Opinion of the 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"

(COM(2001) 182 final - 2001/0180 (COD))

(2002/C 125/14)

On 15 September 2001 the Council decided to consult the European 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 4 March 2002. The rapporteur was Mr Espuny Moyano.

At its 389th Plenary Session on 20 and 21 March 2002 (meeting of 21 March), the European Economic and Social Committee adopted the following opinion by 81 votes to 10, with 21 abstentions.

1. Introduction

1.1. The Commission proposal sets out to establish a framework for regulating the traceability and labelling of genetically modified organisms (GMOs) and of food and feed products produced from GMOs. Its purpose is to facilitate (i) withdrawal of products if unforeseen adverse effects on public or animal health should occur (ii) targeted monitoring of possible environmental effects, and (iii) accurate and complete labelling to enable operators and consumers to exercise real freedom of choice, and the authorities to control and verify labelling claims.

1.2. The draft regulation applies to every stage in the placing on the market of products consisting of, or containing, GMOs and of foods and feed materials produced from GMOs, including additives and flavourings.

1.3. The draft regulation does not apply to medicinal products for human and veterinary use (Council Regulation (EEC) No 2309/93).

1.4. Unique codes

The Commission is to establish a system for the development and assignment of unique codes to GMOs by setting up a regulatory committee (under Article 10 of the draft regulation). The system may be adapted by the same procedure (Article 8).

1.5. Traceability and labelling requirements for GMOs

1.5.1. The labels of pre-packaged products consisting of, or containing GMOs must be marked with the words "This product contains genetically modified organisms".

1.5.2. Information that a product consists of, or contains, a GMO must be provided in the first stage of market placement, together with the relevant unique code.

1.5.3. This information must be transmitted to each subsequent stage.

1.5.4. The information is to be retained for five years.

1.6. Traceability requirements for products produced from GMOs

1.6.1. Operators placing products produced from GMOs on the market must provide operators receiving the products with an indication of each of the food ingredients, additives or flavourings, or feed materials or additives, which is produced from GMOs.

1.6.2. Operators must retain this information for five years.

1.7. Exemptions

1.7.1. Article 6 provides for certain exemptions: for example, operators supplying food to the ultimate consumer are not obliged to retain documentation detailing to whom products were sold.

1.8. The proposal obliges the Member States to adopt inspection and control measures and stipulates that the Commission must have developed prior technical guidance on sampling and testing.

1.9. The Member States are to lay down penalties applicable to infringements of the draft regulation.

1.10. The regulation is to enter into force on the twentieth day following its publication, although the bulk of its content is to apply from the ninetieth day following publication in the Official Journal of the European Communities of the system for development and assignment of the unique codes.

2. General comments

2.1. The Committee recognises the efforts made by the Commission in preparing both the present proposal for a regulation and the Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed, which are clearly related. The EESC acknowledges that existing legislation on the placing on the market and labelling of GMOs is inconsistent and incomplete, and therefore welcomes the fact that the proposal treats food and feed products equally, which will provide greater coherence, clarity and security for operators, users and consumers. Existing legislation does not fully ensure consumers' right to be informed and make informed choices.

2.2. Nevertheless, it is a serious source of concern that certain parts of the proposal are unclear, e.g. with regard to differentiating products using GMOs in the manufacturing process from products manufactured from GMOs.

2.3. The regulation is rightly based on Article 95 of the Treaty establishing the European Community, concerning the approximation of the laws of the Member States which have as their object the functioning of the internal market and taking as a base a high level of protection in the European Union.

2.4. Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, repealing Directive 90/220/EEC, establishes a legal framework for the deliberate release into the environment and placing on the market of genetically modified organisms which is designed to protect human and animal health and the environment. This directive makes it possible to release and place on the market products which are safe for humans, animals and the environment following rigorous scientific testing in accordance with the obligations and procedures which it lays down. Directive 2001/18/EC also introduces an obligation to implement a monitoring plan in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human or animal health or the environment of GMOs or products manufactured from or containing GMOs, after they have been placed on the market.

2.5. As health and the environment are already supposed to be protected by the above legislation, the proposal for a regulation under consideration must focus on regulating the traceability of GMOs and food and feed containing GMOs as a way of further enhancing the level of security and health protection provided by the directive referred to above and improving the labelling of GM food and feed.

2.5.1. However, as the Committee noted in its opinion on the White Paper on Environmental Liability(1)"the liability regime for damage to the environment and to biodiversity urgently needs to be clarified". There must also be clarification regarding liability for adventitious contamination with GMOs of the products of organic farming for which, at present, a 0 % threshold applies. Neither the proposal for a Regulation under review nor the proposal for a Directive which has been submitted on environmental liability clarifies the issue of liability for GMOs. This is unacceptable in the view of the ESC.

2.6. The draft regulation on the general principles of food law and the European Food Authority lays down the main obligations relating to health and food safety, including traceability. The traceability of GMOs or products derived from GMOs must be identical to that stipulated in the draft general food law regulation.

2.7. The traceability requirements would require, in addition to supporting documentation and certificates, a series of additional checks and inspections to be carried out by both economic operators and the supervisory authorities, which would entail additional costs for both raw materials and finished products. A particular problem is posed by imported products (which either contain GMOs or were produced from GMOs) where GMOs are not, however, present in the final product. The Committee is fully aware that the proposals will require commitment from international organisations, national authorities, and trading partners, and it may take some years to achieve full implementation in practice.

2.8. Verification and control will also be necessary, requiring the commitment of additional economic and human resources by the national authorities responsible for implementation. Appropriate additional resources should be allocated at Community and national level to ensure the effective implementation and control of the proposed legislation, so as to avoid diverting such resources from their fundamental mission: to monitor the safety of food and feed products.

2.9. For foods and feed products in which genetically modified material is no longer present but has been used, the traceability and labelling requirements are difficult to verify, which could lead to unfair practices and fraud. An instance would be highly refined oils and hydrolysed maize derived from genetically modified raw materials, which can replace products derived from non-genetically modified raw materials, as their composition, characteristics and uses are identical.

2.10. There is a risk that the introduction of new requirements will result in a higher final product cost, which will probably be passed on to the consumer. However, the Committee underlines that the costs of the new technology should fall on GM producers and products rather than on the traditional products through "GM free" labelling.

2.11. National governments in Europe and the EU's political bodies must ensure that more stringent requirements are also brought in at international level to protect humans and the environment. They are called on to campaign in the various international bodies, and especially in the OECD and the Codex Alimentarius Commission, for the adoption of appropriate rules and regulations. Possible barriers to trade will be reduced to a minimum or abolished completely as a result.

2.12. The application of measures making it possible to distinguish GMO-free products from genetically modified products could confer a competitive advantage on firms choosing to focus on quality, which will then be able to offer the consumer a product which is both traceable and transparent in terms of its ingredients.

3. Specific comments

Point 7.3 of the Legislative financial statement ("Other administrative expenditure deriving from the action" appears to contain an error of calculation concerning the total allocation for missions (Title A7). Since three three-day missions at 1000 EUR each are involved, the total cannot be 1300 EUR as indicated in the proposal.

4. Final considerations

In conclusion, the Committee recognises the major effort made by the Commission to flesh out and clarify the current framework, and would make the following recommendations with regard to traceability and labelling.

4.1. The use of GMOs has led to a great debate in society, in the course of which extreme positions lacking any serious scientific foundation have frequently been adopted. The EESC therefore recommends that the Commission carry out a public information campaign publicising the advantages and risks of the use of GMOs, in relation to food for human consumption, animal feed and the environment. Information produced by independent bodies to help people make informed choices about the food they eat, including on an environmental and ethical basis, and concerning the technologies by which they are produced is essential.

4.2. The two proposed regulations for revamping and improving the labelling and traceability of products containing or consisting of GMOs at all stages in the food chain take account of the precautionary principle and enhance transparency as a prerequisite for the consumer's freedom of choice. They make it easier for the supervisory authorities to carry out their checks and make it easier to research the long-term effects for humans and the environment of genetic engineering in the food sector.

4.3. The authorisation of GMOs is based on prior rigorous initial scientific assessment, which guarantees that the authorised products pose no health risks and may circulate freely as long as consumers are fully informed through traceability and labelling in order to promote choice.

4.4. The use of GMOs is already a reality, given that in 2001 they were being grown on 52,6 million hectares of land, this being a 19 % increase over the previous year, which confirms the steady growth trend. However, surveys among European consumers show that a clear majority are opposed to genetically modified food.

4.5. Notwithstanding the above, the EESC draws the Commission's attention to the importance of carrying out comprehensive tests as a necessary preliminary to authorising the use of new GMOs, proceeding on the basis of the precautionary principle and avoiding undesired effects.

Brussels, 21 March 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) Opinion of the European Economic and Social Committee on the "White Paper on Environmental Liability", OJ C 268, 19.9.2000, p. 19.

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 in the course of the Committee's debates:

Point 2.5

Replace point with the following text: "The draft regulation under discussion cannot focus solely on traceability rules for GMOs and food and feed obtained from GMOs, but must also consider food and feed produced using GMOs. An enzyme or any other molecule which accelerates the process of chemical change participates actively in all the chemical/molecular reactions through which the food is produced, and it is therefore in principle not possible to say that two final products, one of which has been obtained in the natural way and the other using a GMO, are substantially equivalent. Unnatural substances are being used in respect of which no experimental evidence exists proving that they can produce products which are identical to the natural product not only from an organoleptic point of view, but also in terms of wholesomeness, taste, aroma etc. Rules on the labelling and traceability of GMOs should therefore also apply to products obtained using GMOs."

Result of the vote

For: 28, against: 51, abstentions: 14.

Point 2.7

Replace point with the following text: "As the aim is to ensure maximum transparency, the traceability requirements proposed should be monitored, even if this requires a series of additional checks and inspections by both economic operators and the supervisory authorities. Study needs to be devoted to a system which will also guarantee consumers maximum transparency with regard to imported products (which are GMOs, contain GMOs or were produced from GMOs or using GMOs) where GMOs are not, however, present in the final product."

Result of the vote

For: 30, against: 59, abstentions: 16.

Point 4.1

Amend the first sentence as follows: "The use of GMOs has led to a great debate in society, that is to some extent marked by fear and indeed also by ignorance of the potential consequences."

Result of the vote

For: 50, against: 53, abstentions: 9.

New Point 4.3.1

"The fact that meat and other animal products from animals which have been fed genetically modified feed does not have to be labelled accordingly does in the ESC's view, represent a major shortcoming which decisively detracts from the goal of giving consumers freedom of decision."

Result of the vote

For: 43, against: 56, abstentions: 8.