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Council Conclusions on GMO Directive 90/220 and Moratorium



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These are the official minutes of the Environment Council 24 June 1999. Political agreement on the revision of 90/220 means that final legal and translation work needs to be done and it can then be formally adopted at any Council meeting, probably in September/October. Then it comes back to the EP for second reading, probably in January 2000. If the EP passes further amendments, council has to decide whether to accept or go to conciliation-say another three months. If not, it becomes law after publication in the Official Journal. Member states then have 18 months to transpose it into national law.
Unless they all complete the transposition very fast, the de facto moratorium will last at least until mid 2001. Two years minimum but experience suggests it always takes longer.
Detailed analysis of the common position text to follow next week, I hope.

Steve

DELIBERATE RELEASE OF GENETICALLY MODIFIED ORGANISMS
The Council reached a political agreement, with France, Ireland and Italy abstaining, in view of a common position on the proposal to amend Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (GMOs).
The Directive deals with experimental releases of GMOs (deliberate releases for any other purpose than for placing on the market which are in principle limited to individual Member States) in its Part B and placing on the Community market of GMOs in its Part C.
Before any of the (Part B and C) procedures leading to first-time consents is initiated, an environmental risk-assessment based on common principles has to be carried out.
Each Part comprises a standard procedure at the end of which the "lead" competent authority (i.e. the one having received a notification) gives its consent for the deliberate release or the placing on the market. Whilst only one national competent authority is responsible of granting a consent for the standard procedure under Part B, all the competent authorities are involved for the differentiated (simplified) procedure under Part B and the standard procedure under Part C.
For the placing on the market, which involves all the Member States, consent is given only where possible objections have been answered or a decision has been taken by committee procedure and if the lead competent authority is not opposed to the proposed placing on the market. Consent is given following extensive consultation (public, scientific committees) and for a maximum period of 10 years for the initial consent. It specifies mandatory monitoring and labelling requirements.
Under Part B, the standard procedure is complemented by a differentiated one in terms e.g. of information requirements or time-periods whereby, following mandatory consultation of Scientific Committees and public, a committee defines differentiated (in terms of information, time-period, ..) procedures which could subsequently apply to releases meeting certain safety criteria where sufficient experience exists;
Additional procedures are foreseen for the renewal of consents and the handling of consents given under the existing Directive, and for monitoring and handling of new information and objections to GMOs which have already received consents.
Part C requirements do not apply to products authorised by other Community legislation which is "equivalent" as regards risk assessment, risk management, monitoring as appropriate, labelling information to the public and safeguard clause, to this Directive.
Whenever decisions by committee are called for, they follow a Regulatory procedure.
As for labelling, it must be stated clearly that "this product contains genetically modified organisms". The compromise allows threshold levels to be established for each product concerned by the Commission, under the Comitology procedure.
Finally, the text provides for a mandatory consultation of the public for part B and part C both for standard and differentiated procedures. 
Declarations made by Member States and the Council can be found in the Annex.

Declaration by the Council and the Commission
The Commission and the Council note the reason underlying the position adopted by Ireland at this time on the proposed amendment of Directive 90/220/EEC, i.e. the need to complete its national consultation process on GMOs and the environment.
In the interests of achieving as wide a consensus as possible, the Commission and the Council will be sensitive to points which Ireland might raise as a result of the consultation process during the proposal's second reading.
Déclaration sur la suspension de nouvelles autorisations OGM des délégations danoise, française, grecque, italienne et luxembourgeoise
Les gouvernements des Etats membres suivants (Danemark/France/Grèce/Italie/Luxembourg), dans le cadre de l'exercice des pouvoirs qui leur sont conférés en matières de mise en culture et de mise sur le marché d'OGM.
considérant la nécessité de mettre en oeuvre un cadre plus rigoureux et plus transparent, en particulier pour l'évaluation des risques, prenant en compte la spécificité des écosystèmes européens, la surveillance, l'étiquetage,
considérant la nécessité de restaurer la confiance de l'opinion publique et du marché,
soulignent l'importance que la Commission présente sans délai un projet complet de réglementation garantissant un étiquetage et une traçabilité des OGM et des produits dérivés et déclarent que dans l'attente de l'adoption de cette réglementation en conformité avec les principes de prévention et de précaution, ils feront de sorte que les nouvelles autorisations de mise en culture et de mise sur le marché soient suspendues."
Statement by the Austrian, Belgian, Finnish, German, Netherlands and Swedish delegations
Being aware of the increasing public concern about the potential risks to health and environment linked to the release and the placing on the market of GMOs, the above-mentioned delegations
	- stress the need to implement a more transparent and strict framework concerning critical issues such as risk assessment taking into account the specificity of European ecosystems, monitoring and labelling as well as the need to restore the trust of public opinion and of the market;
- reaffirm their intention to work for a rapid finalisation of the legislative process concerning the proposal for an amendment of Directive 90/220/EEC and invite the European Parliament to join the Council and the Commission in their intention so that the legislative process can be rapidly finalised.
Against this background the Governments of these Member States, having regard to the precautionary principle set out in Article 174(2) of the Treaty, intend:
	- to take a thoroughly precautionary approach in dealing with notifications and authorisations for the placing on the market of GMOs,
- not to authorise the placing on the market of any GMOs until it is demonstrated that there is no adverse effect on the environment and human health, and
- to the extent legally possible to apply immediately the principles, especially regarding traceability and labelling, laid down in the political agreement for a revision of Directive 90/220/EEC reached by the Council on 24/25 June 1999. 
Therefore, these delegations invite the Commission as a matter of urgency to make a proposal for effective implementation of the provisions regarding labelling and traceability of GMOs through the comitology procedure foreseen in Directive 90/220/EEC.
These delegations welcome the intention of the Commission in the context of the forthcoming white paper on liability to assess the question of liability for environmental damage linked to the deliberate release and placing on the market of GMOs.
These delegations take note of the possibility for Member States to introduce national measures in conformity with the new provisions laid down in paragraphs 5, 6 and 7 of Article 95 of the EC Treaty."

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Steve Emmott
Policy Advisor-Genetic Engineering
Green Group in the European Parliament
1047 Brussels

Tel +32 2 284 2026
Fax +32 2 284 2026
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