Explanatory Memorandum to COM(2002)85 - Transboundary movement of genetically modified organisms - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)85 - Transboundary movement of genetically modified organisms. |
|---|---|
| source | COM(2002)85  |
| date | 18-02-2002 |
On 24 May 2000, the European Community and its Member States signed up to the Cartagena Protocol on Biosafety. Implementing legislation must now be put in place, at the Community level, in order to conclude this international agreement, in accordance with Article 300 of the Treaty. Against this background, the Commission has committed to present a Proposal for an appropriate legal instrument to implement the provisions of the Protocol. In order to meet our international obligations, this should be presented as a matter of urgency and preferably before the end of 2001 since;
* The Protocol will enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification by Parties to the Convention (Article 37.1 of the Protocol) i;
* There exists a strong political will in Member States to be amongst the first Parties to ratify the Protocol, a view supported by the European Parliament;
* The EU has played a leading role in the conclusion of the Protocol and a fast ratification would provide a strong political signal that its commitment to the Protocol is not diminishing.
Contents
The overall objective of the Biosafety Protocol (BP) is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of genetically modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focussing on transboundary movements (Article 1 of the Protocol).
The Protocol especially refers to the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development (Article 1 of the Protocol). The European Union intends to implement the Protocol in its domestic legislation in the light of the precautionary principle, in accordance with the guidelines developed in the Communication from the Commission on the precautionary principle of 2 February 2000 i.
The definition of an LMO under the Protocol is largely consistent with the definition of a Genetically Modified Organism (GMO) under Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms i. The genetic modification techniques applicable to each definition under the two instruments are not the same, however, although this is not likely to impinge on operational aspects of the legislation.
Furthermore, humans are explicitly excluded from the scope of Directive 2001/18/EC but this is not the case for the Protocol although again, this is unlikely to have any operational consequences.
The Protocol differentiates between and establishes different procedures for transboundary movements of (i) LMOs and (ii) LMO-FFPs (LMOs intended for direct use as food or feed, or for processing - GM commodities in EU terminology).
* For LMOs intended for intentional introduction into the environment, the Protocol establishes an Advanced Informed Agreement (AIA - Article 7 of the Protocol), which forms a central part of the procedure concerning transboundary movements. Full notification by the Exporter/Party of Export to the Party of Import is required under this procedure prior to the first transboundary movement. This procedure also requires the Party of Import to perform a risk assessment on the basis of the information provided in the notification and other available scientific evidence in order to identify and evaluate the possible adverse effects of the LMO on the conservation and sustainable use of biological diversity, taking also into account risks to human health. This risk assessment has to be carried out in a scientific sound manner, in accordance with stringent requirements listed in Annex III of the Protocol. The provisions of the Protocol alternatively allow the Party of Import to use procedures under their national legislation provided that they are consistent with the requirements of the Protocol (Arts. 9.2.c and 9.3 of the Protocol).
* For LMO-FFPs, the procedure for transboundary movements is different and is founded on a pre-market product based information sharing system (Article 11 of the Protocol). This places an obligation on Parties granting authorisation for the placing on the market of new LMO-FFPs on their domestic markets to inform all Parties of these approvals through communication with the Biosafety Clearing House (BCH). The relevant information must be communicated within two weeks of the approval of a new LMO-FFP. This provides for the possibility for Parties intending to import such new LMO-FFPs to submit it to an appropriate authorisation procedure, under their national laws. Parties of import can either react to notifications, submitted through the BCH, on a case-by-case basis or take the decision to impose notification of all LMO-FFPs that will be imported on their territory (Article 11.4 of the Protocol).
Article 14 of the Protocol provides for a disconnection clause for bilateral, regional and multilateral agreements and arrangements. This would allow Member States of the European Union, on the proviso that Community legislation is consistent with the objectives of the Protocol and notified to the BCH, to:
* Utilise the provisions of Community legislation, as opposed to those of the Protocol, for transboundary movements of LMOs in the European Union (as provided for by Article 14.3 of the Protocol) and ultimately for movements to and from EEA countries (although the latter requires further discussion with these countries);
* Utilise the provisions of Community legislation, as opposed to those of the Protocol, for imports of LMOs into the European Union, as provided for by Article 14.4 of the Protocol. This provision is further reinforced by Article 9.2c and 11.4 of the Protocol, which allow for Parties to use their national legal frameworks rather than the AIA procedures for importation of LMOs and LMO-FFPs i.
After careful assessment of the Community legal framework relevant to the Cartagena Protocol on Biosafety, the Commission has concluded that EC legislation is consistent with the provisions of the Protocol and will therefore systematically be applied for both movements of GMOs between Member States and imports of GMOs into the European Union.
All relevant EC legislation and procedures will apply for imports of GMOs into the European Union. This will be clearly stated by the EU at the time of the ratification and relevant legislation will be notified to the Biosafety Clearing House, according to Article 20.3(a) of the Protocol. New legislation and amendments to existing legislation will also have to be notified to the Biosafety Clearing House once they enter into force.
In the first instance, it is paramount for reasons of legal clarity that the proposed measure to implement the Protocol clearly differentiates between the roles of the European Union as (i) an Exporter and (ii) an Importer since:
* As a Party of Export, the European Union will have to introduce exporter obligations, which currently do not exist in Community legislation;
* As a Party of Import, the European Union will to a large extent be able to utilise existing Community legislation.
For Exporter obligations, it will be necessary for the European Union to develop new legislation to meet the requirements of the Protocol. It would, however, seem appropriate to limit the provisions of this legislation to the essential requirements of the Protocol given the diversity of the import procedures to which the Exporter/Party of Export will have to conform.
It will be possible, on the other hand, to address Importer obligations under the existing Community legislation. The European Union should, in the main, be able to utilise the Community legislative framework on the basis that it is consistent with the requirements of the Protocol.
In addition, other essentially horizontal issues must be addressed, for example the repartition of responsibilities between the European Union and the Member States, with particular regard to notification obligations.
The Commission has proceeded so far to extensive consultation with interested parties (Member States, Industries, Environmental Organisations, Trade Associations) and it appears that the overall approach is largely agreed by those parties.
Against the above background, it appears that the most appropriate way to implement the Protocol within a reasonable timeframe is via a single, horizontal legal instrument and a Regulation as opposed to a Directive would allow for more rapid implementation. It will also avoid legislative gaps and inconsistencies between different community and national texts and allow for more consistent practical application.
According to preliminary discussions with representative from the industry and the environmental organisations, it appears that costs involved by administrative formalities linked to the implementation of the Biosafety Protocol are negligible. The implementation of the Protocol should not bring additional costs to those already imposed by existing Community legislation.