Enclosed one will find the General Recognition of Safety Notice for Creatine Monohydrate as
source of creatine in FDA regulated food as submitted by AlzChem Trostberg GmbH.
On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of creatine in combination with resistance training andimprovement in muscle strength in adults over the age of 55.
This opinion addresses the scientific substantiation of health claims in relation to creatine and increase in physical performance during short-term, high intensity, repeated exercise bouts, increase in endurance capacity, and increase in endurance performance. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.
On the basis of the data presented, the Panel concludes that the food constituent, creatine, which is the subject of the health claims, is sufficiently characterized. A cause and effect relationship has not been established between the consumption of creatine and increased attention. A cause and effect relationship has not been established between the consumption of creatine and improvement of memory.
Provided high purity creatine monohydrate is used in foods for particular nutritional uses, the Panel considers that the consumption of doses of up to 3 g/day of supplemental creatine, similar to the daily turnover rate of creatine, is unlikely to pose any risk.