Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed"

(COM(2001) 425 final - 2001/0173 (COD))

(2002/C 221/22)

On 2 October 2001, the Council decided to consult the Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

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 6 May 2002. The rapporteur was Ms Thomas.

At its 391st plenary session on 29 and 30 May 2002 (meeting of 30 May), the Economic and Social Committee adopted the following opinion by 53 votes to 40, with four abstentions.

1. Introduction

1.1. The Commission proposal aims to establish a framework to provide improved, harmonised, uniform and transparent procedures for the safety assessment of genetically modified (GM) food and GM animal feed. Its main objectives are (i) to protect human and animal health (ii) to lay down Community procedures for the regulation of GM food and feed and (iii) to provide for the labelling of GM food and feed to allow the consumer to have a genuine choice.

1.2. The Commission proposal covers GMOs used as food or feed or food or feed containing, consisting of or produced from GMOs, or containing ingredients produced from GMOs (Articles 3 and 16). Products "produced from a GMO" involves those products in which a proportion of the end product has been derived from the original GM material. These would be covered by the proposed regulation. Those products which have been produced with the assistance of a GM organism but where no material derived from the organism is present in the end product termed products "produced with a GMO" would not be covered. This is in line with the current provisions of the Novel Foods Regulation.

1.3. The proposal enables a single application to be filed to obtain both the authorisation for the deliberate release of a GMO into the environment and for authorisation for the use of this GMO in food or feed.

1.4. The current authorisation procedure for GM foods is set out in Regulation (EC) No. 258/97 on novel foods and novel food ingredients(1). Feed containing GMOs have so far been authorised in accordance with Directive 90/220/EEC(2). There is no authorisation procedure for GM feed.

1.5. The authorisation granted in accordance with the established procedure is to be valid throughout the Community for a period of ten years and will be renewable.

2. Labelling

2.1. The proposal extends the current labelling provisions to all GM food regardless of whether DNA or protein can be detected. All food and feed products which are subject to authorisation under the proposed regulation would be subject to mandatory labelling. Thus a number of foodstuffs which are not currently required to be labelled such as highly refined oils derived from GM crops, will be required to be labelled. Similarly, several animal feeds, currently unlabelled, would have to be labelled.

3. Implementation

3.1. GM material may be present in minute amounts in non-GM food and feed as a result of adventitious or technically unavoidable contamination. In these cases, food or feed would not be subject to the labelling requirements of the proposed regulation. It is proposed to establish a threshold of 1 % for minute traces of GM materials. Food or feed containing less than this amount would not need to be labelled.

3.2. Applicants are required to provide a method for detection, including sampling and identification of the transformation event for the purpose of ensuring enforceability.

3.3. It is proposed to establish a Community Reference Laboratory to test and validate the proposed methods for sampling and detection to provide the means for a harmonious approach for control across the Community.

3.4. The Member States are required to introduce effective penalties for infringements of the provisions of this Regulation (Article 44).

4. General comments

4.1. The proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed examined in this opinion should be seen in a wider social context. The continuing moratorium on authorisation for the placing on the market of new GMOs in Europe seems set to end. Agriculture in Europe is on the threshold of a new era in which widespread use will be made of genetically modified products.

4.2. The Committee sees it as a major failing that this period of moratorium has not been used as an opportunity for a structured debate encompassing the whole of society on the pros and cons of employing genetic engineering in agriculture.

4.3. There are widely differing views on genetic engineering within society. However, it is fair to say that arguments vary considerably according to the context. A clear distinction is made between "red genetic engineering" (the use of genetically engineered products in medicine) and "green genetic engineering" (the use of genetically engineered products in agriculture and the food industry).

4.4. There are also two distinctive aspects to the debate on green genetic engineering. The first concerns the deployment of genetically modified organisms in the open countryside (i.e. not within closed conditions) and the use of these by man and animal. The second concerns the use of genetically modified enzymes, vitamins, additives, etc. produced in closed conditions in the processing of agricultural raw materials. The EESC feels it is important that the Commission also adopts this distinction.

4.5. It is also clear in the light of the recently published European Environment Agency report on gene transfer from GM plants(3) that consumers want to be given clear information not only about products, but also about the product chain.

4.6. The European Economic and Social Committee acknowledges the initiative made by the Commission in combining the Proposal for a regulation of the European Parliament and of the Council on traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC(4) and the Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed. The Committee especially welcomes the "one door - one key" procedure which should reinforce both safety and consumer confidence. The EESC accepts that the current Community legislation on GMOs needs to be extended to animal feed and that there needs to be a specific evaluation of genetic modification relating to substances such as food additives, flavourings or feed additives, where they have been produced from GMOs. The EESC is concerned that the two proposals in question only apply to products produced from GMOs, but not to products produced with a GMO, thus excluding certain important links in the food chain from the scope of the proposed regulations. It also urges the Commission to support consumer information campaigns to highlight the possible advantages and risks of GMOs, so as to enable people to make more informed choices.

4.6.1. The Committee notes that some parts of the proposal are complex and could give rise to misinterpretations, e.g. in the cases of Recital 15 and Articles 3 and 16. It thus recommends that the Commission further clarifies and simplifies concepts such as those referred to in Article 2(3) and (6).

4.7. The Commission's proposal on GMOs comes at a time when consumer confidence in safety has been undermined by a series of food scares. Inevitable feelings of uncertainty about new and unfamiliar products are played upon by the mass media and doubts have arisen about the rigour of safety tests meant to assess risks to human health. Moreover, there is an increasing distrust of government departments, politicians, journalists - and even of scientists, which was to some extent compounded by the slowness to react in the BSE crisis. The Committee therefore stresses the importance of effective deployment of the European Food Authority so as to ensure an adequate level of food safety. Also, clear, understandable, accurate and informative classification and labelling has the potential to make an important contribution to dispelling such doubts. The Eurobarometer data provides strong evidence that consumers want to be able easily to identify food that contains GM materials or which has been produced using GM substances. Only on the basis of labelling can a consumer's right to choose be ensured.

4.8. The rationale in the proposal for labelling food and feed products which do not contain any GM materials but which have been produced from GMOs needs to be explained more clearly. The Committee notes that such products will have already been subject to rigorous safety tests with regard to human health (including allergenicity). If the purpose of labelling these products is to inform the consumer that such products, while containing no GM materials, nevertheless originate from GM crops, and thereby provide him or her with more choice, this should be explicitly set out. The EESC regards this in principle as an important advance. However, it will be difficult to explain to consumers why products such as highly refined oils derived from GM crops have to be labelled (even if the modified DNA sequence is not detectable), while animal products derived from animals fed on GM feeds do not. The Committee considers that, in order to ensure complete freedom of choice for the consumer, it is vital to define in the clearest and most transparent way possible the rules for labelling GM products, including food and feed derived from GM crops or products produced with a GMO whether or not containing protein or genetic material detectable from analysis.

4.9. The EESC calls on the Commission to give further thought to the rationale behind the draft proposal. The issue of employing genetic engineering is decided on the basis that only products which in no way harm the environment or consumer health may be authorized and used. This would mean that the consumer could have "blind trust" in all products. Nevertheless, the Commission proposes to provide consumers with information which will enable them to make their own decisions. The Committee welcomes this wholeheartedly. However, if for example animal products involving GM feed are not covered by the labelling regulations, consumers will be deprived of the freedom to choose all the way along the "animal product" production chain; they will be unable to determine whether or not genetic engineering has been involved in the manufacture of the products they buy.

4.10. Food and feed products which have been derived from GM materials but which do not contain any transgenic materials (i.e. DNA and/or protein) might encourage illegal practices and fraud. The Committee is concerned that reliance on documentation for authenticity may not be sufficient to avoid fraud. Some products derived from GM crops such as highly refined oils will be identical in composition to non-GM products. The labelling and detection procedures set out in the proposed regulation do not make clear how enforcement will deal with fraud. The Committee thinks that, in order to be able to resolve these problems and safely follow all GM products throughout the food chain, an effective system of traceability must be better defined.

4.10.1. The Committee welcomes the fact that the proposed Regulation is also to apply to imports from non-EU countries. Effective measures must, however, be taken to ensure that imported products meet the same conditions. In order to guarantee fair competition between the EU and non-EU countries, there must be reliable and effective controls and labelling systems, particularly in the case of imported products. The Committee suggests that a set of standards should be laid down for cases of accidental contamination below the established threshold for GM products authorised in non EU countries but not authorised in the EU.

4.11. There have been concerns that the proposed regulation will lead to increased costs to the consumer. The Committee accepts that the new labelling requirements will impose costs on the final product and that the resulting consumer benefits are broadly supported by the general public as evidenced by for example, the Eurobarometer survey(5) conducted in 2001. However, the Committee suggests that the Commission undertake a regulatory impact assessment to ascertain the costs of traceability, segregation and labelling.

4.12. The EESC regards it as a fundamental failing that GM plants are to be authorized in the absence of any clear liability regulations. It is already possible to foresee that complaints will be brought before the courts. For example, the transfer of GM pollen to fields cultivated in accordance with the EU Regulation on organic farming will mean that the farmer concerned will no longer be able to market his produce as "organic" because it will show up (transferred) GM components. This will obviously cause him some financial loss which no-one can be held liable for in the absence of any clear regulations. The EESC considers it unacceptable that there are no clear regulations on liability.

5. Specific comments

5.1. The Committee accepts that there is a need to set a reasonable threshold for the level of minute traces of adventitious GM materials in conventionally grown foodstuffs (i.e. non-GM). It further accepts that a level of 1 % is at present in line both with the threshold for other substances and with what is technically feasible (Article 5 and Article 18). Nevertheless, the situation should regularly be reviewed as methods of detection improve, so that limits can be set close to the threshold of detectability.

5.2. As regards the definition and introduction of thresholds of contamination for food and feed, the Committee thinks there should be a standard method of analysis recognised at EU and international level as a reference. The Committee therefore welcomes the Commission's proposal to establish a Central Reference Laboratory for the purpose of testing and validating the proposed methods for sampling and detection. It takes the view that effective implementation and management of the proposed labelling and traceability of GM foodstuffs will depend on an efficient and harmonised approach across the community (Article 33).

6. Conclusion

6.1. The European Economic and Social Committee broadly welcomes the initiative introduced by the Commission to clarify and extend the current regulatory framework. GM crops are being widely grown in parts of the world, namely the US, China and Argentina. In Europe, where there is a moratorium on authorisation for the placing on the market of new GMOs, the majority of citizens wish to avoid GM food. The Committee notes that the primary objective of the proposal is to protect human and animal health and welfare in addition to consumers' interests (Article 1). However, the proposal is concerned with authorisation for use and consumption and with labelling of products which will have already been rigorously evaluated for health and environmental risks. The new regulations will enhance transparency by promoting the labelling of GM foodstuffs in the food chain and will promote consumer choice. The extension of regulatory controls to animal feed is particularly welcomed.

6.2. However, the EESC considers that the labelling of GM products should be extended to all foods and animal feed that have been produced with GMOs, that is those products which have been manufactured with GM food processing aids such as enzymes as well as non-GM enzymes which have been produced from GM micro-organisms. This extension will enable consumers to be fully aware of the application of genetic engineering throughout the food product chain and enable them to make a more informed choice.

6.3. The EESC welcomes the proposal to label as GM those food and feed products which have adventitious content of GM materials of 1 % or more. It recommends that a set of standards be developed for application to those imported GM products which are approved in their country of origin but not in the EU. The EESC takes the view that products where the proportion of GMOs has not exceeded 1 % throughout the production chain will in future be regarded by many consumers as being "quality products", on a par with certain regional products, free-range eggs or organic produce, for example.

6.4. The Committee also recommends that the rationale for the labelling of foodstuffs derived from GM products but which do not contain any GM materials be clearly laid out. If the main reason for labelling these foodstuffs is to increase the social and political acceptability of foods derived from GM crops, then this should be clearly stated. The introduction of labelling could be enhanced by a parallel initiative to explain the distinction of foods made "with" GMOs from foods made "from" GMOs to consumers.

6.5. The Committee suggests that the proposed system is evaluated for its vulnerability to fraud and the wider question of enforcement addressed. This is particularly relevant to the proposal to label those foodstuffs which are derived from GM crops but which contain no detectable DNA or protein.

6.5.1. As is their right, consumers are demanding increasingly strict food safety rules throughout the food chain. The Committee takes the view that in order to rise to the challenge of consumer demands, European industry has a vital role to play, guaranteeing the marketing of safe, high-quality products and promoting research and proper evaluation methods. European industries, being subject to strict controls, have to supply accurate, transparent and full information: in the light of the possible risks and benefits of using GMOs, European industries can therefore provide the best option for consumers.

Brussels, 30 May 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) See Opinion of the Economic and Social Committee on the Proposal for a Council Regulation (EEC) on novel foods and novel food ingredients, OJ C 108, 19.4.1993 p. 8.

(2) See Opinion of the Economic and Social Committee on the Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, OJ C 407, 28.12.1998, p. 1.

(3) Genetically modified organisms (GMO): The significance of gene flow through pollen transfer, Environmental issue report No 28 of the European Environment Agency.

(4) See Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, adopted on 21 March 2002.

(5) Eurobarometer 55.2 "Europeans, Science and Technology", December 2001, European Commission, DG Research.

APPENDIX

to the Opinion of the Economic and Social Committee

The following amendments, which received at least one quarter of the votes cast, were defeated during the discussion:

Point 4.6

Delete the following sentence: "The EESC is concerned that the two proposals in question only apply to products produced from GMOs, but not to products produced with a GMO, thus excluding certain important links in the food chain from the scope of the proposed regulations."

Reason

If products had to be labelled when they contained no detectable GMOs, this would give rise to fraud; it would also suggest that there was a difference in the level of safety between identical products. That is not the case.

Result of the vote

For: 46, against: 55, abstentions: 1.

Point 4.8

Delete the following sentence at the end: "The Committee considers that, in order to ensure complete freedom of choice for the consumer, it is vital to define in the clearest and most transparent way possible the rules for labelling GM products, including food and feed derived from GM crops or products produced with a GMO whether or not containing protein or genetic material detectable from analysis."

Reason

If products had to be labelled when they contained no detectable GMOs, this would give rise to fraud; it would also suggest that there was a difference in the level of safety between identical products. That is not the case.

Result of the vote

For: 42, against: 54, abstentions: 1.

Point 4.9

Delete the following sentences at the end: "This would mean that the consumer could have 'blind trust' in all products. Nevertheless, the Commission proposes to provide consumers with information which will enable them to make their own decisions. The Committee welcomes this wholeheartedly. However, if for example animal products involving GM feed are not covered by the labelling regulations, consumers will be deprived of the freedom to choose all the way along the 'animal product' production chain; they will be unable to determine whether or not genetic engineering has been involved in the manufacture of the products they buy."

Reason

Once again, reference is wrongly being made to food safety. In addition, labelling is being urged for even more products where there is no evidence from analyses of the existence of GMOs. This leads to higher cost prices, encourages fraud and brings about distortions of competition, since it is impossible to check imports properly.

Result of the vote

For: 43, against: 58, abstentions: 1.

Point 5.1

Replace the second and third sentences with the following: "The Committee proposes that the 1 % threshold be reconsidered and that any new threshold value should ensure that GMO-free production is possible under existing farming practices and without the need for higher cost measures."

Reason

It is incorrectly implied that GMOs are dangerous substances, although in fact they have to satisfy all safety criteria. It must be made clear that a threshold lower than 1 % would make GMO-free production impossible without excessive additional costs.

Result of the vote

For: 36, against: 54, abstentions: 6.

Point 6.2

Delete.

Reason

Such an extension of labelling is completely pointless, as there is no way of detecting GMOs. This would only further increase the likelihood of fraud. Moreover, such labelling is incompatible with WTO rules.

Result of the vote

For: 41, against: 57, abstentions: 1.

Point 6

Add a new paragraph to point 6: "The labelling rules and the cultivation of GMO products must not impose costly additional measures on EU producers of GMO-free products. This means that the labelling threshold must be sufficiently high to ensure that under normal production conditions no special measures need to be adopted in order to remain below it."

Reason

This conclusion needs to be drawn in order to prevent GMO-free production being threatened by GMO production. On the one hand, measures may be needed which will increase costs, and on the other hand, there is the danger of lower yields if a product has to be labelled as a result of contamination from GMO crops. The latter case would apply if it were no longer possible to sell an organic product as such, as a result of exceeding the labelling threshold. Depending on the situation of the market, non-organic GMO-free product yields might also suffer.

Result of the vote

For: 38, against: 54, abstentions: 3.