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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

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-lysine in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses 1000, 2000, 2500, 2750 and 3000 mg/day L-lysine in food supplements are unlikely to cause adverse health effects. • In adolescents (14 to< 18 years), the specified doses 1000, 2000, 2500, 2750 and 3000 mg/day L-lysine in food supplements are unlikely to cause adverse health effects. • In children (10 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-creatine in food supplements. VKM concludes that: • In adults (> 18 years) a daily dose of 3.0 g/day creatine in food supplements is unlikely to cause adverse health effects. Doses of 5.0, 10.0 and 24.0 g/day creatine in food supplements may represent a risk of adverse health effects. • 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.

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-tyrosine in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses of 1250, 1500, 1750, and 2000 mg/day Ltyrosine in food supplements 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 CLAs in food supplements. VKM concludes that: • In adults (≥18 years), the specified doses 3.0, 3.25 and 3.5 g/day CLAs in food supplements are considered to be unlikely to cause adverse health effects if used for up to six months. • CLA may cause lipid- and carbohydrate disturbances in obese men with metabolic syndrome as well as in overweight/obese subjects with type 2 diabetes. • Use of CLA supplements in lactating and pregnant women may cause reduction in milk production and in the content on milk fat and cause decreased birth weight andlength in their off-springs. • No conclusion can be made for children and adolescents. • Data are insufficient to conclude regarding use of CLAs for more than six months.

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

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of vitamin C and calcium in the Norwegian population. VKM has also conducted scenario estimations to illustrate the consequences of amending maximum limits for vitamin C (to 100, 300, 500, 600, 800 or 1000 mg/day) and calcium (to 800, 1200 or 2000 mg/day) in food supplements.

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

Seasonings and condiments can be candidate vehicles for micronutrient fortification if consumed consistently and if dietary practices ensure bioavailability of the nutrient. In this review, we identify factors that may affect the bioavailability of iron, vitamin A, zinc, and folic acid when added to seasonings and condiments and evaluate their effects on micronutrient status. We take into consideration the chemical and physical properties of different forms of the micronutrients, the influence of the physical and chemical properties of foods and meals to which fortified seasonings and condiments are typically added, and interactions between micronutrients and the physiological and nutritional status of the target population. Bioavailable fortificants of iron have been developed for use in dry or fluid vehicles. For example, sodium iron ethylenediaminetetraacetic acid (NaFeEDTA) and ferrous sulfate with citric acid are options for iron fortification of fish and soy sauce. Furthermore, NaFeEDTA, microencapsulated ferrous fumarate, and micronized elemental iron are potential fortificants in curry powder and salt. Dry forms of retinyl acetate or palmitate are bioavailable fortificants of vitamin A in dry candidate vehicles, but there are no published studies of these fortificants in fluid vehicles. Studies of zinc and folic acid bioavailability in seasonings and condiments are also lacking. publishedVersion

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

Background and objectiveInfants and young children in low to middle-income countries are at risk for adverse neurodevelopment due to multiple risk factors. In this study, we sought to identify stimulation and learning opportunities, growth, and burden of respiratory infections and diarrhea as predictors for neurodevelopment.MethodsWe visited 422 North Indian children 6 to 30 months old weekly for six months. Childhood illnesses were assessed biweekly. At end study, we assessed neurodevelopment using the Ages and Stages Questionnaire 3rd ed. (ASQ-3) and gathered information on stimulation and learning opportunities. We identified predictors for ASQ-3 scores in multiple linear and logistic regression models.ResultsWe were able to explain 30.5% of the variation in the total ASQ-3 score by the identified predictors. When adjusting for child characteristics and annual family income, stimulation and learning opportunities explained most of the variation by 25.1%. Height for age (standardized beta: 0.12, pConclusionOur results support the importance of early child stimulation and general nutrition for child development. Our study also suggests that diarrhea is an additional risk factor for adverse neurodevelopment in vulnerable children.

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.

Objectives Deficiencies of vitamin B12 and folate are associated with delayed development and neurological manifestations. The objective of this study was to measure the effect of daily supplementation of vitamin B12 and/or folic acid on development in young North Indian children. Methods In a randomized, double blind trial, children aged six to 30 months, received supplement with placebo or vitamin B12 and/or folic acid for six months. Children were allocated in a 1:1:1:1 ratio in a factorial design and in blocks of 16. We measured development in 422 children by the Ages and Stages Questionnaire 3rd ed. at the end of the intervention. Results Compared to placebo, children who received both vitamin B12 and folic acid had 0.45 (95% CI 0.19, 0.73) and 0.28 (95% CI 0.02, 0.54) higher SD-units in the domains of gross motor and problem solving functioning, respectively. The effect was highest in susceptible subgroups consisting of stunted children, those with high plasma homocysteine (> 10 μmol/L) or in those who were younger than 24 at end study. With the exception of a significant improvement on gross motor scores by vitamin B12 alone, supplementation of either vitamin alone had no effect on any of the outcomes. Conclusion Our findings suggest that supplementation of vitamin B12 and folic acid benefit development in North Indian Children. Trial Registration ClinicalTrials.gov NCT00717730 publishedVersion

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.