Washington, 29 Jan 2004

The European Commission today sent a strong signal to European Union member states and trading partners that it is in favor of moving ahead with authorizations of genetically modified (GM) varieties and that it is committed to fulfilling its international obligations while respecting the health and environmental concerns of European consumers.

The Commission took two concrete steps on this road today:

It approved the proposal to authorize a GM sweet corn BT11 for food use which will now be forwarded to the EU Council of Ministers for a decision.

Taking the first step required for authorization, it agreed to submit a draft authorization of GM maize NK603 to the Regulatory Committee of EU member states for a decision in February.

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The Commission believes that it is necessary and possible to move ahead with the authorizations process now that a clear regulatory framework is in place for GM food and feed, following the publication of legislation on traceability and labelling of GMOs [Genetically Modified Organisms] in October.

In a comment today, EU Commission President Romano Prodi said: "The EU has put in place a clear, transparent and stringent system to regulate genetically modified food, feed and plants. Our legislation ensures that GMOs authorised in the EU are safe for human consumption and for the release into the environment. Clear labelling rules allow farmers to choose what to plant and consumers to choose what to buy. It is only logical that this safe system continues to be applied in practice and that the EU moves ahead with pending authorisations."

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On the individual safeguard measures adopted by various EU member states, the Commission agreed today on the need to address at the EU level. The Commission was also in favour of proposing labelling thresholds for the adventitious presence of GM seeds in non-GM varieties in the near future.

Regarding coexistence the outcome of the discussion was:

• a blanket ban of all GMOs that could not be justified in terms of protection of human health and the environment would not be in conformity with EU law as coexistence deals only with GMOs that have been authorised in the EU¡ª and are therefore considered to be safe from the environmental and human health point of view;
• GM free zones are possible, if farmers decide to produce without GMOs on a voluntary basis;
• national coexistence measures had to be proportionate, taking into account the characteristics of the specific crop, rather than imposing general restrictions on cultivation;
• the Commission intends to step up its coordination role and actively support an exchange of best practices and information regarding coexistence.

The Commission underlined that member states are legally obliged to notify all national or regional measures on coexistence to the Commission. More information on EU policies and legislation on GMOs can be found at: echnology/gmfood/index_en.htm and at: .

COMMUNICATION TO THE COMMISSION
(from the President in association with Mrs. Wallstr?m, Mr. Byrne, Mr. Fischler, Mr. Lamy, Mr. Liikanen and Mr. Busquin) For an orientation debate on Genetically Modified Organisms and related issues

Introduction

In the last years, the Commission, in close dialogue with Member States and all stakeholders, have invested considerable time and energy in building a comprehensive regulatory framework on genetically modified organisms (GMOs) aimed at restoring the confidence of consumers and public at large. These efforts are also essential elements of the Commission's ongoing strategy for life sciences and biotechnology(1), aiming at making sure that the EU is able to harvest the potential of this high-technology area while ensuring its governance in a balanced and responsible manner. Now that the necessary legislative decisions have been taken and the appropriate procedures have been put in place it is important to demonstrate to the European public and to our trade partners that the EU system of authorisation is working as designed. A clear and predictable legal framework is also crucial in order to reverse the exodus of researchers and the rapid decline in GMO field research in the EU and the consequent negative repercussions in innovation and competitiveness of the European biotechnology industry, while addressing legitimate public concerns.

The purpose of this Communication is

• to inform the Commission on the progress made since the last Commission debate on GMOs of 12 July 2000 and on forthcoming proposals for decisions related to GMOs, including their potential timing, and
• to draw the attention of the Commission to the evolution of the political background on GMOs which needs further consideration.

Progress since 2000

The "interim approach" on GMOs

The last Commission orientation debate on GMOs took place on 12 July 2000.

On that occasion, the Commission agreed on an 'interim approach' for relaunching the authorisations of GMOs, entailing the anticipation of the key provisions (labelling, traceability, monitoring etc) of the forthcoming new environmental legislation. The new requirements would be incorporated into the individual authorisations of GMOs granted under existing legislation. In addition, it was agreed that a package of new measures on GMOs, namely on GM food and feed and on labelling and traceability of GMOs be proposed by the Commission by autumn 2000. The College took note of the pending national safeguard measures adopted by 7 Member States (AU, FR, D, GR, IT, LUX and UK), which affect the marketing and import of several GM products that have been duly authorised at the EU level.

Implementation of the 'interim approach' since 2000

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The new regulatory framework for GMOs has been completed. Directive , which provides for a more complete authorisation procedure for GMOs, has been fully applicable since 17 October 2002(2). The two proposals on genetically modified organisms (GMOs), establishing a comprehensive Community system to trace and label GMOs and to regulate the placing on the market and labelling of GM food and feed have been adopted by the Council and EP and will be fully applicable by April 2004(3). Work on the finalisation on a number of additional implementing measures is progressing smoothly and no delay are envisaged at this stage (i.e. adoption of the measures by the entry into application of Regulations (EC) N¡ã 1829 and 1830)

However, despite the 'interim approach':

no authorisations have been granted since October 1998(4);
no formal decision was taken over the past years in relation to the national safeguard measures on GM products already authorised at EU level.(5) At present, work is progressing in finalising a decision aiming at repealing the national safeguard measure under the Novel Food regulation (Italy), while other nine national safeguard clauses invoked under environmental legislation (Austria, France, Germany, Luxembourg, Greece and UK) are pending. Member States have been officially requested to withdraw the above measures and to lift the relevant restrictions.

To date,

Authorisation procedures under the Novel Foods Regulation are being finalised in line with the interim approach agreed on 12 July 2000 by anticipating the key forthcoming provisions agreed by the Council (i.e. labelling, traceability, monitoring, etc) into individual authorisations of GMOs. Furthermore, Article 46(1) of the new Regulation on GM food and Feed provides that applications made under the Novel Foods Regulation, which have received a final scientific assessment before the coming into application of the new Regulation, are still to be processed under the Novel Foods Regulation. In line with the above, a proposal for the authorisation of GM sweet maize Bt11 was presented to the Regulatory Committee on 8 December, where a qualified majority in favour was not reached(6). In accordance with Comitology procedures, a proposal referring the authorisation back to the Council was prepared for adoption by the Commission; the written procedure(7) was suspended on 12 January.

Applications under Directive are currently being processed in accordance with the authorisation procedure. A meeting of the Regulatory Committee will be called on 18 February in order to consider for approval the most advanced of the above 22 applications in the procedure. This is the Monsanto NK603 GM maize for which the EFSA Panel adopted a favourable opinion (pursuant to Directive and Novel Food Regulation ). This application is for import and processing only. It does not include cultivation as a requested use.

Work is being progressed in the framework of the seed legislation where 23 GM maize varieties inscribed in national catalogues should be inscribed into the Common Catalogue of agricultural plant species. Discussions are finalised for 10 varieties, allowing the Commission to proceed with their inscription.

The new political background

WTO challenges on GMOs

A WTO panel was established on 29 August 2003 at the request of US, Canada and Argentina to rule on the matter of GMOs.

The focus of the WTO complaint is neither the EU legislation on GMOs and GM food approval, nor the recently adopted legislation on traceability and labelling and GM food and feed, but rather the Community's alleged inaction on GMO issues. The WTO panel will be asked to pronounce itself on the compatibility of the Community and Member States measures with relevant provisions of WTO law. The measures as identified by the complainants consist in particular of

Community's suspension of consideration and failure to approve applications for authorisation of GM products, which the complainants allege as caused by undue delays on the part of Community's institutions in the application of Community's legislation; national marketing and import bans (i.e. national safeguards), which according to the complainants are maintained by Member States also in infringement of Community legislation.

New national measures on GMOs

Against the above background, as a reaction to the completion of the legislative framework, a number of Member States are taking steps allegedly to protect their commercial organic and conventional sector by pursuing any available power they retain under Community legislation to operate the most restrictive policy possible in relation to GM crops cultivation(8).

This includes the adoption of national measures on co-existence which are being notified to the Commission in an increasing number. The measures included in the first notifications aimed either to set GM free regions or to limit (as much as possible) cultivation of GMOs by setting strict measures to be complied with at national/regional level. In December 2003 the Commission has recognised that, for the first time, the main principles laid down in the Commission's recommendation on co-existence have been taken into account in a notification, even though additional conditions would need to be fulfilled in order to make the notified measures acceptable to the Commission(9).

The Commission services are also aware of non notified co-existence measures, taken at national, regional or local level which might contradict Community legislation and could require infringement procedures.

Many Member States are now seeking clarification on what sort of co-existence measures would be legally acceptable. Indeed, through those notifications of national measures, Member States are testing the limits how far they can go in establishing GM-free zones. Amongst other issues, the volume of notifications will also test our capacity to process them within the tight deadlines provided.

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Based on legal and scientific considerations, and the case-by-case approach of the environmental legislation, the adoption of blanket policy aimed to make a Member States or any particular part of it "GM-free" would not be acceptable when seeking to impose conditions that could not be justified in terms of protection of human health and the environment. However, from a political point of view it could be difficult to reject these attempts at establishing GM-free zones, which are driven by strong public local concern and economic considerations (such as protection of local traditional agriculture), without offering some alternative solutions together with the necessary legal clarity and guidance to address their concerns and considerations.

The way forward

The EU must demonstrate that its regulatory regime is being properly applied and implemented in a transparent, scientific and rational manner. With regard to the EU defence in the WTO panel, it is essential to ensure by all necessary means that EU legislation is complied with. Procedures should be shown to be operating as intended in a co-ordinated coherent way. This presupposes a number of actions by the Commission in the short run.

In the light of the above,

Decisions aiming at authorising GMOs under Novel Food Regulation and Directive should be submitted to a vote as soon as procedures are finalised. In case of inconclusive opinion of the Regulatory Committee, the issue should be transmitted to the Council in accordance with the appropriate Comitology procedure; In particular, the Commission should transmit without delay the proposal relating to the authorisation of GM sweet maize Bt11 to the Council(10); in case the Council fails to take a decision on the GM sweet maize Bt11 within the 3-months statutory period, the Commission should adopt the decision; submit a draft decision authorizing GM maize NK603 to the Regulatory Committee under Directive in February. In case of inconclusive opinion of the Regulatory Committee, the issue should be transmitted to the Council without delay.

In relation to the pending national safeguard measures, decisions(11) aimed at repealing the safeguard measure invoked both under Novel Food regulation (i.e. Italy) and under environmental legislation (i.e. Austria, France, Germany, Luxembourg, Greece and UK) should be finalised and submitted to the vote in absence of reaction of the Member States concerned. In case of negative opinion of the Regulatory Committee, the issue should be transmitted to the Council in accordance with the appropriate Comitology procedure.

In relation to the notifications of national measures on co-existence, aside from its role as watchdog of the Treaty, the Commission should enhance its co-ordination role as defined in Directive , in order to smooth any potential problems linked to the development of co-existence strategies by Member States.

Member States should be made aware of the legal obligation of notifying their measures on co-existence.

Commission services should elaborate on the interpretation of the co-existence guidelines and establish a coexistence network with all Member States to share information.

For the purpose of ensuring absolute legal clarity, labelling thresholds for the adventitious or technically unavoidable presence of authorised GM seeds in seeds of non-GM varieties should urgently be finalised under the environmental legislation and submitted to the vote (in the Regulatory Standing Committee). Identical thresholds should then be adopted under the seed legislation (in the Management Committee); the setting of specific thresholds under the organic farming regulation should be studied by the Commission services, and recommendations or proposals, as appropriate, submitted to the Commission.

Conclusion

The Commission is invited to endorse the approach set out in the above part 4 of this paper.

(1) COM(2002). The strategy was endorsed by the EP and by the Council.

(2) To date only 6 MS have transposed the Directive, namely UK, DK, SW, P, IRL and IT.

(3) Regulation (EC) No of the EP and of the Council of 22.9.2003 on genetically modified food and feed (OJ L268, 18.10.2003, p.1). Regulation (EC) No concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive (OJ L268, 18.10.2003, p.24).

(4) With the exception of notifications under the simplified procedure of the Novel Foods Regulation (derogation from the full authorisation procedure).

(5) It is important to note that the decisions to take on the national safeguard measures are not decisions to initiate infringement procedures, but a mere application of the relevant legislation in order to guarantee that all GM products are treated in the same way all throughout the EU. In the context of infringement procedures, the Commission can freely decide whether or not any action should be undertaken; this is not the case as regards national measures adopted pursuant to safeguard clauses in harmonisation instruments.

(6) Spain, Ireland, UK, The Netherlands, Finland and Sweden in favour; Belgium, Italy and Germany abstained; France, Austria, Greece, Portugal, Denmark and Luxembourg against.

(7) PE E/2661/2003 doc. COM(2004)10 of 6.1.2004-which is now part of this Commission debate.

(8) Measures have been notified under Article 95 of the Treaty and/or Directive .

(9) Notification of a regional Act by the Austrian region Carinthia under Directive .

(10) Written procedure E/2661/2003 see point 10 of the Commission meeting agenda.

(11) Individual decisions will be presented to the College for adoption by written or oral procedure, as appropriate.

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Item source: 20040010.htm

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