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Antimicrobial resistance (AMR) in bacteria (often referred to as antibiotic resistance) is one of the major public health challenges of our time. AMR can be described as the ability of a bacterium to withstand the effects of an antimicrobial agent. In addition to antimicrobial agents used for treatment and prophylaxis in humans, animals, and plants, chemical susbtances, such as biocides and heavy metals, may also induce resistance in bacteria against antimicrobial agents used in human and veterinary medicine. In June 2016, the Norwegian Environment Agency requested the Norwegian Scientific Committee for Food Safety (VKM) to conduct a literature review regarding development of bacterial resistance to biocides and heavy metals and cross-resistance to antimicrobial agents (e.g., antibiotics) in bacteria, with the following mandate: 1. List chemical substances that may contribute to increased antimicrobial resistance. 2. Describe the substances listed in question 1 that are used/in use in Norway and assess which fields of applications that have the potential to contribute to increased resistance. 3. Range the substances according to field of application that is assumed to have the strongest effect on development of resistance, based on characteristics and amount used. 4. Identify knowledge gaps according to the effect of these substances on development of resistance. In order to answer the mandate, VKM appointed a working group consisting of two members of the Panel on Microbial Ecology, and one external expert, to prepare a draft opinion document and answer the questions. The Panel on Microbial Ecology has reviewed and revised the draft prepared by the working group and approved the opinion document “Antimicrobial resistance due to the use of biocides and heavy metals: a literature review”. A biocide is defined as an active chemical molecule that controls the growth of, or kills, bacteria and other microorganisms in a biocidal product. The biocides are classified into 4 main groups according to their application categories and further sub-divided into 23 product groups. In this assessment, we focus on biocides with potential antibacterial activity and their ability to induce antimicrobial (antibiotic) resistance in bacteria. These products belong mostly to main group 1; Disinfectants. Disinfectants include products used in human hygiene, veterinary hygiene, water treatment, and products used in the field of food and feed, but excludes cleaning products that are not intended to have a biocidal effect, including washing liquids, powders, and similar products. Heavy metals are naturally occurring elements that have a high atomic weight and a density that is at least 5 times greater than that of water. Some heavy metals have been used as antimicrobial agents since antiquity, but often their modes of action have remained unclear. They are able to induce toxicity at low levels of exposure. In this report we have chosen to include the following elements in the category “heavy metals”: silver (Ag), arsenic (As), cadmium (Cd), copper (Cu), mercury (Hg), and zinc (Zn). The selection is based on their area of use and on their ability to induce AMR. Although most biocides and heavy metals are known to be high volume products, the working group was not able to obtain detailed data on the amounts used in Norway. However, there is no doubt that the production and usage volumes and the area of application for several of these substances are several orders of magnitude higher than those of antimicrobial agents used in therapy and prophylaxis. This Opinion document is not a traditional risk assessment, but a literature study that presents and compiles the available information regarding resistance development in bacteria due to use/misuse of biocides and heavy metals. Exposure assessment and risk characterization have therefore been excluded. The following definitions regarding probability of biocides and heavy metals inducing AMR in bacteria are used: Highly likely - is expected to occur in most circumstances Likely - could occur in many circumstances Unlikely - could occur in some circumstances Highly unlikely (effectively zero) - may occur only in very rare circumstances The most commonly used chemical substances with the potential to induce AMR and cross or co-resistance in bacteria are the heavy metals, copper, zinc, and cadmium (“highly likely”). Phenols, especially triclosan, surface-active agents, especially quaternary ammonium compounds (QACs), and the heavy metals arsenic and mercury are classified in the category “likely”. The components in the “unlikely” group are aldehydes, biguanides, organic acids, inorganic acids, antimicrobial dyes, diaminides, and silver. It should be noted that a number of uncertainties are associated with assigning these substances to particular categories of probabilities/likelihoods (highly likely, likely, unlikely, and highly unlikely) in this assessment. Bacteria are living organisms that are continually changing their genetic compositions, and are able to adapt rapidly to altered living conditions. Furthermore, the concentrations of the substances to which the bacteria are exposed affects the probability of inducing resistance. This report reviews the literature describing the current situation with regards to development of resistance in bacteria due to biocides and heavy metals. The current situation and genetic and phenotypic status may change as bacteria continue to adapt to exposure to biocides/heavy metals and antimicrobial agents at varying doses, durations, and combinations. Data gaps There is a lack of knowledge regarding the diverse reservoir of AMR in the environment including soil, sediment, water, air, wild plants, and animals that are impacted by biocides and heavy metals. We have not been able to gather sufficient data on the amount of the different biocides and heavy metals that end up, unintentionally, in the environment in Norway and the extent to which such exposure, alone or in combination with other antimicrobials, may result in development of AMR in microbial communities. Furthermore, limited data are available regarding use/misuse/presence of biocides and heavy metals in consumer products. Knowledge regarding development of resistance in bacteria due to use of biocides or heavy metals in cosmetic products is lacking., NO; PDF; vkm@vkm.no

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 Environment Agency (NEA) asked the Norwegian Scientific Committee for Food Safety (VKM) to assess the risks of negative impacts on biodiversity in Norway from the import and keeping of various species of freshwater plants for aquaria and garden ponds. VKM was asked to assess: (I) species survival under Norwegian conditions, (II) possible impacts on ecosystems and other species, (III) possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites. In addition, VKM was asked to assess the likelihood of escape or release of the organisms. Possible precautionary measures, such as excluding import from certain areas or excluding certain sub-species or populations, should be included in the report. The assessment adopted a fifty-year perspective and stated for each species whether it can survive below a cut-off temperature of 5° C. This is because current legislation includes an exemption for import permit requirements for species that cannot survive below this cut-off temperature. The final report also included information on whether climate change could particularly affect the outlook for the assessed plant species beyond the specified period of 50 years. Finally, it considered whether the export of these species has any significant negative effects on biodiversity of the exporting country. VKM appointed a working group consisting of members of the Panel on Alien Organisms and Trade in Endangered Species, the VKM Secretariat, an external botanist as well as an external expert on invasive aquatic plants to answer the request to answer the request. The Panel on Alien Organisms and Trade in Endangered Species has reviewed, revised, and finally approved the report prepared by the working group. In order to address the assignment from NEA, all specified taxa were subjected to a preliminary screening followed by a risk assessment. In the preliminary screening, taxa were classified into three categories based on their area of occurrence and climatic preferences: Category 1: taxa naturally occurring in tropical climates, Category 2: taxa naturally occurring in temperate and continental climates, Category 3: taxa occurring naturally in Norway. Taxa classified as Category 1 were individually assessed for their ability to survive below 5°C. Taxa classified as Category 2 were individually risk assessed using a modified two-stage Non-native Species Application-based Risk Analysis (NAPRA) Scheme. Taxa classified as Category 3 were assessed as a group with regard to the risk that these species could transfer genetic material to locally adapted genotypes in native populations. Possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites, were assessed for all species. None of the plant species in the Terms of Reference (ToR) are reported to have acted as vectors for harmful hitchhiker organisms, including pathogens and parasites, and we therefore assessed that this risk to Norwegian biodiversity to be low. The effects of climate change beyond a 50-year perspective are difficult to predict, but no immediate change in the risks associated with the ToR species were identified as a consequence of climate change beyond a 50-year perspective. Theoretically, there is a possibility that export of some of the evaluated plant species could have a negative impact on the biodiversity of the exporting country, however all the species used for aquarium and garden ponds are taken from cultivated populations and not from wild populations. Responding to the ToR, VKM concludes that none of the Category 1 species can survive below 5° C . VKM concludes that all species in Categories 1 and 3 pose low risks to Norwegian biodiversity, in regard to species survival under Norwegian conditions, possible impacts on ecosystems and other species, and the possible risks caused by the introduction of harmful hitchhiker organisms, including pathogens and parasites. Some species in category 2 do not exhibit any characteristics related to invasiveness in their current areas of occurrence and they have a limited area of occurrence in Europe. VKM concludes that such species pose a low risk to Norwegian biodiversity in regard to points I,II and III above. Further, VKM notes that those species of Category 3 that are on the Norwegian Red List could have a negative impact on Norwegian biodiversity in regard to point II; possible impacts on ecosystems and other species. Red listed species could potentially transfer novel genetic material to locally adapted genotypes. However, the probability of Red listed species of plants escaping from aquariums or garden ponds and subsequently encounter native populations is low, and therefore VKM concludes that these species pose a low risk to Norwegian biodiversity. Finally, species in Category 2 for which a full modified NAPRA risk assessment was conducted, it is concluded that Crassula helmsii and Myriophyllum heterophyllum pose a high risk with, respectively, medium to high confidence, to Norwegian biodiversity with regard to points I, II and III. In addition, Egeria densa, Hydrilla verticillata, Lagarosiphon major, Lemna gibba, Myriophyllum aquaticum, Najas minor, andTrapa natans pose a moderate risk, with medium to high confidence depending on the species, to Norwegian biodiversity, with regard to points I, II and III . All other species are considered to pose a low risk, with low to high confidence depending on the species, to Norwegian biodiversity with regard to points I, II and III above., NO; PDF; vkm@vkm.no

The Norwegian Scientific Committee for Food Safety (VKM) was requested by the Norwegian Environment Agency in November 2015 to develop a knowledge base for assessment of the environmental risks related to the use of genetically modified (GM) virus vaccine vectors for vaccination of domesticated animals. The Agency requested that the task be conducted in the form of a desk study with the following mandate: (1) to provide a short description of GM virus vectors in use in veterinary vaccines; (2) summarize available information relevant to environmental risk assessment (ERA) of GM veterinary virus vaccines; and (3) identify environmental risk factors and knowledge gaps of relevance to ERA of GM virus vaccines within the Norwegian context. This report provides background for future environmental risk assessment of veterinary medicinal products containing or consisting of GMO for use in Norway. VKM has appointed a working group consisting of members of the Panel on Microbial Ecology and the VKM secretariat to answer the request. The VKM Panel has reviewed and revised the draft prepared by the working group and finally approved the opinion. This Report contains the findings of a desk study of current virus vectors used in GM virus vectored vaccines of domesticated livestock. A survey of the published literature for current knowledge in the area was undertaken with the aim of providing information relevant to the ERA of veterinary GM virus vectors (GM-VV). In identifying potential risk factors associated with vaccination of domesticated animals using GM-VV, focus was on the Norwegian environment, but relevant parallels were drawn from other European countries. The European Commission directive 2001/18, that regulates the deliberate release of genetically modified organisms into the environment, the European Union Regulation for approval of medicinal products (726/2004/EU), and other relevant guidelines from the European Medicines Agency (EMA) on ERA of GMOs and live recombinant vector vaccines for veterinary use served as reference documents. Virus vaccine vectors, according to the Directive 2001/18/EC, are genetically modified if they were produced using techniques of recombinant gene technology. The environment, according to the Directive, constitutes all components of the ecosystem (excluding the vaccinated animals) that could be at risk of the deliberate use (or release) of veterinary GM-VV. Enumeration of GM virus vectors was limited to those applied in domesticated livestock vaccination, but evaluation of relevant environmental risk factors of the GM vaccine vectors was extended to other animals, e.g. wild animals as well as to humans and microorganisms, as these are the at-risk non-target components of the environment. The Report, however, did not dwell extensively on risks to human health and non-domesticated animals. Nonetheless, occupational and non-occupational risk routes of handling GM-VV were briefly discussed, and parallels were drawn from the use of GM-VV to control rabies in wildlife. The DNA virus genera of poxvirus, herpesvirus and adenovirus are the most commonly employed in GM vaccine vectors for domesticated animal vaccination. Most virus vector strains are specific to the animal species, but some have been used across species. For example, canarypox virus and human adenovirus serotype 5 (HAd5) vectors derived from the genera of pox- and adenoviruses respectively. Canarypox virus has been used to vaccinate cat, horse, ferret, dog, sheep and rabbit; HAd5 has been used in field trial for vaccination of dog, fox, pig and cattle. Target veterinary diseases for vaccination are those for which there currently exist no efficient therapeutic and prophylactic measures. Animal health is the main driver that determines the choice of disease against which GM-VVs are produced, the most successful application of GM-VVs in the vaccination of domesticated animals being the control of avian diseases. Hazards and potential risk to the environment are linked to shedding, survival and potential dissemination of the GM-VV. For example, as a consequence of delivery mechanism, GM-VVs have been delivered directly into the environment, in the case of the rabies GM vaccine bait used to control rabies in several parts of Europe. Although this is not applicable to the Norwegian mainland, relevant parallels can be drawn from these experiences. Studies on the GM rabies vaccines currently in use show that they are stable for few months in the environment, but residual pathogenicity cannot be ruled out entirely. In addition, successive selections from the original strain may produce hazardous and uncontrolled results, and variants may remain pathogenic both in target and non-target species. Compared to other geographic regions, the Norwegian physical and veterinary environments are unique in many ways, especially in relation to climate, diversity of both macro- and microorganisms, farm and animal handling practices (e.g. animal species and population, confinement, distances of animal transportation, manure and carcass disposal, and government regulations) –factors that are relevant to ERA of GM-VV. Finally, some knowledge gaps and the limitations these could portend to ERA of GM-VV in Norway were highlighted in the Report in the following context: GM-VV are currently not used in livestock vaccination in Norway. Thus, information on the ERA of GM-VV within the Norwegian context could not be derived; Even in countries with experience of the use of GM-VV, ERA-relevant important information such as post-release data, is not publicly available; Climate change will impact some factors relevant for ERA of GM-VV, especially within the Norwegian context. The extent of such impact is currently unknown., 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

What do Norwegians eat, which substances does the food contain, and what is the relation between intake of various foods and health and disease? This is one in several areas where we need more knowledge, according to a summary report from the Norwegian Scientific Committee for Food Safety, VKM. The aim of the report is to highlight research needs and data gaps that are of future importance for food safety and protection of biodiversity. The summary includes research needs and/or data gaps identified in VKMs scientific opinions during the period 2005 – 2015. Highlights needs of research needs and data gaps of great importance The report highlights the following research needs and data gaps as they are of great importance: Knowledge on possible impacts of climate change and globalization on Norwegian food production and food safety Knowledge on possible impacts of climate change and globalization on Norwegian nature and biodiversity Knowledge on what we eat, which substances the food contains, and the relationships between intake of various foods and health and disease Knowledge of foodborne pathogens, food production and antibiotic resistance in Norway Knowledge on how to assess simultaneous exposure to multiple chemicals Knowledge on health and environmental effects on nanomaterials in food and cosmetics Six different areas The report has divided more specified reported research needs and data gaps in six different areas: agriculture, terrestrial food production and terrestrial animals fisheries, aquaculture, seafood production and aquatic animals human health biodiversity combined exposures surveillance data for food and diet, NO; PDF; vkm@vkm.no

In 2015, The Norwegian Environment Agency requested the Norwegian Scientific Committee for Food Safety (VKM) to provide a scientific assessment of the information requirements laid down in the declaration form for the Regulation on microbial products and its guidelines, if these are sufficient to conduct a health and environmental risk assessment of the use of microbial cleaning products in Norway. VKM appointed a working group consisting of members of the Panel on Microbial Ecology. The Panel on Microbial Ecology has reviewed and revised the draft prepared by the working group, and the assessment has been adopted. Based on scientific assessment of the information requirements laid down in the declaration form of the Regulation on microbial products, the VKM Panel recommends that the information requirements in their current form should be revised to facilitate health and environmental risk assessment of the use of microbial cleaning products in Norway. There seems to be a general lack of accuracy when it comes to specification of the microbial content and concentrations (metabolically active vs. inactivated or dead cells) in the product. Without proper taxonomic classification, no meaningful risk assessment is feasible. The taxonomic affiliation of the organisms present in the product should be specified to at least species, preferably strain level. The declaration should in our opinion not necessarily rely on specific methods, as long as the methods described are scientifically adequate. However, the identification should be based on new molecular methods, for e.g. the potential role of the microorganism in the product acting as a pathogen or an allergen, its association to intestinal dysbiosis or genes coding for antibiotic resistance can be identified. Rather than specifying a list of specific antibiotics one should employ generic classes of antibiotics as stipulated in the Nordic Ecolabelling guidelines. The Panel recommends a multiphasic approach to future assessments, as this allows for the implementation of current and most effective methods as they are developed and verified. There seems to be lack of emphasis on environmental impacts, especially on the potential for persistence and spread in the environment (terrestrial or aquatic), the potential for pathogenic effects on domestic or wild vertebrates, arthropods or plants. Furthermore, there is little emphasis on the effects with increased use and accumulation, persistence and spread, both indoor, in terrestrial and aquatic environments and on long-term effects on the microbial community. The state (living, dead, inactivated) and form (vegetative, viable spores (bacteria and fungi) or cysts (protozoans)) of the microorganism present should be specified. If the product contains organisms that form endospores, spores or cysts, procedures for activation of the spores or cysts and for further cultivation should be described. This makes it possible to test whether the spores or cysts are not viable. The method employed for eventual inactivation or sterilization such as heat or chemical treatment, radiation, or dose, and the exposure time and concentration of the micro- organism should be described. Information on how the product has been tested to ensure that it does not contain live microorganisms is also required. The declaration should provide information about the procedures and quality controls securing a product without contaminations, pathogens, or known relevant virulence or resistance factors that may increase health or environmental risks. The safety reassurances provided by producers of microbial cleaning products, should also cover properties related to allergenicity, sensitization, plant pathogenicity and environmental impacts. How the microbes in the product and their pathogenic properties develop with time through and after shelf life should also be described. In our opinion a declaration should include information about intended use and instructions for use, if specific precautions (personal protection, waste, containers etc.) need to be taken. Furthermore, information relating to user groups should be provided; for example if the product is suitable for use in certain settings and environments such as healthcare institutions, food facilities, and areas with vulnerable people (immunocompromised, infants, elderly, pregnant women etc.) or production animals. The term “Environmental Damage” is not sufficiently defined. What kind of shift in the microbial community and local community can be expected in the receiving environment, especially if exposure is chronic and frequent? The document focuses only on the introduction of foreign genes into the ecosystem. The environment can also be permanently altered (or damaged) if the introduction of the new organisms results in the extinction of the naturally existing closely related species. In addition, metabolic products that might affect resident microbial communities could be valuable information. A re-evaluation of current national and international regulatory and policy frameworks may be necessary. This can include an evaluation of the most appropriate instruments (e.g. product declaration forms, regulations, standards, codes of practice, etc.) to use for strengthening these frameworks to mitigate risks to human health and the environment., NO; PDF; vkm@vkm.no

Carnation FLO-40685-2 is a genetically modified variety of Dianthus caryophyllus L. used as a decorative plant species. The purple colour of the flowers results from expression of the two introduced genes dfr and f3’5’h, encoding the enzymes dihydroflavonol 4-reductase (DFR) and flavonoid 3’,5’-hydroxylase (F3’5’H). Together with endogenous enzymes involved in the anthocyanin biosynthesis pathway, DFR and F3’5’H enables the production of the anthocyanidins (plant pigments) delphinidin and cyanidin in the flower petals. Anthocyanidins and their sugar derivatives, anthocyanins, make up a large group of natural colours and are accepted food additives (E 163). The colours of most flowers, berries and fruits consist of a combination of anthocyanidins and anthocyanins. Carnation line FLO-40685-2 also contains a mutated herbicide tolerance gene from Nicotiana tabacum, coding for an acetolactate synthase (ALS) variant protein, used to facilitate the selection of GM plantlets during the genetic transformation process. There are four transgenic inserts in the genome of FLO-40685-2, at four different loci. Only one of the loci includes the intended full length T-DNA sequence. Flanking sequences indicate no disruption of endogenous genes by the inserts. In silico analyses show no significant homologies between the DFR, F3’5’H an ALS proteins and known toxins or IgE-bound allergens. Expression of any new open reading frame(s) (ORF) with significant similarity to known toxin(s) or allergen(s) is highly unlikely. No observed changes in the introduced trait, i.e. the particular flower colour, indicative of instability, have been reported during numerous generations of vegetatively propagated plants since 1997. Considering that carnation FLO-40685-2 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers the comparative analysis of the anthocyanidins delphinidin, cyanidin, petunidin and pelargonidin in the flower petals sufficient for the risk assessment. The reported morphological differences between FLO-40685-2 and the conventional counterpart (parental variety) Cream Cinderella do not raise safety concerns. Based on current knowledge and the scope of the application, the VKM GMO Panel concludes that the DFR, F3’5’H and ALS proteins and anthocyanidin pigments are unlikely to increase a potential health risk related to an accidental intake or other exposure routes to carnation FLO-40685-2 compared to the conventional counterpart or other non-GM carnations. Likewise, the VKM GMO Panel concludes that carnation FLO-40685-2, based on current knowledge and the intended use as cut ornamental flowers, does not represent an environmental risk in Norway., NO: PDF; vkm@vkm.no

The current information requirements regarding microorganisms employed in the clean-up of contaminated soil and water (bioremediation) is not sufficient to conduct health and environmental risk assessments of such products. That is the main conclusion in a report conducted by the Norwegian Scientific Committee for Food Safety (VKM). The Norwegian Environment Agency has requested the report. Bioremediation involves the use of organisms, primarily microorganisms, to transform or break down toxic compounds to less toxic alternatives. The degradation process is enhanced by administering additional microorganisms, so-called bioaugmentering. The declaration form According to the Norwegian regulation on the declaration and labelling of microorganisms, importers, manufacturers as well as distributors of microbiological products in Norway are required to label and declare products in the Product registry employing a separate declaration form. The Norwegian Environment Agency uses the information obtained to assess the health and environmental risks of such products should they be applied. Limited knowledge on bioremediation Based on current knowledge, VKM is of the opinion that bioaugmentering as a remediation process seems to be relatively cost effective and easy to undertake. The method poses less stress to the environment than conventional methods used to clean-up polluted ground. There is, however, the potential risk that the introduced microorganisms can affect both the existing microbial community and the ecosystem as a whole. Limited information requirement VKM concludes that today's demand on the information requirements in the declaration form is not sufficient to be able to carry out a health and environmental risk assessment. More precise descriptions of products are required to be able to conduct meaningful risk assessments, among others. VKM also points out that today's requirements lacks emphasis on the environmental impact posed by foreign organisms. In particular, the potential spread of microorganisms in terrestrial or aquatic environments and the subsequent long-term effects. Additionally, today's requirements do not emphasize the potential of foreign organisms to inflict disease on animals and plants. About the assignment The Norwegian Environment Agency requested the Norwegian Scientific Committee of Food Safety (VKM) to evaluate whether the current requirements for information regarding microorganisms used to clean-up contaminated soil (bioremediation measures) is sufficient to conduct health and environmental risk assessment. If the current requirements are insufficient, VKM was asked to provide what requirements should apply. In addition, VKM was requested to provide an overview of the different methods of bioremediation measures and microorganisms currently used. VKMs panel for microbial ecology has been responsible for this work., NO; PDF; vkm@vkm.no

International wildlife trade is estimated to be worth billions of dollars annually and to include hundreds of millions of plant and animal specimens. The commerce is diverse, ranging from live animals and plants, to parts of organisms and derivatives thereof utilized for food, clothing, medicine, building materials, decorative items etc. International trade in endangered species is regulated through the CITES Convention (The Convention on International Trade in Endangered Species of Wild Fauna and Flora). The aim of the Convention is to prevent trade across borders leading to over-exploitation of species. Currently more than 35,000 species are protected at various levels by CITES (Appendices I, II, III). Currently 182 countries (Parties) have joined and are thereby bound by the Convention. The parties have to adopt their own domestic legislation to ensure that CITES is implemented at the national level. They are obligated to designate one or more Management Authorities to administrate a licensing system for imports and exports, and one or more Scientific Authorities to advise them on possible impacts of trade on species survival. The supreme decision making body of CITES is the Conference of the Parties (CoP), where all the Parties are represented. The Parties have agreed upon a resolution with a set of criteria for listing of species in the CITES Appendices, the Resolution Conf. 9.24. All amendments to Appendix I and II (i.e. transfer of already listed species between Appendix I and II, inclusion of new species, or removal of species listed in Appendix II) have to be done in accordance to the latest revision of the Resolution: Res. Conf. 9.24 (Rev. CoP16). All Parties are eligible to propose amendments to the Appendices in advance of the CoP. The Norwegian Environment Agency has assigned VKM to review a list of proposals for amendments to Appendix I and II submitted ahead of the seventeenth meeting of the CoP (CoP17) that will be held in the autumn of 2016. The list of proposals includes six different organismal groups: mammals, birds, reptiles, amphibians, terrestrial invertebrates and plants. VKM has put forward a project group comprising participants from the panel on Alien organisms and trade in endangered species (CITES), VKM’s secretariat as well as external experts. The project group has reviewed the information given in each proposal and searched for additional data in order to assess the impact of legal and illegal trade. VKM has summarized the material on each species in fact-sheets. The fact sheets will constitute the scientific basis for a national public hearing of the listing proposals prior to the CoP17. If accepted, the amendments will be effectuated three months after the meeting., NO; PDF; vkm@vkm.no

Carnation SHD-27531-4 is a genetically modified variety of Dianthus caryophyllus L. used as a decorative plant species. The red-purple colour of the flowers results from expression of the two newly introduced genes dfr and f3’5’h, encoding the enzymes dihydroflavonol 4-reductase (DFR) and flavonoid 3’,5’-hydroxylase (F3’5’H). The two enzymes enable the production of the pigments delphinidin and cyanidin (anthocyanidins) in the flower petals. Anthocyanidins and their sugar derivatives, anthocyanins, make up a large group of natural colours and are accepted food additives (E 163). The colours of most flowers, berries and fruits consist of a combination of anthocyanidins and anthocyanins. Carnation line SHD-27531-4 also contains a mutated herbicide tolerance gene from Nicotiana tabacum, coding for an acetolactate synthase (ALS) variant protein, used to facilitate the selection of GM plantlets during the genetic transformation process. Southern blot analysis and sequencing indicate only a single copy of the intended T-DNA insert in the SHD-27531-4 genome. Flanking sequences show no disruption of endogenous genes. In silico analyses show no significant homologies between the DFR, F3’5’H an ALS proteins and known toxins and IgE-bound allergens. No observed changes in the introduced trait, i.e. the particular flower colour, indicative of instability, have been reported during several generations of vegetatively propagated plants. Considering that carnation SHD-27531-4 is not intended for cultivation or use as food or feed, the VKM GMO Panel considers the comparative analysis of the anthocyanidins delphinidin, cyanidin, petunidin and pelargonidin in the flower petals sufficient for the risk assessment. The reported morphological differences between SHD-27531-4 and the parent cultivar do not raise safety concerns. Based on current knowledge and the scope of the application, the VKM GMO Panel concludes that the DFR, F3’5’H and ALS proteins and anthocyanidin pigments are unlikely to increase a potential health risk related to an accidental intake or other exposure routes to carnation SHD-27531-4 compared to the conventional counterpart or other non-GM carnations. Likewise, the VKM GMO Panel concludes that carnation SHD-27531-4, based on current knowledge and the intended use as cut ornamental flowers, does not represent an environmental risk in Norway., 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 (VKM) has been asked by the Norwegian Environment Agency to undertake an assessment of the risks of negative impacts on biodiversity in Norway stemming from the import of terrestrial scorpions, tarantulas, mantids, and stick insects for private use. The committee was asked to assess (1) species survivability under Norwegian conditions, (2) possible impacts of private import on ecosystems and other species, (3) possible risks arising from the introduction of accompanying organisms such as pathogens and parasites, and (4) the likelihood of escape or release of the imported organisms and precautionary measures that could prevent this from happening. The committee was asked to adopt a fifty year perspective in this assessment. Furthermore, any known negative effects on biodiversity of the exporting country should be stated in the report. These factors should, however, not be included as a part of the actual risk assessment. VKM appointed a working group consisting of members of the Panel on Alien Organisms and Trade in Endangered Species and the VKM Secretariat to answer the request. The Panel on Alien organisms and Trade in Endangered Species has reviewed, revised and finally approved the report prepared by the working group. VKM adopted a two-stage procedure, including an initial screening of all species included in the Terms of Reference and a risk assessment of the species judged to have a potential for establishment in Norway. The initial screening identified taxa with a potential for establishing populations in Norway based on the similarity between climatic conditions in Norway and the organisms current distribution. In cases where a taxon’s likelihood of establishment was assessed as being very unlikely, no further assessments were conducted. In cases where the climate conditions of the taxon’s current habitat resemble those of Norway now or in a 50-year perspective, a risk assessment was carried out for that taxon in stage two of the procedure. Where very limited or no background information existed, taxa were classified as “lack of information” and could not be assessed further. The working group screened 6600 species for establishment potential under Norwegian climatic conditions; 6489 species were deemed very unlikely to establish populations and were not assessed further. Sixty-one species were classified as “lack of information”. Fifty-one species were assessed as having potential for establishing populations in Norway, and were risk assessed in stage two of the procedure. For the risk assessment, the working group used an adaptation of the Great Britain Non-Native Species Secretariat`s risk assessment template; the original template was deemed as it cover all aspects of the Terms of Reference. The stage two assessment includes judging the probability of entry, a further and more detailed evaluation of the probability of establishment, judging the probability of spread, an assessment of environmental consequences or impact, and finally an overall risk rating for the taxon in question. VKM concludes that there is a potential for establishment in Norway in a 50-year perspective, for 20 species of tarantulas, 10 mantids and 20 phasmids (but no scorpions). Only two mantid species, Mantis religiosa and Orthodera novaezealandiae, are assessed as having a moderate risk of causing negative impacts on Norwegian biodiversity and ecosystems. If they can enter the country, these species is likely to be able to establish viable populations in Norway in a 50 year perspective. M. religiosa devours large numbers of prey and is currently spreading in Europe and in North America; however, there are no reports of significant impacts of this species on native biodiversity., 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

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorised in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13th February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorised in the European Union., NO; PDF; vkm@vkm.no

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorised in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13th February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorised in the European Union., 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 associated with magnesium in food supplements. VKM is requested to evaluate upper tolerable intake levels for magnesium and high and low intakes in the Norwegian population. Pending establishment of common maximum limits in the EU, the NFSA is evaluating the national maximum limits for vitamins and minerals in food supplements. This risk assessment is the scientific basis for NFSA's evaluation of national limits for magnesium. Directive 2002/46/EC on food supplements was implemented in Norwegian law in 2004 in Regulation 20 May 2004 No. 755 on food supplements. Common maximum and minimum levels of vitamins and minerals in food supplements shall be set in the EU. Until common limits are established in the EU, the national limits apply. The present report is a risk assessment of magnesium in food supplements. It is based on published articles retrieved from literature searches and previous risk assessments of magnesium. Magnesium is an essential alkaline mineral and occurs as free cation Mg2+ in aqueous solution, or as the mineral part of a large variety of compounds such as chlorides, carbonates and hydroxides. Dietary sources of magnesium include green leafy vegetables, legumes, whole grain cereals, dark chocolate, nuts, fish and seafood, banana and coffee. NFSA has especially requested VKM to consider water as a source of magnesium. A few waterworks reported magnesium concentrations at 10 mg/L. Consumption of water from these waterworks may contribute up to 10% of recommended magnesium intake. However, most waterworks reported negligible magnesium concentrations. Magnesium has multiple functions in the body; it is a required cofactor for more than 300 enzyme systems in the body; for energy-dependent membrane transport, for gene regulation, and for sustained electrical potential in excitable cells. Magnesium also plays a major role in bone and mineral homeostasis. No tolerable upper intake level (UL) has been established for magnesium intake from food sources for the reason that no adverse effects have been recognised in healthy populations. Magnesium salts in food supplements may cause osmotic diarrhoea which is the most frequently reported adverse effect. However, these effects are considered relatively mild. Previous reports have arrived on UL or guidance levels (GLs) for supplemental magnesium ranging from 250 mg/day in the EU (Scientific Committee for Food (SCF, 2001)) through 350 mg/day in the USA (Institute of Medicine (IOM, 1997)) and up to 400 mg per day in the UK (Expert group on Vitamins and Minerals (EVM, 2003)). The UL from SCF (2001) is below the recommended daily dietary intakes for adults. Since the critical endpoint (gastrointestinal symptoms) is mild, rapidly reversible and no NOAEL could be identified, VKM finds it appropriate to base the UL for magnesium salts in food supplements on the LOAEL from IOM (1997). For the same reason, an uncertainty factor of 1 may be applicable for establishing a UL for magnesium salts in food supplements. VKM therefore proposes an amendment of the ULs suggested by SCF (2001) for magnesium in supplements. The IOM (1997) suggestion of a UL at 350 mg supplementary magnesium per day for adults was based on a LOAEL for mild diarrhea. VKM found no results to support an alteration of this UL. VKM therefore suggests a UL of 350 mg magnesium in food supplements per day in adults which is in accordance with the UL suggested by (IOM, 1997). This UL will also cover the recommended intakes for the adult population. According to the habitual dietary intakes of magnesium estimated from nationwide dietary surveys in Norway, about 25% of adults have intakes of magnesium below the recommendations from food and supplements. Almost the same percentage was below the recommended intakes among 9-year-old children, while approximately 70% of 13-year-olds had an intake of magnesium below the recommendations. It should be noted that the intakes have been estimated with use of different dietary survey methods for the different age categories and a comparison of estimates across age groups can be misleading and has a high degree of uncertainty. Concentration of magnesium in water is low and about 60% of the waterworks reporting to the Norwegian Waterworks Registry had a magnesium concentration below 2 mg/L, indicating water as a negligible source of magnesium for the majority of the population., NO; PDF; vkm@vkm.no

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and glyphosate-tolerant genetically modified maize MON 89034 x NK 603 from Monsanto (Unique Identifier MON-89Ø34-3 × MON-ØØ6Ø3-6) was approved under Regulation (EC) No 1829/2003 in the EU for food and feed uses, import and processing on 28 July 2010 (Commission Decision 2010/420/EC). Genetically modified maize MON 890314 x NK 603 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority and the Norwegian Environment Agency related and to the EFSA public hearing of the applications EFSA/GMO/NL/2007/38 and EFSA/GMO/NL/2009/72 in 2007 and 2009/2010 (VKM 2008a, VKM 2010a). In addition, the parental lines MON 89034 and NK 603 have been evaluated by the VKM GMO Panel as single events and as a component of several stacked GM maize events (VKM 2005a,b,c,d,e, VKM 2007a,b, VKM 2008b,c,d, VKM 2009a,b, VKM 2010 a,b, VKM 2011, VKM 2012a,b, VKM 2013 a,b, VKM 2014). The food/feed and environmental risk assessment of the maize MON 89034 x NK 603 is based on information provided by the applicant in the applications EFSA/GMO/NL/2007/38 EFSA/GMO/NL/2009/72 and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 89034 x NK 603 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010a), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize MON 89034 x NK 603 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, effects on biogeochemical processes and interactions between the GM plant and target and non-target organisms. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Likewise, the VKM mandate does not include evaluations of herbicide residues in food and feed from genetically modified plants. The hybrid maize MON 89034 x NK 603 has been produced by conventional crosses between inbred lines containing MON 89034 and NK 603 events to combine resistance to certain lepidopteran pests and to confer tolerance towards glyphosate-containing herbicides. Maize MON 89034 was developed to provide protection against specific lepidopteran target pest, including Ostrinia nubilalis, Spodoptera spp. and Agrotis ipsilon. Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis subsp. aizawai and kurstaki. Maize NK 603 has been developed to provide tolerance to glyphosate by the introduction, of a gene coding for 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4 (CP4 EPSPS). Molecular characterisation Southern and PCR analyses indicate that the recombinant inserts in the single maize events MON 89034 and NK 603 are retained in maize stack MON 89034 x NK603. Genetic stability of the inserts has previously been demonstrated in the parental lines MON 89034and NK603. The level of Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins in grain and forage from the stacked event are comparable to the levels in the corresponding single events. Phenotypic analyses also indicate stability of the insect resistance and herbicide tolerance traits of the stacked event. Based on current knowledge and the previous assessments of the parental maize events, the VKM GMO Panel considers the molecular characterisation of maize MON 89034 x NK 603 satisfactory. Comparative assessment The applicant has performed comparative analyses of data from field trials located at representative sites and environments in Argentina in 2004/2005 and Europe in 2007. With the exception of small intermittent variations and the insect resistance and herbicide tolerance conferred by the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins, the results showed no biologically relevant differences between maize stack MON 89034 x NK 603 and conventional control. Based on the assessment of available data, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is compositionally, agronomical and phenotypically equivalent to its conventional counterpart, except for the new proteins. Food/feed safety assessment A whole food feeding study on broilers has not indicated any adverse health effects of maize MON 89034 x NK 603, and shows that it is nutritionally equivalent to conventional maize varieties. The Cry1A.105, Cry2Ab2, and CP4 EPSPS proteins do not show sequence resemblance to other known toxins or IgE allergens, nor have they been reported to cause IgE mediated allergic reactions. However, some studies have indicated a potential role of Cry-proteins as adjuvants in allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is nutritionally equivalent to conventional maize varieties. It is unlikely that the Cry1A.105, Cry2Ab2, and CP4 EPSPS proteins will cause toxic or IgE-mediated allergic reactions to food or feed based on maize MON 89034 x NK 603 compared to conventional maize. Environmental risk Considering the intended uses of maize MON 89034 x NK603, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize MON 89034 x NK603. Maize MON 89034 x NK 603 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize MON 89034 x NK603. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. Overall conclusion Based on current knowledge, the VKM GMO Panel concludes that maize MON 89034 x NK 603 is compositionally, nutritionally, agronomically and phenotypically equivalent to its conventional counterpart except for the new proteins. It is unlikely that the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins will cause an increased risk of toxic or IgE-mediated allergic reactions to food or feed based on maize MON 89034 x NK 603 compared to conventional maize varieties. The VKM GMO Panel concludes that maize MON 89034 x NK603, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage., NO; PDF; vkm@vkm.no