Friday, July 29, 2011

EFSA finalises the assessment of ‘general function’ health claims

Scientists on the European Food Safety Authority’s NDA Panel[1] have reached a major milestone in their work on health claims by publishing evaluations of the last group of ‘general function’ claims[2], excluding those related to botanical substances.

The publication of the final series of 35 evaluations is the culmination of more than three years’ work by EFSA’s experts. Since 2008 the Panel has assessed 2,758 food-related general function health claims to determine whether they were supported by sound scientific evidence, thereby assisting the European Commission and Member States in the establishment of a list of claims authorised for food. These approved claims will enable European consumers to make informed choices about their diet.

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.”

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.

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.

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