Scientific Documents

Calcium and bone growth - Scientific substantiation of a health claim related to calcium 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 (27 KB)

Opinion (70 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: calcium 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 calcium which is a well recognised nutrient and is measurable in foods by established methods. Calcium occurs naturally in foods in many forms which are generally well utilised by the body. This evaluation applies to calcium 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 (i.e., calcium) is sufficiently characterised.

The claimed effect is that calcium is needed for ‘healthy 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 31 publications were considered by the applicant as pertinent to the claim, including 18 randomised controlled trials (RCT) in humans, two meta-analyses and one pooled analysis of human intervention studies, two systematic reviews and 8 guidelines/consensus opinions/text book chapters.

Reports from authoritative bodies and reviews show that there is good consensus on the role of calcium in bone growth and development. Calcium is an important structural component of bone. Adequate calcium intake throughout childhood and adolescence is needed to achieve maximum peak 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 dietary 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.

The 18 RCT presented focused on the effect of increasing calcium intake (in addition to the usual diet) from supplements or foods on bone mineral content (BMC) and bone mineral density (BMD) in children and adolescents aged 3-18 years. In these studies, both BMC and BMD generally increased with calcium supplementation. These increases were small and significant only for total body BMC and upper limb BMD, but not hip or spine BMD, and were most apparent in those children on initial low calcium intakes. The increase in BMD generally did not persist following withdrawal of supplementation. However, because of the relatively short duration of these studies (mostly 3 months to 2 years, maximum 7 years) it was not possible to establish whether the temporary acceleration in bone mineral accretion with supplementation would result in increased peak bone mass at maturity if the higher levels of calcium intake were maintained.

The Panel concludes that, on the basis of the data provided, a cause and effect relationship has been established between the intake of calcium and normal growth and development of bone in children and adolescents. Recommended intakes of calcium to meet requirements for normal growth and development of bone in children and adolescents have been established. Calcium intakes may be inadequate in sub-groups of children and adolescents in some EU countries, especially in girls.

The following wording reflects the scientific evidence: “calcium 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 calcium 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 or adolescents; the UL for calcium in adults is 2500 mg/day.