EHPM Urges Commission to Conduct Detailed Analysis into Negative EFSA Claims Opinions

EFSA published its final batch of article 13.1 claims opinions at the end of July, which are now being considered by the European Commission as it develops a draft Union List of claims permitted for use in the EU.

Nov 4 2011 --- Food supplement trade association EHPM has urged the European Commission not to automatically consider claims that have received negative opinions from the European Food Safety Authority (EFSA) as rejected.

In a letter to the European Commission last month EHPM said that a number of article 13.1 claims dossiers that have received unfavourable EFSA opinions have not been because a cause and effect was not established, but because the information provided didn’t meet the expectations of the EFSA, for example the substance not being well characterised or there being insufficient data.

The trade association said that some claims also received unfavourable opinions because they were not within the scope of the Nutrition and Health Claims Regulation, adding that these should be authorised under the provision of Article 10.3 of the regulation allowing reference to general and non specific benefits if it is accompanied by a specific authorised health claim.

EFSA published its final batch of article 13.1 claims opinions at the end of July, which are now being considered by the European Commission as it develops a draft Union List of claims permitted for use in the EU.

“Claims given negative EFSA opinions should not automatically be considered as rejected,” said EHPM Director of European Policy Cynthia Rousselot. “It is important to remember that no guidelines were available from EFSA as to how much scientific evidence was needed or regarding its method for dossier evaluation until well after the deadline for submission.”

“Many of the unfavourable opinions are the result of failures in the procedures, namely a lack of clarity on a number of important issues,” she continued. “The first opportunity that the sector had to discuss EFSA’s assessment of the article 13 claims came three years after the claims were submitted and after EFSA had already delivered opinions on 936 claims. We are very concerned about the large number of claims that have received negative opinions and have throughout the process called for further evaluation regarding EFSA’s assessment criteria, which we believe is not appropriate for food research.”

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).

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 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.

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