2 Marketing of maize genetically modified
for resistance to certain pests and herbicides
| (26698)
10785/05
COM(05) 284
| Draft Council Decision concerning the placing on the market, in accordance with Directive 2001/18/EC, of a maize product (Zea mays L. line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium
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| Legal base | Article 18(1) of Directive 2001/18/EC; QMV
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| Document originated | 29 June 2005
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| Deposited in Parliament | 6 July 2005
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 14 July 2005
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| Previous Committee Report | None, but see footnote 5
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | For debate in European Standing Committee A (together with the draft Decision relating to maize genetically modified for resistance to corn rootworm)
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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,[5]
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 The Directive has now been replaced by Directive 2001/18/EC,[6]
which introduces a number of procedural changes,[7]
and this document —
which would permit the importation and use of a maize product
genetically modified for resistance to certain lepidopteran pests
and for tolerance to the herbicide glufosinate-ammonium —
is the latest proposal for a consent to be granted under the new
Directive, following an application submitted to the relevant
Netherlands authority. It does not, however, cover the cultivation
of the product, or its use as (or in) food, which would be subject
to separate consideration.
The current proposal
2.2 Under the procedure laid down, the Netherlands
authority conducted an initial assessment of the notification
submitted to it in February 2003, and concluded that there were
no reasons to withhold consent for the placing on the market of
the product in question, provided certain conditions were met.
This assessment was subsequently transmitted in August 2003 to
the Commission and to the other Member States, some of which raised
and maintained objections.[8]
The Commission therefore consulted the European Food Safety Authority
(EFSA), which assessed the available information, and concluded
in September 2004 that 1507 maize is unlikely to have any adverse
effect on human or animal health or, in the context of its proposed
use, on the environment. It also found that the monitoring plan
provided by the applicant was in line with the intended uses.
2.3 In view of this, the Commission published a draft
Decision, authorising the use of this product, subject to certain
conditions, including a requirement for post-market monitoring,
and a provision preventing the granting of a consent unless and
until an authorisation for the use of 1507 maize in human food
is approved. However, when that draft Decision was considered
by Member States' officials in the appropriate Regulatory Committee
on 17 May 2005, the vote was inconclusive, and, under the relevant
rules of procedure, it has now been referred to the Council for
a decision. If a sufficient majority either to adopt or reject
the proposal is not forthcoming in the Council within three months,
it will be referred back to the Commission for a final decision.
The Government's view
2.4 In his Explanatory Memorandum of 14 July 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 has consulted the statutory Advisory
Committee on Releases to the Environment (ACRE), which in turn
has sought comments from the relevant sub-group of the Advisory
Committee on Animal Feedingstuffs. He says that, notwithstanding
the views expressed by some other Member States, ACRE concluded
in February 2004 that "sufficient information has been provided
by the notifier to demonstrate that import and use of 1507 maize
does not pose a greater risk to human health and the environment
than non-GM maize" ACRE also said that, whilst it did not
consider that case-specific monitoring was required, consent for
release should be conditional on the notifier providing a more
detailed general surveillance plan for monitoring the safety of
1507 maize as animal feed before it is imported into the Community,
and it recommended that monitoring reports should be provided
by the applicant on an annual basis. The Minister says that these
concerns were reflected in the opinion which the UK subsequently
issued on the proposal, and that they have been met by the coming
into force of Regulation (EC) No. 1830/2003 on traceability and
labelling. He also describes as "prudent" the condition
attached to the Commission Decision, under which consent would
not be granted unless and until a separate authorisation for the
use of 1507 maize in human food is approved, in that this ensures
that authorisations for animal feed and food uses will remain
in step with one another.
Conclusion
2.5 As we noted in our Report of 4 July in connection
with the authorisation of the marketing of a maize product genetically
modified for resistance to corn rootworm,[9]
any such proposal is inevitably of public concern, and gives rise
to differences of view between Member States. In view of this,
we concluded that, 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,
that proposal should be debated in European Standing Committee
A. Since similar considerations apply in the case of the current
document, we believe that it too should be debated, and that the
two documents should be debated together in European Standing
Committee A.
5 OJ No. L.117, 8.5.90, p.15. Back
6
OJ No. L.106, 17.4.01, p.1. Back
7
(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
8
These related to such matters as molecular characterisation, detection
methods, allergenicity, toxicity, and monitoring and traceability. Back
9
(26536) 8635/05; see HC 34-i (2005-06), para 2 (4 July 2005). Back
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