International Regulations

The International Context Relevant To Biosafety

Biotechnology is transforming industry. It is an integral part of the knowledge-based economy and is the main driver for the creation of new types of enterprises and the revitalisation of old industries. The application of genetic modification technologies has widely been recognised to bring immense benefits in terms of efficiency gains, improving environmental performance and reducing health risks in many industrial sectors.

However, there has been a significant public controversy on the benefits and potential risks associated with the technology. The debate was originally confined to the national or regional level, and led to the development of global biosafety guidelines on how to control potential hazards arising from the release of modified organisms [also termed genetic modified organisms (GMO) or living modified organisms (LMO)] and their use in food and feed. UNIDO, together with the United Nations Environment Programme (UNEP), the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) spearheaded the discussions, and in 1991 presented the first Voluntary Code of Conduct for the Release of Organisms into the Environment.

The need for internationally agreed and binding principles regarding the safety assessment in biotechnology eventually led to the adoption of the Cartagena Protocol of the Convention on Biodiversity in 2000. The uptake of the Cartagena Protocol (more than 155 countries have ratified the protocol) has led to the institution of national biosafety regulatory frameworks in over 110 industrialised and developing countries.

Other relevant agreements and conventions include the WTO agreements (SPS, TBT, TRIPS, Article XX of GATT), Codex Alimentarius, etc. A country’s national regulations need to be consistent with all the policy international declarations, organisations, and agreements to which a country is party.

Click on the respective link on the left menu to obtain further information on the main policy declarations, multilateral agreements as well as international standard setting bodies and organisations that have relevance to biotechnology.

(Last revision: 15 June 2010)