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` () (98/C 407/01)

On 9 April 1998 the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 7 July 1998. The rapporteur was Mr Colombo.

At its 357th plenary session (meeting of 9 September 1998) the Economic and Social Committee adopted the following opinion by 80 votes to 2, with one abstention.

The Economic and Social Committee welcomes the proposed amendment, subject to the following comments, and is following developments in the regulation of the growth area of biotechnology with the keenest interest. The vitality and competitiveness of European industry must receive encouragement and support not only under Framework Programme R& D activities () but also in the shape of transparent risk assessment and public information procedures, which are a precondition for guaranteeing market growth in this new technology sector and optimizing its benefits in terms of health, environmental protection and quality of life.

1. Background to the proposal and major innovations

1.1. The proposed amendment, which had long been announced by the Commission, in its 1994 Communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment, and subsequently in its report on the review of Directive 90/220/EEC (), should be viewed against the background of this sector's increasingly high profile which is generating growing public interest in the Member States regarding the impact of new genetic modification technologies on public health, consumer safety and the environment.

1.2. The 1994 Communication seemed to focus attention primarily on more flexible legislation and simplified procedures to boost new technologies with the potential to improve competitiveness and employment. Legislators are now more concerned with reassuring and informing the general public more fully as well as with guaranteeing assessment and monitoring of the immediate and long-term health and environmental risks.

1.3. This approach reflects the reactions of consumer organizations and environmentalists in many Member States in the face of the first few genetically modified products in the sector of seeds and plants intended for animal and human consumption which are being marketed and imported in Europe. The call for proper information, transparency and better guarantees against risks has gathered further momentum following a broader campaign for food safety and labelling, to ensure supervision of the full cycle 'from earth/farmyard/laboratory to the table`. The controversy surrounding 'new foodstuffs` and strains of genetically modified soya or maize has had an impact on Directive 90/220 procedures and triggered a number of partial technical amendments, in particular labelling, which was not planned for in the version adopted originally ().

1.4. Another important factor is the tightening-up of the requirement concerning independent scientific appraisal of the health and environmental safety and other aspects, over and above the administrative safeguards provided by 'Comitology`. Following the blow to consumer confidence dealt by the spread of BSE, there is now generally greater awareness of the potential risks of technological methods and processes which disregard the precautionary principle, and there are calls for independent assessment and monitoring procedures. This proposal incorporates the Commission's new approach in that it provides for mandatory consultation of scientific committees on any aspect likely to affect human health and the environment.

1.5. Lastly, the proposal takes account of the difficulties and disagreements arising between Member States under the decentralized risk assessment system (in cases where Member States refuse to accept the assessment made by the first Member State in which the notification was submitted). It therefore seeks to finalize a common strategy for all Member States on risk assessment aims and methodology (new Annex II), as a step towards a more centralized Community system of authorization (13th recital).

1.6. Specific mention is made of the possibility of taking ethical aspects into account for purposes of assessment.

1.7. Given the problems that have arisen over the application of Article 16 of Directive 90/220 in Member States which have decided to limit or ban the use/placing on the market of genetically modified products authorized on the basis of the Directive's procedures, it is proposed that the existing IIIa) Committee procedure should be replaced by the IIIb) procedure, thereby giving the Member States greater influence over decision-making. In this manner the Council can reject the Commission's proposal by a simple majority, whereas the qualified majority required under the IIIa) procedure has sometimes left the Commission with the task of adopting the proposed measures.

1.8. A multilateral procedure is envisaged that could facilitate alignment of the risk assessment systems.

1.9. The concepts of monitoring and sanctions have been introduced.

2. General comments

2.1. Revision of the directive on the deliberate release into the environment of GMOs was overdue both because major strides have been made in biotechnology over the past seven years and the marketing of such products is expanding rapidly, bringing public calls for rules ensuring better and more up-to-date information and protection against risks. Firms too are calling for greater clarity and flexible and detailed rules, while emphasizing the risk that they will be put at a competitive disadvantage by the complexity of the rules and procedures and the long delays in issuing authorization in Europe.

2.2. In its opinion on the proposal amending Directive 90/219, the ESC reserved the right to take a position on the interactions between the two new versions of 219 and 220. In particular, it recommended (point 2.9) that a clear distinction be preserved between contained use and deliberate release, 'ensuring that the classification of certain GMMs as safe in contained use does not have automatic consequences for the application of Directive 90/220/EEC` ().

2.3. In this respect the proposal currently being considered is undeniably a significant improvement - even on the original draft revision of Directive 90/219, on which the ESC had expressed several criticisms (), some of which were incorporated into the Council's common position ().

2.3.1. The main innovative features in this proposal are as follows:

a) provision is made for two categories of release, the first of which is governed by a simplified procedure; however, the difference between the two lies essentially in the timespan between notification and reply and is far less concerned with the nature of the modification; therefore organisms that are considered safe are also subject to notification and control, albeit under a swifter procedure;

b) introduction of the concept of monitoring after release and setting of a deadline beyond which authorization has to be renewed;

c) introduction of labelling of products by category, thereby responding to strong pressure from consumers, recently reiterated in the ESC opinion on food legislation ();

d) introduction of maximum time limits for a series of procedural steps provided for in the proposal;

e) establishment of common risk assessment methods and objectives, in an effort to facilitate consensus and the harmonization of results among Member States.

2.4. However, the ESC's generally positive view of the new approach needs to be accompanied by a number of important qualifications:

2.4.1. The progress of this directive does not seem sufficiently coordinated with the passage of other legislation on the release of GMOs. Reference has already been made above to discrepancies with Directive 90/219 but it is equally important to ensure smooth coordination with the legislation mentioned in Articles 5 and 10 of the present version, which provide for 'a specific environmental risk assessment similar` to that laid down in Articles 6 to 9 and to Articles 11 to 18, respectively. This reference is to the vertical legislation on 'novel` foodstuffs which has already come into force (), and the provisions on 'novel` seeds, 'novel` animal feeding stuffs and pesticides containing GMOs which are in the process of preparation.

2.4.2. Care must be taken to avoid creating a legal vacuum with references to vertical legislation which either does not exist or has not been updated. The delays in drafting vertical directives have so far led to the products being assessed under the horizontal Directive 90/220; consideration should be given to the possibility that experience thus accumulated and centralized might offer a better guarantee for an assessment of GMOs, also for the public. It must be remembered that the framing of these two specific horizontal instruments (Directives 90/219 and 90/220) had been justified on grounds of the specific risk assessments involved.

2.4.3. Article 9 of Regulation 258/97 on new foodstuffs currently refers to the old version of Directive 90/220 as regards the procedures to be followed, documents to be submitted, risk assessment and so on. Its references to articles and annexes will therefore have to be updated in line with the current amendment or it will have to make provision in the body of the text for a specific risk assessment. The same goes for the directives currently being drafted and the cross-references in the transport Directive and Directive 90/679/EEC on safety in the workplace must also be updated.

2.4.4. Given the slow progress of vertical legislation, it appears evident that Directive 90/220 and its annexes will continue to be the basic reference point for risk assessment for some time to come and will be a model for specific assessment schemes. Hence the importance of the risk assessment principles contained in Annex II, upon which the vertical legislation will also be based. Here the ESC is concerned to note that the proposal and, particularly, the annexes do not properly develop the part concerning interaction between GMOs and their ecosystems - be they ecosystems outside the place of production or ecosystems involved in biological production processes.

2.4.4.1. In the former case, it would be highly recommendable that a link be created with existing legislation on environmental impact assessment (EIA) in the case of GMOs entering the market. This link should also take account of a cost-benefit assessment, from both the economic and environmental angles, of their impact on farming practices, and, hence, on agricultural ecosystems. This is of great importance in the run-up to the launch of Agenda 2000, which envisages a further reduction of the environmental impact of farming - a reduction already under way with the CAP (). In this regard, a careful analysis should be made, for example, of the chemical impact of the introduction of herbicide-resistant plants. More generally, with regard to the possible effects on biodiversity, account must be taken of the current negotiations to draw up an international protocol on 'biosafety` along with guidelines for an environmental impact assessment system.

2.4.4.2. Likewise, given the growing interest for deriving non-food products from agricultural raw materials, the impact of such new products should be analysed, with regard both to safety in the place of production and environmental impact during usage, looking ahead to their possible inclusion in the eco-labelling system.

2.5. While the benefits of a simplified procedure are undoubtable, it is worth noting that the vital mechanism for choosing between the simplified and non-simplified procedures is still in suspension, since the relevant criteria have not yet been established. The provisions of the previous directive regarding the simplified procedure are to be deleted but Decision 94/730/EC laying down simplified procedures for genetically modified plants is to remain in force. The basis is therefore experience to date which mainly relates to plants. For the time being, animals and micro-organisms are omitted completely. Though, as a rule, micro-organisms are covered by Directive 90/219, when used in production processes, which are not deemed to be 'confined spaces`, they risk falling into a legal loophole.

2.5.1. The Plant Committee has been making an admirable effort to deal with GMO cases and to liaise with the Scientific Committees on food and animal nutrition on aspects relating to human consumption, despite the fact that this does not fall within its remit. However, it is worth noting that there is currently no committee to assess the effects of introducing GMOs into production processes on the end products - both food and non-food (ranging from textile fibres to animal hides, lubricants, bioplastics and various industrial processes in which GMOs can be used instead of chemicals, or simply because of their low cost).

2.6. Since the Committee procedure provided for in Article 21 and its interconnnection with consultation of the Scientific Committee(s) are fundamental in order to determine a number of unresolved aspects of the legislation, the mechanisms to govern procedures, participation, transparency and the inter-relationship between the Committee of Member States' representatives and the Scientific Committees set up under Commission Decision 97/579/EC of 23 July 1997 need to be clearly defined.

2.6.1. More generally, the ESC observes that, under Article 7, which has not been amended, the mechanisms for consultation of the public and of specific groups still fall under the jurisdiction of Member States; there is currently a considerable disparity which could even distort the authorization mechanisms (see Article 6b, paragraph 4b, which provides that the public consultation periods be excluded from the 90 days available to the competent authority). It would be advisable to provide for a harmonization of criteria and to consider establishing consultative mechanisms at EU level, given the sensitivity of public opinion to such matters.

2.7. The definition of the criteria for analysing transgenic organisms still leaves much to be desired. In particular, the annexes devote much space to plants but do not deal in sufficient detail with criteria for animals or for transgenic plants for animal genes, both questions which are becoming increasingly vital from the angle both of health and environmental risks and the ethical aspects of using human and animal genes in animal and human organisms (cf. the difficult progress of the directive on biotechnological patents).

2.7.1. The ESC observes that the more detailed criteria for higher plants were added in 1994 under the technical amendment procedure on the basis of experience at the time and that there is still little experience as regards the other organisms. The ESC presumes that updating of the annexes will be postponed until later adjustments to keep pace with technical progress are made on the basis of Article 20.

2.8. The drawing-up of the monitoring criteria, described in Annex VII, is of special importance, particularly with regard to human health aspects; the use of an antibiotic-resistant gene as a marker which triggered consumer alarm, is just one example of the possible and unnecessary risks connected with these new technologies if the precautionary principle is not adhered to and if the best available technologies (BAT) are not used. This example shows the importance of early consultation of the Scientific Committees on a case-by-case basis.

2.8.1. As a precautionary measure to protect the environment and health, the ESC is therefore of the view that no antibiotic-resistant marker genes should be used when genetically modified organisms are deliberately released into the environment.

2.9. In a field which is of such public concern, the ESC firmly believes that the drafting of suitable legislation on risk assessment and control must be accompanied by a strong campaign to raise awareness and promote scientific debate. The public should be correctly informed and there should be more dialogue between the authorities, industry and socio-occupational, environmental and consumer associations.

3. Specific comments

3.1. Articles 1 and 2 - scope and definitions

3.1.1. The scope and definitions have been clarified. The reference to 'direct and indirect risks to human health and the environment which the deliberate release of GMOs into the environment may pose`, is particularly important since this broadens the concept of risk assessment, paving the way for the new Annex II.

3.2. Article 4

3.2.1. It might be advisable to refer to the precautionary principle with regard to potential risks for health and the environment (see comments on markers in point 2.8).

3.3. Articles 5 and 10

3.3.1. See previous comments on the need for close coordination between the current, horizontal directive and existing sectoral directives, or others that are in the pipeline. Clearly, the present directive will serve as point of reference for products which are not covered by sectoral provisions.

3.4. Article 6b

3.4.1. Paragraph 4b refers to public consultation as provided in Article 7, which is left to the discretion of Member States. It would be advisable to further align these consultation practices in order to avoid distortions and discrimination in the field of public information.

3.5. Article 13a - criteria for applying the simplified procedure

3.5.1. The criteria and information requirements of the simplified procedure are rightly subject to consultation of Scientific Committees and to the procedure laid out in Article 21.

3.6. Article 13b, c and e

3.6.1. In paragraph 4 of Article 13b, the form in which the dossier is to be made available to the public should be clarified.

3.6.2. In paragraph 6 of Article 13b, the expiry of authorization after seven years should be more closely examined. There is a link with the monitoring plan, on whose results the notifier is required to present a report during the year prior to expiry, along with a copy of the original authorization and 'any other new information which has become available with regard to the risks of the product...` (paragraph 2 of Article 13c).

3.6.3. However, as the notifier is required under Article 13e to submit regular reports of the monitoring to the Commission and the competent authorities, as well as to communicate new information on risks immediately, it is debatable whether a fixed seven-year deadline for renewal is necessary in view of the existence of a set of procedures for withdrawal of authorization, already provided for in Article 6d and Article 16.

3.6.4. Undue stringency could well discourage industry but without providing greater guarantees of public safety.

3.6.5. Provision could be made for more flexible renewal deadlines at the stage of notification and presentation of the monitoring plan (Article 11, paragraph 2d), on a case by case basis, depending on the risks inherent in the interaction between the specific GMO and the ecosystem, which will only become apparent over a shorter or longer period.

3.7. Article 17

3.7.1. Paragraph 2 should clarify how the information is to be made available to the public.

3.8. Article 18

3.8.1. The ESC asks to be sent the report referred to in paragraph 2.

3.9. Article 20a - consultation of Scientific Committees

3.9.1. It is highly advisable for the Scientific Committees to be consulted when determining the criteria relating to the simplified procedure and in the case of any objections being raised by a Member State under Article 16. The said procedure should be extremely transparent and the various scientific bodies should be effectively coordinated so as to guarantee an overall assessment of all health and environmental risks.

3.9.2. The ESC observes that the Scientific Committees to be involved in the assessment are not specified; it recommends a horizontal and comprehensive evaluation of the risks.

3.10. Article 21 - the Regulatory Committee

3.10.1. The change of the type of Committee from Type IIIa to Type IIIb strengthens the decision-making powers of Member States with respect to the Commission (a simple majority is sufficient to reject the Commission's proposal). However, this does not mean that it will be easier to win public support and to align the assessments of Member States.

3.11. Article 22a - sanctions

3.11.1. The introduction of the paragraph on sanctions in the event of violation of national implementing provisions is most welcome; due consideration should also be given to the problem of civil liability for damage caused by the deliberate release of GMOs into the environment.

3.11.2. Pending a horizontal set of reference rules to govern liability for environmental damage, consideration must be given to the advisability of inserting a reference to national legislation providing for insurance schemes or guarantee funds in respect of products containing GMOs.

3.12. Annex III

3.12.1. A reference to best available technologies (BAT) and a cost-benefit assessment could usefully be included among the information required in notifications.

3.13. Annex IV

3.13.1. In connection with the proposed particulars for mandatory labelling, consumer associations have already raised objections regarding use of the wording 'this product may contain GMOs` for 'novel` foods and demanded accurate information. Producers, in their turn, are worried that this wording could trigger unwarranted alarm. The ESC shares the concern of both parties and notes that Council Regulation 1139/98 () offers a preliminary solution for several foods (containing genetically modified soya beans and maize).

3.13.2. However, it must be remembered that Directive 90/220, unlike Regulation 258/97, is a horizontal directive which encompasses all kinds of products containing GMOs; these may not necessarily be intended for the end consumer but be used as raw materials in processing, where the producer has difficulty in ascertaining the nature of the product and ruling out the presence of GMOs. In the ESC's view, the vertical directives should help solve the matter of labelling, depending on its end use and guaranteeing that the consumer receives full information, and the horizontal directive should accommodate such flexibility.

3.14. Annex V

3.14.1. The reiteration of the conditional form ('should`) allows undue flexibility for criteria which should be binding for the purpose of category I classification.

3.15. Annex VI

3.15.1. The assessment report should also comprise elements linked with the environmental impact assessment (EIA) referred to in point 2.4.4.1.

Brussels, 9 September 1998.

The President of the Economic and Social Committee

Tom JENKINS

() OJ C 139, 4.5.1998, p. 1.

() The Commission recently launched, on 9 June 1998, 154 new research projects in this sector, with funding of ECU 138 million, thereby bringing the number of projects financed since 1995 under the Fourth Framework Programme to a total of 456. The Fifth Programme provides for increased support for 'quality of life and management of biological resources` and the ESC is currently drawing up an opinion specifically concerning priorities in relation to the potential benefits in terms of quality of life, health and protection of the environment.

() COM(96) 630 final of 10.12.1996.

() On 18 June 1997, a technical amendment to Annex III introduced mandatory labelling of all GMOs authorized for placing on the market within the meaning of the Directive.

() OJ C 295, 7.10.1996.

() OJ C 62, 26.2.1998.

() OJ C 19, 21.1.1998.

() Regulation No 258/97 concerning novel foods and novel food ingredients, OJ L 43, 14.2.1997.

() The ESC has adopted a specific own-initiative opinion on the impact of GMOs on the CAP, in which the anticipated advantages and risks in the agricultural sector are studied in depth.

() OJ L 159, 3.6.1998.