On 12 June 2013, the European Commission proceeded to adopt six new general function health claims and published an amendment to Regulation (EU) No 432/2012 establishing the EU list of permitted health claims made on foods. The addition of six new general function health claims follows the completion of EFSA evaluations which, at the time of adoption of Regulation (EU) No 432/2012, were not yet finalised. The European Commission and Member States also agreed on the future adoption of a Regulation approving a claim on carbohydrates, a Regulation approving 2 health claims based on newly developed scientific evidence as well as a Regulation rejecting various health claims based on newly developed scientific evidence.

Background

As from 14 December 2012, 222 so-called "general function health claims" are permitted to be made on foods according to Regulation (EU) No 432/2012. [See our earlier update of 31 May 2013]. The list of health claims and their conditions of use are the outcome of a long and controversial claims assessment process by EFSA (the European Food Safety Authority) and subsequent approval process by the European Commission and Member State representatives.

Both the approved and rejected claims are included in an on-line register on the European Commission website. Claims that have not yet been evaluated may continue to be made subject to the general transition periods that are laid down in Regulation (EC) No 1924/2006.

Commission Regulation (EU) No 536/2013 expands the list of permitted health claims with the inclusion of six new health claims. The Regulation will apply as of from 2 January 2014 (see the following links for different language versions: EN, FR, DE, ES, PL).

Newly permitted health claims

The six new health claims relate to the health benefits of DHA and EPA, dried prunes and fructose as follows:

  • Alpha-cyclodextrin as part of a starch-containing meal contributes to the reduction of the blood glucose rise after that meal;
  • DHA contributes to the maintenance of normal blood triglyceride levels;
  • DHA and EPA contribute to the maintenance of normal blood pressure;
  • DHA and EPA contribute to the maintenance of normal blood triglyceride levels;
  • Dried plums/prunes contribute to normal bowel function;
  • Consumption of foods containing fructose leads to a lower blood glucose rise compared to foods containing sucrose or glucose.

The Regulation also lays down the conditions of use for these claims. For instance, claims relating to DHA and EPA long-chain omega-3 fatty acids cannot be used on or for products aimed at children. Any use of these claims that does not comply with the Regulation will be banned EU wide from 2 January 2014.

It is important to note that the new Commission Regulation (EU) No 536/2013 adopting these claims constitutes an amendment to Regulation (EU) No 432/2012, which implies that the provisions of Regulation (EU) No 432/2012 apply equally to the new health claims, including for example, Recital 9 concerning the flexibility that may be allowed in terms of the wording of the claim.

In addition, the status of the claims 'on hold' remains unchanged. The claims on hold include, for example, claims on ‘botanicals’, claims relating to caffeine, very low calorie diets and foods with reduced lactose content. These claims may still be used provided that they comply with the general principles and transitional requirements of Regulation (EC) No 1924/2006 and relevant national law. The list of these specific claims is also available on the website of the EU health claims register referred to above.

Other developments on health claims

In addition to the adoption of the six new general function health claims referred to above, the European Commission and the EU Member State experts represented in the Standing Committee on Food Chain and Animal Health (SCFCAH) meeting of June 12 also made progress on the evaluation of other claims whose scientific assessment has been finalised by EFSA. These include claims referred to under Regulation (EC) No 1924/2006 as Article 13(1) claims (or 'general function claims') and Article 13(5) claims (based on newly developed scientific evidence or with a request for the protection of proprietary data).

For example, the SCFCAH approved the inclusion of one new general function health claim on carbohydrates and the maintenance of normal brain function in the list of permitted health claims. The health claim is authorised under the condition that it is used only for foods containing mainly complex carbohydrates and which are either low in sugars or contain sugars naturally.

The Standing Committee also approved the inclusion on the list of permitted health claims of two claims based on newly developed scientific evidence with a request for the protection of the proprietary data (Article 13(5)). These health claims concern:

  • reformulated non-alcoholic drink; and
  • slowly digestible starch.

In parallel, SCFCAH decided to refuse the authorisation of 17 other health claims submitted under Article 13(5).

The Regulations approved by SCFCAH still need to be scrutinised by the European Parliament and the Council before they are published in the Official Journal of the European Union. More details on the deliberation of SCFCAH are available in the summary report of its meeting that was published on 1 July 2013.

Business Impact

Food business operators that market foods containing substances subject to the new general function health claims should carefully review product formulation and labels, as well as any off-label promotional material, to ensure that only permitted claims are made in accordance with the applicable conditions laid down for each claim. This also applies to food business operators that wish to use the newly approved general function health claims as an additional promotional tool for their products. The new claims may be made as of from 2 January 2014, thus providing food business operators with six months to adapt their labels and commercial communication.

As regards the claims referring to reformulated non-alcoholic drinks and slowly digestible starch, the applicants received a 5-year protection period for the proprietary data which was the basis for submission. Once the protection period expires the claims will remain on the list of permitted health claims.

The irregular and piecemeal approach to establishing the list of approved and rejected health claims results in difficulties for the industry to adopt a general strategy to prepare for any possible revision of their labels or communication. Nevertheless, the number of claims on the positive list is rising, therefore gradually expanding the choice of functional substances in foodstuffs. At the same time, Member State competent authorities are still in the process of organising enforcement of these new rules with certain countries having adopted guidance documents including on the flexibility permitted around the wording of the various claims. It therefore remains important to stay "tuned" to national approaches throughout the EU.