REPORT on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory

20.4.2011 - (COM(2010)0375 – C7‑0178/2010 – 2010/0208(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Corinne Lepage

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory

(COM(2010)0375 – C7‑0178/2010 – 2010/0208(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to Parliament and the Council (COM(2010)0375),

–   having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0178/2010),

–   having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–   having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–   having regard to the opinion of the European Economic and Social Committee of 9 December 2010[1],

–   having regard to the opinion of the Committee of the Regions of 28 January 2011[2],

–   having regard to Rules 55 and 37 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A7-0170/2011),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment  1 Proposal for a regulation – amending act Citation 1
Text proposed by the Commission	Amendment
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 […] thereof,	Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,
Justification
See opinion of the JURI committee
Amendment  2 Proposal for a regulation - amending act Recital 2
Text proposed by the Commission	Amendment
(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market.	(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market, taking into account, in accordance with Annex II of Directive 2001/18/EC, the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects, 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, animal health and welfare, the environment and 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.
Amendment  3 Proposal for a regulation - amending act Recital 2 a (new)
Text proposed by the Commission	Amendment
	(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 of 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 plants 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 new guidelines on GMO risk assessment are adopted. These guidelines should not be based primarily 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. Until the risk assessment provisions are properly implemented, no new GMO variety should be authorised. 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 of GMOs are secured; and that the enforcement of intellectual property rights does not prevent independent researchers from accessing all relevant material.
Amendment  4 Proposal for a regulation - amending act Recital 4 a (new)
Text proposed by the Commission	Amendment
	(4a) Given the importance of scientific evidence in taking decisions on the prohibition or approval 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.
Justification
GMOs are evaluated on the basis of data submitted by the applicant. Given the cost and economic boundaries limitations of EFSA, Member States that have the capacity to decide must also take responsibility and work on collecting information and transferring it to Europe.
Amendment  5 Proposal for a regulation - amending act Recital 5
Text proposed by the Commission	Amendment
(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 EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.	(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. Issues related to the placing on the market and the import of GMOs should remain regulated at EU level to preserve the internal market. Cultivation might require more flexibility in certain instances as it is an issue with a strong local/regional/territorial dimension and an issue of particular importance for the self-determination of Member States. The common 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) TFEU Member States should therefore be entitled to have a possibility to adopt binding legislative provisions concerning the cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
Amendment  6 Proposal for a regulation - amending act Recital 6
Text proposed by the Commission	Amendment
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products.	(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are 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.
Amendment  7 Proposal for a regulation - amending act Recital 7
Text proposed by the Commission	Amendment
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. This should apply as well 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. 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.	(7) Member States should therefore be authorised to adopt, on a case-by-case basis, measures restricting or prohibiting the cultivation of particular GMOs or groups of GMOs or of all GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. 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 of adopting these measures should apply as well 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. 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. Those measures should allow all operators concerned, including growers, sufficient time to adapt.
Amendment  8 Proposal for a regulation - amending act Recital 8
Text proposed by the Commission	Amendment
(8) 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 Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 should furthermore be in conformity with the Treaties, in particular as regards 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, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation.	(8) 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 Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds relating to the public interest. 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 national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union.
Amendment  9 Proposal for a regulation - amending act Recital 8 a (new)
Text proposed by the Commission	Amendment
	(8a) Restrictions on or prohibitions of cultivation of particular 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.
Amendment  10 Proposal for a regulation - amending act Recital 9
Text proposed by the Commission	Amendment
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of GMOs on their territory. In addition 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 which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States’ measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by 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 their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.	(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to 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. In addition 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 which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States’ measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by 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 their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.
Amendment  11 Proposal for a regulation - amending act Recital 9 b (new)
Text proposed by the Commission	Amendment
	(9b) Restrictions or bans on 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.
Amendment  12 Proposal for a regulation – amending act Article 1 – point -1 (new) Directive 2001/18/EC Article 22
Text proposed by the Commission Amendment   Directive 2001/18/EC is amended as follows:   (-1) Article 22 is replaced by the following:   ‘Article 22   Free circulation   Without prejudice to Article 23 or Article 26b, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.’
Justification
Article 22 should not preclude the possibility for Member States to adopt rules concerning the restriction or prohibition of the cultivation of GMOs on their territory in accordance with the new article 26b.
Amendment  13 Proposal for a regulation – amending act Article 1 – point -1 a (new) Directive 2001/18/EC Article 25 – paragraph 5 a (new)
Text proposed by the Commission Amendment   Directive 2001/18/EC is amended as follows:   (-1a) 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 of GMOs, such as seed material, shall not be restricted or impeded.’
Justification
The Environment Council, in December 2008 concluded that ‘independent researchers should be given access to all relevant material, while respecting intellectual property rights’. Currently, it is often impossible for independent researchers to conduct research on a GM-variety, as the access to the GM-material is restricted and farmers are obliged not to pass on GM-material for research purposes. In order for Member States to be able to investigate the compatibility of a certain GM-variety with a specific receiving environment, access to the GM material must not be restricted.
Amendment  14 Proposal for a regulation – amending act Article 1 – point -1 b (new) Directive 2001/18/EC Article 26 a – paragraph 1
Text proposed by the Commission Amendment   Directive 2001/18/EC is amended as follows:   (-1b) 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."
Amendment  15 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – introductory part
Text proposed by the Commission Amendment Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that: Member States may adopt, on a case-by case-basis, measures restricting or prohibiting the cultivation of 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that:
Amendment  16 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a
Text proposed by the Commission Amendment (a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs; (a) those measures are based on   i) scientifically justified grounds relating to 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 this Directive, 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 of adequate data or the existence of contradictory data or persisting scientific uncertainty concerning the potential negative impacts of the release of GMOs on the environment of a Member State or region, including on biodiversity;   ii) 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;   iii) other grounds that may include land use, town and country planning, or other legitimate factors;
Amendment  17 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a a (new)
Text proposed by the Commission Amendment   (aa) in cases where those measures concern crops which are already authorised at Union level, Member States ensure that farmers who cultivated such crops legally have sufficient time to finish the current cultivation season;
Amendment  18 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a b (new)
Text proposed by the Commission Amendment   (ab) those measures respect local agricultural and cultural traditions;
Amendment  19 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a c (new)
Text proposed by the Commission Amendment   (ac) those measures have been the subject of a prior public consultation lasting at least 30 days;
Justification
To enable the competent authorities to take informed decisions, the parties concerned must be able to notify their observations before the adoption of such measures, which could have an impact on various sectors.
Amendment  20 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point b
Text proposed by the Commission Amendment b) those measures are in conformity with the Treaties. b) those measures are in conformity with the Treaties, in particular the principle of proportionality.
Amendment  21 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 a (new)
Text proposed by the Commission Amendment   Member States shall make publicly available any such measure to all operators concerned, including growers, at least three months before the start of the growing season. In the event that the GMO concerned is authorised less than three months before the start of the growing season, Member States shall make those measures publicly available upon their adoption.
Amendment  22 Proposal for a regulation – amending act Article 1 – point 1 Directive Directive 2001/18/EC Article 26 b – paragraph 1 b (new)
Text proposed by the Commission Amendment   Member States shall adopt those measures for a maximum of five years and shall review them when the GMO authorisation is renewed.
Amendment  23 Proposal for a regulation - amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 2
Text proposed by the Commission Amendment By way of derogation to 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, one month prior to their adoption for information purposes’. By way of derogation to Directive 98/34/EC, Member States that intend to adopt measures under this Article shall communicate them to the other Member States and to the Commission, one month prior to their adoption for information purposes.
Justification
The word ‘reasoned’ is not necessary. It is subjective and may unnecessarily restrict possibilities for Member States.
Amendment  24 Proposal for a regulation - amending act Article 1 – point 1 a (new) Directive 2001/18/EC Article 26 b a (new)
Text proposed by the Commission Amendment   (1a) The following Article is inserted:   ‘Article 26ba   Liability requirements   Member States shall establish a general mandatory system of financial liability and financial guarantees, for example through insurance, which applies to all business 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.’
Justification
If different cultivation rules apply in different Member States, it is even more important that each Member State has a strict system in place in order to ensure that the polluter pays for unintended effects or damages. So far, conventional or organic farmers are often not adequately protected from possible contaminations with GMOs.
Amendment  25 Proposal for a regulation Article 1 – point 1 b (new) Directive 2001/18/EC Article 26 b b (new)
Text proposed by the Commission Amendment   (1b) The following Article is inserted:   ‘Article 26 bb   ‘GMO-free’ labelling   The Commission shall propose harmonised conditions under which operators may make use of terms indicating the absence of GMOs in products.’
Justification
The 13 July 2010 guidelines on the co-existence of crops state that Member States may take measures to avoid the economic implications of the presence of GMOs below the Community 0.9% labelling threshold. To avoid distortions of competition, the conditions under which operators may make use of terms indicating the absence of GMOs in products should be harmonised at Community level.
Amendment  26 Proposal for a regulation – amending act Article 2
Text proposed by the Commission	Amendment
This Regulation shall enter into force on the […] day following that of its publication in the Official Journal of the European Union.	This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

• [1]  OJ C 54, 19.2.2011, p. 51.
• [2]  Not yet published in the Official Journal.

EXPLANATORY STATEMENT

1 - Background

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 (GMOs) and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed establish a very tight framework which, if correctly enforced, should offer a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. The Directive only allows GMOs to be placed on the market if a specific environmental risk assessment has been carried out in accordance with the principles set out in Annex II and on the basis of information provided by the notifier and specified in Annex III. Annex II, which establishes the principles applicable to the environmental risk assessment, requires that direct and indirect immediate and delayed effects be taken into account, as well as an analysis of the cumulative long-term effects relevant to the release and the placing on the market of the GMO. These cumulative long-term effects refer to the accumulated effects of consents on human health and the environment, including on flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics.

Annexes II and III of the Directive specify the need to conduct studies on the conditions of release and the receiving environment, involving an in-depth study of the receiving environments in which cultivation is foreseen, as well as information on the interactions between the GMOs and the environment.

Annexes III to VII call for information on monitoring, control, waste treatment and emergency response plans, covering monitoring techniques, control of the release, waste treatment and especially emergency response plans to allow the introduction of methods for decontamination of the areas affected, isolation of the affected areas, and the protection of human health and the environment should undesirable effects occur.

Directive 2001/18 also states in Article 19 entitled ‘Consent’ that when a consent has been given for the placing on the market of a GMO, it can be used without further notification in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to.

2 – Objectives of the Commission proposal

This proposal is made against the backdrop of persistent opposition within European public opinion to the release of GMOs and their use in agriculture. According to the latest Eurobarometer survey on this issue published in October 2010, 61% of Europeans consider that GM food makes them feel uneasy and the same proportion (61%) disagree with the idea that the development of GM food should be encouraged. Only 21% agree (as opposed to the 58% who disagree) with the statement that ‘GM food is safe for future generations’. Less than a quarter of European citizens (23%) agree with the idea that ‘GM food does no harm to the environment’, whilst over 53% disagree with this statement (and a quarter ‘don’t know’). Finally, in no country was there a majority of respondents who agreed with the statement that GM food is good for the national economy.

The lack of trust placed by European public opinion in agricultural GMOs is first and foremost related to the fact that Directive 2001/18 has not been seriously enforced. The studies envisaged are not in fact conducted by the parties requesting authorisation, be they the studies on long-term effects, the prior studies on receiving environments, or the consideration of socio-economic impacts.

The requirements in the Directive regarding risk assessment are not being observed, and these shortcomings in its implementation explain the opposition encountered in several Member States to the cultivation of GMOs on their territory. It should be emphasised here that the cultivation and release of GM plants on the national territory is a separate issue from those of authorisations for marketing and consumption and the freedom of movement of goods and products, which are not covered by this text.

In its conclusions which it adopted unanimously on 4 December 2008, the Council called for the strengthening of environmental assessment and of monitoring arrangements; it noted that the mandate given by the Commission to EFSA included a detailed assessment of the long-term environmental effects of GM plants (GMPs), and development of the detailed risk assessment.

In accordance with the legislation, the Council asks in particular that consideration be given to the potential ecological effects of the GMPs in receiving environments, identification of the EU geographic regions where the GMPs may be released, and selection of appropriate techniques to assess the potential long-term effects including experimental methodologies. The Council also called for a stricter definition of the criteria and requirements for assessing GMPs, with the need to ensure coherence between risk assessments of GMPs which produce active substances covered by directive 91/414/EEC and those of the corresponding plant protection products.

The Council also demanded that regular and in-depth monitoring be performed and disclosed by authorisation holders in order to detect any potentially adverse effects foreseen by the Directive. The monitoring activities should be developed, and the findings forwarded to the Commission and made available to the general public. No serious monitoring study has, however, been carried out to date, and the control systems are not in place.

The Council also asked for the submission of a report on the implementation of the Directive, including an assessment, inter alia, of socio-economic implications of deliberate releases and placing on the market of GMOs, so that a report could be submitted by June 2010.

Finally, the Council sought improvements in how EFSA worked. At the time, it was stated that the Member States could have more opportunity to provide their views on the additional information provided by the notifier, that an extensive network of scientific organisations should be formed, that it was essential that any potential divergence between scientific opinions be identified and discussed, that it was essential that systematic and independent research be conducted on the risks, and that independent researchers should be given access to all relevant material. Few independent studies have, however, been conducted into the risks. Furthermore, even though clear conflicts of interest have been discovered, a reform of the expertise procedures at EFSA seems to be on the agenda but has not yet been undertaken.

As a result, the reluctance shown by some Member States seem to be fully justified by these inconsistencies and shortcomings in the effective enforcement of Directive 2001/18, and thus of Regulation 1829/2003.

The primary objective is therefore to progress towards the effective application of the existing legislation on risk assessment.

3 – Legal elements of the proposal

In this context, the objective of the Commission proposal for a regulation to give Member States competence on the use of their territory to grow GMOs is welcome. It should be coupled with the drafting of new guidelines on the assessment of health and environmental risks which must finally allow for the effective application of the rules laid down by Directive 2001/18 and Annex II thereof. This proposal should also be read in the light of Article 19(1) of the Directive that defines the specific conditions of use on which the Member States should be more demanding.

First of all, the wording of the proposal should not be limited to a negative definition of the grounds that may be invoked by the Member States. The respective opinions issued by Council and Parliament's legal services both expressed strong reservations about the legality of national measures that could be taken by Member States on the basis of reasons that had very little to do with environmental considerations, such as public morality, public order or ethics. It was also time to recognise that the environmental risk assessment conducted at Community level could not be exhaustive given the diversity of European ecosystems and the diversity of possible direct or indirect impacts.

In order to comply with the internal market and the Community assessments – provided that the necessary reforms are able to restore the credibility of EFSA's GMO panel – the grounds invoked by the Member States should be supplementary to those assessed by EFSA. The grounds invoked by the Member States may not then exclude environmental or agri-environmental grounds, particularly those of a local and/or regional nature, which have not been covered by a Community assessment. The grounds invoked by the Member States will inevitably be based at least partly on scientific data if they concern some form of environmental impact .

The distinction made by the Commission in its explanatory memorandum between a ‘scientific’ assessment conducted at Community level on the one hand, and grounds that have nothing to do with the scientific debate on the environmental impact on the other, is simplistic and takes no account of the complexity of the link between risk assessment and risk management. This distinction also ignores the fact that the failure to consider scientific uncertainties, although provision is made for this in the texts, may make it difficult to reach appropriate risk management decisions, or indeed to apply the precautionary principle. Whether it be the impact of using a herbicide associated with a herbicide-tolerant GM plant, the impact of changes in agricultural practices caused by the use of a GMO, or the risk of harmful insects developing resistance to Bt toxins in a given region, all these aspects involve an assessment of scientific data - or the lack thereof - relating to the environmental impact.

On the issue of the contamination of conventional or organic farming by GMOs, also known as ‘coexistence’, the Commission has always justified its refusal to legislate at Community level by the diversity of agricultural practices, climates and geography among and within Member States. This same diversity exists for ecosystems and receiving environments, and justifies the application of subsidiarity to the cultivation of GMOs, following the same logic.

Finally, in order to put an end to the current situation regarding the absence of studies, even though these are required by the existing legislation, the Member States should be given greater powers where there is a lack of relevant information about the impact on the national, regional and/or local territory. It is necessary to respect the rights of the Member States when it comes to the use of their own territory, an area which is covered by subsidiarity and which in no way calls into question the rules governing the internal market and the free movement of goods and products throughout the territory of the Union.

The high level of protection in the field of health and the environment targeted by Directive 2001/18 and other Community texts can only be achieved if all the necessary studies on the receiving environment and the conditions in the monitoring plans are effectively at the disposal of the Member States, and take account of the specific characteristics of their territory, their agricultural methods and their spatial planning choices.

Finally, the measures taken by Member States should apply to a given GMO or, as the case may be, a group of GMOs with similar characteristics, rather than to all GMOs. These measures should be substantiated. The possible cultivation of a GMO should also not result in additional costs for farmers working in conventional or organic farming. It should thus be compulsory for Member States to take measures to avoid the presence of GMOs in other products, and particular attention should be paid to any possible cross-border contamination.

OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS

15.3.2011

Jo LEINEN,

Chair

Committee on the Environment, Public Health and Food Safety

BRUSSELS

Subject:           Legal basis of the proposal for a Regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory (COM(2010)375 final)

Dear Mr Chair,

By letter of 10 March 2011 you asked the Committee on Legal Affairs pursuant to Rule 37(2) to consider whether the legal basis of the above Commission proposal was valid.

Background

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on deliberate release into the environment of genetically modified organisms[1] and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed[2] establish a harmonised system for risk assessment of environmental and health factors related to the authorisation of GMOs and lay down detailed procedural rules for their subsequent marketing authorisation. Directive 2001/18/EC also contains provisions on the deliberate release[3] of GMOs for purposes other than placing on the market[4] (e.g., for cultivation). The authorisation procedure is in essence as follows: (i) an application for authorisation, including an evaluation of environmental and health risks, is submitted by an applicant to the competent authority of a Member State; (ii) the competent authority issues an assessment report concerning the risk evaluation. Other Member States can present objections, in which case the Commission will intervene in the procedure. If there are no objections, the GMO is authorised at national level, whilst in the most usual case of objections and diverging evaluations, the GMO will be authorised by the Commission. Article 22 of the Directive sets out the "free movement clause" prohibiting Member States from restricting the placing on the market of GMOs authorised under the Directive. Under Article 23 of the Directive, Member States can restrict or prohibit the use and/or sale of GMOs for health and environmental reasons only in the event that new information with regard to health and environmental risks becomes available after the authorisation of a GMO. Regulation No 1829/2003 contains similar provisions for the authorisation of GMOs for food and feed use, food and feed containing or consisting of GMOs and food and feed produced from or containing ingredients produced from GMOs. In that respect the Regulation is a lex specialis when it comes to the authorisation of GMOs related to food and feed.

It should also be noted that the Directive and the Regulation establish a legal framework for the authorisation of genetically modified organisms (GMOs) which is fully applicable to GMOs to be used for cultivation purposes throughout the EU as seeds or other plant-propagating material. Under this set of legislation, GMOs for cultivation should undergo an individual risk assessment before being authorised to be placed on the Union market. The aim of the authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market.

On 13 July 2010 the Commission proposed to modify Directive 2001/18/EC as regards the possibility for the Member States to adopt measures restricting or prohibiting the cultivation of all or particular GMOs on all or parts of their territory. On the same date, the Commission published a Communication on the freedom for Member States to decide on the cultivation of genetically modified crops[5] in which it explains the reasons behind its proposal to introduce a more flexible approach under the existing legislation as regards GMO cultivation.

Within the Council, the ad hoc Working Party created by COREPER to examine the proposal identified a number of issues and concerns, including the choice of legal basis. In response, the Council Legal Service gave an opinion[6] concluding that the proposal as it stands is not validly based on Article 114 TFEU. The Commission strongly disagreed with that conclusion[7].

Parliament's Legal Service examined the question at your request and in its opinion of 17 November 2010 concluded as follows: "The Legal Service has not identified any grounds such as to call into question the choice of Article 114 TFEU as the legal basis of the proposal."

The rapporteur, Corinne Lepage, proposes to change that legal basis and replace Article 114 TFEU by Article 192 TFEU (amendment 1)[8]. The rapporteur also proposes other amendments which would purportedly modify the proposal of the Commission in such a way as to justify recourse to Article 192 TFEU.

I. The legal basis in question

The Commission proposal is based on Article 114 TFEU, which reads as follows:

"Article 114

(ex Article 95 TEC)

1. Save where otherwise provided in the Treaties, the following provisions shall apply for the achievement of the objectives set out in Article 26. The European Parliament and the Council shall, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

2. Paragraph 1 shall not apply to fiscal provisions, to those relating to the free movement of persons nor to those relating to the rights and interests of employed persons.

3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

4. If, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.

5. Moreover, without prejudice to paragraph 4, if, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.

6. The Commission shall, within six months of the notifications as referred to in paragraphs 4 and 5, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.

In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 and 5 shall be deemed to have been approved.

When justified by the complexity of the matter and in the absence of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.

7. When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national provisions derogating from a harmonisation measure, the Commission shall immediately examine whether to propose an adaptation to that measure.

8. When a Member State raises a specific problem on public health in a field which has been the subject of prior harmonisation measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council.

9. By way of derogation from the procedure laid down in Articles 258 and 259, the Commission and any Member State may bring the matter directly before the Court of Justice of the European Union if it considers that another Member State is making improper use of the powers provided for in this Article.

10. The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 36, provisional measures subject to a Union control procedure."

The rapporteur proposes to change this legal basis to Article 192 TFEU, which reads as follows:

"Article 192

(ex Article 175 TEC)

1. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall decide what action is to be taken by the Union in order to achieve the objectives referred to in Article 191^[9]*.

2. By way of derogation from the decision-making procedure provided for in paragraph 1 and without prejudice to Article 114, the Council acting unanimously in accordance with a special legislative procedure and after consulting the European Parliament, the Economic and Social Committee and the Committee of the Regions, shall adopt:

(a) provisions primarily of a fiscal nature;

(b) measures affecting:

— town and country planning,

— quantitative management of water resources or affecting, directly or indirectly, the availability of those resources,

— land use, with the exception of waste management;

(c) measures significantly affecting a Member State’s choice between different energy sources and the general structure of its energy supply.

The Council, acting unanimously on a proposal from the Commission and after consulting the European Parliament, the Economic and Social Committee and the Committee of the Regions, may make the ordinary legislative procedure applicable to the matters referred to in the first subparagraph.

3. General action programmes setting out priority objectives to be attained shall be adopted by the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions.

The measures necessary for the implementation of these programmes shall be adopted under the terms of paragraph 1 or 2, as the case may be.

4. Without prejudice to certain measures adopted by the Union, the Member States shall finance and implement the environment policy.

5. Without prejudice to the principle that the polluter should pay, if a measure based on the provisions of paragraph 1 involves costs deemed disproportionate for the public authorities of a Member State, such measure shall lay down appropriate provisions in the form of:

— temporary derogations, and/or

— financial support from the Cohesion Fund set up pursuant to Article 177. "

II. The Commission's choice of legal basis

The Commission opts for Article 114 TFEU. The proposal amends the Directive 2001/18/EC, adopted on the basis of Article 95 TEC (now 114 TFEU), by inserting a new Article 26b which would provide the Member States with a legal basis to adopt measures restricting or prohibiting the cultivation of all or particular GMOs which have already been authorised in accordance with Part C of the Directive or Regulation No 1829/2003 in all or parts of their territory, subject to compliance with certain conditions.

"Article 26bCultivation

Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that:

(a)         those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs;

and,

(b)         that they are in conformity with the Treaties.

By way of derogation to 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, one month prior to their adoption for information purposes."

In recital 5 of the proposal it is stated that "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 EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market." Recital 6 of the proposal specifies as follows: "In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products". In recital 7 of the proposal it is also stated that: "Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. This should apply as well 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. 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." Recital 9 reads as follows: "On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonise the conditions of cultivation in Member States but to grant freedom to Member States to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of GMOs on their territory. (...)"

Article 26b would apply to both GMOs authorised under Directive 2001/18/EC and under Regulation No 1829/2003.

III. Approach of the Court of Justice: aim and content of the proposed measures

Certain principles emerge from the case law of the Court. First, in view of the consequences of the legal basis in terms of substantive competence and the procedure, the choice of the correct legal basis is of constitutional importance[10].

The choice of the legal basis for an act does not turn on the relevant institution's conviction as to the objective pursued but must be "based on objective factors which are amenable to judicial review"[11], such as the aim and content of the measure[12].

IV. Analysis

Article 114 TFEU: the original legal basis

Article 114 TFEU mandates via the ordinary legislative procedure Community measures "which have as their object the establishment and functioning of the internal market". This article should be read in the context of Article 26 TFEU, establishing free movement of goods as a fundamental principle in the establishment of the internal market. In addition Article 114(3) should be noted as establishing a "high level of protection" in measures dealing with health, safety, environmental and consumer protection. Paragraphs (4) to (9) permit Member States to take national measures to introduce justified prohibitions or restrictions on imports, exports or goods in transit, pursuant to Article 36 TFEU, after a harmonisation measure has been adopted. Paragraphs (4) to (9) therefore represent a significant qualification of the overall aim of the article in fostering the establishment and functioning of the internal market.

The aim and content of the measure is to grant freedom to Member States to invoke grounds other than scientific assessment of health and environmental risks in order to ban or restrict the cultivation of GMOs on their territory. To this end, the new Article 26b allows Member States to adopt measures restricting or prohibiting the cultivation of GMOs (i) which have been authorised in accordance with Part C of Directive 2001/18/EC or Regulation No 1829/2003, and consist of genetically modified varieties placed on the market in accordance with relevant EU legislation on the marketing of seed and plant propagating material, (ii) under the following conditions: "(a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs; and, (b) that they are in conformity with the Treaties." The proposal therefore attempts to clarify the existing legal framework in that it explicitly gives the Member States room for manoeuvre in prohibiting or restricting cultivation of GMOs in all such cases which are not harmonised, i.e. not related to the assessment of the adverse effect on health and environment. It appears that the proposal does not in fact pursue any objective other than introducing a certain "flexibility" into the existing centralised system of authorisation of GMOs. For this reason the legal basis chosen by the Commission is correct.

This conclusion is not influenced by the fact that the added value of the Commission proposal seems questionable because the practical implication of Article 26b can only be seen as limited. In this context the reference to the Treaties in point (b) of that article is of interest. Leaving aside the obvious question of conformity with the Treaties of measures adopted by the Union or Member States, the provision seems to refer implicitly to paragraphs (4) to (9) of Article 114 TFEU and Article 36 TFEU. Detailed analysis of grounds for restricting or prohibiting the cultivation of GMOs has been made by the Parliament Legal Service in its opinion (paras 13-23). It suffices to say that the possibilities for Member States to take restrictive measures on "other grounds" seem in this case to be limited.

Although this seems not to be a genuine case of abandonment of Union competence, Article 114 TFEU would still be an appropriate legal basis also in the event that the proposal were to be considered as a "de-harmonisation" measure[13]. In particular the argument that "de-harmonisation" on the basis of Article 114 TFEU is allowed only if the purpose of the amendment aiming at such "de-harmonisation" is to improve the functioning of the internal market is difficult to accept. Article 114 TFEU grants the Union legislator the competence to establish harmonising measures to ensure the smooth functioning of the internal market and consequently to adapt measures already taken to changing circumstances, either by increasing or lowering the degree of harmonisation already achieved, or even by repealing a harmonising measure. Article 114 TFEU has to be read in the light of Article 2(2) TFEU, which expressly states that: "When the Treaties confer on the Union a competence shared with the Member States in a specific area, the Union and the Member States may legislate and adopt legally binding acts in that area. The Member States shall exercise their competence to the extent that the Union has not exercised its competence. The Member States shall again exercise their competence to the extent that the Union has decided to cease exercising its competence." Advocate General Poiares Maduro stated in his opinion in the Vodafone case that "Article 95 can, indeed, provide the basis for an intensification of regulation in addition to deregulatory measures"[14] and the Court held, in the same case: "Where an act based on Article 95 EC has already removed any obstacle to trade in the area that it harmonises, the Community legislature cannot be denied the possibility of adapting that act to any change in circumstances or development of knowledge having regard to its task of safeguarding the general interests recognised by the Treaty"[15].

Article 192 TFEU as the legal basis

ENVI’s rapporteur suggests Article 192 TFEU as the appropriate legal basis on the following ground: "The fact that Member States are responsible for factors relating to the conservation of fauna and flora, land use or town and country planning, on which they retain significant powers, justifies basing this Regulation on Article 192 of the Treaty."

Article 192(1) TFEU permits measures to be taken under the ordinary legislative procedure to enact Union policy under Article 191 on, inter alia, preserving, protecting and improving the quality of the environment, and protecting human health. Article 192(2) permits measures to be taken under a special legislative procedure which concern, inter alia, measures affecting the quantitative management of water resources, and land use. The amendment does not specify which paragraph of Article 192 should be considered appropriate.

In terms of the proposal it would seem that Article 192(1) may be considered more relevant: 1. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall decide what action is to be taken by the Union in order to achieve the objectives referred to in Article 191." As pointed out above, the aim of the proposal is to grant freedom to Member States to invoke grounds other than scientific assessment of health and environmental risks in order to ban or restrict cultivation of GMOs on their territory. It is therefore clear that the proposal does not seek to achieve any of the objectives referred to in Article 191 TFEU. On the contrary, the purpose of the proposal is to allow Member States to invoke reasons going beyond considerations relating to the environment or human health protection in order to restrict or prohibit the cultivation of GMOs in their territory. Thus, looking at the original Commission proposal, it has to be concluded that it does not justify the use of Article 192 TFEU as its legal basis.

However, the rapporteur has tabled a number of amendments for the adoption of which the change of the legal basis might seem necessary. Without making a detailed analysis of the draft report, attention should be paid in particular to amendment 8, which reads as follows:

Amendment  8 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/CE Article 26 b

Text proposed by the Commission Amendment In Directive 2001/18/EC, the following Article shall be inserted with effect from the date of entry into force of this Regulation: 1) The following Article shall be inserted: 'Article 26b 'Article 26b Cultivation Cultivation Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that: Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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: a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs; a) those measures are based on   i) grounds relating to 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 assessment of the negative impacts on the environment conducted under Part C of this Directive; or

	ii) the absence or lack of data on the potential negative impacts of the release of GMOs on the territory or biodiversity of the Member State; or
	iii) other grounds that may include, inter alia, changes in agricultural practices, land use, town and country planning, socio-economic impacts, or other legitimate factors;
and	and
b) that they are in conformity with the Treaties.	b) that they are in conformity with the Treaties.
By way of derogation to 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, one month prior to their adoption for information purposes'.	By way of derogation to 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, one month prior to their adoption for information purposes'.

By way of justification for this amendment the rapporteur writes: "The risk assessment conducted at Community level cannot be exhaustive. In addition, the absence or lack of data relating to the potential negative impacts of GMOs on specific national ecosystems or receiving environments should be a sufficient reason to allow Member States to ban the cultivation of the GMO(s) concerned. It should also be possible for Member States to invoke other factors which may or may not be linked to environmental impacts."

In view of the fact that this amendment substantially enlarges the grounds on which Member States could restrict or prohibit cultivation of GMOs so as actually to include environmental grounds, the amendment has to be seen as modifying the purpose of the proposal. Indeed, all the amendments proposed by the rapporteur aim to give Member States very specific grounds and possiblities to restrict the cultivation of GMOs. Moreover, they refer to conditions relating to environment and its preservation and protection, such as the potential negative impact on the ecosystem, changes in land use, fauna and flora protection, etc. Today, Member States which do not want to allow cultivation of GMOs on their territory try to invoke ethical arguments, which are however difficult to defend before the Court of Justice[16]. As the Parliament Legal Service mentioned in its legal opinion, the amendment of the Directive as proposed by the Commission (i.e. the new Article 26b) will essentially not bring about any change in the current system of authorisations for the cultivation of GMOs. Taking into account the fact that arguments against the cultivation of GMOs are notably based on grounds related to environment, the correct legal basis for the proposal as amended by the rapporteur would have to be Article 192(1) TFEU. It should also be pointed out that measures concerning the release of GMOs into the Union environment on grounds relating to internal market seem inappropriate. In the first place, GMOs cannot be considered in the same way as any other product since they are living organisms which are able to reproduce and multiply and, secondly, they have an impact on production systems and ecosystems, which are extremely diversified across the Union.

Conclusion:

Taking into consideration the package of amendments tabled by the rapporteur to the proposal it is considered that Article 192(1) TFEU is the correct legal basis.

At its meeting of 22 March 2011 the Committee on Legal Affairs accordingly decided by 9 votes for and 8 against[17] to recommend that the proposal should be based on Article 192(1) TFEU.

Yours sincerely,

Klaus-Heiner LEHNE

• [1]  OJ L 106 of 17.4.2001, p. 1.
• [2]  OJ L 268 of 18.10.2003, p. 1.
• [3] "Deliberate release" is defined in Article 2(3) of the Directive, which reads: "'deliberate release' means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment".
• [4]  "‘placing on the market’ means making available to third parties, whether in return for payment or free of charge;
  The following operations shall not be regarded as placing on the market:
  — making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms, including culture collections,
  — making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC,
  — making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive".
• [5]  COM(2010)0380.
• [6]  In principle on grounds relating to "de-harmonisation"; see Council Doc. 15696/10.
• [7]  Commission staff working document of 19.11.2010 on consideration of legal issues on GMO cultivation (SEC(2010) 1454 final).
• [8]  PR\855067EN.doc
• [9] ^* Those objectives include: "(-) preserving, protecting and improving the quality of the environment, (-) protecting human health, (-) prudent and rational utilisation of natural resources, (-) promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change".
• [10]  Opinion 2/00 Carthagena Protocol [2001] E.C.R. I-9713, para. 5; Case C-370/07 Commission v Council [2009] ECR I-8917, paras 46-49; Opinion 1/08, General Agreement on Trade in Services [2009] ECR I-11129, para. 110.
• [11]  Case 45/86 Commission v Council [1987] E.C.R. 1493, para. 11.
• [12]  Case C-300/89 Commission v Council [1991] E.C.R. I-2867, para. 10.
• [13]  As considered by the Council Legal Service in its opinion contesting Article 114 TFEU as a valid legal basis. See the different view taken by the Parliament's Legal Service in para. 12 of its opinion.
• [14]  Opinion in Case C-58/08 Vodafone and Others [2010], not yet reported, para. 9.
• [15]  Case C-58/08 Vodafone and Others [2010], not yet reported, para. 34.
• [16]  C-165/08 Commission v. Republic of Poland [2009] ECR I-6843.
• [17]  The following were present for the final vote: Klaus-Heiner Lehne (Chair), Luigi Berlinguer (Vice-Chair), Evelyn Regner (Vice-Chair), Lidia Joanna Geringer de Oedenberg (Rapporteur), Tadeusz Zwiefka, Françoise Castex, Antonio Masip Hidalgo, Bernhard Rapkay, Alexandra Thein, Diana Wallis, Cecilia Wikström, Jiří Maštálka, Kurt Lechner, Angelika Niebler, Jan Philipp Albrecht, Eva Lichtenberger, Sajjad Karim.

OPINION of the Committee on Agriculture and Rural Development

for the Committee on the Environment, Public Health and Food Safety

on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
(COM(2010)0375 – C7‑0178/2010 – 2010/0208(COD))

Rapporteur: George Lyon

SHORT JUSTIFICATION

Context of the proposal

Your Rapporteur would like to recall some facts and figures on GMO cultivation as a basis for discussion:

- 2 GMO crops are currently authorised for cultivation in the EU: MON810 maize and Amflora potato

- 17 GMOs are awaiting authorisation for cultivation in the EU

- A total of 94,800 ha. of MON810 maize were grown in 5 Member States in 2009 (Spain, Czech Republic, Portugal, Romania and Slovakia), 80% of which were in Spain (compared to 107,700 ha. in 2008, before Germany discontinued cultivation).

Amflora potato is currently cultivated in 3 Member States: Sweden, Germany and Czech Republic.

In 2009, 14 million farmers worldwide planted 134 million ha. of GMOs[1], with 64 million ha. planted in the USA, over 21 million ha. in Brazil and Argentina respectively, and over 8 million ha. in countries such as Canada and India.

These figures illustrate the current deadlock surrounding the decision-making on GMOs in the EU and the lack of answers to genuine concerns expressed by farmers and consumers.

A science-based approach to new technology

Your Rapporteur believes that best scientific advice and a risk-based approach should be the key principles in determining the safety of new technologies. Without the bedrock of scientific advice to anchor decisions on safety of new methods and practices, society runs the risk of decisions being taken on the basis of what is popular rather than what is safe. Other elements such as socio-economic concerns or ethical considerations cannot substitute for science-based decisions on safety. Your Rapporteur recognises that the Commission's proposal as it stands does not undermine the common scientific GMO authorisation procedure in Europe.

Purpose of the proposal

According to the Commission, in parallel to the comprehensive legal framework for the authorisation of products consisting of or derived from GMOs, the proposal seeks to "facilitate decision making", "take into account all relevant factors" and "grant Member States sufficient flexibility to decide on GMO cultivation after they have been authorised at EU level". While serious concerns have been raised by the Council and European Parliament legal services respectively regarding legal certainty, potential threats to the Single Market and WTO incompatibilities, your Rapporteur has come to the conclusion after weighing up all the arguments, that on balance, the proposal may deliver the Commission's objectives and provide some opportunities for progress in unlocking the deadlock on the decision-making surrounding GMOs in the EU.

Position

The general approach taken by your Rapporteur is to strengthen the Commission's proposal in response to concerns about Internal Market and WTO-compliance.

Your Rapporteur has also introduced a requirement to respect the principle of proportionality and the freedom of choice for consumers and farmers. He has also sought to give greater protection to those farmers who wish to cultivate GM-free and greater legal certainty to Member States using this flexibility.

Your Rapporteur believes that Member States should be required to adopt a case-by case approach when deciding to use this new power to ensure the restrictions are crop specific. This would recognise the fact that different GMOs bring both different threats and benefits to different regions, and therefore should be assessed individually to make sure Member States respect the principle of proportionality.

In order to respect the freedom of choice, as recognised in the Council conclusions of 4th December 2008 and the Opinion of the European Economic and Social Committee of 9th December 2010 (NAT 480 - CESE 1623/2010), it is necessary to ensure that Member States have robust co-existence rules in place on their territory. This requires an amendment to Article 26a of Directive 2001/18/EC to give reassurance to non-GM growers and consumers who wish to grow and purchase GM-free products that their right to do so will be respected. Your Rapporteur also believes that Member States should make full use of the flexibility granted under Article 26a and the Commission's new Recommendation on guidelines for co-existence before adopting further restrictive measures under the proposed Article 26b.

In parallel to the co-existence measures, and in order to protect non-GM growers from economic loss due to the adventitious presence of GMOs in their fields and in their seeds, your Rapporteur also asks the Commission to draw up a proposal on technical thresholds for labelling GMO traces in conventional seeds at the lowest practicable, proportionate and functional levels for all economic operators, as asked by the Council Conclusions of 4th December 2008.

Finally, while ensuring that restrictive measures are proportionate and that all necessary practical measures are taken to respect the freedom of choice of farmers and consumers, your Rapporteur proposes to reinforce legal certainty for farmers in the context of this proposal. To achieve this goal, Member States must publicise and implement the restrictions they plan to take using this new power under Article 26b of Directive 2001/187EC at least three months prior to the start of the growing season, so that farmers can plan ahead with some certainty.

Your Rapporteur is therefore ready to grant support to this proposal provided the additional safeguards proposed in this opinion are adopted.

AMENDMENTS

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:

Amendment   1 Proposal for a regulation – amending act Recital 2
Text proposed by the Commission	Amendment
(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market.	(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market, taking into account, in accordance with Annex II of Directive 2001/18/EC, the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects, 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, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market.
Amendment  2 Proposal for a regulation – amending act Recital 5
Text proposed by the Commission	Amendment
(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 EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.	(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 EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional/territorial dimension, and as one of particular importance for the self-determination of Member States. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt binding legislative provisions concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
Amendment  3 Proposal for a regulation – amending act Recital 6
Text proposed by the Commission	Amendment
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products.	(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and in parallel with the measures that Member States must take by application of Article 26a of Directive 2001/18/EC, as amended by this Regulation, to avoid the unintended presence of GMOs in other products.
Amendment  4 Proposal for a regulation – amending act Recital 7
Text proposed by the Commission	Amendment
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. This should apply as well 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. 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.	(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of particular GMOs, a group of GMOs defined by the crop variety, or all GMOs in all or part of their territory, provided those measures have been subject to prior impact assessment and public consultation, and as long as those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months prior to the start of sowing. This choice left to Member States is directly linked to their sovereignty on territorial management and development, land use and the need to preserve the diversity of ecosystems. This should apply as well 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. 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.
Amendment  5 Proposal for a regulation – amending act Recital 8
Text proposed by the Commission	Amendment
(8) 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 Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 should furthermore be in conformity with the Treaties, in particular as regards 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, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation.	(8) 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 Union cannot be revised by a Member State and this situation must not be altered. However Member States may adopt measures restricting or prohibiting the cultivation of particular GMOs, a group of GMOs defined by the crop variety, or all GMOs in all or part of their territory on the basis of duly justified grounds relating to the public interest other than those already addressed by the harmonised set of Union rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment. The distinct notion of 'risk management', as established in Regulation EC No 178/2002 could be used, however, as a basis to justify those measures. Such measures may be justified on the basis of general policy objectives such as:
	- The need to preserve specific types of agriculture such as organic or high nature value farming, as well as traditional types of farming,
	- Grounds related to the protection of the diversity of agricultural production,
	- The protection of GMO-free areas provided that co-existence measures in place are not sufficient to protect,
	- The impossibility to implement co-existence due to specific geographical conditions (e.g. small islands, mountains, small national territory),
	- Socio-economic grounds such as the protection of specific mountain products, product quality policy or labels,
	- Wider environmental policy objectives such as specific habitats, ecosystems, biodiversity, emergence of resistance and landscape features preservation,
	- Territorial management or land use planning,
	- Other legitimate grounds in the public interest or addressing public concerns, duly justified, proportionate and non-discriminatory,
	Those measures should furthermore be in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products, the principle of proportionality and Articles 34 and 36 of the Treaty on the Functioning of the European Union, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation. Those measures should also ensure that the freedom of choice of farmers and consumers is duly respected.
Amendment  6 Proposal for a regulation – amending act Recital 9
Text proposed by the Commission	Amendment
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of GMOs on their territory. In addition 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 which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States' measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by 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 their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.	(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant flexibility to Member States to invoke duly justified grounds in the public interest which are different from those related to the scientific assessment of health and environmental risks carried out pursuant to Part C of Directive 2001/18/EC, such as those grounds listed under Recital 8 of this Regulation, in order to restrict or prohibit the cultivation of GMOs on all or part of their territory in order to ease the decision-making process on GMOs in the Union. In addition 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 regulations1 which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States' measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify per se the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by 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 their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.
Amendment  7 Proposal for a regulation – amending act Recital 9 a (new)
Text proposed by the Commission	Amendment
	(9a) In line with the Environmental Council Conclusions of 4 December 2008, and in order to ensure respect for the freedom of choice and full implementation of the principle of proportionality, the Commission should re-evaluate the appropriate seed thresholds level for labelling GMO traces in conventional seeds. This should be accompanied by relevant proposals on harmonised sampling and analysis methods for those traces, in particular the setting up of a minimum performance limit for detection methods.
Amendment  8 Proposal for a regulation – amending act Article 1 – point -1 (new) Directive 2001/18/EC Article 26a – paragraph 1
Text proposed by the Commission Amendment (-1) Directive 2001/18/EC shall be amended as follows:   Article 26a(1) shall be replaced by the following:   "1. Member States shall take appropriate measures to avoid the unintended presence of GMOs in other products."
Justification
It should be made mandatory for Member States to take the appropriate measures to manage co-existence in their territory in order to allow the freedom of choice to apply and to avoid cross-border difficulties arising from lack of management of co-existence.
Amendment  9 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Introductory part
Text proposed by the Commission Amendment In Directive 2001/18/EC, the following Article shall be inserted with effect from the date of entry into force of this Regulation: (1) The following Articles shall be inserted with effect from the date of entry into force of this Regulation:
Amendment  10 Proposal for a regulation – amending act Article 1 - point 1 Directive 2001/18/EC Article 26 b – paragraph 1
Text proposed by the Commission Amendment Member States may adopt measures restricting or prohibiting the cultivation of all or particular 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that: Member States may adopt measures restricting or prohibiting the cultivation of particular GMOs, a group of GMOs defined by the crop variety, or 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 EU legislation on the marketing of seed and plant propagating material, in all or part of their territory, provided that:
Amendment  11 Proposal for a regulation – amending act Article 1 - point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a
Text proposed by the Commission Amendment (a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs; (a) those measures:   (i) are based on different grounds from those covered by the harmonised scientific assessment of health and environmental risks carried out pursuant to Part C of Directive 2001/18/EC which might arise from the deliberate release or the placing on the market of GMOs, while the distinct notion of 'risk management', as established by Regulation EC No 178/2002, could be used as a basis to justify national/regional restrictive measures;   (ii) may be justified on the basis of general policy objectives such as:   - The need to preserve specific types of agriculture such as organic or high nature value farming, as well as traditional types of farming,   - Grounds related to the protection of the diversity of agricultural production,   - The protection of GMO-free areas provided that co-existence measures in place are not sufficient to protect,   - The impossibility to implement co-existence due to specific geographical conditions (e.g. small islands, mountains, small national territory)   - Socio-economic grounds such as the protection of specific mountain products, product quality policy or labels,   - Wider environmental policy objectives such as specific habitats, ecosystems, biodiversity and landscape features preservation,   - Territorial management or land use planning,   - Other legitimate grounds in the public interest or addressing public concerns, duly justified, proportionate and non-discriminatory.
Amendment  12 Proposal for a regulation – amending act Article 1 - point 1 Directive 2001/18/EC Article 26b – paragraph 1 – point a a (new)
Text proposed by the Commission Amendment   (aa) those measures ensure that the freedom of choice of farmers and consumers is duly respected;
Justification
The fundamental principle of freedom of choice for farmers and consumers should be respected as this will ensure that measures are proportionate, that all stakeholders' interests are taken into consideration, and that a debate takes place in regions on the cultivation of GMOs.
Amendment  13 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a b (new)
Text proposed by the Commission Amendment   (ab) those measures have been the subject of a prior impact assessment showing them to be necessary and proportional;
Justification
In order to confirm the legal validity of measures to restrict or prohibit the cultivation of GMOs adopted by the Member States, a prior impact assessment should be carried out to demonstrate the necessity and proportionality of the proposed measures. In the event of a dispute before the WTO, such impact assessment would make it easier to defend the measure adopted.
Amendment  14 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a c (new)
Text proposed by the Commission Amendment   (ac) those measures have been the subject of a prior public consultation lasting at least 30 days;
Justification
To enable the competent authorities to take informed decisions, the parties concerned must be able to notify their observations before the adoption of such measures, which could have an impact on various sectors.
Amendment  15 Proposal for a regulation – amending act Article 1 - point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point a d (new)
Text proposed by the Commission Amendment   (ad) those measures are adopted and made publicly available to all operators, including growers, at least twelve months prior to the start of sowing;
Amendment  16 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 1 – point b
Text proposed by the Commission Amendment b) that they are in conformity with the Treaties. b) that they are in conformity with the Treaties, in particular with the principle of proportionality, and the Union's international obligations.
Amendment  17 Proposal for a regulation – amending act Article 1 – point 1 Directive 2001/18/EC Article 26 b – paragraph 2 a (new)
Text proposed by the Commission Amendment   The Commission shall assess the need for harmonisation of the sampling and analysis methods for non-authorised GMOs present at a low level in seed, and in particular for the setting of a minimum performance limit for detection methods.
Justification
The lack of harmonisation leads the Member States to apply different rules, which inevitably introduce distortions of competition, since firms are able to adjust their marketing channels. Since traces of non-authorised GMOs in batches of imported seeds are frequently found in spite of the measures taken by operators, the same procedure should be envisaged as is proposed by the Commission for animal feed.
Amendment  18 Proposal for a regulation Article 1 – point 1 Directive 2001/18/EC Article 26b a (new)
Text proposed by the Commission Amendment   Article 26b a   ‘GMO-free’ labelling   The Commission shall propose harmonised conditions under which operators may make use of terms indicating the absence of GMOs in products.
Justification
The 13 July 2010 guidelines on the co-existence of crops state that Member States may take measures to avoid the economic implications of the presence of GMOs below the Community 0.9% labelling threshold. To avoid distortions of competition, the conditions under which operators may make use of terms indicating the absence of GMOs in products should be harmonised at Community level.

PROCEDURE

Title	Amendment of Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
References	COM(2010)0375 – C7-0178/2010 – 2010/0208(COD)
Committee responsible	ENVI
Opinion by Date announced in plenary	AGRI 7.9.2010
Rapporteur Date appointed	George Lyon 30.8.2010
Discussed in committee	26.10.2010		1.12.2010		1.2.2011
Date adopted	15.3.2011
Result of final vote	+: –: 0:	30 4 10
Members present for the final vote	John Stuart Agnew, Richard Ashworth, Liam Aylward, José Bové, Luis Manuel Capoulas Santos, Vasilica Viorica Dăncilă, Michel Dantin, Paolo De Castro, Albert Deß, Herbert Dorfmann, Hynek Fajmon, Lorenzo Fontana, Iratxe García Pérez, Béla Glattfelder, Sergio Gutiérrez Prieto, Martin Häusling, Esther Herranz García, Peter Jahr, Elisabeth Köstinger, Stéphane Le Foll, George Lyon, Gabriel Mato Adrover, Mairead McGuinness, Krisztina Morvai, Mariya Nedelcheva, James Nicholson, Rareş-Lucian Niculescu, Wojciech Michał Olejniczak, Georgios Papastamkos, Marit Paulsen, Britta Reimers, Ulrike Rodust, Alfreds Rubiks, Giancarlo Scottà, Czesław Adam Siekierski, Sergio Paolo Francesco Silvestris, Alyn Smith, Marc Tarabella, Janusz Wojciechowski
Substitute(s) present for the final vote	Luís Paulo Alves, Christa Klaß, Giovanni La Via, Astrid Lulling, Daciana Octavia Sârbu, Christel Schaldemose, Milan Zver

• [1]  Records are taken for maize, soybean, cotton and rapeseed

PROCEDURE

Title	Amendment of Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
References	COM(2010)0375 – C7-0178/2010 – 2010/0208(COD)
Date submitted to Parliament	13.7.2010
Committee responsible        Date announced in plenary	ENVI 7.9.2010
Committee(s) asked for opinion(s)        Date announced in plenary	ITRE 7.9.2010		AGRI 7.9.2010		JURI 7.9.2010
Not delivering opinions        Date of decision	ITRE 29.9.2010		JURI 20.9.2010
Rapporteur(s)        Date appointed	Corinne Lepage 10.9.2010
Legal basis disputed        Date of JURI opinion	JURI 22.3.2011
Discussed in committee	28.2.2011
Date adopted	12.4.2011
Result of final vote	+: –: 0:	34 10 16
Members present for the final vote	János Áder, Elena Oana Antonescu, Kriton Arsenis, Sophie Auconie, Pilar Ayuso, Paolo Bartolozzi, Sergio Berlato, Milan Cabrnoch, Martin Callanan, Nessa Childers, Chris Davies, Esther de Lange, Anne Delvaux, Bas Eickhout, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Christa Klaß, Holger Krahmer, Jo Leinen, Corinne Lepage, Peter Liese, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Gilles Pargneaux, Antonyia Parvanova, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Oreste Rossi, Dagmar Roth-Behrendt, Daciana Octavia Sârbu, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Bogusław Sonik, Claudiu Ciprian Tănăsescu, Salvatore Tatarella, Åsa Westlund, Glenis Willmott, Sabine Wils
Substitute(s) present for the final vote	Margrete Auken, Tadeusz Cymański, João Ferreira, Matthias Groote, Riikka Manner, Justas Vincas Paleckis, Bart Staes, Marianne Thyssen, Michail Tremopoulos
Substitute(s) under Rule 187(2) present for the final vote	Ashley Fox
Date tabled	20.4.2011