"Safe and wholesome"
The rules that govern international trade are those that were agreed during the Uruguay Round of Trade Negotiations and apply to Members of the World Trade Organization (WTO). With respect to food safety matters, those rules are set out in the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement). The overall objective of the SPS Agreement is to permit countries to take legitimate measures to protect the life and health of their consumers (in relation to food safety matters), while prohibiting them from using those measures in a way that unjustifiably restricts trade. Thus the primary goal of the SPS Agreement is to limit the use of any measures that may restrict trade to those that are justified to provide the necessary level of health protection. It recognises the right of Members to protect their consumers at a level they consider necessary, subject to certain disciplines, such as consistency and transparency.
The standards, guidelines, and other recommendations of the Codex Alimentarius Commission are considered by the WTO to reflect international consensus regarding the requirements for protecting human health from foodborne risks. A Member's food safety measures are considered justified and in accordance with the provisions of the SPS Agreement if they are based on Codex standards and related texts. While the adoption and application of Codex standards remains technically non-mandatory, failure to apply Codex standards creates the potential for dispute if a Member applies standards that are more restrictive of trade than necessary to achieve required levels of protection.
Consideration of risk analysis will play a vital role in the future work of the WTO. The SPS Agreement requires "Members [to] ensure that their SPS measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organisations". Members are expected to justify levels of protection higher than those in Codex standards by using risk assessment techniques. They are required to ensure that risk management decisions are transparent, and not arbitrary or unjustifiably different (i.e. are consistent). Furthermore, where different measures have equivalent outputs, the measure chosen should be the one that is the least restrictive of trade.
Although industry and national regulators strive for production and processing systems which ensure that all food be "safe and wholesome", complete freedom from risks is an unattainable goal. Safety and wholesomeness are related to a level of risk that society regards as reasonable in the context, and in comparison with other risks in everyday life.
A Codex standard is the minimum standard for a food elaborated by CAC "so as to ensure a sound, wholesome product free from adulteration, correctly labelled and presented" (3). The word "minimum" does not have any pejorative connotations and simply means the level of quality and soundness of a product judged by consensus to be appropriate for trade internationally and nationally.
A review of current Codex standards and related texts suggests that in many cases there is insufficient quantitative information to translate requirements for "safety and wholesomeness" into a definitive quantitative assessment of the risks to human health in consumer populations. The inevitable default to more qualitative assessments of "safe and wholesome" is likely to be challenged as a basis for international trade restrictions, especially in an increasingly risk-based international trade environment.
The development of Codex-wide principles and strategies for risk management requires that explicit attention be given to the concept of "safe and wholesome". Although Codex standards and related texts are generally aimed at the reduction of risks in food, these risks can rarely be quantified and any balancing of the risk reduction against other factors, such as costs and benefits of risk reduction, is normally a matter of judgement.
