The European Food Safety Authority was established in 2002 in the wake of a number of serious food incidents in the EU, including BSE in the UK. For the last eight years EFSA’s remit has been to provide independent scientific advice and communication on emerging and existing risks.
Although it supports the Commission, Parliament and national food bodies, it involved in risk assessment and not risk management. This means it does not have a direct input into policy making. Transparency forms an important part of founding regulation.
EFSA also has an increasingly industry-facing role, as EFSA is carrying out the evaluations of health claims under the new regulation, and is re-assessing the safety data on food additives, with a view to establishing a positive list.
To support this work, the authority has issued a new guidance document on transparency in the scientific aspects of risk assessment, and is calling for comments over the next 2 months.
The guidance requested by EFSA from its scientific committee, and sets out relevant information to be included in EFSA’s opinions to ensure that the assessments carried out by the committee and panels are transparent.
It is part of a larger framework of good risk assessment practices. In 2006, EFSA published a document on the procedural aspects of risk assessment.
Key elements
The draft guidance document gives a set of general principles including data sources, criteria for the inclusion or exclusion of data, confidentiality, and how to deal with uncertainties and assumptions.
Some of the core points are:
- The rationale for any decision to include or exclude certain data, and a view of the strengths and limitations of the data set that us used.
- Setting out the assumptions that are used in the risk assessment. This could include, for example, extrapolating data from animal to human models;
- Identifying any limitations or uncertainties that come about as a result of limited data;
- How the risk assessment may vary according to population groups or species;
- How to deal with different outcomes compared with other scientific assessments, such as potentially contradictory data and diverging views with other expert bodies.
The draft guidance document is available here.