Risk assessment of "other substances" – L-phenylalanine and DL-phenylalanine. Opinion of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy of the Norwegian Scientific Committee for Food Safety

Abstract

At the request from the Norwegian Food Safety Authority (NFSA), the Norwegian Scientific Committee on Food Safety (VKM) has characterised the risk of specified doses of Lphenylalanine and DL-phenylalanine in food supplements. VKM concludes that: • In adults (≥ 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day Lphenylalanine in food supplements are considered unlikely to cause adverse health effects. • In adolescents (14 to < 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. • In children (10 to < 14 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. Although the highest dose provides 23 mg/kg bw per day which slightly exceeds 22.4 mg/kg bw per day, it is considered unlikely to cause adverse health effects in healthy children 10 to < 14 years. • None of the above conclusions are applicable for patients with phenylketonuria (PKU). • No conclusion can be made regarding DL-phenylalanine