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Commission Regulation (EU) No 1228/2014Show full title

Commission Regulation (EU) No 1228/2014 of 17 November 2014 authorising and refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (Text with EEA relevance)

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ANNEX IPermitted health claims

Application — Relevant provisions of Regulation (EC) No 1924/2006Applicant — AddressNutrient, substance, food or food categoryClaimConditions of use of the claimConditions and/or restrictions of use of the food and/or additional statement or warningEFSA opinion reference
Article 14(1)(a) health claim referring to a reduction of a disease riskAbtei Pharma Vertriebs GmbH, Abtei 1, 37696, Marienműnster, Germany.CalciumCalcium helps to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures

The claim may be used only for food which provides at least 400 mg of calcium per quantified portion.

Information shall be given to the consumer that the claim is specifically intended for women 50 years and older and the beneficial effect is obtained with a daily intake of at least 1 200 mg of calcium from all sources.

For foods with added calcium the claim may be used only for those targeting women 50 years and older

Q-2008-721

Q- 2009-00940

Article 14(1)(a) health claim referring to a reduction of a disease riskAbtei Pharma Vertriebs GmbH, Abtei 1, 37696, Marienműnster, Germany.Calcium and vitamin DCalcium and vitamin D help to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures

The claim may be used only for food supplements which provide at least 400 mg of calcium and 15 μg of vitamin D per daily portion.

Information shall be given to the consumer that the claim is specifically intended for women 50 years and older and the beneficial effect is obtained with a daily intake of at least 1 200 mg of calcium and 20 μg of vitamin D from all sources.

For food supplements with added calcium and vitamin D the claim may be used only for those targeting women 50 years and older

Q-2008-721

Q- 2009-00940

Article 14(1)(a) health claim referring to a reduction of a disease riskDSM Nutritional Products Europe AG, P.O. Box 2676, 4002 Basel, Switzerland.Vitamin DVitamin D helps to reduce the risk of falling associated with postural instability and muscle weakness. Falling is a risk factor for bone fractures among men and women 60 years of age and older.

The claim may be used only for food supplements which provide at least 15 μg of vitamin D per daily portion.

Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20 μg of vitamin D from all sources.

For food supplements with added vitamin D the claim may be used only for those targeting men and women 60 years and olderQ-2010-01233

ANNEX IIRejected health claims

Application — Relevant provisions of Regulation (EC) No 1924/2006Nutrient, substance, food or food categoryClaimEFSA opinion reference
Article 14(1)(a) health claim referring to a reduction of a disease riskGlucosamine hydroclorideSlowing down/reduce the destruction process of cartilage of the musculoskeletal system and consequently reduce the risk of osteoarthritis.Q-2009-00412
Article 14(1)(a) health claim referring to a reduction of a disease riskIsolated soy proteinProtein-rich soybean component has been shown to lower/reduce blood cholesterol; blood cholesterol lowering may reduce the risk of (coronary) heart disease.Q-2011-00784
Article 14(1)(a) health claim referring to a reduction of a disease riskPlant sterols in combination with Cholesternorm®mixActively lowers cholesterol.

Q-2009-00237

Q-2011-01114

Article 14(1)(a) health claim referring to a reduction of a disease riskEicosapentanoic acid (EPA)EPA has been shown to reduce the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour.Q-2012-00573
Article 14(1)(a) health claim referring to a reduction of a disease riskPlant stanols (as plant stanol esters)Consuming 2 g/day plant stanols (as plant stanol esters) as part of a diet low in saturated fat results in a 2-fold greater reduction in LDL-cholesterol than consuming a low saturated fat diet alone. High cholesterol is a risk factor in the development of coronary heart disease.Q-2012-00915

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