Brussels, 12 April 2002
Draft report on the proposal for a European Parliament and Council regulation on genetically modified food and feed (COM(2001) 425 - C5-0368/2001 - 2001/0173(COD)). Committee on the Environment, Public Health and Consumer Policy. March 2002. Rapporteur: Karin Scheele.
Following the revised GMO Release Directive ( 2001/18/EC ), the proposal for a regulation is an important step in regulating the GMO field at Community level.
The proposal for a regulation essentially covers:
- authorisation and labelling of genetically modified food
- authorisation and labelling of genetically modified feed.
To ensure a high level of protection for human and animal health, this proposal extends the scope of current Community legislation on GMOs to feed produced from GMOs. The provisions for food are also more far-reaching than has been the case to date.
The scope has been extended to products produced from GMOs. The traceability of genetic modification in an end product is no longer a prerequisite for authorisation and labelling. That means, for instance, that highly refined soya and maize oils would be authorised and labelled.
In the interests of maximising consumers' freedom of choice, the labelling provisions under this proposal are also to apply to products derived from animals fed with genetically modified feed.
Adventitious or technically unavoidable presence of genetically modified material Thresholds for adventitious and technically unavoidable contamination are necessary.
The proposal provides for a 1% threshold for the presence of GMOs. It is unacceptable that that provision should also apply to GMOs which are not authorised in the Community. It is vital that this be avoided, otherwise all European Union biosafety legislation will be undermined.
The rapporteur has therefore removed Articles 5 and 18 ('Adventitious or technically unavoidable presence of genetically modified material') from the authorisation section and reinserted them in the labelling section (new Articles 13a and 26a).
The threshold laid down is to be reduced to 0.5% and should be taken as an aggregate value for contamination in the ingredient concerned. This should be determined on the basis of the raw ingredient.
In order to streamline and rationalise the current authorisation procedure for genetically modified foods, the Commission proposes that the European Food Safety Authority should carry out risk assessments. As provided for in the proposal for a European Food Safety.Authority, that Authority should also carry out risk assessment for genetically modified feed.
The proposed regulation is based on the 'one door - one key' principle. Thus, so it is intended, a single application will suffice for:
- authorisation for the deliberate release of a GMO into the environment in accordance with the criteria under Directive 2001/18/EC
- and authorisation for the use of that GMO in food and/or feed in accordance with the criteria under the proposed regulation.
The authorisation procedure is excessively localised and over-specific.
The release of genetically modified organisms into the environment is regulated by the Release Directive ( 2001/18/EC ). It must be ensured that the provisions of the new regulation are compatible with the Release Directive and complement rather than supersede it.
It makes no sense to decisively alter a directive which was adopted only one year ago following a lengthy and complex conciliation procedure between Parliament and the Council.
Transparency of the authorisation procedure Recitals 5 and 6 call for a clear and transparent authorisation procedure. Accordingly, amendments have been tabled to several articles with a view to guaranteeing the public's right to information.
Draft report on the proposal for a European Parliament and Council regulation 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 - C5-0380/2001 Œ 2001/0180(COD)). Committee on the Environment, Public Health and Consumer Policy. March 2002. Rapporteur: Antonios Trakatellis.
[Draft resolution and amendments]
The legislative proposal concerns (a) traceability and labelling of genetically modified organisms (GMOs), (b) traceability of food and feed products produced from genetically modified organisms, and (c) amendment of Directive 2001/18/EC .
Community legislation on GMOs is totally fragmented (see annex), making it difficult to adopt cohesive provisions and apply unequivocal Community rules. Moreover, there are already a number of Community regulations and provisions governing the placing on the market, circulation, labelling, presentation and advertising of food and its ingredients. This problem, in conjunction with the inability to monitor the rapid developments in biotechnology and the production of GMOs and their products, led to reservations and a moratorium over the last three years on the marketing authorisation procedures at EU level, pending the adoption of an integrated traceability and labelling system.
Directive 2001/18/EC on the deliberate release of GMOs into the environment does not in fact extend labelling to operators placing GMOs on the market, while the traceability and labelling of products produced from GMOs also remain outside its scope.
The need for a cohesive and integrated system of labelling and tracing
In the past, the European Parliament has criticised the Commission's piecemeal and inconsistent approach to GMOs and called on the Commission to submit proposals, including proposals on animal feed labelling in a way which is more coherent and provides consumers with certainty of choice, on the one hand, and gives industry a solid legal framework to work with, on the other hand.
The objective of the current proposal is to make it possible to register and monitor the placing on the market of GMOs, and food and feed produced from them, and so facilitate consumer choice whilst at the same time facilitating the process of withdrawing a product should it be deemed necessary. It does not, however, fulfil the desired objective of a more consistent approach and coherent regulation of GMOs, as it results in further fragmentation of Community legislation. Ignoring in practice the need to simplify and improve the regulatory framework, the Commission has submitted two proposals for regulations, the one under review and another, separate proposal on genetically modified food and feed (COM (2001) 425). This fact demonstrates an inherent inability to adopt a coherent legal framework for GMOs at EU level and undermines any attempt at codifying and reformulating Community legislation on GMOs.
International aspects of GMOs
The need for legal certainty within the Community also arises when obligations under multilateral trade arrangements and international agreements on GMOs must be transposed into Community law. The proposal under review is directly related to the Cartagena Protocol on Biosafety adopted at the Conference on the Convention on Biodiversity held in Montreal on 29 January 2000, which concern transboundary movements of GMOs, and with the OECD's provisions concerning a unique code for GM (transgenic) plants.
The objective of the Protocol is to contribute to ensuring an adequate level of protection and safety during the transfer, handling and use of GMOs; it lays down the procedures for granting authorisation, following notification, for living modified organisms (LMOs) as well as a system of notification for LMOs intended for direct use as foods or feed, or for further processing. However, it does not contain any provision or specific reference to the traceability of GMOs and their products. This fact does not ensure legal certainty and is a shortcoming, possibly even an obstacle to adopting rules within the Community, not only for domestic Community products, but, principally, for imported products.
Furthermore, it cannot be predicted to what extent the uniform rules on monitoring, traceability and labelling of GMOs and their products will apply at international level.
Moreover, the entry into force of the Protocol is dependent on the will of the parties concerned (of the 107 states which have signed it to date - which include the European Community and its Member States - only 12 states have completed the ratification procedures). However, the Commission recently submitted a regulation on the transboundary movement of genetically modified organisms, aimed at transposing the Protocol into Community law.
Effective implementation of the provisions of the regulation - shortcomings of the proposal If the provisions of the regulation on traceability and labelling are to be effectively implemented in the EU, the rules must be equally applicable to products produced within the Community and to those imported from third countries. At the present time, the agro-food sector is developing at a pace and the area under cultivation with GMOs worldwide is expanding rapidly, totalling 50 million hectares, whereas in Europe the figure is no more than 12 000 hectares. Given, however, that there are no uniform international rules or a single framework for regulating traceability and labelling, there are risks involved in venturing to adopt traceability and labelling rules for GMO products which cannot be applied to monitor products from third countries.
In the event that the EU unilaterally applies traceability and labelling requirements to imported products and carries out checks without an adequate scientific basis, it may create a trade dispute with third countries which results in the matter being referred to the WTO. It is indicative that during negotiations at the fourth WTO Ministerial Conference held in Doha in Qatar in November 2001, the USA (a country with 30.3 million hectares of GMOs under cultivation) refused to entertain any discussion of labelling GMOs.
Traceability and labelling should also apply to GMOs and products containing traces of genetically modified DNA (GM-DNA) or genetically modified protein (GM protein), otherwise it would be increasingly misleading to consumers to label products produced from GMOs in which there is no trace of GM-DNA or GM protein. Furthermore, such a provision would be contrary to the objectives of the regulation and financially onerous for companies and consumers alike.
Another issue which must be given serious consideration is that although current techniques, such as the polymerase chain reaction (PCR), enable even traces of GM-DNA to be traced, there are products - for example citric acid, vitamin C or highly refined maize oil produced from GM maize - which nevertheless test negative, i.e. they show no difference from the corresponding conventional products. A regulation which aims to trace and label those substances, as the present proposal does, therefore represents a serious risk because their producers or importers could claim that they are produced from natural products or that they are free of GMO materials. These products would therefore clearly be in a more advantageous position than the corresponding products produced within the EU, while consumers could be misled.
A similar problem arises with products which are absolutely identical to the conventional products, such as sugar from GM beet and sugar from non-GM beet. In this case, traceability and labelling do not help consumers at all because, despite their similarity to the conventional products, it is possible that they may be priced differently since, owing to the poor information and doubt that surrounds GMO food, consumers are prepared to pay more for the natural product. It is therefore obvious that the provisions of this EU regulation, in the case of products which do not contain GM-DNA or GM protein, will lead to:
- fraud and deception
- misleading of consumers
- distortion of prices and competition
- less favourable treatment of EU producers and companies.
The rapporteur's proposal
Clearly, both traceability and the ensuing labelling of products should fulfil certain conditions in regard to implementation. There is no doubt that we should seek to set up a regulatory system by taking appropriate administrative, legislative and regulatory measures in respect of GMOs so that we are able to facilitate their registration and movement in a way which safeguards human health and protects the environment and, above all, builds consumer confidence. In order to command respect, however, the rules of this system must be simple, clear, ensure transparent monitoring of their application, and not allow fraud, deception or distortion of competition, particularly between domestic and imported products. Moreover, the system should provide for the possibility of unilateral implementation of the rules by the EU, so that their effectiveness is not undermined by imports from third countries.
An unequivocal rule which sets a sound framework is one which ensures that every product which tests positive for GMOs or GMO material product is subject to mandatory traceability and labelling. Furthermore, the GMO concerned must have been granted authorisation pursuant to current EU rules (Directive 2001/18/EC ) and therefore the original authorisation procedure should have safeguarded human health, ensured protection of the environment and eco-systems and the smooth operation of the market with regard to the GMO and its products.
Your rapporteur differentiates between the following three categories of products in the amendments to the regulation:
First category: GMOs and GMO products which are checked using analytical methods. This category includes products such as maize, soya, maize meal, soya meal and primary products in general in which GMO material is easily traced.
Second category: this category includes the conventional products corresponding to the first category which have been contaminated adventitiously or unavoidably through mixing with genetically modified material. In this case, in order to exempt them from the traceability and labelling requirements, certain conditions should apply together with a maximum level of GMO material. The following three conditions are proposed:
(a) The presence of GMO materials from one or more GMOs does not exceed 1% or the maximum permissible levels established in accordance with the procedures laid down in Directive 2001/18/EC . Your rapporteur has no problem with low levels but if we are to be rational and prudent, we must consider in detail what, in maximum terms, an adventitious or unavoidable admixture might amount to.
(b) The presence of these GMO materials is adventitious and technically unavoidable. Companies should be able to prove to the authorities that they have taken the necessary measures to avoid the presence of GMOs or GMO material.
(c) The specific GMO or, in the case of more than one GMO, the specific types, must have been subject to a risk assessment by the relevant scientific authority (authorities) or by the European Food Safety Authority as a basis for authorisation and must not pose a risk to human health or the environment.
Third category: products produced from GMOs but not containing GMO material such as vitamin C, citric acid, maize oil etc. For this category there should be no traceability and labelling requirement.
Your rapporteur's proposals are based on the above logical considerations. They also allow the EU to implement them unilaterally without creating barriers to trade and distortion of competition, and at the same time provide consumers with reliable information. In this respect, I would draw attention to the fact that the screening techniques are now so sensitive and reliable that in the event that a product does not test positive for GMO material, we can be fully confident in the results and not subject that product to the labelling requirement. That would be inconsistent when present legislation (see Regulation 49/2000/EC which exempts from labelling products produced from GM soya beans and GM maize) and the proposed regulation exempt from the traceability and labelling requirements products which have been contaminated adventitiously or unavoidably through mixing with genetically modified material, while the regulation imposes the traceability and labelling requirements on products which do not contain genetically modified material.