# L_2012119EN.01001201.xml

| 4.5.2012 | EN | Official Journal of the European Union | L 119/12 |
| --- | --- | --- | --- |

4.5.2012

EN

Official Journal of the European Union

L 119/12

---

COMMISSION REGULATION (EU) No 379/2012

of 3 May 2012

refusing to authorise certain health claims 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. |
| --- | --- |

(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’. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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 Valio Ltd, 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 Lactobacillus rhamnosus GG (LGG) on maintenance of defence against pathogenic gastrointestinal micro-organisms (Question No EFSA-Q-2010-01028) (2). The claim proposed by the applicant was worded as follows: ‘Lactobacillus GG helps to maintain defence against intestinal pathogens’. |
| --- | --- |

(5)

Following an application from Valio Ltd, 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 Lactobacillus rhamnosus GG (LGG) on maintenance of defence against pathogenic gastrointestinal micro-organisms (Question No EFSA-Q-2010-01028) (2). The claim proposed by the applicant was worded as follows: ‘Lactobacillus GG helps to maintain defence against intestinal pathogens’.

| (6) | On 1 June 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 not been established between the consumption of Lactobacillus rhamnosus GG 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. |
| --- | --- |

(6)

On 1 June 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 not been established between the consumption of Lactobacillus rhamnosus GG 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.

| (7) | Following an application from Gelita AG, 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 collagen hydrolysate on maintenance of joints (Question No EFSA-Q-2011-00201) (3). The claim proposed by the applicant was worded as follows: ‘Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiological effect on the maintenance of joint health in physically active people’. |
| --- | --- |

(7)

Following an application from Gelita AG, 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 collagen hydrolysate on maintenance of joints (Question No EFSA-Q-2011-00201) (3). The claim proposed by the applicant was worded as follows: ‘Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiological effect on the maintenance of joint health in physically active people’.

| (8) | On 20 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 not been established between the consumption of collagen hydrolysate 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. |
| --- | --- |

(8)

On 20 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 not been established between the consumption of collagen hydrolysate 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.

| (9) | The health claims subject to this Regulation are health claims as referred to in point (a) of Article 13(1) of Regulation (EC) No 1924/2006 and may benefit from the transitional period laid down in Article 28(5) of that Regulation. As the Authority concluded that cause and effect relationships have not been established between the foods and the claimed effects, the claims do not comply with Regulation (EC) No 1924/2006, and therefore they may not benefit from the transitional period provided for in that Article. |
| --- | --- |

(9)

The health claims subject to this Regulation are health claims as referred to in point (a) of Article 13(1) of Regulation (EC) No 1924/2006 and may benefit from the transitional period laid down in Article 28(5) of that Regulation. As the Authority concluded that cause and effect relationships have not been established between the foods and the claimed effects, the claims do not comply with Regulation (EC) No 1924/2006, and therefore they may not benefit from the transitional period provided for in that Article.

| (10) | In order to ensure that this Regulation is fully complied with, both food business operators and the national competent authorities should take the necessary actions to ensure that, at the latest six months following the entry into force of this Regulation, the health claims listed in its Annex are no longer used. |
| --- | --- |

(10)

In order to ensure that this Regulation is fully complied with, both food business operators and the national competent authorities should take the necessary actions to ensure that, at the latest six months following the entry into force of this Regulation, the health claims listed in its Annex are no longer used.

| (11) | 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. |
| --- | --- |

(11)

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.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them, |
| --- | --- |

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council have opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The health claims 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.

2.   However, the health claims referred to in paragraph 1 used prior to the entry into force of this Regulation may continue to be used for a maximum period of six months after the entry into force of this Regulation.

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, 3 May 2012.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  The EFSA Journal 2011; 9(6):2167.

2

(3)  The EFSA Journal 2011; 9(7):2291.

3

---

ANNEX

Rejected health claims

| 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 | Lactobacillus rhamnosus GG (LGG) | Lactobacillus GG helps to maintain defence against intestinal pathogens | Q-2010-01028 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Collagen hydrolysate | Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiological effect on the maintenance of joint health in physically active people | Q-2011-00201 |

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

Lactobacillus rhamnosus GG (LGG)

Lactobacillus GG helps to maintain defence against intestinal pathogens

Q-2010-01028

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

Collagen hydrolysate

Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiological effect on the maintenance of joint health in physically active people

Q-2011-00201

---