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The EFSA Journal is an open-access, online scientific journal that publishes the scientific outputs of the European Food Safety Authority. EFSA’s various output types are devoted to the field of risk assessment in relation to food and feed and include nutrition, animal health and welfare, plant health and plant protection.


Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

EFSA Panel on Contaminants in the Food Chain (CONTAM) Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye, Manfred Metzler, Carlo Stefano Nebbia, Michael O’Keeffe, Ivonne Rietjens (until 2 May 2014), Dieter Schrenk, Vittorio Silano, Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester. EFSA Journal 2014;12(8):3802 [174 pp.]. doi:10.2903/j.efsa.2014.3802 Abstract

Beauvericin and enniatins are mycotoxins produced by various Fusarium species. The European Commission asked EFSA for a scientific opinion on the risk to human and animal health related to the presence of beauvericin and enniatins in food and feed. A total of 12 685 analytical results for beauvericin and enniatins in food, feed and unprocessed grains were evaluated. For the assessment of enniatins, the sum of enniatins A, A1, B and B1 were considered. The most important contributors to the chronic dietary exposure to beauvericin and the sum of enniatins were ‘Grains and grain-based products’, especially ‘Bread and rolls’, ‘Fine bakery wares’ and ‘Pasta (raw)’. Given the lack of relevant toxicity data, a risk assessment was not possible. To obtain some insights in the possible risks of both mycotoxins at the estimated acute dietary exposure levels, these were compared to the LD 50 values of beauvericin and of the drug fusafungine (a mixture of enniatins). For the chronic exposure, an estimate for the LOAEL of fusafungine was considered. The CONTAM Panel concluded that acute exposure to beauvericin and enniatins do not indicate concern for human health. There might be a concern with respect to chronic exposure but no firm conclusion could be drawn, thus relevant in vivo toxicity data are needed to perform a human risk assessment. Animal exposure to beauvericin and enniatins was primarily from consuming cereal grains and cereal by-products. Using the LD 50 values of beauvericin and fusafungine, adverse health effects from the acute exposure to beauvericin and the sum of enniatins for farm and companion animals were unlikely. The chronic exposure for poultry indicated that adverse health effects from beauvericin and enniatins were unlikely. For other considered animals, the lack of LOAELs/NOAELs precluded the estimation of chronic health risk from beauvericin and enniatins.

7 August 2014 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2014;12(8):3809 [18 pp.]. doi:10.2903/j.efsa.2014.3809 Abstract

Following a request from the European Commission, the European Food Safety Authority (EFSA) evaluated the documentation submitted by France under Article 34 of Regulation (EC) 1829/2003 in support of its request to prohibit the cultivation of genetically modified maize MON 810 in the EU. Neither the scientific publications cited in the documentation submitted by France with relevance to maize MON 810 nor the arguments put forward by France reveal any new information that would invalidate the previous risk assessment conclusions and risk management recommendations made by the EFSA GMO Panel. EFSA considers that the previous GMO Panel risk assessment conclusions and risk management recommendations on maize MON 810 remain valid and applicable. Therefore, EFSA concludes that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the adoption of an emergency measure on the cultivation of maize MON 810 under Article 34 of Regulation (EC) 1829/2003.

1 August 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(8):3813 [19 pp.]. doi:10.2903/j.efsa.2014.3813 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance pyriproxyfen are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of pyriproxyfen as an insecticide on protected tomato and aubergine and field grown cotton. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. A concern is identified.

21 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3691 [74 pp.]. doi:10.2903/j.efsa.2014.3691 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and the co-rapporteur Member State Spain, for the pesticide active substance acibenzolar-S-methyl are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of acibenzolar-S-methyl as a plant activator on pome fruit, tomato and tobacco. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed.

12 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3801 [84 pp.]. doi:10.2903/j.efsa.2014.3801 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria, for the pesticide active substance pyridate are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of pyridate as a herbicide on sweet corn, cauliflower, broccoli and leek. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

8 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3805 [89 pp.]. doi:10.2903/j.efsa.2014.3805 Abstract

The conclusions of the European Food Safety Authority (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 flutianil 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 uses of flutianil as a fungicide on grapevine and ornamental crops. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

6 August 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(8):3819 [28 pp.]. doi:10.2903/j.efsa.2014.3819 Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance oryzalin. In order to assess the occurrence of oryzalin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

29 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3818 [29 pp.]. doi:10.2903/j.efsa.2014.3818 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Exponent International Ltd., on behalf of ICA International Chemicals (PTY) Ltd., to set an import tolerance for the active substance guazatine in citrus fruits. In order to accommodate for the reported post-harvest use of guazatine acetates in South Africa, the United Kingdom proposed the MRL of 4 mg/kg. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the metabolism of guazatine acetates in citrus fruits is not fully elucidated. A tentative MRL proposal of 5 mg/kg for guazatine acetates (corresponding to 4 mg/kg for residues expressed as guazatine) was derived. This MRL proposal should be considered as tentative. The MRL set in the country of origin is 5 mg/kg for guazatine. Although the indicative consumer risk assessment did not identify a consumer health risk for the reported post-harvest use of guazatine acetates on citrus fruits imported from South Africa, EFSA does not propose to set a MRL in citrus since the risk assessment is affected by a high level of scientific uncertainties resulting from the validity of the toxicological reference values, the lack of elucidation of the metabolic pathway in plants and livestock and the validity of the supervised residue trials analysed with an analytical method which is based on the analysis of one constituent of the technical material (marker substance GG-diacetate) only. Thus, EFSA is of the opinion that the available data are not sufficient to demonstrate that the residues of guazatine acetates on citrus fruits resulting from the South African GAP are safe for European consumers.

28 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3811 [18 pp.]. doi:10.2903/j.efsa.2014.3811 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for the active substance propamocarb in spring onions and Chinese cabbage. In order to accommodate for the intended uses of propamocarb, Belgium proposed to raise the existing MRLs from the value of 0.1* mg/kg to 30 mg/kg for spring onions and from 10 mg/kg to 20 mg/kg for Chinese cabbage. Belgium drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive MRL proposal of 30 mg/kg for the proposed uses on spring onions and of 20 mg/kg for Chinese cabbage. Adequate analytical enforcement methods are available to control the residues of propamocarb in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of propamocarb on spring onions and Chinese cabbage will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

8 August 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(8):3807 [38 pp.]. doi:10.2903/j.efsa.2014.3807 Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance phenmedipham. In order to assess the occurrence of phenmedipham residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

1 August 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2014;12(8):3810 [73 pp.]. doi:10.2903/j.efsa.2014.3810 Abstract

A European Union-wide baseline survey on Listeria monocytogenes was carried out in 2010 and 2011. Packaged (not frozen) hot or cold smoked or gravad fish, soft or semi-soft cheeses (excluding fresh cheeses) and packaged heat-treated meat products were sampled in 26 European Union Member States and in one country not belonging to the European Union. Multiple-factor analysis (Generalized Estimating Equations) was used to investigate the statistical association between several factors on which information was gathered during the baseline survey, and two outcomes: prevalence of Listeria monocytogenes and proportion of samples with counts exceeding 100 cfu/g, in the surveyed fish and meat products (no analysis is presented for cheese samples, owing to the small number of contaminated samples). Sparseness issues led to instability of the effect estimates for some of the factors. For fish samples, factors that exhibited a stable association with at least one of the two outcomes were 'Subtype of the fish product' (factor related to the type of processing), 'Number of antimicrobial preservatives and/or acidity regulators' and 'Possible slicing'. For meat products, the corresponding factors were 'Type of the meat product', 'Animal species of the origin of the meat product', 'Possible slicing' and 'Remaining shelf-life' (days between sampling and 'Use by date'). Furthermore, a statistical model was developed that allowed the use of estimates of the proportion of samples with an L. monocytogenes count > 100 cfu/g obtained from a single-unit sample survey of a population of RTE foods, in order to estimate the probability that if a five-unit sample had been taken from the same population, no individual unit, out of n = 5 units constituting the sample, would have exceeded the level of 100 cfu/g. The model was applied using data from the baseline survey for fish, cheese and meat products, at the end of shelf-life.

12 August 2014 Mail Print Cite