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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 of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactobacillus helveticus Rosell-52 ND, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. helveticus Rosell-52 ND was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. helveticus Rosell-52 ND in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. helveticus Rosell-52 ND, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. helveticus Rosell-52 ND causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactobacillus salivarius W24, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. salivarius W24 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. salivarius W24 in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. salivarius W24, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. salivarius W24 causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactobacillus delbrueckii subsp. bulgaricus, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. delbrueckii subsp. bulgaricus was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. delbrueckii subsp. bulgaricus in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. delbrueckii subsp. bulgaricus, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. delbrueckii subsp. bulgaricus causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis for regulation of 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 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 a risk assessment of Lactobacillus acidophilus W37, Lactobacillus acidophilus DDS-1, Lactobacillus acidophilus La-5 and Lactobacillus acidophilus La-14 based on previous risk assessments and also publications retrieved from literature search. The risk of the Lactobacillus strains listed above was assessed for the general population. However, in previous assessments of probiotics published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups with mature gastro-intestinal tract. VKM has also assessed the risk of L. acidophilus W37, L. acidophilus DDS-1, L. acidophilus La-5 and L. acidophilus La-14 in food supplements and other foods independent of the dose and have assessed exposure in general terms. VKM concludes that it is unlikely that L. acidophilus W37, L. acidophilus DDS-1, L. acidophilus La-5 and L. acidophilus La-14 would cause adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactobacillus casei W56, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. casei W56 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. casei W56 in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. casei W56, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. casei W56 causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis for regulation of 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 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 a risk assessment of Lactobacillus rhamnosus Rosell-11 ND, Lactobacillus rhamnosus W71, Lactobacillus rhamnosus GG and Lactobacillus rhamnosus Lr-329 based on previous risk assessments and also publications retrieved from literature search. The risk of the Lactobacillus strains listed above was assessed for the general population. However, in previous assessments of probiotics published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups with mature gastro-intestinal tract. VKM has also assessed the risk of L. rhamnosus Rosell-11 ND, L. rhamnosus W71, L. rhamnosus GG and L. rhamnosus Lr-329 in food supplements and other foods independent of the dose and have assessed exposure in general terms. VKM concludes that it is unlikely that L. rhamnosus Rosell-11 ND, L. rhamnosus W71, L. rhamnosus GG and L. rhamnosus Lr-329 would cause adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis for regulation of 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 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 a risk assessment of Lactobacillus plantarum W62, Lactobacillus plantarum 299v and Lactobacillus plantarum HEAL9 based on previous risk assessments and also publications retrieved from literature search. The risk of the Lactobacillus strains listed above was assessed for the general population. However, in previous assessments of probiotics published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups with mature gastro-intestinal tract. VKM has also assessed the risk of L. plantarum W62, L. plantarum 299v and L. plantarum HEAL9 in food supplements and other foods independent of the dose and have assessed exposure in general terms. VKM concludes that it is unlikely that L. plantarum W62, L. plantarum 299v and L. plantarum HEAL9 would cause adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactobacillus paracasei 8700:2, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. paracasei 8700:2 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal flora (age group 0-36 months), population with mature gastro-intestinal flora (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. paracasei 8700:2 in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. paracasei 8700:2, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. paracasei 8700:2 causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut flora and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Bacillus coagulans, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of B. coagulans was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of B. coagulans in food supplements independent of the dose and have assessed exposure in general terms. Other sources of B. coagulans, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that B. coagulans causes adverse health effects in the general healthy population with mature gastro-intestinal tract. Acquired resistance genes have been detected in this species and the assessment of susceptibility to antibiotics for each single strain is required. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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 L-proline in food supplements are unlikely to cause adverse health effects. In adolescents (14 to, NO; PDF; vkm@vkm.no

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 L-tyrosine in food supplements may represent a risk of adverse health effects. In adolescents (14 to, NO; PDF; vkm@vkm.no

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, NO; PDF; vkm@vkm.no

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, NO; PDF; vkm@vkm.no

According to information from NFSA, L-citrulline is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of 1000, 1500 and 2000 mg/day of L-citrulline in food supplements. The values used for comparison with the estimated exposures in the risk characterization are 65 mg/kg bw per day for children (10 to, NO; PDF; vkm@vkm.no

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., NO; PDF; vkm@vkm.no

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 glycine in food supplements. VKM concludes that: In adults (≥18 years), the specified doses 20, 50, 100, 300, 500 and 650 mg/day of glycine from food supplements are unlikely to cause adverse health effects. In adolescents (14 to, NO; PDF; vkm@vkm.no

In this study the relationships between perceived social support, self-regulation and consuming behaviors of tobacco and other psychoactive substances we investigated. The sample consisted of 340 adult participants. Social support correlated positively with self-regulation, but was solely in the aspect of satisfaction with social support that this trend was noted clearly. The number of support providers differed considerably with the use of tobacco, which suggests the affiliative scope of some psychoactive substances. Accordingly, the use of tobacco may be associated with a larger social network, but not with the quality of social support. Neste estudo, investigaram-se as relações entre suporte social percebido, auto-regulação e comportamentos de consumo de álcool, tabaco e outras substâncias psicoactivas. A amostra foi constituída por 340 participantes. O suporte social correlacionou-se favoravelmente com a auto-regulação, mas somente na vertente de satisfação com o apoio social é que se observou esta tendência de forma evidente. O número de figuras de apoio diferenciou-se significativamente com o uso de tabaco, o que sugere o âmbito afiliativo de algumas substâncias psicoactivas. Nesse sentido, o uso de tabaco pode estar associado a uma rede social mais ampla, mas não com a qualidade do suporte social. Neste estudo, investigaram-se as relações entre suporte social percebido, auto-regulação e comportamentos de consumo de álcool, tabaco e outras substâncias psicoactivas. A amostra foi constituída por 340 participantes. O suporte social correlacionou-se favoravelmente com a auto-regulação, mas somente na vertente de satisfação com o apoio social é que se observou esta tendência de forma evidente. O número de figuras de apoio diferenciou-se significativamente com o uso de tabaco, o que sugere o âmbito afiliativo de algumas substâncias psicoactivas. Nesse sentido, o uso de tabaco pode estar associado a uma rede social mais ampla, mas não com a qualidade do suporte social.

Resumo Neste estudo, investigaram-se as relações entre suporte social percebido, auto-regulação e comportamentos de consumo de álcool, tabaco e outras substâncias psicoactivas. A amostra foi constituída por 340 participantes. O suporte social correlacionou-se favoravelmente com a auto-regulação, mas somente na vertente de satisfação com o apoio social é que se observou esta tendência de forma evidente. O número de figuras de apoio diferenciou-se significativamente com o uso de tabaco, o que sugere o âmbito afiliativo de algumas substâncias psicoactivas. Nesse sentido, o uso de tabaco pode estar associado a uma rede social mais ampla, mas não com a qualidade do suporte social. Abstract In this study the relationships between perceived social support, self-regulation and consuming behaviors of tobacco and other psychoactive substances we investigated. The sample consisted of 340 adult participants. Social support correlated positively with self-regulation, but was solely in the aspect of satisfaction with social support that this trend was noted clearly. The number of support providers differed considerably with the use of tobacco, which suggests the affiliative scope of some psychoactive substances. Accordingly, the use of tobacco may be associated with a larger social network, but not with the quality of social support.

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Streptococcus thermopilus, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of S. thermophilus was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal flora (age group 0-36 months), population with mature gastro-intestinal flora (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of S. thermophilus in food supplements independent of the dose and have assessed exposure in general terms. Other sources of S. thermophilus, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that S. thermophilus causes adverse health effects in the general healthy population with mature gastro-intestinal tract. Acquired resistance genes have been detected in this species and the assessment of susceptibility to antibiotics for each single strain is required. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut flora and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

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. These risk assessments will provide NFSA with the scientific basis while 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 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 a risk assessment of Lactococcus lactis W58, and it is based on previous risk assessments and articles retrieved from a literature search. The risk of L. lactis W58 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. lactis W58 in food supplements independent of the dose and have assessed exposure in general terms. Other sources of L. lactis W58, such as foods, have not been included in the present risk assessment. VKM concludes that it is unlikely that L. lactis W58 causes adverse health effects in the general healthy population with mature gastro-intestinal tract. However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development., NO; PDF; vkm@vkm.no

The Norwegian Food Safety Authority (NFSA) requested the Norwegian Scientific Committee for Food Safety (VKM) to prepare a guidance document outlining the methodology to be used for the safety assessments of microorganisms used as “other substances”., NO; PDF; vkm@vkm.no

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 daily intake of 300, 600 and 900 mg of curcumin in food supplements. For the risk characterisation, the value used for comparison with the estimated exposure are the ADI of 3 mg/kg bw per day, based on a multigeneration reproductive toxicity study in rats. VKM concludes that a daily intake of 300, 600 or 900 mg of curcumin in food supplements may represent a risk of adverse health effects in children (10 to, NO; PDF; vkm@vkm.no

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-glutamine and L-glutamic acid in food supplements. VKM concludes that: L-glutamine In adults (≥18 years), the specified doses of 3500, 5000, 8000, 10000, 12000, 15000 and 16500 mg/day L-glutamine in food supplements are considered unlikely to cause adverse health effects. In adolescents (14 to L-glutamic acid In adults (≥18 years), the specified doses of 1000, 2000, 3000, 4000, 5000 and 5500 mg/day L-glutamic acid in food supplements are considered unlikely to cause adverse health effects. In adolescents (14 to, NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of intake of 3100 mg pe day and 6200 mg per day of D-ribose in food supplements. In the risk characterization, the values used for comparison with the estimated exposure are 20 g per day (corresponding 286 mg/kg bw per day in a 70 kg adult) from the human studies and a NOAEL of 3.6 g/kg bw per day from the subchronic toxicity and embryotoxicity/teratogenicity studies in rats. VKM concludes that it is unlikely that daily doses of 3100 mg or 6200 mg D-ribose in food supplements causes adverse effects in children (10 to, NO; PDF; vkm@vkm.no

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, NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of intake of 1.5 mg/day of piperine ((E,E)-piperine) in food supplements. Piperine is a naturally occurring alkaloid which is the major pungent compound found in spices like black pepper (Piper nigrum L.) and long peppers (Piper longum L.). Using the MOE approach, for a daily intake of 1.5 mg piperine from food supplements and a NOAEL of 5 mg/kg bw per day based on a 90-day toxicity study in rats, the MOE values are 145, 204 and 234 for children (10 to, NO; PDF; vkm@vkm.no

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)., NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of lycopene in food supplements. For the risk characterisation, the value used for comparison with the estimated exposure is the ADI of 0.5 mg/kg bw per day established by EFSA. An ADI is set to cover the general population, including children. The ADI was used for comparison with the estimated exposure in the risk characterization. VKM concludes that it is unlikely that a daily dose of 10 mg lycopene from food supplements causes adverse health effects in children (10 to, NO; PDF; vkm@vkm.no

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 and length 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., NO; PDF; vkm@vkm.no

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 L-phenylalanine and DL-phenylalanine in food supplements. VKM concludes that: In adults (≥ 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 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., NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of intake of 3 g/day of inulin in food supplements. In the risk characterization, the intake of 5 g/day of inulin from agave and Jerusalem artichoke and 10 g/day of inulin from chicory root and globe artichoke (corresponding to 71 and 143 mg/kg bw per day, respectively, in a 70 kg adult) were chosen as the values for comparison. No specific studies on children (10 to, NO; PDF; vkm@vkm.no

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