# L_2015277EN.01001301.xml

| 22.10.2015 | EN | Official Journal of the European Union | L 277/13 |
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22.10.2015

EN

Official Journal of the European Union

L 277/13

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COMMISSION REGULATION (EU) 2015/1898

of 21 October 2015

refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,

Whereas:

| (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 a list of permitted claims. |
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(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 a list of permitted claims.

| (2) | 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’, for a scientific assessment, as well as to the Commission and the Member States for information. |
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(2)

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’, for a scientific assessment, as well as to the Commission and the Member States for information.

| (3) | The Authority is to deliver an opinion on the health claim concerned. |
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(3)

The Authority is to deliver an opinion on the health claim concerned.

| (4) | The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. |
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(4)

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

| (5) | Following an application from Clasado Limited, 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 Bimuno® GOS and reducing gastrointestinal discomfort (Question No EFSA-Q-2014-00022 (2)). The claim proposed by the applicant was worded as follows: ‘Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce abdominal discomfort’. |
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(5)

Following an application from Clasado Limited, 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 Bimuno® GOS and reducing gastrointestinal discomfort (Question No EFSA-Q-2014-00022 (2)). The claim proposed by the applicant was worded as follows: ‘Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce abdominal discomfort’.

| (6) | On 16 July 2014, 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 not been established between the consumption of Bimuno® GOS and reducing gastrointestinal discomfort. In that opinion, the Authority also noted that except for one unpublished human intervention study, all the human and non-human studies provided by the applicant for this claim were already submitted in previous applications for the same claim, and they were assessed with unfavourable outcomes (3). Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
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(6)

On 16 July 2014, 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 not been established between the consumption of Bimuno® GOS and reducing gastrointestinal discomfort. In that opinion, the Authority also noted that except for one unpublished human intervention study, all the human and non-human studies provided by the applicant for this claim were already submitted in previous applications for the same claim, and they were assessed with unfavourable outcomes (3). Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (7) | The comments from the applicant 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. |
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(7)

The comments from the applicant 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.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

The health claim listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 October 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 404, 30.12.2006, p. 9.

1

(2)  
  EFSA Journal 2014; 12(7):3756.

2

EFSA Journal

(3)  EFSA Journal 2011;9(12):2472, EFSA Journal 2013;11(6):3259.

3

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ANNEX

Rejected health claim

| Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
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| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Bimuno® GOS | Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce abdominal discomfort | Q-2014-00022 |

Application — Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Bimuno® GOS

Regular daily consumption of 1,37 g galacto-oligosaccharides from Bimuno® may reduce abdominal discomfort

Q-2014-00022

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