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

• CELEX: Regulation (EU) No 1228/2014
• Articles: 5

Article 1

1.   The health claims listed in Annex I to this Regulation may be made on foods placed on the Union market in compliance with the conditions laid down in that Annex.

2.   The health claims referred to in paragraph 1 shall be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.

Article 2

The health claims listed in Annex II to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I Permitted health claims

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 a reduction of a disease risk

Abtei Pharma Vertriebs GmbH, Abtei 1, 37696, Marienműnster, Germany.

Calcium

Calcium 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 risk

Abtei Pharma Vertriebs GmbH, Abtei 1, 37696, Marienműnster, Germany.

Calcium and vitamin D

Calcium 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 risk

DSM Nutritional Products Europe AG, P.O. Box 2676, 4002 Basel, Switzerland.

Vitamin D

Vitamin 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 older

Q-2010-01233

ANNEX II Rejected health claims

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

Glucosamine hydrocloride

Slowing 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 risk

Isolated soy protein

Protein-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 risk

Plant sterols in combination with Cholesternorm®mix

Actively lowers cholesterol.

Q-2009-00237

Q-2011-01114

Article 14(1)(a) health claim referring to a reduction of a disease risk

Eicosapentanoic 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 risk

Plant 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