EFSA's Scientific Committee proposes harmonisation of risk assessment methodology

The Scientific Committee of the European Food Safety Authority (EFSA) proposes, in its opinion published today, a harmonised and transparent scientific approach for the risk assessment of substances which have both genotoxic and carcinogenic properties. The Scientific Committee undertook this work through EFSA’s self-tasking procedure. Following a review of the methods currently utilised and a period of public consultation, the Scientific Committee recommends using the “margin of exposure” (MOE) approach in assessing risks associated with substances which are both genotoxic and carcinogenic. By providing an estimate of risk specific to individual substances in this category this methodology can be utilised to differentiate between different levels of risk. It can therefore assist risk managers in deciding if and where further actions are required in order to reduce exposure to such genotoxic and carcinogenic substances. Whilst EFSA has already consulted on the scientific methodology proposed, the European Commission intends to initiate dialogue with stakeholders in future regarding the possible application of the MOE approach in managing risks associated with such substances where found in food and feed.

For substances which are both genotoxic (damaging DNA, the genetic material of the cells) and carcinogenic (leading to cancer), it is generally assumed that even a small dose may have a potential adverse effect. In general, the advice given by risk assessors up until now in Europe has been to keep exposure to such compounds at the lowest possible level. But this approach, known as the ALARA principle (“as low as reasonably achievable”) does not allow one to distinguish between different levels of risk. Scientists who advise on the levels of risks associated with these substances use different methods world-wide and the estimate of risk is critically dependent on which model is used.

In its opinion the Scientific Committee recommends utilising the “margin of exposure” (MOE) as a harmonised approach for assessing the risks posed by substances which are both genotoxic and carcinogenic. The advantage of this methodology is that it allows the comparison of risks posed by these substances based on their individual potency and on possible levels of exposure in the population. The MOE approach can therefore better support risk managers in defining possible actions required to keep exposure to such sustances as low as possible.

The Scientific Committee recommends that the MOE approach be utilised to assess the possible risks associated with genotoxic and carcinogenic substances found in food and feed, irrespective of their origin. It can be applied to substances occuring naturally in foods, environmental contaminants or to those resulting from food preparation or manufacturing processes. The Scientific Committee is of the opinion that, in principle, substances which are both genotoxic and carcinogenic should not be deliberately added to food and feed at any point in the food chain

In order to pursue dialogue in the scientific community and familiarise regulatory risk assessors with the proposed risk assessment approach both within and outside the EU, EFSA is organising an international conference in collaboration with the World Heath Organisation (WHO) and with the support of the International Life Sciences Institute (ILSI Europe) on 16-18 November 2005 in Brussels.

Whilst EFSA has undertaken a scientific consultation on the proposed methodology, the European Commission intends to initiate dialogue and organise consultations with stakeholders in future concerning possible applications of the MOE risk assessment outcomes in risk management.

Notes to editors

Substances which have both genotoxic and carcinogenic properties have the potential of interacting directly with the genetic material (DNA) found in cells and inducing cancer.

The harmonised approach for the risk assessment of substances with both genotoxic and carcinogenic properties, outlined in the opinion of the Scientific Committee, is based on calculating margins of exposure (MoE) by comparing best estimates of human exposure with effect levels observed in animal bioassays. A high MOE means lower risk for consumers.

EFSA made available for public comments from April to June 2005 a draft opinion of the Scientific Committee proposing a harmonised methodology for the risk assessment of substances which are both genotoxic and carcinogenic. EFSA received comments from national authorities of EU Member States, research institutes and stakeholders as well as from EFSA’s own Scientific Panels. Whilst the approach as such was unanimously welcomed and agreed, comments were made relative to improving and clarifying certain aspects of the opinion.

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