Risk Assessment of "Other Substances" – Creatine

ABSTRACT

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis for regulating the addition of "other substances" to food supplements and other foods. "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/ or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any potential beneficial effects from these substances, only possible adverse effects. The present report is a risk assessment of creatine as food supplement, and is based on previous risk assessments and articles retrieved in literature searches. According to information from the Norwegian Food Safety Authority (NFSA), creatine is an ingredient in food supplements sold in Norway, and NFSA has requested a risk assessment of the following doses of creatine in food supplements 3.0, 5.0, 10.0 and 24.0 g/day. The average daily intake from the diet is about 1 g creatine, and the endogenous production also amounts to about 1 g/day. Most of the creatine supplements are in the form of creatine monohydrate. Creatine is an organic acid occurring in the body as either phosphocreatine (2/3) or as free creatine (1/3). Phosphocreatine provides phosphate groups for synthesis of adenosine triphosphate, the major energy-providing compound in the body. Previous risk assessments (AESAN, 2012; EFSA, 2004; SCF, 2000; VKM, 2010) all concluded that creatine supplementation with 3.0 g/day is unlikely to cause adverse health effects in adults. This is supported by human and animal data obtained in a literature search and assessed in the present report. Most of the studies with daily creatine intake above 3 g often (i) involved few and highly trained individuals of whom some took high daily loading doses of creatine for a short period, and (ii) were designed to test clinical benefit without emphasis on possible adverse effects. VKM therefore considers that there is insufficient evidence to conclude regarding possible adverse effects at doses of creatine above 3 g/day for the general population. VKM concludes that In adults (≥ 18 years) the specified dose of 3.0 g/day creatine in food supplements is considered unlikely to cause adverse health effects. The documentation for absence of adverse health effects of doses 5.0, 10.0 and 24.0 g/day creatine in food supplements in the general population is limited. Hence, these doses may represent risk of adverse health effects in adults. In children (10-14 years) and adolescents (14-17 years), the specified doses of 3.0, 5.0, 10.0 and 24.0 g/day creatine in food supplements may represent a risk of adverse health effects. Children below 10 years were not included in the terms of reference.