The General Principles of EU Food Law: Risk Analysis

© 2004-2005 William Charteris
www.billcharteris.com
www.imperialconsulting.net

With the adoption of REG 178/2002, the General Principles of Food Law (Articles 5 to 10) entered into force on February 21, 2002. Existing food law principles and procedures must be adapted by January 1, 2007 to comply with the general framework established by the regulation.

Together with national laws, REG 178/2002 establishes the rights of consumers to safe food and to accurate and honest information. Its seeks to ensure a high level of protection of human life and health, while taking into account the protection of animal health and welfare, plant health, and the environment. In addition, it establishes in EU law that the three inter-related components (assessment, management, and communication ) of risk analysis provide the basis for food law in relation to the measure under consideration. Moreover, it establishes a framework for the greater involvement of stakeholders at all stages in the development of food law and establishes the mechanisms necessary to increase consumer confidence in food law.

‘Risk’ is generally understood to describe the probability that some undesirable event may occur. It is sometimes used to describe the combination of that probability (e.g. frequent, likely, occasional, seldom, and unlikely) and the corresponding consequence of the event (e.g. catastrophic, critical, moderate, and negligible). Risk is a dominant feature of our society. In modern life, we are exposed to a broad range of possible hazards, the assessment and management of which are complex, costly, plagued by uncertainty, and often controversial. Risk analysis is necessarily a snapshot of the information available at the time that a particular decision is made. The level of treatment depends on both the importance of the risk and the costs of the mitigation measures.

‘Risk assessment’ is the process of evaluation of the likelihood and severity (and attendant uncertainties) of an adverse effect/event occurring following exposure to a hazard. It comprises hazard identification, characterization, exposure assessment, and risk characterization. A major risk assessment (e.g. dioxin, lead, etc.) can be very costly and require multidisciplinary scientific expertise and vast amounts of data to produce a quantitative expression of risk that can be used as a basis for making clear risk management decisions despite the uncertainty.

In European food law practice, the risk assessment process is mandated by REG 178/2002, with EFSA being charged with promoting and coordinating the development of uniform risk assessment methodologies, but its procedures and methodologies are not standardized. Rather, it is subject to various national and international guidelines which dynamically seek to harmonize the approach taken by various bodies in the face of scientific advances and thereby achieve a consistently high standard of risk assessment and risk communication going forward.

Risk assessment is constrained by the available scientific evidence and associated uncertainties with the result that the ‘Precautionary Principle’ and ‘science policy’ also play a very important role in risk management decisions. Recognizing the pervasiveness of scientific uncertainty, the European Commission has issued a communication on the Precautionary Principle. In it, the Commission considers the application of the Precautionary Principle to be part of risk management, when scientific uncertainty precludes a full assessment of the risk and when decision-makers consider that the chosen level of environmental protection or of human, animal, and plant health may be in jeopardy.

This abstract is taken from a paper entitled 'Uncertainty and risk', which was published on December 20, 2004. The paper comprises 3,900 words and 25 references. Individual copies of the paper may be requested by e-mail from the author.