Select Committee on European Communities Second Report - Written Evidence

Memorandum by AgrEvo

  AgrEvo informed the Committee that they were firmly in agreement with the position of EuropaBio (see pages 326-331) and the Green Industry Biotechnology Platform (GIBIP). They forwarded the position paper below to the Committee.

  1. The Green Industry Biotechnology Platform (GIBIP), representing 20 European companies active in improving plant using biotechnology, welcomes the adaptation of the regulatory framework on modern biotechnology to the rapidly evolving scientific knowledge and increasing familiarity with biotechnology. It is of utmost importance that the regulatory framework provides for both the necessary safeguards for human health and the environment and enables the European society to fully benefit from biotechnology.

  2. The Report on the Review of Directive 90/220/EEC (Com(96)630) issued by the Commission in December 1996, presented a good analysis of the functioning of the Directive, based on the experience gathered in the Member States following the first years of implementation. However, GIBIP believes that the current Commission Proposal on the Revison of Directive 90/220/EEC does not fully address the identified weaknesses of the current process. Furthermore, the Proposal introduces new provisons which add even further complexity. It is considered very important that the work of the EU Risk Assessment Working Group is revitalized, in order to harmonize Community risk assessment and to establish baseline criteria which are science-based.


  3. To facilitate the practical implementation of the Directive, certain terms used such as "genetically modified organisms" or "placing on the market" require further clarification.

  4. Clarification of the scope of the risk assessment is necessary to avoid duplication of safety review, e.g., with Dir.91/414/EEC or with the Novel Food Regulation.

  5. Although other related legislation is being introduced (e.g. the Novel Foods and Novel Food Ingredients Regulation), the current Proposal does not make cross-references to this. It should clearly exempt those categories of products which are covered by other vertical (product) legislation as applicable.


  6. Science-based legislation should foresee a mechanism for rapid adaptation to technical progresses. The current Proposal no longer provides for this regarding research and development activities.

  7. The current Proposal brings substantial improvement to the procedure for research and development trials. The introduction of a multistate approval procedure should, however, also foresee different categories for genetically modified organisms according to familiarity and be further expanded so that review by one Member State only is required for a multistate trial (Article 6c).


  8. A mechanism should be introduced whereby questions, comments and objections raised by Member States during the 60-day-review period and which fall outside of the scope of the Directive should be automatically rejected (Article 13).

  9. The duration of the complete procedure for placing on the market is still not clearly defined, as critical steps (Regulatory Committee, Scientific Committees) remain without time-limitation. It is therefore questionable whether the amendments introduced for certain steps will improve the predictability of the duration of the process as compared to the current situation (Articles 20a and 21).

  10. The Proposal does not address the non-compliance of the Member States regarding the specified time-lines.

  11. The limitation of authorisations to 7 years is neither coherent with other legislation on genetically modified organisms (e.g., no time-limitation under the Novel Food Regulation), nor adapted to the reality of plant breeding and marketing. The proposed time-limit for authorisations under Directive 90/220/EEC should be withdrawn as it does not contribute to the safeguard of the environment or human health, but increases the development risk for the European biotechnology industry. In any event, the existing measures (Article 11 (6) or Article 16 of Directive 90/220/EEC) require notification of any new information concerning potential adverse effects and allow Member States to take safeguard measures, including product withdrawal. This also applies to previously authorised products (Articles 13b, 13c, 13d, and 22b).

  12. Post-marketing product stewardship is common practice for companies. Mandatory monitoring as introduced in the Proposal should be related only to cases where potential risks have been identified during the risk assessment under Directive 90/220. Monitoring will have to be based on sound scientific principles, criteria and protocols, related to these potential risk(s) (Article 13e).

  13. The Proposal should provide clarity on the applicability, procedures and information requirements for the following categories of genetically modified plants (GMPs);

    —  GMPs used for processing but not for cultivation in the European Union;

    —  GMPs developed by combining previously authorised GMPs by traditional breeding methods;

    —  new uses of GMPs previously approved.

  Where these products fall within the scope of the Directive, simplified procedures should apply.

  14. Public involvement (availability of a summary of the dossier and publication of the Scientific Committee reports) will improve transparency. However, public consultation should start once the rapporteur Member State deems the dossier to be complete. The procedure for addressing public comments requires clarification (Article 17).

  15. GIBIP strongly believes that only a clear, transparent, timely and science-based regulatory framework, compatible with international legislation, will ensure environmental and human safety, while at the same time supporting the competitiveness of the European biotech industry and enhancing products acceptance.

March 1998

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