

The impact on small and medium-sized enterprises will

1.8
also be minimal.

2. Aim of the proposal

The aim of the proposal is to amend Directive 96/22/EC
2.1
of 29 April 1996, as amended by Directive 2003/74/EC. The
proposed directive prohibits the placing on the market of
certain substances for administering to any animals, the meat
and products of which are intended for human consumption,
for purposes other than those provided for in point 2 of
Article 4.

List of prohibited substances:

List A:

— Thyrostatic substances

— Oestradiol 17b and its ester-like derivatives.

List B:

— Beta-agonists.

2.2

The changes proposed are the following:

a) exclude pet animals from the scope of the legislation,

b) prohibit any use of oestradiol 17ß in food-producing

animals.

2.3
The Commission proposes making only very limited
changes that are needed to prevent the further suffering of pet
animals as a result of no appropriate treatment being available
and to take account of scientific and expert advice concerning
oestradiol 17ß (1).

3. Background

3.1
Article 2(a) of Council Directive 96/22/EC specifically
prohibits the placing on the market of substances listed in
Annex II for administering to animals of ‘all species’.

3.2
A price-comparison of products having a thyrostatic
action reveals that using them for food-producing animals is of
limited economic benefit.

3.3
Illegal use more commonly involves the illegal produc-
tion or import of these substances. In the last five years, no
illegal use of stilbene derivates, their salts or esters has been
detected.

3.4
The directive referred to above does not provide for
marketing authorisations to be granted for products containing
substances to treat hyperthyroidism in pet animals.

3.5
In 1981 (with Directive 81/602/EEC), the EU prohibited
the use of substances having a hormonal action for growth
promotion in farm animals, including oestradiol 17ß.

(1) ‘Prevention and Control of Animal Diseases’

http://ec.europa.eu/food/animal/resources/publications_en.htm.

C 10/58

EN

Official Journal of the European Union

15.1.2008

3.6
Although Directive 96/22/EC originally aimed to ban the
use of oestradiol 17ß and its ester-like derivates for all purposes,
it ultimately did no more than limit the circumstances in which
oestradiol 17ß may be administered for purposes other than
growth promotion. This product is totally carcinogenic, as it can
both cause and promote tumours.

3.7
The report presented to the Council and Parliament on
11 October 2005 concludes that because the use of alternative
substances such as prostaglandins is widespread, use of oestra-
diol 17ß could be phased out for food-producing animals.

Pet animals affected by hyperthyroidism often suffer as a

3.8
result of the ongoing unavailability of appropriate treatment.

4. Comments

The European Economic and Social Committee takes

4.1
note of the measures proposed by the European Commission.

Brussels, 26 September 2007

4.2
The changes proposed in relation to oestradiol 17ß are
the direct result of the activities required by Article 11(a) of
Directive 2003/74/EC.

4.3
The changes made are extremely limited and are needed
to prevent the further suffering of pet animals as a result of no
appropriate treatment being available.

This proposal is relevant to pet owners, practicing veteri-
industry and Member

the veterinary pharmaceutical

4.4
narians,
State authorisation agencies.

The proposal will help to ensure a high level of protec-

4.5
tion of human health.

4.6
New authorisations must, however, consider potential
misuse and products that are likely to be misused could, there-
fore, be rejected.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the
European Parliament and of the Council amending Regulation (EC) No 1924/2006 on nutrition and
health claims made on foods’

COM(2007) 368 final — 2007/0128 (COD)

(2008/C 10/16)

On 26 July 2007 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

Since the Committee unreservedly endorses the contents of the proposal and has already set out its views
on the subject in its earlier opinions CESE 308/2004 and CESE 1571/2006, adopted on 26 February 2004
and 13 December 2006 (*), it decided, at its 438th plenary session of 26 and 27 September 2007, by
163 votes to 1 with 7 abstentions, to issue an opinion endorsing the proposal and to refer to the position it
had taken in the above-mentioned documents.

Brussels, 26 September 2007.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

(*) EESC opinions on the Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims
made on foods — COM(2003) 424 final — 2003/0165 COD (OJ C 110 of 30.4.2004) and on the Proposal for a Regu-
lation of the European Parliament and of the Council amending Regulation (EC) No …/… on nutrition and health claims made
on foods — COM(2006) 607 final — 2006/0195 COD (OJ C 325 of 30.12.2006).