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The Cartagena Protocol and the Biosafety Clearing-House– GMO worldwide

Biosafety Clearing-House (BCH)

The Federal Office of Consumer Protection and Food Safety (BVL) is the competent national authority to the Cartagena Protocol on Biosafety to the Convention of Biological Diversity (Cartagena Protocol) in Germany. The Cartagena Protocol stipulates that national contact points and other contact points must be designated in each Party, which must maintain contact with the Secretariat of the Biosafety Clearing-House (BCH) whilst executing the tasks associated with the Cartagena Protocol.
Thus, the BVL is responsible for the report of export and the unintentional transboundary movement of GMOs if Germany is affected. Furthermore, BVL provides information relating to genetic engineering in Germany at the BCH Central Portal. The BCH is a key element of the Cartagena Protocol and aims at making information regarding genetic engineering accessible to the Parties and the general public worldwide. This includes, for example, the provisions of GMO legislation applicable in Germany and decisions relating to deliberate releases of GMOs in Germany, including summaries of the risk assessments on which these decisions are based.
The BCH Central Portal is available under; the German BCH Internet presence is available under

The framework of the Cartagena Protocol

The objective of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) is to define consistently high requirements for decisions on the transboundary movement (transport) of GMOs, both worldwide and at the level of public international law. This is to prevent GMOs from damaging biological diversity. Another priority of the Cartagena Protocol relates to the risks for human health posed by GMOs.

GMOs which are intended for use as medicinal products for humans (e.g. vaccines) are excluded from the regulations of the Protocol. GMOs which are already included in other international agreements or for which other international organisations are responsible are also excluded from the regulations.

The following key points are included in the Cartagena Protocol:

  • Establishing the Biosafety Clearing-House (BCH) as a Central Platform
  • Regulations on handling, transporting, packaging and labelling GMOs.
  • Each Party to the Protocol is entitled to make a decision on handling a GMO in its country based on a scientific risk assessment before this organism reaches the target country.
  • Measures to be taken in the event of the unintentional transboundary movement of GMOs. Here, the priority is to ensure that the country affected is informed quickly and comprehensively.
  • Parties to the Protocol 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 obligated to promote and facilitate public awareness on the issue of the safe handling and trading of GMOs.

Background information on the Cartagena Protocol

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) was adopted in Montreal in January 2000 and entered into force on 11 September 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 enable the sustainable use and the equitable sharing of resources derived from the exploitation of biological diversity. The contribution made by 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 24 May 2000 and deposited the ratification document which formalised its membership at the United Nations in New York on 20 November 2003. The Cartagena Protocol entered into force in Germany 90 days later, on 18 February 2004. There are now 170 Parties (status on 04 April 2016).

With the Cartagena Protocol, compulsory standards for handling GMOs for exportation were defined at the level of international public law for the first time. There have been mandatory genetic engineering regulations in place in the European Union 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 countries outside Europe in the development of their own national regulations.

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

As a national competent authority, the Federal Ministry of Food and Agriculture (BMEL) plays 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 BMELV therefore represents Germany at the regular Conference of the Parties.

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