USE IN STOCKFEEDING OF SUBSTANCES HAVING
A HORMONAL OR THYROSTATIC ACTION AND BETA-AGONISTS
(21460)
10060/00
COM(00) 320
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Draft Directive amending Council Directive 96/22/EC concerning the
prohibition on the use in stockfeeding of certain substances having a
hormonal or thyrostatic action and beta-agonists
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| Legal base:
| Article 152(4)(b) EC; co-decision; qualified majority voting
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| |
| Document originated:
| 24 May 2000 |
| Forwarded to the Council:
| 3 July 2000 |
| Deposited in Parliament:
| 25 July 2000 |
| Department: |
Agriculture, Fisheries and Food
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| Basis of consideration:
| EM of 3 August 2000 |
| Previous Committee Report:
| None |
| To be discussed in Council:
| Following receipt of European Parliament opinion
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| Committee's assessment:
| Politically important |
| Committee's decision:
| Not cleared; further information requested
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Background
8.1 The use in stockfeeding within the Community
of certain substances having a hormonal or thyrostatic[20]
action and beta-agonists[21]
is regulated by Council Directive 96/22/EC[22].
In particular, this prohibits the placing on the market of:
— stilbenes, stilbene
derivatives, their salts and esters and thyrostatic substances
for administering to animals of all species;
— beta-agonists for administering to animals
intended for human consumption; and
— the administration to a farm animal of
beta-agonists, and of substances having a thyrostatic, oestrogenic[23],
androgenic or gestagenic action, and the placing on the market
for human consumption of any animals containing these substances
(and any meat derived from them).
8.2 The Directive does, however, allow a
number of exceptions to these prohibitions, in that:
— certain substances
(oestradiol 17, testosterone and progesterone) may be administered
by a veterinarian to farm animals for therapeutic purposes;
— veterinary products containing allyl
trenbolone and beta-agonists may be administered by a veterinarian
for therapeutic purposes to horses and pets;
— veterinary products containing beta-agonists
may be administered by a veterinarian for therapeutic purposes
to cows when calving; and
— veterinary medicinal products having
an oestrogenic, androgenic or gestagenic action may be administered
to farm animals for zootechnical[24]
treatment.
8.3 The main effect of this complex series
of provisions is to ban the use of hormone growth promoters in
food-producing animals, and hence in meat, except for therapeutic
purposes or zootechnical treatment.
8.4 Broadly speaking, these restrictions
also apply to animal products imported from third countries. This
in turn led to a dispute with the United States and Canada, on
which the World Trade Organisation (WTO) Dispute Settlement body
ruled in February 1998 that the steps taken by the Community were
in breach of the Organisation's rules, essentially because they
had been based on general studies rather than the particular risk
thought to arise from the use of growth hormones.
8.5 As a result of that ruling, the Commission
initiated assessments of six hormonal substances (oestradiol 17,
testosterone, progesterone, trenblone acetate, zeranol and melengestrol
acetate) whose administration for animal growth promotion purposes
is prohibited by Directive 96/22/EC. This led to a report in April
1999 from the Scientific Committee on Veterinary measures relating
to Public Health (SCVPH) which concluded that the use of these
six hormones in cattle for growth promotion purposes posed a risk
to consumers, and that no acceptable daily intake (ADI) can be
established for them when they are administered to animals for
growth promoting purposes. The Committee also took the view that
oestradiol 17 has to be considered as a complete carcinogen, as
it exerts both tumour initiating and tumour promoting effects.
8.6 The UK Government subsequently asked
its own Veterinary Products Committee (VPC) to look at the SCVPH
report. This resulted in advice from the VPC in October 1999 to
the effect that the scientific evidence in the SCVPH report did
not support the Community ban on the use of hormonal growth promoters.
Concern was also expressed about certain conclusions reached by
the SCVPH.
8.7 This led the SCVPH in turn to review
the position in the light of the VPC comments, and of observations
from the Commission's own Committee on Veterinary Medical Products
(CVMP) and the Joint Food and Agriculture Organisation/World Health
Organisation Expert Committee on Food Additives (JECFA). However,
in a final opinion issued on 3 May 2000, the SCVPH concluded that
"this recent information did not provide convincing data
and arguments demanding revision of the conclusions drawn in the
opinion of the SCVPH of 30 April 1999...".
The current proposal
8.8 Against this background, the Commission
has now proposed that oestradiol 17 and its derivatives should
be banned in food producing animals, and its use allowed in non-food
producing animals only where there is no alternative treatment.
The five other growth-promoting hormones would continue to be
prohibited for use for growth-promoting purposes, but would still
be available for certain therapeutic and zootechnical purposes,
subject to strict controls. The position would, however, be provisional,
pending the availability of more complete scientific evidence.
The Government's view
8.9 In her Explanatory Memorandum of 3 August
2000, the Minister of State at the Ministry of Agriculture, Fisheries
and Food (Baroness Hayman) says that the Government does not consider
that the scientific case for a ban has been made, and hence does
not support this proposal. She adds that its position will remain
unchanged unless new scientific evidence is made available for
full evaluation by independent UK experts, but that the UK will
nevertheless continue to fulfil its Community obligations by enforcing
such proposals as may be agreed by the Council.
8.10 As regards the impact of the proposal,
the Minister goes on to say that it is recognised that prohibiting
the use of oestradiol 17 for zootechnical purposes would create
problems for veterinarians, and she notes that the Commission
has said it will draw up a list of alternative treatments before
the Directive comes into force. She comments that it will not
be possible to tell the effect of this proposal until the Commission
has come forward with this list, and that a Regulatory Impact
Assessment cannot therefore be provided at this stage. However,
she suggests that the costs of removing oestradiol 17 "are
not likely to be substantial".
Conclusion
8.11 Whilst we accept that there is room
for legitimate differences in scientific interpretation, it is
disturbing that there should apparently be such a gulf between
the views expressed by the SCVPH and other expert bodies such
as the Veterinary Products Committee over oestradiol 17, which
the former has classified as a complete carcinogen. We would,
therefore, be glad to know whether, in that instance, the differences
which exist are simply over the appropriate action to be taken,
or if they extend to the fundamental question of whether oestradiol
17 should be regarded as a carcinogen. Pending clarification of
this point, and the Government providing a Regulatory Impact Assessment,
we are not clearing the document.
20 Thyrostatic substances reduce the activity of the
thyroid gland, which affects metabolism. A decrease in metabolic
rate manifests in a number of ways, including an increase in body
weight. Back
21
Beta-agonists give a positive response when combined with a specific
receptor site in the body, and can also promote the production
of lean meat in treated animals. Back
22
OJ No. L 125, 23.5.96, p.3. Back
23
Oestrogenic substances are involved in ovulation and the development
of female secondary sexual characteristics. In males, the effects
are manifested by growth promotion. Back
24
Zootechnical treatment means administering to a farm animal a
substance for synchronizing oestrus and preparing donors and recipients
for the implantation of embryos. Back
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