Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.

In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 µg/kg body weight (bw) per day. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health from the presence of BPA in foodstuffs and to establish a tolerable daily intake (TDI). For this re-evaluation, a pre-established protocol was used that had undergone public consultation. The CEP Panel concluded that it is Unlikely to Very Unlikely that BPA presents a genotoxic hazard through a direct mechanism. Taking into consideration the evidence from animal data and support from human observational studies, the immune system was identified as most sensitive to BPA exposure. An effect on Th17 cells in mice was identified as the critical effect; these cells are pivotal in cellular immune mechanisms and involved in the development of inflammatory conditions, including autoimmunity and lung inflammation. A reference point (RP) of 8.2 ng/kg bw per day, expressed as human equivalent dose, was identified for the critical effect. Uncertainty analysis assessed a probability of 57-73% that the lowest estimated Benchmark Dose (BMD) for other health effects was below the RP based on Th17 cells. In view of this, the CEP Panel judged that an additional uncertainty factor (UF) of 2 was needed for establishing the TDI. Applying an overall UF of 50 to the RP, a TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure.

Strategies to reduce exposure of fumonisins from complementary foods in rural Tanzania.

Feeding infants with maize can expose them to fumonisin mycotoxins. We assessed fumonisin exposure from complementary foods in rural Tanzania and determined strategies to reduce the exposure. We conducted a cross-sectional study in four villages of Tarakea division, Northern Tanzania. We used a repeat 24-hour dietary recall to collect data of maize consumption as complementary food for 254 infants aged 6-8 months. Fumonisin concentrations in the maize were also estimated. Fumonisin exposure was assessed using @risk analysis software. With the software, several maximum fumonisin contamination and maize consumption patterns were combined in order to determine effective strategies for minimizing fumonisin exposure. Of the infants, 89% consumed maize at amounts up to 158g/person/day (mean; 43g/person/day±28). The maize was contaminated with fumonisins at levels up to 3201µgkg(-1) . Risk of fumonisin intake above the provisional maximum tolerable daily limit of 2µgkg(-1) body weight was 15% (95% confidence interval; 10-19). The risk was minimized when the maximum contamination was set at 150µgkg(-1) . The risk was also minimized when the maximum consumption was set at 20g/child/day while keeping the maximum contamination at the European Union (EU) maximum tolerated limit (MTL) of 1000µgkg(-1) . Considering the economical and technological limitations of adopting good agricultural practices in rural Tanzania, it is practically difficult to reduce contamination in maize to 150µgkg(-1) . We suggest adoption of the EU MTL of 1000µgkg(-1) for fumonisins in maize and reduction, by replacement with another cereal, of the maize component in complementary foods to a maximum intake of 20g/child/day.

Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids was requested by the European Commission to re-evaluate the risks to public health related to the presence of plasticisers such as phthalates, structurally similar substances and replacement substances, as a consequence of migration from food contact materials (FCMs). As the first part of the two-part mandate, EFSA was tasked with identifying and prioritising those plasticisers used in FCMs that may warrant further data collection and eventual risk assessment. Close collaboration with the European Chemicals Agency (ECHA) was requested in the mandate. Substances potentially used as plasticisers were identified using Annex II of the mandate, ECHA's PLASI inventory, the Plastics Regulation and the Regenerated Cellulose Film Directive, the ECHA database, the ECHA grouping approach, and consultation with the Member States. Only substances authorised for FCMs at EU or at national level were prioritised. Five substances classified either as carcinogenic, mutagenic, toxic to reproduction Cat. 1 (under CLP) or as endocrine disruptors, persistent, bioaccumulative and toxic, very persistent/very bioaccumulative (under REACH) were placed into an 'exclusion group'. Prioritisation was based on the date of the most recent risk assessment in the context of FCM, with substances assessed before 2001 being placed in the high-priority group, substances assessed between 2001 and 2011 in the medium-priority group and substances assessed after 2011 in the low-priority group. For the EU stream, the 76 substances were split into 59 high-, 14 medium- and 3 low-priority substances. For the nationally authorised stream, the split of the 72 substances is 66, 3 and 3, respectively. The outcome of follow-up calls for data in support of the exposure assessment will be used for a final ranking.

Update of the risk assessment of nickel in food and drinking water.

The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post-implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL 10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 µg/kg bw. Eczematous flare-up reactions in the skin elicited in nickel-sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest-observed-adverse-effect-level of 4.3 µg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel-sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern.

Risk assessment of aflatoxins in food.

EFSA was asked to deliver a scientific opinion on the risks to public health related to the presence of aflatoxins in food. The risk assessment was confined to aflatoxin B1 (AFB1), AFB2, AFG1, AFG2 and AFM1. More than 200,000 analytical results on the occurrence of aflatoxins were used in the evaluation. Grains and grain-based products made the largest contribution to the mean chronic dietary exposure to AFB1 in all age classes, while 'liquid milk' and 'fermented milk products' were the main contributors to the AFM1 mean exposure. Aflatoxins are genotoxic and AFB1 can cause hepatocellular carcinomas (HCCs) in humans. The CONTAM Panel selected a benchmark dose lower confidence limit (BMDL) for a benchmark response of 10% of 0.4 µg/kg body weight (bw) per day for the incidence of HCC in male rats following AFB1 exposure to be used in a margin of exposure (MOE) approach. The calculation of a BMDL from the human data was not appropriate; instead, the cancer potencies estimated by the Joint FAO/WHO Expert Committee on Food Additives in 2016 were used. For AFM1, a potency factor of 0.1 relative to AFB1 was used. For AFG1, AFB2 and AFG2, the in vivo data are not sufficient to derive potency factors and equal potency to AFB1 was assumed as in previous assessments. MOE values for AFB1 exposure ranged from 5,000 to 29 and for AFM1 from 100,000 to 508. The calculated MOEs are below 10,000 for AFB1 and also for AFM1 where some surveys, particularly for the younger age groups, have an MOE below 10,000. This raises a health concern. The estimated cancer risks in humans following exposure to AFB1 and AFM1 are in-line with the conclusion drawn from the MOEs. The conclusions also apply to the combined exposure to all five aflatoxins.

Evaluation of public and animal health risks in case of a delayed post-mortem inspection in ungulates.

The potential effects of a 24 or 72-h delay in post-mortem inspection (PMI) of ungulates on public health and monitoring of animal health and welfare was evaluated. The assessment used a survey of meat inspectors, expert opinion, literature search and a stochastic model for Salmonella detection sensitivity. Disease detection sensitivity at a delayed PMI is expected to reduce detection sensitivity to a variable extent, depending on the hazard and on the signs/lesions and organs involved. No reduction is expected for Trichinella detection in meat from susceptible animal species and any decrease in detection of transmissible spongiform encephalopathies (TSEs) will not exceed the current tolerance for fallen stock. A 24-h delay in PMI could result in a small reduction in sensitivity of detection for tuberculosis, echinococcosis and cysticercosis. A greater reduction is expected for the detection of pyaemia and Rift valley fever. For the detection of Salmonella, the median model estimates are a reduction of sensitivity of 66.5% (90% probability interval (PI) 0.08-99.75%) after 24-h delay and 94% (90% PI 0.83-100%) after 72-h delay of PMI. Laboratory testing for tuberculosis following a sampling delay of 24-72 h could result in no, or a moderate, decrease in detection depending on the method of confirmation used (PCR, culture, histopathology). For chemical contaminants, a delay in meat inspection of 24 or 72 h is expected to have no impact on the effectiveness of detection of persistent organic pollutants and metals. However, for certain pharmacologically active substances, there will be a reduced effectiveness to detect some of these substances due to potential degradation in the available matrices (tissues and organs) and the non-availability of specific preferred matrices of choice.

Comparing the effect of various contamination levels for salmonella in chicken meat preparations on the probability of illness in belgium.

At the urging of competent national authorities, a limited risk assessment on Salmonella in chicken meat preparations in Belgium was undertaken following a retail-to-table approach. The input distribution of Salmonella was based on surveillance data in Belgium. To analyze the relative impact of reducing the risk of salmonellosis associated with a decrease in the Salmonella contamination level, different distributions based on the actual situation but limiting the number of portions containing Salmonella at 1 CFU per 1, 10, and 25 g of meat were used in the quantitative microbial risk assessment model. The quantitative microbial risk assessment model also was run several times with a theoretical fixed input of Salmonella assuming all portions possessed the same fixed contamination level set at 1,000, 100, 10, and 1 CFU/g of meat and 1 CFU per 10, 25, 100, and 1,000 g of meat. With regard to the initial contamination level, the results indicate, both by the narrowing of the current distribution and by the fixed input, that especially the higher levels of contamination (>1 CFU/g) contribute to the increased risk for salmonellosis.

Overview of available toxicity data for calystegines.

Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short-term toxicological studies in rodents on individual calystegines or mixtures of calystegines were retrieved. Overall, these studies are insufficient to conclude on the possible chronic toxicity effects of calystegines in humans, in particular considering the short duration of the studies and potential lower sensitivity of rats and mice to glycosidase inhibitors, compared to other species such as goats and guinea pigs. Several studies and case reports were retrieved on the toxic effects induced in livestock or experimental animals following consumption or administration of plants containing calystegines. However, the concurrent presence of other alkaloids, in particular swainsonine, did not allow using these studies to draw conclusions on the toxicity of calystegines. Since no experimental data on genotoxicity of calystegines were retrieved, in silico predicting models were applied to identify possible alert for genotoxicity of five calystegines recently detected in food. In most of the cases, the outcome of the computational predictions indicated no alerts for genotoxicity; however, the low reliability of the results prevents a firm conclusion on the genotoxic potential of the substances. Overall, the available data do not allow drawing conclusions on the possible toxic effects of calystegines in humans or in livestock, and more data in relevant experimental models would be necessary to characterise the toxic profile of this group of substances.

Scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids in feed and food, in particular in lupins and lupin-derived products.

The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids (QAs) in feed and food. This risk assessment is limited to QAs occurring in Lupinus species/varieties relevant for animal and human consumption in Europe (i.e. Lupinus albus L., Lupinus angustifolius L., Lupinus luteus L. and Lupinus mutabilis Sweet). Information on the toxicity of QAs in animals and humans is limited. Following acute exposure to sparteine (reference compound), anticholinergic effects and changes in cardiac electric conductivity are considered to be critical for human hazard characterisation. The CONTAM Panel used a margin of exposure (MOE) approach identifying a lowest single oral effective dose of 0.16 mg sparteine/kg body weight as reference point to characterise the risk following acute exposure. No reference point could be identified to characterise the risk of chronic exposure. Because of similar modes of action for QAs, the CONTAM Panel used a group approach assuming dose additivity. For food, the highest mean concentration of Total QAs (TotQAs) (i.e. the 6 most abundant QAs) was found in lupin seed samples classified as 'Lupins (dry) and similar-'. Due to the limited data on occurrence and consumption, dietary exposure was calculated for some specific scenarios and no full human health risk characterisation was possible. The calculated margin of exposures (MOEs) may indicate a risk for some consumers. For example, when lupin seeds are consumed without a debittering step, or as debittered lupin seeds high in QA content and when 'lupin-based meat imitates' are consumed. For horses, companion and farm animals, other than salmonids, the available database on adverse effects was too limited to identify no-observed-adverse-effect levels and/or lowest-observed-adverse-effect levels and no risk characterisation was possible. For salmonids, the CONTAM Panel considers the risk for adverse effects to be low.

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction.

EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and polychlorinated biphenyls (PCBs) from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)) as well as dioxin-like (DL-) and non-dioxin-like (NDL-) PCBs. The data provided by the applicant were assessed with respect to the efficacy of the process, absence of solvent residues and on information demonstrating that the process does not adversely affect the nature and characteristics of the product. According to data provided, the process was effective in producing a sunflower meal that contained concentrations of PCDD/Fs and DL-PCBs, and NDL-PCBs (6 indicator PCBs) about 90% lower than in the sunflower cake. The data showed that it is possible to meet the current EU maximum levels with respect to these contaminants using this process. It is unlikely that hazardous substances (i.e. hexane) remain in the final product. The extraction of the oil from the sunflower cake produces sunflower meal, which has a different nutrient content and nutritional value than the original sunflower cake, but is suitable to be used in animal nutrition with no specific legal limitations in the use or the inclusion levels in the diets. The applicant indicated that the crude oil, as well as the co-products resulting of the processing of this oil, could only be used for technical purposes. No information was provided regarding the disposal or reuse of the hexane. EFSA concluded that the proposed detoxification process to remove PCDD/Fs and PCBs from sunflower cake by means of solvent extraction to produce sunflower meal, met the acceptability criteria provided in Commission Regulation (EU) 2015/786.

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion.

In 2017, EFSA published a 'simplified' food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter presents several novel food safety challenges because donated food may be nearing the end of its shelf-life and several actors are involved in the food donation chain, each reliant on each other to assure food safety. In this opinion, the simplified approach to food safety management is presented based on a fundamental understanding of processing stages and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. Control is achieved using PRP activities as previously described but with a modified 'temperature control' PRP and the addition of PRPs covering shelf-life control, handling returned foods, shelf-life evaluation for food donation, allocation of remaining shelf-life, and freezing food intended for donation. Examples of the simplified approach are presented for retail distribution centres, supermarkets, restaurants and food donation.

Effect on public health of a possible increase of the maximum level for 'aflatoxin total' from 4 to 10 µg/kg in peanuts and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs.

EFSA was asked to deliver a scientific opinion regarding the effect on public health of a possible increase of the maximum level (ML) for 'aflatoxin total' (AFT; sum of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2) from 4 to 10 µg/kg in peanuts and processed products thereof. Aflatoxins are genotoxic and cause hepatocellular carcinomas in humans. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 8,085 samples of peanuts and 472 samples of peanut butter, with > 60% left-censored. The mean concentration of AFT in peanuts was 2.65/3.56 µg/kg (lower bound (LB)/upper bound (UB)) with a maximum of 1,429 µg/kg. The mean concentration in peanut butter was 1.47/1.92 µg/kg (LB/UB) with a maximum of 407 µg/kg. Peanut oil was not included since all data were left-censored and the ML does not apply for oil. Exposure was calculated for a 'Current ML' and 'Increased ML' scenario, and mean chronic exposure estimates for consumers only, amounted to 0.04-2.74 ng/kg body weight (bw) per day and 0.07-4.28 ng/kg bw per day, respectively. The highest exposures were calculated for adolescents and other children. The CONTAM Panel used the cancer potencies estimated by the Joint FAO/WHO Expert Committee on Food Additives for the risk characterisation. Under the scenario of the current ML, the cancer risk was estimated to range between 0.001 and 0.213 aflatoxin-induced cancers per 100,000 person years. Under the scenario of the increased ML, it ranged between 0.001 and 0.333 aflatoxin-induced cancers per 100,000 person years. Comparing these data calculated under the current ML scenario with the yearly excess cancer risk of 0.014 shows a higher risk for consumers of peanuts and peanut butter in some surveys. The calculated cancer risks indicate that an increase of the ML would further increase the risk by a factor of 1.6-1.8.

Update of the Scientific Opinion on opium alkaloids in poppy seeds.

Poppy seeds are obtained from the opium poppy (Papaver somniferum L.). They are used as food and to produce edible oil. The opium poppy plant contains narcotic alkaloids such as morphine and codeine. Poppy seeds do not contain the opium alkaloids, but can become contaminated with alkaloids as a result of pest damage and during harvesting. The European Commission asked EFSA to provide an update of the Scientific Opinion on opium alkaloids in poppy seeds. The assessment is based on data on morphine, codeine, thebaine, oripavine, noscapine and papaverine in poppy seed samples. The CONTAM Panel confirms the acute reference dose (ARfD) of 10 µg morphine/kg body weight (bw) and concluded that the concentration of codeine in the poppy seed samples should be taken into account by converting codeine to morphine equivalents, using a factor of 0.2. The ARfD is therefore a group ARfD for morphine and codeine, expressed in morphine equivalents. Mean and high levels of dietary exposure to morphine equivalents from poppy seeds considered to have high levels of opium alkaloids (i.e. poppy seeds from varieties primarily grown for pharmaceutical use) exceed the ARfD in most age groups. For poppy seeds considered to have relatively low concentrations of opium alkaloids (i.e. primarily varieties for food use), some exceedance of the ARfD is also seen at high levels of dietary exposure in most surveys. For noscapine and papaverine, the available data do not allow making a hazard characterisation. However, comparison of the dietary exposure to the recommended therapeutical doses does not suggest a health concern for these alkaloids. For thebaine and oripavine, no risk characterisation was done due to insufficient data. However, for thebaine, limited evidence indicates a higher acute lethality than for morphine and the estimated exposure could present a health risk.

Update: methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin.

EFSA was asked by the European Commission to update the Scientific Opinion on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The RPA shall be based on the reasonably achievable lowest residue concentration that can unequivocally be determined by official control laboratories, i.e. the reasonably achievable lowest decision limit (CCα). The aim is to check whether this concentration is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step-wise approach applies toxicological screening values (TSVs), based on genotoxic potential, pharmacological activity, as well as other effects of the substance. The highest dietary exposure corresponding to the reasonably achievable lowest CCα for the substance has to be estimated and compared with the TSV. Where equal to or lower than the TSV, the reasonably achievable lowest CCα can be accepted as the RPA. If higher, the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible within a short to medium time frame, a substance-specific risk assessment should be considered. This also applies when the potential adverse effects do not allow use of the decision tree, as for high potency carcinogens, inorganic substances or compounds with allergenic effects or causing blood dyscrasias. The CONTAM Panel concluded that RPAs should be food matrix independent. RPAs cannot be applied to non-edible matrices, which are also monitored for non-allowed pharmacologically active substances.

Importance of a canteen lunch on the dietary intake of acrylamide.

A food and drink intake survey was carried out among university students and staff members. Consumption data were collected on days when the participants took hot lunch in a university canteen. The dietary acrylamide exposure was calculated through a probabilistic approach and revealed a median intake of 0.40 microg/kg bw/day [90% confidence interval: 0.36-0.44], which is in accordance with previous exposure calculations. Biscuits (35.4%), French fries (29.9%), bread (23.5%), and chocolate (11.2%) were identified to be the main sources of dietary acrylamide. Foodstuffs consumed in between the three main meals of the day (so called snack type foods) contributed the most to the intake (42.2%). The exposure was lower in an intervention group which received free portions of fruit and vegetables, indicating that a nutritionally balanced diet may contribute to a decreased acrylamide intake. French fries had a significant impact on the acrylamide intake, due to the frequent consumption in the canteen. This demonstrates the important responsibility of caterers and canteen kitchens in the mitigation of acrylamide exposure through reduction of acrylamide in their prepared products, in particular in French fries.

Modeling the effect of temperature on the growth rate and lag phase of Penicillium expansum in apples.

The objective of the present study was to develop validated models that describe the effect of storage temperature on the growth rate and lag phase of six Penicillium expansum strains. The growth of the selected strains was therefore studied on Apple Puree Agar Medium (APAM) at 30, 25, 16, 10, 4 and 2 degrees C. Growth rates and lag phases were estimated using linear regression. Several secondary models were evaluated and for the growth rate, a modification of the extended Ratkowsky model was selected. Regarding the lag phase, the Arrhenius-Davey model provided the best adjustment to the observed data. Model validation was performed in two steps. Firstly, the developed models were validated on APAM. The obtained bias factors (Bf) ranged from 0.91 to 1.14 and the accuracy factors (Af) were <1.2 for the validation performed on APAM, indicating that the models were good predictors of the true mean colony growth rate and lag phase. Afterwards, an external validation was carried out in apples. For the growth rate, Bf ranged from 0.64 to 0.81 and Af<1.39, indicating conservative predictions. On the contrary for the lag phase, a clear deviation was observed between predictions and observed values on apples (0.351.6). These results highlight that the use of simulation or synthetic media for the development of predictive models for the lag phase of moulds can lead to inadequate predictions and that a validation on the real food matrix is necessary. Application of the developed models is possible in the framework of Quantitative Risk Assessment to develop control strategies against blue mould rot in apple and enables the inclusion of strain variability. However, possible underestimation of the lag phase should be taken into account.

Influence of storage conditions of apples on growth and patulin production by Penicillium expansum.

Penicillium expansum causes blue mould rot, a serious post-harvest disease of apples, and is the main producer of the mycotoxin patulin. The present study aimed to determine the influence of storage conditions (i.e. temperature and O(2) level) on growth and patulin production by different P. expansum strains on a simulation medium and on apples. Growth was strongly influenced by the temperature, while the used atmosphere (20, 3, and 1% O(2); <1% CO(2)) had no effect. Optimal growth was observed at 25 degrees C for every strain tested. Patulin production was stimulated when the temperature decreased (from 20 to 10 or 4 degrees C), while a further decrease of the temperature to 1 degrees C caused a reduction in patulin production. The temperature at which the stimulation was changed into suppression was strain dependent. Similar results were observed for the O(2) level. A reduction of the O(2) level from 20 to 3% O(2) could stimulate or suppress patulin production depending on the strain, while a clear decrease of the patulin production was observed when the O(2) level was reduced from 3 to 1%. These results show that the induction of limited stress to the fungus, such as lowering the temperature or lowering the O(2) levels stimulates patulin production. However, the combination of different stress conditions (e.g. low temperature and low O(2)) will result in a reduced formation of the toxin. The combination of stress conditions, at which the transition from stimulation to suppression is observed, is strain dependent. Moreover, patulin production is characterized by a high natural variability. The presented results show that the temperature and O(2) level has to be as low as possible during the storage of apples in order to suppress patulin production and to guarantee food safety.

Variability and uncertainty assessment of patulin exposure for preschool children in Flanders.

The objective of the present study was to evaluate the patulin exposure of children consuming organic, handcrafted or conventional apple juice through a probabilistic approach and to evaluate the effectiveness of several risk management options aiming to reduce the risk for children due to patulin exposure. However, a large part of the data on patulin contamination of apple juice fell under the limit of detection (LOD). Different methods were tested to deal with these so-called left censored data and a uniform distribution with uncertain bounds was selected to handle this censorship. Variability and uncertainty assessment of patulin exposure showed that 0.9% [90% confidence interval (CI): 0.3-1.8%] of the children consuming only organic apple juice exceed the tolerable daily intake (TDI). For consumers of conventional and handcrafted apple juice this was respectively 0.1% [90% CI: 0-0.3%] and 0% [90% CI: 0-0.2%]. Reduction of the patulin contamination in apple juice to concentrations below 25 microg/kg reduced the percentage of the children exceeding the TDI to 0% [90%CI: 0-0.2%] for organic apple juice. Reduction of the apple juice consumption was less effective than a reduction of the patulin concentration in apple juice and is only useful when the patulin concentration of apple juice is below 25 microg/kg.

Dyes in aquaculture and reference points for action.

The European Commission requested EFSA to evaluate whether a series of dyes are covered by the 'Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin' and to which group they should be attributed according to this guidance. Although these substances are not registered for use in food-producing animals in the European Union, they may be used illegally in aquaculture for their antimicrobial properties. It was concluded that acriflavine, 3-aminoacridine, aminoacridine, basic blue 7, brilliant green, leucobrilliant green, C.I. basic blue 26, chloranil, crystal violet, leucocrystal violet, dichlone, ethyl violet, methylene blue, new methylene blue, Nile blue, pararosaniline base, proflavine, proflavine hydrochloride, rhodamine 6G and trypan red are covered by the guidance document and belong to group I. A toxicological screening value of 0.0025 µg/kg body weight per day is applicable. Azure blue and potassium permanganate were excluded from the evaluation due to their inorganic nature.

Risks for public health related to the presence of furan and methylfurans in food.

The European Commission asked EFSA for a scientific evaluation on the risk to human health of the presence of furan and methylfurans (2-methylfuran, 3-methylfuran and 2,5-dimethylfuran) in food. They are formed in foods during thermal processing and can co-occur. Furans are produced from several precursors such as ascorbic acid, amino acids, carbohydrates, unsaturated fatty acids and carotenoids, and are found in a variety of foods including coffee and canned and jarred foods. Regarding furan occurrence, 17,056 analytical results were used in the evaluation. No occurrence data were received on methylfurans. The highest exposures to furan were estimated for infants, mainly from ready-to-eat meals. Grains and grain-based products contribute most for toddlers, other children and adolescents. In adults, elderly and very elderly, coffee is the main contributor to dietary exposure. Furan is absorbed from the gastrointestinal tract and is found in highest amounts in the liver. It has a short half-life and is metabolised by cytochrome P450 2E1 (CYP2E1) to the reactive metabolite, cis-but-2-ene-1,4-dialdehyde (BDA). BDA can bind covalently to amino acids, proteins and DNA. Furan is hepatotoxic in rats and mice with cholangiofibrosis in rats and hepatocellular adenomas/carcinomas in mice being the most prominent effects. There is limited evidence of chromosomal damage in vivo and a lack of understanding of the underlying mechanism. Clear evidence for indirect mechanisms involved in carcinogenesis include oxidative stress, gene expression alterations, epigenetic changes, inflammation and increased cell proliferation. The CONTAM Panel used a margin of exposure (MOE) approach for the risk characterisation using as a reference point a benchmark dose lower confidence limit for a benchmark response of 10% of 0.064 mg/kg body weight (bw) per day for the incidence of cholangiofibrosis in the rat. The calculated MOEs indicate a health concern. This conclusion was supported by the calculated MOEs for the neoplastic effects.