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Summaries of EU Legislation

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Exports of genetically modified organisms to non-EU countries

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Exports of genetically modified organisms to non-EU countries

SUMMARY OF:

Regulation (EC) No 1946/2003 – transboundary movement of genetically modified organisms

SUMMARY

WHAT DOES THIS REGULATION DO?

It seeks to implement certain points of the Cartagena Protocol on preventing biotechnological risks. This is because some genetically modified organisms (GMOs) may have adverse effects on the environment and human health.

To ensure an adequate level of protection, it creates a system for notifying and exchanging information on the export of GMOs to non-EU countries.

KEY POINTS

This Regulation distinguishes between GMOs intended for deliberate release into the environment (i.e. field tests, or to cultivate, import or transform GMOs into industrial products) and GMOs intended for food or feed, or for processing.

Exporters of GMOs intended for deliberate release into the environment must notify the competent national authority of the non-EU country importing the GMOs (and notify it again if there is no reply). The notification must contain the information specified in Annex I to this Regulation. The exporter must keep this notification and acknowledgment of receipt for 5 years, plus send copies to the authorities in their EU country and to the European Commission.

The European Commission or the EU country that took the decision must notify the Biosafety Clearing House (BCH) of any decision regarding the use of GMOs intended for food or processing that may be transferred across international borders. The notification must contain the information specified in Annex II to this Regulation. These GMOs may not be moved across boundaries if they have not been authorised within the EU.

If an EU country becomes aware of an unintentional export of potentially dangerous GMOs, it must inform the public, notify the European Commission and consult the affected country to enable them to take the necessary remedial action.

EU countries must submit reports on the application of this Regulation every 3 years.

BACKGROUND

In 2000, the EU and its countries signed the Cartagena Protocol, which is designed to ensure that movements of GMOs (especially between countries) do not pose a risk to the environment or human health.

Since then, in 2011, the EU signed the Nagoya-Kuala Lumpur Supplementary Protocol. This elaborates on the international rules and procedures of the Cartagena Protocol to respond to damage caused by GMOs transferred across international borders.

KEY TERM

* Genetically modified organisms: organisms to which gene therapy has been applied. This can artificially change their genetic makeup, giving them new properties (e.g. a plant’s resistance to drought, insects or disease). Since the long-term impact of GMOs on the environment and human health remain largely unknown, the EU takes the precautionary approach.

ACT

Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movement of genetically modified organisms (OJ L 287, 5.11.2003, pp. 1–10)

RELATED ACTS

Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety (OJ L 201, 31.7.2002, pp. 48–49)

Council Decision 2013/86/EU of 12 February 2013 on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (OJ L 46, 19.2.2013, pp. 1–3)

last update 24.11.2015

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