The European Food Safety Authority (EFSA) published its second batch of opinions on Article 13.1 claims (based on generally accepted scientific evidence) on February 25, 2010. Out of approximately 430 claims evaluated in 31 scientific opinions only eight claims were approved. Approved claims include those concerning Vitamin D, melatonin, guar gum, meal replacements and potassium. Among those rejected are 173 claims concerning antioxidants and 91 claims concerning bacteria and yeasts. Numerous claims related to one particular substance or function were also rejected. The main reason for rejection was lack of conclusive evidence.
The claims evaluation is a task that EFSA carries out under the provisions of the EU Claims Regulation (Regulation (EC) No 1924/2006). It is intended to assist the European Commission in the establishment of the EU list of approved claims. Article 13.1 claims, also known as “functional claims”, are those that are based on generally accepted scientific evidence. The second batch of the opinions raises even less enthusiasm than the first one, published on October 1, 2009, where EFSA backed only half of the evaluated claims. So far mainly claims concerning commonly known vitamins and minerals have, in the view of EFSA, been supported by sufficient scientific evidence to merit approval.
Scope and outcome of the review
The second batch of EFSA opinions contains the assessment of one of the most awaited categories of claims - claims concerning antioxidants. These claims were evaluated in relation to a range of foods and food constituents, including processed fruits and vegetables and juices in general, as well as specific fruits (bananas, acerola, guava, grapefruit etc.), flavonoids from different sources; algae (chlorella, spirulina), spices and herbs (cinnamon, oregano, thyme, rosemary, lemon balm, chamomile), royal jelly, gingko, and a range of botanicals. The claims were grouped by EFSA according to the claimed effect. However, the claimed effect “protects cells from premature aging” was found not to fulfill the criteria laid down in the EU Claims Regulation. As regards the claimed effect “antioxidant activity/content” and/or “antioxidant properties”, EFSA stated that no evidence has been provided to establish that these properties constitute a beneficial physiological effect as required by the EU Claims Regulation.
As for the claimed effects referring to the "protection of body cells and molecules (such as DNA, proteins and lipids) from oxidative damage, including UV-induced oxidative damage", it was found that such protection may amount to a beneficial physiological effect. However, a cause and effect relationship could not be found between the consumption of the foods/food constituents in question and the claimed effect. This was due to the lack of in vivo human studies that would provide evidence supporting the claimed effect. The animal and in vitro studies were not considered as sufficient to predict the occurrence of the claimed effect in humans. As a result, no claims on antioxidants have so far been endorsed by EFSA.
An opinion on 91 claims on different strains of bacteria and yeast followed the tracks of similar opinions published within the first batch. EFSA concluded that no scientific assessment was possible due to the insufficient characterization of the substance subject to the claim.
Another major group of claims was evaluated in relation to various foods and their claimed effect for maintenance of joints, bone, and muscles. However, no claim was approved as the evidence provided was not conclusive. The same applies to the range of other substances and their claimed functions which included inter alia linoleic acid and maintenance of neurological function, dried plum and maintenance of normal bowel function, lutein and the maintenance of vision, carbohydrates and their glycaemic index, and various claims related to ALA, honey and Camellia sinensis (green and black tea).
The 8 claims approved by EFSA within the second batch include the following:
- “Vitamin D contributes to the normal function of the immune system and healthy inflammatory response” and “Vitamin D contributes to the maintenance of normal muscle function”;
- “Melatonin contributes to the alleviation of subjective feelings of jet lag”;
- “Regular consumption of guar gum contributes to the maintenance of normal blood cholesterol levels”;
- “Substituting two daily meals with meal replacements in the context of energy restricted diets helps to lose weight” and “Substituting one daily meal and one snack with meal replacements helps to maintain body weight after weight loss”;
- “Potassium contributes to normal muscular and neurological function” and “Potassium helps maintain normal blood pressure”.
EFSA specifies in its opinions the conditions of use for the approved claims.
EFSA approach and next steps
Despite the fact that Article 13.1 claims should only be subject to EFSA ‘consultation’ and not the subject of an EFSA ‘opinion’, as is the case for Article 14, claims relating to child development and health, and to disease risk reduction, and Article 13.5 claims based on proprietary data, the criteria used continue to be very rigorous. As such, EFSA requires that substances be sufficiently characterized, that human studies be provided as extrapolation of the results on studies in animals is not sufficient, that studies presented be relevant to the claimed effect, and that the wording of the claim reflect the available scientific evidence. Only then, according to EFSA, will a claim comply with the obligation to provide an independent warranty based on the scientific assessment of the highest possible standard.
The next batch of opinions from EFSA is expected in July 2010. Moreover, the scientific evaluation of Article 13.1 health claims is expected to be finalized by the end of 2011. This deadline may, however, not be respected given that the European Commission is preparing an addendum to the list of claims already submitted for assessment.
Regulatory follow-up on the first batch of claims
It is the European Commission, in its role of risk manager, that proposes which claims should finally make their way to the EU list of approved claims within Article 13.1 of the Regulation. The Commission has recently decided that the publication of the EU list of claims will also take place in batches. The draft measure from the Commission proposing the inclusion of the first batch of claims on the EU positive list is expected to be submitted to the Standing Committee on the Food Chain and Animal Health (SCFCAH) at the end of April. Discussions are anticipated on the wording, conditions of use, and claims that should be rejected. Once the draft measure is approved within the Standing Committee (a committee chaired by the Commission and consisting of representatives of EU Member States), it will be submitted to the European Parliament and the Council, which will have three months to scrutinize the proposed regulation. The first batch of formally approved claims may be adopted at the earliest in July, however, given the holiday period, September/October 2010 may be more realistic.
Claims that have not been approved will only be included in the on-line Community Register. Moreover, no legal measure will be taken formalizing their unapproved status. In fact, not all unapproved claims are intended to be placed on a ‘negative’ list. The Commission makes a distinction between claims that may clearly be rejected and the following situations:
- claims for which available evidence is considered insufficient to substantiate them - the Commission is discussing the possibility of giving companies interested in these claims the opportunity to submit additional data. This is particularly in cases where the substance in question was perceived as not sufficiently characterized. The timeframe for this additional submission should be relatively short (three to four months), in order to discourage the continued use of unapproved claims. Eligibility criteria are not known yet;
- claims for which evidence of traditional use has not been taken into account. There is an ongoing discussion within the Commission concerning the overlap of these claims with Traditional Herbal Medicines. No solution has yet been set forth;
- claims for which trials on people suffering ill health have been extrapolated to substantiate the claim. Discussions are ongoing.
Another issue related with the establishment of the EU positive list of health claims is the establishment of nutrient profiles. Article 4 of the EU Claims Regulation provides that only foods compliant with nutrient profile for a defined category of food are permitted to bear claims. The Commission is already delayed in its task of establishing nutrient profiles. They were originally due by January 19, 2009. Commission officials, however, declared on a number of recent occasions that nutrient profiles will be established. The dossier does not currently have any specific timeframe. However, the Commission has indicated a number of basic criteria that it will take into account.
The Commission proposes to establish profiles for a limited number of food categories in order not to complicate the system. The reference nutrients selected are fat, salt, and sugar. The profile will be based on a threshold system per specified quantity of food (100g and 100ml). Nevertheless, it is not clear whether the categories of foods that do not have profiles established will be prohibited from making claims or free to make them. Once established, a transitional period of two years is foreseen to permit the food industry to make necessary adjustments in order to comply with nutrient profiles. The Commission also hopes that this period will be long enough to enable food manufacturers to add all the possible changes resulting from the adoption of the EU list of permitted claims, nutrient profiles, and the expected new labeling provisions (Food Information to Consumers Regulation) to food labels.
The negative scientific assessment of a claim by EFSA does not mean that a product bearing the claim must be withdrawn from the market. Neither does it amount to an automatic inclusion of the claim on a list of rejected claims.
All claims that have not been approved by the Commission must be withdrawn from foodstuffs on the market within six months.