From the US Food and Drug Administration and
the European Food Safety Authority
FDA
Safety notice
Based on the information that AlzChem provided, as well as other information available to FDA, we have no questions at this time regarding AlzChem’s conclusion that creatine monohydrate is GRAS under its intended conditions of use.
EFSA
Health claims
Scientific Opinion on the substantiation of health claims related to creatine and increase in physical performance during short-term, high intensity, repeated exercise bouts, increase in endurance capacity, and increase in endurance performance pursuant to Article 13(1) of Regulation (EC) No 1924/200
EFSA
Creatine monohydrate
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
EFSA
Attention and memory
Scientific Opinion on the substantiation of health claims related to creatine and increased attention and improvement of memory pursuant to Article 13(1) of Regulation (EC) No 1924/200
EFSA
Creatine and exercise
Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/200
FDA
Safety notice
Based on the information thatAlzChem provided, as well as otherinformation available
to FDA, we have no questions at this time regarding AlzChem’s conclusionthat creatine
monohydrate is GRAS under its intended conditions of use
EFSA
Creatine monohydrate
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.
EFSA
Health claims
Scientific Opinion on the substantiation of health claims related to creatine and increase in physical performance during short-term, high intensity, repeated exercise bouts (ID 739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924), increase in endurance capacity (ID 1527, 1535), and increase in endurance performance (ID 1521, 1963) pursuant to Article 13(1) of Regulation (EC) No 1924/2006.
EFSA
Attention and memory
Scientific Opinion on the substantiation of health claims related to creatine and increased attention (ID 1524) and improvement of memory (ID 1528) pursuant to Article 13(1) of Regulation (EC) No 1924/2006.
EFSA
Creatine and exercise
Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Targets
Follow food laws in concert with broader food control system to set technical provision for fortified foods
General considerations
Decide on composition (such as range of foods, range of creatine levels and chemical forms, minimum-maximum levels), labeling and advertising (e.g., nutrition and health-related claims, declaration), and trade issues.
International regulatory context
Comply with the Codex Alimentarius and TBT Agreement.