# L_2014307EN.01002301.xml

| 28.10.2014 | EN | Official Journal of the European Union | L 307/23 |
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28.10.2014

EN

Official Journal of the European Union

L 307/23

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COMMISSION REGULATION (EU) No 1135/2014

of 24 October 2014

on the authorisation of a health claim made on foods and referring to the reduction of disease risk

(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 17(3) 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’. |
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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’.

| (3) | 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. |
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(3)

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.

| (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 Rank Nutrition Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was asked to deliver an opinion on a health claim related to ‘Increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects.’ (Question No EFSA-Q-2013-00265) (2). The claim proposed by the applicant was worded as follows: ‘Folic acid supplementation raises maternal red blood cell folate. Low maternal red blood cell folate is a risk factor for neural tube defects in the developing foetus’. |
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(5)

Following an application from Rank Nutrition Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was asked to deliver an opinion on a health claim related to ‘Increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects.’ (Question No EFSA-Q-2013-00265) (2). The claim proposed by the applicant was worded as follows: ‘Folic acid supplementation raises maternal red blood cell folate. Low maternal red blood cell folate is a risk factor for neural tube defects in the developing foetus’.

| (6) | On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 26 July 2013 that a cause and effect relationship had been established between increasing maternal folate status by supplemental folate intake and a reduced risk of neural tube defects (NTDs). 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. |
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(6)

On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 26 July 2013 that a cause and effect relationship had been established between increasing maternal folate status by supplemental folate intake and a reduced risk of neural tube defects (NTDs). 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.

| (7) | Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim is to include certain particulars. Accordingly, those particulars should be set out in the Annex to this Regulation as regards the authorised claim 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 opinion of the Authority. |
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(7)

Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of authorising a health claim is to include certain particulars. Accordingly, those particulars should be set out in the Annex to this Regulation as regards the authorised claim 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 opinion of the Authority.

| (8) | 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 the Annex to this Regulation. |
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(8)

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 the Annex to this Regulation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

1.   The health claim listed in the Annex to this Regulation may be made on foods placed on the Union market in compliance with the conditions laid down in that Annex.

2.   The health claim referred to in paragraph 1 shall be included in the Union list of permitted claims as provided for in Article 14(1) 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, 24 October 2014.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  EFSA Journal 2013; 11(7):3328.

2

EFSA Journal

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ANNEX

PERMITTED HEALTH CLAIM

| Application — Relevant provisions of Regulation (EC) No 1924/2006 | Applicant — Address | Nutrient, substance, food or food category | Claim | Conditions of use of the claim | Conditions and/or restrictions of use of the food and/or additional statement or warning | EFSA opinion reference |
| --- | --- | --- | --- | --- | --- | --- |
| Article 14(1)(a) health claim referring to a reduction of a disease risk | Rank Nutrition Ltd, Long Barn, Etchden Court, Bethersden, Kent, TN26 3DP, United Kingdom. | Folic acid | Supplemental folic acid intake increases maternal folate status. Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus. | The claim may be used only for food supplements which provide at least 400 μg of folic acid per daily portion.
  Information shall be provided to the consumer that the target population is women of child-bearing age and the beneficial effect is obtained with a supplemental folic acid daily intake of 400 μg for at least one month before and up to three months after conception. | | Q-2013-00265 |

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

Applicant — Address

Nutrient, substance, food or food category

Claim

Conditions of use of the claim

Conditions and/or restrictions of use of the food and/or additional statement or warning

EFSA opinion reference

Article 14(1)(a) health claim referring to a reduction of a disease risk

Rank Nutrition Ltd, Long Barn, Etchden Court, Bethersden, Kent, TN26 3DP, United Kingdom.

Folic acid

Supplemental folic acid intake increases maternal folate status. Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus.

The claim may be used only for food supplements which provide at least 400 μg of folic acid per daily portion.

Information shall be provided to the consumer that the target population is women of child-bearing age and the beneficial effect is obtained with a supplemental folic acid daily intake of 400 μg for at least one month before and up to three months after conception.

Q-2013-00265

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