Opinion of the Economic and Social Committee on the "Proposal for a European Parliament and Council Directive amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists"
Date: 2000-10-19
Institutions: European Economic and Social Committee
Subjects: animal breeding, application of EU law, health control, hormone, veterinary drug, veterinary legislation

16.1.2001

EN

Official Journal of the European Communities

C 14/47

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

(2001/C 14/11)

On 13 July 2000 the Council, acting under Article 152 of the EC Treaty, decided to consult the Economic
and Social Committee on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was instructed to prepare
the Committee’s work on this subject, adopted its opinion on 6 October 2000. The rapporteur was
Mr David Evans.

At its 376th plenary session, held on 19 October 2000 the Committee adopted the following opinion by
93 votes in favour with 1 abstention.

1.

The Commission Proposal

1.1.
Council Directive 96/22/EC requires Member States to
prohibit the use of oestrogenic, andropenic and gestagenic
substance on farm animals, except for ‘therapeutic purposes
and zootechnical treatment (1)’. Imports from third countries
of animals or animal products which have been treated with
these substances for growth promotion purposes are also
prohibited.

1.2.
In February 1998 the WTO ruled that the ban on
import was not compatible with EU rules. The Commission
therefore initiated a complementary risk assessment in accord-
ance with the WTO Agreement on the application of Sanitary
and Phytosanitary measures. Six hormonal substances were
subject
testosterone,
progesterone,
zeranol, melengestrol
acetate.

to this assessment: oestradiol 17 ß,

trenbolone

acetate,

1.3.
On 30 April 1999 the Scientific Committee on Vet-
erinary measures relating to Public Health (SCVPH) issued an
opinion concerning the assessment of potential adverse effects
on human health of hormone residues in beef. The major
conclusions were, first, that as concerns excess intake of
hormone residues and their metabolites, and in view of the
intrinsic properties of hormones and the epidemiological
findings, a risk to the consumer had been identified with
different levels of conclusive evidence for the six hormones
evaluated. Second, for the six hormones endocrine, develop-
mental, immunological, neurobiological, immunotoxic, geno-
toxic and carcinogenic effects could be envisaged and, of the
various susceptible risk groups, prepubertal children were the

(1) Zootechnical

treatment shall mean the administering to an
individual farm animal of any substance under Article 5 of this
Directive for synchronising oestrus and preparing donors and
recipients for the implantation of embryos, after examination of
the animal by a veterinarian or, in accordance with the second
paragraph of Article 5 under his responsibility (see Direc-
tive 96/22/EC Article 1 c).

group of greatest concern. Third,
in view of the intrinsic
properties of the hormones and taking into account epidemiol-
ogical findings, no threshold levels and therefore, no Accept-
able Daily Intake (ADI) could be established for any of the six
hormones when administered to bovine animals for growth
promotion purposes.

As regards oestradiol 17 the SCVPH considered there
1.4.
to be a substantial body of recent evidence suggesting that it
has to be considered as a complete carcinogen, as it exerts
both tumour initiating and tumour promoting effects and that
the data currently available made it impossible to give a
quantitative estimate of the risk.

1.5.
Subsequent to this SCVPH opinion, further scientific
information became available from the UK Veterinary Products
Committee, the Committee on Veterinary Medical Products of
the EC, and the Joint FAO/WHO Expert Committee on Food
Additives. The SCVPH reviewed this further information and
on 3 May 2000 concluded that it did not provide convincing
data and arguments requiring revision of the conclusions
drawn in the opinion of 30 April 1999.

1.5.1.
Under existing provisions of Community law, the
EMEA is required to examine requests by an interested
manufacturer to establish a Maximum Residues Limits for
veterinary medicinal products used for therapeutic or zootech-
nical purposes.

1.5.1.1.
EMEA has evaluated oestradiol 17 ß upon the
request of producers within the strict context of defined
conditions of use, and concluded that it was not necessary to
set an MRL for oestradiol 17 ß; for therapeutical purposes.

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1.5.1.2.
broader context and this explains the different conclusions.

The SCVPH has examined the question in a much

1.5.1.3.
The Commission proposal represents an approach
based on risk management, which takes into account the
alternatives of oestradiol 17 ß, the lack of possible control in
case of misuse and the opinion of both scientific committees.

In the light of all the available scientific evidence, the
1.6.
opinions expressed by the responsible EU and other scientific
advisory bodies, and the need to avoid any unnecessary risks
to consumers, the Commission proposes:

1)

2)

to definitively ban the use of oestradiol 17 ß and its ester-
like derivatives in farm animals and only to allow
its administration to non-farm animals for therapeutic
purposes;

to continue provisional ban on the use of the other five
hormones until more complete scientific information
becomes available. The use of those substances may
however still be authorised for ‘therapeutical purposes
and zootechnical treatment’ under the conditions of
Directive 96/22 EC.

This proposal will mean that imports of beef and beef
1.7.
products,
from countries where oestradiol 17 ß and its
ester-like derivatives can be legally used for therapeutical
zootechnical purposes, will be subject to strict controls and
monitoring which will mean that no imports are possible in
some cases, if sufficient guarantees are not provided to the EU
according to the provisions foreseen by Council Directive
96/23/EC (1).

2. WTO Implications

2.1.
An important aspect of this new proposal concerns
the continuing WTO dispute between the EU and the USA/
Canada over the use of hormones in fattening cattle.

In 1996 the USA and Canada held formal consultations
2.2.
with the EU under the WTO dispute settlement mechanism
regarding the EC ban on imports of meat
treated with
hormones. These talks led to the setting-up of WTO panels
which in August 1997 delivered the opinion that the EC
measures were not in conformity with WTO rules. The EU
objected to these conclusions and asked that they be reviewed
by the Appellate Body.

(1) OJ L 125, 23.5.1996, p. 10-32.

2.3.
The Appellate Body reported in February 1998, arguing
that although scientific studies submitted by the EU showed a
general risk of cancer, they were not ‘sufficiently specific to the
case in hand’ to be relevant. The Appellate Body did however
say that a WTO member:

— has the right to choose the level of health protection it

deems appropriate;

— is not obliged to assess risk in a quantitative form in order

to be able to take measures;

— is not obliged to follow majority and mainstream scien-
tific views. Minority or divergent views can also be taken
into account.

2.4.
It also dealt with the issue of growth promotion
hormones as against naturally-occurring hormones, pointed
out that WTO rules permit members to take provisional
measures when the scientific information is insufficient, and
recommended the EU to bring its measures into conformity
with its obligations under the SPS Agreement.

2.5.
The EU was subsequently given until 13 May 1999 to
implement these recommendations. A few days after this date,
both the USA and Canada sought WTO authorisation of
counter measures and this was implemented in July 1999.

3. Comments

3.1.
The proposed directive is fully supported by the latest
scientific information available, is based on risk assessment in
accordance with the SPS provisions and is intended to
regularise the EU’s position under the WTO rules by applying
a total ban on 17 ß oesteradiol, and provisional bans on
the other substances. The Committee fully supports the
Commission proposal.

3.2.
However, the Committee would like to acquire sup-
porting evidence for the Commission’s decision to allow the
administration of oestradiol 17 ß to non-farm animals, like
pets for example. In this context, and with regard to recital 12
of the proposal, the Committee understands that Commission’s
intention is to give priority to the control of hormones in farm
animals and to consider pet animals at a later stage. The current
text is ambiguous and allows for misleading conclusions or
misuse.

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3.3.
Our overriding concern in looking at this proposal
must be with the safety of the EU consumer and particularly
the more vulnerable groups identified in the latest scientific
information. The proposal depends on a balanced assessment
of the risks involved in the use of these substances, both for
therapeutic and zootechnical purposes, where there are animal
health and welfare issues involved, as well as potential
economic ones, and for growth promotion purposes where
the motivation is purely economic. In making this proposal,
the Commission and its advisory bodies have had to take
into account both the complex scientific data and changing
practices in animal husbandry, not only in the EU but in third
countries. Research on these matters is continuous and the
Committee emphasises the need for the Commission to keep
the legislation under review in the light of further knowledge.

There are important international trade implications,
3.4.
and we are concerned about the effectiveness of the EU
controls, which inevitably are very complex, over imports
from third countries where these substances may be used, for
whatever the stated purpose. The Committee therefore calls on
the Commission to examine the systems which apply to the
verification and control over meat
imported from third
countries, and to ensure that these are fully consistent with the
priority which must be given to consumer safety.

3.5.
As regards oestradiol 17 ß, this substance can poten-
tially be used in all farm animals and residue intake can be
for all segments of the human population, and
relevant

Brussels, 19 October 2000.

especially the groups at high risk (such as very young children).
Avoiding such intake is important to safeguard human health.
It is relevant that the residues resulting from the use of this
substance cannot be detected through the routine analytical
methods at present available. It is also relevant that there are
alternatives available, though these may be subject to different
controls in the different EU Member States. The Committee
fully supports therefore the Commission proposal not to allow
the use of this substance.

3.6.
As regards the other five substances the Committee
also supports the Commission proposal, but considers there is
a need for further examination of the balance of risks and
benefits involved in their use. In particular, while recognising
that zootechnical use (which is primarily concerned with the
synchronising of oestrus for insemination purposes) is subject
to licensing and scrutiny, we believe it should be subject to
further consideration. We question whether:

— this use is consistent with the precautionary principle;

— imports from third countries where these substances are
used for therapeutic or zootechnical treatment are subject
to harmonised and systematic controls;

— across the EU the administration of such substances is
properly registered at the farm records so as to allow for
monitoring by the competent authorities; in addition, we
wonder whether appropriate controls take place and, if
not, we strongly recommend that the Commission takes
the necessary measures to this end.

The President

of the Economic and Social Committee

Göke FRERICHS