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The German Biosafety Clearing-House

The Cartagena Protocol

The objective of the Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) is to define uniformly high requirements for the import and export (transboundary movement) of GMOs, both globally and at the level of public international law. The idea behind this is to prevent the use of GMOs from damaging biological diversity. In addition the Cartagena Protocol examines putative risks of GMOs for human health.

The regulations of the Protocol do not apply to GMOs that are used as medicinal products in humans (e.g. vaccines). GMOs which are governed by other international agreements or for which other international organisations are responsible are excluded from the regulations. Up to now there are no such exceptions.

The Cartagena Protocol contains the following key points:

  • Establishing the central platform of the Biosafety Clearing-House (BCH) as a source of information.
  • Regulations on handling, transport, packaging and identification of GMOs.
  • Each Party to the Protocol is entitled to make a decision on handling a GMO in its State based on a scientific risk assessment before this organism reaches the country of import.
  • Measures to be taken in the event of the unintended transboundary movement of GMOs. Here, the priority is to ensure that the State affected is informed quickly and comprehensively.
  • Parties must allow access to information regarding GMOs which may be imported.
  • Support will be provided for Parties with little experience of GMO evaluation and/or limited financial, technical or administrative capabilities in order to establish the capacities needed for the successful implementation of the Cartagena Protocol.
  • The Parties to the Cartagena Protocol are obliged to promote and facilitate public awareness on the issue of the safe handling and trading of GMOs.

In the EU the Cartagena Protocol is implemented into valid law by Commission Regulation (EC) No 1946/2003.

Background information on the Cartagena Protocol

The Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) was adopted in Montreal in January 2000 and entered into force on September 11, 2003. It is an agreement which ensues from the Convention on Biological Diversity (CBD), which was signed in Rio in 1992. The objective of the CBD is to preserve biological diversity and to enable the sustainable use and equitable sharing of resources gained through the exploitation of biological diversity. The contribution of biological safety to the protection of biodiversity was considered to be of such great importance, that it was given its own protocol, the Cartagena Protocol.

Germany signed the Cartagena Protocol on May 24, 2000 and deposited the ratification document which formalised its membership at the United Nations in New York on November 20, 2003. The Protocol on Biosafety entered into force in Germany 90 days later, on February 18, 2004. There are now 170 Contracting Parties (status of March 15, 2017).
With the Cartagena Protocol for the first time compulsory standards for handling of GMOs for exportation were defined at the level of international public law. There have been mandatory genetic engineering regulations in place in the European Union (EU) Member States since 1990. The Protocol has not introduced any significant innovations to these. However, the Cartagena Protocol does provide an important foundation for many states outside Europe which are still developing their own national regulations.

The contents of the Protocol are governed in the EU by Commission Regulation (EC) No 1946/2003, which entered into force on November 3, 2003. This regulation is directly applicable in the EU Member States, i.e., it does not require transposition into national legislation.

As a competent national authority, the Federal Ministry of Food and Agriculture (BMEL) has an important role in the Cartagena Protocol alongside the BVL. In particular, it carries out political tasks and is the national focal point for Germany. The BMEL therefore represents Germany at the regular Conferences of the Parties.

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