Commission Regulation (EC) No 983/2009
of 21 October 2009
on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Whereas:
Pursuant to Regulation (EC) No 1924/2006 health claims made on food 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 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 of the application, and to deliver an opinion on a health claim concerned.
The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
On 19 August 2008, the Commission and the Member States received seven opinions on applications for health claim authorisation from the Authority. On 22 September 2008, the Commission and the Member States received one opinion on an application for health claim authorisation from the Authority. On 22 October 2008, the Commission and the Member States received eight opinions on applications for health claim authorisation from the Authority. On 31 October 2008, the Commission and the Member States received five opinions on applications for health claim authorisation from the Authority. On 14 November 2008, the Commission and the Member States received two opinions on applications for health claim authorisation from the Authority.
Six opinions were related to applications for reduction of disease risk claims, as referred to in Article 14(1)(a) of Regulation (EC) No 1924/2006, and seventeen opinions were related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006. Meanwhile one application for health claim authorisation was withdrawn by the applicant and one application for health claim authorisation will be subject to a further decision.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the consumption of plant sterols and the claimed effect. Subject to a revised wording the claim should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and in particular Article 14(1)(a) thereof, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of plant stanol esters and the claimed effect. Subject to a revised wording the claim should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and in particular Article 14(1)(a) thereof, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of ALA and LA and the claimed effect. A health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of vitamin D and the claimed effect. A health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of calcium and vitamin D and the claimed effect. A health claim reflecting this conclusion should be considered as complying with the requirements set out in Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of calcium and the claimed effect. A health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
On the basis of the data presented, the Authority concluded that a cause and effect relationship was established between the intake of total protein and the claimed effect. A health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and it should be included in the Community list of permitted claims.
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 the Annex I to the present Regulation as regards the seven 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 have to be 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 as they demonstrate the same relationship that exists between a food category, a food or one of its constituents and health, included in Annex I they should be subject to the same conditions of use indicated therein.
On the basis of the data presented, the Authority concluded that a cause and effect relationship could not be established between the consumption of NeOpuntia® 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 that a cause and effect relationship had not been established between the consumption of Lactobacillus helveticus fermented Evolus® low-fat milk products 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 that a cause and effect relationship had not been established between the consumption of the food/constituent (DHA and ARA) starting at six months of age 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. In addition, the Authority concluded that the consumption of baby foods/formula supplemented with DHA and ARA from six months to one year of age might have a beneficial effect on visual acuity maturation in infants breast-fed until the age of 4-6 months. The Authority concluded also that no evidence had been presented on the effects of DHA and ARA supplementation starting at six months of age on visual maturation in healthy infants that had not been breastfed but fed unenriched formula during the first months of life. A health claim reflecting this conclusion could not comply with the general principles and requirements of Regulation (EC) No 1924/2006, and especially Articles 3, 5 and 6, and should not be authorised.
On the basis of the data presented, the Authority concluded that the food category dairy foods (milk and cheese) subject of the health claim has not been sufficiently characterised, and a cause and effect relationship had not been established between the consumption of milk or cheese 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 that the food category dairy foods (milk and cheese) subject of the health claim has not been sufficiently characterised and that a cause and effect relationship had not been established between the daily consumption of dairy foods (milk, cheese and yogurt) 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 that the food for which the claim is made, ‘regulat®.pro.kid IMMUN’, has not been sufficiently characterised, and that a cause and effect relationship had not been established between the consumption of regulat®.pro.kid IMMUN 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 that the food for which the claim is made ‘regulat®.pro.kid BRAIN’, has not been sufficiently characterised, and that a cause and effect relationship had not been established between the consumption of regulat®.pro.kid BRAIN 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 that a cause and effect relationship had not been established between the consumption of DHA and eicosapentaenoic acid (EPA) 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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 that a cause and effect relationship had not been established between the consumption of DHA and EPA 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.
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.
In accordance with Article 28(6) of Regulation (EC) No 1924/2006 health claims as referred to in Article 14(1)(b) of that Regulation and not authorised by this Regulation may continue to be used for six months after the adoption of a decision pursuant to Article 17(3) of Regulation (EC) No 1924/2006. However, for applications which were not made before 19 January 2008, the requirement provided for in Article 28(6)(b) is not fulfilled, and the transition period laid down in that Article is not applicable. Accordingly, a transition period of six months should be provided for, to enable food business operators to adapt to the requirements laid down in this Regulation.
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
Article 2
The health claims set out in Annex II to this Regulation are rejected.
F3Article 3
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F4Article 4
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
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 reduction of disease risk | Unilever PLC; Port Sunlight, Wirral, Merseyside, CH62 4ZD, UK and Unilever NV, Weena 455, Rotterdam, 3013 AL, Nederland | Plant sterols: Sterols extracted from plants, free or esterified with food grade fatty acids | Plant sterols have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease | F5Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the range ‘7 % to 10 %’ for foods that provide a daily intake of 1,5-2,4 g plant sterols or the range ‘10 % to 12,5 %’ for foods that provide a daily intake of 2,5-3 g plant sterols and the duration to obtain the effect ‘in 2 to 3 weeks’ must be communicated to the consumer. | F5Q-2008-085 Q-2009-00530 and Q-2009-00718 Q-2011-01241 | |
Article 14(1)(a) health claim referring to reduction of disease risk | McNeil Nutritionals, 1 Landis und Gyr Strasse, 6300 Zug; Switzerland | Plant stanol esters | Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease | F5Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols/stanols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the range ‘7 % to 10 %’ for foods that provide a daily intake of 1,5-2,4 g plant sterols/stanols or the range ‘10 % to 12,5 %’ for foods that provide a daily intake of 2,5-3 g plant sterols/stanols and the duration to obtain the effect ‘in 2 to 3 weeks’ must be communicated to the consumer. | F5Q-2008-118 Q-2009-00530 and Q-2009-00718 Q-2011-00851 Q-2011-01241 | |
Article 14(1)(b) health claim referring to children’s development and health | Unilever PLC; Port Sunlight, Wirral, Merseyside, CH62 4ZD, UK and Unilever NV, Weena 455, Rotterdam, 3013 AL, Nederland | α-linolenic acid & linoleic acid | Essential fatty acids are needed for normal growth and development of children | F6Information to the consumer that the beneficial effect is obtained with a daily intake of 2 g of α-linolenic acid (ALA) and a daily intake of 10 g of linoleic acid (LA) | Q-2008-079 | |
Article 14(1)(b) health claim referring to children’s development and health | Association de la Transformation Laitière Française (ATLA), 42, rue du Châteaudun, 75314 Paris Cedex 09, FRANCE | Calcium | Calcium is needed for normal growth and development of bone in children | The claim can be used only for food which is at least a source of calcium as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006 | Q-2008-322 | |
Article 14(1)(b) health claim referring to children’s development and health | Association de la Transformation Laitière Française (ATLA), 42, rue du Châteaudun, 75314 Paris Cedex 09, FRANCE | Protein | Protein is needed for normal growth and development of bone in children | The claim can be used only for food which is at least a source of protein as referred to in the claim SOURCE OF PROTEIN as listed in the Annex to Regulation (EC) No 1924/2006 | Q-2008-326 | |
Article 14(1)(b) health claim referring to children’s development and health | Yoplait Dairy Crest Ltd, Claygate House, Claygate, Surrey, KT10 9PN, UK | Calcium and vitamin D | Calcium and vitamin D are needed for normal growth and development of bone in children | The claim can be used only for food which is at least a source of calcium and vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006 | Q-2008-116 | |
Article 14(1)(b) health claim referring to children’s development and health | Association de la Transformation Laitière Française (ATLA), 42, rue du Châteaudun, 75314 Paris Cedex 09, FRANCE | Vitamin D | Vitamin D is needed for normal growth and development of bone in children | The claim can be used only for food which is at least a source of Vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006 | Q-2008-323 |
ANNEX II
Application – Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
|---|---|---|---|
Article 14(1)(a) health claim referring to reduction of disease risk | NeOpuntia® | NeOpuntia® helps to improve blood lipid parameters associated with cardiovascular risks, especially the HDL-cholesterol | EFSA-Q-2008-214 |
Article 14(1)(a) health claim referring to reduction of disease risk | Lactobacillus helveticus fermented Evolus®low-fat milk products | Evolus® reduces arterial stiffness | EFSA-Q-2008-218 |
Article 14(1)(b) health claim referring to children’s development and health | regulat®.pro.kid IMMUN | regulat®.pro.kid IMMUN supports, stimulates and modulates the immune system of children during growth | EFSA-Q-2008-082 |
Article 14(1)(b) health claim referring to children’s development and health | Dairy products | Three portions of dairy food everyday, as part of a balanced diet, may help promote a healthy body weight during childhood and adolescence | EFSA-Q-2008-110 |
Article 14(1)(b) health claim referring to children’s development and health | Dairy products | Dairy foods (milk & cheese) promote dental health in children | EFSA-Q-2008-112 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) | DHA and ARA support neural development of the brain and eyes | EFSA-Q-2008-120 |
Article 14(1)(b) health claim referring to children’s development and health | regulat®.pro.kid BRAIN | regulat®.pro.kid BRAIN contributes to mental and cognitive development of children | EFSA-Q-2008-083 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Calming | EFSA-Q-2008-091 and EFSA-Q-2008-096 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Provide serenity and room for a beneficial development of the child | EFSA-Q-2008-092 and EFSA-Q-2008-097 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Help to support vision | EFSA-Q-2008-095 and EFSA-Q-2008-100 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Help to support mental development | EFSA-Q-2008-098 and EFSA-Q-2008-104 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Help to promote concentration | EFSA-Q-2008-094 and EFSA-Q-2008-099 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Helps to promote the thinking capacity | EFSA-Q-2008-093 and EFSA-Q-2008-101 |
Article 14(1)(b) health claim referring to children’s development and health | Docosahexaenoic Acid (DHA) and eicosapentaenoic acid (EPA) | Help to support the learning ability | EFSA-Q-2008-102 and EFSA-Q-2008-103 |