The Convention on Biological Diversity was created in Nairobi in May 1992 and opened for signature at the United Nations Conference on Environment and Development (UNCED) in Rio de Janeiro on 5 June 1992. The Convention came into force on 29 December 1993. Today, it is the main international instrument for studying biodiversity issues. It takes a comprehensive approach to the conservation of biological diversity, the sustainable use of natural resources and the fair and equitable sharing of benefits arising from the exploitation of genetic resources.

Biosafety is one of the problems addressed by the Convention. This concept relates to the need to protect human health and the environment from the potentially adverse effects of biotechnology-related products. At the same time, modern biotechnology is known to have enormous potential that can promote human well-being by providing solutions to urgent needs in the areas of food, agriculture and health care. The Convention clearly recognizes these two facets of modern biotechnology e. On the one hand, it provides access to technologies, including biotechnology, necessary for the conservation and sustainable use of biological diversity, as well as for the transfer of biological diversity (see for example article 16, paragraph 1 and article 19, paragraphs 1 and 2). On the other hand, articles 8 (g) and 19, paragraph 3, of the Convention aim to establish appropriate procedures to improve the safety of biotechnologies in accordance with the general objective of the Convention, which is to reduce all potential threats to biological diversity, taking also into account risks to human health. Article 8 (g) deals with measures that Parties should take at the national level, while article 19, paragraph 3, indicates the way forward in developing a legally binding international instrument to address the issue of biosafety.

At its second meeting, held in November 1995, the Conference of the Parties to the Convention formed an Ad Hoc Open-ended Working Group on Biosafety in order to develop a draft protocol on biosafety, focusing specifically on the transboundary movement of any living modified organism resulting from biotechnology that could have an adverse effect on the conservation and sustainable use of biological diversity. After several years of negotiations, the Protocol, known as the Cartagena Protocol on Biosafety of the Convention on Biological Diversity, was developed and adopted in Montreal on 29 January 2000 at an extraordinary meeting of the Conference of the Parties. The conclusion of the Biosafety Protocol was welcomed as an important step because it establishes an international regulatory framework to reconcile commercial imperatives and environmental protection in relation to the rapidly growing global biotechnology industry. The Cartagena Protocol also creates a favourable context for the sensible and environmentally friendly use of biotechnologies, thus making it possible to maximize their potential while reducing possible risks to the environment and human health.