On 3 September 2013, the European Commission adopted Regulation (EU) No 851/2013 authorising three general function health claims based on proprietary scientific evidence. The use of the three new claims is thus restricted to the advantage of their respective applicants. So far only one claim, referring to the effect  of Water Soluble Tomato Concentrate on normal platelet aggregation and healthy blood flow, benefited from the restriction of use. The protection period of 5 years has been established to foster innovation in the area of functional food ingredients. Once the protection period elapses, other companies will be able to use the claims. In the meanwhile, however, any applicant may request an authorisation for a similar claim based on their proprietary studies.

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 2012]. Another 6 claims were added to the list in June 2013 by Regulation (EU) No 536/2013 [See our earlier update of 3 July 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 on nutrition and health claims made on foods.  

Article 13(5) of Regulation (EC) No 1924/2006 provides for a possibility to amend the list of authorised claims by addition of claims based on newly developed scientific evidence and/or which include a request for the protection of proprietary data. As a counterpart for the effort put into development of the scientific evidence an applicant may receive protection of the data submitted and regarded as proprietary for the 5 years following the authorisation of a claim. This means that the data cannot be used by another applicant and that the claim authorised on the basis of such data may only be used by a successful applicant within this period.

Commission Regulation (EU) No 851/2013 expands the list of permitted health claims with the inclusion of three new proprietary health claims. The Regulation will enter into force on 24 September 2013 (see the following links for different language versions: EN, FR, DE, ES, PL).

Newly permitted health claims

The three new proprietary health claims relate to slowly digestible starch, reformulated, non-alcoholic, acidic drinks and cocoa flavanols and are worded as follows:

  • "Consumption of products high in slowly digestible starch (SDS) raises blood glucose concentration less after a meal compared to products low in SDS"
  • "Replacing sugar containing, acidic drinks, such as soft drinks (typically 8-12 g sugars/100 ml), with reformulated drinks contributes to the maintenance of tooth mineralisation"
  • "Cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow."

The claims are authorised to the benefit of GlaxoSmithKline, Mondelēz International and Barry Callebaut respectively.

The Regulation also lays down detailed conditions of use for these claims. For instance, the claim on cocoa flavanols can be used only for cocoa beverages (with cocoa powder) or for dark chocolate which provide at least a daily intake of 200 mg of cocoa flavanols with a degree of polymerisation 1-10.

The new Commission Regulation (EU) No 851/2013 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. This is further confirmed by Recital 19 of Regulation (EU) No 851/2013.

Business Impact

The proprietary health claims are listed separately from all other generally available Article 13 and 14 health claims in the EU health and nutrition claims register. As from the entry into force of the new Regulation at the end of September 2013, the three applicants will have a de facto monopoly on the use of their authorised claims. Other companies will not be able to use these claims without infringing the law. However, now that a cause and effect relationship has been proven to exist, competitors interested in making similar claims may be more inclined to fund research to gather the necessary scientific evidence needed for substantiation.

The successful applicants may also licence their data to other applicants for corroboration of the same or similar claims. This is specifically envisaged by Article 21(1) of Regulation (EC) No 1924/2006.