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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.


Editorials

Hardy A, Dorne JLCM, Aiassa E, Alexander J, Bottex B, Chaudhry Q, Germini A, Nørrung B, Schlatter J, Verloo D, Robinson T EFSA Journal 2015;13(3):e13031 [3 pp.]. doi:10.2903/j.efsa.2015.e13031

27 March 2015 Mail Print Cite

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015;13(3):4055 [16 pp.]. doi:10.2903/j.efsa.2015.4055 Abstract

Cibenza® EP150 is a feed additive containing a protease produced by fermentation of a single strain of Bacillus licheniformis. The final preparation contains the enzyme, spores of the production organism and spent medium. It is intended for use as a zootechnical feed additive for chickens for fattening, chickens reared for laying and all relevant minor avian species in the growing or fattening phases but excluding laying birds. Chickens for fattening appeared to tolerate the additive at ten times the recommended dose and consequently the additive is considered safe at the recommended dose of 500 mg/kg complete feedingstuffs. This conclusion applies to chickens reared for laying and can be extrapolated to minor avian species used for meat production and ornamental birds when the same dose is applied. Use of the additive in feed for chickens for fattening, chickens reared for laying and other avian species is considered safe for consumers. The additive is not a skin irritant but is an eye irritant. Because of the observed severe irritation in the eye and the known capacity of enzyme products to induce sensitisation, the additive has the potential to be a skin sensitiser and to induce sensitisation following respiratory exposure. The organism, a strain of a naturally-occurring soil bacterial species, and its fermentation products are considered not to present a hazard for the environment. A significant production benefit of the addition of the additive using the recommended dose was seen in chickens for fattening but only when a reduced protein diet was provided. No effects were seen when a standard poultry diet was fed. This conclusion on efficacy is taken to apply to chickens reared for laying and can be extrapolated to other avian species used for meat production when the same dose is used. Use of the additive is compatible with coccidiostats.

31 March 2015 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015;13(3):4053 [22 pp.]. doi:10.2903/j.efsa.2015.4053 Abstract

Chemical group 31 consists of aliphatic and aromatic hydrocarbons, of which 17 are currently authorised for use as flavours in food. This opinion concerns nine compounds from this group. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unable to perform an assessment of 1,4(8),12-bisabolatriene [01.016] due to the lack of data on its purity. The Panel concludes that d-limonene [01.045] is safe for all animal species, except for male rats, at the proposed maximum dose level (25 mg/kg feed). 1-Isopropyl-4-methylbenzene [01.002] is safe for all target species, except cats, at the proposed maximum dose level (25 mg/kg feed), with a margin of safety ranging from 1-fold (no margin of safety) to 3.2-fold. For cats the calculated maximum safe concentration is 14 mg/kg complete feed. For the compounds belonging to Cramer Class I, terpinolene [10.005], alpha-phellandrene [10.006], 1-isopropenyl-4-methylbenzene [10.010], alpha-terpinene [10.019], gamma-terpinene [01.020] and l-limonene [01.046], the calculated safe use level is 1.5 mg/kg complete feed for cattle, salmonids and non-food-producing animals and 1 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances. Overall, the FEEDAP Panel is not in the position to conclude on the use of these additives in water for drinking. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feeds. All compounds should be considered irritant to skin, eyes and respiratory tract and as skin sensitisers. No risk for the safety for the environment is foreseen. Since all of the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

31 March 2015 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015; 13(3):4054 [9 pp.]. doi:10.2903/j.efsa.2015.4054 Abstract

Hostazym® C is an enzyme preparation of glucanase produced by a non-genetically modified strain of Trichoderma citrinoviride. In 2013, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of the product as a feed additive for poultry and pigs. The Panel could not conclude on the safety for the target species, the consumer and the user because the presence of genotoxic activity in the fermentation product could not be excluded. The applicant provided new experimental data to support the safety of the fermentation product used to formulate the additive. The FEEDAP Panel concludes that the fermentation product used to formulate Hostazym® C is unlikely to present a genotoxic hazard. Taking also into consideration the findings of the previous opinion, Hostazym® C is considered safe for target animals and consumers. With regard to user safety, the conclusion of the previous opinion that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser, applies.

31 March 2015 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015;13(3):4052 [16 pp.]. doi:10.2903/j.efsa.2015.4052 Abstract

The product L-lysine monohydrochloride (HCl) is produced by fermentation with a genetically modified strain of Escherichia coli. L-Lysine is an essential amino acid for all animal species. L-Lysine and its salts are widely used in the feed industry to optimise dietary protein intake. The amino acid L-lysine itself is considered safe for target animals, consumers and the environment. However, the genetic modification, including the presence or absence of antibiotic resistance genes in the product under assessment, is insufficiently characterised. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the safety of the product L-lysine HCl produced by fermentation with this recombinant E. coli strain for target animals, consumers, users and the environment. Regardless of the assessment of the genetic modification, the FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of the product L-lysine HCl via water for drinking and feed. From the results provided, it is concluded that there are no concerns for users with respect to skin or eye irritancy, or dermal sensitisation. Nevertheless, the level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. The concerns regarding the safety of the genetic modification may also have implications for the safety of the user. The product L-lysine HCl is an efficacious source of the supplemented amino acid, for maintaining or restoring the adequate balance of dietary amino acids, for all non-ruminant species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it must be protected from degradation in the rumen.

31 March 2015 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015;13(3):4051 [17 pp.]. doi:10.2903/j.efsa.2015.4051 Abstract

The subject of this assessment was the L-threonine produced by a genetically modified strain of Escherichia coli.
L-Threonine is an essential amino acid for all animal species. It is widely used in the feed industry to optimise dietary protein intake. The amino acid L-threonine itself is considered safe for target animals, consumers and the environment. However, the recipient strain and its genetic modification, including the presence or absence of an antibiotic resistance gene in the product under assessment, are insufficiently characterised. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot make a conclusion on the safety of the product L-threonine produced by fermentation with this recombinant strain of  E. coli  for target animals, consumers, users and the environment. Regardless of the assessment of the genetic modification, the FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of L-threonine via water for drinking and feed. There are no concerns for users in respect of irritation to skin or eyes. In the absence of any data on sensitisation, it must be concluded that the product may have the potential to be a dermal sensitiser and should be handled accordingly. The level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. The product is considered an efficacious source of the amino acid L-threonine for all animal species. For the supplemental L threonine to be as efficacious in ruminants as in non-ruminant species, it must be protected against degradation in the rumen.

31 March 2015 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Nicholas Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare M. Nielsen, Jaroslava Ovesná, Joe Perry, Christoph Tebbe. EFSA Journal 2015;13(3):4039 [11 pp.]. doi:10.2903/j.efsa.2015.4039 Abstract

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2013 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel concludes that the data related to insect resistance monitoring does not indicate a significant and consistent decrease in susceptibility of the target pest field populations to Cry1Ab protein in Spain over the 2013 growing season. However, considering that the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the EFSA GMO Panel reiterates its previous recommendations for improvement of the insect resistance management plan of maize MON 810. The EFSA GMO Panel also recommends, as part of general surveillance, the continuation of the screening and discussion of literature on possible adverse effects of maize MON 810 on rove beetles. In the absence of information on the general surveillance of maize MON 810 in 2013, the EFSA GMO Panel cannot conclude on potential unanticipated adverse effects due to the cultivation of maize MON 810 in 2013, or on possible changes to the methodology as compared to previous growing seasons. 

10 March 2015 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. EFSA Journal 2015;13(3):4033 [15 pp.]. doi:10.2903/j.efsa.2015.4033 Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides here a scientific opinion on the safety of erythritol (E 968) in light of the proposed extension of use of erythritol to be added at a maximum level of 1.6 % (16 g/L) as a flavour enhancer in non-alcoholic beverages. In 1999, the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives (JECFA) evaluated erythritol and assigned an ADI (acceptable daily intake) “not specified”. In 2003, the European Union (EU) Scientific Committee on Food (SCF) concluded that erythritol is safe for use in foods. The EU approval of erythritol does not yet cover its use in beverages because the SCF opinion stated that the laxative threshold may be exceeded, especially by young consumers, through ingestion of erythritol in beverages. Based on the new data comprising a revised exposure estimate taking into account the proposed maximum level of 1.6 % erythritol in non-alcoholic beverages, the history of its use, the absorption characteristics of erythritol and the lack of adverse findings, including laxation, the ANS Panel concluded that the acute bolus consumption of erythritol via non-alcoholic beverages at a maximum level of 1.6 % would not raise concerns for laxation. 

5 March 2015 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen EFSA Journal 2015;13(3):4028 doi:10.2903/j.efsa.2015.4028 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies derived Dietary Reference Values for vitamin A. The Panel considered that a concentration of 20 µg retinol/g liver can be used as a target for establishing the Average Requirement (AR) for vitamin A. In the absence of a better characterisation of the relationship between vitamin A intake and liver stores, a factorial approach was applied. This approach considered a total body/liver retinol store ratio of 1.25, a liver/body weight ratio of 2.4 %, a fractional catabolic rate of body retinol of 0.7 % per day, an efficiency of storage in the whole body for ingested retinol of 50 % and reference weights for women and men in the EU of 58.5 and 68.1 kg, respectively. ARs of 570 µg retinol equivalent (RE)/day for men and 490 µg RE/day for women were derived. Assuming a coefficient of variation (CV) of 15 %, Population Reference Intakes (PRIs) of 750 µg RE/day for men and 650 µg RE/day for women were set. For infants aged 7–11 months and children, the same equation as for adults was applied by using specific values for reference weight and liver/body weight ratio. For catabolic rate, the adult value corrected on the basis of a growth factor was used. ARs range from 190 µg RE/day in infants aged 7–11 months to 580 µg RE/day in boys aged 15–17 years. PRIs for infants and children were estimated using a CV of 15 % and range from 250 to 750 µg RE/day. For pregnancy and lactation, additional vitamin A requirements related to the accumulation of retinol in fetal and maternal tissues and transfer of retinol into breast milk were considered and PRIs of 700 and 1 300 µg RE/day, respectively, were set.

5 March 2015 Mail Print

Statements of EFSA

European Food Safety Authority EFSA Journal 2015;13(3):4072 doi:10.2903/j.efsa.2015.4072 Abstract

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for Azorubine/Carmoisine (E 122) taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Azorubine/Carmoisine (E 122) used as a food additive. In that opinion, the Panel concluded that, at the high percentile of exposure (95th), using either the maximum permitted levels (MPLs) or the reported use levels provided by industry, intake estimates for 1- to 10-year-old children could be above the Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Following this conclusion, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as analytical data submitted to EFSA by Member States, and the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided to EFSA for five out of the 50 food categories in which Azorubine/Carmoisine (E 122) is authorised as a food additive, whereas analytical data from Member States were provided to EFSA for 32 food categories. Using MPLs, exposure estimates exceeded the ADI at the high level for toddlers and children. In the refined exposure scenarios, the ADI was not exceeded for any of the population groups at either the mean or the higher exposure level.

31 March 2015 Mail Print

European Food Safety Authority EFSA Journal 2015;13(3):4070 doi:10.2903/j.efsa.2015.4070 Abstract

The European Food Safety Authority (EFSA) carried out an exposure assessment of Quinoline Yellow (E 104), taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Quinoline Yellow (E 104) and concluded that, at the maximum usage levels, refined intake estimates were generally well above the Acceptable Daily Intake (ADI) of 0.5 mg/kg body weight (bw)/day. Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission as regards the conditions of use such that Maximum Permitted Levels (MPLs), when not withdrawn (n = 14), were decreased by a factor of 1.1 to 50, depending on the food category, applicable from 1 June 2013 onwards. Following this, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Quinoline Yellow (E 104) in foods were requested from relevant stakeholders through a call for usage and analytical data. Usage levels were provided to EFSA for 6 out of 28 food categories in which Quinoline Yellow (E 104) is authorised. In addition, 6 266 analytical results were reported. Following the amendment of Annex II to Regulation (EC) No 1333/2008, exposure estimates for Quinoline Yellow (E 104) presented in this statement were based on the currently authorised MPLs and analytical levels combined with food consumption data from the EFSA Comprehensive Food Consumption Database. Three scenarios were considered: (1) exposure estimates based on MPLs, (2) a refined brand-loyal exposure scenario and (3) a refined non-brand-loyal exposure scenario. Mean and high-level exposure estimates of Quinoline Yellow (E 104) were below the ADI for all population groups in all three scenarios.

25 March 2015 Mail Print

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2015;13(3):4043 [88 pp.]. doi:10.2903/j.efsa.2015.4043 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 for the pesticide active substance benzovindiflupyr, and the considerations as regards the applications for maximum residue levels (MRLs), are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of benzovindiflupyr as a fungicide on cereals (wheat, triticale, rye, barley, oats). MRLs were considered in soya beans and sugar cane. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment and the proposed MRLs, 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.

18 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):3999 doi:10.2903/j.efsa.2015.3999 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, Belgium, and the co-Rapporteur Member State, Greece, for the pesticide active substance metalaxyl-M 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 metalaxyl-M as a fungicide on sunflower, spinach, tomato 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. Concerns are identified.

3 March 2015 Mail Print

Reasoned Opinions

European Food Safety Authority EFSA Journal 2015;13(3):4062 [20 pp.]. doi:10.2903/j.efsa.2015.4062 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 Technology Crops Limited to modify the existing maximum residue level (MRL) for the active substance picloram in borage and corn gromwell seeds. In order to accommodate for the intended use of picloram, the United Kingdom proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.01 mg/kg to the proposed MRL of 0.03 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 data on rape seed are sufficient to derive a MRL proposal of 0.03 mg/kg extrapolated to borage and corn gromwell seeds. Although the rape seed samples were analysed for picloram and its conjugates, expressed as picloram, EFSA is of the opinion that the trials can be used to derive a MRL according to the current enforcement residue definition limited to picloram. This MRL proposal might slightly overestimate the actual magnitude of picloram residues. However, since the total residues in rape seed are very low, this discrepancy is considered of low relevance. Although the chronic and acute dietary intake for borage and corn gromwell seeds could not be calculated since there is no reported consumption data for these crops, EFSA concludes that the intended use of picloram on borage and corn gromwell seeds will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.

31 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4071 [16 pp.]. doi:10.2903/j.efsa.2015.4071 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 ISK Biosciences Europe N.V. to modify the existing maximum residue level (MRL) for the active substance pyriofenone in table grapes. In order to accommodate for the intended use of pyriofenone, the United Kingdom proposed to raise the existing MRL to 0.9 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 data are sufficient to derive a MRL proposal of 0.9 mg/kg on table grapes. Adequate analytical enforcement methods are available to control the residues of pyriofenone in the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of pyriofenone on table grapes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

30 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4059 [28 pp.]. doi:10.2903/j.efsa.2015.4059 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS-DE), received an application from LELF to modify the existing MRLs for the active substance fluazifop-P in lupins and linseeds. Afterwards, France, hereafter referred to as the evaluating Member State (EMS-FR), received an application from Syngenta Agro SAS to modify, according to the above regulation, the existing MRLs for fluazifop-P in several commodities, including lupins and linseeds. Amendments of the existing MRLs of fluazifop-P in several vegetables, pulses, oilseeds and in roots of herbal infusions (dried) and roots or rhizome of spices were proposed. Both EMS-DE and EMS-FR drafted 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, data are sufficient to derive MRL proposals of 0.4 mg/kg on celeriac, 0.5 mg/kg on Jerusalem artichokes, 1.5 mg/kg on peas (without pods), 0.9 mg/kg on globe artichokes, 4 mg/kg on beans, lentils, lupins (pulses), herbal infusions (dried roots) and spices (roots or rhizome), 9 mg/kg on linseeds, poppy seeds and safflower seeds. Adequate analytical enforcement methods are available to control the residues of fluazifop-P in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of fluazifop-P on celeriac, Jerusalem artichokes, peas (without pods), globe artichokes, beans, lentils, lupins, linseeds, poppy seeds, safflower seeds, herbal infusions (dried roots) and spices (roots and rhizome) is unlikely to pose a consumer health risk.

25 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4050 [66 pp.]. doi:10.2903/j.efsa.2015.4050 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 fenpropimorph. In order to assess the occurrence of fenpropimorph 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 import tolerances and European authorisations reported by Member States (including 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 chronic/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.

18 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4047 [20 pp.]. doi:10.2903/j.efsa.2015.4047 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 maximum residue levels (MRLs) for the active substance bifenazate in blueberries, cranberries, gooseberries and azaroles (based on the intended use on kiwiberries). In order to accommodate for the intended uses of bifenazate, Belgium proposed to raise the existing maximum residue limits (MRLs) from the limit of quantification (LOQ) to 0.7 mg/kg. 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 a MRL proposal of 0.7 mg/kg for the intended indoor use on blueberries, cranberries, gooseberries and kiwiberries (azaroles). The intended outdoor use in Belgium is not supported by residue data. Adequate analytical enforcement methods are available to control the residues of bifenazate in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of bifenazate on blueberries, cranberries, gooseberries and kiwiberries (azaroles) will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

17 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4049 [23 pp.]. doi:10.2903/j.efsa.2015.4049 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), received an application from Kanesho Soil Treatment SPRL/BVBA to modify the existing maximum residue levels (MRLs) for the active substance dazomet in fruits and several vegetables. In order to accommodate for the pre-planting uses of dazomet, Belgium proposed a modification of the MRLs, as methyl isothiocyanate (MITC). 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 proposals of 0.02 mg/kg on carrots, 0.05 mg/kg on radishes, 0.1 mg/kg on the group ‘fruiting vegetables’, except sweet corn, 0.03 mg/kg on the groups ‘leafy brassica’ and ‘lettuces and other salad plants’ and 0.15 mg/kg on the group ‘spinaches and similar leaves’. The proposed MRLs apply to the active substance metam as well. In contrast, EFSA does not recommend the lowering of the current MRL value from the limit of quantification (LOQ) of 0.02 mg/kg to the LOQ of 0.01 mg/kg in fruits, pending the Article 12 review. Adequate analytical methods are available to control residues of MITC for the proposed MRLs. Based on the risk assessment results, EFSA concludes that the proposed uses of dazomet on the vegetables under consideration will not result in a consumer exposure exceeding the toxicological reference values for MITC and therefore are unlikely to pose a consumer health risk.

17 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4046 [23 pp.]. doi:10.2903/j.efsa.2015.4046 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta France SAS to modify the existing maximum residue level (MRL) for the active substance cyprodinil in celery. In order to accommodate for the intended uses of cyprodinil, France proposed to raise the existing MRL from the value of 5 mg/kg to 7 mg/kg. France 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 submitted data support a MRL proposal of 5 mg/kg for the proposed outdoor uses on celery and therefore, that there is no need to change the current MRL value of 5 mg/kg set under Regulation (EC) No 396/2005. The intended indoor use on celery was not adequately supported by residue data and therefore no MRL proposal could be made to accommodate the intended indoor use. Adequate analytical enforcement methods are available to control the residues of cyprodinil in celery. Based on the risk assessment results, EFSA concludes that the proposed use of cyprodinil on celery will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. 

13 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4045 [19 pp.]. doi:10.2903/j.efsa.2015.4045 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from BASF France SAS to modify the existing maximum residue levels (MRLs) for the active substance boscalid in beans and peas with pods. In order to accommodate for the intended use of boscalid, France proposed to raise the existing MRL from the value of 3 mg/kg to 6 mg/kg. France 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 5 mg/kg for the intended field use on beans and peas with pods. Adequate analytical enforcement methods are available to control the residues of boscalid. Based on the risk assessment results, EFSA concludes that the proposed use of boscalid on beans and peas with pods will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk

13 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4044 [24 pp.]. doi:10.2903/j.efsa.2015.4044 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), received an application from Sumitomo Chemical Agro Europe S.A.S. to modify the existing maximum residue levels (MRLs) for the active substance bromuconazole in wheat and rye. In order to accommodate for the intended use of bromuconazole, Belgium proposed to raise the existing MRLs from the value of 0.2 mg/kg to 0.3 mg/kg. 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 proposals of 0.2 mg/kg for the intended use on wheat and rye, which do not require a modification of the existing MRLs. An adequate analytical enforcement method is available to control the residues of bromuconazole in cereals. Based on the risk assessment results, EFSA concludes that the proposed use of bromuconazole on wheat and rye will not result in a consumer exposure exceeding the toxicological reference values of bromuconazole and therefore is unlikely to pose a consumer health risk related to this compound.

12 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4041 [21 pp.]. doi:10.2903/j.efsa.2015.4041 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Nissan Chemical Europe S.A.R.L. to modify the existing maximum residue level (MRL) for the active substance pyridaben in cucurbits – edible peel. In order to accommodate for the intended uses of pyridaben, the Netherlands proposed to raise the existing MRL from 0.1 mg/kg to a MRL of 0.15 mg/kg. the Netherlands 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 0.15 mg/kg for the proposed use on cucurbits – edible peel. A fully validated analytical enforcement method is available to control the residues of pyridaben in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of pyridaben on cucurbits – edible peel will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

10 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4037 doi:10.2903/j.efsa.2015.4037 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from K-I Chemical Europe SA/NV to modify the existing maximum residue levels (MRLs) for the active substance mepanipyrim in strawberries, tomatoes, aubergines, and cucumbers. In order to accommodate for the intended uses of mepanipyrim, the EMS proposed to raise the existing MRLs from 1.5 mg/kg to 3 mg/kg in strawberries, from 0.8 mg/kg to 1.5 mg/kg in tomatoes and aubergines and from 0.01 mg/kg to 0.5 mg/kg in cucumbers. 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 3 mg/kg on strawberries, 1.5 mg/kg on tomatoes (extrapolated to aubergines) and 0.5 mg/kg on cucumbers. Adequate analytical enforcement methods are available to control the residues of mepanipyrim in on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of mepanipyrim on strawberry, tomato, aubergine and cucumber will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

5 March 2015 Mail Print

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2015;13(3):4061 [31 pp.]. doi:10.2903/j.efsa.2015.4061 Abstract

Following a request from the European Commission, EFSA was asked to provide urgent technical assistance in the field of plant health as regards the list of host plants of Xylella fastidiosa reported in Appendix В of the recently published EFSA Scientific Opinion on X. fastidiosa. In this technical report the list of host plants is categorised focusing on plant species traded as plants for planting and taking into account available data and information on the trade and cultivation of host plants and on infection with X. fastidiosa. Based on this characterisation, a definition of the host plants of X. fastidiosa which have been both (1) naturally infected and (2) confirmed by at least two different testing methods is provided, together with indication when vector transmission has been confirmed by two testing methods. An electronic dataset is appended to this technical report and provides a searchable list of host plant species.

20 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4042 [17 pp.]. doi:10.2903/j.efsa.2015.4042 Abstract

‘Top-down’ (e.g. surveillance-based) and ‘bottom-up’ approaches (e.g. using the standard microbial risk assessment paradigm) were combined to assess the risk of foodborne transmission of Ebola virus to persons in Europe arising from the consumption of raw food other than bushmeat imported from African countries where human outbreaks due to Zaïre Ebola virus (ZEBOV) have occurred. Using the ‘top-down’ approach, it was concluded that food other than bushmeat has never been identified as associated with human ZEBOV cases in any of the reported outbreaks. There is no evidence for foodborne transmission of ZEBOV to persons in the European Union (EU). The ‘bottom-up’ approach revealed that the necessary sequence of events in the risk pathway involves many hurdles: 1) the raw food to be exported has to be contaminated with ZEBOV at the point of origin; 2) the imported food needs to contain viable virus when it arrives in the EU; 3) the person has to be exposed to the virus; and 4) the person needs to get infected following exposure. Each of these steps is necessary in order for a case of disease to occur and none have been documented to happen in practice. Due to lack of data and knowledge, which results in very high uncertainty, it is not possible to quantify the risk of foodborne transmission of ZEBOV derived from the consumption of these imported foods, or in fact whether or not this mode of transmission could occur at all. The overall conclusions of both approaches are consistent and suggest that the risk of foodborne transmission of ZEBOV via food other than bushmeat imported into the EU remains a theoretical possibility only and has never been demonstrated in practice. However, the uncertainty in the combined assessment is considered high given the lack of data.

18 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2014-00876 [28 pp.]. doi:10.2903/j.efsa.2015.4048 Abstract

Visual inspection of a bee hive or commodity combined with the use of traps is recommended to screen for small hive beetle (SHB) presence. Any observation or result of a screening test suggesting the presence of SHB should be confirmed. Treatments like heating, freezing and/or irradiation can be applied to eradicate SHB from non-living bee products and from used beekeeping equipment, but cannot be applied to living material as these will kill bees and brood along with the SHB. Prevention, control and/or reduction of an SHB infestation in a honey bee hive while keeping the bees and/or brood alive, could be achieved using mechanical control, chemical and biological treatments or applying good beekeeping practices. It is feasible and effective to conduct surveillance in SHB-affected zones and control for pest freedom during transport of commodities and at the place of destination via internationally recognised systems of health certificates. This strongly depends on the delay between the health checks and the departure from the place of origin, because the free-flying pest may infest the bees and/or products between these two steps if adequate precautions are not taken to avoid the infestation. If SHB has been detected very early after its arrival and is not yet widespread, it is recommended applying an eradication approach rigorously and immediately after SHB detection to prevent further spread of the pest since none of the available risk mitigation methods can be applied to fully control the pest outside of managed bee colonies and/or commodities. Implementation of all available methods to prevent, control and reduce SHB infestation is recommended when eradication is considered not to be a feasible option anymore in the considered zone. Screening for the presence of SHB in swarms and feral colonies will inform risk managers on the feasibility to eradicate the pest in the considered zone.

17 March 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(3):4038 [169 pp.]. doi:10.2903/j.efsa.2015.4038 Abstract

The results of the control activities related to pesticide residues in food carried out in 2013 in the EU Member States, Norway and Iceland (hereafter referred to as reporting countries) are summarised in this report. In total, 80 967 samples of a wide variety of unprocessed raw agricultural commodities and processed food products were analysed for residues of 685 distinct pesticides. A substantial number of samples (8 270) were taken for products from third countries, which are subject to increased import controls under Regulation (EC) No 669/2009. In the framework of the EU-coordinated monitoring programme, which aims to provide statistically representative results for the EU, 11 582 samples of 12 different food commodities were analysed for 209 distinct pesticides. Overall, 97.4 % of the tested food samples fell within the legal limits and 54.6 % of the samples contained no quantifiable residues at all. In general, a higher prevalence of residues exceeding the Maximum Residue Levels (MRL) was observed for products imported from third countries (5.7 % for imported products versus 1.4 % for products produced in reporting countries). The results of the dietary exposure estimations support the conclusion that, in the light of current knowledge, the presence of residues found in the food products covered by the EU-coordinated monitoring programmes was unlikely to have a long-term effect on the health of consumers. The probability of being exposed to pesticide residues in the food products covered by the EU-coordinated programme exceeding the toxicological threshold for short-term exposure that may lead to negative health outcomes was low.

12 March 2015 Mail Print Cite