Scientific issues related to Codex Alimentarius goals: a review of principles, with examples.

The Codex Alimentarius provides the food standards and guidelines recognized by the World Trade Organization as the primary authority for use in settlement of related trade disputes. Codex bases its decisions primarily on scientific principles and evidence, although other legitimate factors such as economic and societal values may be considered. Codex has two primary aims: to protect consumers' health and assure fair practices in food trade. Codex documents may provide templates for individual nations but are not binding for domestic policies. Despite many advances over the last couple of decades, misunderstandings and controversies have interfered with important aspects of progress which Codex needs to accomplish, especially in the areas of claims of benefits related to food or nutrient consumption and the establishment of the safety of these items. Claims for health benefits should be based on the totality of available scientific evidence, including observational data collected from large populations as well as the results from randomized clinical trials. Safety should be evaluated by risk assessment on high quality experimental data, with anecdotal information having a lesser role. Regulatory policy would be improved if "history of safe use" were to be better defined and described.