Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims made on foods 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 claim set out in Annex I to this Regulation may be made on foods on the European Union market in compliance with the conditions set out in that Annex. That health claim shall be included in the Community list of permitted claims referred to in Article 14(1) of Regulation (EC) No 1924/2006.
The health claims set out in the Annex II to this Regulation shall not be included in the Community list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
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 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 Danone France, 150 Bd Victor Hugo, 93589 Saint-Ouen Cedex, France 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
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 a reduction of a disease risk Lycopene-whey complex Lycopene-whey complex prevents oxidative damage of plasma lipoproteins, which reduces the build up of arterial plaques and reduces the risk of heart disease, stroke and other clinical complications of atherosclerosis Q-2008-703 Article 14(1)(a) health claim referring to a reduction of a disease risk Bimuno TM (BGOS) Prebiotic Regular consumption of Bimuno TM (BGOS) Prebiotic helps to protect against the bad bacteria than can cause the travellers’ diarrhoea Q-2009-00232
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