(1)

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 the Union list of permitted health claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisation 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 (‘the Authority’).

(3)

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

(4)

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

(5)

Following an application from Nestlé S.A., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447). The claim proposed by the applicant was worded as follows: ‘Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal’.

(6)

On 8 April 2021, the Commission and the Member States received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, the effect of beta-glucans in reducing post-prandial blood glucose responses is well established. However, the evidence provided had been insufficient to establish an effect on reduction of post-prandial glycaemic responses at doses of 1,3 g beta-glucans per 25 g of available carbohydrate incorporated into ready-to-eat breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or extrusion), as requested by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(7)

Following an application from Pharmactive Biotech Products, S.L., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Affron® and the contribution to the maintenance of a healthy mood (Question No EFSA-Q-2020-00617). The claim proposed by the applicant was worded as follows: ‘Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings’.

(8)

On 6 July 2021, the Commission and the Member States received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of Affron® and increase in positive mood. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(9)

Following an application from Praline i Cokolada j.d.o.o., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract and the maintenance of normal blood pressure (Question No EFSA-Q-2020-00718). The claim proposed by the applicant was worded as follows: ‘MegaNatural®-BP helps maintain healthy blood pressure’.

(10)

On 9 August 2021, the Commission and the Member States received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP, a grape seed extract standardised for total phenolics, gallic acid and the sum of catechin and epicatechin content, and maintenance of normal blood pressure. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(11)

Following an application from Sensus B.V. (Royal Cosun), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and the maintenance of normal defecation (Question No EFSA-Q-2020-00631). The claim proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency’. The applicant also provided three alternative wordings for the claim.

(12)

On 12 August 2021, the Commission and the Member States received the scientific opinion (5) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Frutalose® and the maintenance of normal defecation under the proposed conditions of use. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

(13)

The comments by Nestlé S.A. on the Authority’s opinion on the health claim relating to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447), received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,