EN Official Journal of the European Union C 157/155

Opinion of the European Economic and Social Committee on the ‘Co-existence between genetically modified crops, and conventional and organic crops’

(2005/C 157/29)

On 29 January 2004, the European Economic and Social Committee, acting under Rule 29(2) of its Rules of Procedure, decided to draw up an opinion on ‘Co-existence between genetically modified crops, and conventional and organic crops’.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 21 September 2004. The rapporteur was Mr Voss.

At its 413th plenary session on 15/16 December 2004 (meeting of 16 December 2004), the European Economic and Social Committee adopted the following opinion by 47 votes in favour, 13 votes against and 4 abstentions:

1. Introduction

1.1 The EESC considers it necessary to develop and lay down rules on coexistence between the cultivation of genetically modified crops on the one hand, and the conventional and organic cultivation of crops and environmental protection on the other. These rules must be sustainable, legally certain, and practicable, and must apply to the entire food sector and to agricultural, fishery and forest production including that for pharmaceutical, non-food and research purposes.

1.2 The Commission a) wants to leave significant aspects of coexistence to national legislation, and b) is minded to address the issue of the adventitious or technically unavoidable presence of GMOs in non-GMO seed, which is central to the future of coexistence, by means of the comitology procedure under Directive 2000/18 and under the directives on the marketing of seed. Therefore, the EESC is not being consulted on these issues. It therefore makes sense to join the debate on these issues by drawing up an own-initiative opinion, thus drawing particular attention to the associated economic and social issues and providing an opinion on these to the Council, the Commission and the Parliament.

1.3 The purpose of this own-initiative opinion is twofold: firstly, to shed light on the most important substantive aspects of coexistence; and secondly, to make proposals as to which of these aspects should, in the EESC's view, be dealt with by European legislation, which should be dealt with by national legislation, and what practical objectives and guidance the relevant businesses, in particular farms, need.

1.4 As the Commission ended the moratorium on marketing GMOs as foodstuffs, which had been in force since 1998, in May this year and intends to take a decision in the near future on the cultivation of GMOs (1), it is of vital importance to set up a practical framework for coexistence.

2. General preliminary remarks and definitions of terms

2.1 Due to the authorisation of the marketing of genetically modified organisms (GMOs): — for plant and microbe cultivation and stock farming; — for research purposes; — as food and animal feed; — as a raw material for other purposes, including cultivation for pharmaceutical production; — for the purpose of managing the natural environment (for example to break down pollutants), and — as an aid to agriculture and forestry (for example, to control parasites and weeds), the need arises to lay down practical provisions for the implementation of such marketing and for the handling of these products in food, animal feed and the natural environment.

2.2 The following matters have already been settled at European level: — risk assessment and risk management (2); — authorisation; — labelling requirements for food and animal feed (3) — traceability (4), and — transboundary transport outside the European Community (implementing the International Cartagena Protocol on Biosecurity) (5).

2.3 The following areas have yet to be dealt with at European level: — labelling requirements for seed and reproductive material; the Commission is currently drawing up a proposal on this matter (6), and — the practicalities of the economic, social and cultural consequences of the use of GMOs (7); the parliaments and governments of Member States are currently dealing with this in the framework of the implementation of Directive 2001/18 and the development of their national legislation relating to rules on cultivation and civil liability relating to this.

2.4 Existing EU legislation states that GMOs require particular risk assessment, risk management and labelling and traceability throughout their life cycle. It is based on the assumption that it should be possible to refrain from the active and passive use of GMOs and strictly forbids the use of GMOs in organic agriculture and organic food (with the exception of a few veterinary products). It also provides for the possibility, on a case-by-case basis, of subjecting the release of GMOs in particular areas to special conditions or prohibiting it altogether.

2.5 GMOs are living organisms that are capable of reproducing and spreading within the natural environment. The biological systems into which they are to be introduced, and from which they cannot then be easily removed, can neither be hermetically partitioned nor similarly controlled in the way that is possible in closed scientific, industrial or craft facilities. The biosphere is fundamentally a globally interconnected, open system, of whose laws and behaviour we currently only have limited knowledge and control.

2.6 For these reasons, the European legislators have taken the precautionary principle along with case by case assessment and regulation as the basis for dealing with GMOs. At the same time, they have considered transparency and freedom of choice in respect of the use of GMOs to be of great importance.

2.7 This is taking place against a background where a majority of the citizens of the European Union are either sceptical or hostile to the use of GMOs in agriculture, forestry, food and feed.

2.8 The coexistence of agriculture and land use with and without genetically modified organisms therefore affects: — agriculture, forestry, and fisheries, including management of land ownership; — the whole of the food sector (processing, trade, catering); — regional and local land use and economic development; — consumer protection; and — environmental protection within the temporal and spatial framework appropriate to each.

2.9 The European Commission, in non-binding opinions, has until now reduced coexistence to the purely economic factors of various forms of agriculture existing alongside each other. It suggests that regulating these aspects should be left largely to individual Member States. However, this position has caused controversy in the Council of Ministers and has been criticised by the European Parliament (8).

3. Main aspects of coexistence (structure)

3.1 Current scientific thinking

3.1.1 In order to regulate coexistence effectively, a sound scientific basis is needed for estimating the speed and breadth of the spread and interbreeding of GMOs of various plant species (and, where applicable, the spread of micro-organisms and animals). Reliable, practical experience and estimates of possible modes of transmission during production, storage, transport and processing are also essential.

3.1.2 The Commission has obtained various reports and opinions (9) on this subject; however, these do not yet give a coherent picture. Further studies have been commissioned. At the first scientific conference on coexistence (10), which was held in November 2003, the assembled scientists established that there was a considerable need for research and felt that their ability to make firm statements on the possibilities of coexistence was limited. An opinion of the EU Scientific Committee from 2001 (11) points to significant uncertainties and does not unequivocally commit itself to the limits for food, feed and seed suggested by the Commission.

3.1.3 The current state of knowledge of cross-breeding behaviour, propagation, and persistence of genetically modified plants does not at present allow any reliable predictions to be made as to the feasibility of coexistence.

3.1.4 This particularly applies to long-term forecasts and to various ecosystemic surroundings and conditions of cultivation.

3.1.5 The evaluation and estimation of the ability of particular GMOs to co-exist must be undertaken plant species by plant species, taking into consideration the regional circumstances and the various production systems. Such evaluations and estimates also need to take into account the changes to cultivation methods this involves (for example, the use of total herbicides made possible as a result of appropriate resistance).

3.1.6 Particular difficulties in forecasting and monitoring arise where plant species are involved that are genetically capable of interbreeding with naturally-occurring, non-cultivated related species. Oilseed rape, whose genetic origins are in Europe, has many direct and indirect wild and cultivated cross-breeding partners. These include cabbage, rape, mustard (rocket), wild radish, annual wall rocket, common dogmustard, wild mustard, wild cabbage and Mediterranean mustard. The same also applies to beet, for example.

3.2 Risk management, monitoring and registration of cultivation

3.2.1 The identification and labelling of GMOs is the material precondition for the implementation of the registration of cultivation and the monitoring of GMOs required by Directive 2001/18. It is also a precondition for taking particular GMOs out of circulation if this becomes necessary due to new scientific information or to the expiry of a time-limited authorisation. The labelling of GMOs capable of reproducing is of decisive importance for effective risk management, especially in the event that emergency measures become necessary. It cannot, therefore, focus solely on the question of whether or not it will lead to the limit for a labelling requirement in food and feed being exceeded, particularly since the proposed limits with respect to consumer information cease to be relevant if an authorisation is withdrawn.

3.2.2 An assessment of the risks associated with GMOs is required under Directive 2000/18 and similar provisions in other Community regulations and directives and is a precondition of their authorisation. However, the way in which cultivation is carried out in practice will have a decisive effect on whether the measures provided for in the directive to limit cultivation and to control and monitor its effects and to withdraw authorisation can actually be carried out. Thus, the issue of coexistence cannot be limited to the economic aspects of cultivation alone, but is an integral part of the risk management and prevention laid down by law.

3.3 Traceability and control in the human and animal food chain by sampling, testing and documentation

3.3.1 Measures for identifying and labelling GMOs throughout the food chain are set out in the directive on traceability and labelling of GMOs (part of the general principles and requirements of food legislation (12)). These extend beyond the identification of the GMOs in the final product, as products now need to be labelled even if no trace of the GMOs can be detected in the end product.

3.3.2 The information needed to identify a GMO are recorded in a central database and published (13).

3.3.3 The Joint Research Centre of the EU is now working towards the standardisation and validation of the sample collection and test procedures that are required in this context.

3.3.4 The identification of specific DNA or of a specific protein of a GMO is technically possible, using currently available analysis techniques, between 0.001 and 0.05 per cent of the total of the sample being analysed. The costs for non-specific, qualitative tests for the presence of GMOs are currently between 100 and 150 EUR per test. The costs for specific and quantitative tests vary between 250 and 500 EUR per test.

3.3.5 Considerable differences persist within the Community as to the reliability and across-the-board availability of detection procedures and the technical capacity to put them into practice. As yet, adequate provision for such procedures has been made in only a few Member States; in some, no such provision has been made at all.

3.3.6 Currently, there are, in practice, considerable difficulties particularly with quantitative and specific tests for the presence of GMOs, particularly where the manufacturer has provided no appropriate detection procedure or insufficient reference material. This applies especially to those GMOs that are not permitted in the EU, but whose presence in imported seed and raw materials cannot be ruled out.

3.4 Good professional practice in agriculture

3.4.1 Good professional practice needs to be adhered to throughout the food production chain: — in research and development, particularly where the release of GMOs for scientific purposes is involved (2001/18 Part B); — in the development of seed, particularly with respect to the composition of the stock material and of the various stages of the basic seed; — in maintenance breeding and reproduction; — in the reproduction, preparation, treatment and packaging of the seed; — in the cultivation, processing, harvesting and transport of the plant products; — in selecting and preparing harvested seed for replanting; — in the buying, processing, storage and transport of agricultural raw materials and products; — in further processing of food and feed, and — in packaging, distribution and labelling of finished products.

3.4.2 In most areas, good professional practice is in many ways already established. Complementing them with specific provisions for handling GMOs is the key condition for the practical implementation of the legally defined rules for risk management, traceability, and labelling of GMOs. The greatest need for this action is in the areas of seed and agricultural production, but also with respect to the buying, storage and transport of agricultural produce.

3.4.3 Both the success and the requirements of good professional practice depend substantially on the success with which good professional practice was adhered to in the prior stages of the production process.

3.4.4 In order to avoid interbreeding and other spreading of GMOs on to fields and the environment at large, as well as the mixing of GMO seed with non-GMO seed, various measures (appropriate to the crop in question and the regional circumstances) need to be taken. The Commission has spelled some of these out in its guidelines on coexistence (14) and requested Member States to issue appropriate regulations. These affect both farmers who plant GMOs and those who want to keep them out of their produce. They also apply to agricultural service companies and businesses, including those involved in storage and transport, as well as the authorities responsible for agricultural practice and institutions involved in protecting the countryside and the environment.

3.5 Composition, control and labelling of seed

3.5.1 Seed is the first stage in the production chain. It reproduces by a factor of between 40 and 1000 depending on type and may in some cases remain in the soil for long periods. GMOs in seed fertilise neighbouring crops and any wild relations growing nearby through external pollenisation. Seed and pollen can thereby be dispersed across great distances. Scientists agree that these space and time elements mean that the presence of GMOs in seed is a key factor in coexistence.

3.5.2 Directive 2001/18 provides for the establishment of limits for certain product groups, below which limits labelling of GMOs is not required if certain conditions are met. The regulations on genetically modified food and feed (15) and on traceability (16) set a limit of 0.9 % for those products.

3.5.3 The Commission has proposed that the directives on plants and seed should also contain such limits on GMOs in seed, which should be between 0.3 and 0.7 per cent. Due to legal concerns, the Commission withdrew this proposal in October 2003 and drew up a new proposal. This contained only limits of 0.3 % for rape seed and maize seed. However, the Commission withdrew this proposal, too, in September 2004. Further risk assessments are now planned in order put the decision on a sounder scientific basis and, in particular, to obtain a more accurate picture of the economic effects. It is clear that setting purity standards for non-genetically modified seed will have significant effects on whether coexistence of certain plant species and types of production will even be possible and, where applicable, on the costs associated with it.

3.5.4 On the question of whether limits should be set on the adventitious and technically unavoidable presence of GMOs in seed, and if so what limits. There are differing opinions, not only among the governments of Member States, but also among the businesses and organisations affected.

3.5.5 Unlike food and feed, seed labelling is not designed as information to help final consumers make a free choice. Rather, it provides key information for those releasing GMOs into the environment in line with the legal provisions and for the authorities responsible for implementing the deliberate release directive. Lack of information about the presence of GMOs in certain seed makes it all but impossible to comply with the legal requirements for their registration, monitoring (post-market monitoring) and, in the case of any subsequent ban, retrieval.

3.5.6 If, for instance, a GMO should subsequently prove to be allergenic, or where the transfer of its properties to wild relations generates a competitive advantage and thus produces undesired shifts in the ecological balance, the GMO in question would have to be banned and withdrawn from circulation. For this purpose, limits in the area proposed by the European Commission would be wholly unacceptable. Assuming that all the seed of the affected plant species is contaminated with up to 0.5 % of this GMO, then retrieval and emergency measures would have to cover the entire yield and the entire seed of the species concerned.

3.5.7 Practical experiences with a product recall in the USA illustrate both the difficulties and the possible costs. In 2000, after the US Environmental Protection Agency banned the use of the genetically modified maize variety Starlink due to possible allergenic effects, the total costs across the product chain were around US$1 billion. Contaminated seed and crops were bought up on a large scale and withdrawn from the market. To this day, however, it has been impossible to eliminate the contamination completely. In 2003, more than 1 % of samples tested showed traces of Starlink.

3.5.8 Moreover, the presence of GMOs in non-genetically-modified seed has a critical impact on the costs incurred in the downstream farming and processing sectors. A huge amount of expensive testing and monitoring is involved in cases where, under legal provisions permitting a certain degree of contamination, all non-genetically-modified products still have to be routinely checked to ensure that their contamination with GMOs does not exceed the legal labelling limit of 0.9 % for food and feed, or correspondingly lower levels for upstream products.

3.5.9 The contamination of conventional and organic seed with GMOs will also be a key factor in determining the party liable for any financial damage incurred by exceeding the labelling limits for food and feed, as well as the lower limits derived from this that commercial and processing businesses are demanding. Naturally, any potentially liable parties will first of all demand proof that the damage involved has not been the result, at least in part, of the condition of the seed rather than the transfer of GMOs in the field.

3.5.10 Also, the presence of GMOs in conventional and organic seed adversely affects farmers' scope for breeding and planting their own seed. The original seed contamination can accumulate in subsequent generations, especially, of course, when combined with further contamination from neighbouring fields. That might not only generate substantial financial losses for the farmers concerned, but could also harm seed diversity and the suitability of seed for local conditions.

3.6 Product and environmental liability

3.6.1 Under Directive 85/374/EEC concerning liability for defective products, manufacturers and suppliers of GMOs are liable only for defective products in the case of culpable or negligent damage to life, limb or property (17). This liability is, however, restricted to final products for private use and consumption and therefore does not cover either the seed or any financial damage incurred by a reduction in the value of the yield or its derivative products.

3.6.2 This comprehensive Community restriction on product liability makes it difficult for national rules to place direct liability on GMO suppliers for any damage falling within the scope of civil law as well. It puts the entire civil liability on the users (i.e. the farmers) as the direct manufacturers of the final product.

3.6.3 The scope of the new environmental liability directive (2004/35/EC) covers ‘any deliberate release into the environment, transport and placing on the market of genetically modified organisms as defined by Directive 2001/18/EC’. This directive authorises Member States (but not individual citizens) to require those responsible to remove and remedy environmental damage if they are at fault or negligent and a causal link can be established between the damage and the activities of individual operators (18). Member States are required to implement this Directive by 30 April 2007. The fact that a GMO is authorised for release within the Community will, generally speaking, rule out the conditions for negligence or intent, unless specific conditions for release were breached. In its opinion on the environmental liability directive (19), the EESC had already stated that ‘the definition of biodiversity should include the effect of GMOs, in both the short and long term’.

3.7 Civil liability

3.7.1 The unwelcome presence of GMOs in products, production facilities and production areas can cause financial damage to farmers, processors and traders of food and feed if this hampers or prevents the production and sale of products without genetic modification or makes special measures for inspection and removal necessary. It can also make measures to return areas to their original state necessary if the release of GMOs is not permitted in those places (for example environmentally sensitive areas). Such measures cost money.

3.7.2 The insurance industry is at present ruling out insurance against such civil claims.

3.7.3 The European Commission feels that the Member States should determine the civil liability for these costs. This will obviously have an effect on competition within the Community. Differing national rules in this area may significantly distort competition in the internal market and create legal uncertainty in cases where cause and effect cross the Community's internal borders.

3.7.4 Individual liability for the costs incurred by third parties in avoiding damage (testing, monitoring and other measures to prevent cross-breeding and contamination with GMOs) is hardly legally practicable. In contrast to compensation for damages actually incurred, these very considerable costs, which will arise in all regions where GMOs are cultivated, cannot be dealt with by civil liability provisions. The affected farmers, businesses and authorities could, however, be compensated by special funds financed by the companies and farmers who bring the costs about.

3.8 Macroeconomic and microeconomic costs

3.8.1 The cultivation of GMOs will make measures for control and prevention of the unwelcome presence of GMOs necessary right across the food and feed production sector. There may also be an impact on markets in certain regions and for certain kinds of production and product types (for example, regional quality labels and organic farming and production). In addition to the market players, this affects various authorities and institutions of the Member States and of the Community.

3.8.2 The monitoring and prevention measures required for coexistence to some extent involve radical changes in farming, craft and industrial practice and tradition. The economic, social and cultural impact, especially on farmers and the craft-based food industry, has not so far been consistently examined and presented. This is, however, essential so as not to adversely affect either their ability to survive and compete, or the market and price structure.

3.8.3 A comprehensive picture of these costs is needed in order to evaluate what measures and regulations on coexistence will be most appropriate. To date, however, only limited, piecemeal information and estimates exist on this subject (20)

3.8.4 The EESC considers a comprehensive overview and estimate of costs that will arise out of coexistence measures for a) individual market players in various types of production and regions and b) the public purse to be an essential requirement for a forward-looking and sustainable solution for coexistence. Clear, binding and reliable arrangements are needed as to who should bear or indeed avoid these costs.

3.8.5 The Commission is right when it writes in its guidelines on coexistence: ‘As a general principle, during the phase of introduction of a new production type in a region, operators (farmers) who introduce the new production type should bear the responsibility of implementing the farm management measures necessary to limit gene flow. Farmers should be able to choose the production type they prefer, without imposing the necessity to change already established production patterns in the neighbourhood.’

3.8.6 The increased production costs resulting from the requisite coexistence measures must not be passed on in higher consumer prices. That would curb freedom of choice, not least for more socially disadvantaged consumers. Agricultural and craft-based food production not involving genetic engineering must not be threatened by cost and price increases and forced into niche production.

4. EESC Recommendations

4.1 Principles of coexistence

4.1.1 Rules on coexistence should be driven by the principles of caution, maintaining natural and agricultural biodiversity, minimum cost, maximising economic and social opportunities, promoting regional diversity and economic autonomy, and the polluter pays principle. They should be sustainable in the long term, robust, realistic and forgiving of mistakes.

4.1.2 The necessary measures and the resulting costs should, as a matter of principle, be borne by those economic players who make them necessary by supplying and using GMOs. The burden on those who wish to produce and consume without GMOs should be kept to a minimum, and such measures must not push up their production costs and prices. Nor should they be borne by the taxpayer.

4.1.3 Measures to prevent the appearance and spread of GMOs should, as a matter of principle, take place at the stage where they are least costly and most effective.

4.1.4 GMO cultivation must not be allowed wherever this would make production of plants of the same or similar types without genetic manipulation no longer possible or disproportionately difficult.

4.2 Elaboration of scientific principles and dealing with the current state of scientific knowledge

4.2.1 Until an adequate scientific basis is established, the conditions for coexistence must be developed using the precautionary principle, the aim being to prevent changes that are difficult or impossible to reverse and whose consequences for coexistence cannot adequately be assessed. Such preventive action should also include the economic, social and agricultural aspects of coexistence.

4.2.2 The Commission is called upon to launch a coherent, interdisciplinary, scientific and practical research programme to bridge the huge gaps in knowledge about coexistence.

4.2.3 The opinion of the Scientific Committee on Plants (21) referred to by the Commission in the discussion on GMO limits in seed is not satisfactory. It fails to answer the question of what limits are required for labelling to meet the provisions of Directive 2001/18. Nor does it adequately answer the question of which kinds of seed contamination will, in practice, lead to which kinds of contamination in the yield and final product. The Commission should therefore again submit specific questions to the EFSA Scientific Committee.

4.2.4 Furthermore, the scientific and practical studies by the European Food Safety Agency, the European Environment Agency and the Joint Research Centre available at national and regional level should be summarised and made accessible to the Member States.

4.2.5 The Committee recommends that the Commission join forces with a number of European regions to undertake practical, large-scale coexistence trials under various conditions. By cultivating species of maize, rape, potatoes, beet and tomatoes that are not genetically modified but are quite distinct from other species, all those involved should test and study the practical implications of cross-breeding prevention, various safe distances, the cleaning of machinery, separation during transport, storage and processing and other coexistence measures.

4.3 Precautions and use of the best available technologies in risk management

4.3.1 Labelling and good professional practice must be aimed at making it possible to monitor the spread and effects of GMOs as accurately as possible. It should also facilitate the fullest possible elimination of a GMO from the environment, seed and produce.

4.3.2 Under no circumstances should the setting of thresholds for labelling or provisions for good professional practice impede or render impossible the aims and objectives of Directive 2001/18 and Regulations 1830/2003 and 1829/2003.

4.3.3 It should therefore be a fundamental requirement that the best available technology and practice is used in cultivation, transport, processing, import and export of GMOs.

4.3.4 In this context, the particular requirements of protecting nature and the diversity of Europe's ecosystems must also be taken into consideration.

4.4 Obtaining and keeping the information necessary for identification and labelling

4.4.1 It should be a fundamental requirement that the identification of GMOs and their labelling at various stages of production is carried out as accurately as possible at the beginning of the chain of production and is passed on to subsequent stages in the chain in as complete a form as possible.

4.4.2 The loss of information must be prevented. Once information has been obtained, this should be documented and passed on, regardless of any threshold values that may be in place.

4.4.3 The provision and validation of test procedures and reference material is the responsibility of the companies and institutions that want to supply a particular GMO or release it for the purpose of scientific tests. They also have a duty to keep these up to date and to make them available to all interested parties at minimum cost.

4.4.4 Sampling procedures should, especially at the beginning of the production chain, be selected such that they provide the highest possible level of certainty and secure the maximum possible information. They should therefore be based on the most reliable technology available, and not on any threshold limits for labelling that may apply.

4.5 Binding, practicable, verifiable and robust standards for good professional practice at all stages of production are a key criterion for coexistence.

4.5.1 They should be set out in such a way that they achieve the goals of coexistence and precaution in the long term and can be adapted to ongoing developments in science and technology.

4.5.2 In order to avoid a) damaging the single market in food and feed and the agricultural order within the Community and b) distortions in competition, the rules on good professional practice should, whilst remaining flexible enough to take account of the various conditions of cultivation and processing, be set or harmonised at a high (i.e. Community) level.

4.6 The regulations on labelling and purity of seed are crucial in guaranteeing coexistence.

4.6.1 Therefore, when setting limits for labelling of GMOs in seed, the highest technically and practically achievable level of precision and transparency should be sought. Although the technically reliable detection threshold in a sample is currently as low as 0.01 %, in practice the size and number of samples to be taken mean that a level of 0.1 % of the entire batch of seed is more realistic.

4.6.2 The limit for labelling GMOs in non-genetically-modified seed must be set at the virtual detection threshold.

4.6.3 The respective seed directives should, in addition, contain strict rules (maximum limits) concerning the marketability of non-genetically modified seed.

4.7 Civil liability provisions must fully cover compensation for financial damages

4.7.1 The reproductive capability of GMOs and the fact that their unwelcome presence can cause financial damage to those affected makes it necessary to adapt the civil liability provisions in Member States to ensure that such damages are covered.

4.7.2 The civil liability provisions should ensure that those involved are liable only to the extent that they are able to prevent possible damages. Liability for keeping to good professional practice and any further expenses of the supplier of a GMO should rest with the users of that GMO. Conversely, the liability for damage occurring despite good professional practice being observed should rest with the supplier. If appropriate, the Community rules on legal liability should be adapted accordingly.

4.7.3 Suppliers or users of GMOs should be able to prove their ability to cover, whether through insurance or by similar means, any liability for damages that arise from their activities.

4.8 The total costs of coexistence need to be established, kept to a minimum, and shared in line with the polluter-pays principle.

4.8.1 The Commission is asked to submit a comprehensive and systematic assessment of the costs involved in coexistence, the changes to market conditions and the impact on the various sectors and production patterns in the farming and food industry, especially on small and medium-sized enterprises, traditional farming, including part-time farmers, the traditional craft-based food industry, the organic farming and food industry and seed production and reproduction businesses. In particular, this should include the effects on employment.

4.8.2 Beyond that, the Commission should set out what effects the necessary coexistence measures and the separation of means of productions and goods flows will have on achieving the aims of the Common Agricultural Policy and the reform thereof. Particular attention should be given to the effects on business structures and on local and regional cultivation, processing, origin and quality control programmes and their labelling.

4.8.3 The Commission is also asked to set out how the extra costs of coexistence are to be shared out and compensated for according to the polluter pays principle, and what measures are necessary in order to reliably prevent any negative impact on the prices of non-GMO foodstuffs across the single market.

4.8.4 When establishing the proportionality of particular measures, the effects on the whole production chain should be taken into consideration.

4.9 Recommendations for Community and national legislation

4.9.1 The following aspects of coexistence must be regulated at European level: — labelling requirements for the presence of GMOs in non-genetically-modified seed; — purity requirements for non-genetically-modified seed with regard to the adventitious presence of GMOs under the existing seed directives; — the requisite targets, results, legal provisions and minimum standards of good practice in GMO cultivation and the financing of the costs that arise from complying with them; — and civil liability both for users and suppliers of GMOs for potential damage connected with co-existence.

4.9.2 The following aspects of coexistence must be regulated at national and regional level: — specific measures to prevent undesired cross-breeding and the transfer of GMOs in line with the conditions obtaining in each region; — regional provisions for the cultivation of certain GMOs where this makes economic sense and is commensurate with the regional cost-benefit ratio between cultivation and the precautionary measures required; these provisions may also include banning the cultivation of certain GMOs; — measures to protect nature conservation areas in line with the Directive 92/43 on habitats, flora and fauna (22), Directive 79/409 on the protection of birds (23), and other ecologically sensitive areas; and — measures to safeguard regional economic and cultural interests.

5. Practical and topical aspects of coexistence

5.1 In July 2004 the European Economic and Social Committee invited players from the entire production chain to a hearing in order to obtain a detailed picture of the current and likely future situation. The following conclusions, amongst others, were reached:

5.2 The testing and tracing of GMOs along the whole production chain will certainly lead to considerable additional costs. Simple, qualitative tests currently cost between EUR 100 and 150, while the cost of more sophisticated and quantitative tests varies between EUR 250 and 400. In the process a sample is tested for one specific gene sequence only. The possible presence of a number of different GMOs will mean a corresponding increase in the cost of testing.

5.3 The first case in which a GMO had to be taken out of circulation on health grounds (Starlink maize in the USA) has so far cost more than US$ 1 bn. Nevertheless, more than two years after the start of retrieval operations, it has still not proved possible to withdraw the GMO completely from circulation.

5.4 The amount and distribution of testing and tracing costs essentially depend on whether the GMO-free status of certain products is the generally accepted and maintained standard on the market, which may be departed from only in exceptional cases, or whether proof of GMO-free status has to be provided by producers, processors and traders in every single case.

5.5 Once a GMO has been placed on the market it is, in principle, no longer possible to guarantee its complete absence from other varieties. It is, however, possible to keep the level of fortuitous and technically unavoidable contamination with the GMO in question below 0.1 %, which is effectively the threshold for reliable detection.

5.6 Keeping non-GMO seed free of unintentional mixing with GMO seed imposes considerable additional demands on seed production. The lower the threshold, the higher the prevention and monitoring costs for seed production and propagation.

5.7 Depending on the method of propagation used for the plant species in question, ensuring GMO-free status will be possible only by maintaining a considerable physical distance during cultivation and a complete separation during the processing, packing and sales processes. ISO standards and HACCP protocols, which are in some cases still at the development stage, must likewise be complied with, and external inspections carried out.

5.8 That purity has to be guaranteed up to the 0.1 % detectability threshold in the USA too, where GMOs are grown in large quantities, and by firms which prepare GMO and non-GMO seed in the same installations, was convincingly demonstrated by a leading international seed producer.

5.9 There are at present no binding practical limit values or standards for GMO contamination in seed production either within the EU or internationally. The monitoring of seed in the Member States is at present subject to different regulations. The official approach in dealing with contamination (tolerance of between 0.1 % and 0.5 %) also differs.

5.10 Although seed producers at present categorically refuse to give a complete guarantee of the GMO-free status of their products, direct negotiations in Italy between the Italian farmers' union Coldiretti and leading seed producers have resulted in guarantees supervised by third parties. In Austria, supplying seed that contains GMOs (more than 0.1 % in a test sample) has been forbidden by a regulation since 2002. Despite intensive monitoring, no violations of this regulation have been detected since then.

5.11 The additional costs for seed production and propagation vary, according to industry estimates, between 10 and 50 %.

5.12 If GMOs are commercially used in a region where GMO-free seed is propagated, large areas need to be designated as protected zones for cultivation as is already done in some countries for various crops. Particularly long separation distances are required for rape cultivation.

5.13 All market players, with the exception of the seed producers, see compliance with strict purity rules for seed (labelling if above the 0.1 % detection threshold) as the decisive pre-condition for guaranteeing GMO-free products in future.

5.14 Guaranteeing GMO-free status below 0.1 %, as required by manufacturers of foodstuffs, starch and pet food, already adds EUR 3 per tonne to the cost of buying up and processing maize. These costs would rise considerably if there were extensive use of GMOs in agriculture. In addition, the potential cost of failure to prevent contamination above the tolerance threshold varies between EUR 150,000 and 7.5 m, depending on batch size.

5.15 The parallel purchase of GMO and GMO-free commodities at one location appears impracticable. What is required is complete separation for the purposes of buying, storage, drying and transport.

5.16 Purchasing companies and cooperatives already guarantee that their products are GMO-free by contractual agreements with the farmers supplying them. Inter alia, a positive list of accepted and tested seed varieties is drawn up, and a continuous monitoring system established from cultivation to supply and delivery checks.

5.17 From the standpoint of the purchasing companies, systems which guarantee GMO-free status below the threshold currently applied by their customers will work only if there is a regional separation of GM and non-GM cultivation. The costs of such management are estimated at EUR 150 to 250 per hectare. The additional cost of separate transport and storage is estimated at EUR 10 to 20 per tonne.

5.18 IP (Identity Preservation) and quality assurance systems also exist at processing plants, such as mills. Their customers at present expect purity guarantees between 0.1 % and a maximum of 0.5 %. Standard PCR (Polymerase chain reaction) tests and traces are carried out on all deliveries. In addition, suppliers are audited and proof required that they buy and process exclusively GMO-free goods. During transport, points where mingling or contamination could occur, such as road haulage and port warehouses where GMO goods are handled, are, wherever possible, avoided.

5.19 In the case of mills processing maize, the cost of keeping equipment clean is currently estimated at EUR 2.50, in addition to the extra charges demanded by suppliers (see above). As these costs can be passed on only in relation to goods for which a guarantee is required, but are nevertheless incurred for the entire volume processed they are in some cases considerably higher for GMO-free end products. For example, maize meal constitutes only 50 % of the processed product, i.e. the additional costs (EUR 2.50 plus EUR 3.00 = EUR 5.50) make a significant difference, at EUR 11 per tonne. The cost of failing to prevent contamination and of supplying goods to customers with a GMO content above the guaranteed threshold could, depending on the batch size and processing, run into tens of millions of euros. It is not at present possible to insure against this risk.

5.20 Consumer caution has meant whole areas where GMO cultivation gives rise to an increased risk of contamination being effectively boycotted whether or not contamination has actually occurred. The mere fact that GM wheat was on an experimental basis in a particular German federal state caused the largest German milling group to stop buying wheat from that area.

5.21 The policy of most of the large retailers and branded good manufacturers in the EU of guaranteeing that they do not use GMOs has in the past few years led to the emergence of extensive quality assurance systems in which individual companies invest tens of millions of euros annually. These consist of a comprehensive documentation and audit system for the suppliers, as well as regular spot checks on goods on offer. These additional costs have usually not been passed on to customers. No systematic quantification has so far taken place in relation to individual products and product groups.

5.22 From a regional point of view, the requirements for coexistence of GMO and non-GMO cultivation vary widely. Particularly in regions with small-scale agriculture, parallel cultivation within a region appears to be impracticable. For example, according to Italy's register of farm land, 90 % of cultivated land in Tuscany is unsuitable for coexistence. The same applies to many more of Europe's regions. Moreover, technically demanding separation, monitoring and planning measures would often be beyond the scope of small and part-time farmers. This is also true of the small-scale processing of regional speciality products.

5.23 Regional quality marks and guarantees of origin, which play an ever more important role in the marketing of premium high-quality products, have up to now not used GMOs. The introduction of GMOs in the regions in question would have a massive impact on the actual production costs and image of these products. This is one reason why may regions of Europe have declared themselves GMO-free zones, although the legal basis for this is controversial and requires clarification by European and domestic legislation. The possibility that individual farmers, as a result of the freedom to cultivate GMOs guaranteed by European law, could impose enormous additional costs and problems on many neighbouring farms and enterprises is considered extremely regrettable by those affected and a threat to social stability.

5.24 A particular source of concern to regional authorities, farmers' associations and processors is the possibility that future GMO varieties (for example pharmaceutical varieties) unlike the existing ones, will have to be hermetically separated from food and animal feed production for health reasons. This has already led to massive additional problems and uncertainty in the USA .

5.25 In some Member States legislation regulating coexistence has been passed, or else the legislative procedure is almost complete. Legal and procedural systems already differ widely from country to country. These differences cannot be explained by regional peculiarities. It is already clear that the approach adopted to ensuring coexistence will need to be harmonised.

5.26 Coexistence of methods of cultivation with and without GMOs and the possibility of GMO-free food is the EU's stated political objective. If it appears that this goal cannot be attained within the existing legal framework, it will be in the interest of consumers, farmers and the other economic players involved to amend the relevant regulations and directives in good time.

Brussels, 16 December 2004 The President of the European Economic and Social Committee Anne-Marie SIGMUND

(1) Communication for an orientation debate on Genetically Modified Organisms and related issues

http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=IP/04/118|0|RAPID&lg=EN

GMO authorisations under EU law – Current situation

http://zs-l.de/saveourseeds/downloads/com_stand_gvo_28_01_04.pdf

Questions and answers on GMO legislation in the EU

http://zs-l.de/saveourseeds/downloads/com_fragen_antworten_28_01_04.pdf

(2) Directive 2001/18/EEC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms

OJ L 106, 17.4.2001, p. 1.

(3) Regulation (EC) No 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed

OJ L 268, 18.10.2003, p. 1.

(4) Regulation (EC) No. 1830/2003 of the European Parliament and the Council of 22 September 2003 on traceability and labelling of genetically modified organisms

OJ L 268, 18.10.2003, p. 24.

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, 16.1.2004, p. 5.

(5) Regulation (EC) No. 1946/2003 of the European Parliament and the Council of 15 July 2003 on transboundary movements of genetically modified organisms

OJ L 287, 5.11.2003, p. 1.

(6) European Commission, September 2003, Questions and Answers about GMOs in seeds

http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.getfile=gf&doc=MEMO/03/186|0|RAPID&lg=EN&type=PDF

(7) Commissioner Fischler, June 2003: Communication to the Commission on the Co-existence of Genetically Modified, Conventional and Organic Crops (pdf)

http://zs-l.de/saveourseeds/downloads/Communication_Fischler_02_2003.pdf

(8) European Parliament resolution on coexistence between genetically modified crops and conventional and organic crops (2003/2098(INI))

OJ C 91 E, 15.4.2004, p. 680.

(9) Joint Research Centre, 2002, Scenarios for co-existence of genetically modified, conventional and organic crops in European agriculture.

http://www.jrc.cec.eu.int/download/gmcrops_coexistence.pdf

Round Table on research results relating to co-existence of GM and non-GM crops.

http://europa.eu.int/comm/research/biosociety/news_events/news_programme_en.htm

(10) First European Conference on Co-existence of Genetically Modified Crops with Conventional and Organic Crops 13-14 November, 2003, Helsingør, Denmark

http://www.agrsci.dk/gmcc-03/

(11) Opinion of the Scientific Committee on Plants concerning the adventitious presence of GM seeds in conventional seeds

http://europa.eu.int/comm/food/fs/sc/scp/out93_gmo_en.pdf

(12) Regulation (EC) No. 178/2002 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 and laying down procedures in matters of food safety.

(13) Commission Decision of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council (notified under document number C(2004) 540) (2004/204/EC)

OJ L 65, 3.3.2004, p. 20.

(14) Commission Recommendation 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 (notified under document number C(2003) 2624)

OJ L 189, 29.7.2003, p. 36.

(15) Regulation (EC) No 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed

OJ L 268, 18.10.2003, p. 1.

(16) Regulation (EC) No. 1830/2003 of the European Parliament and the Council of 22 September 2003 on traceability and labelling of genetically modified organisms

OJ L 268, 18.10.2003, p. 24

(17) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products

http://europa.eu.int/eur-lex/en/consleg/main/1985/en_1985L0374_index.html

(18) Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage, OJ L 143, 30/04/2004 P. 56 – 75, see Article 3 and 4 and Annex III.

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=DE&numdoc=32004L0035&model=guicheti

(19) Opinion of the Economic and Social Committee on the Proposal for a Directive of the European Parliament and the Council on environmental liability with regard to the prevention and remedying of environmental damage, COM(2002)17 final – 2001/0021 (COD)), CES 868/2002, OJ C 241 of 7.10.2002, pp. 37-45

(20) DG Agriculture, ‘Economic Impacts of Genetically Modified Crops on the Agri-Food Sector’ (2000)

http://europa.eu.int/comm/agriculture/publi/gmo/fullrep/index.htm

(21) Opinion of the Scientific Committee on Plants concerning the adventitious presence of GM seeds in conventional seeds

http://europa.eu.int/comm/food/fs/sc/scp/out93_gmo_en.pdf

(22) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora, OJ L 206, 22.7.1992, pp. 7-50

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31992L0043&model=guicheti

(23) Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds, OJ L 103, 25.4.1979, pp. 1-18.

http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdoc=31979L0409&model=guicheti