Working Principles of Risk Analysis and the Use of Precaution

Background Paper:
Working Principles of Risk Analysis and the Use of Precaution
Issue: The science base of Codex was challenged in 2000, when the EC proposed to modify the
Draft Working Principles of Risk Analysis, being considered within the Codex Committee on
General Principles (CCGP), to provide for the use of the “Precautionary Principle” when
“relevant scientific evidence is insufficient.” The EC had recently released an official
Communication from the Commission on the Precautionary Principle and sought international
endorsement through Codex. The “Precautionary Principle” was subsequently adopted into EC
Many national delegations, immediately objected that the “Precautionary Principle” was not
defined and could be used as rationale for a technical barrier to trade. An international debate
was launched in a multitude of international forums.
Ultimately, Codex adopted the Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarius in 2003 and the Working Principles for Risk Analysis for
Food Safety for Application by Governments in 2007. The first text clarifies that the
Commission and its subsidiary bodies are the risk managers in Codex and the FAO/WHO expert
bodies are the risk assessors in the framework of Codex. Both texts recognize Precaution as “an
inherent element of risk analysis” but do not codify the “Principle.”
The report of the 22nd session of the Codex Alimentarius Commission in 1997 adopted risk
analysis definitions to be included in the Procedural Manual and considered a strategy and action
plan put forward by the Executive Committee for the development and application of risk
analysis principles and guidelines in Codex activities. Also considered were recommendations
of the WHO/FAO Expert Consultation to provide assistance to developing countries on the
application of risk management. The Codex Committee on General Principles was requested to
elaborate “integrated principles for risk management and risk assessment policy setting, risk
communication and documentation.”
The report of the 15th session of the CCGP in 2000 reflect significant agreement over many
aspects of risk analysis but an extended debate over the application of precaution, the
precautionary principle or a precautionary approach. The Latin American nations led a strong
chorus of opposition to the precautionary approach noting that it originated in discussions related
to environment and was not appropriate to food safety or to Codex. Eventually the compromise
language was reached and subsequently, several additional texts on risk analysis have been
developed for use by specific subsidiary bodies of the Commission.
August 2012
Industry Role: The food industry was also actively engaged in this debate and argued that
Codex standards are based on scientific principles and, where appropriate, other legitimate
factors relevant to health protection and fair trade and that the “Principle” did not qualify. (The
criteria for other legitimate factors were adopted in 2001.) The industry argued that if the
“precautionary principle” were to be adopted by Codex, it would invite the use of nonscientific
issues to overrule science on product safety and would be employed as an unjustified technical
barrier to trade. The industry agreed that precaution was inherent in the risk analysis process.
August 2012