1 Marketing of oilseed
rape genetically modified for glyphosate tolerance
| (25946)
12343/04
COM(04) 572
| Draft Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC, of an oilseed rape product (Brassica napus L.GT73 line) genetically modified for glyphosate tolerance
|
| Legal base | Article 18(1) of Directive 2001/18/EC; QMV
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| Document originated | 8 September 2004
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| Deposited in Parliament | 17 September 2004
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 6 October 2004
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| Previous Committee Report | None, but see footnote 2
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| To be discussed in Council | Before 9 December 2004
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| Committee's assessment | Politically important
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| Committee's decision | For debate in European Standing Committee A
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Background
1.1 Until recently, the deliberate release into the environment
of genetically modified organisms was subject within the Community
to the provisions of Directive 90/220/EEC, but that Directive
has now been replaced by Directive 2001/18/EC, which introduced
a number of procedural changes.[1]
This is the second proposal[2]
for a consent to be granted under the new Directive, and would
permit the importation of a variety of oilseed rape genetically
modified for increased tolerance to the herbicide glyphosate,
and its subsequent use in animal feed, but would not extend to
its cultivation within the Community, or its use in human food
(though we understand that oil from this line has been authorised
for use in human food since 1997 under the Novel Food Regulation
(258/97)).
The current proposal
1.2 The proposal follows an application submitted to the relevant
authority in the Netherlands, which, under the procedure laid
down, conducted an initial assessment of the notification. This
concluded that there was no scientific evidence of any risk to
human health or the environment, though, when it was forwarded
by the Commission to the other Member States, a number raised
objections based on the molecular characterisation of the product,
its allergenicity, and the arrangements for its monitoring, labelling
and detection. However, the European Food Safety Authority took
the view in February 2004 that the product is "as safe as
conventional oilseed rape for humans and animals, and, in the
context of the proposed uses, for the environment". The Commission
therefore proposed to the relevant Regulatory Committee of Member
States set up under Directive 2001/18/EC that approval should
be given, subject to the necessary steps being taken to ensure
the product's labelling and traceability. That Committee failed
to give a favourable opinion when it considered the application
on 16 June 2004, and the matter was referred to the Council on
9 September. It now has three months in which to act, failing
which the Commission would be obliged to adopt the measure.
The Government's view
1.3 In his Explanatory Memorandum of 6 October 2004, the Minister
of State (Environment and Agri-Environment) at the Department
for Environment, Food and Rural Affairs (Mr Elliot Morley) says
that the Government consulted the statutory Advisory Committee
on Releases to the Environment (ACRE), which in turn sought comments
from the Advisory Committee on Animal Feedingstuffs (ACAF), whose
views were incorporated into the two sets of advice produced by
ACRE in March and September 2003. He says that ACRE concluded
in the second of these that it could not at that stage agree that
consent should be granted, because the post-marketing monitoring
plan was inadequate[3]
and because of uncertainties about animal feed safety. The Minister
adds that his Department also consulted the Food Standards Agency,
the Health and Safety Executive, the statutory conservation bodies
and the GM Inspectorate, and that the comments from those bodies
as well as the ACRE advice were endorsed by the Government and
the devolved administrations (and reflected in the opinions which
the UK submitted to the Commission in March and October 2003,
in accordance with Directive 2001/18).
1.4 The Minister adds that, of the concerns contained
in the UK's opinion, those relating to traceability and labelling
have been alleviated by the coming into force of the new provisions
set out in Regulation 1830/2003, and that the official Regulatory
Committee made a number of amendments to the text of the draft
Decision in so far as it concerns post-market monitoring (though
he says that an agreed requirement to monitor and report any significant
accidental spillage had not been included in the final text).
However, on animal feed safety, the ACAF continued to have reservations
over the studies which had taken place, and requested that a further
study should be carried out before coming to a final conclusion.
For this reason, the UK voted against the application in the
Regulatory Committee.
1.5 The Minister says that, since then, an ACAF sub-group
has considered the views expressed by the EFSA as well as further
information provided by the applicant, and has indicated that
"the results of the rat feeding studies probably do not represent
a feed safety issue". However, it has said that it can reach
a conclusion only after receiving relevant data from a further
study using 15% oilseed rape seed. Consequently, the sub-group
has recommended that the UK should abstain when the matter is
considered by the Council, with a request for further information.[4]
Conclusion
1.6 Now that Directive 2001/18 has entered into
force, it seems likely that there will be an increasing number
of proposals of this kind coming before the Council, and we recognise
that, to some extent, they are each liable to give rise to similar
concerns. We also recognise that, although any proposal involving
the marketing of genetically modified crops is inevitably of considerable
interest, particularly at the present time, it may well be possible
for us to clear individual proposals without recommending them
for further consideration, particularly where the course of action
proposed is supported by the UK.
1.7 However, we consider that, on basis of the
information available to us so far, the present proposal raises
issues which need to be explored further. First, it is proposed
that the UK should abstain when the matter is considered by the
Council, apparently because — notwithstanding the resolution
of its doubts over animal feed safety — the Advisory Committee
on Animal Feedingstuffs is still not able to give the proposal
its full endorsement. It is not, however, clear why that should
be so, nor what the Advisory Committee's remaining reservations
are. Secondly, to the extent that the UK is not yet able to support
the approval of this product for use in animal feed, it seems
to us that this might have implications for the authorisation
granted in 1997 for the use of this same line of oilseed rape
in human food. In our view, these are matters which it would
be helpful for the Government to explain further to the House,
and, for that reason, we are recommending that this document should
be debated in European Standing Committee A.
1 (18909) 6378/98; see HC 155-xxvi (1997-98), para
5 (29 April 1998) and HC 34-iii (1998-99), para 1 (9 December
1998).Official Report, European Standing Committee A,24 March
1999. Back
2
The first such proposal related to a genetically modified maize
line: see (25530) 8235/04; HC 42-xx (2003-04), para 1 (18 May
2004). Official Report, European Standing Committee A, 21 June
2004. Back
3
Though we understand that the EFSA found that the monitoring plan
was appropriate for the intended uses. Back
4
The Minister says that this voting position had yet to be agreed,
and that a decision was being sought by 30 September. Back
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