(1)

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (4) and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (5) establish a comprehensive legal framework for the authorisation of genetically modified organisms (GMOs), which is fully applicable to GMOs to be used for cultivation purposes throughout the Union as seeds or other plant-propagating material (hereinafter ‧GMOs for cultivation‧).

(2)

Those legal acts provide that GMOs for cultivation are to undergo an individual risk assessment before being authorised to be placed on the Union market , taking into account, in accordance with Annex II to Directive 2001/18/EC, the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects of GMOs on human health and the environment . The aim of this authorisation procedure is to ensure a high level of protection of human life and health, of animal health and welfare, of the environment and of consumer interests, whilst ensuring the effective functioning of the internal market. A uniform high level of protection of health and the environment should be achieved and maintained throughout the territory of the Union. [Am 2]

(2a)

The Commission and Member States should ensure, as a priority, the implementation of the Environment Council Conclusions adopted on 4 December 2008, namely a proper implementation of the legal requirements laid down in Annex II to Directive 2001/18/EC for the risk assessment of GMOs. In particular, the long-term environmental effects of GM crops, as well as their potential effects on non-target organisms, should be rigorously assessed; the characteristics of the receiving environments and the geographical areas in which GM crops may be cultivated should be duly taken into account; and the potential environmental consequences brought about by changes in the use of herbicides linked to herbicide-tolerant GM crops should be assessed. More specifically, the Commission should ensure that the revised guidelines on risk assessment of GMOs are adopted. Those guidelines should not be based only on the principle of substantial equivalence or on the concept of a comparative safety assessment, and should make it possible to clearly identify direct and indirect long-term effects, as well as scientific uncertainties. The European Food Safety Authority (EFSA) and the Member States should aim to establish an extensive network of scientific organisations representing all disciplines including those relating to ecological issues, and should cooperate to identify at an early stage any potential divergence between scientific opinions with a view to resolving or clarifying the contentious scientific issues. The Commission and the Member States should ensure that the necessary resources for independent research on the potential risks arising from the deliberate release or the placing on the market of GMOs are secured, and that the enforcement of intellectual property rights does not prevent independent researchers from accessing all relevant material. [Am 44]

(2b)

There is a need for the precautionary principle to be taken into account in the framework of this Regulation and when implementing it. [Am 46]

(3)

In addition to the authorisation for placing on the market, genetically modified varieties also need to comply with the requirements of Union legislation on the marketing of seed and plant propagating material, as set out in particular in Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (6), Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (7), Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (8), Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants (9), Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material (10) Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (11), Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (12), Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (13), Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (14), Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (15), and Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (16). Directives 2002/53/EC and 2002/55/EC contain provisions which allow the Member States to prohibit, under certain well-defined conditions, the use of a variety in all or in parts of their territory or to lay down appropriate conditions for the cultivation of a variety.

(4)

Once a GMO is authorised for cultivation purposes in accordance with the Union legislative framework on GMOs and complies, as regards the variety that is to be placed on the market, with the requirements of Union legislation on the marketing of seed and plant propagating material, Member States are not authorised to prohibit, restrict, or impede its free circulation within their territory, except under the conditions defined by Union legislation.

(4a)

Given the importance of scientific evidence in taking decisions on the prohibition or authorisation of GMOs, EFSA and the Member States should collect and publish annually the results of research regarding the risk or evidence of any accidental presence, contamination or danger to the environment or human health of GMOs, on a case-by-case basis. Due to the high cost of expert consultation, Member States should promote collaboration between research institutions and national academies. [Am 4]

(5)

Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level. Contrary to Issues related to the placing on the market and the import of GMOs, which should remain regulated at Union level to preserve the internal market, . Cultivation has been acknowledged as might require more flexibility in certain instances as it is an issue with a strong local/regional local,regional and/or territorial dimension and an issue of particular importance for the self-determination of Member States . The Union authorisation procedure should not be adversely affected by such flexibility. However, the harmonised environmental and health risks assessment might not address all possible impacts of GMO cultivation in different regions and local ecosystems. In accordance with Article 2(2) of the Treaty on the Functioning of the European Union (TFEU), Member States should therefore be entitled to adopt rules legally binding acts concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the Union market. [Am 5]

(6)

In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom flexibility to decide whether or not they wish to cultivate GM crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled required to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products on their territory and in border areas of neighbouring Member States . [Am 6]

(7)

Member States should therefore be authorised to adopt , on a case-by-case basis, measures restricting or prohibiting the cultivation of all or particular GMOs or of groups of GMOs or of all GMOs in all or part of their territory, and amend those measures as they deem appropriate, at all stages of the authorisation, renewal of authorisation or withdrawal from the market of the concerned GMOs. This Cultivation is closely linked to land use and the conservation of fauna and flora, areas in which the Member States retain significant powers. The possibility for Member States to adopt such measures should also apply to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC. Any such 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, as or in products, and of the products of their harvest. Similarly they should not affect the cultivation of non genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of EU authorised GMOs are found Those measures should allow all operators concerned, including growers, sufficient time to adapt. [Am 7]

(8)

In accordance with the legal framework for the authorisation of GMOs, the level of protection of human and animal health and of the environment chosen at Union level cannot be diverged from by a Member State, and this principle must be maintained. However Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs or of groups of GMOs or of all GMOs in all or part of their territory on the basis of grounds relating to the public interest 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. Those measures may be based on grounds relating to environmental or other legitimate factors such as socio-economic impacts, which might arise from the deliberate release or the placing on the market of GMOs where those factors have not been addressed as part of the harmonised procedure provided for in Part C of Directive 2001/18/EC, or in the event of persisting scientific uncertainty. Those measures should be duly justified on scientific grounds or on grounds relating to risk management or other legitimate factors which might arise from the deliberate release or the placing on the market of GMOs. Those measures should furthermore be proportionate and in conformity with the Treaties, in particular as regards the principle of non-discrimination between domestic and imported products and Articles 34 and 36 TFEU, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation. [Am 8, 40]

(8a)

Restrictions on or prohibitions of cultivation of GMOs by a Member State should not prevent or restrict the use of authorised GMOs by other Member States, provided effective measures are taken to prevent cross-border contamination. [Am 9]

(8b)

Member States should be allowed to base the measures restricting or prohibiting the cultivation of GMOs on duly justified grounds relating to local or regional environmental impacts which might arise from the deliberate release or the placing on the market of GMOs and which are complementary to the environmental impacts examined during the scientific assessment of the impacts on the environment conducted under Part C of Directive 2001/18/EC, or grounds relating to risk management. Those grounds may include the prevention of the development of pesticide resistance amongst weeds and pests; the invasiveness or persistence of a GM variety, or the possibility of interbreeding with domestic cultivated or wild plants; the prevention of negative impacts on the local environment caused by changes in agricultural practices linked to the cultivation of GMOs; the maintenance and development of agricultural practices which offer a better potential to reconcile production with ecosystem sustainability; the maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features; the absence or lack of adequate data concerning the potential negative impacts of the release of GMOs on the local or regional environment of a Member State, including on biodiversity. Member States should also be allowed to base such measures on grounds relating to socio-economic impacts. Those grounds may include the impracticability or the high costs of coexistence measures or the impossibility of implementing coexistence measures due to specific geographical conditions such as small islands or mountain zones; the need to protect the diversity of agricultural production; the need to ensure seed purity. Member States should also be allowed to base such measures on other grounds that may include land use, town and country planning, or other legitimate factors. [Am 47]

(9)

In accordance with the principle of subsidiarity, the purpose of this Regulation is not to harmonise the conditions of cultivation in Member States but to grant freedom flexibility to Member States to invoke other grounds than scientific assessment of health and environmental risks to ban restrict or prohibit the cultivation of GMOs on their territory on grounds relating to environmental or other legitimate factors such as socio-economic impacts, which might arise from the deliberate release or the placing on the market of GMOs where those factors have not been addressed as part of the harmonised procedure provided for in Part C of Directive 2001/18/EC or in the event of persisting scientific uncertainty . One of the purposes of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (17), which is to allow the Commission to consider the adoption of binding acts at Union level, would not be served by the systematic notification of Member States' measures under that Directive. Moreover, since Member States cannot adopt under this Regulation measures restricting or prohibiting the placing on the market of GMOs, and thus this Regulation does not modify the conditions for placing on the market of GMOs authorised under existing legislation, the notification procedure under Directive 98/34/EC does not appear to be the most appropriate channel for providing information to the Commission. Therefore, by way of derogation, Directive 98/34/EC should not be applicable. A simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the Commission to be aware of these measures. Measures which Member States intend to adopt should thus be communicated, together with the reasons for those measures, to the Commission and to the other Member States not later than one month prior to their adoption for information purposes. [Am 10]

(9a)

Restrictions on or prohibitions of cultivation of GMOs by Member States should not prevent biotechnology research from being carried out provided that, in carrying out such research, all necessary safety measures are observed. [Am 11]

(10)

Article 7(8) and Article 19(8) of Regulation (EC) No 1829/2003 provide that references made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive are to be considered as applying equally to GMOs authorised under Regulation (EC) No 1829/2003. Accordingly, measures adopted by the Member States in accordance with this Regulation should also apply to GMOs authorised in accordance with Regulation (EC) No 1829/2003.

(11)

Directive 2001/18/EC should therefore be amended accordingly,

(1)

Article 22 is replaced by the following:

‘Article 22

Free circulation

Without prejudice to Article 23 or Article 26b, Member States shall not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.’

(2)

In Article 25, the following paragraph is added:

‘5a.     Without prejudice to the protection of intellectual property rights, access to material necessary for independent research on potential risks arising from the deliberate release or the placing on the market of GMOs, such as seed material, shall not be restricted or impeded.’

(3)

Article 26a(1) is replaced by the following:

‘1.     Member States shall take appropriate measures to avoid the unintended presence of GMOs in other products on their territory and in border areas of neighbouring Member States.’

(4)

The following Article is inserted:

‧Article 26b

Cultivation

Member States may adopt , after a case-by-case examination, measures restricting or prohibiting the cultivation of all or particular GMOs or of groups of GMOs defined by crop or trait or of all GMOs authorised in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, and consisting of genetically modified varieties placed on the market in accordance with relevant Union legislation on the marketing of seed and plant propagating material, in all or part of their territory , provided that: [Am 40]

Under the same conditions, regions within Member States may also adopt measures restricting or prohibiting the cultivation of GMOs on their territory. [Am 51]

Member States shall make publicly available any such measures to all operators concerned, including growers, at least six months before the start of the growing season. In the event that the GMO concerned is authorised less than six months before the start of the growing season, Member States shall make those measures publicly available upon their adoption. [Am 43]

Member States shall adopt those measures for a maximum of five years and shall review them when the GMO authorisation is renewed . [Am 22]

By way of derogation from Directive 98/34/EC, Member States that intend to adopt reasoned measures under this Article shall communicate them to the other Member States and to the Commission not later than one month prior to their adoption for information purposes.‧

(5)

The following Article is inserted:

‘Article 26c

Liability requirements

Member States shall establish a general mandatory system of financial liability and financial guarantees, for example through insurance, which applies to all operators and which ensures that the polluter pays for unintended effects or damage that might occur due to the deliberate release or the placing on the market of GMOs.’