In Article 19(3) the Parties are called upon to consider the need for and modalities of a protocol for the safe transfer, handling and use of LMOs resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity (see Examples 3 and 4).

Taking into account the provisions above, the Conference of the Parties to the Convention on Biological Diversity decided, at its second meeting, to develop a protocol on biosafety, specifically focusing on transboundary movement of LMOs that may have adverse effects on the conservation and sustainable use of biological diversity taking into account human health.

As a preliminary tool to serve as interim guidance for biosafety, a set of International Technical Guidelines for Safety in Biotechnology was drafted by UNEP and adopted by the Global Consultation of Government-designated Experts in Cairo, Egypt in December 1995.

In 1996, the Conference of the Parties for the Convention on Biological Diversity established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft protocol. This Working Group met six times between 1996 and 1999 and, at the conclusion of its last meeting, a draft protocol was submitted for consideration by the Conference of the Parties at an extraordinary meeting in February 1999, in Cartagena, Colombia. The Conference of the Parties was not able to finalize its work in Cartagena. As a result, the Conference of the Parties suspended its first extraordinary meeting and agreed to reconvene as soon as possible.

The Conference of the Parties reconvened and adopted the Cartagena Protocol on Biosafety on 29 January 2000 in Montreal, Canada. The Protocol entered into force on 11 September 2003 upon ratification by the fiftieth Party. As of September 2011, 161 Parties had acceded/ratified the Protocol.