Export of GMO - Obligations of exporters under Regulation (EC) No 1946/2003

Anyone wishing to send genetically modified organisms (GMO) to countries outside the EU has to comply with a number of things if the GMO are to be released into the environment in the importing country. In the EU, the Cartagena Protocol was transposed into applicable law via EU-Regulation (EC) No. 1946/2003. This regulation also contains the rules for exporters of GMO.
If a GMO originating in the EU is intended to be released into the environment in a country outside the EU, the EU-based exporter has to

• obtain an import permit in the importing country; and
• prepare a specific export notification.

One stumbling block is that Regulation (EC) No. 1946/2003 already requests certain information - on the planned import and the GMO - with an application for import, regardless whether the importing country itself asks for this information or not. It is mandatory for an EU-based applicant, even if the importing country is not a Party to the Cartagena Protocol.

The competent authorities for import permits in the Parties and from other countries can be found in the Biosafety Clearing-House at https://bch.cbd.int/en/countries.

Articlel 4 - Notification to Parties and non-Parties of import

The exporter shall ensure notification, in writing, to the competent authority of the Party or non-Party of import prior to the first intentional transboundary movement of a GMO intended for deliberate release into the environment and destined for the use specified in accordance with Annex I, point (i). The notification shall contain, as a minimum, the information specified in Annex I. The exporter shall ensure the accuracy of the information contained in the notification.

When the import permit has been granted and GMO are to be shipped, the exporter shall inform the competent authority in his EU Member State and the EU Commission about the export. Such an export notification according to Article 6 of Regulation (EC) No. 1946/2003 includes at least a copy of the application documents submitted to the importing country and a copy of the permit.

Article 6 - Informing the Party of export

The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission.

In Germany, the BVL is the competent national authority for these export notifications. If you have any questions about this topic, we will be happy to advise you! Do not hesitate to send an e-mail: gentechnik@bvl.bund.de

However, the Cartagena Protocol does not only apply to the export of GMO that are released into the environment in the importing country. Also, if GMO are intended for contained use, e.g. for further research in the laboratory, or if they are used as food, feed or for direct processing in the importing country, shipments of these GMO require specific information in accompanying documents. The exporter holds responsible for this information. Further information is available on our homepage.

Of course, the regulations of the Cartagena Protocol also apply the other way around for importers. In Germany or the EU, respectively, the legal standards for permits for the import of food or feed and permits for the release of GMO into the environment are in line with the requirements of the Cartagena Protocol. Permits for commercialization (i.e. food, feed and their production in the field) are applied for at the EU level. In Germany, applications for (experimental) field trials of GMO for research purposes and for the placing on the market of organisms that are not used as food or feed are submitted to the BVL.