Scientific Documents

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

Summary (91 KB)

Opinion (140 KB)

Summary

Following an application from Yoplait Dairy Crest Limited submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to calcium and vitamin D and bone strength.

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

The constituents subject of the health claim are calcium and vitamin D, both of which are well recognised nutrients and are measurable in foods by established methods. This evaluation applies to calcium and 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 constituents that are the subject of the health claim (calcium and vitamin D) are sufficiently characterised.

The claimed effect is that calcium and vitamin D ‘are needed for building stronger bones’ in children and adolescents. The proposed target population for the health claim is children and adolescents (up to 18 years). Normal growth and development of bone to achieve maximum peak bone mass at maturity helps to maximise bone strength. The Panel considers that normal growth and development of bone is beneficial to children’s health.

A total of 16 publications were considered pertinent to the health claim by the applicant – 5 reports from authoritative bodies and reviews, and 11 human studies, including 8 intervention studies and three observational studies.

Reports from authoritative bodies and reviews show that there is good consensus on the roles of calcium and vitamin D in growth and development of bone.

Calcium is an important structural component of bone. Adequate calcium intake throughout childhood and adolescence is needed to achieve maximum bone mass in young adulthood which is an important determinant of bone mineral status in later life. The growth and development of bone is related to the quantity of calcium consumed and recommended intakes of calcium to meet requirements for growth and development of bone in children and adolescents have been established by various authorities. Inadequate calcium intake may contribute to impaired bone development in early life. Calcium intakes may be inadequate in sub-groups of children and adolescents in some EU countries, especially in girls.

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 in turn needed for the normal mineralisation of bone. The serum 25(OH)D, or calcidiol, level is a good marker of nutritional 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 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 many European countries, particularly in winter months, indicative of inadequate vitamin D intake.

The human observational and intervention studies support the association between serum 25(OH)D as an indicator of nutritional status for vitamin D and bone mineral density (BMD) and/or bone mineral content (BMC) in children and adolescents and an effect of combined supplementation of the usual diet with calcium and vitamin D on bone mass (BMD and BMC). There was no clear indication of a specific dose response between calcium intake or vitamin D status and BMC or BMD, and separate effects of vitamin D and calcium could not be distinguished in these studies.

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

The following wording reflects the scientific evidence: “calcium and vitamin D are 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 calcium and 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). No Tolerable Upper Intake Levels (UL) have been established for calcium in children and adolescents; the UL for calcium in adults is 2500 mg/day; UL have been established for vitamin D in children and adolescents (25mg/day up to age 10 years; 50mg/day for age ≥11 years).