CAC/GL 44-2003 Principles for the Risk Analysis of Foods Derived from Modern Biotechnology
SECTION 1 - INTRODUCTION
1. For many foods, the level of food safety generally accepted by the society reflects the history of their safe consumption by humans. It is recognised that in many cases the knowledge required to manage the risks associated with foods has been acquired in the course of their long history of use. Foods are generally considered safe, provided that care is taken during development, primary production, processing, storage, handling and preparation.
2. The hazards associated with foods are subjected to the risk analysis process of the Codex Alimentarius Commission to assess potential risks and, if necessary, to develop approaches to manage these risks. The conduct of risk analysis is guided by general decisions of the Codex Alimentarius Commission1 as well as the Codex Working Principles for Risk Analysis2.
3. While risk analysis has been used over a long period of time to address chemical hazards (e.g. residues of pesticides, contaminants, food additives and processing aids), and it is being increasingly used to address microbiological hazards and nutritional factors, the principles were not elaborated specifically for whole foods.
4. The risk analysis approach can, in general terms, be applied to foods including foods derived from modern biotechnology. However, it is recognised that this approach must be modified when applied to a whole food rather than to a discrete hazard that may be present in food.
5. The principles presented in this document should be read in conjunction with the Codex Working Principles for Risk Analysis to which these principles are supplemental.
6. Where appropriate, the results of a risk assessment undertaken by other regulatory authorities may be used to assist in the risk analysis and avoid duplication of work.
