Transboundary movement of genetically modified organisms (GMOs). Cartagena Protocol on Biosafety

PURPOSE : to establish a common system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensure coherent implementation of the provisions of the Protocol on behalf of the Community in order to 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 sustainable use of biological diversity, taking also into account risks to human health. LEGISLATIVE ACT : Regulation 1946/2003/EC of the European Parliament and of the Council on transboundary movements of genetically modified organisms. CONTENT : this Regulation is designed to implement part of the Cartagena Protocol on Bio-safety in the Community. While existing Community legislation covers to a large extent imports and trade in GMOs, the proposal is intended to fulfil the requirements under the Protocol on exporters by establishing a common system of notification and information for transboundary movements of GMOs. As regards identification and accompanying documentation, the Regulations states that exporters shall ensure that the following information is stated in a document accompanying the GMO and is transmitted to the importer receiving the GMO: a) that it contains or consists of GMOs; b) the unique identification code(s) assigned to those GMOs if such codes exist. For GMOs intended for direct use as food or feed, or for processing, the information shall be supplemented by a declaration by the exporter: a) stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and b) giving details of the contact point for further information. Concerning the issue of confidentiality, the Commission and the Member States shall not divulge to third parties any confidential information received or exchanged under this Regulation. The Commission shall designate a Community focal point and shall, where appropriate, identify any Community competent authority. Each Member State shall designate one focal point, as well as one or more competent authorities. A single entity may fulfil the functions of both focal point and competent authority. On the issue of penalties, the Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measure necessary to ensure that they are implemented. The Member States shall notify those provisions to the Commission, by not later than 5 November 2004 and shall notify it without delay of any subsequent amendment affecting them. At regular intervals and at least every three years, unless otherwise determined under Article 33 of the Protocol, Member States shall forward to the Commission a report on the implementation of this Regulation. The Commission shall, at intervals to be determined by the Conference of the Parties to the Convention serving as the meeting of the Parties to the Protocol, compile a report on the basis of the information provided by the Member States and present it to the Conferenceof the Parties to the Convention serving as the meeting of the Parties to the Protocol. As existing Community legislation, and in particular Directive 2001/18/EC and sectoral legislation providing for a specific risk assessment to be carried out in accordance with the principles set out in that Directive, already contain rules which are in line with the objective of the Protocol, there is no need to adopt supplementary provisions with regard to imports of GMOs into the Community. ENTRY INTO FORCE : 25 November 2003. This Regulation shall apply from the date of entry into force of the Protocol, or from the date of entry into force of this Regulation, which ever shall be the latest.�