The Cartagena Protocol on Biosafety

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The Cartagena Protocol on Biosafety is a supplement to the Convention on Biological Diversity. It seeks to regulate the import and export of genetically modified organisms (GMOs). The Protocol was signed 29 January 2000 and entered into force 11 September 2003. It was ratified by 147 Parties.

Purpose and issues

The purpose of the Cartagena Protocol on Biosafety is to protect biodiversity, by seeking to make international trade in genetically modified organisms (GMOs) safer. It was adopted by virtue of Article 19.3 of the Convention on Biological Diversity of 5 June 1992, and applies particularly to transboundary movements, transfer, handling, and use of GMOs.

This Protocol notably aims to address issues arising from biotechnologies. The Preamble recognises two facets of biotechnologies: their potential adverse effects on biological diversity, yet also their great potential for human well-being. The Protocol aims to reconcile trade requirements and environmental protection, and particularly to make it possible for developing countries to deal with risks from GMOs.


The Cartagena Protocol is grounded in the precautionary principle as defined in principle 15 of the Rio Declaration on Environment and Development. To this end, it implements notification and decision procedures.

The decision procedure allows countries to accept or refuse imports of GMOs. Exporting states must notify importing states of the transboundary movement of GMOs. Importing states must then acknowledge receipt of this notification (article 9). Following this notification, article 10 provides for the Party of import to approve or prohibit the import, setting out the reasons on which the decision is based. The Party of import may also request additional relevant information in order to come to its decision. It is worth noting that lack of scientific certainty regarding the extent of the potential adverse effects of a GMO shall not prevent the Party of import from taking a decision. Likewise, this Party may, at any time, in light of new scientific information on potential adverse effects, review and change a decision.

Additionally, the Protocol defined the world’s first shared risk assessment procedure (Annex III). Besides aiding decision-making where there is a lack of scientific knowledge, this assessment helps Parties take measures to prevent adverse effects of GMOs (article 16).

The Cartagena Protocol also provides for several measures allowing for information on GMOs. For example, it led to the creation of Biosafety Clearing-Houses, whose purpose is to gather and make available information on GMOs in order to facilitate decision-making. Handling, transport, packaging, and identification of GMOs are addressed in Article 18, which requires that documentation accompany GMOs during transport. This documentation must clearly identify products that may contain GMOs as well as their intended use. If the GMOs in question are intended for direct use as food or feed, the documentation must indicate that they are not intended for intentional introduction into the environment. If they are destined for contained use, that also must be specified. If they are intended for intentional introduction into the environment, their identity, relevant traits, and requirements for safe handling must be specified. Finally, Article 23 addresses public awareness and participation.

Article 27 provides for the elaboration of rules in the field of liability and redress for damage resulting from GMOs. After several meetings, a working group reached a consensus on propositions made at the 4th MOP held in Bonn, May 2008. Party states accepted the need to implement a legally binding liability and redress regime, and enacted an administrative approach to liability. Victims will henceforth have to appeal to administration for redress. However, the question of burden of proof was not definitively decided upon; a final decision will be taken at the next COP in Nagoya, 2010.

Effects and application

The first effect of the Protocol is its incorporation into regional and/or national legislation. For example, the European Community adopted a European regulation on transboundary movements of genetically modified organisms. However, application of the Protocol is limited in that several countries have neither signed nor ratified it. This is the case for several major exporters of GMOs, such as Argentina, Canada, the United States, or other important international players such as Australia or Russia.

Finally, considerable legal problems arise in the area of coordinating the protocol with other international trade agreements. The Preamble emphasizes that “this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements”. However, the Protocol specifies nothing regarding any potential conflict between it and existing trade rules. Where a country refuses to import GMOs, for example, there is no written statement regarding whether the WTO would be competent to judge a conflict between States.


The Cartagena Protocol uses a typical system of National Reports for monitoring purposes. During the year leading up to each COP, each Party state must prepare a Report detailing the domestic measures it has taken in implementing the Protocol. Only 78 of 147 Party States submitted a National Report to the Secretariat for the first national reports.

As a second means of monitoring, the Protocol sets out a Compliance Committee responsible for monitoring compliance in the legislation of Party States. This Committee is made up of 15 members elected by the Conference of the Parties, representing various regions. It offers advice to Party States whose legislation does not comply with the Protocol, and formulates recommendations for the Conference of the Parties. The main limit of this committee is that it only receives submissions from a Party State (or by the European Community), and not from individual citizens, NGOs, or other international organisations. Its effectiveness is thus limited.

Finally, the Protocol provides for an evaluation of its effectiveness every five years. The particulars of this evaluation are not, however, specified.

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