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Short summary At the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of specified doses of L-threonine in food supplements. VKM concludes that:  In adults (≥18 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects.  In adolescents (14 to

Short summary At the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of specified doses of L-aspartic acid in food supplements. VKM concludes that: In adults (≥18 years), adolescents (14 to < 18 years) and children (10 to < 14 years), the specified doses 3000, 3500, 4000, 4500, 5000 and 5700 mg/day L-aspartic acid in food supplements may represent a risk of adverse health effects.

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 associated with magnesium in food supplements. VKM is requested to evaluate upper tolerable intake levels for magnesium and high and low intakes in the Norwegian population. Pending establishment of common maximum limits in the EU, the NFSA is evaluating the national maximum limits for vitamins and minerals in food supplements. This risk assessment is the scientific basis for NFSA's evaluation of national limits for magnesium.

At the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of daily doses of 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements. In the absence of long-term studies in healthy individuals, VKM used a NOAEL of 3000 mg/kg bw per day from a 90-days toxicological study in rodents. • In adults (≥18 years), the specified doses 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements are unlikely to cause adverse health effects. • In adolescents (14 to < 18 years), the specified doses 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements are unlikely to cause adverse health effects. • In children (10 to < 14 years), the specified doses 50, 500, 1000, 1500 and 1800 mg/day L-serine in food supplements are unlikely to cause adverse health effects.

At the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of specified doses of L-histidine in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses 550 and 600 mg/day L-histidine in food supplements are unlikely to cause adverse health effects. • In adolescents (14 to

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 and energy drinks sold in Norway. VKM has assessed the risk of doses given by the NFSA. These risk assessments will provide the NFSA with the scientific basis for regulating the addition of “other substances” tofood 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 or physiological effect. They areadded 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 claimed beneficial effects from these substances, only possible adverse effects. The present report is limited to the use of L-glutamine and L-glutamic acid in food supplements. Risks related to glutamine and glutamic acid added to food and drinks, protein hydrolysates or high dietary protein intake are outside the scope of the opinion. The report is based on previous risk assessments of glutamine and glutamic acid and scientific papers retrieved from a comprehensive literature search.

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of specified doses of L-arginine and arginine alpha-ketoglutarate in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses of 3000, 3500, 4000, 4500, 5000, 5500 and 6000 mg/day of arginine in food supplements are considered unlikely to cause adverse health effects. The dose 6800 mg/day may represent a risk of adverse health effects. • In adolescents (14 to

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of specified doses of L-leucine, L-isoleucine and L-valine in food supplements. VKM concludes that: Due to lack studies addressing adverse effects of the specified doses 2500, 3000, 4000, 5000 and 5250 mg/day L-leucine, 1500, 1750, 2000 and 2500 mg/day L-isoleucine and 1500, 1750, 2000, 2250 and 2500 mg/day L-valine in food supplements, no conclusions can be made for adults (≥ 18 years), adolescents (≥ 10 and < 18 years) or children (< 10 years).

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of specified doses of L-tryptophan in food supplements. VKM concludes that the specified doses 250 mg/day, 300 mg/day, and 450 mg/day tryptophan may represent a risk of adverse health effects in adults (≥18 years), adolescents (14 to

At the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of specified doses of L-proline in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses 50, 500, 1000, 1500 and 1800 mg/day Lproline in food supplements are unlikely to cause adverse health effects. • In adolescents (14 to < 18 years), the specified doses 50, 500, 1000, 1500 and 1800 mg/day L-proline in food supplements are unlikely to cause adverse health effects. • In children (10 to < 14 years), the specified doses 50, 500, 1000, 1500 and 1800 mg/day L-proline in food supplements are unlikely to cause adverse health effects.

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

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of specified doses of L-cysteine and L-cystine in food supplements. VKM concludes that:  In adolescents (14 to

The Norwegian Scientific Committee for Food Safety (VKM) received a request from the Norwegian Food Safety Authority to assess whether the Tolerable Upper Intake Level (UL) of folic acid should be amended in light of new scientific evidence suggesting a possible link between high intake levels of folic acid and risk of cancer. Folic acid obtained from both food supplements and fortified foods should be assessed. Folic acid is a synthetic form of folate and is commonly used in food supplements and in food fortification because of its stability and bioavailability. Folic acid is reduced, methylated and released into the circulation. Natural folates occur in reduced forms, e.g. as tetrahydrofolate (THF), which are unstable and may thus loose biochemical activity during harvesting, storage, processing, and preparation.

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in food supplements. VKM concludes that: • The specified doses of 1500, 1750 or 1825 mg/day of EPA in food supplements are unlikely to cause adverse health effects in adults (≥18 years). Due to few studies in children and adolescents, no conclusion can be drawn for these groups for EPA. • The specified doses of 1050 and 1290 mg/day of DHA in food supplements are unlikely to cause adverse health effects in the general population including children (≥10 years), adolescents and adults (≥18 years). • No dosage of DPA in food supplements can be evaluated due to lack of data. It is emphasised that this risk assessment concerns the single fatty acids EPA, DPA or DHA separately and not mixtures of these as found in e.g. fish oil and cod liver oil.

Beta-carotene is a provitamin, i.e. a precursor of vitamin A (retinol), which is classified as an essential nutrient for humans. Beta-carotene is one of many carotenoids found in plants, fungi and bacteria. Carotenoids are therefore predominantly obtained through foods of plant origin or food supplements. Carrots contribute approximately half of the total beta-carotene intake in the Norwegian diet, followed by mixed frozen vegetables, tomatoes, fruits and berries. VKM emphasises that this opinion on upper level (UL) for beta-carotene addresses beta-carotene in food supplements only. Beta-carotene from regular foods such as vegetables and fruits is not considered to be a health concern. In 2002, the Scientific Committee on Food (SCF) established a tolerable upper intake level (UL) for vitamin A (SCF, 2002). However, the SCF opinion covers only retinol compounds (various forms of vitamin A). The bioconversion of carotenoids to vitamin A in the body is well regulated and therefore only intake of vitamin A has been considered relevant for vitamin A toxicity (Blomhoff et al., 2003; EFSA, 2008). The Norwegian Food Safety Authority is considering whether beta-carotene should be regulated separately from retinol compounds.