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Unless comprehensive steps are taken to tackle Chronic Wasting Disease (CWD), it will continue to spread within the Norwegian cervid population. The disease will not disappear by itself. This is the main conclusion of a new risk assessment report published by the Norwegian Scientific Committee for food safety (VKM). The Norwegian Food Safety Authority (Mattilsynet, NFSA) and the Norwegian Environment Agency (Miljødirektoratet, NEA) requested the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) for a scientific opinion on Chronic wasting disease (CWD) in cervids. The project was divided into two phases, and VKM published the scientific opinion from phase I “CWD in Norway” in June 2016. The current report is the result of phase II. VKM was asked to provide updated information on food safety, aspects important for transmission of CWD within and between populations and species, and the potential origin of the disease in Norway. Moreover, VKM was asked to highlight important risk factors with regard to disease transmission, and how these risk factors might affect choice of management strategy. Finally, VKM was asked to highlight relevant management strategies from North America or elsewhere. VKM appointed a working group consisting of one member of the Panel on Microbial Ecology, one member of the Panel on Biological Hazards, and five external experts, as well as VKM`s secretariat to answer the questions from NEA and NFSA. One member of the Panel on Alien Organisms and Trade in Endangered Species (CITES), one member of the Panel on Animal Health and Welfare, as well as one member of the Panel on Biological Hazards commented on the draft report. The Panel on Biological Hazards assessed and approved the final report. Background Chronic wasting disease (CWD) is a prion disease that affects deer, moose, reindeer, and related species (cervids). Prion diseases are chronic neurodegenerative diseases that occur naturally in humans and ruminants, and are invariably fatal. Some prion diseases, such as classical scrapie in sheep and goats and chronic wasting disease (CWD) in cervids, are contagious, spreading directly between animals or via environmental contamination. In contrast, prion diseases known to affect humans are not known to be contagious. Prions are extraordinary agents consisting of misfolded protein aggregates that are remarkably stable and can remain infectious for years in the environment. Prion proteins are present in most animals, but the misfolding makes them very hard to break down. Consequently, misfolded prion proteins accumulate in the brain and eventually in other tissues, causing damage to those tissues. Until recently, CWD was only known from North America and South Korea. During a routine marking event in April 2016, a female reindeer (Rangifer tarandus) of the Nordfjella wild reindeer herd in Norway exhibited unusual behaviour, and died shortly afterwards. This unusual death was routinely investigated, and the animal was diagnosed with CWD. This was the first time CWD had been diagnosed outside North America and South Korea and the first case of natural CWD in reindeer. In addition, two moose (Alces alces) in Selbu, Norway were diagnosed with CWD in May 2016. Selbu is located approximately 300 km northeast of the Nordfjella mountain range. Currently there is considerable uncertainty regarding the nature of the CWD diagnosed in the two moose. Some of the characteristics of these cases indicate consistency with atypical prion disease, as described in domestic animals, but a final conclusion depends on the results from ongoing investigations. Following the diagnosis in reindeer, Norwegian authorities initiated a screening programme in which hunters were requested to collect tissue and the heads of dead cervids during the 2016 hunting season. Animals that had died from causes other than hunting were also tested for CWD. Since March 2016, 4629 samples of moose, 2550 samples of red deer, 627 samples of roe deer, 860 samples of reindeer, 2494 semi-domesticated reindeer, 163 farmed deer and 104 samples of unidentified species were tested for CWD. Two additional cases of CWD were diagnosed in wild reindeer in the Nordfjella population. Together with a clinical, pathological and epidemiological picture consistent with contagious CWD, as described from North America, this indicated that there is an ongoing outbreak of CWD in the wild reindeer population of the northern part of Nordfjella wild reindeer range. Results An increase in the distribution and prevalence of CWD will increase exposure of other species, including domestic animals and humans, to this infectious agent. There is currently no evidence indicating transmission of CWD to domestic animals or humans, either by direct contact with cervids, cervid meat, or other products from cervids, or through the environment. VKM continues to support the conclusion from phase I concerning food safety of meat from cervids, that the zoonotic risk of CWD (transmission to humans) is very low. Preliminary results from characterisation of the moose cases and the agent involved indicate that important features deviate significantly from those found in the reindeer and in North American cervids, raising uncertainty with regards to the zoonotic potential. Therefore, based on the data currently available, VKM is not able to reach an evidence-based conclusion regarding the food safety of meat from moose and other cervids infected with this potentially new variant of CWD. Whereas direct transmission (animal-to-animal) seems most important in the early phases of a CWD epizootic, the role of indirect transmission (from the environment) increases as the prevalence increases. Once contagious CWD is established, it is very likely that the disease will increase in prevalence within the affected population and spread to contact populations. The rate of increase in prevalence, the resulting impact in a given population, and the efficacy of spread will depend on a range of environmental factors, and the characteristics of the species and population in question. For example, in affected populations of a gregarious species like reindeer, CWD is likely to lead to population decline in the long-term. Experiences from North America indicate that prions aggregate in the environment, making eradication of the disease extremely difficult once it has been allowed to develop and become endemic. It is therefore important that efficient measures are implemented at the earliest opportunity in order to have a realistic chance of eradicating local occurrence of CWD and preventing further spread. Contagious CWD found in a confinable population, such as many wild reindeer herds, should be managed by eradication of the host population, fallowing of the area (> 5 years), and restocking from a healthy population. The report explains that culling of the Nordfjella reindeer herd is a necessary, immediate response to the current situation. However, as part of an adaptive management strategy, this measure should be under active review and may be revised in the event that new cases of CWD are discovered. In contrast, in continuous populations, such as most red deer, moose, and roe deer populations, spatially targeted culling within a defined containment zone should be used to control a CWD outbreak. Confinement of CWD-infected populations should be increased where possible and contact with other populations of cervids restricted, for example by fencing, herding, enhancing natural or man-made obstacles, or decreasing the densities of the relevant cervid populations. Potential “hotspots” for disease transmission (supplementary salt-licks, supplementary feeding sites etc.) should be eliminated in areas with CWD as well as the surrounding areas, and should further be considered for other parts of the country. Precautionary measures should be implemented to prevent anthropogenic spread of the disease. Finally, increasing the national surveillance of CWD in cervids is essential to ensure that there is a comprehensive basis for future evidence-based management. This is required to ensure that cases and spread of disease are identified as soon as possible, as late discovery will limit the chances for successful eradication of CWD in Norway., NO; PDF; vkm@vkm.no

Outdoor housing and participation in sled dog races can be stressful for dogs, but there is not enough knowledge to assess the degree of risk for reduced animal welfare. That is the conclusion in a risk assessment from the Norwegian Scientific Committee for Food Safety (VKM). The Norwegian Food Safety Authority (NFSA) has requested VKM for an opinion regarding the risk of reduced animal welfare, associated with dogs kept permanently outdoors and dogs that are used for long-distance sled dog racing in Norway. Outdoor housing Permanently housing of dogs outdoors is relatively common in Norway, in particular for polar breeds and sled dogs.VKM has identified several factors why housing dogs outdoors may be stressfull for the dogs. Risk associated with weather conditions and temperature Weather conditions have been identified as a risk for dogs kept permanently outdoors. For dogs to be suited to cold weather conditions, exposed body parts should be covered by fur and the coat should be extremely thick in order to avoid frostbite and hypothermia. The temperature tolerance observed in polar dogs does not apply to mixed breeds like Alaskan husky, due to variability in the thickness and structure of insulating fur. Risk of infection and social stress With regards to outdoor housing, additional hazards were identified in association with large group housing. Keeping dogs in such conditions, irrespective of whether tethered or kept in pens, increases the risk of exposing them to pathogenic agents. Crowding dogs together may also expose them to social stress from more dominant individuals. However, scientific data on risks of reduced animal welfare associated with dogs kept permanently outdoors is scarce. The extent to which dogs tolerate being permanently kept outdoors, will largely depend on management practices. Assigning a specific risk is not possible as many factors are involved. Risk-reduction measures include access to heated rooms, daily removal of faeces, regular cleaning and disinfection of premises and equipment, and careful management of groups of dogs with stable hierarchies. Sled dogs Sled dog racing has become increasingly popular in Norway. According to the NFSA, many dogs that participate in long-distance races, such as the Finnmark Race and the Femund Race, often experience health problems. Sled dogs are subjected to strenuous physical activities, both during racing and during the training season. VKM has identified several factors why sled dog racing may reduce animal welfare. Current obligatory resting times not sufficient Insufficient recovery period could result in fatigue or even fatalities, and is therefore a significant hazard. In Norwegian sled dog races, there are rules for obligatory resting at checkpoints, ranging from 8 to 33 hours in total, depending on the length of the race. Increasing the obligatory resting time, starting with 10 hours per day, e.g. 24 hour period (which is the minimum biological requirement in dogs,) and adjusting upwards, will decrease the risk of reduced welfare. Other risk factors Low ambient temperatures do not generally represent a problem while dogs are running. Hyperthermia may become an issue in sled dogs with thick coats, especially during extensive physical work at warm winter days. Dogs demonstrating repeated vomiting during a race have an increased risk of aspiration pneumonia, may not obtain the required energy intake, and may develop more severe gastrointestinal-disorders and dehydration. Compulsory veterinary controls by appropriately experienced veterinarians should alleviate some of the risks. Gastric ulcers are often associated with strenuous physical activity. Longer and / or more frequent rest periods, together with access to adequate food and drink, can reduce the risk of reduced animal welfare. Updating guidelines and improving existing regulations The risk assessment will be used by NFSA as a scientific framework for updating “Guidelines for outdoor housing of dogs” from 2003, and compliance with the present Animal Welfare Act. This information is intended to provide a more solid scientific basis for ensuring animal welfare, better guidance for both owners and race veterinarians, and to improve existing regulations in sled dog racing. The VKM Panel on Animal Health and Welfare is responsible for the assessment., 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 intake of iron in the Norwegian population in relation to tolerable upper intake levels (ULs). The existing maximum limit for iron in food supplements is 27 mg/day. VKM has also conducted scenario calculations to illustrate the consequences of amending the maximum limit to 5, 10, 20, 30, 40 or 50 mg/day. Iron deficiency is one of the most common nutritional disorders in the world. Individuals with increased iron demand such as growing children and pregnant women, those who experience blood loss such as menstruating women are particularly at risk for the consequences or iron deficiency. Iron deficiency can lead to fatigue and anaemia. The most common adverse effects of iron supplementation are reversible gastrointestinal symptoms. Chronic iron excess can lead to iron overload which is associated with several irreversible severe health outcomes such as cancers and cardiovascular diseases. Up to 1% of the population have a genetic trait that leads to accumulation of iron and renders them more vulnerable to iron excess. An adult needs approximately 10 mg iron per day to overcome daily loss. The tolerable upper intake level (UL) for iron in adults range from 45 to 60 mg/day. However, all previous reports acknowledge the challenges in defining upper levels. The Expert Group on Vitamins and minerals (EVM), UK report provided a guidance level (GL) of 17 instead of a UL and the Nordic Nutrition Recommendations (NNR) (2012) suggested an UL of 60 mg/day, but did not suggest any clear upper levels for children. Institute of Medicine (IOM), US (2001) gives the most substantiated tolerable upper intake levels based on gastrointestinal effects, which is 40 mg/day for infants and children, regardless of age, and 45 mg/day for adolescents and adults. The Joint FAO/WHO Expert Committee on Food Additives 2003 (JECFA) also took the potential serious effects of iron overload into account and suggested a GL of 50 mg/day in adults or 0.8 mg/kg per day in children and adolescents. Because the risks and consequences from overload are significant and potentially serious, VKM suggests that the GL from JECFA (2003) is used. Using the GL from JECFA (2003), none of the suggested doses can be given to 2 or 4-year-old children, 9 year olds can add 5 mg iron from supplements, 13 year olds 20, and adults 30 mg without exceeding the guidance levels., NO; PDF; vkm@vkm.no

Nemasys C with the nematode Steinernema carpocapsae as the active organism is sought be be used as a plant production product in Norway. Nemasys C is intended for use against the codling moth (Cydia pomonella) and oriental fruit moth (Cydia molesta), the larva stage in shore flies (Ephydriae), pupal stage in large pine wevils (Hylobius abietes) and larva including; Spodoptera spp., Chrysodeixis chalcides, Mamestra brassicae and Duponchelia fovealis in greenhouses, domestic gardens, outdoor crops and lawns, orchards and forest plantations. In this regard, the Norwegian Food Safety Authority has asked for the opinion of VKM on specific issues related to the assessment of potential health and environmental risk; in particular if the nematode is naturally occurring in Norway, the potential for establishing and spreading under Norwegian conditions, possible taxonomic challenges, and potential for health risk related to its use. The assessment was finalized in January 2017 and adopted by VKM’s Panel on Plant Protection Products. VKM’s conclusions are as follows: Distribution; Evaluate if the nematode is naturally occurring in Norway Steinernema carpocapsae has been identified in a soil sample from an orchard in Western Norway (Sogn) in 2001. It is not likely that the occurrence on that location is caused by application of S. carpocapsae as a biological control agent, since this species has been applied only in a research project at a distant location in Norway in 2006, i.e. later than the species was found in Sogn. Thus, VKM considers that S. carpocapsae occurs naturally in Norway. The distribution of the species within Norway is not known, since no systematic mapping has been performed. Assess the potential for establishment and spread of the nematode under Norwegian conditions specified for use in greenhouses and outdoor cultivation. Steinernema carpocapsae may be able overwinter at least in coastal areas of Southern Norway, and therefore local establishment of the species is possible. The potential for spreading from treated areas is considered to be low because of low active mobility and low potential for reproduction in soil. A possible route for long-range transport is by anthropogenic dislocation of growing medium e.g. with potted plants. The risk of speading is lower in greenhouse cultivation than outdoor, provided that the growing medium (eg. soil) from the culture is handed properly. Consider possible taxonomic challenges related to the risk assessment The taxonomy of S. carpocapsae is well established. The nematode can be identified based on morphological characteristics and the DNA sequence of the internal transcribed spacer region of the ribosomal gene array (ITS rDNA). (Adams and Nguyen 2002). There are no taxonomic challenges related to assessment of this nematode. The human health risk for operators related to the properties of NEMASYS C and with the nematode Steinernema carpocapse as the active organism. The use of plant protection products containing entomopathogenic nematodes against insects has not been associated with health effects on humans. The symbiotic bacteria Xenohabdus spp. has not been linked to pathogenic effects in humans. It is therefore the view of VKM that the use of the nematode S. carpocapsae with the symbiotic bacteria Xenohabdus nematophilus will pose a minimal health hazard for operators., NO; PDF; vkm@vkm.no

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 Bifidobacterium lactis Bi-07, Bifidobacterium bifidum W23, Bifidobacterium longum Rosell-175, Bifidobacterium breve Rosell-70, and Bifidobacterium animalis sub. lactis Bb12 based on previous risk assessments and also publications retrieved from literature search. The risk of the Bifidobacterium 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 Bifidobacterium spp. in food supplements and other foods independent of the dose and have assessed exposure in general terms. VKM concludes that it is unlikely that B. lactis Bi-07, B. bifidum W23, B. longum Rosell-175, B. breve Rosell-70, and B. animalis sub. lactis Bb12 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@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 Food Safety Authority (NFSA) asked the Norwegian Scientific Committee for Food Safety (VKM) for an opinion of risks of reduced welfare implications associated with the different marking and tracing methods, and combinations thereof, for farmed salmonid fish, restricted to Atlantic salmon (Salmo salar) and Rainbow trout (Oncorhynchus mykiss) in Norway. A working group was established comprising members from the Panel on Animal Health and Welfare and external experts from the Institute of Marine Research, the Norwegian Institute of Nature Research, and VKM staff. The Panel on Animal Health and Welfare has reviewed and revised the draft prepared by the working group and has approved the opinion. There are environmental concerns of escaped farmed salmon interbreeding with wild fish, potentially threatening genetic integrity, and transmission of diseases. The Norwegian government intends to prevent or reduce escapes of farmed salmonids from occurring, and wishes to have those farmed fish that have escaped removed from the environment. In order to facilitate these actions, it is essential to be able to identify escaped fish. In addition, reliable methods for tracing the origin of the escaped fish are also crucial. Mandatory marking of all farmed fish in Norwegian aquaculture has therefore been suggested. On this basis, this VKM report will be used by the NFSA to evaluate which marking methods are most suitable, from both short- and long-term perspectives, in relation to the Animal Welfare Act. In order to fulfil the requirements, the marking must enable visual identification of escaped fish and also enable an individual fish to be traced back to its origin. There is no single marking system that fulfils both these criteria. A variety of marking and tracing methods are available for mass marking of farmed fish. These methods differ with regard to their suitability for actually distinguishing wild from farmed (escaped) fish in the field. External marks may be lost or fade over time. Morphology will often differ between wild and farmed fish. However, the differences are often small if the fish has escaped early in the production cycle. Reliable determination of origin, based on morphological variation, requires experience and handling of the fish. Adipose fin removal is the only definitely visible and 100 % permanent marking method, as the adipose fin does not regenerate. Marking is commonly done by attaching a tag, either externally on the surface of the fish, in tissue, or internally in the body. All marking procedures involve handling fish; this is stressful to the fish, and/or may induce pain. All marking will therefore have an impact on fish welfare. With most marking methods, the risk of reduced fish welfare decreases with time. Tracing methods differ with regard to their suitability for being used to trace the marked fish back to its origin, either on an individual level (a mark that identifies each fish) or the farm level (a mark that identifies each farm). In order to visually identify escaped fish and enable tracing back to the farm of origin, a combination of both marking and a tracing method, with sufficient number of available codes, is necessary. Visible marking methods, such as adipose fin removal, VIA tags, VIE tags, freeze branding, or injection of pigments may be used for identifying the fish. These can be combined with tracing using natural marks or the use of CW tags or PIT tags that, with varying reliability, may enable both identification of a fish on an individual level or batch level and from where it originated. Chemical marking along with all types of natural marks (i.e. scales, otoliths, biochemical or genetic composition in tissue) was evaluated as representing the lowest risk of reduced fish welfare. However, these marks require analysis after catch and sampling, in order to determine whether the fish is wild or farmed. All other marking methods presented in this report represent a high risk of reduced fish welfare during or shortly after marking. This risk is reduced to moderate for most of the methods on a long-term scale. Spraying of pigments and most externally attached tags remain a high risk of reduced welfare, on both short-term and long-term scales. VKM concluded that there are no combinations of marking and tracing methods that are feasible without an increased risk of reduced animal welfare. VKM also recognizes a number of uncertainties and data gaps related to how and to what extent the different marking methods affect may fish welfare. For example, the functional role of the adipose fin is still unclear, making evaluation difficult concerning how fin clipping affects fish long term. It must also be emphasized that, regardless of the method used to tag fish, there will always be higher risks of reduced fish welfare associated with large-scale marking as opposed to small-scale marking. VKM therefore highlights the need for more scientific documentation and suggests that marking methods should be tested in large-scale trials., 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

In 2013, VKM summarised the risk assessment of L-methionine as follows (In: Risk assessment of histidine, methionine, S-adenosylmethionine and tryptophan, ISBN: 978-82-8259-079-2) "In 2005, Institute of Medicine, US (IOM) concluded that it was insufficient data to establish a tolerable upper intake level (UL) for methionine. One relevant new animal and four human studies with methionine were identified after 2002. Two of the new studies in humans reported on methionine-loading tests. One study in infants showed serious adverse health effects in infants given a protein hydrolysate with L-methionine equivalent to 8800 mg/L. There are indications that intake of methionine during the so called acute methionine-loading test is associated with adverse health effects such as dizziness, nausea, sleepiness and decreased or increased blood pressure. In the loading test, 100 mg methionine per kg body weight is given after a 12-hour fast. This intake (100 mg/kg body weight) of L-methionine may be regarded as the lowest observed adverse effect level (LOAEL). Although IOM has concluded that no UL could be established for methionine it has been reported that use of methionine as a single amino acid may have adverse health effects. An intake at 100 mg/kg body weight of L-methionine may be regarded as a LOAEL. With a conservative approach and the use of an uncertainty factor of 10 for between people variations and a factor of 3 for the uncertainty of LOAEL, a tentative guidance level (GL) of 100/30 ~ 3 mg of L-methionine per kg body weight can be suggested. In a 70 kg man this is equivalent to an intake of 210 mg per daily dosage". In this Statement, VKM maintains the guidance level from 2013 at 210 mg methione per day., 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

Culture plants are exposed to many different pests. Only a small number of pests survive in animal stomach and in manure. Among these are a few who have limited geographic coverage today, and they can expand their area through the proliferation of gastric contents and manure from slaughterhouses for farmland. The most serious pests that can spread with slaughterhouse waste is wild oats, potato wart fungus, potato cyst nematodes and cockspur grass. However, it is uncertainty related to the probability of cockspur grass to survive through the digestive tract and manure. This is the key message in a risk assessment from the Norwegian Scientific Committee for Food Safety (VKM). Plant pests evaluated The Norwegian Food Safety Authority (NFSA) commissioned the Norwegian Scientific Committee for Food Safety (VKM) to assess if the current practice, that manure and digestive tract content from slaughterhouses are spread on adjacent farms, is a pathway for spread of plant pests to new agricultural areas. The assessment deals with manure from ruminants (cows, sheep and goats), pigs and horses. Poultry is not considered in the assessment, as they are fed concentrate only. There is no import to Norway of animals for slaughter in domestic slaughterhouses. About half the ingredients used in concentrate production is imported. The import of hay and cereal straw is very limited. The weed species evaluated were restricted to vigorous and competitive weed species, invasive alien species, and species with hard seeds that are known to be robust under anaerobic conditions. A huge number of plant pathogenic fungi, viruses and bacteria were considered in the assessment. Only phytophageous insects and mites that feed on plants that are likely to be eaten by grazing animals or harvested, were considered. VKM´s panel on plant health was responsible for the risk assessment., 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 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 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

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 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

Genetically modified LLcotton25 from Bayer CropScience expresses the bar gene from Streptomyces hygroscopicus ATCC21705 encoding the phosphinothricin-acetyl–transferase (PAT) enzyme, which confers tolerance to the active herbicide glufosinate-ammonium. Updated bioinformatics analyses of the inserted DNA and flanking sequences in LLCotton25 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the bar gene have been shown over several generations of LLCotton25. Data from field trials indicate that with the exception of the newly introduced trait, LLCotton25 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. 33-day nutritional assessment trial with broilers has not revealed adverse effects of cottonseed meal from LLCotton25. Toxicity testing of the PAT protein in a repeated-dose dietary exposure test with rats did not indicate adverse effects. The PAT protein produced in LLCotton25 does not show amino acid sequence resemblance to known toxins or IgEdependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the PAT protein will cause toxic or IgE-mediated allergic reactions to food or feed containing LLCotton25 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that LLCotton25 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that LLCotton25 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

Genetically modified cotton GHB614 from Bayer CropScience expresses a modified epsps gene (2mepsps) gene from maize encoding the enzyme 5-enolpyruvylshikimate 3-phosphate synthase (2mEPSPS), which confers tolerance to the herbicide glyphosate. Updated bioinformatics analyses of the inserted DNA and flanking sequences in GHB614 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the 2mepsps gene has been shown over several generations of cotton GHB614. Field trials indicate that with the exception of the introduced trait, cotton GHB614 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. A 42-day nutritional assessment trial with broilers did not reveal adverse effects of cottonseed meal from GHB614. The 2mEPSPS protein produced in GHB614 does not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the 2mEPSPS protein will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton GHB614 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced trait, the VKM GMO Panel concludes that cotton GHB614 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that GHB614 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

Genetically modified cotton 281-24-236 x 3006-210-23 (MXB-13) from Dow AgroSciences was produced by conventional crossing of the single-event GM-cotton cultivars 281-24-236, which expresses the cry1F and pat genes, and 3006-210-23, which expresses the cry1Ac and pat genes. The resulting stacked event cotton MXB-13 expresses all three proteins: Cry1Ac, Cry1F and the phosphinothricin-acetyl–transferase (PAT) enzyme. The Cry-proteins confer resistance against specific lepidopteran pests and the PAT-enzyme renders cotton MXB-13 tolerant to application of the herbicide glufosinate-ammonium. Updated bioinformatics analyses of the inserted DNA and flanking sequences in cotton MXB-13 have not indicated potential production of putative harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional inserts and consistent expression of the cry1Ac, cry1F and pat genes have been shown over several generations of cotton MXB-13. Data from several field trials performed in the USA indicate that with the exception of the introduced traits, cotton MXB-13 is compositionally, phenotypically and agronomically equivalent to its conventional counterparts and other cotton cultivars. A 90-day sub-chronic oral toxicity study with rats and a 42-day nutritional assessment trial with broilers have not revealed adverse effects of cottonseed meal from cotton MXB-13 compared to meal from the conventional counterpart PSC355 and other cotton cultivars. Toxicity testing of the Cry1Ac, Cry1F and PAT proteins in repeated-dose dietary exposures with mice and rats did not indicate adverse effects. The Cry1Ac, Cry1F and PAT proteins produced in cotton MXB-13 do not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor have they been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the Cry1Ac, Cry1F and PAT proteins will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton MXB-13 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced traits, the VKM GMO Panel concludes that cotton MXB-13 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterparts and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that cotton MXB-13 does not represent an environmental risk in Norway., NO; PDF; vkm@vkm.no

The Norwegian Scientific Commitee for Food Safety (VKM) appointed a working group of experts to answer a request from the Norwegian Food Safety Authority regarding health risk assessment of Lactobacillus reuteri Protectis® in a food supplement intended for use by infants and young children. The mandate of this health risk assessment was not to evaluate the health claims related to the products as such health claims are assessed by EFSA. The specific strain DSM 17938 is a “daughter strain” of the strain ATCC 55730 which was originally isolated from normal human milk. ATCC 55730 harbours two plasmids carrying transferable resistance genes against tetracycline and lincosamides respectively. The “daughter strain” DSM 17938 was established in 2008 by curing the ATCC 55730 for these plasmids, but is in all other respects claimed to be identical to ATCC 55730 and bioequivalence of the two strains has been suggested. The strain DSM 17938 was still resistant to tetracycline (although at a considerably lower level than ATCC 55730) and a number of other antibiotics, but these resistances were all considered being intrinsic by FBO. The absence of possible transferable/mobile genes has, to our knowledge, not been confirmed in later studies. We are not aware of any data indicating that L. reuteri has been the cause of serious human diseases – and none of the studies examined has reported any adverse or undesirable short time effects. It has also been used in preterm infants with dosage corresponding to the actual recommended doses - without reporting any adverse, short term reaction. There is therefore no evidence leading to consider the strain DSM 17938 at the dosage recommended as unsafe. However, more long-term data are still lacking and the long-term safety for the age groups considered in this assessment cannot be established. As evidence is accruing that the early microbial composition of the infant 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 particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, albeit still unknown, adverse effects on it’s development. As the long-term data are lacking it is not possible to answer whether the amount of the food supplement or the age of the infant or young child is of importance. However, if later long-term data should reveal any adverse reaction, it is reasonable to assume that the actual age group will be the most vulnerable. As the safety was not entirely established, the question of whether there are any vulnerable groups (i.e. premature, infants or children with diseases) where there are health risks associated with the intake of Lactobacillus reuteri Protectis®, as a food supplement was not considered., 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 (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 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.