Bacitracin is a hexapeptide antibiotic, with a substituted thiazolidine nucleus, produced by some strains of B. licheniformis. It is mainly active against Grampositive bacteria, although many differences in susceptibility exist among the bacterial species.Alpharma A.S. Norway has produced bacitracin for use in human medicine since 1954. Until 1998, the fermentation waste from the production of bacitracin was added to animal feed in some European countries, including Norway, to promote growth of pigs and domestic fowl. In 1998, fermentation waste containing bacitracin as a food additive was banned by the EU to reduce the risk of developing bacitracin-resistant bacteria in animals, and the subsequent possible transfer of such bacteria to humans via the food chain. Use of fermentation waste containing bacitracin as a feed additive has not been officially banned in Norway, but it is no longer used for this purpose. Alpharma is therefore actively seeking alternative uses for their production waste. As the waste material is rich in nutrients, the company proposes that it could be developed as a soil additive by fermenting it with chipped bark and lime. The Norwegian Food Safety Authority (Mattilsynet) commissioned the Panel on Biological Hazards of the Norwegian Scientific Committee for Food Safety (Vitenskapskomitéen for mattrygghet) to develop a risk assessment regarding the use of composted waste material from Alpharma’s production of bacitracin, as a soil additive. In response, an ad hoc Working Group of experts was appointed with the mandate to draft a risk assessment which should include the following elements: assessment of risk to human health and/or the environment in relation to residual content of bacitracin in the finished soil additive product and assessment of the risk in relation to dissemination of the production strain and antimicrobial resistance genes. The Panel on Biological Hazards concludes that the risks to human health and the environment posed by residual bacitracin present in the finished product are minimal. Furthermore, as Bacillus licheniformis is considered essentially non-pathogenic, occurring rarely as an opportunistic pathogen, the risk posed by this bacterium to human health or the environment is very low. It is reasonable to assume that during the early composting process horizontal transfer of bacitracin and erythromycin resistance genes, from the B. licheniformis producer strain to environmental bacteria, will exceed background levels. However, this is considered to represent a low risk to human health and the environment.

Several studies have demonstrated that fresh herbs and green or leafy vegetables can be contaminated by intestinal pathogenic bacteria such as Salmonella spp. Although systematic surveys are probably not conducted in any countries some places, in recent years the Rapid Alert System for Food and Feed (RASFF) has received approximately 30 alerts annually on the detection of potentially pathogenic bacteria contaminating such products. Fresh herbs and green or leafy vegetables are mainly imported from southern Europe, but some are also imported from tropical and sub-tropical regions where the endemic level of intestinal pathogenic microbes is high. Traditionally such products have been imported particularly from South-East Asia, especially from Thailand. These imports occur predominantly through “immigrant-shops”, with the products largely used within the immigrant community, which also includes associated restaurants and catering-companies. However, such products are apparently also becoming more popular amongst the general public, and can therefore also be available on request in normal chain-stores. It is, however, difficult to estimate the total volume of these products imported into Norway because various different customs’ tariff codes are used. In 2006, 2 163 518 kg were registered as being imported into the EU (of which 25 % were basil, peppermint, or coriander). The total import into Norway must therefore be considered as low, but is probably increasing. The import of these products, and thus also their use, occurs predominantly in the larger towns and cities. The food customs in the countries where these herbs originate dictate that they are normally cooked together with food. It is highly probable that the immigrant communities have largely continued this tradition, and therefore any contaminated products are unlikely to represent a risk of infection. In Norwegian food traditions, however, such ingredients are used without heating, being added directly to the cooked food for flavouring and/or decoration. The products have a relatively short shelf-life (3-5 days) and are largely imported in small quantities by numerous small importers. Besides the general requirements that a producer/importer/distributor is responsible for a product offered for sale being “safe”, there are no other specific requirements on the testing of these products. The short shelf-life and the multitude of small importers (who probably do not always have satisfactory internal controls) also mean that fulfilment of such requirements would be unrealistic. In 2005, the Norwegian Food Safety Authority (Mattilsynet) conducted an ad hoc survey of 162 products, mostly from Thailand, and found that 28 % were contaminated with Salmonella, and 35 % with E. coli at > 100 CFU/gram. This resulted in a general prohibition of import of such products from Thailand, upon which the Thai authorities themselves undertook an initiative such that 14, later increased to 23, so called “risk-products” exported to Norway and the EU, would be accompanied by a certificate documenting that they have been analysed for Salmonella and E. coli before export. Thereupon the import prohibition was rescinded. However, in 2006, Salmonella was again detected in various ad hoc samples. Therefore, in 2007 a project was initiated with the intention of investigating the occurrence of Salmonella and Campylobacter in such products, and additionally to evaluate any possible effect from the Thai certification initiative. In this project, Salmonella was detected in 15 % of 159 products, whereas Campylobacter was not detected at all. Risk simulation demonstrated that the chance of products being contaminated with Salmonella was 3 % (0-9 %) for products which were accompanied by a certificate, and 20 % (11-31 %) for products without certification. On this basis, The Norwegian Scientific Committee for Food Safety (VKM), panel on Biological Hazards was commissioned to undertake a risk assessment on the use of fresh herbs and green or leafy vegetables imported from South-East Asia. In response, an ad hoc Working Group of experts was appointed with the mandate to draft a risk assessment. In the surveys from 2005 and 2007, a total of 18 different serovariants of Salmonella were detected. All these have also been identified in patients to various extents, but only 9 of them in patients who have probably been infected in Norway. The domestic cases caused by these serovariants constitute 13 % of the total number of cases with these serovariants – a number that does not exceed the average proportion of domestic cases for all Salmonella variants. Therefore these data do not provide statistical support for the theory that fresh herbs/green or leafy vegetables represent a significant infection potential. However, statistical traces are not generally associated with sporadic cases and the sources for practically all the 300 – 400 domestic cases of salmonellosis diagnosed in Norway annually remain unknown. As fresh herbs/green or leafy vegetables each time will only be used in small quantities, the direct use of such food probably only represents a marginal risk. The risk of infection will probably be particularly associated with the following conditions: Food which is decorated with these products, or to which these products have been added for flavouring, that are not consumed immediately, but stored for a sufficient period at a suitable temperature for microbial replication to occur. In such instances, the food can become hugely contaminated over the course of a few hours; Other sensitive products (meat, eggs, dressings, etc.) may be cross-contaminated, and perhaps stored for a while in conditions suitable for microbial replication; For highly immunosuppressed individuals, the necessary infective dose will be very low. It is conceivable that serious illness in such patients could develop even when the products are used “correctly”. The panel’s principle conclusions are: Both national and international studies have demonstrated that a relatively high proportion of fresh herbs/green or leafy vegetables imported from South-East Asia might be contaminated with intestinal pathogenic microorganisms. Such products have also been recognised as the sources of outbreaks on several occasions. However, there is no statistical evidence that suggests that these products constitute an important source of infection in Norway. Nevertheless, as the sources of sporadic cases of infection are practically never identified, it is not possible to estimate the actual risk. Thailand, as the most important production country in this context, has introduced a requirement that risk products that are exported to EU and Norway shall be accompanied by a certificate documenting that the products have been analysed for Salmonella and coli before export. This initiative has substantially reduced the contamination rate, but has not eliminated it entirely. Due to different food customs in the producer countries and Norway respectively, contaminated products are likely to represent a considerably greater infection risk to the general public than to immigrant communities, who probably have mostly continued with their original food traditions. It is also probable that the trend towards increased use of a steadily broader spectrum of fresh herbs/green or leafy vegetables will be applicable to the general public. However, the use of such products in hospitals or by severe immunocompromissed patients should be avoided. The significant reduction in risk that apparently has resulted for those products which are certified should be explored further, with direct communication with Thai authorities in instances of problems. Further investigation at varying time intervals should be supplemented by ad hoc or systematic sampling, in order that any failings or weaknesses in the system can be documented.

The Norwegian Scientific Committee for Food Safety was asked by the Norwegian Food Safety Authority (Mattilsynet) to evaluate the probability of introduction of rabies to Norway through: The importation of young dogs and cats under the present regulations; The importation of young dogs and cats if the regulations are changed to allow importation of unvaccinated animals younger than three months from certain EEA countries; The importation of dogs and cats from an EEA country when the animals are both identified, vaccinated and have valid serology tests; The free passage of wild animals across the Norwegian border? The first three questions were answered by a quantitative approach using a simulation model. The EEA countries were classified into 4 groups based on the estimated prevalence of rabies in dogs and cats, with the estimate increasing from Group 1 to Group 4. He estimates for the prevalence of rabies were based upon the number of reported cases of rabies in dogs and cats for the years 2003-2004 and corrected for possible underreporting. Group 1 – No rabies cases reported during the last two years (except in bats), AND negligible probability of importation of rabies cases from close areas: Cyprus, Iceland, Ireland, UK, Sweden, Denmark, (Norway). Group 2 – No rabies cases reported during the last two years (except in bats or in imported animals), but non-negligible probability of importation of from close areas: Italy, France, Spain, Greece, Portugal, Belgium, Liechtenstein, Luxembourg, Netherlands, Finland and Malta. Group 3 – Low-prevalence endemic area, with few rabies cases reported: Germany, Austria, Slovenia, and Czech Republic. Group 4 – Large number of rabies cases reported in domestic and wild animals: Slovak Republic, Poland, Lithuania, Latvia, Estonia, and Hungary. Any significant change in the prevalence of rabies in exporting countries will cause a change in the probability of introduction of rabies to importing countries, Therefore, continuous surveillance of rabies is necessary and the probability of the introduction of rabies should be re-evaluated if significant changes in the prevalence of rabies occur in exporting countries. The number of imported cats and dogs is important for assessing the probability of introducing rabies. In this report, three scenarios based upon three different numbers of imported cats and dogs from each of the different groups of countries have been considered (100, 1000 or 10 000). Provided that the current rabies situation in the different group of countries remained constant, it was estimated that with an annual importation of 10 000 vaccinated and tested dogs and cats from countries in Group 3, this would, on average, cause the importation of one rabies infected animal approximately every 11 000 years. With similar importation scenarios from countries in Group 1 and 2, the number of years between every estimated imported case of rabies would be even higher. By annual importation of 10 000 vaccinated and tested dogs/cats from countries in Group 4, it was estimated that on average one rabies infected animal would be imported every 58 years with a 95% confidence interval of 16-194 years. With an annual importation of 10 000 unvaccinated dogs and cats younger than three months from countries in Group 3, it was estimated that this would, on average, cause the importation of one rabies infected animal every 2 000 years. With similar importation scenarios from the countries in Groups 1 and 2, the number of years between every estimated rabies import would be even higher. With an annual importation of 10 000 unvaccinated dogs and cats younger than three months from countries in Group 4, it was estimated that, on average, one rabies infected animal would be imported every 21 years with a 95% confidence interval of 11-35 years. By reducing the number imported in each category to 1000 or 100, the number of years would increase by a factor of 10 or 100, respectively, for each group. The probability of introducing rabies to Norway via wild fauna is most likely low. There are two different ways that rabies could be introduced by wildlife; either by migrating carnivores or through bats. Migration of wild carnivores (in the context red fox, raccoon dog, wolf and Arctic fox) is buffered by the geographical separation of Norway from the epidemic areas. The probability of introduction of rabies to Norway through bats is unknown and could be higher than through wild carnivores.

On 10. March 2006 , The Norwegian Food Safety Authority (Mattilsynet) decided that, on the basis of VKM’s previous risk assessment (2005), Nutramigen 1 with Lactobacillus rhamnosus GG (LGG) could not be marketed in Norway as medical foods for infants (0-4 months). In addition, The Norwegian Food Safety Authority (Mattilsynet) decided (08. November 2006) to withdraw permission for marketing of Nutramigen 2 with LGG, which is a milk supplement for infants aged between 4 and 6 months, with cow’s milk and soy protein allergy. On 13. December 2006, Mead Johnson Nutritionals appealed against this decision from The Norwegian Food Safety Authority (Mattilsynet). The Norwegian Food Safety Authority forwarded the appeal from the companies, asked the VKM Panel on biological hazards and the VKM Panel on nutrition, dietetic products, novel food and allergy, for a new risk assessment including the new data provided in the appeal. LGG is one of the most studied probiotic strains. Lactic acid produced by LGG in the human gut results in a decrease in faecal pH, which in turn inhibits colonisation by potentially pathogenic bacteria. Short-term beneficial effects from administration of LGG to infants and young children with infectious diarrhoea have been reported in a number of studies, but a prophylactic effect on diarrhoea has not been documented. Furthermore, whilst some studies have reported a prophylactic, or even a curative, effect of LGG on atopic eczema in young children, more recent studies do not report such effects. Some even suggest an increased incidence of allergic sensitization in children receiving LGG supplemented formula at an early age. There are no published data that demonstrate long-term clinical benefits of infant formula supplemented with LGG for children between 4 months and 3 years, although no immediate deleterious effects of LGG have been found. Possible long-term effects of LGG on intestinal colonisation, and its effects on long-term gastrointestinal and immune functions, are not known. LGG, as an ingredient in infant formula and baby foods, is intended for daily use in the target group, and not for short-term, specific treatment. Furthermore, the targeted consumer group includes children below the age of twelve months. These two aspects demand particular consideration with regard to the unknown effects of long-term treatment with large doses of live bacteria on the ecology of the microbiota of the gastrointestinal tract and on the immune system. Neither of these systems is fully matured in infants and small children, and therefore may be particularly susceptible. There is no documented prophylactic effect of LGG on any disease in children. The effect of treatment with LGG-supplemented formula in small children is questionable, except for a documented short-term effect on infectious diarrhoea. Panel on Biological Hazards and Panel on nutrition, dietetic products, novel food and allergy at the Norwegian Scientific Committee for Food Safety find that the data available are not sufficient to support the suggested beneficial effects, or the safety, of LGG in infant formula and baby foods for children aged between 4 months and 3 years, when the products are intended for daily use.

coli is part of the normal gastrointestinal microbial flora of humans and animals. E. coli bacteria causing enteric/diarrhoeal disease are categorized into different groups based on their virulence properties and pathogenic features in humans. Enterohaemorrhagic E. coli (EHEC) are E. coli strains that cause bloody diarrhoea and haemolytic uraemic syndrome (HUS) in humans, and have a defined zoonotic association. The major virulence factor of EHEC (and the actual cause of HUS) is the ability to produce Shiga toxins (Stx), thus the name Shiga Toxin Producing E. coli (STEC). With enteropathogenic Escherichia coli (EPEC), the diarrhoea in these patients is due to attaching and effacing (A/E) lesions in the enteric epithelium. This risk assessment was conducted after a human outbreak of STEC O103 in 2006, associated with contaminated dry-fermented sausages. The Norwegian Scientific Committee for Food Safety (Vitenskapskomitéen for mattrygghet), Panel on Biological Hazards, was asked by the Norwegian Food Safety Authority (Mattilsynet) for a risk assessment regarding shiga toxin-producing E. coli (STEC) in the Norwegian meat chain, with emphasis on dry-cured sausages. In response, an ad hoc Working Group of experts was appointed with the mandate to draft a risk assessment regarding this issue. The current report approaches the task by following and analysing the entire process, from the origin of the meats at farm level, to the final production and storage of dry-cured sausages. An overall aim of the report has been to identify and describe potential intervention options in various parts of this chain. The main conclusions from the risk assessment are as follows: It is not possible to give any reliable quantitative estimates of the current risk associated with consumption of dry-cured sausages. There are no clear indications of any general change in the epidemiology of STEC infections in humans in Norway over the last decade. There is no documentation that there has been any change in the occurrence of various STEC in the domestic animal reservoir during the last decade. The combination of proper slaughter hygiene and use of thermal decontamination of sheep, cattle and pig carcasses represents an efficient way to reduce STEC contamination. This approach would not only cause a reduction in the contamination level of STEC, but also provide a general beneficial effect on the level of other enteric pathogens, such as Salmonella and Yersinia enterocolitica. Proper use of starter cultures in fermentation, combined with higher fermentation temperatures, will reduce the probability of growth of STEC in contaminated drycured sausages. A combination of higher fermentation temperatures, a lower pH during the process, and heat-treatment of the final product should effectively eliminate the potential risk for transmission of STEC infections from consumption of dry-cured sausages. A 5 log reduction is possible. Technological options are available to reduce significantly the transfer of potential pathogens through meats in general, and specifically through dry-cured sausages. The most important data gap is the lack of information about the actual occurrence of STEC infections in humans in Norway. Improved laboratory diagnostic procedures and epidemiological surveillance, combined with better reporting and tracing in the health care system are necessary. The implementation of properly designed base-line studies of various domestic animals, to provide data on the occurrence of various serotypes and their virulence factors present is recommended. Also, this would provide a better basis for comparison with human isolates.

Pasteurisation of all consumer milk became mandatory in Norway in 1953, and this has been an important component of the protective measures that have reduced the incidence of milk and food borne diseases. In 2004, a complete recast of the hygiene legislation addressing both food hygiene and veterinary aspects was adopted by the European Union, the so-called “Hygiene package”. According to this legislation, each member state may, on its own initiative, prohibit or restrict the marketing of some foods like raw milk or raw cream, intended for direct human consumption within its territory. In response to this, the Norwegian Food Safety Authority (Mattilsynet) commissioned the Panel on Biological Hazards of the Norwegian Scientific Committee for Food Safety (Vitenskapskomitéen for mattrygghet), to prepare a risk assessment regarding the consumption of raw milk and raw cream. In response, an ad hoc Working Group of experts was appointed with the mandate to draft a risk assessment which should include the following components: identification and characterization of microbiological hazardous agents present in Norwegian raw milk; characterization of the public health consequences of these agents; assessment of the probability of transmission of these agents to humans by distribution of raw milk and cream. Additionally, the risk assessment should identify potential hazards to human health from the importation of raw milk, identify hazards associated with equipment used for production and storage of raw milk, and assess the risks associated with the potential transfer of antimicrobial resistance genes. Observations concerning infections related to consumption of raw milk and raw cream in Norway, other European countries and North America, show that a number of pathogenic microorganisms, including emerging pathogens, can occur in raw milk and raw cream. These pathogenic microorganisms and their toxins may represent a real threat to human health. The panel concluded that the risks associated with E. coli O157:H7 and other EHEC, C. jejuni and L. monocytogenes in raw milk and cream are high. Furthermore the importation of raw milk to Norway may result in the (re)introduction of microorganisms, which have been eradicated, or never previously have been present, in Norway. This can have serious consequences for both human and animal health.

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of Lactobacillus paracasei ssp. paracasei F19 (F19) in processed cerealbased baby foods intended for small children 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search. A notification regarding two products of processed cereal-based baby foods (hereafter called cereals), intended for small children and supplemented with the bacterium F19 initiated this work. A daily supply of a monoculture of a particular bacterial strain in large quantities to an age group without a fully established intestinal flora, may have unknown adverse effects. There are however, to our knowledge, no studies investigating possible short or long term adverse health effects of F19 in processed cereal-based baby food given to children 13 months onwards. The documentation and information provided by the notifier regarding the genetic stability of F19 in the two products during processing and storage, is considered insufficient and does not allow any conclusions to be drawn. Moreover, the documentation obtained is not conclusive regarding the antibiotic resistance pattern of the bacterial strain used in the products in question, as the information on different antibiotics is partly inconsistent. The information about specific localization (chromosomal, plasmid) of the resistance genes is not sufficient. Studies demonstrate that F19, as well as other bacterial strains considered probiotic, is able to “crosstalk” with enterocytes in mice and that the result of the “crosstalk” depends upon the microbiota present. Whether F19 has a similar “crosstalk-profile” in humans is unknown. However, as the strain is originally of human origin, it seems reasonable to assume that such “crosstalk” may occur. Thus, before giving F19 daily for months and years, it seems reasonable to ask for additional molecular and physiological studies to unravel the functional impact of possible changes in genetic expression in children. Lactobacillus infections do occasionally occur, mainly as bacteremia, endocarditis and localized infections (e.g. abscesses, peritonitis, and meningitis) in patients with severe underlying diseases. Most of them are elderly, but children are not excluded. The species most often isolated are L. casei and L. rhamnosus, followed by L. paracasei. The increasing use of immunosuppressive therapy and broad spectrum antibiotics which are ineffective against Lactobacillus, might increase the importance of these bacteria as possible pathogens. In order to be able to draw any conclusions regarding beneficial effects of F19, there is a need for randomized placebo-controlled studies in larger populations and in the relevant age group. According to EFSA, Lactobacillus paracasei ssp. paracasei F19 is sufficiently characterized. The documentation provided is, however, not sufficient to claim positive health effects and thus F19 is not proven to be probiotic. There are no published dose-response studies of F19 in children, neither regarding survival of F19 in the gastrointestinal tract, nor possible negative health effects. Thus the potential for negative health effects as e.g. spreading of antimicrobial resistance or unfavourable impact on the genetic expression in children related to the frequency and/or dose of a monoculture of F19 cannot be assessed.

This preliminary risk assessment is a result of self-tasking by the Panel on Biological Hazards, Norwegian Scientific Committee for Food Safety. The suggestion was offered to the Norwegian Food Safety Authority (Mattilsynet), which responded and requested a risk profile, or a preliminary risk assessment, to evaluate whether a full risk assessment would be needed at a later date. Yersinia enterocolitica is one of a few zoonotic bacteria that have a stable reservoir within the domestic animal population in Norway. This bacterial species has been isolated from human patients with acute enteritis, who sometimes exhibit symptoms resembling appendicitis. Y. enterocolitica has attracted considerable attention due to its ability to cause serious post-infectious complications. Serious clinical consequences occur relatively often with Y. enterocolitica as a relatively high frequency of people in Norway possess the tissue type HLA-B27. A severe sequela linked to this tissue type is reactive arthritis. The cold climate in Norway may enhance growth of Y. enterocolitica. Although the predominant cause of yersiniosis in Norway is Y. enterocolitica O:3, and the pig is considered the main source of infection, the relative contribution of pork consumption compared with other risk factors, for example drinking untreated water, is unknown. In Norway, a decline in human cases of yersiniosis has been recorded since the beginning of the 1990s. This decline has been attributed to implementation of improved slaughtering methods, including enclosure of the anus into a plastic bag after rectum-loosening. In Norway, most fattening pigs are slaughtered at the age of 150 to 180 days. By this age the tonsils may be an even more significant source of human pathogenic Y. enterocolitica than intestinal contents, since the occurrence in the intestinal tract and faeces is reduced at the time of slaughter. Accordingly, hygienic handling of the head and the plucks during slaughter and dressing is very important to avoid contamination of the carcass. The most efficient way to limit the spread from tongue and tonsils is probably decapitation early on in the carcass dressing procedure. In such a procedure, the head, including tongue and tonsils, should be removed on a separate line. Also, avoidance of incision of the sub-maxillary lymph nodes might reduce the spread, Epidemiological data suggest that it is possible to reduce the herd prevalence of Y. enterocolitica O:3 by minimising contact between infected and noninfected herds. Further, attempts to reduce the prevalence at the top levels of the breeding pyramids may be beneficial for the industry as a whole. The meat industry might be able to categorise herds using serological methods, and use these results in its strategy to reduce the risks for consumers. However, such a strategy has to be evaluated in a cost benefit context. The apparently low prevalence of pathogenic Y. enterocolitica in food may be due to lack of suitable selective methods. The culturing methods, which are used routinely in microbiological laboratories, are insufficiently sensitive. There is a need for a standardised DNA-based technique, with improved sensitivity, for the detection of Y. enterocolitica in clinical, food and environmental samples.

The Norwegian department of agriculture decided to re-evaluate the Regulation No. 951 of 4 July 2003 on fertilizers and soil improvers of organic origin. The Norwegian Food Safety Authority (NFSA) requested VKM for a statement on the use of manure from farms where grey water and human waste (sewage) is disposed of directly to the farm manure cellar. Consideration was given to differences in risk according to the types of domestic wastewater, the species of animal from which the manure derived, the extent and type of sanitary facilities, the crops to which the amended manure is applied, and the effects of storage on infection risk. According to current legislation, sewage sludge cannot be spread on land where vegetables, potatoes, berries or fruit are grown. Furthermore, sewage cannot be spread on meadows or used for horticultural purposes. In private gardens, parks, playgrounds and similar residential areas, sewage may be used only as a component in a fertiliser, and not applied at the surface. Use of sewage as a fertilizer for the cultivation of grains is permitted. Sewage can also be used when establishing vegetation along roads and embankments. VKM concludes that manure cellars, to which wastewater, from private household use, and sewage from toilets in the outbuildings are drained, may contain pathogens from humans, in addition to those pathogens originating from animals. The quantity and species of pathogens in this sewage-amended manure would reflect the species and prevalence of pathogens in the population using the facilities. Although the prevalence of intestinal pathogens in the Norwegian human population is relatively low, it should be noted that farms in Norway often provide tourist accommodation, camping facilities, and may house migrant short-term employees during the summer season during which labour requirements are increased. Thus non-Norwegian populations may also use toilet facilities on these farms, and thus when considering the risk of human pathogens, consideration should also be given to people from countries where the prevalence of such pathogens may be higher. As many viruses and parasites are host-specific, the risk of contamination of produce with human pathogens from such manure is likely to be greater than from manure which has not been amended with untreated sewage. Pathogen survival is affected by storage, but it should be noted that some pathogens have robust and environmentally resistant transmission stages (e.g. parasite oocysts, cysts and eggs), a proportion of which may survive for prolonged periods in stored manure.

In the light of the recent findings of the tapeworm Echinococcus multilocularis (EM) in four red foxes from three different locations in Sweden, the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen; VKM), Panel of Biological Hazards (Faggruppe hygiene og smittestoffer) took the initiative to undertake a risk assessment regarding the probability of this parasite being introduced to mainland Norway and thus becoming a threat to public health in the country. EM is a small tapeworm that resides in the intestine of carnivores (e.g. foxes, dogs) that function as final hosts for the adult tapeworm. The infection here gives few or no symptoms. Adult tapeworms produce eggs that are released in the faeces of the carnivores and may be ingested by mammals, usually rodents or lagomorphs1, which act as intermediate hosts. In the intermediate hosts, the larval form of the tapeworm produces cysts, predominantly in the liver, where they proliferate and may invade the surrounding tissues. If the infected intermediate host is eaten by a susceptible final host, the adult tapeworm develops in the intestine and the lifecycle is completed. EM is of public health significance as humans may act as accidental intermediate hosts if they ingest eggs, either through contaminated foods or water, or from contact with infected final hosts (dogs, foxes) or their faeces. In untreated patients the disease is often fatal (10 year survival rate of 29 %), and in treated patients the 10 year survival rate is 80 %. The anthelmintic treatment is long-term (for several years, possibly life-long) and expensive. Liver transplantation may be required. Conclusions: Based on the fact that EM is endemic in many European countries, that the incidence in endemic countries is increasing, and that the areas of endemicity are expanding it seems likely that EM will be imported into Norway at some point, perhaps within the next 10 years. Given the high numbers of pets crossing the border between Sweden and Norway and the paucity of checks regarding compliance with treatment legislation, this seems to be a likely route of entry of EM to Norway, should this occur. Introduction of checks may reduce this likelihood. Under the current monitoring conditions, VKM find it less likely that EM will be detected upon the first introduction to Norway. EM will probably only be detected once the prevalence in foxes is greater than 1%. The red fox population size is estimated to be between 70 000 to 120 000 animals. This means between 700 to 1200 red foxes would need to be infected before EM infection is likely to be detected under the current monitoring program. If EM is identified early enough after introduction, then it might be possible to avoid the establishment of EM in Norway and/or to limit the region of endemicity. This is dependent on optimal detection techniques and sufficient monitoring. VKM considers that it is unlikely that EM will be imported to Norway via contaminated produce (berries, fruits and mushrooms). Norway’s strong ‘outdoor’ culture, in which hunting, camping, berry-picking and other outdoor activities play a significant role, may place the Norwegian population at greater likelihood of contracting EM than populations in other European countries. However, it should be noted that even in countries with endemic EM, human echinococcosis is, apparently, relatively rare.

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of B. lactis Bb12 in baby foods focusing on the age groups 4-6 months, 612 months and 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search. An notification for use of processed cereal-based baby foods (from now on called cereals) intended for infants and small children supplemented with the microorganism Bifidobacterium lactis (B. lactis) Bb12 in Norway initiated this work. Studies of potential hazards and positive health effects from cereals containing B. lactis Bb12 intended for infants and young children have not been reported in the available literature. However, reports on safety of and positive health effects from infant and follow on formula supplemented with B. lactis Bb12 are available and have been assessed by VKM. In most of these clinical studies B. lactis Bb12 was administered in combination with other probiotic strains. Clinical studies report no serious adverse events of infant formula supplemented with B. lactis Bb12. The effect of long term daily consumption of such supplemented formula by the actual age groups is not known. A few studies have demonstrated some effect of supplementing baby food with probiotics, including B. lactis Bb12, on diarrhoea and atopic eczema while other studies do not show such effects. Thus, the scientific evidence for a favourable effect of supplementing formula or solid food with B. lactis Bb12, is weak and in some cases lacking. There are no studies demonstrating a positive effect of cereals supplemented with B. lactis Bb12 intended for infants and small children. Several health claims related to probiotics have been assessed by EFSA, including claims on reduction of gastro-intestinal discomfort, normal functioning of the alimentary tract, building of the natural intestinal barrier, improvement of the general immunity, mental and cognitive developments of children and immune system of children during growth. In the opinions so far, EFSA has concluded that a cause and effect relationship has not been established between the consumption of the probiotic containing products and the claimed effect. None of the products assessed so far contained B. lactis Bb12 (1 November 2009). Commercially produced cereals are frequent given to infants and small children in Norway from an early age and this is particularly important for the establishment of the intestinal bacterial flora and the development of the intestinal mucosal immune system. According to the notifier, one portion (25gram) of the cereal powder contains 1 x 109 B. lactis Bb12 in monoculture. Taking into consideration that the daily intake is often greater than one portion of cereals, even in infants below 6 months of age, this would represent a daily intake of 1-2 x 109 cfu B. lactis Bb12 for an infant 4-6 months and even more in infants above 6 months. If a considerable amount of the B. lactis Bb12 survives the transport to the small intestine, it would represent a dominating and monocultural supply, often several times a day, to the small intestine. The immaturity and vulnerability of the intestinal microbiota and the immune system makes the two lowest age groups, 4 – 6 and 6 – 12 months, at the highest risk of unwanted health effects due to the daily intake of probiotics.

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

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.

The Norwegian Food Safety Authority (NFSA) and Norwegian Environmental Authority (NEA) asked the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) for an opinion on factors associated with the introduction of Chronic Wasting Disease (CWD) to Norway. VKM appointed a working group consisting of two members of the Panel on Biological Hazards, one member of Panel on Animal Health and Welfare, and two external experts to prepare the answer to the questions. The Panel on Biological Hazards has reviewed and revised the draft prepared by the working group and approved the opinion. CWD was diagnosed in March 2016 in a wild reindeer (Rangifer tarandus) from the Nordfjella mountain area in Norway and in May and June in two mooses (Alces alces) in Selbu in South Trøndelag County, approximately 300 km north from the first case. There is currently no information to determine the origin(s) of CWD agents in Norway. However, the sporadic or genetic (somatic mutation) occurrence of prion disease in cervids cannot be excluded, nor can introduction from North America or other countries. Furthermore, there is no evidence that it has not been circulating at low levels in the Norwegian cervid populations for years, but has not previously been identified. In this scientific opinion, information on prion diseases in general, and CWD in particular, is presented in the light of experiences with this disease in North America. Prions are among the most resilient pathogens known and dissemination of prions into ecosystems is likely to result in long-term problems. Prions bind strongly to soil and remain infectious. In CWD, prions are present in most peripheral organs and also shed into the environment via saliva, faeces, and urine, as well as with the placenta. CWD transmits easily among cervids, either through direct contact, or indirectly via the environment. Migration of animals is relevant for the spread between areas. Strain diversification might occur in CWD and may influence transmission properties of the agents. Clinical signs of CWD are non-specific and do not alone enable confirmation of the diagnosis. Analysis of tissue from the brainstem at the level of the obex by approved methods is necessary for diagnosis of CWD. Prion infectivity is assessed by bioassays, often involving transgenic mice. In vitro conversion assays, like protein misfolding cyclic amplification (PMCA), provide sensitive quantification of converting activity, which is a good approximation of infectivity. Genetic variation (polymorphisms) in the gene that encodes PrP (PRNP) can modulate sensitivity towards CWD. The level of such genetic variation in Norwegian wild and semi-domesticated cervids is currently unknown. Cattle and sheep are at very low risk of developing CWD and it is highly unlikely that prion diseases in sheep or cattle are the origin of CWD. Although transmission of CWD to humans has never been known to occur, and animals other than cervids have not been found to be infected, indicating a species barrier, this possibility cannot be excluded. Thus, measures for reduction of human exposure are recommended. Taking into account uncertainties regarding the plasticity of the CWD agents and the lack of transmission data from the Norwegian isolates, this scientific opinion considers the zoonotic risk of CWD to be very low.

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.

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.

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 VKM Report 2017:9 9 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.