EFSA was asked by the German Federal Institute for Risk Assessment (BfR) to re-evaluate the TDI for phenol of 1.5 mg/kg bw/day, since this value is within the same dose range which was reported to be associated with some haematotoxic and immunotoxic effects in an oral study on phenol. The Panel comprehensively reviewed the available toxicological studies, mainly those using an oral route of exposure. The CEF experts did not consider immunotoxicity as a suitable endpoint on which to base a new TDI for phenol, given the study limitations and the lack of confirmation of phenol-induced immunotoxic effects in other studies. The Panel considered a gavage developmental toxicity study and an oral two-generation reproduction toxicity study as the two most robust toxicity studies, and performed a dose-response analysis of these data using the benchmark dose (BMD) approach. The lower 95 % confidence bound (one-sided) of the BMD, denoted BMDL, was then taken as the reference point. The lowest reference point for deriving a health based guidance value was provided by the BMDL₁₀ of 52 mg/kg bw/day for reduced maternal body weight gain from a developmental toxicity study where rats were exposed to phenol by gavage from gestational day 6 to 16. The CEF Panel set a TDI for phenol to 0.5 mg/kg bw/day, by applying a standard uncertainty factor of 100 (for inter- and intra-species differences) to this BMDL₁₀ value. The Panel did not assess the hazards related to the possible oxidation products of phenol, e.g. quinones/hydroquinones. Therefore, the above TDI only covers phenol. Exposure to phenol may occur via sources other than food contact materials, e.g. flavourings, smoke flavourings, traditionally smoked foods, floor waxes, cosmetics, disinfectants, etc.. The European Commission may wish to take note of all these sources of exposure if setting a restriction for phenol in food contact materials.

Based on a comprehensive review of literature and OIE (World Animal Health Organisation) outbreak reports, this scientific opinion reports, first, that there is no evidence that Rift Valley fever (RVF) has spread to previously uninfected countries during the past 10 years. Nevertheless, RVF has moved north within Mauritania, in a desert area. Secondly, maps of Europe and the southern Mediterranean Basin are provided, displaying the geographic distribution of the reported presence of nine potentially competent Rift Valley fever virus (RVFV) vectors of the region, based on a systematic literature review. From environmental and eco-climatic data, predicted presence maps were generated that suggest the suitability of several parts of Europe and the southern Mediterranean Basin for these potentially competent RVFV vectors. Thirdly, to assess the risk of introduction of RVFV into some designated countries in the southern Mediterranean Basin (hereafter defined as the region concerned, RC), especially through the movements of live animals and vectors, a quantitative model was constructed and model parameters were derived based on expert knowledge elicitation (EKE). The EKE model indicates that some hundreds of RVFV-infected animals will be moved into the RC when an epidemic in the source areas occurs. The risk of RVFV entering the RC through the movement of vectors is expected to be small in comparison with the risk of entry through infected animals. Because of a lack of quantitative information on the seasonality of vector abundance and vertical transmission of RVFV within local vector species, the risk of endemicity could not be assessed. However, based on the abundance of the vector Culex pipiens, the livestock densities and the temperature in the region, there is a potential for the occurrence of RVF spread in the coastal areas of the RC.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape Ms8, Rf3 and Ms8 x Rf3. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import, processing and feed uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3 in the EU pose a significant and imminent risk to the environment. The EFSA GMO Panel does not consider the occurrence of occasional feral oilseed rape Ms8, Rf3 and Ms8 x Rf3plants, pollen dispersal and consequent cross-pollination as environmental harm in itself. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape Ms8, Rf3 and Ms8 x Rf3.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape GT73. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape GT73 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import, processing and feed uses of oilseed rape GT73 in the EU pose a significant and imminent risk to the environment. The EFSA GMO Panel does not consider the occurrence of occasional feral oilseed rape GT73 plants, pollen dispersal and consequent cross-pollination as environmental harm in itself. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73.

Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion re-evaluating the safety of anthocyanins (E 163). The Panel concluded that the currently available toxicological database was inadequate to establish a numerical ADI for anthocyanins. For anthocyanins extracted from edible fruits and vegetables by aqueous processes, changes in composition would not be expected. The Panel concluded that provided exposure from use as a food additive was comparable to that from the diet the underlying conclusion in the 1975 SCF opinion that such food additives derived from natural sources would still apply. The majority of data are on aqueous grape skin extract (GSKE) and blackcurrant extracts and the Panel considers that exposures estimated from current uses and use levels these extracts are unlikely to be of safety concern. The Panel recommends that the specifications for E 163 should be modified to reflect this conclusion. For anthocyanins extracted from other sources and/or using non-aqueous extraction methods the absence of characterisation does not allow verification that this conclusion in the 1975 SCF opinion could be applied. The Panel noted that for some extracts it had proven possible to assess a group based on toxicological and compositional data on representative samples across the range of extracts. The Panel concluded that refined exposure estimates of anthocyanins used as a food additive were higher than dietary intakes and that these did not include intakes from colouring foods. Therefore the Panel would recommend that appropriate characterisation and toxicological data should be required to permit a further re-evaluation of anthocyanins including comparative data on anthocyanins (E 163) produced by aqueous extraction.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 20 aliphatic secondary alcohols, ketones and related esters evaluated by the JECFA at the 59^th and 69^th meetings in 2002 and 2008. This revision is made due to inclusion of one additional substance, 4-methylpent-3-en-2-one [FL-no: 07.101], cleared for genotoxicity concern. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 20 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 20 substances, the information is adequate.

Maize 98140 contains a single insert consisting of the gat4621 and the Zm-hra expression cassettes, providing herbicide tolerance. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the GAT and Zm-HRA protein in maize 98140 have been sufficiently analysed. The minimum standards for the design of field trials, set out in the EFSA GMO Panel guidance document, were not met. Therefore the EFSA GMO Panel was not in a position to conclude on the comparative assessment of the compositional, agronomic and phenotypic characteristics, on the basis of the data provided. In the absence of conclusions on the comparative assessment of composition, the risk assessment was restricted to the newly expressed proteins and to specific metabolites resulting from the acetylase activity of the GAT4621 protein. The EFSA GMO Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 98140 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, the available data and the poor survival capacity of maize outside cultivated land, the EFSA GMO Panel concluded that there is very little likelihood of environmental effects due to the accidental release into the environment of viable grains from maize 98140. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize 98140 to bacteria have not been identified. The monitoring plan and reporting intervals were in line with the intended uses of maize 98140.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process “Schoeller Arca Systems”, EC register number RECYC075. The process recycles damaged food contact re-usable polypropylene (PP) and high-density polyethylene (HDPE) crates which have been used in a closed and controlled product loop into new recycled crates. Through this process, damaged crates are firstly ground into flakes which are further blended with virgin PP or HDPE or used at 100 % to manufacture new recycled PP and HDPE crates. The CEF Panel concluded that the input of the process “Schoeller Arca Systems” originates from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The Panel considered that the repeated grinding and injection moulding of PP and HDPE crates, which is part of the recycling process, under conditions described by the applicant, is not of safety concern. Therefore the recycling process “Schoeller Arca Systems” is able to produce recycled PP and HDPE suitable for manufacturing crates intended to be used in contact at room temperature or below with meat, whole fruits and vegetables as requested by the applicant.

The Panel on Plant Health conducted a pest risk assessment for Bemisia tabaci and the viruses it transmits, including an evaluation of risk reduction options and an assessment of the effectiveness of the special requirements linked to B. tabaci and the viruses listed in Council Directive 2000/29/EC. B. tabaci and a large number of viruses transmitted by this polyphagous insect occur in subtropical and tropical climates around the world. Five entry pathways for B. tabaci and associated viruses were identified, with the plants for planting pathway being most significant and rated for entry of insects and viruses as likely and moderately likely, respectively. The most invasive B. tabaci species and several of its associated viruses responsible for severe diseases in major European food crops are established outdoors in coastal Mediterranean regions. Because of similar climate requirements and host plant preferences, B. tabaci and associated viruses currently not present in Europe are likely to establish within the temperature limits set for B. tabaci. Trade between European Member States allows B. tabaci to reach greenhouses in northern Europe, including those in areas with protected zone status. Because of the cool climate, establishment and spread outdoors of B. tabaci is rated unlikely for northern Europe. This situation is likely to continue even under a climatic scenario with an increase in temperature of +2 °C. B. tabaci -transmitted viruses cause severe diseases with major negative impact on crop production when risk reduction measures are not used. Risk reduction options will also apply to B. tabaci and viruses new to Europe. Risk reductions options are evaluated in terms of reducing B. tabaci populations, crop infestations, virus incidence and the impact of diseases. © European Food Safety Authority, 2013

Following a request from European Commission, the PLH Panel examined the comments of the Portuguese plant health authorities on a previous EFSA opinion with regard to pine wood nematode (PWN) and Pinus pinea and a report on PWN surveys in Portugal. Regarding the comment, based on behavioural responses of PWN to CO2 and to ß-myrcene, that Monochamus galloprovincialis can feed on P. pinea without implying PWN infestation, the Panel noted the uncertainties on how chemical attraction influences the exit of PWN from the vector. The Panel agreed that P. pinea is not a preferred breeding host of M. galloprovincialis, but it noted the evidence from Italy of breeding of M. galloprovincialis in fallen woods of P. pinea, suggesting P. pinea to be an occasional host. The Panel agreed that, although pathogenicity of PWN has been recorded on P. pinea in inoculation experiments on small plants, this does not necessarily relate to pathogenicity on larger trees in the field. The additional information on Portuguese PWN surveys is not sufficient to conclude that P. pinea is resistant to PWN. The Panel also noted that asymptomatic infestations by PWN are well known in other areas, and pine species considered tolerant to PWN could still maintain it at low levels in restricted parts of a tree. The Panel concluded that there is high uncertainty concerning the classification of the risk of spread of PWN with plants and wood of P. pinea, owing to the scarcity of information on the interaction of M. galloprovincialis, PWN and P. pinea, as well as on the field resistance of P. pinea to PWN. Owing to high uncertainty related to the host potential of P. pinea, more studies on the transmission of PWN at feeding wounds and on its survival in trees and wood of P. pinea are needed.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of iron based oxygen absorber systems comprising iron, sodium chloride, water, silica gel, activated carbon, monosodium glutamate, potassium acid tartrate, powdered cellulose, malic acid, chabazite, hydroxypropyl cellulose, potassium carbonate, sodium thiosulfate, propylene glycol, glycerin, polyethyleneglycol sorbitan monooleate, sodium propionate and clinoptilolite, incorporated in sachets, patches and cards. Iron, the main active ingredient reacts with oxygen to form iron hydroxide and iron oxide, thereby removing oxygen from the primary packaging. Only activated carbon has not been evaluated as such, but it meets the specifications for activated charcoal which is authorised as additive for plastic materials and articles in contact with foods. All other ingredients of the oxygen absorber formulations have been evaluated and approved for use as additives in plastic food contact materials and/or as food additives and/or food supplements or feed additives. The active system being based on solid ingredients and not intended for direct contact with liquid food or food with an external liquid surface, migration through the gas phase was screened for 9 representative active systems. No volatiles derived from the active mixtures were detected. Therefore the CEF Panel concluded that the substances do not raise a safety concern when used in oxygen absorbers in sachets, patches or cards, placed in the headspace of the packaging or when used in direct contact with food, excluding liquid food or foods that have an external aqueous liquid phase on the surface such as sliced fruits and fresh meat.

The safety assessment of the additive is based on the separate consideration of its two constituents, bentonite and sepiolite. The currently authorised maximum contents for bentonite and sepiolite when used individually (20 000 mg/kg complete feed) are considered safe for all animal species. In consequence, Toxfin^® Dry would be safe for all animals species and categories up to a maximum concentration of 20 000 mg/kg complete feed. Bentonite and sepiolite, in common with other clays, are not absorbed to any measurable extent. Consequently, it is unlikely that the consumption of edible tissues/products of treated animals would expose the consumer to harmful amounts of residues of any chemical component derived from Toxfin^® Dry. The FEEDAP Panel considers that there is no concern for the safety of consumers of food products derived from animals fed diets containing the additive. Dust generated from Toxfin^® Dry during normal handling has the potential to expose the whole of the respiratory tract of users to potentially harmful substances (bentonite, sepiolite and crystalline silica) for which no safe levels of exposure have been identified. Measures must be taken to limit exposure of users to dust. In the absence of data for sepiolite, it would be prudent to treat ToxFin^® Dry as a skin and eye irritant and a skin sensitiser. Bentonite and sepiolite are naturally occurring clays widely distributed in the environment. Therefore, it is not expected that the use of the additive in animal nutrition would adversely affect the environment. Since only one in vivo study in chickens has been provided, the FEEDAP Panel considers that there is insufficient evidence to conclude on the efficacy of the additive as a substance for reduction of contamination of feed with mycotoxins.

During 2007-2010, 13 545 confirmed human VTEC infections and 777 haemolytic uraemic syndrome (HUS) cases were reported in the EU; isolates from 85 % of cases were not fully serotyped and therefore could not be classified using the Karmali seropathotype concept. Seropathotype group D covered 5 % of isolates from fully serotyped cases; 14 cases (0.7 %) belonged to seropathotype group E, defined by Karmali et al. (2003) as non-human only. Isolates from around 27 % of cases could not be assigned. There were no HUS cases reported for the serotypes in groups D and E but 17 HUS cases could not be assigned. The health outcome was reported for only a fraction of confirmed cases. About 64 % of patients presented with only diarrhoea; VTEC infection resulted in HUS in around 10 % of cases. The new ISO/TS 13136:2012 standard improves the detection of VTEC in food. An alternative concept based on the detection of verocytotoxins alone or genes encoding such verocytotoxins does not provide a sound scientific basis on which to assess risk to the consumer because there is no single or combination of marker(s) that fully define a ‘pathogenic’ VTEC. Strains positive for verocytotoxin 2 gene(vtx2)- and eae (intimin production)- or [aaiC (secreted protein of EAEC) plus aggR (plasmid-encoded regulator)] genes are associated with higher risk of more severe illness than other virulence gene combinations. The 2011 O104:H4 outbreak demonstrated the difficulty of predicting the emergence of ‘new’ pathogenic VTEC types by screening only for the eae gene or by focusing on a restricted panel of serogroups. A molecular approach utilising genes encoding virulence characteristics additional to the presence of vtx genes has been proposed.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked (CAS No. 117675-55-5, FCM Substance No 1022), to be used as liquid absorber in the form of fibres in absorbent pads for the packaging of fresh or frozen meat, poultry, and fish as well as fresh fruits and vegetables. The Panel considered that migration is not expected when the absorption capacity of the pads is not exceeded. Therefore no exposure from the consumption of the packed food is expected. The Panel also considered that none of these starting substances and the cross-linked polymer gives rise to concern for genotoxicity. Therefore the CEF Panel concluded that the use of the substance acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked does not raise a safety concern when used as fibres in absorber pads for the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables under conditions under which the absorption capacity of the pads is not exceeded and mechanical release of the fibres from the pads is excluded.

This scientific opinion of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the powder mixture of the active substances sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate (FCM substance No 1009), bentonite (CAS No 1302-78-9, FCM No 393), sodium chloride (CAS No 7647-14-5, FCM No 985), sodium carbonate (CAS No 497-19-8, FCM No 1008) which are intended to be used as combined oxygen generator and carbon dioxide absorber in packaging containing whole fresh fruits. The powder mixture is placed in a nonwoven polyethylene sachet separated from the food by a pad. In the presence of moisture, sodium carbonate peroxyhydrate first decomposes into sodium carbonate and hydrogen peroxide which decomposes into water and oxygen. Sodium carbonate reacts with carbon dioxide to form sodium bicarbonate. Because the sachet is not placed in direct contact with the food or food exudates, only hydrogen peroxide which decomposes to water and oxygen may be released with no other potential migration of volatile compounds. Based on the conclusion drawn in the EU Risk Assessment Report that hydrogen peroxide is not classified as a mutagen and the results from a subchronic toxicity study with hydrogen peroxide, the Panel concluded that hydrogen peroxide does not raise a safety concern under the intended conditions of use. Therefore the CEF Panel concluded that sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride and sodium carbonate do not raise a safety concern for the consumer when used as combined oxygen generator and carbon dioxide absorber, for packaging of whole fruits. The substances should be used in sachets which prevent the release of the powder mixture into the food. Sachets should not be in direct contact with food or food exudates.

This scientific opinion of EFSA Panel on food contact materials, enzymes, flavourings and processing aids deals with the safety evaluation of the mixture of the active substances citric acid (E330, CAS No 77-92-9, FCM Substance No 139) and sodium hydrogen carbonate (E500ii, CAS No 144-55-8, FCM Substance No 21), which is intended to be used as a carbon dioxide generator in liquid absorbent pads in the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables. Depending on absorption capacity needed, pure cellulose or a mixture of cellulose and polyacrylic acid sodium salt crosslinked may be used as absorber. The Panel noted that if the active substances are used not in direct contact with food, but are placed in a pad under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. Therefore the CEF Panel concluded that the use of the mixture of the active substances citric acid (E330) and sodium hydrogen carbonate (E500ii), as carbon dioxide generator in liquid absorbent pads in the packaging of food such as fresh or frozen meat, poultry, fish, fruits and vegetables, does not raise a safety concern. The absorbent pads should be used only under conditions in which the liquid absorption capacity is not exceeded and direct contact between the substance and the food is excluded.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Cumapol, EC register number RECYC085. The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET articles mainly bottles, containing no more than 5 % of PET from non-food consumer applications. Through this process, washed and dried PET flakes are extruded under vacuum and pelletised. The pellets are crystallised and solid state polymerised (SSP) in a continuous reactor at high temperature under inert gas flow. After having examined the challenge test provided, the Panel concluded that the three steps, the decontamination in the vented extruder (step 2) the crystallisation and pre-heating (step 3) and the decontamination in a continuous SSP reactor (step 4) are the critical steps for the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are the temperature, the pressure and the residence time for the extrusion step 2, the temperature, the pressure, the gas flow and the residence time for crystallisation and pre-heating step 3 and the temperature, the gas flow and the residence time for the SSP step 4. The operating parameters of these steps in the process are at least as severe as those obtained from the challenge test. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore the Panel concluded that the recycled PET obtained from this process intended for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill is not considered of safety concern.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process “CO.N.I.P.”, EC register number RECYC040. The process recycles single use food contact polypropylene (PP) and high-density polyethylene (HDPE) crates which have been used in a closed and controlled product loop into new recycled crates. Through this process, single use crates are firstly ground into flakes which may be used as such or further processed by extrusion or densification into granules. Recycled flakes or granules are used with or without blending with PP or HDPE offcuts or scrap to manufacture new recycled PP and HDPE crates by injection moulding. The Panel concluded that the input of the process “CO.N.I.P.” originates from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The recycling process “CO.N.I.P.” is therefore able to produce recycled PP and HDPE suitable for manufacturing PP and HDPE crates intended to be used in contact with whole fruits and vegetables at room temperature or below as requested by the applicant.

Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to eicosapentaenoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms”. The food constituent, EPA, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour”. Upon a request by EFSA for clarification, the applicant indicated that the disease was ADHD, which is classified as such in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), that the risk factor for the disease was an elevated AA/EPA ratio in blood, and that the target population for the claim was children with diagnosis of ADHD. The Panel considers that the evidence provided does not establish that reducing the AA/EPA ratio reduces the risk of ADHD in children, and considers that the target population is a diseased population (i.e. children with ADHD). The Panel concludes that the claimed effect relates to the treatment of a disease, and that therefore the health claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

In a previous opinion on Biosprint, the FEEDAP Panel could not conclude on the efficacy of this additive when used in feed for cattle for fattening because of insufficient evidence. The European Commission has requested the European Food Safety Authority to re-evaluate the efficacy of the additive Biosprint^® when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for cattle for fattening at a minimum dose of 4.0 × 10⁹ and a maximum dose of 9.0 × 10⁹ CFU/kg complete feedingstuffs. In the present application, the results of two new efficacy studies performed in cattle for fattening were presented. Both showed significant improvements in final body weight, average daily gain and feed to gain ratio in Biosprint^®-treated animals. Taking into account the positive result from the initial application, the FEEDAP Panel concludes that Biosprint^® has the potential to be efficacious in cattle for fattening at the dose of 3.6 × 10¹⁰ CFU/head per day approximately equating to 4 × 10⁹ CFU/kg feedingstuffs.

Provita LE is a preparation of Enterococcus faecium and Lactobacillus rhamnosus authorised for use in piglets and calves. EFSA was requested to re-evaluate Provita LE when used with calves for rearing up to four months in the range of 1 × 10⁹ to 5 x 10⁹ CFU/kg feedingstuffs. The identity of both strains has been established and no resistance to clinically relevant antibiotic detected. L. rhamnosus satisfies the requirements for the qualified presumption of safety approach to safety assessment, and is presumed safe for the target animals, consumers and the environment. Safety of the complete additive for the target species at the proposed dose range was demonstrated in a tolerance study in which no adverse effects were seen when a 100-fold overdose of the additive was administered to calves. The enterococcal strain was shown not to contain marker genes typical of hospital-associated isolates responsible for clinical infections and does not raise additional safety concerns. Since no other sources of concern were identified, Provita LE is considered safe for consumers. No data on skin/respiratory sensitisation were provided. In the absence of data, the potential of the additive to be a skin/respiratory sensitiser cannot be excluded. The dustiness of the additive tested indicated a potential for users to be exposed via inhalation. Given the proteinaceous nature of the active agents, the additive should be considered to have the potential to be a skin/respiratory sensitiser and treated accordingly. E. faecium is a natural component of the gut microbiota and its use as Provita LE in animal feeding is not expected to pose any risk to the environment. The data from three trials presented showed that Provita LE has the potential to improve the zootechnical performance of calves for rearing at 1 × 10⁹ CFU/kg milk replacer or complementary feed.

Lactobacillus kefiri is intended to improve the ensiling process at a dose of 5 x 10⁷ CFU/kg fresh material. This species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been established and no resistance to antibiotics of human and veterinary clinical significance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Given the proteinaceous nature of the active agent and the high dusting potential of the preparation tested, the FEEDAP Panel considers it prudent to treat this additive as a skin and respiratory sensitiser. It is also considered an irritant. The results of three efficacy studies indicated that L. kefiri has the potential to improve the aerobic stability of silage from forages with dry matter content above 40 % at the inclusion level of 5 x 10⁷ CFU/kg forage.

L-cystine is a dispensable sulphur-containing amino acid, naturally occurring in proteins of plants and animals. L-cystine is safe for all animal species if the requirements for sulphur amino acids are respected. The maximum amount of L-cystine that can be safely added to the diet will depend on the levels of other sulphur-containing amino acids. Supplemental L-cystine will not be deposited in animal tissues as such: it will be incorporated in body proteins without causing any change in their natural composition or it will be metabolised and excreted. The product under application does not contain substances of toxicological concern. Thus, the use of L-cystine in animal nutrition does not raise any concerns for consumer safety. In the absence of any data, it would be prudent to consider L-cystine as irritant to skin, eyes and mucous membranes and as a potential dermal sensitiser. Therefore, it would be prudent to assume that exposure of skin, eyes and respiratory tract is hazardous. The use of the natural amino acid L-cystine as feed additive does not represent a risk to the environment. L-Cystine is considered efficacious in partially meeting the requirements for sulphur-containing amino acids in all animal species.

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety for the target species, consumers and the environment. This approach requires the identity of the active agent to be established and the absence of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance to be demonstrated. EFSA considered these issues and reported the results in a previous opinion on the use of the product in chickens for fattening. The applicant is now requesting the authorisation of the additive in diets for turkeys for fattening and turkeys reared for breeding at a dose of 1 × 10⁸ CFU/kg complete feedingstuffs. In the course of the former assessment, safety for users was also examined. In the view of the FEEDAP Panel, the use with these additional avian species will not introduce hazards not already considered. Therefore, in the current assessment, the FEEDAP Panel has considered only the efficacy data for turkeys for fattening and turkeys reared for breeding. Based on results of three trials carried out in turkeys for fattening, the Panel concluded that B. subtilis PB6 has the potential to improve the zootechnical performance parameters at the dose of 1 × 10⁸ CFU/kg feed. This conclusion can be extended to turkeys reared for breeding.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208. The Flavour Industry has provided additional genotoxicity studies for p-mentha-1,8-dien-7-al [FL-no: 05.117]. p-Mentha-1,8-dien-7-al will represent the other nine flavouring substances in FGE.208. Based on the presently available data the Panel concluded that some concern for the genotoxic potential of p-mentha-1,8-dien-7-al remains. In order to clarify the genotoxic potential of this substance, the Panel considered that further in vivo testing should be performed. To address this, an in vivo Comet assay, considering the first site of contact (e.g. stomach or duodenum) and liver, should be carried out according to the Scientific Report of EFSA on Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports.

Following an application from McNeil Nutritionals and Raisio Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone. The food that is the subject of the health claim, plant stanol esters, is sufficiently characterised. The applicant provided five human intervention studies for the scientific substantiation of the claim. The Panel notes that the design of the studies submitted did not allow an evaluation of the quantitative effects of diets low in saturated fat per se on blood LDL-cholesterol concentrations. Therefore, the effect of consuming 2 g/day plant stanols as part of a diet low in saturated fat relative to the effect of consuming a diet low in saturated fat alone cannot be determined on a quantitative basis. The Panel considers that the evidence provided by the applicant does not establish that the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat results in a two-fold greater reduction in LDL-cholesterol concentrations compared with consuming a diet low in saturated fat alone. A claim on plant stanol esters and reduction of blood LDL-cholesterol concentrations (irrespective of the background diet) has already been authorised in the European Union.

Following an application from Leiber GmbH, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Yestimun^® and defence against pathogens in the upper respiratory tract. The food that is the subject of the health claim, Yestimun^®, which consists of (1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall, is sufficiently characterised. The claimed effect, defence against pathogens in the upper respiratory tract, is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of Yestimun^® ((1,3)-(1,6)-β-D-glucans from brewer’s yeast cell wall) and defence against pathogens in the upper respiratory tract.

Probiotic LACTINA^® is a feed additive consisting of six strains of lactic acid bacteria. In 2007 the European Food Safety Authority was requested to evaluate the safety and efficacy of the additive when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for chickens for fattening, piglets and pigs for fattening. At that time the FEEDAP Panel was able to conclude only on the safety for the environment. EFSA is now requested to assess the safety for the target animals and consumers, and the efficacy of the additive when added in diets for chickens for fattening at 5 x 10⁸ - 9 x 10⁹ CFU/kg feed and for piglets at 9 x 10⁸ - 1 x 10¹⁰ CFU/kg feed. The identity of the six strains was established. As no antibiotic resistance of concern was detected and as five of the strains qualify for the Qualified Presumption of Safety approach to safety assessment, their use is presumed safe for target species and consumers. The Enterococcus faecium strain is not a recognised pathogen for animals and as the additive did not adversely affect growth of chickens or piglets, Probiotic LACTINA^® is considered safe for the target species up to 1 x 10¹⁰ CFU/kg feed. The E. faecium strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections. The metabolic pathways of E. faecium are well known. Since no other harmful metabolites are expected and the additive does not contain excipients of concern, it is considered safe for consumers. Probiotic LACTINA^® showed a potential to increase the body weight of suckling piglets when used at approximately 5 x 10⁹ CFU/kg feed. The Panel could not conclude on the efficacy of Probiotic LACTINA^® when used in diets for chickens for fattening or weaned piglets.

One strain of Lactobacillus brevis and four strains of Lactobacillus buchneri are each intended to improve ensiling at proposed doses ranging from 5 × 10⁷ to 1 × 10⁸ CFU/kg fresh material. Both bacterial species are considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. As the identity of all strains was clearly established and as no antibiotic resistance of concern was detected, the use of these strains in silage production is presumed safe for livestock species, consumers of products from animals and the environment. Given the proteinaceous nature of the active agents and the high dusting potential of the products tested, the FEEDAP Panel considers it prudent to treat these additives as skin and respiratory sensitisers. They are also considered irritants. The efficacy of L. brevis to improve the preservation of nutritive value or increase the aerobic stability of silage was not demonstrated.. One strain of L. buchneri has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile materials by reducing the pH and ammonia nitrogen and by increasing the preservation of dry matter. The remaining three strains of L. buchneri showed the potential to improve the aerobic stability, one in all forages and two in easy to ensile materials.

The additive AveMix^® XG 10 is an enzyme preparation of endo-1,4-beta-xylanase (xylanase) and endo-1,3(4)-beta-glucanase (glucanase), produced by two strains of Trichoderma reesei. This product is currently authorised for use in chickens for fattening, laying hens, minor poultry species and weaned piglets as a zootechnical additive, under the functional group of digestibility enhancers. The applicant is now seeking an extension of the authorisation to pigs for fattening and minor porcine species at a recommended dose of 4 000 XU (xylanase units) and 900 BGU (beta-glucanase units) per kg complete feed. The FEEDAP Panel considers that, since the additive has been demonstrated to be safe for piglets at the recommended dose, this conclusion can be extended to pigs for fattening and extrapolated to minor growing porcine species. Supplementation of diets for pigs for fattening with Avemix^® XG 10 at the recommended dose (4 000 XU and 900 BGU/kg) resulted in a significantly higher body weight and daily weight gain in one trial and significantly improved feed to gain ratio in two trials. Therefore, the FEEDAP Panel concludes that AveMix^® XG 10 has the potential to be efficacious in pigs for fattening at this dose. Since the mode of action of xylanases and glucanases can reasonably be assumed to be the same in all porcine species, the conclusions on efficacy for weaned piglets and pigs for fattening can be extrapolated to include all minor porcine species for growing at 4 000 XU and 900 BGU/kg complete feed.

Chemical group 1 (CG 1) consists of straight-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing saturated alcohols and acetals containing saturated aldehydes of which 86 are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of ethyl oleate because of its insufficient purity. The following compounds are considered to be safe for all animal species at the use level proposed for feed flavourings: formic acid, acetic acid, propionic acid, octanoic acid, decanoic acid, dodecanoic acid, tetradecanoic acid, hexadecanoic acid, oleic acid, decanol, dodecanol, decyl acetate and dodecyl acetate. The remaining substances are considered safe for all animal species at 5 mg/kg complete feed (with a margin of safety between 1 and 120) and at 25 mg/kg complete feed (ethyl acetate and hexyl acetate, with a margin of safety between 2 and 6); and at 1 mg/kg complete feed for pigs and poultry and 1.5 mg/kg complete feed for all other species (ethylacrylate, ethyl hex-3-enoate, ethyl trans-2-butenoate, ethyl isobutyrate, ethyl isovalerate, butyl isovalerate, methyl isovalerate, hexyl isobutyrate, methyl 2-methyl butyrate, pentyl isovalerate, butyl 2-methyl butyrate, hexyl isovalerate, ethyl 2-methyl butyrate, hexyl 2-methyl butyrate and methyl 2-methylvalerate). No safety concern would arise for the consumer from the use of compounds belonging to CG 1 up to the highest safe level in feedingstuffs for all animal species. The FEEDAP Panel considers it prudent to treat all compounds under assessment as irritants to skin, eyes and respiratory tract and as skin sensitizers. No risk for the safety for the environment is foreseen. Since all 85 compounds are used in food as flavourings, no further demonstration of efficacy is necessary.

Bonvital is a preparation of a strain of Enterococcus faecium authorised for use in piglets and pigs for fattening, in sows and in chickens for fattening. The applicant is seeking the further authorisation of Bonvital for use in chickens reared for laying and minor avian species. The E. faecium strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics. The safety of Bonvital in chickens for fattening has been established in a previous assessment. Since the applicant proposes the use of the same dose (5 x 10⁸ CFU/kg complete feedingstuffs) in chickens reared for laying, safety for this animal category can be presumed. As the same dose is proposed for minor avian species, this conclusion can be extrapolated to minor avian species to point of lay. The strain is not expected to raise concerns for consumers of animal products. Bonvital is not irritant to skin and eyes. In the absence of data, it should be considered to have the potential to be a skin/respiratory sensitiser and treated accordingly. The use of Bonvital under the conditions proposed is considered safe for the environment. The efficacy in chickens for fattening has been established in a previous assessment. Since the applicant proposes the use of the same dose (5 x 10⁸ CFU/kg complete feedingstuffs) in chickens reared for laying, the conclusion on the major species can be extended to this category. As the same dose is proposed for minor avian species and as the mechanism of action of the additive can reasonably be assumed to be the same as in the major species, efficacy in minor avian species to point of lay can be presumed.

The additive AveMix^® XG 10 is an enzyme preparation of endo-1,4-beta-xylanase (xylanase) and endo-1,3(4)-beta-glucanase (glucanase), produced by two strains of Trichoderma reesei. This product is currently authorised for use in chickens for fattening, laying hens, minor poultry species and weaned piglets as a zootechnical additive, under the functional group of digestibility enhancers. The applicant is now seeking an extension of the authorisation to turkeys for fattening at a recommended dose of 4 000 XU (xylanase units) and 900 BGU (glucanase units) per kg complete feed. The results obtained in a tolerance study in turkeys for fattening showed that the birds tolerated well a 100-fold overdose of the recommended dose. Therefore, the additive is safe for turkeys for fattening when used at the recommended dose. Three efficacy studies carried out in turkeys for fattening showed that the additive has the potential to be efficacious at the dose of 4 000 XU and 900 BGU/kg complete feed.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate one flavouring substance, the dipeptide L-methionylglycine [FL-no: 17.037], in the Flavouring Group Evaluation 305, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance was considered not to have genotoxic potential. The substance was evaluated through a stepwise approach (the Procedure) that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that for the flavouring substance, evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. The present evaluation of the candidate substance L-methionylglycine [FL-no: 17.037] is only applicable for its use in foods that are not heated or intended to be heated. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on microcrystalline wax (E 905) when used as a food additive. Microcrystalline wax (E 905) is authorised quantum satis as a surface treatment agent on non-chocolate confectionery, chewing gum and decorations, coatings and fillings, except fruit based fillings. It is also permitted as a surface treatment of melons, papaya, mango and avocado. The substance was evaluated by the Scientific Committee on Food (SCF) in 1990 and 1995 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the latest in 1995. The JECFA established a group ADI of 20 mg/kg bw/day for mineral oils, paraffins and microcrystalline waxes. The Panel noted that all mineral oil products accumulated in tissues in a dose- and time-dependent manner with the exception of microcrystalline waxes. The Panel concluded that there is no concern for genotoxicity from microcrystalline wax (E 905). The Panel also considered that the available toxicity studies with mineral hydrocarbons, closely related from a chemical point of view with microcrystalline waxes, consistently reported no effects of concern associated with the intake of microcrystalline wax. The Panel further concluded that since no long-term toxicity and carcinogenicity studies with microcrystalline wax E 905 were available, no ADI could be established. The Panel also concluded that the conservative exposure estimates to microcrystalline wax (E 905) from its use at maximum permitted level (following quantum satis rules), resulted in a sufficient margin of safety compared to the NOAEL established by the Panel for the closely related high viscosity mineral oils, and therefore the use microcrystalline wax (E 905) as a food additive with the currently authorised uses would not be of safety concern.

EFSA was asked by the European Commission to deliver a Scientific Opinion on 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 in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The aim is to define an analytical concentration for a non-allowed pharmacologically active substance that can be determined by official control laboratories and is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step-wise approach considers factors such as analytical capability, toxic potential and pharmacological activity of the substance in question, and includes the identification of the Reasonably Achievable Lowest Limit of Quantification (RALLOQ), the establishment of a Toxicological Screening Value (TSV) and the derivation of a Toxicologically Based Limit of Quantification (TBLOQ). The TBLOQ is compared with the RALLOQ for the respective substance. If the TBLOQ is equal to or higher than the RALLOQ, then the latter can be accepted as the RPA. If the TBLOQ is lower than the RALLOQ, then the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible, a substance-specific risk assessment should be considered. The CONTAM Panel concluded that RPAs should be matrix independent. The CONTAM Panel noted that sometimes non-edible matrices are monitored to identify the administration of non-allowed pharmacologically active substances. In these cases, RPAs cannot be applied. The CONTAM Panel also proposed several criteria where the European Commission might consider it appropriate to consult EFSA for a substance-specific risk assessment.

Controls in Member States have revealed the presence of phenylbutazone in horse carcasses intended for the food chain.  Following the request from the European Commission, the European Medicines Agency and the European Food Safety Authority jointly concluded on the risk assessment on residues of phenylbutazone in horse meat in the context of recent fraudulent practices. The Committee for Veterinary Medicinal Products assessed the consumer safety for phenylbutazone in 1997 and identified the main risks for the consumer as idiosyncratic blood dyscrasias and the genotoxic/carcinogenic potential for which no thresholds could be identified and no maximum residue limits could be established. The substance can therefore not be used in animals destined to enter the food chain. These main risks have been re-confirmed in the present statement as no new relevant information has become available since the initial safety assessment. Exposure to phenylbutazone from horse meat consumed as such or present in beef-based products was assessed on the basis of limited monitoring data provided by 19 Member States and of conservative assumptions. Up to 144 and up to 36 800 individuals per 100 million could be potentially exposed across countries and age groups each day. On a given day, the probability of a consumer being both susceptible to developing aplastic anaemia and being exposed to phenylbutazone was estimated to range approximately from 2 in a trillion to 1 in 100 million. The risk of carcinogenicity to humans from exposure was considered very low based on the available experimental data on organ toxicity and carcinogenicity, as well as on the low exposure levels and the infrequent exposure to phenylbutazone from horse meat or adulterated beef-based products.  Measures proposed to further minimise the risk include strengthening of the horse passport system, harmonised monitoring of phenylbutazone and its main metabolite and better reporting of monitoring of veterinary drug residues and other substances across the EU.

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 pyroxsulam are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of pyroxsulam as a herbicide on winter wheat, rye and triticale. 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.

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 Netherlands, for the pesticide active substance L-ascorbic acid are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of L-ascorbic acid as a fungicide on potato, glasshouse tomato and field and glasshouse flower bulbs. 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.

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 Aureobasidium pullulans (strains DSM 14940 and DSM 14941) are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of Aureobasidium pullulans as a fungicide and bactericide on pome fruit. 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.

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 Italy, for the pesticide active substance Bacillus thuringiensis israelensis AM65-52 are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis israelensis AM65-52 as an insecticide on ornamentals. 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.

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 ipconazole are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of ipconazole as a fungicide for seed treatment of wheat and barley. 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.

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 Germany, for the pesticide active substance fluopyram are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of fluopyram as a fungicide on table and vine grapes and greenhouse and field tomatoes and strawberries. 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 and concerns were identified.

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 Greece, for the pesticide active substance fenazaquin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009. The conclusions were reached on the basis of the evaluation of the representative uses of fenazaquin as an acaricide and insecticide on grapes, citrus, pome fruit, stone fruit and greenhouse ornamentals. 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.

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 Portugal, for the pesticide active substance benalaxyl-M are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of benalaxyl-M as a fungicide on grapes. 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.

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 pyriofenone are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of pyriofenone as a fungicide on cereals and grapes. 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.

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 dimethenamid-P. In order to assess the occurrence of dimethenamid-P residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission 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.

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 propamocarb. In order to assess the occurrence of propamocarb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission 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. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

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 bifenox. In order to assess the occurrence of bifenox 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.

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the Evaluating Member State (EMS), received an application from the Landwirtschaftskammer Nordrhein-Westfalen to modify the existing MRL for trifloxystrobin in beans with pods. In order to accommodate for the intended use of trifloxystrobin Germany proposed to raise the existing MRL on beans (with pods) from the value of 0.5 mg/kg to 1 mg/kg. Germany 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 a MRL proposal of 1.0 mg/kg for the intended use on beans with pods. Adequate analytical enforcement methods are available to control the residues of trifloxystrobin in the commodity under consideration. Based on the provisional risk assessment results, EFSA concludes that the intended use of trifloxystrobin on beans with pods will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, herewith referred to as the evaluating Member State (EMS), received an application from Dow AgroScience to set an import tolerance for tricyclazole in rice to accommodate the authorized use in Brazil. Tricyclazole is a non-included active substance and no EU uses are currently authorized. Thus, the existing EU MRL of 1 mg/kg in rice should be lowered to the LOQ. The applicant requested to maintain the existing EU MRL to allow the import of rice treated with tricyclazole from third countries. The EMS confirmed that the MRL should be set provisionally at the level 1 mg/kg to accommodate the Brazilian GAP. EFSA is of the opinion that on the basis of the currently available studies, the toxicological reference values for tricyclazole cannot be set, since the genotoxic potential of tricyclazole could not be totally disregarded. In addition, uncertainties regarding the carcinogenic potential of tricyclazole were identified by EFSA. The submitted residue trials data were found to be insufficient to derive an MRL proposal which accommodates the use of tricyclazole on rice in Brazil. EFSA concludes that the import tolerance request for tricyclazole in rice is not sufficiently supported by data which are needed to justify maintaining the existing EU MRL of 1 mg/kg in rice.

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 prohexadione. In order to assess the occurrence of prohexadione 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 import tolerances and 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. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

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 substances mecoprop and mecoprop-p. In order to assess the occurrence of mecoprop and mecoprop-p 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.

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 trifluralin. Considering that this active substance is no longer authorised within the European Union, that no MRLs are established by the Codex Alimentarius Commission, and that no import tolerances were notified to EFSA, residues of trifluralin are not expected to occur in any plant or animal commodity. Available data were also not sufficient to derive a residue definition or an LOQ for enforcement against potential illegal uses.

In accordance with Article 6 of Regulation (EC) No 396/2005, France, herewith referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing MRLs for the active substance cyproconazole in mustard seed and gold of pleasure. In order to accommodate for the intended use of cyproconazole in France, the EMS proposed to raise the existing MRLs in these crops to 0.4 mg/kg. France drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the proposed extrapolation of residue data from rape seed to mustard seed and gold of pleasure is acceptable and a sufficient number of residue trials has been submitted to derive a MRL proposal of 0.4 mg/kg in the crops under consideration. The submitted residue trials data support the NEU use only. Based on the risk assessment results, EFSA concludes that the intended use of cyproconazole on mustard seed and gold of pleasure will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. EFSA emphasizes that the above assessment does not take into consideration triazole derivative metabolites (TDMs). Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment is performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.

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 flusilazole. In order to assess the occurrence of flusilazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission 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. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS-NL), received an application from LTO Groeiservice to modify the existing MRL for the active substance cyprodinil in radish; a second application from the company Syngenta AGRO S.A.S to modify the existing MRL for the active substance cyprodinil in cucurbits, inedible peel was submitted to France (EMS-FR). In order to accommodate the intended uses of cyprodinil, EMSs proposed to raise the existing MRLs from the limit of quantification to 0.07 mg/kg for radish and to 0.6 mg/kg for cucurbits inedible peel. EMS-NL and EMS-FR drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 0.08 mg/kg for radish and of 0.6 mg/kg for cucurbits, inedible peel. Adequate analytical enforcement methods are available to control the residues of cyprodinil in radishes and cucurbits at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed use of cyprodinil on radish and cucurbits inedible peel under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

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 BASF SE Crop Protection to modify the existing MRLs for the active substance metconazole in barley and oats. In order to accommodate the intended uses of metconazole, the EMS proposed to raise the existing MRLs from 0.1 mg/kg to 0.3 mg/kg. The EMS 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 proposals of 0.4 mg/kg for the proposed uses on barley and oats. Adequate analytical enforcement methods are available to control the residues of metconazole in cereal grains at the validated LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concludes that with regard to the residue definition established for unprocessed commodities the intended use of metconazole on barley and oats will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. The risk assessment however cannot be finalised since the dietary exposure to triazole derivative metabolites (TDMs) and to compounds that might be formed under processing conditions could not be assessed at the moment.

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 propoxycarbazone. In order to assess the occurrence of propoxycarbazone 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. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

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 Syngenta Crop Protection UK Ltd to modify the existing MRLs for the active substance isopyrazam in pome fruits, stone fruits and oilseeds. In order to accommodate for the intended uses of isopyrazam, the United Kingdom proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.01 mg/kg to 0.7 mg/kg in pome fruits, 1.5 mg/kg in apricots and peaches, including nectarines and 0.4 mg/kg in linseed, poppy seed, mustard seed and rape seed. 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 data are sufficient to derive a MRL proposal of 0.7 mg/kg for the intended use on pome fruits, 1.5 mg/kg for the intended use on peaches and 0.4 mg/kg for the intended use on rape seed, linseed, mustard seed and poppy seed. The intended use on apricots is not adequately supported by residue data and no MRL proposal can be therefore derived. Adequate analytical enforcement methods are available to control the residues of isopyrazam in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of isopyrazam on pome fruits, peaches, rape seed, linseed, mustard seed and poppy seed will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

The European Food Safety Authority and the European Centre for Disease Prevention and Control analysed the information submitted by 27 European Union Member States on the occurrence of zoonoses and food-borne outbreaks in 2011. Campylobacteriosis was the most commonly reported zoonosis with 220,209 confirmed human cases. The occurrence of Campylobacter continued to be high in broiler meat at EU level. The decreasing trend in confirmed salmonellosis cases in humans continued with a total of 95,548 cases in 2011. Most Member States met their Salmonella reduction targets for poultry, and Salmonella is declining in these populations. In foodstuffs, Salmonella was most often detected in meat and products thereof. The number of confirmed human listeriosis cases decreased to 1,476. Listeria was seldom detected above the legal safety limit from ready-to-eat foods. A total of 9,485 confirmed verotoxigenic Escherichia coli (VTEC) infections were reported. This represents an increase of 159.4 % compared with 2010 as a result of the large STEC/VTEC outbreak that occurred in 2011 in the EU, primarily in Germany. VTEC was also reported from food and animals. The number of human yersiniosis cases increased to 7,017 cases. Yersinia enterocolitica was isolated also from pig meat and pigs; 132 cases of Mycobacterium bovis and 330 cases of brucellosis in humans were also reported. The prevalence of bovine tuberculosis in cattle increased, and the prevalence of brucellosis decreased in cattle and sheep and goat populations. Trichinellosis and echinococcosis caused 268 and 781 human cases, respectively and these parasites were mainly detected in wildlife. The numbers of alveolar and of cystic echinococcosis respectively increased and decreased in the last five years. One imported human case of rabies was reported. The number of rabies cases in animals continued to decrease. Most of the 5,648 reported food-borne outbreaks were caused by Salmonella,bacterial toxins, Campylobacter and viruses, and the main food sources were eggs, mixed foods and fish and fishery products.

Following a request from the European Commission, the Panel on Plant Protection Products and their Residues (PPR) was asked to deliver a scientific opinion on the report of the FOCUS groundwater working group (FOCUS, 2009) with respect to lower tier leaching assessments. The PPR Panel is of the general opinion that the FOCUS groundwater working group has successfully harmonised major concepts in the leaching models and that, overall, the leaching estimations have improved. Despite several limitations, the PPR Panel considers that the revised FOCUS scenarios cover significant arable areas in the EU, including the New Member States, and allow for decision making at the EU level. The PPR Panel however has observed that flaws in underlying data have become apparent after finalising the report. Also new approaches on scenario selection have become available. The PPR Panel recommends that these flaws and new approaches are taken into account when developing revised scenarios.

Corrections were made to the “suggested citation” section and to clarification on EFSA guidance documents in preparation in section 2.1 page 8 and under “Recommendations” page 22. The changes do not affect the overall conclusions of the Opinion. The original version of the Opinion published has been removed from the website, but is available on request.