Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the Commission related to creatine monohydrate for use in foods for particular nutritional uses.


Food additives, flavourings, processing aids and materials in contact with food (AFC)
Food Additives and Nutrient Sources added to food (ANS)
Panel Members
R. Anton, S. Barlow, D. Boskou, L. Castle, R. Crebelli, W. Dekant, K.-H Engel*, S. Forsythe, W. Grunow, J.-C. Larsen, C. Leclercq, W. Mennes, M.-R. Milana, I. Rietjens, K. Svensson, P. Tobback, F. Toldrá.

The AFC Panel wishes to thank Andrea Palou for his contribution to the draft opinion.

Opinion of the Scientific Committee/Scientific Panel
Question Number
17. Februar 2004
26. April 2004
Last Updated
26. April 2004. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy
Article (155.06 KB)155.06 KB

No abstract available


The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to provide a scientific opinion, based on its consideration of the safety and bioavailability of the nutrient source, creatine monohydrate, when used in the manufacture of foods for particular nutritional uses.

Creatine occurs in the body, with higher concentrations in muscles. It can be obtained from the diet, predominantly meat and fish, and can be synthesized endogenously in the pancreas, kidneys and the liver from the amino acids glycine, arginine and methionine at the rate of 1-2 g/day.

A previous opinion from Scientific Committee on Food (SCF) expressed in 2000 considered the existing evidence as insufficient to provide reassurance about the safety of creatine supplementation involving high loading doses. It was indicated that little information exists on long-term safety of creatine, and that adequate quality control and adequate specifications for food grade materials should be developed.

A high purity (minimum 99.95%) source of creatine monohydrate is considered here. It is produced under conditions that prevent microbiological and heavy metals contamination, and acceptable limits for the impurities creatinine, dicyandiamide and dihydro-1,3,5-triazine are obtained.

The safety and bioavailability of the requested source of creatine, creatine monohydrate in foods for particular nutritional uses, is not a matter of concern provided that there is adequate control of the purity of this source of creatine with respect to dicyandiamide and dihydro-1,3,5-triazine derivatives. The Panel endorses the previous opinion of the SCF that high loading doses of creatine should be avoided. Provided high purity creatine monohydrate is used in foods for particular nutritional uses, the Panel considers that the consumption of doses of up to 3g/day of supplemental creatine, similar to the daily turnover rate of creatine, is unlikely to pose any risk.

Creatine monohydrate, Foods for particular nutritional uses (FPNU), CAS Registry Number 6020-87-7