1999 Protocol on Biosafety

1999 Protocol on Biosafety


The Cartagena Protocol on Biosafety is an international treaty that seeks to protect biological diversity from the potential risks posed by living modified organisms (LMOs) resulting from modern biotechnology. It was adopted in January 2000 and entered into force in September 2003. The objective of the protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling, and use of LMOs resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements. As of January 2014, 132 signatories have ratified or acceded to the protocol. “Living modified organism” is defined in Article 2(4) as “…any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.”

In spite of opposition from environmental and social groups, first articles’ drafts and negotiations continued until the morning hours of 19 January 1999, The Protocol was adopted on 29 January 1999 by consensus. According to the agreed text, in Article 18 “The Parties shall, through their national centers referred to in Article 19, provide facilities for access to genetic resources and for scientific exchange of biomaterials by researchers from the Parties concerned”.

The Protocol was signed on 11 June 1999 (Brasilia – DF) by 66 countries with the largest biodiversity in the world. Then Mexico and the Philippines also signed it in October 1999 with 18 and 15 countries respectively.

The Protocol, which came into force on 11 September 2003, has been ratified by 132 countries; however, Papua New Guinea and The United States of America neither signed nor ratified it.

Although the U.S. does not participate officially in the Protocol, several activities and practices done voluntarily by private companies and institutions within the U.S. follow the basic tenets of the protocol.

The Protocol has been ratified by 132 countries. In some cases, the ratification followed a previous signature on the document:

On 07/04/2017, Ukraine ratified the Cartagena Protocol on biosafety. Previously this treaty has been signed by Ukraine on 09/09/2003 and ratified on 10/07/2014

The Protocol describes the procedures for transboundary movement of LMOs deemed to be “risky.” These are organisms that have or are suspected to have an adverse effect on biological diversity, taking also into account risks to human health. Each Party shall adopt appropriate measures in order to regulate LMOs in accordance with this protocol. The protocol seeks specifically to address the LMOs that are intended for direct use as food or feed, or for processing. The protocol also requires each Party to take appropriate measures regarding these LMOs in order to protect human health, this includes at a minimum an assessment of potential adverse effects on human health, including allergenicity, toxicity, and infectivity, using appropriate scientific methods.

Parties will also establish or maintain lists of LMOs that may be transported between Parties on the basis of written consent. These Lists are open for modifications by request of any Party at any time.