Select Committee on European Communities Second Report - Written Evidence



  EuropaBio welcomes the explicit recognition in the Commission's review (COM(96)630 final) that there are a number of problems with the operation of Directive 90/220 which need to be addressed.

  Many of the conclusions concur with our own view that there is considerable scope—and, indeed, a pressing need—for improvement if Europe is to maximise the competitive benefits of modern biotechnology and secure Single Market objectives.

  The need for change is pressing and recourse to lengthy legislative procedures should be avoided if at all possible. All the flexibilities of the Directive should, therefore, be exploited to the full to meet industry's and academia's requirements before embarking upon any wholesale revision of the Directive. In this connection we urge the Commission to explore the scope for maximum use e.g., of Article 6(5) and all other legislative instruments at the Commission's disposal.

  We have the following detailed comments on the Commission's paper.



  Clarify the scope of this horizontal Directive with respect to other relevant sectoral vertical legislation, including Novel Foods since both are concerned, in part, with human health. Facilitate links to specific product legislation.

  Clarify the status of hybrids between approved GMOs and address the considerable administrative burdens arising from event by event based regulation (Appendix).

  Recognise the need to balance identified risks with benefits.

  Introduce exemptions and accelerated procedures based upon EU and international experience with the same or similar products.

  SOLUTION: the Commission should introduce these changes through appropriate administrative procedures backed, as necessary, by legislative instruments such as Commission Decisions.


  Clear and unambiguous definitions to the wide range of products covered by the Directive and detailed clarification are needed. For example, self cloned organisms should be exempted from the definition as is already the case with Directive 90/219.

  International definitions should be used wherever possible to avoid any international trading problems and to simplify procedures for regulators and industry alike.

  SOLUTION: the Commission should provide comprehensive definitions for all Member States and introduce changes through appropriate administrative procedures backed, as necessary, by legislative instruments such as Commission Decisions.

Risk Assessment Criteria

  Use generally accepted criteria for safety based upon sound scientific principles. Harmonise the approach with that of the Novel Foods Regulation and other relevant EU legislation.

  Overhaul the structure and functioning of the EU Risk Assessment Working Group to make it more effective.

  SOLUTION: the Commission should develop and introduce urgently such risk assessment criteria, in collaboration with Member States, and taking into account other relevant international experience, e.g., OECD.


(a) Risk categories and administrative procedures

    (i)  Implicit consent (comparable to notification procedures under Directive 90/219/EEC) should be introduced for GMOs which are known to be safe for human health and the environment via positive lists which can be updated annually.

    (ii)  Plants, microbes and animals represent different levels of risk. A separate risk group for plants has been introduced. Further risk categorisation should occur for plants and for the microbe and animal groups.

    (iii)  Ensure the 30 days SNIF consultation should take place within the 90 day examination period and not after it. Some Member States do not follow this procedure. The 90 day period must be respected to ensure Single Market objectives are met.

    (iv)  Part B should be enriched by allowing for obtaining environmental clearances e.g., for seeds which are not intended for agricultural use but which are grown for industrial purposes (e.g., for pharmaceutical ingredients/use).

    (v)  Considerable responsibility is vested with individual Member States under Part B with little opportunity for input into decisions from other competent authorities or the Commission. There needs to be greater Commission oversight and control to ensure that the objectives and requirements of the Directive are fully met and that the single market operates effectively.

(b) Simplified procedures

    (i)  "Risk classes" should be introduced with differentiated provisions for release with and without prior consent as well as with implicit consent or "fast-track" systems reflecting experience. This should include "deregulated status".

    (ii)  Precautionary measures such as mandatory monitoring should be reduced or ceased with increased experience. The experience from other Member States should be shared with those Member States authorising field trials of a GMO for the first time.

(c) Multi-state procedures

    (i)  Multi-site and multi release provisions should be introduced with single consents and through harmonised risk assessment evaluations. This should be valid across Member States in standard formats (with an appropriate risk assessment).

    (ii)  Harmonisation should be pursued through greater information sharing and e.g., mutual acceptance of data and decisions.

(d) Risk assessment

    (i)  Risk assessment methodologies must not only have a sound scientific basis and respect international practice but should also be harmonised across Member States with clear guidance on what constitutes risk.

(e) Exchange of information between Member States

    (i)  Any exchange of information between Member States should facilitate rather than delay permits and it should ensure the confidentiality requests of the notifier.

(f) Link between experimental and product releases

    (i)  Data gathered under Part B already helps with assessments under Part C. A clear definition of data requirements under Part C will ensure that notifiers collect appropriate information under Part B. Limited area large scale releases should also be considered positively under Part B.

  SOLUTION: All these improvements under Part B should be introduced through:

    —  appropriate administrative procedures;

    —  using the flexibility of Article 6(5); and/or

    —  where necessary, by legislative instruments such as Commission Decisions.


(a) Risk categorisation and administrative procedures

    (i)  Clarify the scope of the Directive and its relationship with other relevant sectoral legislation, including Novel Foods.

    (ii)  Streamlined procedures and differential risk assessment and treatment should be introduced.

    (iii)  The 90 day review period should be respected by all Member States.

    (iv)  When dossiers are in the 60 day period objections should only be considered where they fall within the scope of 90/220 and to the case under examination.

  SOLUTION: Introduce through appropriate administrative means backed, where necessary, by legislative instruments such as Commission Decisions.

    (v)  Commission adaptation of its internal procedures to speed up proceedings is particularly relevant for the Commission drafting of decisions, the rate limiting steps of the current process. We do not consider that formal amendments are required to provide more expeditious case handling. A public commitment by the Commission to this would be seen as positive by Member States and industry alike—especially if backed by appropriate resources to implement the commitment.

  SOLUTION: the Commission should give a public commitment to deal with cases expeditiously within challenging published set time frames and address the resource implications.

    (vi)  Introduce more "transparency" into the proceedings and only entertain objections or queries from Member States up to 40 days into the 60 day period to allow the notifier to produce additional material and answers so that a decision can be taken within the 60 day period. This will help to reduce as much as possible the need to move to a further phase of the procedure.

    (vii)  Fixed timings (28 days) should be formally introduced for the vote by the A22 Committee. 28 days is already standard procedure for decisions.

    (viii)  A "fast track" system should be introduced for those products already properly evaluated and approved inside or outside Europe.

    (ix)  A fast track procedure should be introduced for extensions of previously authorised products or similar products.

    (x)  More transparency should exist when dossiers enter:

    —  the 60 day;

    —  Commission drafting; and

    —  A21 Committee procedures.

  All the timetables should be respected.

  SOLUTION: Introduce through appropriate administrative means backed, where necessary, by legislative instruments such as Commission Decisions.

(b) Risk assessment and scientific advice

    (i)  Establishment of harmonised risk criteria is necessary and must be presented as targeting control on areas of real risk (cf 90/219). In particular, harmonised understanding about what constitutes an adverse environmental effect should be secured in line with best international practice.

  SOLUTION: The Commission should develop harmonised criteria urgently in collaboration with Member States, and taking into account other international experiences.

    (ii)  Many Member states already have well respected Advisory Committees. The oversight of the EU scientific advisory bodies by DG XXIV and their interface with regulatory processes should lead to enhanced public credibility in the efficacy of the procedures and the decisions. It is important, however, to ensure that such EU scientific bodies do not add another level of bureaucracy which could introduce further delays.

  SOLUTION: Consideration should be given to the interface of the various Scientific Advisory Committees with the regulatory processes.

(c) Labelling

  Standardised labelling procedures are necessary between Directive 90/220, the Novel Foods Regulation and Feeds regulations etc., (to come).

  SOLUTION: EuropeBio members have already taken an initiative on voluntary labelling and other relevant product information under Direct 90/220. This voluntary approach will continue until it is subsumed by implementation of the legislative amendment using the Directive's flexibility.

(d) Confidentiality

  Confidential and sensitive commercial information and the status of notified dossiers should be respected.


  It is necessary to provide for regular adaptation of all annexes through a Regulatory Committee procedure.

  SOLUTION: Introduce through administrative means backed, where necessary, by appropriate legislative instruments such as Commission decisions.

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