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'
Date: 1996-07-10
Institutions: European Economic and Social Committee
Subjects: environmental protection, environmental risk prevention, genetically modified organism, public health, research body













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51996AC0887

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'  


Official Journal C 295 , 07/10/1996 P. 0052 





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.