Title: Codex Principles and Guidelines for food derived from modern biotechnology

Summary of Provisions:

The Codex Alimentarius is a collection of food standards compiled by the Codex Alimentarius Commission (CAC, also summarised on this site). The CAC recognises the challenges that biotechnology might pose for food safety, and produced its first guidance in this area in 2003. So far it has adopted:

• The Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology,
• The Codex Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms,
• The Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, and
• The Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals

The Principles are designed as "a framework for undertaking risk analysis on the safety and nutritional aspects of foods derived from modern biotechnology" (Point 7). The Principles explain, specific to the particular context, what risk assessment is and describe its potential components - including hazard identification, risk management, risk communication and post-market monitoring. The general guidance provided in the Principles is more specifically applied in the three Guidelines

The Guidelines identify the information that is needed for an effective assessment. They encourage the use of the principle of 'conventional counterpart' in safety assessments so that the assessment will demonstrate whether the effects of the new food on human health differ from those of its closest natural relative. The conventional counterpart will have a history of safe use as a food, and therefore risk assessment is only concerned with new or altered hazards. Where no close match is found, more rigorous safety assessment is recommended. The principle of 'substantial equivalence' is also mentioned as useful in risk assessment but it is not viewed as sufficient in itself.

Particular guidance is given on avoiding the use of certain genes/combinations of genes. For example anti-biotic resistance genes that will be expressed in the end product and genes from known allergenic sources are to be avoided (unless their safety has been proven). It is suggested that attention should also be given to issues such as the effects of nutritional modifications on human health, possible immunological effects and whether the gene can be transmitted to human gut bacteria. There is recognition that new genomic knowledge should make the effects of genetic modifications easier to predict, and also that safety assessments may have to be reviewed in light of future scientific knowledge.

Summary of Development:

The Codex Alimentarius Commission was established by the Food and Agriculture Organisation in 1961. It oversees the development of international food safety standards and guidelines. The Principles and Guidelines on foods derived from modern biotechnology, were the first guidelines adopted by the CAC to deal specifically with the products of modern biotechnology.

Current Status

The Codex Commission has 179 member states plus the European Community.

Precursors

Codex Alimentarius Austriacus, 1897-1911.
Codex Alimentarius Europeaus, 1954-1958.

Principles for the Risk Analysis of Foods Derived from Modern Biotechnology
Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms
Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants
Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals

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Related Summaries on the Genomics Gateway Site:

Codex Alimentarius Commission
World Health Organisation
Food and Agriculture Organisation

Page last updated 26th March 2009.