(1)

Regulation (EC) No 1924/2006 provides that health claims made on food are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, Commission Regulation (EU) No 432/2012 (2) was adopted, which established a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children’s development and health.

(3)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims are to be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

In order to stimulate innovation, health claims which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data shall undergo an accelerated type of authorisation.

(6)

Following an application from GlaxoSmithKline Services Unlimited, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a reformulated acidic non-alcoholic drink on reduction of tooth demineralisation (Question No EFSA-Q-2010-00784) (3). The claim proposed by the applicant was worded as follows: ‘ “Toothkind” drinks help to maintain healthy teeth’.

(7)

On 16 December 2010, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented, a cause and effect relationship had been established between the consumption of typical conventional juice drinks at an exposure frequency of four times per day and of typical sugar-containing beverages (8-12 g sugars/100 ml) at an exposure frequency of seven times per day and tooth demineralisation. Furthermore, it concluded that replacement of those beverages with ‘toothkind’ drinks may contribute to reduced tooth demineralisation.

(8)

Following consultation with the Member States, the Commission requested additional advice from the Authority, inter alia, on whether the beneficial effect is shown or expected to be shown for less frequent consumers of conventional juice drinks and typical sugar-containing non-alcoholic beverages. The Authority in its opinion of 8 July 2011 (Question No EFSA-Q-2011-00781) (4) concluded that a beneficial effect on maintaining tooth mineralisation may be expected for people who consume conventional juice drinks or sugar-containing non-alcoholic beverages and who are also frequent consumers of sugars and/or acids from other beverages or foods that can contribute to tooth demineralisation, if one or more servings of conventional juice drinks or sugar-containing non-alcoholic beverages are substituted by an equivalent number of servings of ‘toothkind’ juice drink. Furthermore, it was clarified that ‘reduction of tooth demineralisation’ has a similar meaning to ‘maintenance of tooth mineralisation’. Accordingly, a health claim reflecting this conclusion and accompanied by specific conditions of use should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Union list of permitted claims, established by Regulation (EU) No 432/2012.

(9)

The Authority indicated in its opinion that its conclusions could not have been reached without considering 15 studies claimed by the applicant as proprietary. Those studies are the following:

(10)

All the justifiable information provided by the applicant has been assessed by the Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled for all 15 studies claimed as proprietary. By letter dated 12 June 2013, the applicant informed the Commission that there have been some changes to the structure and location of its business. Therefore, the applicant formally requested that protection of proprietary data is granted to GlaxoSmithKline Services Unlimited and its affiliates, GSK House, 980 Great West Road, Brentford, TW89GS, United Kingdom. Accordingly, the scientific data and other information included in those studies may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.

(11)

Following an application from Kraft Foods Europe — Biscuits R & D submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of slowly digestible starch (SDS) in starch-containing foods and reduction of post-prandial glycaemic responses (Question No EFSA-Q-2010-00966) (5). The claim proposed by the applicant was worded as follows: ‘Slowly digestible starch provides carbohydrates that are regularly and continuously absorbed and released. They contribute to a moderate post-prandial glycaemic response’.

(12)

On 21 July 2011, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented, a cause and effect relationship had been established between the consumption of SDS, as compared to the consumption of rapidly digestible starch (RDS), in cereal products and reduced post-prandial glycaemic responses. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and should be included in the Union list of permitted claims, established by Regulation (EU) No 432/2012.

(13)

The Authority indicated in its opinion that the four studies claimed as proprietary by the applicant were required to establish conditions of use for this specific claim. Those studies are the following:

(14)

All the justifiable information provided by the applicant has been assessed by the Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled for the studies claimed as proprietary. By letter dated 1 October 2012, the applicant informed the Commission about the restructuring process, by means of which the Kraft Foods group span off its business, thereby creating two fully independent groups, one of them being the Mondelēz International group. As from 1 October 2012, Kraft Foods Europe — Biscuits R & D belongs to the Mondelēz International group, and the applicant formally requested that the protection of proprietary data is granted to the Mondelēz International group. Accordingly, the scientific data and other information included in those studies may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.

(15)

Following an application from Barry Callebaut Belgium NV submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of cocoa flavanols on endothelium-dependent vasodilation (Question No EFSA-Q-2012-00002) (6). The claim proposed by the applicant was worded as follows: ‘Cocoa flavanols help maintain endothelium-dependent vasodilation which contributes to healthy blood flow’.

(16)

On 17 July 2012, the Commission and the Member States received the scientific opinion from the Authority which concluded that on the basis of the data presented a cause and effect relationship had been established between the consumption of cocoa flavanols and the claimed effect. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and should be included in the Union list of permitted claims, established by Regulation (EU) No 432/2012.

(17)

The Authority indicated in its opinion that its conclusions could not have been reached without considering one human intervention study claimed by the applicant as proprietary. That study is Grassi D, Desideri G, Necozione S, Di Giosia P, Cheli P, Barnabei R, Allegaert L, Bernaert H and Ferri C, 2011. Cocoa consumption dose-dependently improves flow-mediated dilation and arterial stiffness and decreases blood pressure in healthy subjects.

(18)

All the justifiable information provided by the applicant has been assessed by the Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled for the study claimed as proprietary. Accordingly, the scientific data and other information included in that study may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, under the conditions laid down in that Article.

(19)

One of the objectives of Regulation (EC) No 1924/2006 is to ensure that health claims are truthful, clear and reliable and useful to the consumer, and that the wording and the presentation are taken into account in that respect. Therefore, where the wording of claims used by the applicant has the same meaning for consumers as that of an authorised health claim, because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, they should be subject to the same conditions of use as those listed in the Annex to this Regulation.

(20)

In accordance with Article 20 of Regulation (EC) No 1924/2006, the Register of nutrition and health claims containing all authorised health claims should be updated in order to take into account this Regulation.

(21)

Since the applicants claim protection of proprietary data, it is considered appropriate to restrict the use of these claims in favour of the applicants for a period of five years. However, the authorisation of these claims restricted for the use of an individual operator does not prevent other applicants from applying for authorisation to use the same claims in case the application is based on data and studies other than those protected under Article 21 of Regulation (EC) No 1924/2006.

(22)

The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(23)

Regulation (EU) No 432/2012 should therefore be amended accordingly.

(24)

The Member States have been consulted,