More than 20 years ago, the global community set out to agree on requirements for the safe handling and use of genetic engineering. In Cartagena, Colombia, the international agreement with the unwieldy name Cartagena Protocol on Biosafety to the Convention of Biological Diversity was negotiated and adopted. In 2000, Germany was among the first countries to sign the protocol. It became legally binding on 11 September 2003, when it was ratified by 50 states. On 11 September 2023, the Cartagena Protocol turned 20 years old. It now has 173 Parties and is the most important biosafety instrument at the global level.
The Cartagena Protocol is an agreement under international law at the UN level and is part of the Convention on Biological Diversity. The Convention aims to conserve biodiversity and ensure its sustainable and equitable use. In doing so, it gives high priority to biosafety. With the Cartagena Protocol, an international framework has been set up, which
- defines requirements for the handling, transport, packaging and labelling of genetically modified organisms (GMO),
- mandates the contracting parties to decide in advance, on the basis of scientifically sound risk assessments, whether a GMO may be imported and how it should be handled, and
- defines measures to be taken in the event of an unintentional import/export.
The Cartagena Protocol thus contributes significantly to ensuring that no risks to biodiversity arise from the transport, handling and use of GMO.
Meetings of the Parties to the Protocol further foster its implementation. They take place every other year (except during the Covid pandemic) in conjunction with the regular meetings of the COP to the Convention. Here, the Parties discuss together and with an equal voice. The next meeting, COP MOP 11, will take place from 21 October to 1 November 2024 in Colombia.
In Germany, the Cartagena Protocol is implemented through the Cartagena Protocol Act and via EU Regulation (EC) No. 1946/2003 which applies directly. In Germany and the EU Member States, the Protocol has not brought any significant innovations in the handling of GMO. Binding genetic engineering regulations in line with the Protocol had already been in place since 1990. But for many countries outside Europe, the Cartagena Protocol forms an important basis for their national rules.
The Biosafety Clearing-House
An information platform provides data on genetic engineering worldwide
Export of genetically modified organisms
Obligations of exporters according to Regulation (EC) No. 1946/2003
Frequently asked questions and answers about the Cartagena Protocol
What does the Cartagena Protocol have to do with biodiversity conservation?
The Cartagena Protocol is a follow-up agreement to the Convention on Biological Diversity (CBD). The Convention aims to conserve biodiversity in the long term. In doing so, it aims to enable sustainable use in which opportunities and benefits accrue equally to all groups involved. To address risks to biodiversity that could arise from the use of genetic engineering, the Cartagena Protocol was agreed.
How are Regulation (EC) No. 1946/2003 and the Cartagena Protocol interlinked?
Regulation (EC) No. 1946/2003 transposes the Cartagena Protocol into EU law. The Regulation entered into force on November 3, 2003 and is directly applicable in EU Member States.
What is the Biosafety Clearing-House?
The Biosafety Clearing-House (BCH) is the central database on the Cartagena Protocol.
All information on the Parties, their GMO regulations and GMO is pooled here. The BCH can be found at https://bch.cbd.int.
What do I need to be aware of when exporting GMO?
A shipment of GMO to non-EU countries is always also subject to the legal requirements of the importing country. In addition, it requires specific accompanying documents containing information on the GMO. Furthermore, if the GMO are to be released into the environment in the importing country, a permit must be obtained prior to export according to the national regulations. Subsequently, an export notification must be submitted by the exporter in accordance with Regulation (EC) No. 1946/2003.
What is the Conference of the Parties?
The countries that are Party to the Cartagena Protocol meet every two years to discuss the contents of the Protocol. At the Conferences of the Parties (COP MOP), concrete measures to implement the Protocol are agreed upon.
What do I do if I have questions about the Cartagena Protocol?
Contact us! As the national competent authority on the Cartagena Protocol, we are happy to advise you. Get in touch with us: gentechnik@bvl.bund.de.