THE DELIBERATE RELEASE INTO THE ENVIRONMENT
OF GENETICALLY MODIFIED ORGANISMS
(21298)
8712/00
COM(00) 293
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Commission Opinion on the European Parliament's amendments to the Council's Common Position on the draft Directive on the deliberate release into the environment of genetically modified organisms, and repealing Council Directive 90/220/EEC.
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| Legal base: |
Article 95 EC; co-decision; qualified majority voting
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| Document originated:
| 16 May 2000 |
| Forwarded to the Council:
| 17 May 2000 |
| Deposited in Parliament:
| 5 June 2000 |
| Department: |
Environment, Transport and the Regions
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| Basis of consideration:
| EM of 21 June 2000 and Minister's letter of 20 July 2000
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| Previous Committee Report:
| None, but see paragraphs 14.1 and 14.2 below
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| To be discussed in Council:
| No date known |
| Committee's assessment:
| Politically important |
| Committee's decision:
| Cleared |
Background
14.1 Council Directive 90/220/EEC[28]
deals with the deliberate release into the environment of genetically
modified organisms (GMOs), and established a system of control
requiring prior consent from a Member State competent authority
for any such releases for research and development, and approval
at Community level before any product containing GMOs can be placed
on the Community market. In February 1998, the Commission put
forward a proposal making a number of significant amendments to
the procedures for both kinds of release. We reported on this
proposal on 29 April 1998 and 9 December 1998[29],
following which the subject was debated in European Standing Committee
A on 24 March 1999[30].
14.2 The Commission subsequently put forward
in March 1999 a revised proposal[31],
incorporating about half of the 77 amendments suggested by the
European Parliament at its first reading on 11 February 1999.
In the light of information subsequently provided by the Government,
we cleared this document at our meeting on 23 June 1999, and we
subsequently noted in our Report of 21 July 1999 that the Government
had told us that political agreement had been reached at the Environment
Council on 24 June 1999 on a text which the UK strongly supported.
We were also told that the Council's Common Position was likely
to be formally adopted during September or October 1999, and we
were subsequently informed by the Department of the Environment,
Transport and the Regions that adoption eventually took place
at the Council on 9 December 1999.
The current document
14.3 The current document comprises the
Commission's Opinion on the 29 amendments to the Common Position
text put forward by the European Parliament at its second reading
on 12 April 2000. The Commission had indicated that, whilst 16
of these amendments were not acceptable, it could accept four
in total and a further nine in principle, and we subsequently
received an Explanatory Memorandum of 21 June 2000 from the Minister
for the Environment at the Department of the Environment, Transport
and the Regions (Mr Meacher), in which he reiterated the UK's
strong support for the Common Position, and its wish to see rapid
progress in adopting the revised Directive. He went on to say
that, with this in mind, the UK could accept those European Parliament
amendments which provided clarification, or were consistent with
the principles of the Common Position, but that it would need
to consider its position on a number of the Parliament's amendments
in the light of the negotiation with other Member States and Members
of the European Parliament. However, since the Minister did not
indicate which of the amendments fell into which category, we
asked him to be more specific before we considered the document.
Minister's letter of 20 July 2000
14.4 The Minister has now provided the further
information we asked for in his letter of 20 July 2000. He says
that a large number of the Parliament's 29 amendments appear to
be broadly consistent with the Common Position, and that it is
likely the Council will be able to accept these, either in full
or by negotiating compromises with the Parliament. However, he
identifies the following amendments as differing, or departing
significantly from, the Common Position:
- whereas the Common Position merely requires the
Directive in general terms to take account of international experience
in this field, the Parliament also wishes it to oblige the Commission
to submit amendments which would reflect the requirements of the
Cartagena Biosafety Protocol (concluded in Montreal in January
2000): the Minister says that, whilst he believes it is important
to reflect the Protocol in the Directive, Member States will need
to consider whether specific requirements related to the Protocol
should be dealt with in legislation other than Directive 90/220/EEC,
or in separate proposals for an amendment to this Directive;
- the Parliament has proposed that the Commission
should be required to bring forward general Community-wide rules
on environmental liability arising from GMO releases, as proposed
in its recent White Paper[32]
on the subject: the Minister says that, whilst the Government
believes the Commission should study this possibility, it has
not yet formed a view on whether a general régime would
be appropriate;
- the Parliament has proposed that a long term
aim should be the creation of a centralised procedure for the
release of GMOs: the Minister says that this would have the advantage
of having a single entry point for release authorisations, which
would simplify the regulatory process, but that this may not take
into account considerable differences in agriculture in Member
States;
- the Parliament has proposed that risk management
and labelling should be added to the list of requirements equivalent
to those in Directive 90/220/EEC in order for medicinal products
covered by other Community legislation to be exempt from the part
of this Directive dealing with the placing of GMOs on the market:
the Minister points out that, whilst this would have the benefit
of allowing all GMOs to be treated in the same way, a slightly
different treatment may be justified in the case of medicinal
products, and that those already regulated must have an equivalent
environmental risk assessment and are subject to different, but
stringent labelling and monitoring requirements;
- whilst the Common Position text stipulates that
the 10 year period for marketing authorisations should commence
as soon as a consent is granted, the European Parliament has suggested
that this period should not start until after first registration
of the final product, so as to discount the time taken for industry
to comply with additional regulations (such as on the National
List for seeds) following the granting of a release consent under
Directive 90/220/EEC, and thus allow a full 10 years for marketing:
however, the Minister points out that this would create legal
uncertainty, and he believes that, in order to provide predictability
and transparency in the regulatory system, consents should begin
when they are issued;
- the Parliament has suggested a new provision
under which the locations of GMOs grown should be recorded in
public registers: the Minister points out that this would benefit
traceability and accessibility, but undermine the principle of
a single market for marketing releases, and increase the risk
of criminal damage.
The Minister has also pointed that, whilst the Commission
can accept in principle the amendments set out in the first two
indents above, it is opposed to the others.
Conclusion
14.5 We are grateful to the Minister
for this further information, on which we have no comments. Because
of this clarification and the extensive consideration which has
already been given to this proposal, we are now clearing this
document.
28 OJ No. L 117, 8.5.90, p.15. Back
29 (18909)
6378/98; HC 155-xxvi (1997-98), paragraph 5 (29 April 1998) and
HC 34-iii (1998-99), paragraph 1 (9 December 1998). Back
30 Official
Report, European Standing
Committee A, 24 March 1999. Back
31 (20036)
7138/99; HC 34-xix (1998-99), paragraph 6 (12 May 1999), HC 34-xxiii
(1998-99), paragraph 6 (23 June 1999) and HC 34-xxvii (1998-99),
paragraph 9 (21 July 1999). Back
32 (21012)
6230/00; HC 23-xiii (1999-2000), paragraph 1 (5 April 2000).
See also Official Report, European Standing Committee A,
14 June 2000. Back
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