Scientific Documents

Vitamin D and bone growth - Scientific substantiation of a health claim related to vitamin D and bone growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Summary (90 KB)

Opinion (126 KB)

Summary

Following an application from the Association de la Transformation Laitière Française (ATLA) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin D and bone growth.

The scope of the application was proposed to fall under claims referring to children’s development and health.

The constituent subject of the health claim is vitamin D which is a well recognised nutrient and is measurable in foods by established methods. This evaluation applies to vitamin D naturally present in foods and those forms authorised for addition to foods (Annex II of the Regulation (EC) No 1925/2006).The Panel considers that the food/constituent that is the subject of the health claim (vitamin D) is sufficiently characterised.

The claimed effect is that vitamin D ‘is essential for bone growth’ of children. The proposed target population for the health claim is children aged 3-18 years. The Panel considers that normal growth and development of bone is beneficial to children’s health.

A total of 19 publications were considered pertinent by the applicant to the health claim - 9 reports from authoritative bodies and reviews and 10 human studies, including 6 intervention studies and 4 observational studies.

Reports from authoritative bodies and reviews show that there is good consensus on the role of vitamin D in growth and development of bone. Adequate status for vitamin D is required for efficient calcium absorption and for the maintenance of normal blood levels of calcium and phosphate that are needed for the normal mineralisation of bone. The serum level of calcidiol (25(OH)D) is a good marker of status for vitamin D. Synthesis of vitamin D in the skin by the action of sunlight is insufficient to meet requirements in European countries, especially during winter months when there is little sunlight exposure. Adequate intake of vitamin D throughout childhood and adolescence is needed to achieve a vitamin D status that is sufficient for normal bone mineralisation, and sub-optimal vitamin D status has been shown to reduce bone mineral accretion in children and adolescents. Recommended intakes of vitamin D for normal growth and development of bone have been established for children and adolescents by several expert committees. Sub-optimal vitamin D status has been reported in sub-groups of children and adolescents in a number of European countries, particularly in winter months, indicative of inadequate vitamin D intake.

The human observational and intervention studies presented support the association between serum 25(OH)D as an indicator of vitamin D status and bone health outcomes (bone mineral density and bone mineral content) in children and adolescents as well as a dose response relationship between vitamin D intake and serum 25(OH)D levels. They also provide evidence for the occurrence of sub-optimal vitamin D status in sub-groups of children in a number of European countries, particularly in winter months.

The Panel concludes that, on the basis of the evidence provided, a cause and effect relationship has been established between the intake of vitamin D and normal growth and development of bone in children and adolescents. Recommended intakes of vitamin D to meet requirements for normal growth and development of bone in children and adolescents have been established. Vitamin D intake may be inadequate in sub-groups of children and adolescents in a number of EU countries.

The following wording reflects the available scientific evidence: “vitamin D is needed for normal growth and development of bone in children”.

The Panel considers that in order to bear the claim a food should be at least a source of vitamin D as per Annex to Regulation 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is children and adolescents (up to 18 years). Tolerable Upper Intake Levels (UL) have been established for vitamin D in children and adolescents (25mg/day up to age 10 years; 50mg/day for age ≥11 years).