EFSA launches public consultation on a harmonised risk assessment approach proposed by its Scientific Committee
The Scientific Committee (SC) of the European Food Safety Authority (EFSA) proposes, in its draft opinion published today, a harmonised and transparent scientific approach for the risk assessment of substances which have both genotoxic and carcinogenic properties. Initiated by the Committee through EFSA’s self-tasking process, the resulting draft opinion has now been released for public consultation. EFSA and its Scientific Committee invite members of the scientific community and all interested parties to submit their comments through the EFSA website by 30 May 2005.
It is generally assumed for substances considered to be both genotoxic (i.e. which can harm DNA, the genetic material of cells) and carcinogenic, that there is no dose without a potential effect. In theory, there will therefore always be a risk associated with exposure even at the lowest level. Several approaches are currently in use to assess the risk of these substances within the European Union and world-wide. The scientific basis for these approaches is very much debated with the result that risk assessors tend to advise risk managers to keep exposure to such compounds as low as possible. Consequently, in many countries and notably the EU, risk assessors often advise risk managers to keep exposure to such compounds as low as possible. However, such advice does not provide risk managers with a reliable basis for setting priorities for action, notably in light of the increasing number of substances which may be detected in the future as analytical methodologies continue to improve.
In order to address these needs, the Scientific Committee has developed a harmonised, scientific and transparent approach for the risk assessment of compounds that have both genotoxic and carcinogenic properties. All interested parties are invited to submit their comments by 30 May 2005 in view of the finalisation of this opinion.
According to EFSA’s founding regulation, requests for scientific opinions can be made to the European Food Safety Authority by the European Commission, the European Parliament and Member States. The Authority can also initiate its own work through “self-tasking.”
The harmonised approach for the risk assessment of substances with 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 in animal bioassays.