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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The health claims set out in Annex I to this Regulation may be made on food on the Community market in compliance with the conditions set out in that Annex. Those health claims shall be included in a list of permitted claims referred to in Article 14(1) of Regulation (EC) No 1924/2006.
The health claims set out in Annex II to this Regulation are rejected.
Health claims as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006 and set out in Annex II to this Regulation may continue to be used for six months after the entry into force of this Regulation.
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .
ANNEX I PERMITTED HEALTH CLAIMS 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 Information to the consumer that the beneficial effect is obtained with a daily intake of at least 2 g plant sterols Q-2008-085 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 Information to the consumer that the beneficial effect is obtained with a daily intake of at least 2 g plant stanols Q-2008-118 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 Information to the consumer that the beneficial effect is obtained with a daily intake of 1 % of total energy for linoleic acid and 0,2 % of total energy of α-linolenic acid 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 REJECTED HEALTH CLAIMS 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.