Draft statement of the Council's reasons: Common position for a Regulation on transboundary movements of genetically modified organisms

February 24, 2003

Brussels, 21 Feb 2003

Full text of Document 15546/02

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III. ANALYSIS OF THE COMMON POSITION

1. General

In 2002 it was decided, after consultation of the European Parliament, to conclude the Protocol on behalf of the European Community. The Protocol will enter into force when 50 Parties have deposited the necessary instrument.

Against this background this proposal, which is based on Article 175(1) of the EC Treaty, is mainly concerned with the establishment of a common system of notification and information for transboundary movements of GMOs to third countries and with unintentional transboundary movements, which is needed in order to ensure implementation of the provisions of the Cartagena Protocol relating to those issues. Other provisions of the Protocol fall under other Community legislation.

In general, the Council has agreed upon an approach where the Protocol is followed closely. Within that context, there nevertheless are concrete formulations, which follow EU practice where this has been seen as legally or politically necessary, eg. the term "living modified organisms" used in the Protocol is not used, since the EU internal terminology "genetically modified organism" is understood to be an equivalent term and is the generally applicable term within the EU.

The Council finds it relevant to consider the relationship to possible non-Parties under the Regulation, since not all countries interested in the substance matter regulated under the Protocol nor all signatories to the Protocol will necessarily be Parties to the Protocol at the time of its entry into force. The Council has agreed, on the basis of the context of the various articles and paragraphs, upon those parts of the Regulation which should also relate to non-Parties.

The Commission has not accepted the common position agreed by the Council.

2. European Parliament Amendments

In its Plenary vote on 24 September 2002, the EP adopted 45 amendments to the proposal.

(a) 33 of these have been incorporated (25 to the Articles and 8 to the recitals), either verbatim, in part or in spirit, into the Council's common position:

Amendment 1 is reflected in recital 3.

Amendment 2 is reflected in recital 4.

Amendment 3 is reflected in recital 20 setting out the general importance of the precautionary principle for this Regulation.

Amendment 4, 14 and 23, first part, are reflected in recital 7, Article 3 and Article 6 respectively. These amendments relate to the term "notifier", which would not be precise and practical and has therefore, throughout the text, been replaced with the concrete economic operator in question, primarily the "exporter".

Amendment 5 is reflected in recital 9 recognising the importance of capacities, which are relevant for a number of general purposes and also for making the informed decisions necessary under the Cartagena Protocol. The Council finds that the Commission and Member States should generally make sustained efforts to enable the relevant countries to further develop their human resources and institutional capacities. It is not considered appropriate to set out obligations regarding the general issue of capacity building in a specific regulation such as this. Amendment 47 aims at introducing such obligations in the operative text of this concrete regulation and was therefore not accepted.

Amendment 6, 8, 11 together with 56, 12, 13 and 43 are of an editorial nature and they have been introduced into the text in the most appropriate way with their editorial purpose in mind. These amendments are reflected, respectively, in recital 10, 17, Article 2(3) (which is deleted) together with Article 8(1), Article 3, point 6, Article 3, point 7 and Article 15(2)(g).

Amendment 7 is reflected in recital 15 (see also amendment 45 below).

Amendment 10 is reflected in Article 2(2), but in a wording somewhat closer to the Protocol.

Amendment 18 concerns the issue of a precise definition of "transboundary movement" and is as such reflected in Article 3, point 14.

Amendment 21 and 60 cover some of the same points. Amendment 21 covers four elements and amendment 60 covers four elements. The first and second elements of

amendment 21 ("... communicate its decision ..." and "in calculating the time ...") are reflected in Article 5(2) of the common position. The third and fourth elements of

amendment 21 ("A failure by the Party ..." and "No export may ...") and the second element of amendment 60 (" ... shall take place without ...") are reflected in Article 5(1).

The first element of amendment 60 ("directly or indirectly") has not been accepted, since it is a new concept departing from the terminology otherwise applied. The third element of amendment 60 is of an editorial nature, but was not seen as improving the text. The fourth element of amendment 60 ("exporter") was accepted in line with amendment 4, 14 and 23 as set out above.

Amendment 24 and 25 are reflected in Article 16, which follows the Protocol's provisions regarding confidential and non-confidential information.

Amendment 28 is reflected in Article 9(1).

Amendment 29 covers a number of elements, which are reflected in Article 10 of the common position with some modifications in the formulation bringing the text closer to the Protocol. In addition, the requirement regarding authorisation within the Community has been supplemented by the option that the competent authority of a third country has expressly agreed to the import in question.

Amendment 34, 35 and 36 are reflected in Article 12(4).

Amendment 37 is reflected in Article 10(1).

Amendment 38 and 59 are reflected in Article 14(1).

Amendment 40 is reflected in Article 14(2)(b), with the addition of the word "significant".

Amendment 46 is reflected in Article 19(1).

Amendment 50 and 51 contain three elements. The third element ("intended for contained use or for transit") is reflected in Article 11(1) together with Article 13 of the common position.

(b) 12 amendments have not been incorporated and another 4 have only been partially incorporated. These 16 can be grouped as follows:

Amendment 9 seems to aim at the somewhat diffuse concept of "facilitation" and at respect for any element of importing country's regulatory framework. The Council finds that these elements could give rise to a number of problems of interpretation and has decided to focus on respect for the concrete decision by the Party or non-Party of Import (see amendment 21 and 60 together with Article 5(1) of the common position)

Amendment 15 is close to the text of the Protocol, but is not accepted, since the Council has agreed to follow the principle of keeping the text close to the Community's Custom Code in order to avoid special wording on this point in this concrete Regulation.

Amendment 16 and 17 are of an editorial nature and suggest to use the term "ratified" rather than the broader "concluded", which formally encompasses a.o. ratification and approval, and which has been generally used by the Community. The Council does not find it appropriate to use "ratified" on an ad hoc basis.

Amendment 23, second part, is not accepted. This concerns an obligation for the Commission to make notifications by exporters to Parties or non-Parties of Import publicly available, but the Commission does not possess those notifications.

Amendment is not accepted, since the Council finds that such an additional notification to the BCH is not necessary in the light of the obligations under the Protocol. The Council finds it relevant to point out that provisions regarding the relevant information to the BCH are set out in Article 15(1)(e) and Article 15(2)(c).

Amendment 30 is not accepted, since it addresses special cases of notification of items which do not contain GMOs or GMOs intended for contained use, which is not necessary having regard to the obligations under the Protocol. Moreover, this amendment seems to address issues of compliance by an exporter with the possible legislation of a Party or non-Party of Import, where such compliance could be expected to be inherently req uired, if the legislation in question has been correctly adopted and is consistent with the Protocol.

Amendment 31 and 53 are not accepted as such, since these amendments seem to address issues of compliance by an exporter with the possible legislation of a Party or non-Party of transit. Such compliance could be expected to be inherently required, if the legislation in question has been correctly adopted and is consistent with the Protocol. The Council finds it relevant to point out that Article 13 of the common position covers notification of transit of GMOs in a formulation closely following the Protocol.

Amendment 32 is not accepted, since the main additional wording contained in this amendment addresses transit and periods of storage interrupting transit, and these are not considered to be particular situations, which should be addressed with exceptional attention, as compared with other steps during the transboundary movement of a GMO.

Amendment 44 is not accepted, since it goes beyond the general conditions applying to the establishment of national penalties.

Amendment 45 is not accepted, since it does not constitute an operational legal provision. The Council finds it relevant to point out that the Community and Member States do already support the process in question, which is set out in recital 15 thus also reflecting amendment 7.

Amendment 47 is not accepted, since it aims at introducing obligations regarding the general issue of capacity building in a specific regulation such as this. The Council finds that the Commission and Member States should generally make sustained efforts to enable the relevant countries to further develop their human resources and institutional capacities, whereas it is not considered appropriate to set out obligations on this general issue in this concrete regulation. Amendment 5 aims introducing a recital with regard to the general issue and is accepted by the Council (see above).

Amendment 50 and 51 contain three elements. The first and second element ("for which approval for deliberate release has been provided by that country") are not accepted, since they could bring about a conflict with the general principle in Article 4 of the common position formulated as "... shall ensure notification ... prior to the first intentional transboundary movement ..." regardless of any already existing approval by the Party of Import. Furthermore, the amendment does not qualify the approval in question, whereas the common position has added "the use specified in accordance with Annex I, point (i)".

Amendment 60 has, in part, not been accepted as stated above under amendment 21. The first element of amendment 60 ("directly or indirectly") has not been accepted, since it is a new concept departing from the terminology otherwise applied. The third element of amendment 60 is of an editorial nature, but was not seen as improving the text. The fourth element of amendment 60 ("exporter") was accepted in line with amendment 4, 14 and 23 as set out above.

IV. CONCLUSION

The Council considers that its common position takes account of the Opinion of the European Parliament at first reading to a large extent. The Council's common position represents a balanced solution with the combined aim of ensuring that the Community and its Member States can live up to their obligations under the Protocol by establishing a regime for transboundary movements of GMOs taking into account of the important principles of proportionality and precaution as well as respect for the concrete decisions by possible importing countries.

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