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General Information
Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants (CAC/GL 45-2003)
Codex Alimentarius Commission
Organization(s) involved in the publication of this resource
Codex Alimentarius Commission
  • English
Summary, abstract or table of contents
This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. It addresses safety and nutritional aspects of foods consisting of, or derived from, plants that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits.

This document does not address animal feed or animals fed with the feed. This document also does not address environmental risks.

The Codex principles of risk analysis, particularly those for risk assessment, are primarily intended to apply to discrete chemical entities such as food additives and pesticide residues, or a specific chemical or microbial contaminant that have identifiable hazards and risks; they are not intended to apply to whole foods as such. Indeed, few foods have been assessed scientifically in a manner that would fully characterise all risks associated with the food. Further, many foods contain substances that would likely be found harmful if subjected to conventional approaches to safety testing. Thus, a more focused approach is required where the safety of a whole food is being considered.

This approach is based on the principle that the safety of foods derived from new plant varieties, including recombinant-DNA plants, is assessed relative to the conventional counterpart having a history of safe use, taking into account both intended and unintended effects. Rather than trying to identify every hazard associated with a particular food, the intention is to identify new or altered hazards relative to the conventional counterpart.

This safety assessment approach falls within the risk assessment framework as discussed in Section 3 of the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. If a new or altered hazard, nutritional or other food safety concern is identified by the safety assessment, the risk associated with it would first be assessed to determine its relevance to human health. Following the safety assessment and if necessary further risk assessment, the food would be subjected to risk management considerations in accordance with the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology before it is considered for commercial distribution.

Risk management measures such as post-market monitoring of consumer health effects may assist the risk assessment process. These are discussed in paragraph 20 of the Principles for the Risk Analysis of Foods derived from Modern Biotechnology.

The Guideline describes the recommended approach to making safety assessments of foods derived from recombinant-DNA plants where a conventional counterpart exists, and identifies the data and information that are generally applicable to making such assessments. While this Guideline is designed for foods derived from recombinant-DNA plants, the approach described could, in general, be applied to foods derived from plants that have been altered by other techniques.
Thematic areas
Additional Information
Type of resource
  • Manual / Tutorial / FAQ / Dictionary
  • Report / Review / Fact sheet / Notes
Adobe Acrobat Reader (13 pages)
United Nations Environment Program document: UNEP/CBD/BS/COP-MOP/2/9 ;
Keywords and any other relevant information
LMO categories: Plants