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Source at https://vkm.no/ Summary report from VKM’s scientific opinions for 2016 - 2017The goal of this report is to highlight research needs and data gaps that are of future importance for food safety and protection of the environment and thereby improve the national knowledge base. This report is the latest in a series of reports on research needs and data gaps published periodically by the Norwegian Scientific Committee for Food and Environment (VKM), former Norwegian Scientific Committee for Food Safety (VKM), and thus seeks to highlight research needs and data gaps identified in and related to VKMs scientific opinions for 2016 and 2017 only.

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, 6-12 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 08/107 – final2 6 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.

Faggruppen for ernæring, dietetiske produkter, ny mat og allergi publiserte 27. februar 2006 en norsk tilpasning av en modell for vurdering av berikningssaker. I henhold til de beregninger som ble gjort i den første utgaven av modellen kunne det tilsettes maksimum 1,1 µg vitamin D per 100 kcal matvare/drikke uten at Tolerable Upper Intake Level ble overskredet for noen aldersgruppe i befolkningen. Senere i 2006 ferdigstilte Nasjonalt råd for ernæring rapporten Tiltak for å sikre en god vitamin D-status i befolkningen. Det viktigste tiltaket som foreslås i rapporten er å tilsette vitamin D i all melk og matoljer, og å øke tilsetningen i margarin og smør for å sikre at flest mulig i befolkningen har tilfredsstillende vitamin D-status. På bakgrunn av denne rapporten og henvendelse fra Helsedirektoratet med forslag om økt tilsetning av vitamin D, ga Mattilsynet i januar 2008 tillatelse til tilsetning av vitamin D i melk, smør, margarin og oljer ut over 1,1 µg/100 kcal (vedlegg 3). Faggruppen for ernæring, dietetiske produkter, ny mat og allergi har i denne reviderte utgaven av modell for vurdering av berikningssaker gjort nye beregninger for vitamin D etter prinsippene i modellen som er beskrevet nedenfor. I de nye beregningene er det kalkulert med at melk, smør, margarin og oljer er tilsatt de mengder vitamin D som Mattilsynet har gitt tillatelse til, se tabell i vedlegg 3. I henhold til de nye beregningene kan det i tillegg til de tillatelsene Mattilsynet allerede har gitt for berikning av melk, smør, margarin og oljer tilsettes 0,6 vitamin D/100 kcal mat eller drikke uten at Tolerable Upper Intake Level overskrides for noen aldersgrupper i befolkningen. De nye beregningene for vitamin D er tatt inn i vedlegg 1 til modellen og i oppsummeringen i tabell 1. Det er ikke foretatt andre endringer i revidert versjon for modell for vurdering av berikningssaker enn det som er beskrevet her.

The regulation of infant formulas is under revision, including the national restriction on sales of infant formulas with partially hydrolysed proteins to pharmacies only. In December 2007 the Norwegian Food Safety Authority requested an opinion from the Norwegian Scientific Committee for Food Safety on infant formulas with partially hydrolysed protein. The opinion should cover an evaluation of risks associated with the replacement of conventional infant formulae (based on intact protein) by infant formula based on partially hydrolysed protein, including a specification of the risks associated with the consumption of infant formula based on partially hydrolysed proteins among infants with cow’s milk allergy. Furthermore, the opinion should include an evaluation of the preventive effect from formula with partially hydrolysed proteins on development of cow’s milk allergy. To complete this task, VKM has established an ad hoc group that has prepared this report. The Panel on Nutrition, Dietetic Products, Novel Food and Allergy has discussed and adopted this opinion. The main conclusions are that although no studies show that partially hydrolysed formulas have negative effect on growth, measures should be taken in order to avoid that partially hydrolysed formulas replace regular infant formulas in the general population. Hydrolysed proteins have a high absorption rate, and ingestion of hydrolysed proteins have been shown to increase gastric emptying and plasma glucose-dependent insulinotropic polypeptide relative to the intact protein forms. Feeding partially hydrolysed formulas to infants with cow’s milk allergy constitutes a risk of eliciting an allergic reaction which in worst case may be fatal. The risk that an infant with cow’s milk allergy will receive partially hydrolysed formula may increase if the products are sold with claims such as reduced risk towards cow’s milk allergy and reduced risk of developing cow’s milk allergy together with ordinary infant formula outsides pharmacies. The risk of developing cow’s milk allergy is not shown to be reduced by introducing partially hydrolysed formula instead of regular formula during the first 4-6 months. There has not been demonstrated any preventive effect from hydrolysed formulas after the age of 6 months on the development of allergic disease.

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 longterm 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. Norwegian Scientific Committee for Food Safety 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.

Triclosan is a widely used biocide. It is included in many contemporary consumer- and professional health-care products, particularly oral and dermal products, but also in household items including plastics, textiles and food packaging materials. Concerns have been raised regarding the widespread use of triclosan; both as regards the potential for selection of resistant bacterial strains that may confer cross-resistance to other antimicrobial agents and as regards the potential harm to the environment. Triclosan is classified as “very toxic to aquatic organisms” and “may cause long-term adverse effects to the environment” by the European Commission. In March 2004, the Norwegian Food Safety Authority asked the Norwegian Scientific Committee for Food Safety to prepare an updated risk assessment of the use of triclosan in cosmetics, regarding development of resistance in pathogenic bacteria. The authority also asked for a comprehensive toxicological examination of the chemical with indication of the margin of safety as regards use in cosmetic products. In response, three assessments were initiated; one to address the risk for development of antimicrobial resistance in bacteria, one to address the toxicological aspects, and one to address ecotoxicological matters. From these three assessments, general conclusions have been drawn by the Scientific Committee based on the conclusions from the Panel on Biological Hazards and the Panel on Food Additives, Flavourings, Processing Aids, Materials in contact with Food and Cosmetics.