European Health Claims List Promised by the End of 2011 After EFSA Finalizes Article 13 Assessments
The Commission welcomed the publication of the sixth set covering 35 health claims on food products (also known as "Article 13 claims"). This publication marks the conclusion of EFSA's assessment which started in October 2009.
Jul 29 2011 --- The European Commission will present by the end of the year a list of permitted health claims on food products for all substances other than the so-called "botanicals," after the European Food Safety Authority (EFSA) published today a sixth and final set of opinions on the matter.
The Commission welcomed the publication of the sixth set covering 35 health claims on food products (also known as "Article 13 claims"). This publication marks the conclusion of EFSA's assessment which started in October 2009 (IP/10/1176).
"Ensuring accurate and reliable information on food labels is key to help consumers make healthier choices and strengthen their empowerment," Health and Consumer Policy Commissioner John Dalli said. "The assessment process, conducted by EFSA so far, is a vital step towards the implementation of the health claims Regulation and I thank EFSA for its valuable input to this difficult and challenging task that has no precedent anywhere else in the world." he added. "Now our priority is to adopt, as soon as possible, the list of permitted Article 13 claims," Commissioner Dalli concluded.
The Commission has already started preliminary work with Member States and aims to present the final measure before the end of the year.
Once the list of permitted health claims is adopted and fully operational, EU consumers will be assured that all health claims on the EU market are substantiated by science and are not misleading. This will help consumers choose a healthier diet. The list's adoption will also facilitate the work of enforcement authorities in ensuring compliance with the Regulation and will guarantee fair competition among operators.
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. To do this, claims must not mislead consumers: they must be accurate, truthful, substantiated by science and adopted onto a list of permitted health claims. 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. The six sets of opinions published by EFSA cover about 2,760 health claims of the approximately 4,600 submitted for scientific advice (1550 claims on "botanicals" have been place on hold by the Commission).
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.
Professor Albert Flynn, Chair of EFSA’s NDA Panel, said: “This very challenging task was completed thanks to the dedication and commitment of the experts on the NDA Panel in collaboration with EFSA staff, who have had to cope with an unprecedented and unforeseen workload, coupled with very tight deadlines and often poor information.”
“Despite these challenges our experts have assessed the claims consistently and fairly to the highest possible scientific standards. All this was achieved within the deadline agreed with the Commission.”
“EFSA’s independent evaluation concluded that a considerable number of claims made on foods are backed by sound science, including claims related to a wide range of health benefits.”
According to EFSA, the outcomes of evaluations were favourable when there was sufficient evidence to support the claims. This was the case in about one in five claims, which related mainly to:
• vitamins and minerals;
• specific dietary fibres related to blood glucose control, blood cholesterol, or weight management;
• live yoghurt cultures and lactose digestion;
• antioxidant effects of polyphenols in olive oil;
• walnuts and improved function of blood vessels;
• meal replacement and weight control;
• fatty acids and function of the heart;
• the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralisation or lowering the increase of blood glucose levels after meals;
• carbohydrate-electrolyte drinks/creatine and sports performance.
Experts issued unfavourable opinions in cases where the information provided did not allow a relationship between the food and the claimed effect to be established. Reasons included:
• lack of information to identify the substance on which the claim is based (for example, claims on “probiotics”, or on “dietary fibre” without specifying the particular fibre);
• lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (for example, food with “antioxidant properties” and claims on renal “water elimination”);
• lack of precision regarding the health claim being made (for example, claims referring to terms such as “energy” and “vitality”, or claims on women’s health or mental energy);
• lack of human studies with reliable measures of the claimed health benefit;
• claims referring to food categories which were considered to be too broad, such as “fruits and vegetables” and “dairy products” to be linked to specific effects.
The assessment of general function claims has drawn strong criticism from industry throughout, with a trend of about 80% of claims being turned down and 20% upheld (mainly for vitamins and minerals).
In carrying out this work EFSA has adopted a phased approach due to the large number of claims received and the requirement for EFSA to publish opinions soon after adoption to ensure transparency. EFSA also combined similar claims (for example, by substance and/or benefit) to facilitate the risk assessment process and ensure a consistent approach.
Catherine Geslain-Lanéelle, EFSA’s Executive Director, said: “EFSA’s work on general function health claims has highlighted the importance of constructive dialogue between risk assessors, scientists, decision-makers and stakeholders and has contributed to our thinking on the future shape of our organisation. As a result, EFSA plans to launch an applications help desk to facilitate dialogue with applicants.”
“By ensuring that there is a shared understanding of the scientific evidence required, the work we have undertaken will, we trust, support the work of industry by helping to establish future directions for research and innovation.”
The NDA Panel will continue to assess health claims, such as those submitted by individual applicants concerning claims based on children’s development or health. Following a meeting with stakeholders last year, EFSA has finalised a guidance document for health claims related to gut and immune function and has launched on-line consultations on guidance for health claims related to: bone, joint and oral health; oxidative damage and cardiovascular health; and satiety, weight management and blood glucose concentrations.
Out of the 4,637 claims submitted to EFSA by the European Commission between July 2008 and March 2010, the European Commission asked EFSA to evaluate 2,758 claims by June 2011, 331 claims were withdrawn and 1,548 claims on “botanicals” have been placed on hold by the Commission pending further consideration on how to proceed with these.
Timeline of publications of EFSA’s evaluations in this area:
• 1st October 2009, 521 health claims addressed in 94 opinions
• 25th February 2010, 416 health claims covered in 31 opinions
• 19th October 2010, 808 health claims, addressed in 75 opinions
• 8th April 2011, 442 health claims, addressed in 63 opinions
• 30th June 2011, 536 health claims, addressed in 73 opinions
• 28th July 2011, 35 health claims addressed in 5 opinions
EFSA is liaising with the European Commission and Member States regarding the re-submission of a limited number of ‘general function’ health claims, such as those relating to microorganisms which were considered by the Panel to be insufficiently characterised or claims for which the evidence provided during the initial submission was not sufficient to establish a cause and effect relationship. EFSA expects to receive the claims for reassessment from the European Commission before the end of 2011 and the precise timetable for the further assessment will be drawn up once the re-submission process has been completed.
