Brussels, 28 January 2004
GMOs: Commission takes stock of progress
The European Commission today held an orientation debate on Genetically Modified Organisms (GMOs) and related issues to take stock of the progress made over the last years in building a comprehensive EU regulatory framework on GMOs. It also endorsed the approach ensuring the correct application of the new EU legislation throughout the EU.
"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," said Commission President Romano Prodi.
The Commission approved the proposal to authorize a GM sweet corn BT11 for food use which will now be forwarded to the Council for a decision.
It also agreed to submit a draft authorization of GM maize NK603 to the Regulatory Committee, composed of the Member States, for a decision in February.
Furthermore the Commission agreed on the need to address at the EU level the individual safeguard measures on GMOs which have been adopted by various Member States.
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.
The Commission also discussed national measures on coexistence. Since coexistence deals only with GMOs that have been authorised in the EU - and are therefore considered to be safe from the environmental and human health point of view 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. However, the Commission noted that GM free zones are possible, if farmers decide to produce without GMOs on a voluntary basis. It insisted that 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 underlined that Member States are legally obliged to notify all national or regional measures on coexistence to the Commission.
Furthermore, the Commission intends to step up its coordination role and actively support an exchange of best practices and information regarding coexistence.
More information on EU policies and legislation on GMOs can be found at:
COMMUNICATION TO THE COMMISSION (from the President in association with Mrs Wallström, Mr Byrne, Mr Fischler, Mr Lamy, Mr Liikanen and Mr Busquin)
For an orientation debate on Genetically Modified Organisms and related issues
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
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
The new regulatory framework for GMOs has been completed. Directive 2001/18/EC, 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° 1829 and 1830)
However, despite the 'interim approach':
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
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.
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,
The Commission is invited to endorse the approach set out in the above part 4 of this paper.
(1)COM(2002)27. 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 1829/2003 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 1830/2003 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 2001/18/EC (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 98/34/EC
(9) Notification of a regional Act by the Austrian region Carinthia under Directive 98/34/EC
(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