EN Official Journal of the European Union C 57/11

Opinion of the Committee of the Regions on the Communication from the Commission to the Council and the European Parliament Report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming

(2007/C 57/03)

THE COMMITTEE OF THE REGIONS,

Having regard to the Communication from the Commission to the Council and the European Parliament — Report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming (COM(2006) 104 final),

Having regard to the European Commission's decision of 2 December 2005 to consult it on this matter, under the first paragraph of Article 265 of the Treaty establishing the European Community,

Having regard to its Bureau's decision of 25 April 2006 to instruct the Commission for Sustainable Development to draw up an opinion on this subject,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1),

Having regard to Regulation (EC) No 178/2002/EC of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety (2),

Having regard to 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 and repealing Council Directive 90/220/EEC (3),

Having regard to Resolution 2003/2098 (INI) of the European Parliament on coexistence between genetically modified crops and conventional and organic crops,

Having regard to the European Commission's Recommendation 2003/556/EC of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming,

Having regard to the own-initiative opinion of the European Economic and Social Committee of 16 December 2004 on the coexistence between genetically modified crops, and conventional and organic crops (4),

Having regard to its draft opinion (CdR 149/2006 rev. 2) adopted on 6 October 2006 by its Commission for Sustainable Development (rapporteur: Mr Marrazzo, President of the Lazio Region (IT/PES)),

1. Whereas:

1.1 Generally speaking, the Communication from the Commission to the Council and the European Parliament — Report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming COM(2006) 104 final (hereinafter ‘the report’) distinguishes between, on the one hand, the environmental and health aspects and, on the other, the economic aspects of coexistence between GM, conventional and organic farming.

1.2 Ascertaining the lack of risks to human health and the environment is merely one stage in the procedure envisaged for authorising a GM product under Directive 2001/18/EC. Specific mandatory measures on coexistence are also part of the same procedure.

1.3 The present opinion seeks to bring the debate on coexistence, focused only on the economic aspects, back to the issues of care imposed by the precautionary principle. Conventional and organic crops, too, are part of the environment and are therefore to be protected under the precautionary principle. Now that the European moratorium on GMOs has expired (in 2004), authorisations of GM products in the European Union will in reality increase and for this reason irreversible consequences and speculation must be averted.

1.4 Correct implementation of coexistence requires reconciling health and environmental aspects with economic ones. If ‘coexistence’ between types of farming — in other words, guaranteeing the viability of each type (conventional, organic and GMO) — is to be implemented, it must safeguard each of these methods. Every form of agriculture — conventional, organic and GMO — must be accorded equal respect for its intrinsic rather than economic value, otherwise the very concept of ‘coexistence’ would be negated.

1.5 At the Vienna conference on 4-6 April 2006, the EU chose not to adopt a firm stance on coexistence and to leave farmers free to choose for themselves between traditional, organic or GM farming. The reasons were twofold: firstly, the territorial diversity of individual Member States and, secondly, the inconsistent results from the very few trials carried out so far.

1.6 The market is thus left to find its own dynamics, aided by the choice of consumers, who remain free to choose whether or not to purchase GM products.

1.7 The national competent authorities on the matter took part in a technical meeting on 19 June 2006 and in a meeting of national competent authorities within the terms of Directive 2001/18/EC on 3 July 2006; the next meeting is scheduled for January 2007 to continue the discussion and address potato, maize Bt11 and maize 1570.

1.8 The stances emerging from these meetings have displayed a continuing concern for health and environmental protection aspects: seven out of eight Member States have restated the crucial role of the precautionary principle; eight out of nine countries have made comments concerning Bt11 maize which the European Food Safety Authority has ignored; eight out of nine countries have lamented the insufficient scientific data on the environmental effects of maize 1570; critical comments made in seven out of nine cases on monitoring plans have not been considered by the EFSA.

1.9 European legislation consistently aims to impose constant vigilance regarding the potential risk to human health and the environment, and so an approach which bases the method of coexistence exclusively on economic aspects appears contradictory.

1.10 The precautionary principle, as defined in Article 7 of Regulation (EC) No 178/2002, provides the basis for an operational analysis of risk, and can be invoked when danger threatens and scientific knowledge is insufficient for a full a priori safety assessment to be made. (Judgment of the European Court of Justice of 9 September 2003, case C-236/01.)

1.11 The precautionary principle has its origins in that of sustainable development.

1.12 The sustainable development principle can be defined as the interaction between human activity and the global biophysical context; this relationship must be managed in such a way as to allow, on the one hand, human progress and, on the other, the preservation of the global biophysical balance, maintaining a proper equilibrium between the two.

1.13 It is worth briefly restating the definitions of these two principles, as they are essential to correct implementation of coexistence between agricultural systems.

1.14 Taken together, the regulation on unique identifiers (5), the decision on registers (6), and the regulation implementing Regulation (EC) No 1829/2003 provide for the correct empirical application of the criterion of coexistence of agricultural systems and ensure transparency and traceability.

1.15 This legislation is complemented by the requirement of labelling and traceability of food and feed which contain quantities of GMOs above the tolerance level as a result of technically unavoidable contamination.

1.16 A precautionary approach, which is to include a careful assessment and monitoring of risks, is thus to be taken before products obtained using GMOs are researched, produced and marketed.

1.17 The risk to human and animal health, as well as to the environment, is mentioned systematically in the recitals of each piece of Community legislation.

1.18 The risks of accidental genetic contamination in agriculture and the economic impact of mixing of GM and non-GM crops must be addressed and taken on board if new genetically modified products are to be marketed in the Union.

1.19 To date, the Union has authorised and provided for the introduction of a small number of GMO varieties in the Member States.

1.20 This has, in effect, lent legitimacy to the incremental entry of genetically modified crops into Europe and provoked sharp criticism on the grounds that such crops are incompatible with other crops and there is no proof that they are innocuous for the environment and the very varied genetic heritage that it represents, and for human health.

1.21 Community legislation reflects concern at the risk of accidental contamination: the adventitious introduction of GMOs into organic or conventional crops has been recognised as ‘technically unavoidable’, in effect discounting the possibility of attaining zero tolerance.

1.22 Accidental contamination incurs additional costs for conventional and organic farmers in taking appropriate measures to avoid contamination and the loss of organic status, the very essence of which is purity of cultivation method and result.

1.23 The principle that every farmer is free to exercise economic initiative must be upheld, which includes not only the freedom to choose the most economically viable system of production, but also the need to keep the crops he chooses to produce separate in order to avoid mutual contamination.

1.24 At the same time, consumer choice must also be protected with regard to the product purchased, whose integrity must be maintained not only when it is put on the market, but also in the preceding phase of cultivation, by ensuring traceability and freedom from contamination in the systems of agricultural production.

1.25 GMOs can only be grown or placed on the market in the Union if they are authorised and if health and environmental aspects comply with Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Regulation (EC) No 1829/2003 on genetically modified food and feed.

1.26 Article 26a of Directive 2001/18/EC, as inserted via the amending Regulation (EC) No 1829/2003, states that Member States may take appropriate national coexistence measures to prevent the unintended presence of GMOs in other products, but does not make this compulsory.

1.27 Article 22 of the same directive prevents Member States from prohibiting, restricting or impeding the placing on the market of authorised GMOs.

1.28 In its Recommendation 2003/556/EC of 23 July 2003, the Commission provides crucially important guidelines. The recommendation's recitals: a) specify that ‘Specific coexistence measures to protect the environment and the human health, if needed, are included in the final consent of the authorisation procedure in accordance with Directive 2001/18/EC of the European Parliament and of the Council, with a legal obligation for their implementation’; b) express misgivings about the risks involved in not implementing coexistence correctly, the potential economic loss, and the impact of admixture of GM and non-GM crops, and highlights the value of adopting the most appropriate management measures to minimise admixture; c) recommends that every Member State adopt ‘national strategies and best practices’ in line with the specific agronomic characteristics of the areas concerned.

1.29 The ‘zero tolerance’ option is thus ruled out because it is not practicable; nevertheless, coexistence must be implemented with due care, using ‘best practices’ in order to prevent ‘irreversible consequences’.

adopted the following opinion at its 67th plenary session, held on 6 and 7 December 2006 (meeting of 6 December):

2. The Committee of the Regions' views

The Committee of the Regions

2.1 Preliminary questions

Highlights the following issues which it considers preliminary to a correct implementation of coexistence of farming systems and protection of agricultural biodiversity:

2.1.1 Inadequate monitoring

a. considers the current system of monitoring inadequate and notes the outcome of the policy debate held in the Council on 9 March 2006, during which the greater part of the Member States called for improvement of the system of scientific assessment performed by EFSA in the procedures for GMO authorisation, regretting the limited nature of EFSA actions and the fact that its decisions often ignore the scientific assessments of the Member States.

2.1.2 Inadequate risk-assessment procedure

a. stresses that the risk assessment provided for by Directive 2001/18/EC is carried out by the entity which wishes to market the GM product, while the competent authorities of the Member States and the European Food Safety Authority (EFSA) merely assess the accuracy of the data submitted;

b. calls for the procedure for amending or withdrawing authorisation where risks arise to be made simpler and more rigorous in order to prevent continuing deliberate release for business or contained use while awaiting the withdrawal or amendment of authorisation;

c. calls for a different monitoring system throughout product introduction and marketing, with a dual monitoring procedure and a reduction in the number of cases where the ‘simplified’ procedure under Directive 2001/18/EC is used.

2.1.3 Inadequate seed discipline

a. maintains that setting a threshold for seeds is a crucial issue in the debate and that coexistence of systems cannot work if the seeds used are not pure;

b. at the same time, characterises coexistence as the method which allows every type of farming to be respected and which would be invalidated ab origine if impure seeds were allowed to be introduced into cultivation.

2.1.4 Inadequate protection for conventional and organic farming afforded by the 0.9 % threshold

a. maintains that the 0.9 % reduces the purity of the organic method;

b. maintains, therefore, that if implementing zero tolerance is impossible, the percentage threshold for organic farming must be very close to zero, reducing the presence of GMOs to the level of the technically unavoidable by adopting appropriate measures to prevent accidental contamination;

c. considers that the 0.9 % threshold is also too high for conventional farming, since recurrent contamination year after year can very quickly result in high pollution levels in the environment and in the food production chain.

2.1.5 Inadequacy of the safeguard clause as the sole remedial method in the event of risks to health or the environment:

a. recalls that in Article 23 of Directive 2001/18/EC, European legislation provides a safeguard clause as a preventive method for directly applying the precautionary principle, based on recitals 4, 5, 6, 8, 16, 19, 20, 22 and 56 of the Directive's preamble;

b. regrets that the procedure is overly complicated and hopes that the possibility of invoking the safeguard clause presently enjoyed only by Member States can also be extended, using domestic legislation, to local and regional authorities through decentralisation or delegation;

c. points out that Article 95(5) of the EC Treaty would permit further safeguard measures and regrets the Commission's restrictive decision-making on measures taken by Member States under this provision.

2.2 General comments on the Commission Communication

2.2.1 stresses the importance of close cooperation between the Member States and the exchange of research findings pertaining to coexistence;

2.2.2 considers it vital that coexistence measures maintain the diversity of types and methods of agricultural production and hence the freedom of choice for farmers and consumers;

2.2.3 stresses the need to provide full, objective information regarding GMOs and coexistence to interested parties and the public;

2.2.4 stresses the fact that experience of genetically modified crops in the EU is very limited;

2.2.5 supports the Commission's intention to find out more about national systems of responsibility and the bearing they have on coexistence standards;

2.2.6 stresses the fact that in four Member States, regions are also responsible for legislating on coexistence, while in other cases regional and/or local authorities bear responsibility for implementing coexistence measures;

2.2.7 recalls and endorses the view of the European Economic and Social Committee in its opinion on coexistence, which stated that measures to protect nature conservation areas in line with Directive 92/43/EEC on habitats, flora and fauna and Directive 79/409/EEC on the protection of birds, and other ecologically sensitive areas, should be regulated at national and local level;

2.2.8 stresses that public studies carried out in parts of Lazio involved in GMO trials have shown that GMOs may remain in the soil, especially in certain pedoclimatic conditions, and may seep from the soil into water;

2.2.9 considers that the only way of conducting a truly in-depth and independent assessment of risks involved in cultivating a particular GMO is at local level and through specific studies;

2.2.10 stresses the fact that many local and regional authorities have come out against the growing of GM crops in their territory, proclaimed themselves GMO-free areas and come together to form networks, e.g. the network of 40 GMO-free regions and local authorities. Individual regional authorities have even attempted to have their status as GMO-free areas enshrined in law. The legality of such a step is currently the subject of a dispute at the European Court of Justice between the European Commission and the Land of Upper Austria.

2.3 Building on existing segregation methods/practices

2.3.1 notes that the Commission's communication highlights the ‘limited practical experience with GM crops’;

2.3.2 stresses, therefore, that there are no practices and methods of segregation that have been approved without reservation and which could be followed to ensure risk-free coexistence.

2.4 Proportionality

2.4.1 points out that Commission Recommendation 2003/556/EC introduced the criterion of proportionality as a principle under which coexistence measures must be efficient, cost-effective and proportionate;

2.4.2 points out, however, that the purpose of the tolerance thresholds imposed by legislation for ‘technically unavoidable’ contamination is merely to determine the point at which labelling becomes compulsory and not to establish a limit for coexistence.

2.5 Appropriate scale

2.5.1 notes that, according to the report, the Member States' approaches to coexistence have tended not to apply it at the regional level, but on the smallest possible scale and, at most, spanning neighbouring farms;

2.5.2 considers, therefore, that any idea of implementing coexistence on the basis of measures that have not yet been tested on a large scale or over an extended period is a distant prospect;

2.5.3 stresses that, in the light of current scientific knowledge and the existing legislative framework, it is not the individual farm but rather the region or local authority which is the most appropriate level for the implementation of coexistence.

2.6 Liability rules

2.6.1 notes the Commission's statement that in many Member States, the economic loss that may result from accidental contamination by GMOs falls within the scope of civil liability laws;

2.6.2 stresses, nonetheless, that this is not the only approach they can take, as the recommendation gives each and every Member State freedom of choice; and that criminal or administrative sanctions can also be invoked;

2.6.3 also notes that Directive 2001/18/EC stipulates that its provisions are without prejudice to national legislation in the field of environmental liability.

2.7 Monitoring and evaluation

2.7.1 highlights the fact that the Commission's recommendation stated that the management measures and instruments adopted on coexistence should be subject to ongoing monitoring and evaluation, and called on Member States to establish adequate control and inspection systems;

2.7.2 notes that, as the Commission points out, given the paucity of GM cultivation, many Member States have yet to put together monitoring and evaluation programmes;

2.7.3 notes with some concern that in Member States where there is a difference in market value between GM and non-GM feed and/or where products protected on the grounds of their typically local nature or origin are a source of national pride and added value, the identification of GM and non-GM markets would lead to a drop in consumer interest and hence in market price, with possible adverse economic effects.

2.8 Organic crops

2.8.1 notes but disagrees with the fact that the thresholds of adventitious presence enshrined in Community legislation governing products containing GMOs are equally applicable to conventional and organic produce;

2.8.2 stresses that a ban on using GMOs in organic farming is implicit in the regulation on organic production and that, for this reason, materials, including seeds, whose label indicates the presence of GMOs cannot be used in the production process;

2.8.3 adds that the Commission says nothing about organic production;

2.8.4 asserts the need to apply a threshold as close as possible to zero tolerance in the case of organic production.

2.9 Seed purity standards

2.9.1 observes that seeds are a medium which, intentionally or otherwise, spreads biotechnological innovation among crops and in the environment and for this reason they are a key variable in coexistence;

2.9.2 notes the position expressed by the European Parliament in Resolution 2003/2098 (INI) that information on the presence of GMOs in seed is essential for proper implementation of Directive 2001/18/EC, particularly as regards monitoring of the adverse effects of GMOs on human health and the environment, traceability and emergency measures.

2.10 Choice of measures

2.10.1 supports the need to identify the most appropriate measures to ensure coexistence in which the risk is infinitesimal or as low as possible;

2.10.2 stresses that ‘best practices’ means those methods of separate cultivation which ontologically respect coexistence;

2.10.3 agrees with the observation that there is limited scientific knowledge and practical experience regarding identifying and applying best practices and measures and that for this reason measures should be limited and selective;

2.10.4 highlights the Commission's precise indication of the measures to be adopted to prevent frustration of the precautionary principle in implementing coexistence and infers that the detailed action required could impede the implementation of coexistence or make it so arduous and costly as to become uneconomic;

2.10.5 recalls that in its abovementioned opinion on coexistence, the European Economic and Social Committee recommended that the growing of GM crops be banned when it makes traditional production of plants of the same or related cultures impossible or unduly difficult;

2.10.6 shares the position taken by the European Parliament in Resolution 2003/2098 (INI), which states that a voluntary or regionally restricted renunciation of GMO cultivation may be the most effective and least costly measure for guaranteeing coexistence;

2.10.7 considers the Commission's approach reticent when compared with Recommendation 2003/556/EC, especially as scientific research has produced very few new findings since 2003 and the body of evidence remains small; therefore considers it necessary to wait for more telling scientific results in the medium and long term, since trials in many Member States have stopped;

2.10.8 underscores, in this context, the need for the European Commission to define special instruments for funding research in order to make it possible to assess the socio-economic impact of GMOs at regional and local level;

2.10.9 stresses that, as homogeneous administrative areas, local and regional authorities are the most appropriate level for assessing the impact of the introduction of GM crops in each territorial context, for devising coexistence measures compatible with the principle of sustainable development and for reconciling local interests and managing possible solutions.

2.11 Risk management

2.11.1 notes that, while authorised GMO products can only be banned in accordance with the provisions of Article 23 of Directive 2001/18/EC or Article 95(4) and (5) of the EC Treaty, they have to comply with the precautionary principles which must guide the safe application of coexistence;

2.11.2 points out that when an environmental or health risk is discovered after authorisation has been granted, a procedure for withdrawing the authorisation or for modifying the conditions for its issue can be initiated; and stresses that, given the continuous progress in scientific research, risk profiles which are not scientifically proven today could be identified in the future;

2.11.3 considers that the procedure for amending or withdrawing authorisation where risks arise is too long and complex, and that the monitoring system in force is inadequate; notes the dangers of continuing deliberate release for business or contained use while awaiting the withdrawal or amendment of authorisation;

2.11.4 highlights the tendency among some countries which have been growing GM crops for a number of years to review their positions with a view to restoring certain environments and crops, which have been jeopardised by the presence of parasites displaying forms of resistance to genetic modifications.

3. Recommendations of the Committee of the Regions

3.1 requests that first and foremost, remedies be found to the preliminary questions raised in point 2.1. The following should be addressed as a first step towards correct implementation of coexistence between systems: new monitoring procedures, risk assessment for health and the environment, seed purity, extending the right to invoke the safeguard clause, the possibility of applying ‘best practices’ that emerge from the scientific research in the medium and long term, and the redefinition of the percentage tolerance thresholds; until such time as the abovementioned remedies come into effect, the existing bans on the use of particular GMO products, imposed by the Member States in pursuance of the precautionary principle, will remain in force;

3.2 supports the need for measures to protect nature conservation areas and other ecologically sensitive areas to be regulated at national and local level, as stated by the European Economic and Social Committee in its opinion on coexistence (CESE 1656/2004);

3.3 considers that closer collaboration on coexistence is needed between the EFSA and the relevant national authorities, and asks the Commission to pursue the course it has already embarked upon in this matter;

3.4 affirms the need for regional and local authorities to play an active part in the consultation process on coexistence, and asks the Commission to take greater and more systematic account of the regional and local dimension in the report on coexistence which it is to present in 2008;

3.5 requests to be involved in the drafting of Community legislation that helps to address preliminary questions for coexistence implementation in order to arrive at independent but coordinated standpoints and avoid the kind of glaring inconsistency that can trigger abnormal flows of investment capital to places where legislation is more permissive;

3.6 calls on Member States to draw up appropriate monitoring and evaluation programmes on management measures and instruments to be adopted;

3.7 calls for the introduction of GMOs in a given area to be preceded by concrete studies and invites the Commission and the Member States to set out programmes and resources with a view to giving the utmost technical and financial support to scientific research, including at regional and local level;

3.8 underlines the need for national and regional legislation on coexistence to refer explicitly to the precautionary principle;

3.9 requests the Commission, when drafting its own proposals for legislation, to take appropriate account of: a) the need to harmonise national or local indicators on minimum segregation distances between systems, while respecting the subsidiarity principle; b) Community regulation of border areas and cross-border imports, in keeping with the provisions of the Carthagena Protocol; c) the Community definition of uniform thresholds for conventional farming below 0.9 % and as close as possible to zero tolerance. For seeds and organic farming, the threshold should equate to zero; d) the fact that drawing up good practices and assessment of scientific and economic data concerning segregation measures and the production of crops and seed could be an insurmountable obstacle — empirical rather than ideological — to implementing coexistence of the different agricultural systems: in certain conditions, coexistence is in fact unfeasible or uneconomic; e) the fact that there are homogeneous administrative bodies which have binding legislative powers throughout their own territory and whose legislative autonomy is recognised either by national law or constitutionally and that, by virtue of the subsidiarity principle, the impossibility of their adhering to safeguard measures and best practices should be recognised and the possibility of achieving a GMO-free status must be provided;

3.10 calls on the Member States and regions to ensure cross-border cooperation with neighbouring areas to guarantee the efficient functioning of co-existence measures in border parts;

3.11 in this context, recommends that the Commission set up a website containing links to the existing national location registers in Europe.

Brussels, 6 December 2006. The President of the Committee of the Regions Michel DELEBARRE

(1) OJ L 268 of 18.10.2003.

(2) OJ L 31 of 1.2.2002.

(3) OJ L 106 of 17.4.2001.

(4) CESE 1656/2004.

(5) Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, OJ L 10 of 16.1.2004.

(6) 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 and repealing Council Directive 90/220/EEC, OJ L 106 of 17.4.2001.