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

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may 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’.

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

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

When the health claim is made only on calcium, in order to ensure that a food provides a significant quantity of calcium, it is appropriate to set conditions of use which allow the claim to be made only on foods which provide at least 400 mg of calcium per quantified portion.

Taking into account the high level of vitamin D intake required to achieve the claimed effect (20 μg), when the health claim is made on the combination of calcium and vitamin D, it is appropriate to limit the use of the claim to food supplements. In order to ensure that a food supplement would provide a significant quantity of calcium and vitamin D in the context of this claim, it is appropriate to set conditions of use which allow the claim to be made only on food supplements which provide at least 400 mg of calcium and 15 μg of vitamin D per daily portion.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 30 September 2011 that a cause and effect relationship had been established between the intake of vitamin D and a reduction in the risk of falling, which is positively associated with postural instability and muscle weakness. A reduction in the risk of falling among men and women 60 years of age and older is beneficial to human health by reducing the risk of bone fractures. 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.

In its opinion, the Authority also concluded that 800 I.U. (20 μg) of vitamin D, from all sources, should be consumed daily in order to obtain the claimed effect. Taking into account the high level of vitamin D intake required to achieve the claimed effect (20 μg), it is appropriate to limit the use of the claim to food supplements. In order to ensure that a food supplement would provide a significant quantity of vitamin D in the context of this claim, it is appropriate to set conditions of use which allow the claim to be made only on food supplements which provide at least 15 μg of vitamin D per daily portion.

Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim should include certain particulars. Accordingly, those particulars should be set out in Annex I to this Regulation as regards the authorised claims and include, as the case may be, the revised wording of the claim, specific conditions of use of the claim, and, where applicable, conditions or restrictions of use of the food and/or an additional statement or warning, in accordance with the rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the Authority.

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 wording and presentation are taken into account in that respect. Therefore where the wording of claims 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 indicated in Annex I to this Regulation.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 29 October 2009 that a cause and effect relationship had not been established between the consumption of glucosamine hydrochloride and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 2 February 2012 that a cause and effect relationship had not been established between the consumption of isolated soy protein, as defined by the applicant, and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 17 July 2012 that a cause and effect relationship had not been established between the consumption of a combination of plant sterols and Cholesternorm®mix and the claimed effect at the proposed conditions of use. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 April 2013 that the target population for the claim is a diseased population (i.e. children with ADHD) and that the claimed effect relates to the treatment of a disease.

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 April 2013 that the evidence provided by the applicant does not establish that the consumption of 2 g/day plant stanols (as plant stanol esters) as part of a diet low in saturated fat results in a two-fold greater reduction in LDL-cholesterol concentrations compared with consuming a diet low in saturated fat alone. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

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.

The addition of substances to or the use of substances in foodstuffs is governed by specific Union and national legislation, as is the classification of products as foodstuffs or medicinal products. Any decision on a health claim in accordance with Regulation (EC) No 1924/2006 such as inclusion in the list of permitted claims referred to in Article 14(1) thereof does not constitute an authorisation to the marketing of the substance on which the claim is made, a decision on whether the substance can be used in foodstuffs, or a classification of a certain product as a foodstuff.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,