On 8 April 2011, the European Food Safety Authority (EFSA) published a fourth series of opinions on so-called Article 13.1 health claims, claims that are supposed to be based on generally accepted scientific evidence. Once again, EFSA rejected almost all of the claims. Of the 442 claims assessed in 63 scientific opinions, only 21 claims were found to be sufficiently scientifically substantiated.
Since September 2008, EFSA has been carrying out an evaluation of health claims under the provisions of the EU nutrition and health claims Regulation (Regulation 1924/2006, the "Claims Regulation"). The objective of this exercise is to help the European Commission establish an EU list of permitted health claims referring to general functions of the body. These claims, referred to in Article 13.1 of the Claims Regulation, were supposed to be based on generally accepted scientific evidence. The European Commission submitted to EFSA a list of over 4500 of such proposed claims. However, EFSA has been applying the same rigorous scientific evaluation to Article 13.1 claims as it applies in respect of Article 14 claims (relating to child development and health, and to disease risk reduction) and Article 13.5 claims (based on new science or on proprietary data). As a result, more than 80% of over 2,000 Article 13.1 health claims evaluated to date have been rejected. Most claims within the fourth batch were rejected due to "poor quality of information" provided.
Scope of the 4th batch review
The latest batch of EFSA opinions concerns the evaluation of general health claims in respect of various foods and food constituents. In particular, EFSA looked at the following:
- Various plants and plant products: Almonds; Pine nut oil from Pinus koraiensis Siebold & Zucc; Monomeric flavan-3-ols from apples; Nuts and essential fatty acids (omega-3/omega-6) in nut oil; Camellia sinensis (L.) Kuntze (tea); Maize oil; Coffee; Peanuts; peanut oil and peanut butter manufactured exclusively from roasted peanuts; Olive oil; Walnut
- Probiotics: Lactobacillus johnsonii BFE 6128; Lactobacillus fermentum ME-3; Lactobacillus paracasei LMG P-22043; Lactobacillus plantarum BFE 1685; Bifidobacterium animalis ssp. lactis Bb-12; Bifidobacterium longum BB536; Lactobacillus plantarum 299v; Lactobacillus rhamnosus LB21 NCIMB 40564
- Vitamins and minerals: Phosphorus; Vitamins, minerals and omega-3 fatty acids; Beta carotene; Copper
- Sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose
- Sugar-free chewing gum with carbamide and with fluoride
- Replacement of mixtures of saturated fatty acids (SFAs)in foods or diets with mixtures of MUFAs and/or PUFAs; oleic acid intended to replace SFAs in foods or diets
- Foods with reduced amounts of SFAs
- Resistant starch; Resistant maltodextrin; Sugar beet fibre; Bovine colostrum
- Alpha-linolenic acid (ALA); Gamma linolenic acid (GLA); Rapeseed oil; DHA/EPA
- Meat or fish
- Other substances: Quercetin; Taurine; Lutein; Adenosin triphosphate (ATP); L-lysine; L-tryptophan; Caffeine; L-arginine; Mycoprotein; Epigallocatechin gallate (EGCG) in combination with caffeine; Betaine; Activated charcoal; Galacto-oligosaccharides (GOS); Fructooligosaccharides (FOS) from sucrose; L-carnosine; Choline; Lycopene; Nucleotides; Lutein in combination with zeaxanthin
Outcome of the 4th batch review
The following 21 claims were approved by EFSA as part of the 4th batch of opinions:
- "Consumption of saturated fat increases blood cholesterol concentrations; consumption of foods with reduced amounts of saturated fat may help to maintain normal blood cholesterol concentrations"
- "Replacing digestible starch with resistant starch induces a lower blood glucose rise after a meal"
- "Water contributes to the maintenance of normal physical and cognitive functions"
- "Water contributes to the maintenance of normal thermoregulation"
- "Frequent consumption of sugars contributes to tooth demineralisation. Consumption of foods/drinks containing instead
of sugar replacer> may help maintain tooth mineralisation by decreasing tooth demineralisation"
- "Consumption of foods/drinks containing of sugar replacer> instead of sugar induces a lower blood glucose rise after meals compared to sugar-containing foods/drinks"
- "Consumption of saturated fat increases blood cholesterol concentrations; consumption of mono- and/or polyunsaturated fat contributes to the maintenance of normal blood cholesterol concentrations"
- "Arginine contributes to the maintenance of normal ammonia clearance"
- "Caffeine helps to increase alertness"
- "Caffeine helps to improve concentration"
- "Sugar-free chewing gum with carbamide neutralises plaque acids more effectively than sugar-free chewing gums without carbamide"
- "Betaine contributes to normal homocysteine metabolism"
- "Activated charcoal contributes to the reduction of excessive intestinal gas accumulation"
- "Consumption of olive oil polyphenols contributes to the protection of blood lipids from oxidative damage"
- "Caffeine contributes to an increase in endurance performance"
- "Caffeine contributes to an increase in endurance capacity"
- "Walnuts contribute to the improvement of endothelium-dependent vasodilation"
- "Meat or fish contributes to the improvement of non-haem iron absorption"
- "Choline contributes to normal lipid metabolism"
- "Choline contributes to the maintenance of normal liver function"
- "Choline contributes to normal homocysteine metabolism"
All other claims submitted were rejected for a number of reasons. The main reason for rejection appears to be the fact that the claim was found to be too general and non-specific and as such did not meet the conditions laid down in the Claims Regulation. This was particularly the case for quercetin and claims related to cardiovascular, mental, kidney and liver health. "Immunity" or "skin" claims related to some of the probiotics were also found to be too general, as were those claims on immunity, mouth and "invigoration of the body" related to Camelia sinensis (tea).
Another frequent objection was the lack of sufficient characterisation of the food constituent that was subject to the claim. This concerned claims referring to, for example, royal jelly, ginseng extract, Carica papaya, "foods low in cholesterol" and various other foods and food constituents. On several occasions, such as for anti-inflammatory properties of olive polyphenols, EFSA found that a claim referred to treatment of a disease and could not, therefore, be made lawfully under the provisions of the Claims Regulation. According to EFSA's press release, claims within the 4th batch were rejected due to "poor quality of information".
Background & Next steps
So far, EFSA has delivered three batches of opinions on "general function" claims which account for more than 1700 of the 4500 claims submitted. The publication of the claims in series, and the intended batch-wise publication of the list of approved claims by the European Commission, were heavily criticised by the food industry. The main concern was the lack of a level-playing field among companies wishing to use claims. Some companies would be able to use EU approved claims, while others would need to wait for final review and approval. In response to this, the European Commission has now decided to abandon the batch-wise approach. To date it has not yet published any Regulation incorporating approved health claims on an EU positive list.
Concerns were also raised by food supplements manufacturers and other companies using botanical ingredients that the evaluation of health claims referring to these ingredients is inconsistent with the treatment of botanicals under the EU rules on Traditional Herbal Medicinal Products (THMP). In light of these concerns, the European Commission asked EFSA to finalise the assessment of claims excluding those referring to botanicals. This means that, with the publication of this 4th batch, around 600 claims remain to be evaluated. This process should be finalised by June 2011. It will be followed by a Commission's proposal for a Regulation establishing the EU list of permitted health claims other than botanicals. The assessment of claims on botanicals will follow at a later stage.
Should EFSA finalise its assessment of the remaining 600 claims other than botanicals by the June deadline, it is expected that the Commission will put forward a proposal for a Regulation establishing the EU positive list of permitted "general function" health claims by the end of 2011. This draft Regulation could be adopted early 2012.
A positive opinion, or approval, by EFSA does not mean that the relevant claim is automatically approved and authorised for use in the EU. Such authorisation needs to be formally granted by means of a Regulation adopted by the European Commission, in cooperation with Member State representatives and following a scrutiny procedure that involves the European Parliament and the Council of the EU. Theoretically, when preparing a proposal for a Regulation, the Commission is not bound by EFSA's opinion. In practice, however, the Commission rarely disagrees with EFSA's scientific assessment.
The Claims Regulation requires claims to be clear and comprehensible for consumers. This is not the case with respect to many of the claims evaluated by EFSA: "Walnuts contribute to the improvement of endothelium-dependent vasodilation" or "Water-soluble tomato concentrate helps maintain normal platelet aggregation" are but a few examples. The question therefore is whether it will be possible to deviate from the wording provided by EFSA in its evaluation.
The rejection of any claims also needs to be formally confirmed by a Commission Regulation. In the latter case, companies using a rejected claim will be able to benefit from a transitional period of 6 months following the entry into force of the Regulation to withdraw the relevant claim from their product.
As regards claims that are rejected, there is no "appeal" procedure available to request EFSA to review its own opinion. However, once the EU list of permitted claims is established, it may be amended on the basis of Article 13.4 of the Claims Regulation. This Article provides that changes to the EU list of authorised claims may be made following the, so called, regulatory procedure with scrutiny. The procedure, as is the case for establishing the list, involves the Commission and a committee of Member State representatives as well as the European Parliament and the Council of the EU. Such amendments may be made on the initiative of the Commission, or following a request from a Member State, in consultation with EFSA. The Article 13.4 procedure may be used to submit additional and better-substantiated evidence with respect to rejected claims in order to complete data that EFSA has previously found to be insufficient. However, the drawbacks of the current procedure will persist as companies will not be seen as individual applicants and, thus, will not have control over the dossier. In addition, the level of scientific review will be equally rigorous.
Article 13.5 of the Claims Regulation may be seen as another remedy for mass rejection of general health claims by EFSA. This Article provides for a possibility to modify the EU list of permitted health claims where new scientific evidence becomes available. It also allows companies to apply for protection of proprietary data and to be individually involved in the procedure.