COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC-Treaty concerning the Common Position adopted by the Council with a view to the adoption of a Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC-Treaty concerning the

Common Position adopted by the Council with a view to the adoption of a Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

1. Procedure

A Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (COM (1998) 0085 - C4-0129/98 - 1998/0072(COD)) was forwarded to the Council and the European Parliament on 23 February 1998 in accordance with the co-decision procedure under Article 95 (ex 100A) of the Treaty.

The opinion of the Economic and Social Committee was delivered on 9 September 1998 and on 11 February 1999 the European Parliament delivered its opinion following a first reading.

Following the opinion of the European Parliament and pursuant to Article 251 (2) of the Treaty, the Commission adopted an amended Proposal (COM (1999) 0139 final, OJ No C 139, 19.5.1999, p. 7) which was forwarded to the Council on 26 March 1999.

On 9 December 1999 the Council agreed unanimously upon the Common Position.

2. Objective of the Directive

The Directive aims to revise Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (GMOs). It seeks to increase the efficiency and the transparency of the decision-making process whilst ensuring a high level of protection for human health and the environment.

The Directive clarifies a number of operational aspects including the scope, definitions and administrative procedures. It also promotes a harmonisation of the risk assessment and improves transparency of the decision-making through a clear labelling scheme for all GMOs and the involvement of the public in the authorisation process.

3. Parliamentary amendments accepted by the Commission in the amended Proposal and which have been incorporated totally, partially or in principle in the Common Position

The numbering of recitals, Articles and Annexes in the current document corresponds to that used in the Common Position.

- recital 50 states that all conditions of the original consent can be revised when a consent is renewed (Amendment 4)

- Articles 1 and 4(1), Annex II and recitals 6 and 8 include a reference to the precautionary principle (Amendments 17, 57 and 62)

- Article 2(2) clarifies the definition of "genetically modified organism" but does not include human beings (Amendment 9)

- Article 2(7) now includes a definition for the term "product" (Amendment 12)

- Article 2(8) has been extended by the inclusion of immediate and delayed effects within the definition of "environmental risk assessment" (Amendment 15)

- Article 4(4) now introduces an obligation on Member States to take all necessary measures in the event of a deliberate release or placing on the market of GMOs for which no authorisation have been given (Amendment 20). Amendment 11 is also substantially covered by the new text

- Articles 4(5) and 18(3)(a),(c) and (d), Annexes IIIA(II)(A)(6) and (7), IIIB(D)(12), IV(A)(7) and recitals 39 to 43 introduce means to facilitate the identification, control and retrieval of GMOs including an obligatory requirement on Member States to ensure traceability at all stages of placing on the market of GMOs (Amendments 1, 14, 38, 64, 66 and 92)

- Article 5(2)(a)(v) and (vi) now places an obligation on the notifier to submit a detailed plan for monitoring and also information on remediation methods (Amendments 25 and 26)

- Articles 5 and 8 introduce mandatory public consultation for Part B releases on the basis that the 90-day assessment period for the dossier by the competent authority is not prolonged by more than 30 days. Article 8(1) additionally states that Member States shall lay down the arrangements for this consultation to provide the public with the opportunity to express an opinion and Article 8(2) introduces an obligation on Member States to make available to the public, details of all Part B releases of GMOs in their territory (Amendments 27, 29 and 32)

- Article 7(2) now indicates that the competent authority should evaluate additional information when it becomes available (Amendment 31)

- Article 9, in accordance with Article 8(2), second subparagraph and Article 10(3), now places an obligation on the notifier to send to the competent authority the results of the Part B releases with respect to any risk to human health or the environment. On receipt, the Commission is then required to make these results available to the public (Amendments 33 and 35)

- Article 10(2) now provides that Member States can, on request, receive a full copy of Part B notifications from the relevant Member State (Amendment 34)

- Article 11 strengthens the link of the Directive to product legislation, clarifying that the provisions of Part C do not apply to products authorised by other Community legislation that is at least equivalent with respect to risk assessment, risk management, monitoring, labelling, information to the public and the safeguard clause. For medical products, the exemption requirement extends only to the environmental risk assessment (Amendments 5 and 94)

- Articles 12(2)(e) and 18(3)(f) and Annex VII specify the information requirements for the monitoring plan and includes both duration and frequency (Amendment 65)

- Article 13(3) includes the possibility for the competent authority, through which a product dossier is notified, to indicate in the assessment report that the GMO in question should not be placed on the market (Amendment 39)

- Article 16 introduces an optional time limitation for consents on renewal (Amendments 5 and 42)

- Article 17 now requires that the Scientific Committee(s) delivers an opinion within a specified time period (Amendment 44)

- Article 19 introduces a procedure with respect to the handling of new information (Amendment 89)

- Article 22 (safe guard clause) accounts for new or additional information and places obligations on Member States in the event of severe risks (Amendments 43 and 53)

- Article 28 now refers to the possibility of consulting an Ethics Committee (Amendments 6 and 54)

- Annex II has been expanded to clarify further the principles of the environmental risk assessment (Amendments 58 and 60)

4. Parliamentary amendments accepted by the Commission in the amended Proposal but which have not been incorporated in the Common Position

Amendment 16 concerns the definition of the term "use" but was not included in the Common Position. The Commission accepted not to introduce this definition on the basis that the use of the term within the legal text of the Directive is self-explanatory.

5. Changes in the Common Position with respect to the amended Commission Proposal

The Council has taken account of developments in the field of biotechnology and introduced, by unanimity, a number of major new elements into the amended Commission Proposal as follows.

As a result of that, the majority of the provisions of Directive 90/220/EEC, including its annexes, were substantially modified by the Common Position. In order to maintain the clarity and transparency of the legal text, the Commission supports the initiative of the Council to revise that Directive by presenting a consolidated text for a new Directive. It is foreseen that the current Directive 90/220/EEC will be repealed at the time that the new Directive is transposed in national law (Article 34).

Articles 1, 2(4) and 3 (scope)

The Council has opted to restructure the Articles defining the scope of the Directive. These changes seek to further clarify the scope and therefore extend the link to other Community legislation in the field of biotechnology, in particular to Directive 90/219/EEC. It has been clarified that the Directive covers in principle all placing on the market activities involving GMOs except certain specified exemptions as defined in Article 2(4). The exemptions cover in particular GMOs which are either covered by Directive 90/219/EEC or are used exclusively for activities where appropriate stringent containment measures are used to limit their contact with the general population and the environment.

In line with the clarification of scope, a new provision has been introduced to ensure that GMOs exempted under Article 2(4) of the Directive are labelled appropriately when made available to third parties. The new Article 25 guarantees clear labelling for these GMOs whether intended for contained use or deliberate release in the Community.

The Commission has accepted these amendments since they clarify the scope of the Directive.

Article 4 (general obligations)

Article 4 has been substantiated by explicit reference to the precautionary principle as the basis for the action of Member States to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment. Member States are also required to ensure traceability at all stages of the placing on the market of GMOs. In addition, the article now includes an obligation for Member States and the Commission to give particular consideration to GMOs containing antibiotic resistance marker genes with a view to identifying and phasing out markers which may have adverse effects on human health and the environment. The Commission considers that these provisions confirm the precautionary approach and facilitate control and inspection measures by Member States and can therefore accept these changes.

Articles 5 and 6 (administrative procedures for experimental (Part B) releases)

The Commission had proposed to re-structure the existing administrative procedures for the authorisation of Part B under Directive 90/220/EEC and had introduced a categorisation system for Part B and provisions for multi-state experimental releases. It had also deleted the possibility of establishing simplified procedures as laid down in Article 6(5) of Directive 90/220/EEC, since there were indications that this Article was of insufficient legal certainty.

The Common Position in principle reinstates the existing administrative authorisation system that consists of a standard procedure and a possibility for establishing differentiated procedures by comitology procedure. The means to establish these differentiated procedures have been tightened and the involvement of the Scientific Committee(s) and consultation of the public are now mandatory. In addition the criteria for the application of these differentiated procedures have been strengthened and clarified (Annex V).

The Commission has accepted the Common Position on the basis that the framework for establishing differentiated procedures has been clarified but remains of the opinion that its initial proposal would have provided equally effective and efficient authorisation procedures.

Article 8 (consultation of the public)

The Common Position now foresees mandatory public consultation with respect to proposed releases notified in accordance with the standard procedure in Part B of the Directive. In the spirit of compromise, the Commission has agreed that this public consultation should not prolong the 90-day period established for the decision-making by the competent authority of a Member State by more than 30 days (Article 5(6b)).

Article 11 (relationship to product legislation)

The status of the Directive as the primary legislation within the Community regulatory framework for biotechnology has been strengthened. The Common Position now confirms that only under certain conditions will the requirements of the Directive regarding the placing on the market of GMOs not apply to products authorised under other Community legislation. These conditions specify that other Community legislation has to be at least equivalent with regard to risk assessment, risk management, monitoring as appropriate, labelling, information to the public and the safeguard clause. The Common Position also clarifies that the procedures to determine the equivalence of product legislation shall be laid down in a Regulation based on the appropriate legal basis of the Treaty and that any GMO shall only be placed on the market after having been authorised in accordance with this Directive until such Regulation enters into force.

However, as a means of exemption for medicinal products under Council Regulation No. 2309/93, only the environmental risk assessment requirements will apply.

The Commission believes that the Common Position will clarify the horizontal role of the Directive and improve the harmonisation of the regulatory framework in biotechnology and has therefore accepted these changes to its Proposal.

Article 14 (time-limited consent)

The Common Position now provides that consent shall be granted for a maximum period of 10 years when GMOs are placed on the market for the first time. In the case of renewal of consent, the time limitation is optional and may be limited as appropriate.

The first reading of the European Parliament called for a 12-year limited consent. The Commission has accepted to extend its initial proposal of a 7-year time limitation as a compromise taking into account that the Common Position facilitates the identification and the control of GMOs.

Article 15 (differentiated procedure)

The possibility of establishing simplified procedures for the placing on the market of GMOs has been deleted although a differentiated procedure in terms of notification requirements has now been included as an addition to the standard procedure.

Article 19 (monitoring and handling of new information)

The Common Position now explicitly outlines the action to be taken by the competent authorities of Member States if new information arises on the basis of monitoring plans or from other sources. It also specifies the administrative procedure for cases where an amendment to the existing consent is necessary. The Commission considers this as a useful clarification.

Article 20 (labelling of GMOs)

The Common Position introduces mandatory labelling at all stages of the placing on the market of GMOs and it must be clearly stated on the label that "this product contains genetically modified organisms". In certain cases, thresholds may be established by committee procedure for products where adventitious or technically unavoidable traces of GMOs cannot be excluded. Products contaminated with GMOs below these thresholds do not have to be labelled as genetically modified. The Commission has accepted the Common Position since it confirms the principle of labelling of GMOs at all stages of the placing on the market and the establishment of thresholds allows for practical implementation of the labelling scheme.

Article 26 (adaption of Annexes to technical progress)

The Common Position foresees, in line with technical progress, the possibility to develop Annexes II to VII by committee procedure although certain exemptions will apply. The sections of Annexes II and VII in which the general basic principles are laid down for the environmental risk assessment (Annex II, Parts A and B) and for the monitoring plan (Annex VII Parts A and B) are subject to the full co-decision procedure. The Commission considers that these changes to its Proposal are appropriate.

Article 29 (committee procedure)

The Common Position includes new provisions foreseen for a Regulatory Committee through reference to Council Decision 1999/468/EC of 28 June 1999, which lays down the procedures for the exercise of implementing powers conferred on the Commission. These provisions enable the Commission to adopt measures in accordance with the opinion of the Committee but proposals have to be submitted to the Council for adoption where the envisaged measures are not in accordance with the opinion of the Committee or if no opinion is delivered. The Commission has also to inform the European Parliament of the proposal at this time.

Article 30 (review clause)

The Common Position introduces a review clause, which requires the Commission to submit every three years a report on the operation of this Directive and specifically details the issues to be incorporated in the first report in 2003. This report is to include in particular an assessment of the need to complement the regulatory framework in this field, the feasibility of various options to further improve the consistency and efficiency of this framework and the socio-economic implications of releases into the environment of GMOs. The Commission considers this to be a useful clarification but would like to indicate that the time period between the transposition of the Directive and 2003 might be too short to effectively assess the implications of the Directive.

Article 33 (pending notifications)

A transition clause has been introduced which clarifies that notifications concerning the placing on the market of GMOs as or in products shall be subject to the decision-making of this Directive where procedures under Directive 90/220/EEC have not been completed before the end of the transition period. The notifiers will have a period of three months to adapt their notification to the new scheme. This should serve for a smooth transition.

Annex II (principles of the environmental risk assessment), Annex IV (additional information for Part C dossiers) and Annex VII (monitoring plan)

The Common Position substantiates the framework for the environmental risk assessment and extends the details of specific elements within this framework. Guidance notes will also be developed to supplement the Annex.

The requirements for additional information with respect to Part C notifications and the monitoring plan have also been expanded to include more detail.

In this context the Commission would like to emphasise the importance of research and monitoring results for the development of these guidelines and the adaptation of the Annexes to technical progress in particular under the Fifth Framework Programme for Research.

The Commission considers that the increase in detail provides greater clarity for notifiers and supports the new structure of these annexes.

6. Conclusion

The Common Position maintains in principle the basic structure of the Commission Proposal but builds on specific elements to provide for a more stringent and transparent regulatory framework. Specific changes have been introduced in order to strengthen the principles of the risk assessment procedure and the inclusion of public consultation linked with mandatory labelling at all stages of the placing on the market of GMOs increases transparency. In response to the growing public concerns about potential adverse effects of GMOs, the need for a more transparent and stringent regulatory system for the deliberate release of genetically modified organisms into the environment has now become clear. The Common Position has built upon the original Proposal and the Commission is satisfied it will provide for an effective and efficient regulatory framework that takes into account both public concerns and the interests of industry.

The Commission believes that a rapid revision of Directive 90/220/EEC may contribute significantly to the resolution of the problems that have been encountered in the implementation of the Directive and welcomes the fact that the Common Position was adopted by unanimity.