A qualitative risk assessment of biogenic amines (BA) in fermented foods was conducted, using data from the scientific literature, as well as from European Union‐related surveys, reports and consumption data. Histamine and tyramine are considered as the most toxic and food safety relevant, and fermented foods are of particular BA concern due to associated intensive microbial activity and potential for BA formation. Based on mean content in foods and consumer exposure data, fermented food categories were ranked in respect to histamine and tyramine, but presently available information was insufficient to conduct quantitative risk assessment of BA, individually and in combination(s). Regarding BA risk mitigation options, particularly relevant are hygienic measures to minimize the occurrence of BA‐producing microorganisms in raw material, additional microbial controls and use of BA‐nonproducing starter cultures. Based on limited published information, no adverse health effects were observed after exposure to following BA levels in food (per person per meal): a) 50 mg histamine for healthy individuals, but below detectable limits for those with histamine intolerance; b) 600 mg tyramine for healthy individuals not taking monoamino oxidase inhibitor (MAOI) drugs, but 50 mg for those taking third generation MAOI drugs or 6 mg for those taking classical MAOI drugs; and c) for putrescine and cadaverine, the information was insufficient in that respect. Presently, only high‐performance liquid chromatography (HPLC)‐based methods enable simultaneous and high sensitivity quantification of all BA in foods, hence are best suited for monitoring and control purposes. Monitoring of BA concentrations in fermented foods during the production process and along the food chain would be beneficial for controls and further knowledge. Further research on BA in fermented foods is needed; particularly on toxicity and associated concentrations, production process‐based control measures, further process hygiene and/or food safety criteria development, and validation of analysis methods.

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the setting of Dietary Reference Values (DRVs) for fats. A lower bound of the reference intake range for total fat of 20 energy % (E%) and an upper bound of 35 E% are proposed. Fat intake in infants can gradually be reduced from 40 E% in the 6-12 month period to 35-40 E% in the 2 nd and 3 rd year of life. For specific fatty acids the following is proposed: saturated fatty acid (SFA) and trans fatty acid intake should be as low as possible; not to set any DRV for cis-monounsaturated fatty acids; not to formulate a DRV for the intake of total cispolyunsaturated fatty acids (PUFA); not to set specific values for the n-3/n-6 ratio; to set an Adequate Intake (AI) of 4 E% for linoleic acid (LA); not to set any DRV for arachidonic acid; not to set an UL for total or any of the n-6 PUFA; to set an AI for alpha-linolenic acid (ALA) of 0.5 E%; not to set an UL for ALA; to set an AI of 250 mg for eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) for adults; to set an AI of 100 mg DHA for infants (>6 months) and young children <24 months; to increase by 100-200 mg preformed DHA in addition to the AI for adults as an adequate supply of n-3 long chain PUFA during pregnancy and lactation; not to set any DRV for conjugated linoleic acid. For cholesterol it was decided not to propose a reference value beside the limitation on the intake of SFA.

EFSA was asked to deliver a scientific opinion on acrylamide (AA) in food. AA has widespread uses as an industrial chemical. It is also formed when certain foods are prepared at temperatures above 120 °C and low moisture, especially in foods containing asparagine and reducing sugars. The CONTAM Panel evaluated 43 419 analytical results from food commodities. AA was found at the highest levels in solid coffee substitutes and coffee, and in potato fried products. Mean and 95th percentile dietary AA exposures across surveys and age groups were estimated at 0.4 to 1.9 µg/kg body weight (b.w.) per day and 0.6 to 3.4 µg/kg b.w. per day, respectively. The main contributor to total dietary exposure was generally the category 'Potato fried products (except potato crisps and snacks)'. Preferences in home-cooking can have a substantial impact on human dietary AA exposure. Upon oral intake, AA is absorbed from the gastrointestinal tract and distributed to all organs. AA is extensively metabolised, mostly by conjugation with glutathione but also by epoxidation to glycidamide (GA). Formation of GA is considered to represent the route underlying the genotoxicity and carcinogenicity of AA. Neurotoxicity, adverse effects on male reproduction, developmental toxicity and carcinogenicity were identified as possible critical endpoints for AA toxicity from experimental animal studies. The data from human studies were inadequate for dose-response assessment. The CONTAM Panel selected BMDL 10 values of 0.43 mg/kg b.w. per day for peripheral neuropathy in rats and of 0.17 mg/kg b.w. per day for neoplastic effects in mice. The Panel concluded that the current levels of dietary exposure to AA are not of concern with respect to non-neoplastic effects. However, although the epidemiological associations have not demonstrated AA to be a human carcinogen, the margins of exposure (MOEs) indicate a concern for neoplastic effects based on animal evidence. © European Food SUMMARYFollowing a request from the European Commission, the Panel on Contaminants in the Food Chain (CONTAM Panel) was asked to deliver a scientific opinion on acrylamide (AA) in food. The Panel developed the draft scientific opinion which underwent a public consultation from 1 July 2014 to 15 September 2014. The comments received and how they were taken into account when finalising the scientific opinion were published in an EFSA Technical Report (EFSA, 2015).AA is a low molecular weight, highly water soluble, organic compound. It is used inter alia as an industrial chemical and in the production of polyacrylamides. Heightened concerns about exposure to AA arose in 2002 when it was discovered that it forms when certain foods are prepared at temperatures usually above 120 °C and low moisture. It forms, at least in part, due to a Maillard reaction between certain amino acids, such as asparagine, and reducing sugars. However, several other pathways and precursors have also been proposed to contribute to AA formation. AA forms in numerous baked or fried carbohydrate-rich f...

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' in connection with a recommendation for a QPS status. The list of QPS recommended biological agents is reviewed and updated periodically. Therefore, the only valid list is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status reconfirmed. The new notifications since the last QPS update were reviewed. Gluconobacter oxydans and Alphaflexiviridae were assessed for the first time and were recommended for the QPS list. The information of the previous opinion was updated for the taxonomic units on the QPS list. Qualifications for the taxonomic units included in the QPS recommended list were reviewed and confirmed. Filamentous fungi and enterococci were not recommended for the QPS list following updating and reviewing of current scientific knowledge. SUMMARYThe European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food or feed (2013 update). The question included four specific tasks in the terms of reference (ToR).The first required a preparation of an update of the list of biological agents for intentional use in feed and/or food, or as sources of food and feed additives or enzymes and as plant protection products for safety assessment as notified to EFSA Units and/or Scientific Panels such as Pesticides, the Panels on Additives and Products or Substances used in Animal Feed (FEEDAP) and Genetically Modified Organisms (GMO). The list was updated with the notifications received where applicable by EFSA Panels and Units since the last review.The second ToR was concerned with an annual review of the list of biological agents recommended for the QPS list. Where appropriate new taxonomic units should be assessed for their suitability for an inclusion in the QPS list, and taxonomic units previously assessed should be reviewed where new information has become available. The information provided in the previous opinion should be updated where appropriate. The BIOHAZ Panel confirmed all taxonomic units previously re...

EFSA received a request from the Hellenic Food Authority (EFET) for a scientific opinion on the risk to human health from the presence of nickel (Ni) in food, particularly in vegetables. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) decided to extend the risk assessment also to drinking water. The reproductive and developmental toxicity in experimental animals was selected as the critical effect for the assessment of chronic effects of Ni. A tolerable daily intake of 2.8 µg Ni/kg body weight (b.w.) per day was derived from a lower 95 % confidence limit for a benchmark dose at 10 % extra risk (BMDL 10 ) of 0.28 mg/kg b.w. for post-implantation fetal loss in rats. The current dietary exposure to Ni raises concern when considering the mean and 95th percentile chronic exposure levels for all different age groups. The systemic contact dermatitis (SCD) elicited in Ni-sensitive humans after oral exposure to Ni was selected as the critical effect suitable for the assessment of acute effects of Ni. A lowest BMDL 10 of 1.1 µg Ni/kg b.w. was derived for the incidence of SCD following oral exposure to Ni of human volunteers. The CONTAM Panel applied a margin of exposure (MOE) approach and considered an MOE of 10 to be indicative of a low health concern. The MOEs calculated considering the estimated mean and the 95th percentile acute exposure levels were considerably below 10 for all age groups. Overall, the CONTAM Panel concluded that, at the current levels of acute dietary exposure to Ni, there is a concern that Ni-sensitized individuals may develop eczematous flare-up skin reactions. The CONTAM Panel noted the need for mechanistic studies to assess the human relevance of the effects on reproduction and development observed in experimental animals and for additional studies on human absorption of nickel from food, for example in combination with duplicate diet studies. Following a call for data on Ni levels in food and drinking water (water intended for human consumption and mineral waters), a total of 18 885 food samples and 25 700 drinking water samples were available in the final dataset to estimate dietary exposure to nickel. No speciation data were provided. Samples were collected between 2003 and 2012 in 15 different European countries, with almost 80 % of the total collected in one Member State. The most reported analytical methods were inductively coupled plasma-mass spectrometry (ICP-MS) and atomic absorption spectrometry (AAS), that represented 54 % and 42 % of the methods reported, respectively. The highest sensitivity was reported for the analysis of drinking water with a limit of quantification (LOQ) of 0.001 µg/L (for both ICP-MS and AAS). In food, ICP-MS showed the lowest LOQ for the analysis of 'Alcoholic beverages' (0.002 µg/kg) while the lowest LOQ reported with AAS was 1 µg/kg for samples of 'Fish and seafood' and 'Sugar and confectionery'. In the final dataset, left-censored data represented 66 % of the analytical results, with 35 % in food samples and 89 % in drinking water sa...

Following a request from the European Commission, the risks to human and animal health related to modified forms of the Fusarium toxins zearalenone, nivalenol, T‐2 and HT‐2 toxins and fumonisins were evaluated. Modified (often called “masked”) mycotoxins are metabolites of the parent mycotoxin formed in the plant or fungus, e.g. by conjugation with polar compounds. Fumonisins, which are difficult to extract from the plant matrix, are also termed modified mycotoxins. The CONTAM Panel considered it appropriate to assess human exposure to modified forms of the various toxins in addition to the parent compounds, because many modified forms are hydrolysed into the parent compounds or released from the matrix during digestion. For modified forms of zearalenone, nivalenol, T‐2 and HT‐2 toxins and fumonisins, 100 %, 30 %, 10 % and 60 % were added, respectively based on reports on the relative contribution of modified forms. The same factors were used for animal exposure from feed. In the absence of specific toxicity data, toxicity equal to the parent compounds was assumed for modified mycotoxins. Risk characterization was done by comparing exposure scenarios with reference doses of the parent compounds. In humans, all lower bound (LB) and upper bound (UB) mean and 95th percentile exposures to the sum of modified and parent toxins were below the respective provisional maximum tolerable daily intakes (PMTDIs) and tolerable daily intakes (TDIs), with two exceptions: for zearalenone and modified zearalenone the UB 95th percentile exposure was up to 2.2‐fold the TDI. For fumonisins and modified fumonisins the exposure of toddlers and other children exceeded the PMTDI at both the LB and the UB estimates, which could be of concern. For farm animal species and pets the exposure to the sum of modified and parent toxins was in general not of concern. The risk in fish could not be addressed. The CONTAM Panel identified several uncertainties and data gaps for modified mycotoxins.

European Food Safety Authority (EFSA), Parma, Italy ABSTRACTFood of non-animal origin (FoNAO) is consumed in a variety of forms, and a major component of almost all meals. These food types have the potential to be associated with large outbreaks as seen in 2011 associated with VTEC O104. A comparison of the incidence of human cases linked to consumption of FoNAO and of food of animal origin (FoAO) was carried out to provide an indication of the proportionality between these two groups of foods. It was concluded that outbreak data reported as part of EU Zoonoses Monitoring is currently the only option for EU-wide comparative estimates. Using this data from 2007 to 2011, FoNAO were associated with 10% of the outbreaks, 26% of the cases, 35% of the hospitalisations and 46% of the deaths. If the data from the 2011VTEC O104 outbreak is excluded, FoNAO was associated with 10% of the outbreaks, 18% of cases, but only 8% of the hospitalisations and 5% of the deaths. From 2008 to 2011 there was an increase in the numbers of reported outbreaks, cases, hospitalisations and deaths associated with food of non-animal origin. In order to identify and rank specific food/pathogen combinations most often linked to human cases originating from FoNAO in the EU, a model was developed using seven criteria: strength of associations between food and pathogen based on the foodborne outbreak data from EU Zoonoses Monitoring (2007-11), incidence of illness, burden of disease, dose-response relationship, consumption, prevalence of contamination and pathogen growth potential during shelf life. Shortcomings in the approach using outbreak data were discussed. The top ranking food/pathogen combination was Salmonella spp. and leafy greens eaten raw followed by (in equal rank) Salmonella spp. and bulb and stem vegetables, Salmonella spp. and tomatoes, Salmonella spp. and melons, and pathogenic Escherichia coli and fresh pods, legumes or grain.© European Food Safety Authority, 2013 KEY WORDSFood of non-animal origin, foodborne pathogens, foodborne outbreaks, food/pathogen combination, risk ranking SUMMARYThe European Commission asked EFSA"s BIOHAZ Panel to prepare a scientific Opinion on the public health risk posed by pathogens that may contaminate food of non-animal origin (FoNAO). In particular, this opinion addresses the first two terms of reference for the mandate, namely: (i) to compare the incidence of foodborne human cases linked to FoNAO and foodborne cases linked to food of animal origin (FoAO), and (ii) to identify and rank specific food/pathogen combinations most often linked to foodborne human cases originating from FoNAO in the EU.For the comparison of the incidence of foodborne human cases linked to FoNAO and foodborne cases linked to FoAO, the BIOHAZ Panel concluded that: the analysis of the outbreak data reported as part of EU Zoonoses Monitoring allows attribution of human cases to food of non-animal origin or food of animal origin, and is currently the only option for obtaining a EU-wide comparative estimate of the proportion ...

Leafy greens eaten raw as salads are minimally processed and widely consumed foods. Risk factors for leafy greens contamination by Salmonella spp. and Norovirus were considered in the context of the whole food chain including agricultural production and processing. Available estimates of the prevalence of these pathogens (together with the use of Escherichia coli as an indicator organism) in leafy greens were evaluated. Specific mitigation options relating to contamination of leafy greens were considered and qualitatively assessed. It was concluded that each farm environment represents a unique combination of numerous characteristics that can influence occurrence and persistence of pathogens in leafy greens production. Appropriate implementation of food safety management systems, including Good Agricultural Practices (GAP), Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP), should be primary objectives of leafy green producers. The relevance of microbiological criteria applicable to production, processing and at retail/catering were considered. The current legal framework does not include microbiological criteria applicable at primary production which will validate and verify GAP and GHP. It is proposed to define a criterion at primary production of leafy greens which is designated as Hygiene Criterion, and E. coli was identified as suitable for this purpose. A Process Hygiene Criterion for E. coli in leafy green packaging plants or fresh cutting plants was considered and will also give an indication of the degree to which GAP, GHP, GMP or HACCP programs have been implemented. A Food Safety Criterion for Salmonella in leafy greens could be used as a tool to communicate to producers and processors that Salmonella should not be present in the product. Studies on the prevalence and infectivity of Norovirus are limited, and quantitative data on viral load are scarce making establishment of microbiological criteria for Norovirus on leafy greens difficult.