Opinion of the Economic and Social Committee on the 'Proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms` (96/C 295/12)

On 30 April 1996 the Council decided to consult the Economic and Social Committee, under Article 130s 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 11 June 1996. The Rapporteur was Mr Colombo.

At its 337th Plenary Session (meeting of 10 July 1996), the Economic and Social Committee adopted the following Opinion by 92 votes to two, with three abstentions.

1. Introduction

1.1. The Committee is following with great interest the current debate on possible developments in the biotechnology sector, and intends to be an active participant in the wide-ranging dialogue - not restricted to the institutions - which started at the biotechnology conference of 11 January 1996 at the Borschette Centre, Brussels.

1.2. On that occasion, the ESC representatives stressed the sector's potential in terms of job creation and the concomitant need to ensure public consensus based on information and broad consultation and on rules tailored to the real risks.

1.3. The Commission's proposed amendment must be seen in this context.

2. Need to amend the Directive

2.1. In its Explanatory Memorandum the Commission explains the need to amend Directive 90/219/EEC on the basis of the experience and new knowledge acquired at European and world levels in the field of contained use of genetically modified micro-organisms (GMMs). On the basis of this experience, the Commission argues the case and indeed the need for the Directive to be revamped in order to secure greater transparency, by introducing a classification system, in line with international standard practice and a set of administrative procedures commensurate with the respective risk potential.

2.2. The Committee, which had come out in favour of the approach of the original Directive (), has sought to obtain more data for assessing the implementation of the Directive in the various Member States, all the more so since Article 18 lays down that the Commission shall draw up a triennial summary of the reports sent by the Member States from 1993 onwards.

2.3. Since the legal basis (Article 130s), providing for minimum harmonization levels, allows the Member States to take more rigorous measures to safeguard human health and the environment, the ESC thinks it important to assess the differences between the existing rules in the Member States and the resulting advantages and disadvantages, so as to check whether there is a case for amending the Directive currently in force.

2.4. To that end the Committee examined the first report on the implementation of the Directive, which was published in 1994; at that time, however, Spain had only just adopted a transposition law, while some Member States still lacked the necessary legislation. Thus, the experience of only a few years mentioned in the report is limited to certain countries, with the majority of activities notified to the competent authorities being of type A (small-scale R& D).

2.5. The report also notes differences in the extent of public information and consultation arrangements, which are particularly comprehensive in Denmark and the Netherlands. This more transparent approach does not appear to have significantly reduced the number of activities authorized.

2.6. The Committee notes that the reasons for amending the current Directive do not emerge from the limited information provided by the report on its own. As well as taking account of international trends in this field, the Commission must have obtained additional information in the course of discussions with the interested parties, drawing on the scientific experience accumulated by research centres and European firms. This should have been covered in greater detail in the Explanatory Memorandum to the Commission proposal, just as more details should have been provided of any problems encountered by research centres and the undertakings of the sector in coping with the administrative procedures.

2.7. The Committee has also noted the interest and the debate aroused by the present proposal and calls for a decision to be taken on the basis of complete transparency so as to allay unwarranted fears.

2.8. In a field of technological development where risk assessment involves a number of unknown factors and where public acceptance is of fundamental importance, decisions to amend the existing rules should indeed be taken with great caution, and be subject to maximum safety measures with a view to risk prevention. Only in this way can a sector offering considerable growth potential from the standpoint of production and employment gain the confidence of users and consumers and attract the necessary investment. It is precisely at the marketing stage that consumer concerns become apparent, as demonstrated by certain reactions to foodstuffs produced by genetic modification or genetically modified plants.

2.9. This preoccupation with risk assessment clearly concerns not so much contained use as the subsequent stage of deliberate release to the environment, governed by a different regulatory measure. A clear distinction should continue to be made, therefore, between Directives 90/219 and 90/220, 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.

2.10. In this context, the Committee notes that the Commission is about to publish a progress report on the implementation of Directive 90/220, and reserves the right to comment on this when consulted.

3. Preliminary comments

3.1. The Committee welcomes an updating of Directive 219/90 to keep pace with technical and scientific progress, in terms of better definition and classification of risk levels, and hence of procedural simplification and of better technical protection, provided that the basic premises and philosophy of the Directives adopted in 1990 remain unchanged. It therefore regards the present proposal as an amendment of the existing legislation in the light of experience gained at Community and international level and not as a deregulation measure.

3.2. It should be pointed out that the reason for adoption of specific Directives for genetically modified micro-organisms was acceptance of the idea that the risks associated with GMMs are not fully recognized in that a potential risk can derive from possible unforeseen effects of the building of new combinations of otherwise harmless components. This implies that a declaration that a GMM is safe should be based on knowledge of the GMM as such, and not merely on knowledge of the function of the gene in question in the donor organism and of the behaviour of the host organism considered separately.

3.3. Consequently, restrictions can be removed only when a control body takes the responsibility of including the GMM in question in a list of types of harmless micro-organisms (Annex II.B). In view of the above, the following specific points need to be examined.

4. Specific comments ()

4.1. Article 1 The words 'and the disposal` should be inserted after 'the contained use` in defining the scope of the Directive in accordance with the definitions given in Article 2(c), since particular attention must be paid to the waste generated by contained use. It is at this stage that the danger of release to the environment occurs.

4.2. Article 3 This Article is misleading and contradictory. It is not possible on the one hand to exclude certain procedures and applications from the scope of the Directive and at the same time to adopt detailed arrangements for such procedures in the Directive. This is the case in Articles 5(1), 5(4), 6, 7, 8, 12(1), 19(4) and Annexes IIA, IIB, III, IV, V, Part A.

4.3. Article 5 4.3.1. The Committee endorses the new risk-based classification system, which provides better safety guarantees, and the new division into four classes, which is in accordance with international classifications and more suitable for selection of appropriate containment measures. The existing difference in treatment based on the volume and industrial/non-industrial nature of activities is unsatisfactory.

4.3.2. The lumping-together of risk-free activities (Appendix II A) with very low risk activities in Risk Class I (Appendix II B) appears plausible at first sight; it can, however, only be assessed if the procedure for determining types of GMMs covered by Appendix II B has been clarified.

4.3.3. It is particularly necessary to draft Annex II B accurately because the assessment and assignment of risk class is to be left up to the user.

4.3.4. The Committee welcomes the requirement that, for Class 1, users keep a record of the assessment to be presented on request to the competent authority (Article 8) and inform the competent authority of any new development (Article 12).

4.4. Article 8 In accordance with the above, the Committee suggests that consideration be given to automatic annual transmission of assessment data in respect of Class 1, as redefined to cover activities of negligible risk.

4.5. Article 13 4.5.1. Consultation of the public, essential for retaining their confidence, remains the Member States' prerogative, and is limited in the new wording in terms of the aspects covered by the proposal (word 'all` deleted), and made expressly subject to confidentiality clauses.

4.5.2. The Committee Opinion on the original proposal stressed the importance of the widest possible consultation, and welcomed the fact that the final text of the directive included these elements. The involvement and active participation of all parties and transparency vis-à-vis the public are in any case essential points of the Fifth Environment Programme: it is incomprehensible that the Commission should go back on this, particularly if the new techniques have been shown to be harmless to human beings and the environment. The Committee would also draw attention to its Opinion on the freedom of access to information on the environment () in which it stressed the concept of 'active` information for the public.

4.6. Article 14 This Article confines information on measures in the event of accident to bodies and authorities, with no reference to individuals. It is, however, essential to provide them with information, especially on action to be taken in the event of risk, as some Member States already do in emergencies. Thus, the existing wording of Article 14 offers a greater guarantee of safety for both the public and workers.

4.7. Article 20 The Committee notes that, under the new Directive, all annexes can be modified using the committee procedure set out in Article 21 and calls for wider consultation of experts whose high level of scientific knowledge is recognized in the case of the first two annexes, which define the techniques that result in genetic modification and those that do not.

4.8. Annex II The Committee calls for clarification of the definition procedure used for Part B. In the absence of an exact definition of the procedure, it is impossible to adopt a definitive stance on this issue and by the same token on the definition of Risk Class I.

4.9. Annex III The Committee calls for risk assessment to make express mention of disposal.

Done at Brussels, 10 July 1996.

The President of the Economic and Social Committee Carlos FERRER

() OJ No C 23, 30. 1. 1989.

() For convenience, references are to the Consolidated Text attached to the proposal, following the new numbering of the Directive.

() OJ No C 139, 5. 6. 1989.