2 Marketing of maize genetically modified
for resistance to corn rootworm
| (26536)
8635/05
COM(05) 163
| Draft Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line MON 863) genetically modified for resistance to corn rootworm
|
| Legal base | Article 18(1) of Directive 2001/18/EC; QMV
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| Document originated | 26 April 2005
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| Deposited in Parliament | 17 May 2005
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 17 May 2005
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| Previous Committee Report | None, but see footnote 4
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| Discussed in Council | 24 June 2005
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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
2.1 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,[1]
and, whilst that Directive was in force, four consents relating
to maize imported for use in animal feed were granted in the period
up to 1998. The Directive has now been replaced by Directive 2001/18/EC,[2]
which introduces a number of procedural changes,[3]
and this document — which would permit the importation of
a variety of maize genetically modified for increased tolerance
to corn rootworm, and its subsequent use in animal feed —
is the third proposal for a consent to be granted under the new
Directive, following an application submitted to the relevant
German authority.[4]
The current proposal
2.2 Under the procedure laid down, the German authority conducted
an initial assessment of the notification submitted to it by Monsanto
Europe S.A. in February 2003 concerning the placing on the market
of two generically modified maize products (Zea mays L. line MON
863 and hybrid MON 863 x MON 810). It concluded that there were
no reasons to withhold consent, provided that certain conditions
were met. This assessment was subsequently transmitted to the
Commission and to the other Member States, some of which raised
objections.[5] The Commission
therefore consulted the European Food Safety Authority (EFSA),
which assessed the available information and concluded that MON
863 is unlikely to have any adverse effect on human or animal
health or, in the context of its proposed use, on the environment.
However, in order to complete its safety assessment on the hybrid
MON 863 x MON 810, the Authority has requested a further study.
As a consequence, the draft Decision is restricted to MON 863
maize, and, as Member States were not able to reach agreement
on it at official level in November 2004, it was then referred
to the Council for a decision.
The Government's view
2.3 In his Explanatory Memorandum of 17 May 2005, 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. He says
that ACRE concluded that "[the] risk to human health and
the environment [arising from] marketing of this product for importation
and processing in the UK will be no different from that of [any]
other maize imported for processing and animal feed purposes".
2.4 The Minister adds that the proposal would not permit cultivation
within the Community, and that the UK opinion subsequently submitted
to the Commission reflected ACRE's advice, in that it contained
no safety objections to the application. However, it did raise
two issues which the UK believed should be considered before marketing
consent is given — traceability and labelling, and post-market
monitoring. He says that the first of these concerns has been
met by a provision in the draft Decision requiring consent to
be withheld until new measures, as set out in Regulation (EC)
No. 1830/2003, are in full effect, thus requiring any animal feed
intentionally containing the maize line in question to be labelled.
In the case of post-market monitoring, the Minister says that
the UK would have preferred a reporting interval of six months,
rather than the annual interval specified in the Decision, but
has concluded that the longer period would be sufficient, given
a general requirement in Directive 2001/18/EC to report adverse
effects immediately. It was therefore among the Member States
which supported the proposal when it was first considered.
2.5 The Minister also draws attention to a provision in the draft
Decision which prevents the granting of a consent unless and until
a separate authorisation, currently being assessed for the use
of the maize line in question in human food, has been obtained
under the procedure laid down in Regulation (EC) No. 258/97.
He describes this as a prudent measure, which ensures that authorisations
for animal feed and food uses will remain in step with one another.
Conclusion
2.6 As our predecessors noted on more than one occasion when
recommending for debate earlier documents authorising the marketing
of genetically modified crops, any such proposal is inevitably
of public concern. It is also clear that there continue to be
deep differences of view between Member States in this whole area.
Consequently, although the envisaged authorisation has been supported
by the Government on the basis of the assessments carried out
by the Advisory Committee on Releases to the Environment, we are
recommending the document for debate in European Standing Committee
A. In doing so, we note that the document was apparently considered
by the Environment Council on 24 June, but that, since the Council
was unable to reach an opinion on it by the necessary qualified
majority, it has now been referred back to the Commission, in
accordance with the relevant rules of procedure.
1 OJ No. L.117, 8.5.90, p.15. Back
2
OJ No. L.106, 17.4.01, p.1. Back
3
(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). Stg Co
Deb, European Standing Committee A,24 March 1999. Back
4
The two earlier proposals were (25336) 5916/04; see HC 42-xii
(2003-04), para 1 (10 March 2004); Stg Co Deb, European
Standing Committee C, 26 April 2004, and (25530) 8235/04; see
HC 42-xx (2003-04), para 1 (18 May 2004); Stg Co Deb, European
Standing Committee C, 21 June 2004. Back
5
These related to such matters as molecular characterisation, agronomic
equivalence, sampling methods, antibiotic resistance marker gene,
allergenicity, toxicity, and monitoring of the product. Back
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