Annexes to COM(2010)380 - Freedom for Member States to decide on the cultivation of genetically modified crops - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2010)380 - Freedom for Member States to decide on the cultivation of genetically modified crops. |
|---|---|
| document | COM(2010)380  |
| date | July 13, 2010 |
2.2. Other elements linked to the EU framework of GMO authorisation
It should also be noted that the existing legislative framework on GMOs consists of a clear European Union wide authorisation system, based on a scientific risk assessment. It is possible in principle to differentiate between regions in the risk assessment, on the basis of scientific arguments[9]. If the risk assessment concludes that the cultivation of a GMO raises particular regional concerns, these concerns must be addressed in the EU authorisation through specific conditions or risk management measures. Such measures may include restriction or prohibition measures, if scientifically justified.
Regulation (EC) No 1829/2003 also provides for the possibility for the Commission to take into account legitimate factors other than science in the context of the procedure of authorisation of GMOs to restrict or prohibit their placing on the market However, justifications for such restrictions need to be specific to each GMO and can only be taken into account at the moment of the adoption of the decision of authorisation of the GMO in question. In addition this possibility does not exist under Directive 2001/18/EC and would thus not be applicable to GMOs authorised under this Directive.
Therefore, it appears that the existing framework within which scientific arguments or other legitimate factors may be applied to justify restrictions or prohibitions of GMO cultivation, does not provide the necessary freedom for Member States to decide whether or not they wish to cultivate GMOs in their territory on the basis of their specific conditions.
3. LEGISLATIVE AMENDMENT TO INTRODUCE AN "OPT-OUT CLAUSE"
A certain number of Member States want to have the possibility to opt-out from GM cultivation. So far, several of these Member States have banned the cultivation of GMOs on the basis of the safeguard clause set out in Article 23 of Directive 2001/18/EC or the emergency measures referred to in Article 34 of Regulation (EC) No 1829/2003, which are solely intended to address new risks emerging after an authorisation has been granted. As a result, these measures were not considered to be scientifically justified by the European Food Safety Authority (EFSA). Similarly a certain number of regions have declared themselves to be “GM-free”.
The reasons for banning GMOs in a country or declaring a region GM-free appears to be diverse. These reasons vary from agronomic justifications related to difficulties of ensuring co-existence to political or economic motivations such as meeting the demand of GM-free markets. In other cases, Member States want to preserve certain areas in line with national policies on biodiversity or other broad nature conservation goals.
The Netherlands submitted a declaration to the 23 March 2009 Agriculture and Environment Councils[10] asking the Commission to come forward with a solution on cultivation while taking into account the socio-economic dimension of GMO cultivation and keeping the internal market for GM food and feed products. Austria, supported by twelve Member States[11], presented in the Environment Council of 25 June 2009 a paper[12] that underlined the subsidiarity issue linked to cultivation and suggested an opt-out clause for cultivation to be introduced in the legislation.
In this context it appears appropriate to amend EU legislation in order to provide in the EU legislative framework on GMOs an explicit legal base to authorise Member States to restrict or prohibit the cultivation of all or particular authorised GMO in part or all of their territories on the basis of their specific conditions. This amendment can be done through the inclusion of a new Article 26b in Directive 2001/18/EC and would be applicable to all GMOs which have been authorised for cultivation in the EU, being under Directive 2001/18/EC or under Regulation (EC) No 1829/2003.
According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the EU cannot be revised by a Member State and this situation must not be altered. However, with the new legal base, Member States will be able to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds other than those already addressed by the harmonised set of EU rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment.
Moreover, these national measures will have to be in conformity with the Treaties in particular the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union concerning the free circulation of goods. Measures should refer to the cultivation of GMOs only and not to the free circulation and import of genetically modified seeds and plant propagating material and the products of their harvest. These measures shall also be consistent with EU international obligations, notably those in the context of the World Trade Organisation. To ensure transparency, Member States which intend to adopt measures will have to communicate them, together with their reasons, to the Commission and to the other Member States one month prior to their adoption.
Member States would be further free to amend these measures as they deem appropriate at all stages of the authorisation or re-authorisation of the concerned GMOs.
In summary, this new legal basis does not change the system of EU authorisations of GMOs but it would allow Member States to adopt measures which would be applicable to GMOs which have been authorised under the existing legislation. It is thus a further option for Member States to adopt measures in relation to authorised GMOs, in addition to the measures that they are already entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other crops.
Therefore, and on the basis of the above principles, the Commission has decided to submit to the European Parliament and the Council a legislative proposal which takes the form of a Regulation amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
4. CONCLUSIONS
THE COMMISSION CONSIDERS THAT THIS NEW APPROACH IS NECESSARY TO achieve the right balance between maintaining the EU system of authorisations based on scientific assessment of health and environmental risks and the need to grant freedom to Member States to address specific national, regional or local issues raised by the cultivation of GMOs.
As a first step a revision of the existing Recommendation on co-existence (2003/556/EC) will better reflect the possibilities offered to Member States to adopt measures to avoid unintended presence of GMOs in conventional and organic crops in accordance with the existing legislative framework.
In a second step, the adoption of the legislative proposal providing the possibility for Member States to restrict or prohibit, under certain conditions, the cultivation of all or particular GMOs in part or all their territory by the European Parliament and the Council will offer the possibility to Member States to address specific national or local issues raised by the cultivation of GMOs independently of the authorisation process. This approach on GMO cultivation, while preserving the European Union authorisation system of GMOs, which will continue to apply, as well as the free circulation and import of GM food, feed and seeds, is expected to address the demands of several Member States, and receive stakeholders and public support. It is also in line with the observation of the reality of Member States' practice on GMO cultivation so far and the principle of subsidiarity and proportionality. Meanwhile, the Commission will continue to apply the existing EU legislative framework on GMOs. In this context, and in line with Article 31 of Directive 2001/18/EC, the reports on the implementation of the Directive will pay particular attention to experience acquired with regard to Article 26a and 26b.
The new Recommendation on guidelines for the development of national cultivation measures to avoid the unintended presence of GMOs in conventional and organic crops and a legislative proposal modifying Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory, are annexed to this Communication.
[1] OJ L 106, 17.4.2001, p. 1.
[2] OJ L 268, 18.10.2003, p. 1.
[3] OJ L 268, 18.10.2003, p. 24.
[4] Maize MON 810 has been prohibited by AT, HU and LU on the basis of Article 23 of Directive 2001/18/EC, EL on the basis of Article 23 of Directive 2001/18/EC and Article 18 of Directive 2002/53/EC, FR and DE on the basis of Article 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) No1829/2003. Maize T 25 has been prohibited by AT on the basis of Article 23 of Directive 2001/18/EC. Amflora Potato has been banned by AT, HU and LU on the basis of Article 23 of Directive 2001/18/EC.
[5] PL has also adopted a legislation prohibiting in general the marketing of GM seeds which was not based on the safeguard clauses set out in EU legislation. On 16 July 2009 the Court of Justice of the EU issued a judgement whereby it considered that legislation contrary to EU law and condemned Poland for failure to fulfil its obligations (case C-165/08).
[6] June 2005, December 2006, February 2007 and March 2009.
[7] OJ L 189, 29.07.2003, p. 36.
[8] In accordance with Regulation (EC) No 834/2007 on organic production and labelling of organic products, GMOs shall not be used in organic production, including as seeds, food or feed (Article 9(1)). The aim is to have the lowest possible presence of GMOs in organic products (see Recital 10).
[9] In line with Article 19(3)(c) and Annex II of Directive 2001/18/EC and Article 6 and Article 18 of Regulation (EC) No 1829/2003.
[10] Note with ref. 7581/09 of the Council of the European Union.
[11] BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI.
[12] Note with ref. 11226/2/09 REV 2 of the Council of the European Union.