Transboundary Movements of GMOs
The EU is Party to the Cartagena Protocol on Biosafety and has implemented it through Regulation 1946/2003 on transboundary movements of GMOs.'20 The Regulation, which is based on an article corresponding to the current Article 192(1) TFEU, also provides for additional protective measures compared to the Protocol. Particularly significant in this regard is that the Regulation applies to shipments of GMOs from the EU to any other State, whereas the Protocol only applies to shipments between parties.'1
When drafting the Regulation it was not perceived as necessary to include provisions on import of GMOs into the Union, since existing EU legislation already provides for relevant risk assessment procedures in such cases.''
'о  OJ L 287/1.
The objectives of the Regulation are, somewhat simplified, to establish a common system of notification and information for transboundary movements of GMOs and to ensure coherent implementation of the provisions of the Cartagena Protocol. It applies to the transboundary movements of all GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account risks to human health. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from its scope.23 (Arts 1 and 2.)
Before any first intentional transboundary movement of a GMO intended for deliberate release into the environment, the exporter must ensure notification, in writing, to the competent authority of the country of import. No first intentional transboundary movement may be made without the prior written express consent of that country. However, this does not apply to cases of transboundary movements covered by simplified procedures or bilateral, regional, and multilateral agreements or arrangements entered into in accordance with Articles 13 or 14 of the Cartagena Protocol.  (Arts 4 and 5.)
These requirements also do not apply to transboundary movements of GMOs intended for contained use where such transboundary movements are undertaken in accordance with the standards of the State of import (Art 11).
GMOs that may be subject to transboundary movements for direct use as food or feed or for processing (FFP) are subject to a distinct procedure based on the so-called Biosafety Clearing-House (BCH) established by the Cartagena Protocol. The Commission on behalf of the EU or, where appropriate, the Member State which made the decision shall inform the BCH and other Parties through the BCH of any final decision regarding use, including placing on the market, within the EU or use within a Member State, of a GMO that may be subject to transboundary movements for direct use as FFP. This does not apply to decisions regarding the deliberate release in accordance with Part B of Directive 2001/18/EC of a GMO which is not intended for direct use as FFP in a third country without a subsequent decision.
Exporters must respect any decision on import taken under a regulatory framework that is consistent with the objective of the Protocol.
Developing States and those with an economy in transition may instead choose to apply a special procedure set out in Article 14 of the Cartagena Protocol. In such case the exporter may not proceed with the first export unless the procedure provided for under that provision has been followed. No GMO that may be subject to transboundary movements for direct use as FFP may be exported, unless it is authorised within the EU or the competent authority of a third country has expressly agreed to the import as required under Article 12 of
Regulation (EC) No 178/2002 laying down the general principles and requirements of food law.25
Exporters shall ensure that certain information, including that the shipment contains or consists of GMOs, is stated in a document accompanying the GMO and is transmitted to the importer.
Member States must take appropriate measures to prevent unintentional transboundary movements of GMOs (Arts 12 and 14).