1. It is essential for any revision of 90/220 that in addition to the necessary provisions for safeguarding human health and the environment, the Directive provides for a regulatory framework which enables biotechnology to play its full part in benefiting European society.

  2. Modern biotechnology has a crucial role to play in the improvement of human and animal health and in agricultural practices for the benefit of the rural community and the environment: to mention but two areas where the potential contributions to European society are most advanced. Sound investment must be encouraged. The potential for employment is large (with an improvement in the business environment, the value of products and services using biotechnology in Europe could reach ECU 250 billion by 2005 and provide more than three million jobs).

  3. As the Explanatory Memorandum to the revision of the Directive recognises "This growth sector has not yet reached its full potential and its cruising speed. In addition this new technology will maintain the competitiveness of Europe on the world market and will make a major contribution to economic growth by enhancing the competitive position of industry and agriculture".

  4. Europabio's comments on the Commission proposals are therefore based on the requirement for a balanced package as expressed in the first paragraph, which also reduces trade friction to the minimum. Again, in the words of the Explanatory Memorandum "It is essential that regulation does not unnecessarily hinder the potential for technological innovation".

  5. The current 90/220 has not shown the ability to ensure that European society can utilise the benefits of biotechnology. It is subject to short-term political expediency. Any revision must deal with the need for stability, consistency and timeliness and be based solely on sound scientific criteria.

  6. Europabio is concerned to ensure that the legislation is able to keep pace with rapid technological improvement. "International experience has shown that these figures, (i.e., number of product notifications), will increase rapidly in the next few years" (Explanatory Memorandum).

  7. In conformity with the above, Europabio has been seeking improvements to 90/220 which:

(1)  Will enable the regulators to keep pace with the advances of the technology.

(2)  Reinforce principles of sound science.

(3)  Improve time lines and consistency of decision taking.

(4)  Relate properly to relevant vertical sector specific legislation.

(5)  Recognise the need for improved and streamlined procedures for specific applications and products based on the familiarity principle.

(6)  Recognise the principle of the internal market.

  8. In its Memorandum to the revision proposals, the Commission recognises these concerns and has made proposals to meet all these criteria, with varying degrees of appropriateness. The following comments refer to required adjustments and Europabio's concerns with the new provision of a fixed term approval and for monitoring.

PROPOSALS FOR FURTHER IMPROVEMENTS:

Part B

  9. The multistate procedure introduced in Part B does not make any distinction between Category I and Category II releases (Article 9). It should be possible to shorten the Category I procedure by a further 30 days.

  10. The multistate procedure should be further developed so review by one Member State only is required for multistate trials.

  11. A time-limit should be introduced concerning the public consultation period.

Part C

  12. The proposed seven year authorisation period

  13. The authorisation period should be unlimited. Should an unforeseen problem arise after authorisation, there is always the possibility for revising or withdrawing the authorisation (Article 22).

  The seven year authorisation proposal is ill adapted to plant breeding. Improved varieties which incorporate the same event come on the market every year: therefore for all GM varieties which come on the market after the first year of Part C authorisation the period of normal certainty that a product can be commercialised is less than seven years, diminishing to one. This is unacceptable. The system of variety registration and the costs which go with it exacerbate the problem.

  14. These comments also relate to the concept of fixed renewal periods. Normally they should not be necessary.

  15. All phases of the procedure should be subjected to time disciplines, both by the Commission and the Member States. For example, time limits should be laid down for the deliberations of the Scientific Committee (Article 21).

  16. Monitoring (Article 15). It is imperative that monitoring be targeted only to those issues which could constitute a risk from the GMO which is being authorised. There must be a link between the monitoring required and the safety assessment of the GMO. Monitoring should be restricted to possible ADVERSE effects which may derive from the genetic modification itself. It should be limited to that which is necessary for a company to fulfil its legal obligations under the directive.

  17. Where the following categories fall within the scope of the Directive simplified fast Track procedures should apply:

—  GMOs used for processing but not for cultivation in the European Union.

—  GMOs developed by combining previously authorised GMOs by traditional breeding methods.

—  new uses of GMOs previously approved.

  18. Some definitions are open to different interpretations e.g., "placing on the market" (Article 2(4)). This definition continues to be too widely drawn and causes difficulties where GMOs are made available to third parties for research and other activities which fall short of actual commercialisation. These movements to third parties for research and other activities should be excluded from the definition.

3 June 1998