On October 1, 2009, the European Food Safety Authority (EFSA) issued a first batch of opinions on health claims that are based on generally established scientific evidence. The 94 scientific opinions cover more than 500 health claims made on foods. EFSA rejected about half of these claims primarily because of a lack of information. Claims that it supported include those on functions of vitamins (such as A, B6, B12, C and D) and minerals (such as calcium, iron, magnesium and zinc). EFSA also approved claims on omega-3 fatty acids (ALA, DHA and EPA) and their contribution to the maintenance of “normal blood cholesterol concentrations” or “normal blood pressure.”
Under the EU nutrition and health claims Regulation (Regulation (EC) No 1924/2006), EFSA assists the European Commission in the evaluation of those health claims that are based on generally accepted scientific evidence. The aim of this process is to establish a so-called EU “positive” list of permitted health claims. So far, EFSA has received more than 4,000 so-called Article 13 claims for evaluation. These are also known as “functional claims”. Of these claims, 2,000 have been sent back to the European Commission as the related dossiers were not complete and further information was required. The final number of claims placed on the Community list of approved health claims, however, may be much lower than anticipated, as shown by the fact that approximately half of the claims evaluated within the first batch did not receive a positive opinion.
Scope of the review
In its first batch of opinions, EFSA has focused primarily on claims regarding the health benefits of:
- commonly known vitamins and minerals (such as Vitamin A, pantothenic acid, Vitamin B6, Vitamin B12, Vitamin C, Vitamin K, Vitamin D, niacin, biotin, phosphorus, fluoride, magnesium, manganese, selenium, copper, iron, zinc, boron);
- other nutrients (including chondroitin and chondroitin sulphate, sialic acid, hyaluronic acid, inositol, methylsulfonylmethane, linolenic acid, shark cartilage, olive biophenols, beta glucans, soy isoflavones, glucosamine, isomalto-oligosaccharides, taurine, EPA, DHA, DPA, glucomannan silicon, iodine and thyroid, astaxanthin, isoleucine-prolineproline (IPP), glutamine, thiamine, folate, gamma-aminobutyric acid);
- several strains of bacteria claimed to have beneficial digestive effects (for example, Lactobacillus reuteri ATCC 55730, Lactobacillus johnsonii BFE 6128, Lactobacillus casei F19 (LMG P-17806), Bifidobacterium animalis Lafti B94 (CBS118.529)); and
- several plant extracts (e.g., Corylus avellana L., Picea abies (L.) Karsten, Helianthus tuberosus L., Angelica sinensis (Oliv.) Diels,. Hibiscus sabdariffa L.).
EFSA also reviewed a number of product category-specific claims referring, inter alia, to the link between chewing gum and dental health, and fermented dairy products and digestion.
Some observers had predicted that a more lenient approach might be adopted by EFSA in its evaluation of general functional claims compared to its approach in the evaluation of claims related to disease risk reduction and those made in respect of children’s development and health (so-called “Article 14” claims). However, this was not the case. The methodology applied by EFSA in the evaluation of functional claims under Article 13 was equally rigorous.
It transpires that EFSA requires human studies to be carried out, as it finds that studies carried out on animals do not provide sufficient evidence to measure effects in humans. In addition, EFSA finds that where a claim targets the population at large, it should be supported by studies that show effect in the population at large. It would not be sufficient to merely show evidence in respect of a subgroup of the general public that may show certain specific symptoms. In the same way, where a claim targets a specific subgroup of the population, it should be supported by studies that show effect in that specific subgroup.
For EFSA, it is essential to be able to submit studies that pertain to the actual substance that is at the basis of the claim. Improper identification of such a substance, as was the case apparently for a number of submissions on probiotics and botanicals, resulted in many negative opinions. A significant number of claims has also been rejected as a result of the fact that the claimed effect, in many cases, was found to be “not sufficiently defined“(e.g., “ageing”, “immunity”, “gut health”).
The wording of the proposed claims was also subject of EFSA’s evaluation. EFSA believes that the wording used should properly reflect the available scientific evidence. Where this was not the case, EFSA proposed alternative wording.
The EFSA opinions on this first batch of claims primarily impact the food supplements industry, and the dairy and infant formula product sectors.
The publication of the EFSA opinions also raises a controversial issue that has been the subject of much discussion between the European Commission and EFSA. In its original mandate to EFSA, the European Commission was clear in terms of its request to proceed to timely publication by EFSA of the relevant opinions. However, since then, and, no doubt, following pressure from the food industry, it has questioned whether, during this transition period during which all claims are reviewed, there really is “a level playing field” for food business operators. Indeed, it has been argued that the publication of EFSA opinions in regular batches, as opposed to “all in one go” at the end of 2010, may negatively impact on competitiveness in the food sector, as those operators using claims that have now been rejected will be forced to withdraw these claims from the market sooner than those operators whose claims have not yet been the subject of an EFSA assessment. In subsequent discussions with EFSA, the European Commission did not succeed in EFSA changing its approach. The next batch of EFSA opinions is expected to be published towards the end of November 2009.
Next steps and time-lines
Following the publication of these EFSA opinions, the European Commission will put forward a draft Decision either rejecting or accepting the proposed health claim. The Commission has two months to prepare such a draft, i.e. until the beginning of December 2009. It will submit its draft to the Standing Committee on Animal Health and Food Chain (SCFCAH) for approval. The SCFCAH is a committee made up of Member State experts and is chaired by the European Commission. It is expected that the Commission will follow the EFSA scientific opinion, although, strictly speaking, under the legislation, it is not required to do so. As a “risk manager,” the European Commission is entitled to form its own opinion.
Once a proposed Decision is approved at the level of the SCFCAH, the decision-making procedure requires that the proposal is forwarded to the European Parliament and to the Council (of EU Member States) for their input. Following this process, once the Decision is adopted and published, it will enter into force and it will apply equally in all 27 Member States.
Positive claims will be introduced into the so-called positive list of permitted health claims. Rejected claims will be introduced on a public on-line register of rejected claims. There would be six-month period for the companies concerned to remove the relevant claims from the EU market.