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 of the Council on the adoption of a Regulation of the European Parliament and of the Council on the transboundary movements of genetically modified organisms

2002/0046 (COD)

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 of the Council on the adoption of a Regulation of the European Parliament and of the Council on the transboundary movements of genetically modified organisms

1. PROCEDURE

Transmission of the Proposal to the Council and the European Parliament (COM(2002)85 final - 2002/0046(COD)) in accordance with Article 175(1) of the Treaty - 18 February 2002

Opinion of the Committee of the Regions - 16 May 2002

Opinion of the European Economic and Social Committee - 17 July 2002

Opinion of the European Parliament - first reading - 24 September 2002

Following the opinion of the European Parliament and pursuant to Article 250(2) of the EC Treaty, the Council adopted its Common Position by unanimity on 4.March 2003.

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The objective of this Proposal is to implement the relevant provisions of the Cartagena Protocol on Biosafety by establishing a common system of notification and information for exports to third countries of genetically modified organisms (GMOs). This system will contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and the sustainable use of biological diversity, taking also into account risks to human health and specifically focussing on transboundary movements.

3. COMMISSION COMMENTS ON THE COMMON POSITION

3.1. General comments

In general terms, the Common Position follows the structure of the original Commission's proposal. However, it broadens the original scope of the Proposal and strengthens the obligations lying on Community exporters in a very substantial way, which goes beyond the requirement of the Biosafety Protocol. The Commission was not in a position to support the Common Position, which has been adopted by unanimity. Accordingly, the Commission has made a declaration to the minutes of the Environment Council (See Annex I).

3.2. European Parliament amendments at first reading

At the Plenary Session of 24 September 2002, the European Parliament adopted 45 amendments. In total, 31 of these amendments have been incorporated in the Common Position, fully, in part, or in principle (Amendments 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 18, 21, 23, 24, 25, 28, 29, 34, 35, 36, 37, 38, 40, 43, 46, 51, 56, and 59).

The remaining 14 Amendments (Amendments 9, 15, 16, 17, 27, 30, 31, 32, 44, 45, 47, 50, 53 and 60) were not incorporated for reasons of - depending on the case - legal coherence and legislative technique, clarity in technical terminology, practical feasibility or the need to avoid imposing excessive administrative burden on operators and public authorities.

3.2.1. Parliamentary amendments accepted by the Commission in its amended proposal and incorporated in the common position

Amendment 2 recognises the right of citizens to a free choice in regard to GMOs. Incorporated in principle in Recital 4.

Amendments 6, 8, 11, 12, 13, 28, 40, 43 and 56 improve the editorial quality of the Proposal. They have been incorporated, in full or in principle, respectively in the following parts of the of the Common Position: Recital 10, Recital 17, Article 8(1), Article 3(6), Article 3(7), Article 9(1), Article 14(2)(b), Article 15(2)(g) and Article 8(1).

Amendment 10 rewords the exemption for GMOs that are pharmaceuticals for human use. Incorporated in principle in Article 2(2) of the Common Position.

Amendment 14 deletes the definition of "notifier" in Article 3(11) of the Proposal. This amendment has been taken into account in the Common Position with the deletion of Article 3(11) of the original Proposal.

Amendment 18 aims at providing a definition of "transboundary movements". Incorporated in principle in Article 3(14) of the Common Position.

The first part of Amendment 23, which suppresses the reference to the "notifier", has been incorporated in Article 6 of the Common Position. The second part of Amendment 23 was not incorporated.

Amendments 24 and 25 reflect the provisions of Article 21 of the Biosafety Protocol that deals with confidential information. Incorporated in principle in Article 16 of the Common Position.

Amendments 34, 35 and 36 complement the identification requirements of the Proposal. Incorporated in principle under the provisions of Article 12 of the Common Position.

Amendment 37 ensures transposition of article 11(4) of the Biosafety Protocol. Incorporated in principle under the provisions of the new Article 10(1) of the Common Position.

Amendment 46 adjusts the deadlines for monitoring and reporting obligations, in line with Directive 2001/18/EC on the deliberate release into the environment of GMOs [1]. Incorporated in principle in Article 19(1) of the Common Position.

[1] OJ L 106, 17.4.2001, p. 1-39

Amendment 51 excludes GMOs intended for contained use and GMOs in transit from the application of the Advanced Informed Agreement procedure. It has been incorporated in principle under the provisions of Article 11(1) of the Common Position, regarding contained use, and in its Article 13, regarding transit.

3.2.2. Parliamentary amendments accepted by the Commission in its amended proposal and not incorporated in the common position

Amendment 15: The Commission could accept, in principle, to amend the definition of "exporter" contained in the original Proposal, under the condition that it would be replaced by a reference to the relevant provisions of the Community's Customs Code. The Council has preferred to maintain a slightly amended version of the original Commission Proposal. The Commission can support the wording of the Common Position, given its consistency with the Custom's Code.

Amendment 50: The Commission regrets that the Council has not taken on board this amendment, that clearly ruled out re-notification of subsequent movements of a specific GMO that had already been approved in a given country.

3.2.3. Principal divergences between the amended proposal and the Council's Common Position

Amendment 21 deals with the procedure to be followed in cases of non-decision by a Party of Import on a notification of a GMO. The Commission could support the whole amendment, but the fourth sentence. The reason was that imposing the explicit consent of the Party of Import prior to a transboundary movement was going beyond the provisions of the Protocol and was prejudging future international discussions and practices. The Council has not followed the line of the Commission and has decided by unanimity to incorporate, in principle, the whole Amendment 21, which is now to be found in the Article 5 of the Common Position. The Commission has expressed a reservation on this point and has issued a declaration to the minutes of the Environment Council of 17 October 2002 (see Annex I).

Amendment 29 sets up procedures for GMOs intended for direct use as food or feed, or for processing, that does not fully reflect Article 11 of the Biosafety Protocol. More importantly, by limiting Community exports to GMOs that have been approved into the EU for direct use as food or feed, or for processing, it contradicts Article 12 of Regulation 178/2002/EC laying down the general principles and requirements of food law. For these reasons, the Commission was not in a position to accept this amendment. However, the Council has not followed the line of the Commission and has decided by unanimity to incorporate, in principle, Amendment 29, which is now to be found in the Article 10 of the Common Position. The Commission has expressed a reservation on this point at the Environment Council on 17 October 2002.

Amendments 38 and 59 put an obligation on Member States to take appropriate measures to prevent unintentional transboundary movements of living modified organisms. The Commission believes that the concept of unintentional transboundary movements mainly covers cases of accident. This aspect is already adequately covered by Community legislation, namely Directive 2001/18/EC. The Council has not followed the line of the Commission and has decided by unanimity to incorporate amendments 38 and 59 in Article 14(1) of the Common Position. The Commission has issued a declaration to the minutes of the Environment Council (see Annex I).

3.3. New provisions introduced by the Council and the Commission's position

In addition to the above-mentioned changes, The Council has also introduced several other modifications, mainly aiming at reorganising the text in line with the structures of the Protocol. Many of them are fairly minor. The Commission can agree in principle with the modifications listed below, otherwise stated.

Title: modification from "transboundary movement" to "transboundary movements".

Recitals of the Common Position

Recital 1 includes a new reference to the decision made by the Community, on 25 June 2002, to conclude the Cartagena Protocol on Biosafety.

In Recital 3, the reference to an eventual amendment of Directive 2001/18/EC by the upcoming Regulation on the Labelling and Traceability of GMOs has been deleted. This change is in line with Amendment 1 of the European Parliament.

Recital 6 includes a precision on the scope of the notification procedure, which only concerns GMOs intended for deliberate release into the environment.

Recital 7 and 12: simplification of the wording. This includes a suppression of the reference to "notifier", in line with Amendment 4 of the European Parliament.

A new Recital 8 has been added, requiring the express consent of the importing Party or non-Party before the first transboundary movement of a GMO destined for deliberate release into the environment. This is in line with the corresponding Article 5(1) of the Common Position, on which the Commission issued a declaration at the Environment Council (see Annex I). Reservation by the Commission.

A new Recital 9 provides for a political recognition of the importance of capacity building, in line with Amendment 5 of the European Parliament.

Recital 14: deletion of the reference to the Proposal on the labelling and traceability of GMOs, which is replaced by a more general reference to Community legislation containing rules concerning traceability, labelling and identification of GMOs.

A new Recital 15 provides for a political recognition of the importance of the elaboration of international rules and procedures in the field of liability and redress for damages resulting from transboundary movements of GMOs, in line with Amendment 7 of the European Parliament.

A new Recital 16 has been added, providing for a political recognition of the work being currently undertaken at international level on the development of accompanying documentation for GMOs.

Recital 17: addition of a reference to the consultation of affected or potentially affected states in case of an unintentional transboundary movement, in line with the provisions of Article 14(2)(b) of the Common Position.

Recital 18: suppression of the reference to "on a regular basis".

A new Recital 20 introduces an additional reference to the precautionary principle. It incorporates, in principle, Amendment 3 of the European Parliament.

Articles of the Common Position

Article 1 (Objective)

- Introduction of a reference to Directive 2001/18/EC and to the implementation of the Cartagena Protocol in the objective of the Proposal. The Commission considers that the recitals are addressing the legal/political articulation with the Protocol and Directive 2001/18/EC. Operational provisions should ideally only focus on practical objectives of the proposals, with rights and obligations it implies for operators and public administrations;

- Replacement of the term "exports" by "transboundary movements" in the objective of the Proposal and throughout the text. The Commission always expressed preference for definition taken from the Community's Customs Code (i.e. "exports");

Article 2 (Scope)

- Replacement of the term "exports" by "transboundary movements" (see Commission comments under Article 1 above);

Article 3 (Definitions)

- Addition of the term "appropriately" to the use of method of containment for GMOs other than micro-organisms (Article 3(5)(b));

- Deletion of the definition of "product", which was barely used in the Proposal (former Article 3(6) of the original Proposal);

- Clarification of the definition of "notification" by the addition of a reference to the role of the "exporter" and to "non-Parties" (Article 3(8));

- Replacement of the term "product" by "GMO" in the definition of "export" ((Article 3(10));

- Replacement of the term "product" by "GMO" in the definition of "import" ((Article 3(11)) and clarification of the scope (introduction of a GMO into the customs territory of a third country);

- Replacement of the term "product" by "GMO" in the definition of "exporter" (Article 3(12)) and clarification of the role of the exporter with regard to the notification;

- Addition of a new definition of "importer" (Article 3(13));

- Modification of the definitions of "Party" and "non-Party" in Article 3(15) and (16);

- Clarification of the definition of "Competent authority" to take into account the situation of non-Parties (Article 3(19)).

Article 4 (Notification to Parties and non-Parties of Import)

- Suppression of the reference to "national" for competent authorities;

- Introduction of a reference to a "use specified in accordance with Annex I, point (i)" for the GMOs subject to the Advanced Informed Agreement procedure. The Commission considers that intended uses are already included into the notification (Annex I of the Common Position). Therefore, such an addition has limited added value;

- Article 4(2) of the original Proposal has been moved to the new Article 8 ("Exception from Chapter II, section 1").

Article 5 (Cases of non-decision):

- Introduction of an obligation for exporters not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in pursuance of Articles 9 and 10 of the Protocol or where appropriate equivalent procedures required by a non-Party of import have been followed. Reservation from the Commission, which preferred a solution more in line with the wording of Articles 9 and 10 of the Biosafety Protocol;

- Introduction of a reference to simplified procedures and to procedures pursuant to bilateral, regional or multilateral agreements or arrangements;

- Introduction of a reference to upcoming procedures and mechanisms, to be decided upon at international level, to facilitate decision making and promote compliance.

Article 6 (Informing the Party of Export)

- Introduction of a deadline of five years to keep record of information related to a notification;

- Addition of decisions of Parties or non-Parties to the list of documents subject to the provisions of Article 6.

Article 7 (Review of decisions)

- New article based on Article 12 of the Biosafety Protocol.

Article 8 (Exceptions from Chapter II, section 1)

- New Article that regroups the exemptions from the Advanced Informed Agreement previously covered under Articles 2 and 4 of the original Proposal;

- Adds new exemptions for simplified procedures, in accordance with Article 13(1)(b) of the Protocol and for movements of GMOs between Parties to specific bilateral, regional or multilateral agreements or arrangements referred to under Article 14(3) of the Protocol.

Article 9 (Information to the BCH)

- New title more in line with the wording of the Biosafety Protocol: "Information to the BCH" instead of "Notification to the BCH";

- New repartition of responsibilities between Community and national levels for the information to the BCH, based on which level has made the decision subject to the information obligation. From a formal and Community law point of view, issues relating to the authorisation of GMOs are a matter of Community competence. Even though Member States are responsible for initiating the authorisation procedures, they do this within the framework of Community law;

- Limitation of the exemption for decisions regarding field trials to GMOs authorised under Part B of Directive 2001/18/EC, and which are not intended for direct use as food or feed or for processing in a third country without subsequent decision. ). This is a new restriction, which is not foreseen by the Protocol.

Article 10 (Parties' and non-Parties' national decisions on import)

- New Article setting up export procedures for GMOs intended for direct use as food, feed or for processing. Part of this new Article incorporates in principle Amendments 29 and 37 of the European Parliament (see comments under Paragraphs 3.2.3 above - Amendment 29 and 3.2.1 - Amendment 37). Reservation from the Commission, who preferred a solution more in line with Article 11 of the Biosafety Protocol and Article 12 of Regulation 178/2002/EC laying down the general principles and requirements of food law [2].

[2] OJ L 31, 1.2.2002, p. 1-24

Article 11 (GMOs intended for contained use)

- New Article implementing the provisions of Article 6(2) of the Biosafety Protocol. This Article excludes, under certain circumstances GMOs destined for contained use from the application of the Advanced Informed Agreement procedure. It also recognises the right of Parties to regulate the import of GMOs destined for contained use on their territory.

Article 12 (Identification and accompanying documentation)

- Article 12(1), which will apply to all GMOs, is a redrafted version of the original Commission proposal, adapted to the latest developments of the Labelling and Traceability Proposal;

- Article 12(2) applies to GMOs intended for direct use as food, feed or for processing. It implements the provisions of article 18(2)(a) of the Biosafety Protocol. In its last sub-paragraph, it provides for derogation for GMO mixtures, in line with the Biosafety Protocol and without prejudice to existing and upcoming Community legislation relevant to the labelling and traceability of GMOs. This sub-paragraph is the result of a compromise at the Environment Council and has been agreed by the Commission;

- Article 12(3) and (4) respectively implement the provisions of Article 18(2)(b) of the Biosafety Protocol (GMOs for contained use) and 18(2)(c) (GMOs for deliberate release into the environment).

Article 13 (Transit)

- New article that takes on board the provisions of the original Commission proposal (former Article 7 of the original Proposal), but extends the notification obligation, under certain circumstances, to all GMOs (and not just GMOs for deliberate release into the environment).

Article 15 (Participation in the international information procedure)

- New repartition of responsibilities between Community and national levels for the information to the BCH, based on which level has made the decision subject to the information obligation;

- New detailed information obligations for decisions on GMOs pursuant to Part B of Directive 2001/18/EC or risk class 3 or 4 of containment (Article 15(1)(e));

- New information obligation on safeguard measures, according to Article 23 of Directive 2001/18/EC, or emergency measures according to Article 35 of the Proposal for a Regulation on genetically modified food and feed (COM/2001/0425 final) [3], taken by a Member State.

[3] OJ C 304 E, 30.10.2001, p. 221-240

Article 17 (Competent authorities and focal points)

- New possibility for the Commission to identify, where appropriate, any Community competent authority;

- New repartition of responsibilities between the Community and national levels for the designation of competent authorities and focal points.

Article 20 (Entry into force)

- Addition of a new conditions for the entry into force of the Regulation, to take into account the fact that the Community has already deposed its instrument of ratification.

4. CONCLUSION

Despite a consequent improvement of the original Proposal on many aspects, some of the changes introduced by the Council, especially with regard to the questions of explicit consent and of exports of GM commodities, do alter the coherence of the Proposal with other pieces of Community legislation. Furthermore, these changes are also likely to create problem in terms of practical implementation of the Proposal, notably in terms of international trade. The Commission therefore cannot support the Common Position adopted on the 4 March 2003.

5. COMMISSION STATEMENTS

See Annex I.

ANNEX I Declaration from the Commission

The Commission takes note that there is unanimity in the Council concerning the need for Community exporters to have the explicit consent by the Party of import before proceeding with the first intentional transboundary movement of a GMO intended for deliberate release into the environment (Article 5(1)).

The Commission considers that the compromise reached in the Council goes beyond the strict wording of the Cartagena Protocol on Biosafety and may unnecessarily impede exports of such GMOs, which have been given consent for a part B or part C release, from the Community to third countries, by creating an excessive administrative burden not necessarily commensurate with the objectives to be achieved.

The Commission also notes the unanimous support of the Council for the addition of a new Article 14(1) [4] that puts an obligation on Member States to take appropriate measures to prevent unintentional transboundary movements of GMOs. The Commission underlines the inconsistency of such a provision with the risk assessment and management measures foreseen under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Directive 90/219/EEC on the contained use of genetically modified micro-organisms, as last amended by Directive 98/81/EC, given that the safety for human health and the environment of such GMOs that are released into the environment is ensured through these measures.

[4] Reference adapted to the final version of the Common Position