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Just Published: June, 2016

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

Dietary Reference Values for vitamin B6

Nutrition
Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen-Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuh€auser-Berthold, Gra_zyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sj€odin, Martin Stern, Daniel Tome, Dominique Turck, Henk Van Loveren, Marco Vinceti and Peter Willatts
EFSA Journal 2016;14(6):4485 [79 pp.].
doi
10.2903/j.efsa.2016.4485
Abstract

Following a request from the European Commission, the EFSA Panel  on Dietetic Products, Nutrition and Allergies (NDA) derives Dietary Reference Values (DRVs) for vitamin B6. The Panel considers that plasma pyridoxal 50 -phosphate (PLP) concentration is the biomarker of status suitable for deriving DRVs for  vitamin B6. Considering that  a plasma PLP  concentration of  30 nmol/L,  as a population mean, is indicative of an adequate vitamin B6 status, the Panel proposes to use this cut-off value to set Average Requirements (ARs). Population  Reference Intakes (PRIs) are derived for  adults and children from ARs, assuming a coefficient of variation (CV) of 10%. For women, the AR and PRI are set at 1.3 and 1.6 mg/day. For men, the AR of 1.5 mg/day is derived by an allometric scaling from the AR for women, and a PRI of 1.7 mg/day is set. For all infants aged 7–11 months, an Adequate Intake of 0.3 mg/day is set, averaging the results of two extrapolation approaches based on an allometric scaling: upwards extrapolation from the estimated vitamin B6 intake of exclusively breastfed infants from  birth  to  6 months, and downwards extrapolation from  the ARs for  adults applying a growth factor. For all children, ARs are derived from adult ARs using an allometric scaling and growth factors. For children of both sexes aged 1–14 years, ARs range between 0.5 and 1.2 mg/day. For children aged 15–17 years, the Panel derives the same ARs as for adults. PRIs for children aged 1–17 years range  between 0.6 and  1.7 mg/day.  Extrapolation  of  ARs by  an allometric  scaling  considered differences in reference body weight. For pregnant and lactating women, additional requirements are considered, based on the  uptake of  vitamin B6 by the  fetal and maternal tissues and the  losses through breast milk, and PRIs of 1.8 and 1.7 mg/day, respectively, are derived.

 

Chemical Group 3 for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta Lopez-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4512 [21 pp.].
doi
10.2903/j.efsa.2016.4512
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 43 compounds belonging to chemical group 3 (α,β-unsaturated straight-chain and branched-chain aliphatic primary alcohols, aldehydes, acids and esters) when used as feed flavourings for all animal species and categories. They are currently authorised as flavours in food. This opinion concerns 17 compounds from this group. The FEEDAP Panel established the following conclusions: geraniol [02.012] and citral [05.020] are safe for all target species at the proposed maximum use level of 25 mg/kg feed; farnesol [02.029], (Z)-nerol [02.058], geranyl acetate [09.011], geranyl butyrate [09.048], geranyl formate [09.076], geranyl propionate [09.128], neryl propionate [09.169], neryl formate [09.212], neryl acetate [09.213], neryl isobutyrate [09.424] and geranyl isobutyrate 09.431] are safe at the maximum proposed use level of 5 mg/kg feed for all target species; 2-methyl-2-pentenoic acid [08.055], (2E)-methylcrotonic acid [08.064], ethyl (E,Z)-deca-2,4-dienoate [09.260] and prenyl acetate [09.692] are safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and fresh water environments. As 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.

Inositol for dogs and cats

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4511 [9 pp.].
doi
10.2903/j.efsa.2016.4511
Abstract

Inositol (cyclohexenehexol) is a sugar alcohol synthesised by most plants and animals. It exists in nine possible stereoisomers, four of which are physiologically active. Inositol is an essential micronutrient for salmon, carp, tilapia and shrimps, particularly juveniles. In a previous opinion on inositol, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP6) could not conclude on the safety and efficacy of inositol when used in pet food at the recommended use levels of between 500 and 3,000 mg/kg owing to insufficient evidence. The European Commission requested that the European Food Safety Authority re-evaluate the safety and efficacy of inositol when used as nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having a similar effect) in food for dogs and cats. In the present application, the applicant proposed a maximum supplementation level of 1,500 mg inositol/kg dry complete feed for dogs and cats. The FEEDAP Panel concluded, based on the free inositol concentrations found in commercial diets for pets, that inositol up to a total content of 3,000 mg free inositol/kg dry complete feed (88% dry matter) could be considered safe for dogs and cats. Evidence is lacking for any benefit of inositol supplementation of foods for dogs and cats.

Lactobacillus plantarum NCIMB 42150 for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Maria Luisa Fernández-Cruz, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4506 [9 pp.].
doi
10.2903/j.efsa.2016.4506
Abstract

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a specific strain of Lactobacillus plantarum when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 colony forming unit (CFU)/kg fresh material. L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than demonstrating the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Five studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. In addition, in four studies, formic acid was included as positive control. The mini-silos were then stored for 90–103 days at 20–24°C. After opening, the contents of the silos were analysed. Results showed that this strain of L. plantarum has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by increasing the production of lactic acid, reducing the pH and increasing the preservation of dry matter when used at an application rate of 1 × 108 CFU/kg.

Bacillus subtilis DSM 28343 for chickens for fattening

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Maria Luisa Fernández-Cruz, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4507 [11 pp.].
doi
10.2903/j.efsa.2016.4507
Abstract

The additive is a preparation containing viable spores of a strain of Bacillus subtilis which has never been authorised in the EU. It is intended to be used in feeds for chickens for fattening at the recommended dose of 1 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. The bacterial species B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the active agent has been established and the susceptibility to antibiotics and lack of toxigenic potential have been demonstrated, the use of Bacillus subtilis DSM 28343 can be presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Bacillus subtilis DSM 28343 is not an eye/skin irritant but should be considered as a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the skin sensitisation potential.Bacillus subtilis DSM 28343 at the proposed dose has the potential to be efficacious in improving growth of chickens for fattening.B. subtilis DSM 28343 is compatible with the coccidiostats lasalocid A sodium, diclazuril, monensin sodium, maduramicin ammonium, decoquinate, nicarbazin, robenidine hydrochloride and halofuginone hydrobromide.

Priority topics for guidance development by EFSA’s Scientific Committee

Cross-cutting science
Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Michael John Jeger, Katrine Helle Knutsen, Simon More, Alicja Mortensen, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R. Schlatter, Vittorio Silano, Roland Solecki and Dominique Turck
EFSA Journal 2016;14(6):4502 [9 pp.].
doi
10.2903/j.efsa.2016.4502
Abstract

EFSA asked its Scientific Committee to review its own cross-cutting guidance for scientific assessments in order to identify gaps requiring either new or the revision of existing guidance. Through strategic discussions, the Scientific Committee identified topics to be included in its 2016–2018 work programme without ranking their priority. Three topics were identified for activity leading to the development of new guidance: individual susceptibility and uncertainty factors; interpretation of epidemiological studies; history of use. These will be further discussed and introduced into the rolling work programme as time and resources become available. Work is already underway in three areas which will lead to new or revised cross-cutting guidance: chemical mixtures; follow up on the Threshold of Toxicological Concern approach; nanotechnologies. The Scientific Committee will continue to keep priorities for cross-cutting guidance across EFSA's fields of responsibility under review.

POs-Ca® (calcium phosphorylated oligosaccharides) as a source of calcium

Food ingredients and packaging
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 ParentMassin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes
EFSA Journal 2016;14(6):4488 [26 pp.].
doi
10.2903/j.efsa.2016.4488
Abstract

POs-Ca® is a calcium salt of phosphoryl oligosaccharides (POs) obtained from potato starch. POs-Ca® is stable at the temperature and pH values encountered for its intended use in chewing gum, hard confectionary, sugar-free soft candy and apple juice. POs-Ca® is highly soluble in water and readily dissociates into phosphorylated oligosaccharides and calcium in the gastrointestinal tract. POs-Ca® is expected to be absorbed, distributed and eliminated in a manner similar to other dietary sources of calcium and oligosaccharides. Calcium was bioavailable as revealed by the increase in plasma calcium concentrations after intra-gastric administration in rats. POs are not acutely toxic and a no observed adverse effect level of 1,000 mg/kg body weight (bw) per day, the highest dose tested, was established from a 90-day oral toxicity study in rats. No evidence of genotoxicity was observed in a reverse bacterial mutation assay and an in vitro mammalian chromosome aberration test. Overall, the Panel considered that the toxicity data provided in support of the current application were in line with the Tier 1 requirement of the Guidance for submission for food additive evaluations issued by the ANS Panel in 2012 and, in the absence of an indication for a toxic potential of POs-Ca®, there was no need for additional data. Overall, the Panel concluded that calcium is bioavailable from POs-Ca® and although the toxicity database was too limited to derive an acceptable daily intake, there is no safety concern for its use as a source of calcium added for nutritional purposes to food, food supplements and foods for special medical purposes at the proposed use and use levels. The Panel noted that POs-Ca® would be a major contributor to the daily intake of calcium with respect to the overall average daily intake of calcium.

Dicopper oxide for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4509 [19 pp.].
doi
10.2903/j.efsa.2016.4509
Abstract

The compound under assessment, dicopper oxide, contains ≥ 86% copper (Cu). Dicopper oxide is a safe source of copper for chickens for fattening. This conclusion is extended to all animal species/categories provided the maximum authorised copper content in feed is respected. There is no indication that the toxicity of dicopper oxide is essentially different from that described for divalent copper. As dicopper oxide is used as a substitute for other copper-containing additives and its bioavailability is in the range of copper sulphate, the standard copper-containing additive, no influence of the use of dicopper oxide in animal nutrition on the copper content of food of animal origin is expected. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concludes that the use of dicopper oxide in animal nutrition is of no concern for consumer safety. Dicopper oxide is not an irritant to skin but a moderate irritant to the eye. Owing to the nickel content in the additive, it should be considered as a dermal and respiratory sensitiser. Dicopper oxide poses a risk to users upon inhalation exposure. There was no available evidence suggesting that dicopper oxide would pose additional risks to the environment than the other sources of copper already authorised. The substitutive use of dicopper oxide for other copper compounds would therefore not change the previous conclusion of the Panel concerning safety from the environment. Based on the results of a tolerance study in chickens for fattening and a short-term bioavailability study, the FEEDAP Panel concluded that dicopper oxide is an effective source of copper for all animal species.

Evaluation of new scientific information on Phyllosticta citricarpa

Plant health
Claude Bragard, David Caffier, Thierry Candresse, Elisavet Chatzivassiliou, Katharina Dehnen-Schmutz, Gianni Gilioli, Jean-Claude Gregoire, Josep Anton Jaques Miret, Michael Jeger, Alan MacLeod, Maria Navajas Navarro, Bjoern Niere, Stephen Parnell, Roel Potting, Trond Rafoss, Vittorio Rossi, Gregor Urek, Ariena Van Bruggen, Wopke Van Der Werf, Jonathan West and Stephan Winter
EFSA Journal 2016;14(6):4513 [53 pp.].
doi
10.2903/j.efsa.2016.4513
Abstract
Following a request from the European Commission, the EFSA Panel on Plant Health (PLH) was asked to assess two publications, authored by Magarey et al. and Martınez-Minaya et al. from 2015, with regard to a need to update the EFSA Scientific Opinion from 2014 on the risk of Phyllosticta citricarpa (Guignardia citricarpa) for the EU territory. The EFSA PLH Panel was also requested to assess any other relevant scientific information published after the finalisation of the EFSA Scientific Opinion. The fungus P. citricarpa (McAlpine) Van der Aa causes the citrus disease citrus black spot (CBS), and is regulated as quarantine organism in Council Directive 2000/29/EC. The Panel assessed the two publications in detail as well as all relevant publications published until 31 March 2016. A comparison with the EFSA PLH Panel (2014) was made, survey data on CBS from South Africa used in Magarey et al. (2015) were evaluated, and the citrus production areas in the EU were characterised and compared with results from Magarey et al. (2015). Uncertainty and model sensitivity were discussed. It was concluded that the evidence presented in Magarey et al. from 2015 does not require an updating of EFSA PLH Panel (2014). The conclusion in the Opinion that probability of CBS establishment in the EU is moderately likely is not affected by the paper by Magarey et al. (2015) predicting establishment in some of the EU locations they selected. The high level of uncertainty regarding the probability of establishment is also unchanged by Magarey et al. (2015). The Panel concluded that Martınez-Minaya et al. (2015) does not provide new evidence requiring an update to EFSA PLH Panel (2014), principally because it had already been concluded that global climate zones are based on factors and thresholds that are broad and not necessarily representative of those that are critical for the pathogen and its host.

Enviva® PRO 202 GT for poultry

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4505 [2 pp.].
doi
10.2903/j.efsa.2016.4505
Abstract

The additive Enviva® PRO 202 GT is a preparation containing viable spores of three strains of Bacillus amyloliquefaciens. The additive is intended for use in feed for chickens for fattening, chickens reared for laying and minor poultry species for fattening and to point of lay at a minimum dose of 30 mg/kg feed, which corresponds to 7.5 × 107 CFU/kg complete feedingstuffs. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agents was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Enviva® PRO 202 GT is non-irritant to skin and eyes and is not a dermal sensitiser. Given the proteinaceous nature of the additive, there is a potential for respiratory sensitisation, although the risk is low due the low dusting potential. Data from three trials provide evidence that the inclusion of Enviva® PRO 202 GT at the recommended dose has the potential to improve the performance of chickens for fattening. This conclusion extends to the additive when used with chickens reared for laying and is extrapolated to minor avian species for fattening and to point of lay when used at the same dose. The three active agents are compatible with narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, diclazuril, robenidine hydrochloride, decoquinate and semduramycin sodium and nicarbazin.

ROVABIO® SPIKY for poultry species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4510 [10 pp.].
doi
10.2903/j.efsa.2016.4510
Abstract

ROVABIO® SPIKY is a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase that is authorised as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species for fattening and reared for laying. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) issued two opinions on this additive. Safety aspects regarding the use of this additive in feed have been previously established. The Panel concluded that the additive is safe for the consumers and the environment and that the additive is not irritant to the skin or eyes but should be considered a potential skin sensitiser and potentially harmful if inhaled. The Panel considered that these conclusions are still valid for the current application. The current application covered the use of the additive in all poultry species at the dose of 1,100 U xylanase and 760 U glucanase per kg feed. In previous assessments, the Panel concluded that the additive is safe and efficacious under the proposed conditions of use in chickens and turkeys for fattening or raised for laying/breeding and to minor poultry species for fattening or raised for laying/breeding. In order to support the safety for laying animals, the applicant provided a tolerance trial in laying hens from which the Panel concluded that the additive is safe for laying hens at the recommended dose. The safety established in laying hens is considered to apply also to breeding hens and can be extrapolated to minor poultry species for laying. Regarding the efficacy the additive increased the metabolisable energy content of the diets in one trial and the performance of the laying hens in two trials at the recommended dose. Therefore, the FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens. This conclusion applies also to breeding hens and can be extrapolated to include all minor poultry species for laying.

Ferric oxide for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4508 [26 pp.].
doi
10.2903/j.efsa.2016.4508
Abstract

The additive under assessment, ferric oxide, contains between 57% and 69% iron (Fe). The EFSA FEEDAP Panel could not conclude on the safety of ferric oxide for the target animals owing to that (i) the application of ferric oxide red is for all animal species, (ii) lifetime administration to animals is not excluded and (iii) a sufficient biological and toxicological database was not available. Regarding (i) the very low absorption of iron from the ferric oxide by target animals and (ii) the homoeostatic regulation of iron metabolism in animals, any influence of feeding the ferric oxide on the iron content of edible tissues and products is not expected. The use of ferric oxide in animal nutrition is unlikely to result in a direct exposure of the consumer to this oxide. Consequently, the supplementation of feed for food-producing animals with ferric oxide would likely not constitute a risk to consumers. Ferric oxide is an irritant to skin and eyes by mechanical action. Owing to the nickel content in the additive, the ferric oxide should be regarded as dermal and respiratory sensitiser. Inhalation of ferric oxide, and the contained chromium and nickel, is a hazard; as exposure by inhalation is likely, handling ferric oxide would be a risk for the users. As there is concern about the possible genotoxicity of ferric oxide, any route of exposure should be considered as hazardous. Iron oxides are ubiquitous in the environment. Any additional input from the nutritional use of ferric oxide in food-producing animals is considered negligible. It is unlikely that the use of the additive in animal nutrition would pose a risk to the environment. Ferric oxide should not be considered as iron source capable to meet iron requirements of animals.

Iron oxide black, red and yellow for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4482 [16 pp.].
doi
10.2903/j.efsa.2016.4482
Abstract

Iron oxides black, red and yellow are intended to be used as colourings to add and restore colour to feedingstuffs at a recommended concentration between 500 and 1,200 mg/kg. No data on the tolerance of target animals were provided. The iron oxides black, red and yellow are excreted essentially unchanged in the faeces of the target animals. Iron absorption from these water insoluble iron oxides is low. However, no conclusion on the safety of the iron oxides under assessment for the target animals could be made as a sufficient biological and toxicological database, particularly genotoxicity data, was not available. The use of the iron oxides in animal nutrition is unlikely to result in a direct exposure of the consumer and would not influence the iron content of edible tissues and products from animals treated with iron oxides. Consequently, the supplementation of feed for food-producing animals with the iron oxides under assessment would not provide a risk to consumers. Iron oxide black, red and yellow should be considered as irritant to skin and eyes. In the absence of any information, the Panel on Additives and Products or Substances used in Animal Feed FEEDAP cannot conclude on the potential of the additives to be a skin sensitiser. As the inhalation of iron oxides could cause unspecific lung inflammation, inhalation exposure of users should be considered to be a hazard. As there is concern about the possible genotoxicity of iron oxides, any route of exposure should be considered as hazardous. The use of iron oxide black, red and yellow in animal nutrition does not pose a risk to the environment. The iron oxides are effective in colouring feedingstuffs.

Dry grape extract for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4476 [2 pp.].
doi
10.2903/j.efsa.2016.4476
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of dry grape extract when used as feed flavouring for all animal species and categories. The additive under assessment (dry grape extract) is a mixture of two extracts from seeds and skin of Vitis vinifera subsp. vinifera. Flavouring preparations produced from food, such as extracts of grapes, can be used in and on food without specific authorisation. The FEEDAP Panel concludes that the additive dry grape extract is safe at the maximum proposed use level (100 mg/kg complete feed) for all animal species except dogs, for which no safe dietary concentration could be established. No safety concern would arise for the consumer from the use of the dry grape extract up to the highest safe level in feeds. The grape seed extracts tested are irritating to skin and eyes. However, the extent to which these observations would also apply to the behaviour of the complete additive containing grape skin extracts in addition is unknown. In the absence of data, it is not possible to conclude on the potential of the additive to be skin or respiratory sensitiser. The use of dry grape extract at the maximum proposed dose is not considered to be a risk for the environment. Since the major component of the additive, the proanthocyanidin-rich seed extract, is recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary.

Chemical Group 8 for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4475 [26 pp.].
doi
10.2903/j.efsa.2016.4475
Abstract

This opinion considers the safety and efficacy of 29 compounds belonging to chemical group 8. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the following conclusions: menthol [02.015] is safe at 25 mg/kg complete feed for all target species; menthyl acetate [09.016], d-carvone [07.146] and methyl dihydrojasmonate [09.520] at 5 mg/kg for all species; α-ionone [07.007], β-ionone [07.008] and d,l-isoborneol [02.059] at 5 mg/kg feed for salmonids, veal calves and dogs, and at 1 mg/kg feed for the remaining species; d,l-isobornyl acetate [09.218] at 5 mg/kg for all target species except chickens for fattening, laying hens, piglets and cats, for which 1 mg/kg is safe; d,l-borneol [02.016], fenchyl alcohol [02.038], α-irone [07.011], (Z)-β-damascone [07.083], β-damascenone [07.108], (E)-β-damascone [07.224], cyclohexyl acetate [09.027], carvyl acetate [09.215], dihydrocarvyl acetate [09.216] and fenchyl acetate [09.269] at 1 mg/kg for all target species; and d,l-isomenthone [07.078], nootkatone [07.089], Z-jasmone [07.094], 3-methyl-2-cyclopenten-1-one [07.112], isophorone [07.126], dihydrojasmone [07.140], l-carvone [07.147], d-fenchone [07.159], trans-menthone [07.176], d-camphor[07.215] and d,l-bornyl acetate [09.017] are safe only at concentrations below the proposed use levels (0.5 mg/kg for cattle, salmonids and non-food producing animals, and 0.3 mg/kg for pigs and poultry). No safety concern would arise for consumers from the use of these compounds as proposed in feeds. Hazards for skin and eye contact, and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. Use of the majority of the compounds in animal feed at the maximum safe level is considered safe for the environment. As all of the compounds are used in food as flavourings and their function in feed is essentially the same as that in food no demonstration of efficacy is necessary.

Chemical group 29 for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino Lopez Puente, Marta Lopez-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
EFSA Journal 2016;14(6):4441 [16 pp.].
doi
10.2903/j.efsa.2016.4441
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 12 compounds belonging to chemical group 29 (thiazoles, thiophene and thiazoline). They are currently authorised as flavours in food. This opinion concerns 10 compounds from this group. The FEEDAP Panel concludes that 2-isopropyl-4-methylthiazole is safe at the proposed maximum use level of 0.5 mg/kg complete feed for cattle, salmonids and non-food producing animals and at the proposed normal use level of 0.1 mg/kg complete feed for pigs and poultry. All the other compounds, 4,5-dihydrothiophen-3(2H)-one, 2-isobutylthiazole, 5-(2-hydroxyethyl)-4-methylthiazole, benzothiazole, 2,4,5-trimethylthiazole, 2-acetylthiazole, 2-ethyl-4-methylthiazole, 5,6-dihydro-2,4,6-trans(2-methylpropyl)4H-1,3,5-dithiazine and thiamine hydrochloride are safe at the proposed maximum use level of 0.05 mg/kg feed for all animal species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and fresh water environments. As all 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. In the absence of data on the stability in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

Bactocell PA 10 for poultry and pigs

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4483 [2 pp.].
doi
10.2903/j.efsa.2016.4483
Abstract

Bactocell PA is the trade name for formulations of feed additives based on viable cells of a strain of Pediococcus acidilactici. This opinion concerns the re-evaluation of the use of the additives in feed for pigs and chickens for fattening and a new application for use with minor porcine and avian species. Pediococcus acidilactici is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agent was established and its susceptibility to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, including minor porcine and avian species, consumers and the environment. Bactocell PA is non-irritant to skin and eyes and is not a dermal sensitiser. The presence of particles of respirable size and the proteinaceous nature of the additive indicates a risk of respiratory sensitisation. Data from the individual trials provides evidence that the inclusion of Bactocell PA at a dose of 1 × 109 colony-forming unit (CFU)/kg complete feed (5 × 108 CFU/L if delivered via water for drinking) has the potential to improve the performance of pigs for fattening and chickens for fattening. Previous opinions have established efficacy for weaned piglets and for laying hens at the same dose. As the mechanism of action of the additive can be reasonably assumed to be the same, efficacy for minor avian and porcine species can be presumed when used at the same dose. Therefore, Bactocell PA can also be considered efficacious for minor avian species (fattening and laying) and minor porcine species (weaned and for fattening) at a dose of 1 × 109 CFU/kg feed (5 × 108 CFU/L if delivered via water for drinking). Pediococcus acidilactici is compatible with the coccidiostats halofuginone, diclazuril, decoquinate and nicarbazin.

Lactobacillus plantarum DSM 29025 for all animal species

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4479 [10 pp.].
doi
10.2903/j.efsa.2016.4479
Abstract

Lactobacillus plantarum is a technological additive intended to improve the ensiling process at a minimum proposed dose of 5.0 × 107 colony-forming units (CFU)/kg fresh material. The bacterial species L. plantarum 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 clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered to have the potential to be a respiratory sensitiser. Three studies with laboratory-scale silos were made using samples of forage of differing dry matter and water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile material by improving the preservation of nutrients. This was shown at the proposed application rate of 5 × 107 CFU/kg forage.

Levucell SB for piglets and sows

Animal feed
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
EFSA Journal 2016;14(6):4478 [3 pp.].
doi
10.2903/j.efsa.2016.4478
Abstract

Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. Saccharomyces cerevisiae is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to establish safety for the target species, consumers and the environment. The identity of the strain present in the additive was established. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. Based on the data provided, the formulation Levucell® SB20, the uncoated form, is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in two other forms (Levucell® ME10 and Levucell® ME Titan) is not expected to introduce hazards for users. In four studies conducted in sows, the supplementation of Levucell® SB in the sows’ feed at the recommended dose increased the daily weight gain of piglets. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that Levucell® SB has the potential to be efficacious in sows at the dose of 1 × 109 colony-forming unit (CFU)/kg feed. The results in the studies done in weaned piglets showed that the supplementation of Levucell® SB in the feed at the recommended dose resulted in a statistically significant improvement on the feed to gain ratio in two studies and in an improvement of the final body weight (and average daily weight gain) in another study. The FEEDAP Panel concluded that Levucell® SB has the potential to be efficacious in weaned piglets at the dose of 2 × 109 CFU/kg feed.

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

Microplastics and nanoplastics in food and seafood

Chemical contaminants
Jan Alexander, Lars Barregård, Margherita Bignami, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Carlo Stefano Nebbia, Isabelle Oswald, Annette Petersen, Vera Maria Rogiers (until 9 May 2016), Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter Vollmer, Heather Wallace
EFSA Journal 2016;14(6):4501 [30 pp.].
doi
10.2903/j.efsa.2016.4501
Abstract

Following a request from the German Federal Institute for Risk Assessment (BfR), the EFSA Panel for Contaminants in the Food Chain was asked to deliver a statement on the presence of microplastics and nanoplastics in food, with particular focus on seafood. Primary microplastics are plastics originally manufactured to be that size, while secondary microplastics originate from fragmentation. Nanoplastics can originate from engineered material or can be produced during fragmentation of microplastic debris. Microplastics range from 0.1 to 5,000 μm and nanoplastics from approximately 1 to 100 nm (0.001–0.1 μm). There is no legislation for microplastics and nanoplastics as contaminants in food. Methods are available for identification and quantification of microplastics in food, including seafood. Occurrence data are limited. In contrast to microplastics no methods or occurrence data in food are available for nanoplastics. Microplastics can contain on average 4% of additives and the plastics can adsorb contaminants. Both additives and contaminants can be of organic as well of inorganic nature. Based on a conservative estimate the presence of microplastics in seafood would have a small effect on the overall exposure to additives or contaminants. Toxicity and toxicokinetic data are lacking for both microplastics and nanoplastics for a human risk assessment. It is recommended that analytical methods should be further developed for microplastics and developed for nanoplastics and standardised, in order to assess their presence, identity and to quantify their amount in food. Furthermore, quality assurance should be in place and demonstrated. For microplastics and nanoplastics, occurrence data in food, including effects of food processing, in particular, for the smaller sized particles (< 150 μm) should be generated. Research on the toxicokinetics and toxicity, including studies on local effects in the gastrointestinal (GI) tract, are needed as is research on the degradation of microplastics and potential formation of nanoplastics in the human GI tract.

Scientific Opinions: Guidance of the Scientific Committee/Scientific Panel

Framework to make protection goals operational for use in EFSA’s ERA

Cross-cutting science
Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Michael John Jeger, Katrine Helle Knutsen, Simon More, Alicja Mortensen, Hanspeter Naegeli, Hubert Noteborn, Colin Ockleford, Antonia Ricci, Guido Rychen, Josef R. Schlatter, Vittorio Silano, Roland Solecki and Dominique Turck
EFSA Journal 2016;14(6):4499 [50 pp.].
doi
10.2903/j.efsa.2016.4499
Abstract

Maintaining a healthy environment and conserving biodiversity are major goals of environmental protection. A challenge is that protection goals outlined in legislation are often too general and broad to be directly applicable for environmental risk assessment (ERA) performed by EFSA. Therefore, they need to be translated into specific protection goals (SPGs). This Guidance presents a framework, which accounts for biodiversity and ecosystem services, to make general protection goals operational for use in all areas of EFSA's ERAs. The approach to follow has three sequential steps: (1) the identification of relevant ecosystem services; (2) the identification of service providing units (SPUs) for these ecosystem services; and (3) the specification of options for the level/parameters of protection of the SPUs using five interrelated dimensions. This last step involves the specification of options for the ecological entity and attribute to protect and the magnitude, temporal scale and spatial scale of the biologically relevant and, in the case of regulated products, tolerable effects, the latter defined in dialogue with risk managers. In order to promote transparency and consistency when developing options for the level/parameters of protection, this guidance provides considerations to justify the selected options.

Conclusions on Pesticide Peer Review

Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain FZB24

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4494 [18 pp.].
doi
10.2903/j.efsa.2016.4494
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State (RMS), France, for the pesticide active substance Bacillus amyloliquefaciens strain FZB24 and the considerations as regards the application for inclusion of the active substance in Annex IV of Regulation (EC) No 396/2005, 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 B. amyloliquefaciens strain FZB24 as a fungicide on cucurbits (cucumber, courgette and melon), potato and grapevine. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance picoxystrobin

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4515 [26 pp.].
doi
10.2903/j.efsa.2016.4515
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Czech Republic and co-rapporteur Member State Romania for the pesticide active substance picoxystrobin and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of picoxystrobin as a fungicide on wheat (including spelt), triticale, barley, oats and rye. MRLs were assessed in oilseed rape and sunflower. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance cyazofamid

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4503 [24 pp.].
doi
10.2903/j.efsa.2016.4503
Abstract

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

Peer review of the pesticide risk assessment of the active substance 8-hydroxyquinoline

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4493 [16 pp.].
doi
10.2903/j.efsa.2016.4493
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Spain for the pesticide active substance 8-hydroxyquinoline are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of 8-hydroxyquinoline as a fungicide/bactericide on field tomatoes. The representative use evaluated for the approval of 8-hydroxyquinoline was as a fungicide/bactericide on glasshouse tomatoes. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance maleic hydrazide

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4492 [22 pp.].
doi
10.2903/j.efsa.2016.4492
Abstract

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

Peer review of the pesticide risk assessment of the active substance flurtamone

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4498 [24 pp.].
doi
10.2903/j.efsa.2016.4498
Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Czech Republic, and the co-rapporteur Member State, Ireland, for the pesticide active substance flurtamone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of flurtamone as a herbicide on spring cereals (barley, wheat) and winter cereals (barley, oat, rye, triticale, wheat, spelt). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Reasoned Opinions

Modification of the existing maximum residue levels for cyflufenamid in stone fruits and globe artichokes

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4519 [14 pp.].
doi
10.2903/j.efsa.2016.4519
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Greece, received an application from Nisso Chemical Europe GmbH to modify the existing maximum residue levels (MRLs) for the active substance cyflufenamid in apricots, cherries, peaches, plums and globe artichokes. According to EFSA, the data are sufficient to derive MRL proposal of 0.06 mg/kg for the proposed southern Europe uses on apricots, peaches, plums; of 0.1 mg/kg for cherries and of 0.03 mg/kg on globe artichokes. Adequate analytical enforcement methods are available to control the residues of cyflufenamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of cyflufenamid on the above-mentioned crops will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of the existing maximum residue levels for fluopyram in various crops

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4520 [27 pp.].
doi
10.2903/j.efsa.2016.4520
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS) Hungary and Greece received applications from Bayer CropScience AG to modify the existing maximum residue levels (MRLs) for the active substance fluopyram in apricots, sweet peppers, sweet corn, spinaches, witloof, herbs and edible flowers, peas (with pods), lentils, other legume vegetables, sesame seeds, sunflower seeds, rapeseeds, pumpkin seeds, safflower seeds, borage seeds, hemp seeds, castor beans, barley, buckwheat, oat and sugar beet roots. In order to accommodate the intended European uses, both EMS proposed to raise existing EU MRLs for all requested crops, except for sweet corn and sugar beet roots. According to EFSA, the data are sufficient to derive MRL proposals for all requested crops, except for sugar beet. For sweet corn EFSA proposes to decrease the MRL value to the LOQ of 0.01 mg/kg since residues above the LOQ were not observed in the primary and rotation crop studies. Based on the risk assessment results, EFSA concludes that the proposed use of fluopyram on the crops under consideration for which new MRL proposals were supported will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Revision of review of the existing MRLs for thiabendazole

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4516 [45 pp.].
doi
10.2903/j.efsa.2016.4516
Abstract

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission a mandate to update its previous review of the existing maximum residue levels (MRLs) for thiabendazole on the basis of the new toxicological reference values as indicated in the EFSA conclusion on the peer review of thiabendazole under Regulation (EU) No 1141/2010. 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 missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure will also need to be considered.

Modification of the existing MRL for pyrimethanil in leek

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4514 [13 pp.].
doi
10.2903/j.efsa.2016.4514
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), France, received an application from BASF to modify the existing maximum residue level (MRL) for the active substance pyrimethanil in leek. To accommodate for the intended use of pyrimethanil, France proposed to raise the value of the existing MRL from 1.0 to 4.0 mg/kg. According to EFSA, the data are sufficient to derive the MRL proposal of 4.0 mg/kg for the proposed use on leek. Adequate analytical enforcement methods are available to control the residues of pyrimethanil on leek. Based on the risk assessment results, EFSA concludes that the proposed use of pyrimethanil on leek will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of existing MRL for aminopyralid in maize

European Food Safety Authority
Pesticides
EFSA Journal 2016;14(6):4497 [16 pp.].
doi
10.2903/j.efsa.2016.4497
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Hungary, received an application from Dow AgroSciences Ltd to set a maximum residue level (MRL) for the active substance aminopyralid in maize. In order to accommodate for the intended uses of aminopyralid, Hungary proposed to raise the existing MRL from the limit of quantification of 0.01 mg/kg to 0.05 mg/kg. Hungary 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 0.05 mg/kg for the proposed uses on maize. Adequate analytical enforcement methods are available to control the residues of aminopyralid in the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of aminopyralid on maize will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.