EFSA Publishes Updated Database of Health Claims
As of May 2010, EFSA has published 125 opinions providing scientific advice for more than 900 “general function” health claims on a list of 4,637 claims submitted to EFSA by the European Commission between July 2008 and March 2010.
10 May 2010 --- The European Food Safety Authority (EFSA) has published the updated database of general function claims under Article 13.1 of the Regulation on Nutrition and Health Claims. This database contains the 4.637 health claims submitted to EFSA for evaluation.
“General function” claims under Article 13.1 of the EC Regulation on nutrition and health claims refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioural functions; slimming and weight control, satiety or reduction of available energy from the diet. These claims do not include those related to child development or health or disease risk reduction .
EFSA said that its scientific evaluation will help ensure that claims made on food labelling and advertising regarding nutrition and health are meaningful and accurate, and can thereby help consumers in making healthy diet choices.
As of May 2010, EFSA has published 125 opinions providing scientific advice for more than 900 “general function” health claims on a list of 4,637 claims submitted to EFSA by the European Commission between July 2008 and March 2010.
The updated final list containing the 4,637 claims was published on the website in May 2010. This list was the result of a consolidation process carried out by the Commission, after examining over 44,000 claims supplied by the Member States. Claims have been sent to EFSA by the Commission between July 2008 and March 2010, when EFSA received the latest 452 claims for evaluation.
EFSA expects to complete the evaluation of the general function health claims by the end of 2011.
List of claims submitted to EFSA
The list of claims submitted to EFSA for evaluation can be found both in the Register of Questions and the Access database.
Register of Questions
EFSA’s Register of Questions provides an overview of EFSA’s work on the list of Article 13.1 health claims, including the evaluation status, question number and assessment deadline for each claim. All the correspondence between EFSA and the European Commission can be found at the bottom of the section related to the specific mandate (Mandate number: M-2008-1061).
Access database
The updated consolidated database of Article 13.1 health claims published in May 2010 contains the 4,637 main health claim entries submitted to EFSA for evaluation. Around 10,500 similar health claims / health relationships have been clustered within these main health claim entries. These health claims/relationships describe similar effects of a substance on the body and include the conditions of use and literature that EFSA will have to take into account in its scientific evaluation.
All 4,637 main health claim entries are also available in the Register of Questions.
Compared to the first version of the Access database published in January 2009, the following changes are reflected in the update:
• Misplaced claims. A number of similar health claims which in the previous version were accidentally placed under a wrong main health claim entry have been assigned to the correct one.
• Missing claims. A number of similar health claims indentified by Member States which had not yet been submitted to EFSA when the previous version of the Access database had been published were added.
• Clarifications. Clarification EFSA has received for around 2,000 claims from Member States following a request for further information were included.
How EFSA evaluates claims
Screening of claims
Before embarking on the scientific evaluation of the claims, EFSA screened all the claims received from the Commission in 2008 in order to differentiate between those claims which could already be assessed by the Panel and those for which more information was needed. To this end, in October 2008 EFSA’s scientists agreed to apply six criteria to ensure a thorough and consistent screening of the health claims entries. The outcome of this screening is indicated for each main health claim entry in the Access database.
In January 2009 EFSA sent back to the Commission for further clarification more than 2,000 claims which were vague, not properly described, whose conditions of use had not been spelled out, or whose scope or health relationship were unclear. In November 2009, EFSA received feedback with additional information from the Member States.
Procedures for the evaluation of claims
In the light of the experience gained with the evaluation of Article 13.1 health claims, EFSA briefed Member States and the European Commission on the evaluation status for these claims at a meeting on 6 October 2009. A briefing document prepared by the NDA Unit describes how EFSA has followed consistent procedures for evaluation of Article 13.1 health claims, including the use of uniform scientific criteria for substantiation of claims and for the characterisation of foods. The document (updated on 17th November, 2009) takes into account the discussion at the meeting as well as additional comments received. It describes how the NDA Panel:
• undertakes the assessment of health claims,
• decides whether a claim is substantiated;
• the basis upon which proposes wording for claims;
• the timeline for their evaluation.
This document takes into account also comments received following a public consultation.
EFSA also prepared a report related to technical aspects of the evaluation of Article 13 health claims.
In addition, EFSA has combined the references for around 2,200 health claim entries into consolidated lists of references. Due to their large number, references were published in four parts. This compilation of references includes:
• All references submitted for main healthclaims entries which passed the initial EFSA screening.
• References for those main health claim entry for which an opinion of the NDA Panel has been published after having received further clarification from Member States transmitted to EFSA by the European Commission in November 2009.
EFSA is continuing to compile the references for the remaining claims and the documents will be updated as opinions on Article 13.1health claims are published.
