Carcinogenic, ethanol, acetaldehyde and noncarcinogenic higher alcohols, esters, and methanol compounds found in traditional alcoholic beverages. A risk assessment approach.

Greek fermentation and distillation industries produce traditional spirit beverages, such as tsipouro and tsikoudia, consumed both in bottles and bulk quantities by the general population or tourists. The same spirits are also produced by individuals at home since previous centuries, as a part of the local culture but mainly due to the Greek agricultural sector unique characteristics (small cultivation areas with great number of farmers). In this study, the concentrations of carcinogenic compounds: ethanol and acetaldehyde; and noncarcinogenic: higher alcohols (1-propanol, isobutanol, and isoamyl alcohol), esters (ethyl acetate), and methanol were measured to estimate the potential cancer risk and daily intake of these compounds. The margin of exposure (MOE) of carcinogenic compounds was found to be less than 500 (mean value), well below the toxic threshold of 10,000, above which there is not public concern, as suggested by the European Food Safety Authority. Additionally, through risk assessment of noncarcinogenic compounds, we identified two specific compounds in-bulk spirits (produced by individuals), namely ethyl acetate and isobutanol, with health risk index (HRI) greater than 1 (indicating a possibility to induce side effects by consumption of high amounts). Our results indicate that bottled spirits, which are produced in a controlled environment (alcohol industries), showed higher human safety level in terms of both carcinogenic and noncarcinogenic risk assessment studies, comparing to bulk beverages produced by individuals (with out strict regulations).

Health risk assessment of aflatoxin M1 in infant formula milk in IR Iran.

In this study, two accurate, precise, selective and sensitive methods were developed for determining aflatoxin M1 (AFM1) in infant formula milk using immunoaffinity column clean-up followed by high performance liquid chromatography (HPLC) with fluorescence detection. The validated methods were used for determination of AFM1 in 29 samples of 6 different infant formula milk brands and the risk of AFM1 in infants aged zero to 6 months old was assessed using cancer risk, Margin of Exposure (MOE) and Hazard Index (HI). Only one sample (3.4%) was contaminated with AFM1. Although the results showed that MOE values for the mean and median exposure to AFM1 was <10,000 in infants, the additional cancer risk due to mean and median exposure to AFM1 in infant <6 months were 0.00010 and 0.00012 additional cases per year per 105 individuals, respectively, which indicates no health concern. In addition, HI values for the mean and median exposure to AFM1 for infants were quite below one which indicates no health concern. To the best of our knowledge, this is the first report on risk assessment of AFM1 in infant formula milk consumed by Iranian infants <6 months old, presenting a low risk for the evaluated groups.

Multiresidue analysis of insecticides and fungicides in apples from the Greek market. Applying an alternative approach for risk assessment.

Pesticides are widely used in agriculture and their proven high toxicity makes the need of monitoring their presence in food imperative. A multi residue method is applied in apples samples (81) collected from the Greek market for the monitoring of 40 analytes. Pesticides levels were evaluated by gas and liquid chromatography-mass spectrometry using a QuEChERs protocol. Risk for consumers was assessed by a newly developed methodology, employing the source related Hazard Quotient (HQs) and the adversity specific Hazard Index (HIA). The 84% of the apple's samples were positive for at least one pesticide, 21% for one pesticide, 55.6% for two to four pesticide residues and 7.4% for more than 4 pesticide residues. The most frequently detected compound was carbendazim (45.7%) followed by chlorpyrifos (44.4.0%). The mean detected concentration levels varied from 0.169 ppm (fluopyram) to 0.005 ppm (triazophos). 19 of the 40 investigated pesticides were not detected in any apple sample. For all individual pesticides, the source related Hazard Quotient (HQs) was <1 indicating no risk. HIA, resulting from the sum of all HQs was found HIA < 1 in nine out of ten toxicity groups, except to the neurotoxicity group, which presented HIA 2.258, indicating moderate risk.

Cumulative risk assessment of pesticide residues in different Iranian pistachio cultivars: Applying the source specific HQS and adversity specific HIA approaches in Real Life Risk Simulations (RLRS).

Iran is a major supplier of the world pistachio market. In this study, we collected five pistachio cultivars from four main pistachio-producing zones in August and September 2016, and determined the residues of 18 organophosphorus, carbamate, pyrethroid and nicotinoid pesticide in these samples using Gas Chromatography-Mass Spectrometry, as an efficient method for determination of pesticides' residues. Next, single-chemical and chronic cumulative risk assessment was done based on the new approaches of the food specific Hazard Quotient and adversity specific Hazard Index. Fifteen from eighteen food-specific Hazard Quotients were above 1 even in cases when the respective contamination was bellow MRLs. The adversity specific Hazard Indexes values were above 1 for five from six adversities indicating various risks in the resulted levels of pistachios' contamination from the pesticides' mixture. However, no risk for carcinogenicity was found. Our results indicate the necessity of taking appropriate measures to control/standardize pesticides practice in pistachio cultivation in Iran and the need to re-establish the MRLs based on cumulative exposure.

Indicator PCBs in farmed and wild fish in Greece - Risk assessment for the Greek population.

Health benefits of fish consumption could be counterbalanced by the intake of contaminants after long term fish consumption, burdened even in trace levels. The presence of the indicator PCBs (NDL-PCBs and PCB 118) in farmed and wild seabream and seabass was evaluated. For the determination of PCB, a GC-MS method was developed and evaluated. The association of PCB accumulation in fish with seasonality, locality, production mode and species was also investigated. A new approach for the risk characterisation after exposure to NDL-PCB through fish consumption in Greece was developed, based on the real exposure and the permitted maximum levels of both aggregated dietary exposure and exposure through fish consumption. PCB levels determined in fish were below established permitted limits (6.24 ng/g 95th percentile), while PCB levels and congener distribution varied significantly between farmed and wild fish (p = 0.001). Seasonality was highlighted as an important factor affecting NDL-PCBs accumulation, with high levels coinciding with the reproduction period of each species. Differences were also depicted for sampling sites, with PCB 118 presenting significantly higher values in open seas while NDL-PCB congeners in closed seas. Risk assessment of NDL-PCB intake through fish consumption corrected for the aggregated exposure revealed no risk for the consumers.

Risk assessment of exposure to aflatoxin B1 and ochratoxin A through consumption of different Pistachio (Pistacia vera L.) cultivars collected from four geographical regions of Iran.

Iran is one of the main suppliers of pistachio for the European market accounting for over 90% of its demands; hence, efficient analytical methods are required for detection of mycotoxins contamination in pistachio kernels before exporting them. In this study, aflatoxin B1 (AFB1) and ochratoxin A (OTA) levels in five pistachio cultivars collected from four sites of Iran, were measured by HPLC. Based on the results, risk assessment for AFB1 and OTA residues was done. The highest mean concentrations of AFB1 and OTA were found in Ahmad-aghaei (4.33 and 2.19 ng/g, respectively) and Akbari (4.08 and 1.943 ng/g, respectively) cultivars from Rafsanjan, Iran. Even the highest concentrations of AFB1 and OTA in analyzed samples were lower than the corresponding maximum limits set by EU authorities. The hazard index (HI) value for consumers of Iranian pistachio is below one. It could be concluded that consumption of pistachio cultivated in these regions poses no health risk of mycotoxins exposure.

Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen.

The conclusions of EFSA following the peer review of the initial assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Austria, for the pesticide active substance quinoxyfen are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of information targeted at the assessment of the potential persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) and persistent organic pollutant (POP) properties of quinoxyfen according to Article 11(2) of Regulation (EC) No 1107/2009. The reliable end points, appropriate for use in these regulatory hazard cut off assessments are presented. Missing information identified as being required by the regulatory framework is listed. The concern is identified that quinoxyfen may be considered to exhibit the hazard properties of both a PBT and vPvB substance considering the triggers specified in Annex II of Regulation (EC) No 1107/2009.

Peer review of the pesticide risk assessment of the active substance chlorothalonil.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co-rapporteur Member State, Belgium, for the pesticide active substance chlorothalonil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of chlorothalonil as a fungicide on wheat, barley, tomato and potato. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance tolclofos-methyl.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co-rapporteur Member State, Denmark, for the pesticide active substance tolclofos-methyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of tolclofos-methyl as a fungicide on potatoes, lettuce and ornamentals. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance thiophanate-methyl.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co-rapporteur Member State, Finland, for the pesticide active substance thiophanate-methyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiophanate-methyl as a fungicide on wine grapes, tomato, aubergine, leek, fresh beans with pods and wheat (winter and durum). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance indoxacarb.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Spain, for the pesticide active substance indoxacarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of indoxacarb as an insecticide on maize, sweet corn and lettuce. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance fenpicoxamid (XDE-777).

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance fenpicoxamid (XDE-777) and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of fenpicoxamid (XDE-777) as a fungicide on cereals (winter and spring wheat, durum wheat, rye and triticale). MRLs were assessed in rye and wheat (including triticale and spelt). An MRL application for the import tolerance on bananas was also assessed. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance desmedipham.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co-rapporteur Member State, Denmark, for the pesticide active substance desmedipham are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of desmedipham as a herbicide on sugar beet/fodder beet. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance phenmedipham.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co-rapporteur Member State, Denmark, for the pesticide active substance phenmedipham are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of phenmedipham as a herbicide on sugar beet/fodder beet. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance copper compounds copper(I), copper(II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper(I) oxide, Bordeaux mixture.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Germany, for the pesticide active substance copper compounds are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of copper compounds as a fungicide on grapes, tomatoes and cucurbits. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance ethoprophos.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co-rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethoprophos as a nematicide and an insecticide on potatoes. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance Pasteuria nishizawae Pn1.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Denmark, for the pesticide active substance Pasteuria nishizawae Pn1 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Pasteuria nishizawae Pn1 as a nematicide on sugar beet. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented.

Peer review of the pesticide risk assessment of the active substance dimethenamid-P.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co-rapporteur Member State Bulgaria for the pesticide active substance dimethenamid-P and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimethenamid-P as a herbicide on annual monocotyledonous and dicotyledonous weeds in winter oilseed rape, maize, sweet corn, soya bean, sunflower and sugar beet. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance trinexapac (variant evaluated trinexapac-ethyl).

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Lithuania, and co-rapporteur Member State Latvia for the pesticide active substance trinexapac and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of trinexapac as a plant growth regulator on barley (winter and spring) and wheat (winter). MRLs were assessed in rye. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. The confirmatory data following the review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 were also assessed under this conclusion. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.