Amended proposed regulation on the trans-border movement of GMOs

October 21, 2002

Brussels, 18 Oct 2002

Amended proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON THE TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED ORGANISMS
Full Text

[...] 3. COMMISSION OPINION ON THE AMENDMENTS ADOPTED BY THE PARLIAMENT

At the Plenary Session of 24 September 2002, the European Parliament adopted 48 amendments, out of the 60 amendments that were tabled.

The Commission can accept 15 amendments fully, 12 in principle and 2 partly. The Commission cannot accept 19 amendments.

More specifically, the Commission fully agrees to amendments 2, 6, 8, 11, 28, 35, 37, 39, 40, 41, 43, 46, 50, 51 and 56.

The Commission agrees in principle to amendments 10, 12, 13, 14, 15, 18, 23, 24, 25, 26, 34 and 36.

Amendments 21 and 60 can be accepted partly.

The Commission cannot accept amendments 1, 3, 4, 5, 7, 9, 16, 17, , 29, 30, 31, 32, 38, 44, 45, 47, 53 and 59.

[...]

3.3. Amendments not accepted by the Commission

The Commission cannot accept Amendment 1, which deletes in Recital 3 of the Proposal the reference to an eventual amendment of Directive 2001/18/EC by the upcoming Regulation on the Labelling and Traceability of GMOs. The Commission's amended proposal on Labelling and Traceability still mentions an amendment of Directive 2001/18/EC . Therefore, the Commission cannot accept this amendment.

Amendments 3 and 4 raise problems of redaction and of substance:

­ On a linguistic point of view, in both amendments, the modification, in the Swedish text of Recital 6 and 7 of the Proposal, from 'should' to 'shall' (in Swedish) could be seen as inconsistent with the inter-institutional rules on the wording of recitals (Le considérant est formulé dans un langage non-impératif, ne devant pas pouvoir être confondu avec celui du dispositif).

­ On the substance, Amendment 3 adds in Recital 6 a reference to the precautionary principle, which should not be a problem as such, but shall be reflected in all languages, and not just Swedish. The same applies to Amendment 4 where an important question of substance (suppression of the reference to "notifier" and replacement by a single reference to exporter) is introduced in Recital 7 and would need to be reflected in all languages, not just Swedish.

For these reasons, the Commission cannot accept amendments 3 and 4 as they stand now.

Amendments 5 and 47 raise the important issue of capacity building in developing countries, but do not provide for operational mechanisms. The Commission believes that this issue would be better addressed in a more appropriate framework, like for example the European Development Fund. Therefore, these amendments cannot be accepted.

Amendments 7 and 45 raise the issue of environmental liability. The Commission believes that this Proposal is not the right instrument to tackle this issue. This should be addressed in the horizontal instrument on environmental liability currently discussed at Community level and, in parallel, in international negotiations in this field. Therefore, the Commission cannot accept these amendments.

Amendment 9 recognises the need for exporters to respect the importing country's regulatory framework for GMOs. The Commission believes that such an obligation is implicit and that this addition is not necessary. It may also give an "a priori" legitimacy to legislation of third countries, which are not in line with the Biosafety Protocol (i.e. authorisation procedures that do not rely on scientific risks assessment). For these reasons, the Commission cannot accept this amendment.

Amendments 16 and 17 raise drafting problems. "Conclusion" is the appropriate general terminology, even if "ratification" is more used in common language. "Conclusion" allows encompassing different terminology amongst Member States and at international level. Therefore, the Commission cannot accept these amendments.

Amendment imposes on the Commission an obligation to notify to the Biosafety Clearing House, on behalf of the Community, any final decision regarding Community use, including placing on the market, of a GMO that may be subject to transboundary movements for release into the environment. This is not in line with the procedures foreseen in Articles 8, 9, 10 and 12 of the Biosafety Protocol for GMOs for deliberate release and in Article 11 of the same agreement for GMOs to be used as food or feed, or for processing. This risks creating legal uncertainty. Therefore, the Commission cannot accept this amendment.

Amendment 29 raises a fundamental problem. It, first of all, 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. Therefore, the Commission cannot accept this amendment.

Amendment 30 is not in line with the scope of both the Biosafety Protocol and the Labelling and Traceability Proposal, mainly by enlarging the scope of the Proposal to food and feed produced with the aid of GMOs. The Commission insists on maintaining coherence between different pieces of legislation on biotechnology, and therefore cannot accept this amendment.

Amendment 31 on transit of GMOs is not entirely in line with Article 6 (1) of the Biosafety Protocol, notably by confusing transport and transit and not mentioning the role of the Biosafety Clearing House. Article 7 of Commission's Proposal is clearer and more in line with Protocol. For these reasons, the Commission cannot accept amendment 31.

Amendment 32 aims at detailing the obligation to transmit accompanying documentation throughout all the different steps of the transboundary movement of a GMO (notably transit and storage). However, the wording of the amendment is rather cumbersome, and the added value limited since the original provisions already encompass the practical situations the Parliament wishes to cover. Therefore, the Commission cannot accept this amendment and wishes to retain the original wording, which is more clear and general, avoiding potential practical problems and gaps.

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 . Therefore, the Commission cannot accept these amendments.

Amendment 44 puts an obligation on Member States to lay down, after joint consultation, rules on uniform penalties applicable to infringements of the provisions of this Proposal for a Regulation. This aspect is of Member State competence. If there is certainly a need for co-ordination and harmonisation of sanctions is to be encouraged, this goes legally beyond what can be inserted into a Community Regulation. For these reasons, the Commission cannot accept this amendment.

Amendment 53 introduces transit in the scope of the Proposal. The Commission believes that transit is already covered by the notification and information procedures foreseen under its Proposal. For this reason, the Commission cannot accept this amendment. [...]

Brussels, 16.10.2002 COM(2002) 578 final 2002/0046 (COD)

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