European Commission - Press release
Food: Commission launches final discussions with Member States on list of health claims
Brussels, 28 November 2011 – Today, in an informal meeting of the Working Group, the European Commission is discussing with the Member States the draft list of permitted health claims to be authorised for use on food. The process for the adoption of this list is entering its final stage after long discussions with the Member States and interested stakeholders. As already announced (IP/11/933), the list now discussed with the Member States contains Article 13 health claims for all substances other than so-called "botanicals". On the latter, the European Commission is still reflecting how they should be best assessed for use on food.
The list tabled for discussion now includes about 240 health claims covering some 500 entries from the consolidated list of claims submitted by Member States. The scientific substantiation of these has been favourably assessed by the European Food Safety Authority (EFSA).
For example, these health claims cover the role of walnuts, protein, vitamins and minerals, fibre, omega 3 fatty acids, and other substances like polyphenols from olive oil, in functions of the body. These include the functioning of the immune system and the heart, keeping cholesterol levels normal, maintaining muscle mass etc. If the scientific assessment concludes that the claimed role in functions of the body is founded such claim can be recommended for approval.
When approved the health claims will ensure a high level of protection for consumers, by facilitating the choice of products for a varied and balanced diet which is a prerequisite for good health. Claims must not mislead consumers: they must be accurate, truthful and substantiated by science.
A number of claims remain on hold1:
Those pending a further assessment by EFSA
Those with a favourable EFSA assessment that remain under consideration before a decision can be taken
The Claims Regulation aims to ensure a high level of protection for consumers, by facilitating the choice of products for a varied and balanced diet which is a prerequisite for good health. Claims must not mislead consumers: they must be accurate, truthful and substantiated by science. They shall be included in a list of permitted health claims to be adopted by the Commission. EFSA (European Food Safety Agency) is the body that assesses the science used to substantiate health claims.
At the beginning of the process, the Member States submitted, in total, to the Commission more than 44,000 health claims. The Commission consolidated these into a list of approximately 4,600. These were assessed by EFSA who published six sets of opinions covering about 2,760 health claims of the approximately 4,600 submitted for scientific advice (1550 claims on "botanicals" are awaiting assessment by EFSA and together with another 500 already assessed are subject to a reflection by the Commission pending finalisation of their consideration for authorisation).
Due to the large number of health claims received and the delay in submissions by stakeholders to Member States, the deadline of 31 January 2010, stipulated in the Health Claims Regulation, for the adoption of a list of permitted health claims could not be met. With the aforementioned review of the adoption process the deadline for EFSA to finalise its evaluation of all claims, other than botanicals, was extended to the end of June 2011.
The European Commission has been discussing the EFSA opinions with Member States and stakeholders as they have been published. It was decided that before authorisation was finalised a further assessment should be made for claims for micro-organisms where the EFSA opinions concluded that they were insufficiently characterised, and for claims for which the evidence was insufficient for EFSA to reach a conclusion about the cause and effect relationship.
Other claims already assessed are on hold for a number of reasons.
Claims for which high levels of intake are required await a safety assessment or further consideration, and
claims for which EFSA has not suggested any or suitable conditions of use also remain under consideration.
For more information, please visit:
Frédéric Vincent (+32 2 298 71 66)
Aikaterini Apostola (+32 2 298 76 24)
Details will be listed on the website of DG Health and Consumers