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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature: review (EFSA's Scientific Opinion). Used for read across purposes.

Data source

Reference
Reference Type:
review article or handbook
Title:
Scientific Opinion on the Tolerable Upper Intake Level of calcium
Author:
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Year:
2012
Bibliographic source:
EFSA Journal, 10(7):2814

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not applicable. This is a a review performed by the Europan Food Safety Authority (EFSA). The safety of calcium was re evaluated in order to estimate revised Tolerable Upper Intake Levels (ULs).
GLP compliance:
no
Remarks:
not applicable for reviews

Test material

Constituent 1
Reference substance name:
Calcium
EC Number:
231-179-5
EC Name:
Calcium
Cas Number:
7440-70-2
IUPAC Name:
calcium
Details on test material:
Not applicable

Results and discussion

Applicant's summary and conclusion

Conclusions:
EFSA concludes that the safe exposure level of 2500 mg calcium/day established before by SCF, does not need any further refinement, based on the most recent data. The level covers adults, including pregnant and lactating women. A UL for infants, children and adolescents could not be set, based on the hitherto available information.
Executive summary:

The summary presented below is the original abstract of the review:

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to re-evaluate the safety in use of calcium. The Panel was requested to consider if the Tolerable Upper Intake Level (UL) for calcium established by the SCF in 2003 (2,500 mg/day for adults, including pregnant and lactating women), which was based on different intervention studies of long duration in which total daily calcium intakes of 2,500 mg from both diet and supplements were tolerated without adverse effects, needed to be changed on the basis of new available evidence. A number of placebo controlled human intervention studies in adults published since then also showed that total daily calcium intakes of 2,500 mg from both diet and supplements are tolerated without adverse effects. The Panel considers that no relationship has been established between long-term calcium intakes from diet and supplements and increased risk of nephrolithiasis, cardiovascular disease or prostate cancer. No new data have become available which would require a revision of the UL for calcium for adults, including pregnant and lactating women, of 2,500 mg. No new data have become available which would allow the setting of a UL for infants, children or adolescents. Data from European populations indicate that intakes of calcium in high consumers among adult males can be close to the UL. Although available data do not allow the setting of a UL for infants, children or adolescents, no risk has been identified with highest current levels of calcium intake in these age groups.