1272.pdf

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Scientific Opinion on the substantiation of health claims related to calcium and vitamin D and maintenance of bone (ID 350) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Vitamin D   bone   calcium   health claims  
ID:    350  
Produkty: Witamina D, wapń  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is calcium and vitamin D, both of which are well recognised nutrients and are measurable in foods by established methods.
Calcium occurs naturally in foods and is authorised for addition to foods (Annex I of Regulation (EC) No 1925/2006 and Annex I of Directive 2002/46/EC). Vitamin D occurs naturally in foods as vitamin D3 (cholecalciferol). Both vitamin D3 and vitamin D2 (ergocalciferol) are authorised for addition to foods (Annex I of Regulation (EC) No 1925/2006 and Annex I of Directive 2002/46/EC). This evaluation applies to calcium and vitamin D naturally present in foods and those forms authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, calcium and vitamin D, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “bone health”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel notes that the claimed effect relates to the maintenance of normal bone.
The Panel considers that the maintenance of normal bone is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stanu kości

The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus on the roles of calcium and vitamin D in the maintenance of normal bone at all ages.
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, development and maintenance of bone is related to the quantity of dietary calcium consumed and recommended intakes of calcium to meet requirements for growth, development and maintenance of bone at all ages have been established by various authorities. Inadequate dietary calcium intake may contribute to impaired bone development in early life and to the accelerated loss of bone mass in adults and in the elderly. Available evidence indicates that calcium intakes may be inadequate in sub-groups of the population in some EU countries, especially children, women and the elderly (AAP, 1999; AFSSA, 2001; Branca, 1997; COMA, 1991; DGE, 2000; Elmadfa and Weichselbaum, 2004; FAO/WHO, 2001; FNB, 1999; Food Safety Authority of Ireland, 1999; Greer et al., 2006; JHCI, 2003; IoM, 1997; National Health and Medical Research Council, 2006; Nordic Council of Ministers, 2004; SCF, 2003; Theobald, 2005; WHO, 2003).
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. Serum 25(OH)D concentration 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 is needed to achieve a vitamin D status that is sufficient for normal bone mineralisation throughout childhood and adolescence and for bone maintenance in adults and the elderly. Sub-optimal vitamin D status has been shown to reduce bone mineral accretion in children and adolescents, and to accelerate bone loss in adults and the elderly. Recommended intakes of vitamin D to meet requirements for growth, development and maintenance of bones have been established for all life-stage groups by several expert committees. Sub-optimal vitamin D status has been reported in sub-groups of children, adolescents, adults and the elderly in a number of European countries, particularly in winter months, indicative of inadequate vitamin D intake (AFSSA, 2001; COMA, 1998; Cranney et al., 2007; Davies et al., 2005; DGE, 2000; EVM, 2002; FAO/WHO 2001; FNB, 1999; Greer et al., 2006; Holick, 2004, 2005; Nordic Council of Ministers, 2004; Norman et al., 2007; Ovesen et al., 2003; SACN, 2007; SCF, 1993, SCF 2003, WHO, 2003).
The Panel concludes that a cause and effect relationship has been established separately between the consumption of calcium and vitamin D and the maintenance of normal bone.
The Panel notes that the evidence provided does not establish that it is necessary for calcium and vitamin D to be consumed together in the same food in order to obtain the claimed effect.

4. Uwagi do zaproponowanego brzmienia oświadczenia

The Panel considers that the following wording reflects the scientific evidence: “Calcium and vitamin D are needed for the maintenance of normal bone”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claim a food should be at least a source of calcium and 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 the general population.
No Tolerable Upper Intake Levels (UL) have been established for calcium in children and adolescents; the UL for calcium in adults is 2500 mg (SCF, 2003). ULs have been established for vitamin D in children, adolescents, and adults (25µg/day up to age 10 years; 50µg/day for age ≥11 years) (SCF, 2002).

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, calcium and vitamin D, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “bone health”. The target population is assumed to be the general population. Maintenance of normal bone is beneficial to human health.
A cause and effect relationship has been established separately between the consumption of calcium and vitamin D and the maintenance of normal bone.
The following wording reflects the scientific evidence: “Calcium and vitamin D are needed for the maintenance of normal bone”.
Conditions and possible restrictions of use
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 the general population.