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Authorised health claims and the conditions applying to them provided for in Articles 13(3) and (5), 14(1), 19(2), 21, 24(2), and 28(6) of Regulation (EC) N° 1924/2006 and the national measures referred to in Article 23(3)

Authorised health claims

Authorised health claims that can be used by all food business operators provided that they comply with the particular conditions of use of the authorised claim and with the principles and requirements of Regulation (EC) No 1924/2006



Article 14(1)(a) health claims referring to the reduction of a risk factor in the development of a disease


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
Commission Regulation
Sugar-free chewing gum Sugar-free chewing gum helps neutralise plaque acids. Plaque acids are a risk factor in the development of dental caries. Information shall be given to the consumer that the beneficial effect is obtained with chewing of 2-3 g of sugar-free chewing gum for 20 minutes, at least three times per day after meals. Q-2010-00120 pdf Commission Regulation (EU) No 665/2011pdf
Sugar-free chewing gum Sugar-free chewing gum helps reduce tooth demineralisation. Tooth demineralisation is a risk factor in the development of dental caries. Information shall be given to the consumer that the beneficial effect is obtained with chewing of 2-3 g of sugar-free chewing gum for 20 minutes, at least three times per day after meals. Q-2010-00119 pdf Commission Regulation (EU) No 665/2011pdf
Plant sterols/Plant stanol esters Plant sterols and plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-2,4 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 entire range ‘7 to 10 %’ and the duration to obtain the effect ‘in 2 to 3 weeks’ must be communicated to the consumer Q-2008-779 Commission Regulation (EC) No 384/2010 of 5/05/2010pdf
Oat beta-glucan Oat beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3 g of oat beta-glucan.

The claim can be used for foods which provide at least 1g of oat beta glucan per quantified portion.
Q-2008-681 Commission Regulation (EU) No 1160/2011 of 14 November 2011 pdf
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. Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-2,4 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 entire range “7 to 10 %” and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer. Q-2008-085 Commission Regulation (EC) No 983/2009 of 21/10/2009 pdf Amended by Commission Regulation (EU) No 376/2010 of 3/05/2010 pdf
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. Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-2,4 g plant 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 entire range “7 to 10 %” and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer. Q-2008-118 Commission Regulation (EC) No 983/2009 of 21/10/2009 pdf Amended by Commission Regulation (EU) No 376/2010 of 3/05/2010
Chewing gum sweetened with 100% xylitol Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children Information to the consumer that the beneficial effect is obtained with a consumption of 2-3g of chewing gum sweetened with 100% xylitol at least 3 times per day after the meals Q-2008-321 Commission Regulation (EC) No 1024/2009 of 29/10/2009pdf

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Article 14(1)(b) health claims referring to children's development and health


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
Commission Regulation
α-linolenic acid (ALA) & linoleic acid (LA), essential fatty acids Essential fatty acids are needed for normal growth and development of children. Information 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 Commission Regulation (EC) No 983/2009 of 21/10/2009 pdf Amended by Commission Regulation (EU) No 376/2010 of 3/05/2010 pdf
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 1924/2006. Q-2008-116 Commission Regulation (EC) No 983/2009 of 21/10/2009pdf
Docosahexaenoic acid (DHA) Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age. Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 mg of DHA. When the claim is used on follow-on formula, the food shall contain at least 0,3 % of the total fatty acids as DHA.

Q-2008-211

Q- 2008-688

Q-2008 -689

Commission Regulation (EU) No 440/2011 of 6 May 2011pdf

Docosahexaenoic acid (DHA) Docosahexaenoic acid (DHA) maternal intake contributes to the normal development of the eye of the foetus and breastfed infants Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and eicosapentaenoic acid (EPA). The claim can be used only for food which provides a daily intake of at least 200 mg DHA. Q-2008-675 Commission Regulation (EU) No 440/2011 of 6 May 2011 pdf
Docosahexaenoic acid (DHA) Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants. Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and EPA. The claim can be used only for food which provides a daily intake of at least 200 mg DHA Q-2008-773 Commission Regulation (EU) No 440/2011 of 6 May 2011 pdf
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 1924/2006. Q-2008-322 Commission Regulation (EC) No 983/2009 of 21/10/2009pdf
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 1924/2006. Q-2008-323 Commission Regulation (EC) No 983/2009 of 21/10/2009pdf
Phosphorus Phosphorus is needed for the normal growth and development of bone in children. The claim can be used only for food which is at least a source of phosphorus 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 1924/2006 Q-2008-217 Commission Regulation (EC) No 1024/2009 of 29/10/2009pdf
Iodine Iodine contributes to the normal growth of children The claim can be used only for food which is at least a source of iodine 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-2008-324 COMMISSION REGULATION (EU) No 957/2010 of 22 October 2010pdf
Iron Iron contributes to normal cognitive development of children The claim can be used only for food which is at least a source of iron 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-2008-325 COMMISSION REGULATION (EU) No 957/2010 of 22 October 2010pdf
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 1924/2006. Q-2008-326 Commission Regulation (EC) No 983/2009 of 21/10/2009pdf

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


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
Commission Decision
Water-soluble tomato concentrate (WSTC I and II) Water-Soluble Tomato Concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow Information to the consumer that the beneficial effect is obtained with a daily consumption of 3g WSTC I or 150mg WSTC II in up to 250ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid. Q-2009-00229 and Q-2010-00809 Commission Decision 2009/980/EU Amended by Commission Decision 2010/770/EU pdf

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