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Methods to generate evidence for regulatory toxicology are increasingly shifting from classical animal experiments to new approach methodologies (NAMs), with a corresponding need for methods to incorporate them in systematic reviews and other evidence synthesis processes. While many tools have been created for assessing in vitro studies, no single tool is obviously authoritative specifically for assessing the internal validity of in vitro study designs. We therefore aim to address this situation by developing a new tool, INVITES-IN, for evaluating the internal validity of in vitro studies, using methods that ensure we are building on prior work, with a degree of rigour consistent with our intent to provide an authoritative assessment tool. The current protocol describes three of the four studies that will be performed to create the release version of INVITES-IN. In the first study, evaluation of existing assessment tools will be combined with focus group discussions to identify how characteristics of the design or conduct of an in vitro study can affect its internal validity. In the second study, group agreement on internal validity domains and items of importance for in vitro studies will be identified via a modified Delphi methodology. In the third study, the draft version of INVITES-IN will be created. A separate protocol will be prepared for the fourth study, which includes the user testing, validation of the tool, and collection of users’ experience., Revised version

Risk and risk–benefit assessments of food are complex exercises, in which access to and use of several disconnected individual stand-alone databases is required to obtain hazard and exposure information. Data obtained from such databases ideally should be in line with the FAIR principles, i.e. the data must be Findable, Accessible, Interoperable and Reusable. However, often cases are encountered when one or more of these principles are not followed. In this project, we set out to assess if existing commonly used databases in risk assessment are in line with the FAIR principles. We also investigated how access, interoperability and reusability of data could be improved. We used the OpenFoodTox and the Seafood database as examples and showed how commonly used freely available open-source tools and repositories can be implemented in the data extraction process of risk assessments to increase data reusability and crosstalk across different databases.

Source at https://vkm.no/

Source at https://vkm.no/ At request from the Norwegian Food Safety Authority (NFSA), VKM has identified food groups and food items consumed by the Norwegian population that are relevant for monitoring regarding content of one or more undesirable chemical substances (Figure 1). Undesirable chemical substances were defined as chemical substances in food that may constitute a potential health risk. VKM has created a knowledge base (an Excel file) as a tool for planning and prioritising monitoring of foods and undesirable chemical substances. The substance groups included in the knowledge base are flavourings, food additives, metals and metalloids, natural toxins, persistent organic pollutants, process-induced contaminants, substances in food contact materials, substances in food supplements, and trace elements. More than 40 different substances were included.

At request from the Norwegian Food Safety Authority (NFSA), VKM has identified food groups and food items consumed by the Norwegian population that are relevant for monitoring regarding content of one or more undesirable chemical substances (Figure 1). Undesirable chemical substances were defined as chemical substances in food that may constitute a potential health risk. Paid open access

VKM has performed a risk-benefit assessment of sunscreen use and six UV filters. This task was undertaken on the initiative of a VKM Panel in response to the apparent paradox between the need for protective measures, such as use of sunscreens, to reduce Norway’s high incidence and mortality of skin cancer and a consumer concern for the safety of sunscreens. Concerns include safety of ingredients and sunscreens’ effect on vitamin D synthesis. Sunscreen products are legally regulated as cosmetic products in the EU, and only approved UV filters up to a maximum determined concentration are allowed in the ready-foruse preparation. VKM used a systematic approach to assess risks and benefits of sunscreen use and risks of six selected UV filters: bis-ethyl-hexyloxyphenol methoxyphenyl triazine (BEMT), butyl methoxydibenzoyl methane (BMDBM), 2-ethylhexyl salicylate (EHS), ethylhexyl triazone (EHT), octocrylene (OC), and titanium dioxide in nanoform (NP-TiO2). These UV filters are among the most frequently used in sunscreens on the Norwegian market. Sunscreen sprays and lip products were not included. Scientific publications and reports up to 2020 were retrieved to assess adverse and protective effects of sunscreen and adverse effects of UV filters. We assessed risk of bias in the studies and evidence for health outcomes with the aid of validity tools, and estimated exposure to each UV filter using probabilistic methods. The evidence showed that sunscreens were beneficial in protecting against certain skin cancers. Insufficient evidence precluded determination of the hazard associated with sunscreen use. The UV filters occurred in concentrations similar to or below the limits set in the EU cosmetics regulative. VKM considered that little to no hazard was associated with use of the six evaluated UV filters. VKM concludes that the risks related to use of the six evaluated UV filters are negligible since the real-life use of these UV filters is several-fold lower than the amounts that may cause any adverse health effect. The evidence for harmful health effects of sunscreens is insufficient to determine risk. Sunscreen use protects against certain skin cancers and is beneficial for the general Norwegian population. Risk-benefit assessment of sunscreen - Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food, and Cosmetics of the Norwegian Scientific Committee for Food and Environment

Hentet fra: https://vkm.no/risikovurderinger/allevurderinger/dioksinerimatentildennorskebefolkningen.4.413ea92416707dc4375a0a18.html Dioxins and dioxin-like polychlorinated biphenyls (dl-PCBs) are lipophilic chemicals with long half-lives in the environment. Dioxins include both polychlorinated dibenzo-p-dioxins (PCDD) and polychlorinated dibenzofurans (PCDF). Several congeners of PCDDs and PCDFs may occur, with varying number and positions of chlorine atoms in the molecules. Seventeen of these congeners are relatively persistent in animals and humans and exert similar toxicity. A subgroup of 12 out of 209 possible polychlorinated biphenyl (PCB) congeners show toxicological properties similar to PCDDs/PCDFs, and this subgroup is termed dl-PCBs (EFSA et al., 2018). Paid open access

Butylated hydroxytoluene (BHT, E321) is a synthetic antioxidant authorised as food and feed additive in the EU. In addition, BHT is used in e.g. cosmetics and food contact materials. To our knowledge, risk assessments including exposure estimates for BHT from multiple sources and exposure pathways have not been performed. BHT is characterised by extensive use and multiple exposure sources and routes. Therefore, it is important that these sources and routes are included in the estimations to arrive at the most accurate picture of the population's exposure. In addition, the main sources contributing to the exposure should be identified. Toxicity An acceptable daily intake (ADI) of 0.25 mg/kg bodyweight (bw) per day was established by EFSA based on effects on the litter size and pup body weight in two 2-generation studies in rats (EFSA, 2012). The ADI was based on the no observed adverse effect level (NOAEL) of 25 mg/kg bw per day in these two studies and an uncertainty factor of 100. The ADI was used as reference point for BHT toxicity in this risk assessment. Exposure The exposure was estimated for «realistic» and «high» scenarios. The consumption data used for the exposure estimation were from Norkost 3 (foods), EuroMix (foods and personal care products) and the Environmental Protection Agency (US; indoor dust). The concentration data used were from scientific literature, and identified through literature searches. The concentration data for the exposure estimation from foods and PCPs were limited and therefore considered to be the largest source of uncertainty in the exposure estimates. Data considered most realistic for the Norwegian exposure were used for «realistic» exposure estimation, whereas the «high» exposure scenario was a worst-case estimation representing a risk assessment for potentially high consumers. To calculate the total internal exposure, absorption factors for BHT uptake from the gastrointestinal tract and skin were used. BHT reaching the physical barriers in the body was defined as external exposure, and the absorbed BHT was defined as total internal exposure. The «realistic» total internal exposure from all routes, for the lowest 5 and the highest 95 percentile, was estimated to be within 1.4 – 9.7 µg BHT/kg bw per day for females and 0.8 – 9.7 µg BHT/kg bw per day for males. The 50 percentile was estimated to be within 3.5 – 4.2 and 2.2 – 2.8 µg BHT/kg bw per day (rounded numbers) for females and males, respectively. The «high» total internal exposure from all routes, for the lowest 5 and the highest 95 percentile, was estimated to be within 23 – 281 µg BHT/kg bw per day for females and 9 - 319 µg BHT/kg bw per day for males. The 50 percentile was estimated to be within 85 – 111 and 46 – 61 µg BHT/kg bw per day (rounded numbers) for females and males, respectively. The predominant route of exposure is oral intake; on average 80% of the internal exposure in females is from food, dust and oral intake of PCPs, while for males even more (92%). Sources of BHT exposure were mainly from food through oral intake (females 41%, males 59%, with substantial contributions also from PCPs through oral uptake (females 38%, males 34%) and through dermal uptake from PCPs (females 21%, males 7.1%). The main contributors to the estimated dietary «realistic» external exposure were the food groups «milk, cream, ice cream», followed by «chewing gum» and «fatty fish». The personal care product categories «body lotion» and «deodorant»» were the two major contributors to the estimated dermal «realistic» external exposure. Oral exposure from personal care products was mainly from toothpaste. Risk characterisation and conclusions Both «realistic» and «high» total internal BHT exposure was used in the risk characterisation. The estimated «realistic» exposure was below the ADI for both women and men. The 50 percentile of the estimated «high» exposure (the worst-case estimation representing a cautious risk assessment approach) was below the ADI, whereas the 95 percentile was above the ADI. Thus, a small fraction of the population may exceed the ADI and be at risk for negative effects on reproductive health. The Panel concludes that BHT exposure is unlikely to cause adverse health effects in adults.

Source at https://vkm.no/download/18.7d363f6e16d16151068849d0/1568620629508/Ranking%20of%20substances%20for%20monitoring%20in%20foods,%20drinks%20and%20dietary%20supplements.pdf The Norwegian Food Safety Authority (NFSA) requested the Norwegian Scientific Committee for Food and Environment (VKM) to provide an overview of substances in foods, drinks and dietary supplements that may constitute a potential health risk for humans, based on the VKM members’ expert judgements. VKM was further requested to perform a ranking of these substances. Additionally, VKM should give an overiview of the foods, drinks and dietary supplements most relevant for monitoring, and describe what would be the adequate sampling procedure and number of samples. Monitoring procedures were included to ensure that the monitoring performed is representative for the occurrence of the substances in foods, drinks and/or dietary supplements consumed by the Norwegian population. The substances requested to be included were food additives and flavourings, substances used in food contact materials, environmental contaminants, process-induced substances and natural toxins. Substances not to be included were veterinary medicine residues, illegal pharmaceuticals and pesticide residues. The overview provided by VKM included substances belong to the following groups and subgroups of substances: Natural toxins; with the sub-groups mycotoxins, plant toxins, marine and freshwater algae toxins Metals and metalloids Persistent organic pollutants (POPs); with the sub-groups brominated flame retardants, dechloranes, dioxins and dioxin-like polychlorinated biphenyls (DL-PCBs), non-dioxin-like polychlorinated biphenyls (NDL-PCBs), perfluorinated and polyfluorinated alkyl substances (PFAS) and siloxanes Substances in food contact materials; with the sub-groups bisphenols and phthalates Flavourings Additives; with the sub-groups nitrites and nitrates, phosphates, sweeteners and synthetic antioxidants Process-induced contaminants; with the sub-groups acrylamide, esterified 3- and 2- monochloropropane-1,2-diol (MCPD), glycidyl fatty esters (GEs), furans, heterocyclic aromatic amines (HAAs) and polycyclic aromatic hydrocarbons (PAHs) «Other substances» Trace elements The ranking of the substances is based on inherent toxicity (hazard) and level of exposure (both occurrence and intake). In addition, vulnerable groups, adequacy of toxicity data and lack of exposure data were considered. A simple methodology was chosen. More advanced methodology may be used in later updates of this ranking, if found useful.

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

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of 100 or 300 mg/day of caffeine in food supplements and in energy drinks containing 32 mg/100 ml. VKM concludes that: • It is unlikely that a dose of 100 mg of caffeine per day from food supplements causes adverse health effects in children (10 years and above), adolescents (14 to

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of intake of 100 mg/day of coenzyme Q10 in food supplements. For the risk characterization, the values used for comparison with the estimated exposure are 900 mg/day (corresponding to 12.9 mg/kg bw per day in a 70 kg adult) based on human studies (4 weeks) and the NOAEL of 1200 mg/kg bw per day based on a long-term toxicity study in rats (52 weeks). No specific studies on children (10 to