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


Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, 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 2015;13(7):4200[8 pp.]. doi:10.2903/j.efsa.2015.4200 Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of the authorisation of OPTIPHOS® (6-phytase) as a feed additive for pigs for fattening. The phytase present in this additive is produced by a genetically modified strain of Komagaetella pastoris (formerly known as Pichia pastoris). The additive is presented in solid and liquid forms and is authorised for use in avian species, weaned piglets, pigs for fattening and sows. The Panel issued an opinion on the safety and efficacy of OPTIPHOS® as a feed additive for avian and porcine species. This opinion considered the safety aspects of the additive with regard to the consumer, the user, the environment and the genetic modification of the production strain. The applicant seeks a modification of the terms of the authorisation for pigs for fattening, which consists in lowering the minimum recommended dose from 250 OTU/kg feed to 125 OTU/kg feed. Four trials were provided to support the efficacy of the product at the newly recommended dose. Three of these trials were balance trials and the results showed an increase in the retention of phosphorus in pigs for fattening fed diets supplemented with OPTIPHOS® at 125 OTU/kg. Therefore, the FEEDAP panel concluded that OPTIPHOS® has the potential to be efficacious in pigs for fattening at the new minimum recommended dose.

29 July 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(7):4185[54 pp.]. doi:10.2903/j.efsa.2015.4185 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies derived Dietary Reference Values (DRVs) for phosphorus. The Panel considered data from balance studies, losses of phosphorus from the body and intestinal absorption for possible use in a factorial approach, and studies on phosphorus intake and long-term health outcomes. The Panel concluded that these data were insufficient for setting DRVs for phosphorus. Data on the calcium to phosphorus ratio in bones of healthy adults, adjusted for the proportion of phosphorus found outside bone, and data on whole-body calcium and phosphorus contents in Caucasian adults indicate that the calcium to phosphorus molar ratio in the body ranges from 1.4:1 to 1.9:1. Although the fractional absorption of phosphorus is higher than that of calcium, the Panel considered that the actual amounts of calcium and phosphorus that are available for absorption from the diet cannot be determined; therefore, the whole-body calcium to phosphorus ratio was used to set DRVs. The data were considered insufficient to derive Average Requirements and Population Reference Intakes. Based on the DRVs for calcium and considering a molar calcium to phosphorus ratio of 1.4:1 to 1.9:1, amounts of phosphorus were calculated. The Panel chose the lower bound of this range (a ratio of 1.4:1, which results in a higher phosphorus intake value) for setting an Adequate Intake (AI), taking into account estimated phosphorus intakes in Western countries, which are considerably higher than the values calculated. The AI is 160 mg/day for infants (7–11 months) and between 250 and 640 mg/day for children. For adults, the AI is 550 mg/day. Taking into consideration adaptive changes in phosphorus metabolism that occur during pregnancy and lactation, it was considered that the AI for adults also applies to pregnant and lactating women.

28 July 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, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Maria Luisa Fernandez-Cruz, 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 2015;13(7):4199[8 pp.]. doi:10.2903/j.efsa.2015.4199 Abstract

Biosprint® is a zootechnical feed additive consisting of a dried preparation of a strain of Saccharomyces cerevisiae. It is already authorised for use in feed for piglets, cattle for fattening, dairy cows, horses and sows. The applicant has now requested that the product be authorised for use as a zootechnical additive (functional group: gut flora stabilisers) in diets for dairy buffaloes, dairy sheep and dairy goats, and for buffaloes and goats for fattening. Saccharomyces cerevisiae is considered by the European Food Safety Authority (EFSA) to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been previously established and as the additive essentially consists of only the active agent, safety for the new target species, for consumers of milk and/or meat derived from minor ruminants and for the environment is presumed. The efficacy of the additive has been demonstrated for dairy cows and cattle for fattening (considered the relevant major species). As the mechanism of action of the additive can be reasonably assumed to be the same, efficacy for minor ruminant species used for milk and/or for fattening when used at minimum doses established for the major species can be presumed without the need for specific studies. This would be 2 × 109 colony-forming units (CFU)/kg feed for minor dairy ruminants and 4 × 109 CFU/kg feed for minor ruminants used for fattening.

27 July 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(7):4186[63 pp.]. doi:10.2903/j.efsa.2015.4186 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for magnesium. The Panel considers that Average Requirements (ARs) and Population Reference Intakes (PRIs) for magnesium cannot be derived for adults, infants or children, and therefore defines Adequate Intakes (AIs), based on observed intakes in healthy populations in the European Union (EU). This approach considers the range of average magnesium intakes estimated by EFSA from dietary surveys in children and adults in nine EU countries. For adults, an AI for magnesium is set at 350 mg/day for men and 300 mg/day for women. For children aged 1 to < 3 years, an AI for magnesium is set at 170 mg/day for both sexes. For children aged 3 to < 10 years, an AI for magnesium is set at 230 mg/day for both sexes. For children aged 10 to < 18 years, an AI for magnesium is set at 300 mg/day for boys and 250 mg/day for girls. For infants aged 7–11 months, an AI for magnesium of 80 mg/day is derived by extrapolating upwards from the estimated magnesium intake in exclusively breast-fed infants aged 0–6 months and by considering observed average intakes in the few surveys for which data are available. For pregnant and lactating women, the Panel considers that there is no evidence for an increased need for magnesium, and the same AI is set for them as for non-pregnant, non-lactating women.

27 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4173[28 pp.]. doi:10.2903/j.efsa.2015.4173 Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1). The Flavour Industry has provided additional genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. This substance was tested in vivo in a combined micronucleus assay in bone marrow and Comet assay in liver and duodenum. It did not induce any increase in micronucleated polychromatic erythrocytes of the bone marrow of male rats in the micronucleus test and it did not induce DNA damage in duodenum of the same animals as analysed by the Comet assay. The Comet assay performed in liver shows a positive result and therefore the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of this subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), there is a potential safety concern for these substances.

23 July 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(7):4183[32 pp.]. doi:10.2903/j.efsa.2015.4183 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on lacto-N-neotetraose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. Lacto-N-neotetraose (LNnT) is a synthetic tetrasaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes for infants and young children and other foods for infants and young children, as well as in foods or food supplements for adults. The information provided on the potential mutagenicity of LNnT does not raise safety concerns as regards the genotoxicity of this NFI. Based on the observations from a sub-chronic 90-day toxicity study in rats, the Panel considers that the no observed adverse effect level is 2 500 mg/kg body weight per day. The applicant provided a double-blind, randomised, controlled clinical trial on the effects of LNnT consumed in combination with another oligosaccharide (2’-O-fucosyllactose (2’-FL)) in infants. The Panel concludes that LNnT is safe for infants (up to one year of age) when added to infant and follow-on formulae, in combination with 2’-FL, at concentrations up to 0.6 g/L of LNnT and up to 1.2 g/L of 2’-FL, at a ratio of 1:2 in the reconstituted formulae; is safe for young children (older than one year of age) when added to follow-on and young-child formulae, at concentrations up to 0.6 g/L of LNnT (alone or in combination with 2’-FL, at concentrations up to 1.2 g/L, at a ratio of 1:2). The Panel also concludes that LNnT is safe when added to other foods at the uses and use levels proposed by the applicant.

20 July 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(7):4184[32 pp.]. doi:10.2903/j.efsa.2015.4184 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 2'-O-fucosyllactose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 2'-O-fucosyllactose (2'-FL) is a synthetic trisaccharide, which is intended to be used in infant and follow-on formulae, foods for special medical purposes for infants and young children, and other foods for infants and young children, as well as in foods or food supplements for adults. The information provided on the potential mutagenicity of 2'-FL does not raise safety concerns as regards the genotoxicity of this NFI. Based on the observations from a sub-chronic 90-day toxicity study in rats, the Panel considers that the no observed adverse effect level is 2 000 mg/kg body weight per day. The applicant provided a double-blind, randomised, controlled clinical trial on the effects of 2’-FL consumed in combination with another oligosaccharide (lacto-N-neotetraose (LNnT)) in infants. The Panel concludes that 2’-FL is safe for infants (up to one year of age) when added to infant and follow-on formulae, in combination with LNnT, at concentrations up to 1.2 g/L of 2’-FL and up to 0.6 g/L of LNnT, at a ratio of 2:1 in the reconstituted formulae; is safe for young children (older than one year of age) when added to follow-on and young-child formulae, at concentrations up to 1.2 g/L of 2’-FL (alone or in combination with LNnT, at concentrations up to 0.6 g/L, at a ratio of 2:1). The Panel also concludes that 2’-FL is safe when added to other foods at the uses and use levels proposed by the applicant.

20 July 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, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. EFSA Journal 2015;13(7):4152[74 pp.]. doi:10.2903/j.efsa.2015.4152 Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day (group ADI for polysorbates 20, 40, 60, 65 and 80) and the Scientific Committee on Food (SCF) derived a group ADI of 10 mg/kg bw/day. Small amounts of polyoxyethylene sorbitans are absorbed. Similar toxicokinetics would be expected for all polysorbates based on their similarities in structure and metabolic fate. The acute toxicity is very low. There is no concern regarding genotoxicity, carcinogenicity or developmental toxicity. From a limited number of studies, there is no indication of reproductive toxicity. The Panel considered the long-term carcinogenicity study in rats with a No Observed Adverse Effect Level (NOAEL) equivalent to 2 500 mg/kg bw/day – consistent with the NOAEL defined in subchronic studies – as the key study and allocated a group ADI of 25 mg/kg bw/day using an uncertainty factor of 100. The estimated exposure of toddlers at the highest level in non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day). The Panel is aware that for three food categories no reported uses have been obtained and that other dietary sources of exposure to polysorbates could not been considered in this opinion and therefore more data (usage and analytical data) are needed to decrease uncertainties in the refined exposure assessment scenario used.

17 July 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(7):4182[9 pp.]. doi:10.2903/j.efsa.2015.4182 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin D and its contribution to the normal function of the immune system. The Panel considers that vitamin D is sufficiently characterised. A contribution to the normal function of the immune system is a beneficial physiological effect. The Panel has previously assessed claims on vitamin D and its contribution to the normal function of the immune system with favourable outcomes. The target populations were the general population and children aged 3 to 18 years. The Panel considers that the role of vitamin D in the functioning of the immune system applies to all ages, including infants and young children (from birth to three years of age). The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system. The following wording reflects the scientific evidence: ‘Vitamin D contributes to the normal function of the immune system.’ The target population is infants and young children up to three years of age.

17 July 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(7):4180[90 pp.]. doi:10.2903/j.efsa.2015.4180 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to niacin and contribution to normal energy-yielding metabolism. The Panel considers that niacin, the food constituent that is the subject of the health claim, is sufficiently characterised. Contribution to normal energy-yielding metabolism is a beneficial physiological effect. The Panel has previously assessed a claim on niacin and contribution to normal energy-yielding metabolism with a favourable outcome. The target population was the general population. The Panel considers that the role of niacin in contributing to normal energy-yielding metabolism applies to all ages, including infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been established between the dietary intake of niacin and contribution to normal energy-yielding metabolism. The following wording reflects the scientific evidence: ‘Niacin contributes to normal energy-yielding metabolism.’ The target population is infants and young children up to three years of age.

17 July 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(7):4181[9 pp.]. doi:10.2903/j.efsa.2015.4181 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to biotin and contribution to normal energy-yielding metabolism. The Panel considers that biotin, the food constituent that is the subject of the health claim, is sufficiently characterised. Contribution to normal energy-yielding metabolism is a beneficial physiological effect. The Panel has previously assessed a claim on biotin and contribution to normal energy-yielding metabolism with a favourable outcome. The target population was the general population. The Panel considers that the role of biotin in contributing to normal energy-yielding metabolism applies to all ages, including infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been established between the dietary intake of biotin and contribution to normal energy-yielding metabolism. The following wording reflects the scientific evidence: ‘Biotin contributes to normal energy-yielding metabolism.’ The target population is infants and young children up to three years of age.

17 July 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(7):4187[13 pp.]. doi:10.2903/j.efsa.2015.4187 Abstract

Following an application from Cross Vetpharm Group UK Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort. The Panel considers that the food is sufficiently characterised in relation to the claimed effect. A reduction of gastrointestinal discomfort is a beneficial physiological effect for infants and young children. The applicant provided two human intervention studies for the substantiation of the health claim. No conclusions could be drawn from one of the two studies for the scientific substantiation of the claim, as the information provided in the publication and that supplied later by the applicant was inadequate to allow a scientific evaluation. The second study with methodological limitations showed an effect of the food on crying time in infants fed exclusively with milk. This study also provided some evidence for the proposed mechanism by which β-galactosidase could exert the claimed effect. In weighing the evidence, the Panel took into account that one study with methodological limitations showed an effect of β-galactosidase from Kluyveromyces lactis in Colief® on infant crying time, that no other human studies in which these results have been replicated were provided, and that there was some evidence for a mechanism by which the food could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort.

17 July 2015 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2015;13(7):4178[30 pp.]. doi:10.2903/j.efsa.2015.4178 Abstract

The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty acid profile. Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil-containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties. There is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87705 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87705 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope of the application. The EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 addresses the scientific comments raised by Member States. The EFSA GMO Panel concludes, considering the scope of the application, that soybean MON 87705 × MON 89788 is as safe as its comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. The GMO Panel recommends a post-market monitoring plan, focusing on import data and, if needed, on consumption data for the European population, for the marketed foods and feed.

16 July 2015 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2015;13(7):4167[29 pp.]. doi:10.2903/j.efsa.2015.4167 Abstract

Soybean FG72 was developed by biolistic transformation to express the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole- and glyphosate-based herbicides. The molecular characterisation of soybean FG72 did not give rise to safety issues. The agronomic and phenotypic characteristics of soybean FG72 tested under field conditions revealed no biologically relevant differences between soybean FG72 and its conventional counterpart that would give rise to any food and feed or environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins HPPD W336 and 2mEPSPS, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean FG72. The nutritional characteristics of soybean FG72 is not expected to differ from that of non-GM soybean varieties. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of this application, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean FG72 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, the EFSA GMO Panel considers that the information available for soybean FG72 addresses the scientific comments raised by Member States and that soybean FG72, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

16 July 2015 Mail Print Cite

EFSA Panel on Plant Protection Products and their Residues (PPR) Alf Aagaard, Theo Brock, Ettore Capri, Sabine Duquesne, Metka Filipic, Antonio F. Hernandez-Jerez, Karen I. Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Matthias Liess, Alberto Mantovani, Colin Ockleford, Bernadette Ossendorp, Robert Smith, Paulo Sousa, Ingvar Sundh, Aaldrik Tiktak, Ton Van Der Linden. EFSA Journal 2015;13(7):4176[145 pp.]. doi:10.2903/j.efsa.2015.4176 Abstract

The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) was tasked to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev. 4 (final), 17 October 2002). This scientific opinion of the PPR Panel is the second of three requested deliverables within this mandate. The scientific background for the risk assessment on sediment organisms in edge-of-field surface waters is provided, with reference to benthic ecology and ecotoxicology, available test protocols and current knowledge on exposure and effects of sediment-bound plant protection products (PPPs). The scientific opinion provides approaches on how to derive regulatory acceptable concentrations (RACs) for sediment organisms and exposure to active substances of PPPs and transformation products of these substances, and how to link them in a tiered approach to predicted environmental concentrations (PECs) for the sediment compartment. A list of uncertainties in relation to such approaches is given.

16 July 2015 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2015;13(7):4165[23 pp.]. doi:10.2903/j.efsa.2015.4165 Abstract

Single events NK603 and T25 were combined to produce the stack two-event maize NK603 × T25. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single maize events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of maize NK603 × T25, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of maize NK603 × T25. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering the scope of application EFSA-GMO-NL-2010-80, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for maize NK603 × T25 addresses the scientific comments raised by Member States and that maize NK603 × T25, as described in this application, is as safe as its non-GM comparator and non-GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.

15 July 2015 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Klaus Depner, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde, Preben Willeberg. EFSA Journal 2015;13(7):4164[70 pp.]. doi:10.2903/j.efsa.2015.4164 Abstract

An assessment of a report issued by the European Commission in 2002 is presented about the oral vaccination of foxes against rabies, as well as additional topics such as the rabies aetiology and its occurrence in Europe, the target species for oral vaccination, i.e. foxes and raccoon dogs, the oral vaccines available and their thermostability, rabies surveillance and monitoring, and the recent international guidelines for rabies surveillance are discussed. Foxes are the only known reservoir for rabies in Europe, and raccoon dogs are important transmitters, while other carnivores play a less important epidemiological role. The demographic expansion of raccoon dogs and their movements after hibernation are risk factors for rabies recurrence. The combined densities of foxes and raccoon dogs, which often share the same habitats, could allow rabies epizootics to persist. The epidemiological role and the pathogenesis of rabies in raccoon dogs and other carnivores must still be clarified. Four vaccines are authorised in the EU and their effectiveness is proven to successfully contribute to rabies elimination. Experimental and field evidence shows that climatic and weather conditions may impact on bait casings and vaccine stability. Data on the stability of vaccine baits under different field conditions should be provided. It is recommended that bait should keep its integrity at the release point. Because of bait stability issues, the season most appropriate for implementing oral rabies vaccination or a heat-stable vaccine should be considered. Rabies surveillance and monitoring of vaccination, based on assessment of bait uptake and seroconversion in host species, are important tools for the evaluation and adjustment of vaccination campaigns, although alternatives to tetracyclines as biomarkers should be developed. Oral immunisation by vaccine baits has proven to be successful in eliminating terrestrial wildlife rabies, but long-term strategy, temporal continuity of vaccination and cross-border cooperation are needed and recommended.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4171[8 pp.]. doi:10.2903/j.efsa.2015.4171 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety re-evaluation of perfluoromethyl perfluorovinylether, CAS No 1187-93-5 and FCM No 391, as a co-monomer for fluoro- and perfluoropolymers. The polymers are intended to be used for the production of O-rings, gaskets and seals for repeated use in food processing applications that may contact all types of food at temperatures ranging from low up to 200 °C, from a few minutes to hours. The worst-case specific migration of the substance was estimated to be lower than 0.07 µg/kg food, based on its residual amount in a perfluoropolymer sample containing the maximum level of use of perfluoromethyl perfluorovinylether. The migration of volatile and semivolatile substances was estimated to be lower than 0.07 µg/kg food and lower than 1 µg/kg food, respectively. Overall migration was calculated under repeat use conditions, and was 4 µg/kg in 3 % acetic acid, 3 µg/kg in 20 % ethanol and 9 µg/kg in olive oil. No oligomers below 1 500 Da were detected. Based on toxicological data available and evaluated in 2001 (SCF) and 2004 (EFSA), the CEF Panel concluded that the substance is not of genotoxic concern. Therefore, the CEF Panel concluded that the substance is not of safety concern for the consumer if it is used as a co-monomer for fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with not less than 150 kg food.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4174[13 pp.]. doi:10.2903/j.efsa.2015.4174 Abstract

Dimethyl ether was previously evaluated by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) and considered to give rise to no safety concerns under the conditions of use and the maximum residual limits proposed by the applicant. The present scientific opinion of the EFSA CEF Panel deals with the re-evaluation of the safety of dimethyl ether as an extraction solvent under new intended conditions of use and new maximum residual limits. The applicant requests a change in the residual limit of dimethyl ether in defatted animal protein products (in particular collagen) from 0.009 mg/kg to 3 mg/kg, and a new use for the extraction of protein products to yield gelatin with a residual limit of 0.009 mg/kg is also requested. The Panel notes the maximum residual limit requested by the applicant is much higher than the existing limit. Nonetheless, the margin of exposure for this new application is considered to be adequate. No new toxicity data were provided for dimethyl ether and, since the previous EFSA evaluation, only two in vitro genotoxicity studies have become available. These studies do not indicate any genotoxic potential for the assessed substance. The Panel thus considers that the use of dimethyl ether as an extraction solvent, under the intended conditions of use and with the proposed residual limits of 3 mg/kg in the defatted protein products and 9 μg/kg specifically in gelatin, is of no safety concern.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4169[13 pp.]. doi:10.2903/j.efsa.2015.4169 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process ExtruPET (EU register number RECYC0124), which is based on the Starlinger IV+® technology. The input of the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5 % of PET from non-food consumer applications. In this technology, washed PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then pre-heated in a third reactor and fed to the solid state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and are the temperature, the gas flow and the residence time for the drying and crystallisation step, and the temperature, the pressure and the residence time for the extrusion and crystallisation step and the SSP step. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET are not intended to be used, and should not be used in microwave and conventional ovens.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4168[11 pp.]. doi:10.2903/j.efsa.2015.4168 Abstract

Following a request from the European Commission, EFSA was asked to review Commission proposals for classification of the substances used as sizing agents and provide an opinion on whether or not the proposed classifications could imply an unacceptable risk to human health. Glass fibre-reinforced plastics are composite materials made of a polymer matrix reinforced with glass fibres. The glass fibres therein are coated with a surface treatment (‘sizing agent’) to hold individual filaments together and to promote adherence to the polymer matrix. Glass fibre-reinforced plastic is covered by Regulation (EU) No 10/2011, which stipulates that substances used for its manufacture should be listed in the Union List. From January 2016, the Plastics Regulation will also apply to glass fibre-sizing agents, and these substances shall be included in the Union List. On the basis of the low migration from glass fibre-reinforced plastics and the low consumer exposure expected, the CEF Panel does not expect any particular health risks from sizing agents compared with other plastics. For substances classed as coupling agents and for the substances considered polymer production aids, aids to polymerisation or solvents used to make plastics, any use of glass fibre-reinforced plastics does not seem to merit deviation from risk management decisions that were taken earlier. For the reactive polymers used for sizing the glass fibres, two possibilities are presented: evaluation of these polymers by EFSA and then specific authorisation via the Union List or regulation through the starting materials, if already listed, in accordance with the derogation in Article 6(3) of Regulation (EU) No 10/2011. In either case, the data required and the risk assessment process used should be the same or equivalent. The difference will be in the data that are presented to EFSA, and this is a decision in the remit of the Commission.

14 July 2015 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde and Preben Willeberg EFSA Journal 2015;13(7):4163[92 pp.]. doi:10.2903/j.efsa.2015.4163 Abstract

Since entering the eastern EU at the start of 2014, African swine fever (ASF) has spread locally in the wild boar population, independently of outbreaks in domestic pigs. No correlation between the density of the wild boar population and the case notification in an area has been observed. The source of virus introduction appeared to be the low biosecurity level in backyard farms; yet, direct contact between pigs and wild boar has not been reported. Potential wild boar management strategies aimed at controlling ASF were evaluated. First, the published literature was searched for evidence of changes in wild boar demography after implementing different management strategies. A reduction in a wild boar population of more than 60 % as a result of conventional hunting has not been documented in Europe. Secondly, during a consultation meeting, 30 experts identified different wild boar management tools to indirectly combat ASF spread. In the third step, an epidemiological simulation model was developed, to compare the effects of implementing individual or combinations of management tools to control ASF. The model demonstrated that measures such as attempts to reduce the wild boar populations more than 70 % would, in theory, be effective in controlling ASF, but in practice would impossible to be achieved in one hunting season. On the other hand, conventional management strategies, such as implementing a feeding ban or targeted hunting of females, can effectively prevent the spread of ASF in the control area only after multiple years of application. The model predicted that a combination of different tools, such as the exclusion of contact to carcasses and the intensification of conventional hunting, reducing reproduction in the following year by 30-40%, would be effective to stop the spread of ASF in wild boar.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4170[13 pp.]. doi:10.2903/j.efsa.2015.4170 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Coveris (EU register No RECYC0126), which is based on the same Starlinger Decon technology. The decontamination efficiency of the process was demonstrated using the same challenge test. The input of this process is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % of PET from non-food consumer applications. In this technology washed and dried PET flakes are pre-heated before being Solid State Polycondensed in a continuous reactor (SSP) at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions it was demonstrated that the recycling process under evaluation, using a Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg /kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill is not considered of safety concern. Trays made of this PET are not intended to be used, and should not to be used in microwave and conventional ovens.

14 July 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(7):4172[33 pp.]. doi:10.2903/j.efsa.2015.4172 Abstract

Safety Authority was requested to evaluate the genotoxic potential of 14 flavouring substances in Flavouring Group Evaluation 210 (FGE.210). In FGE.210, the Panel concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210 Revision1, the Panel concluded that the concern for genotoxic potential is ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170] while for allyl a-ionone [FL-no: 07.061], for a-damascone [FL-no: 07.134] and four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] the concern for genotoxicity remains and additional data were requested. The Flavour Industry has submitted additional genotoxicity data for allyl a-ionone [FL-no: 07.061], that are evaluated in the present revision of FGE.210 (Revision 2). Based on these new data the Panel concluded that the genotoxicity concern for allyl a-ionone [FL-no: 07.061] can be ruled out. For a-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] additional genotoxicity data are still required.

10 July 2015 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Klaus Depner, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde and Preben Willeberg EFSA Journal 2015;13(7):4188[63 pp.]. doi:10.2903/j.efsa.2015.4188 Abstract

Enzootic bovine leukosis is a disease of cattle caused by bovine leukemia virus (BLV). The virus causes a persistent, life-long infection in a subset of B cells. Malignant tumours (lymphomas) ultimately develop in 2–5% of infected animals, predominantly in adult cattle older than 3–5 years. Lymphomas invariably lead to death of the animal within months. Before 1960, BLV was endemic in dairy herds in Northern/Eastern Europe and North America. Since then it has spread to all continents. The disease has been successfully controlled and eliminated from many countries in Europe. There is no evidence to suggest that any significant reservoir of BLV exists among other species, nor for any role of BLV in human disease or cancers. BLV exhibits a slow, progressive spread within a herd and it is likely to persist if control measures are not applied. The main modes of transmission are perinatal from cow to calf, via colostrum and milk, and close contact that allows transfer of infected lymphocytes, such as dehorning and injections using non-sterile utensils. Transfer between herds is almost entirely by movement of infected animals. Suitable methods have been developed for diagnosis of BLV infection in specimens of blood, milk and lymphomas. EBL has a negative impact on milk yield and leads to increased premature culling. The welfare consequences of lymphomas vary according to the location and magnitude of organ involvement. Criteria for maintaining country freedom from EBL differ substantially between OIE and EU. Surveillance for freedom should be based on a combination of serological testing of adult animals and identification of lymphomas at slaughter.

10 July 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(7):4149[72 pp.]. doi:10.2903/j.efsa.2015.4149 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for vitamin E. In this Opinion, the Panel considers vitamin E as α-tocopherol only. The Panel considers that Average Requirements (ARs) and Population Reference Intakes (PRIs) for vitamin E (as α-tocopherol) cannot be derived for adults, infants and children, and therefore defines Adequate Intakes (AIs), based on observed intakes in healthy populations with no apparent α‑tocopherol deficiency in the EU. This approach considers the range of average intakes of α-tocopherol and of α-tocopherol equivalents estimated by EFSA from dietary surveys in children and adults in nine countries. The Panel notes the uncertainties in the available food composition and consumption data, the fact that most EU food composition databases contain values for vitamin E as α-tocopherol equivalents, as well as the contribution of average α-tocopherol intakes to average α-tocopherol equivalent intakes in these countries. For adults, an AI for α-tocopherol is set at 13 mg/day for men and 11 mg/day for women. For children aged 1 to < 3 years, an AI for α-tocopherol is set at 6 mg/day for both sexes. For children aged 3 to < 10 years, an AI for α-tocopherol is set at 9 mg/day for both sexes. For children aged 10 to < 18 years, an AI for α-tocopherol is set at 13 mg/day for boys and 11 mg/day for girls. For infants aged 7–11 months, an AI for α-tocopherol of 5 mg/day is derived by extrapolating upwards from the estimated α-tocopherol intake in exclusively breast-fed infants aged 0–6 months and rounding. For pregnant or lactating women, the Panel considers that there is no evidence for an increased dietary α-tocopherol requirement, and the same AI is set as for non-pregnant non-lactating women.

9 July 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(7):4150[64 pp.]. doi:10.2903/j.efsa.2015.4150 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for cobalamin (vitamin B12). The Panel considers that the approach based on a combination of biomarkers of cobalamin status, i.e. serum cobalamin, holotranscobalamin (holoTC), methylmalonic acid (MMA) and plasma total homocysteine (tHcy), is the most suitable approach to derive DRVs for cobalamin. The Panel notes the uncertainties with respect to cut-off values for cobalamin insufficiency of these indicators and that an Average Requirement (AR) cannot be determined from the limited data available. There is consistent evidence in adults that a cobalamin intake of 4 μg/day and greater is associated with serum concentrations of holoTC and cobalamin within the reference ranges derived from healthy subjects, together with MMA and tHcy concentrations below the cut-off values for adults, which indicates an adequate cobalamin status. Therefore, the Panel sets an Adequate Intake (AI) for cobalamin at 4 μg/day for adults based on data on different biomarkers of cobalamin status and in consideration of observed mean intakes, which range between 4.2 and 8.6 μg/day in adults in several EU countries. AIs for infants and children are calculated by extrapolation from the AI for adults using allometric scaling and applying a growth factor. Estimated AIs range from 1.5 μg/day in infants aged 7–11 months to 4 μg/day in children aged 15–17 years. For pregnancy and lactation, additional cobalamin intakes related to the accumulation of cobalamin in fetal tissues and transfer of cobalamin into breast milk are considered and AIs of 4.5 and 5 μg/day, respectively, are proposed.

9 July 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(7):4160[17 pp.]. doi:10.2903/j.efsa.2015.4160 Abstract

Lignosulphonates are amorphous branched polymers of lignin, containing sulphonated covalently linked phenyl propane monomers, produced from the sulphite pulping of lignocellulosic biomasses. The calcium lignosulphonate, sodium lignosulphonate and magnesium lignosulphonate under assessment are considered together under the term lignosulphonate. Lignosulphonate is safe for chickens for fattening, laying hens, pigs for fattening and cattle for fattening at a maximum concentration of 10 000 mg/kg complete feed. A margin of safety cannot be identified. Therefore, this conclusion cannot be extended to all animal species/categories. No concern for consumer safety would arise from the use of lignosulphonate in animal nutrition. Lignosulphonate is not an irritant to the skin and eyes and is not a skin sensitiser. Exposure to dust by inhalation is considered a hazard. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of lignosulphonate for the environment. Lignosulphonate is effective as a pellet binder at a minimum level of 7 500 mg/kg feed.

6 July 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(7):4159[26 pp.]. doi:10.2903/j.efsa.2015.4159 Abstract

ENZY PHOSTAR® is a preparation of 6-phytase produced by a genetically modified strain of Komagataella pastoris to be used as a zootechnical additive in avian and porcine species. Neither the production strain nor its recombinant DNA was detected in the final products. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in the tolerance studies performed, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe at the minimum recommended dose for the species/categories studied. The conclusion was extended to chickens reared for laying and turkeys reared for breeding and it was extrapolated to other avian species and minor porcine species at the corresponding dose. The recipient strain is considered to qualify for the Qualified Presumption of Safety approach to safety assessment and the genetic modification to which it was subject to does not give rise to concern; consequently, it was concluded that the use of ENZY PHOSTAR® as a feed additive gives rise to no concern for consumers. The additive is hazardous by inhalation. The solid formulation of the additive is not a dermal or eye irritant, but it is a skin sensitiser, and the liquid formulation should be considered a potential irritant and a potential skin sensitiser. No risks to the environment are expected. It was concluded that the additive has the potential to be efficacious at the dose of 125 U/kg in laying hens, 250 U/kg in chickens for fattening and all pig categories and at 500 U/kg in turkeys for fattening. The conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to all minor poultry species, other avian species and minor porcine species.

6 July 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(7):4156[25 pp.]. doi:10.2903/j.efsa.2015.4156 Abstract

The products L-lysine monohydrochloride (HCl) and L-lysine sulphate are feed additives produced by fermentation with genetically modified strains of Escherichia coli (CGMCC 3705) and Corynebacterium glutamicum (CGMCC 3704), respectively. Neither the E. coli production strain nor its recombinant DNA was detected in the final product. Therefore, the product L-lysine HCl does not give rise to any safety concern with regard to the genetic modification of the production strain. The product L-lysine HCl is considered safe for target species when supplemented in appropriate amounts. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns about the safety of L-lysine HCl for target species when administered via water for drinking. The use of concentrated L-lysine HCl does not give rise to safety concerns for the consumer. L-lysine HCl produced by E. coli CGMCC 3705 is not considered as a skin or eye irritant or skin sensitiser. The product should be considered a hazard by inhalation. With respect to L-lysine sulphate, the insufficient characterisation of the genetic modification of the production strain and uncertainties about the possible absence/presence of its recombinant DNA, including antibiotic resistance genes, in the product do not allow to conclude on the safety of L-lysine sulphate product for target species, consumers, users and the environment.
L-Lysine sulphate produced by C. glutamicum CGMCC 3704 is not a skin or eye irritant or skin sensitiser. The product should be considered a hazard by inhalation. The products L-lysine HCl and L-lysine sulphate are regarded as efficacious sources of the supplemental amino acid L-lysine 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.

6 July 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(7):4155[22 pp.]. doi:10.2903/j.efsa.2015.4155 Abstract

The product L-lysine sulphate is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli K-12. Neither the production strain nor its recombinant DNA was detected in the final product. Therefore, the product L-lysine sulphate, feed grade, manufactured by fermentation with E. coli CGMCC 3705, does not give rise to any safety concern with regard to the genetic modification of the production strain. Owing to potential adverse effects of the intrinsic high sulphate content in the product under application, a maximum supplementation of complete feed up to 1 % L-lysine sulphate is considered safe for all animal species and categories. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the use in animal feed of L-lysine sulphate produced by E. coli CGMCC 3705 does not pose a risk to the consumer or the environment. L-Lysine sulphate is not considered a skin or eye irritant or a skin sensitiser. The product should be considered a hazard by inhalation. The L-lysine sulphate under assessment is regarded as an efficacious source of the amino acid L-lysine for all animal species. For supplemental L-lysine sulphate to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

6 July 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(7):4157[7 pp.]. doi:10.2903/j.efsa.2015.4157 Abstract

VevoVitall® consists of 99.9 % benzoic acid. It is already authorised in the European Union as a zootechnical additive for weaned piglets and pigs for fattening. VevoVitall® is intended to be used in pigs for reproduction to reduce the pH of their urine. The applicant initially linked this effect to the reduction of the ammonia emission from the target animal’s manure and the control of urinary tract disorders in sows, but subsequently removed these claims from the scope of the application. In 2012, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of VevoVitall® as a feed additive for pigs for reproduction, covering gestating and lactating sows, boars and gilts. The Panel could not conclude on the safety of the additive for the target species or on its efficacy because of the lack of data provided by the applicant. The FEEDAP Panel considered the new information provided by the applicant on safety and efficacy, concluding that VevoVitall® is safe for sows, gilts and boars at the highest proposed use level (10 000 mg/kg complete feed), but no margin of safety could be established. VevoVitall® at 5 000 mg/kg has the potential to introduce a small reduction in urine pH in sows. No conclusion on the effects on urine pH could be drawn for boars and gilts. The FEEDAP Panel considers that an effect on urinary pH alone is of little practical or biological relevance unless it is demonstrated to be linked to a clear beneficial effect on animal production, performance, welfare or the environmental consequences of animal production.

3 July 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(7):4158[18 pp.]. doi:10.2903/j.efsa.2015.4158 Abstract

Cylactin® is the trade name for a preparation of Enterococcus faecium. It is currently authorised for use several animal species. The product is intended for use with sows at a minimum dose of 7 × 108 and a maximum dose of 1.25 × 109 colony-forming unit (CFU)/kg feed and with weaned and suckling piglets and pigs for fattening at a minimum dose of 3.5 × 108 and a maximum dose of 1.0 × 109 CFU/kg feed. The characterisation of the additive was fully described and its safety for consumers, users and the environment was assessed in previous opinions and it was found not to give rise to any concerns. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unaware of any new data which would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the safety and efficacy of Cylactin® when used with the target animals. Results on the safety and efficacy apply to all forms of the additive when delivering the same dose. When used at 100 times the maximum recommended dose, Cylactin® did not show any adverse effect on the performance or mortality of piglets and sows. Therefore, the additive is considered safe for suckling and weaned piglets, pigs for fattening and sows at the maximum proposed dose. Cylactin® has the potential to be efficacious in sows and suckling piglets when supplemented to both sows and suckling piglets at 7.0 × 108 and 1 × 109 CFU/kg feed, respectively. Cylactin® also has the potential to be efficacious in weaned piglets when supplemented at the minimum recommended dose of 3.5 × 108 CFU/kg feed. Insufficient data were provided to support the efficacy of Cylactin® when used in pigs for fattening.

3 July 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(6):4145[23 pp.]. doi:10.2903/j.efsa.2015.4145 Abstract

The EFSA ANS Panel delivered a scientific opinion re-evaluating the safety of oxidised polyethylene wax (OPEW) (E 914) as a food additive. E 914 is authorised at quantum satis only for the surface treatment of some fruits. The Scientific Committee on Food (SCF) evaluated the use of OPEW as a food additive but could not allocate an ADI and as an additive in food contact materials. The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated OPEW as a food contact material and established a TDI of 1 mg/kg bw/day. The ANS Panel considered that OPEW—an oxidised form of long-chain acids, alcohols and esters with a low epoxide and peroxide content—is stable in food matrices. Various 90-day studies in rats and a 90-day study in dogs reported no evidence of accumulation. In one rat study, at the highest dose, statistically significant increases in serum glucose and serum alkaline phosphatase and fatty livers were observed without other abnormalities. The lowest no observed adverse effect level (NOAEL) was considered 800 mg/kg bw/day. OPEW is not genotoxic. Owing to the lack of chronic toxicity and carcinogenicity studies, the limitations of the reprotoxicity study and the unavailability of the key 90-day study, the Panel considered that the overall toxicity database was insufficient to derive an ADI. Mean intake estimates of OPEW ranged from 0.001—0.03 mg/kg bw/day and high intake estimates ranged from 0.03—0.18 mg/kg bw/day across all population groups. Considering the NOAEL of 800 mg/kg bw/day, the calculated margin of safety (MoS) at the highest intake level of 0.18 mg/kg bw/day was 4 400. The Panel concluded that the exposure estimates of E 914 from its use at the maximum reported use level resulted in a sufficient MoS and that, despite the limitations in the database, E 914 is of no safety concern at the maximum reported use level in its currently authorised use.

2 July 2015 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2015;13(7):4127[31 pp.]. doi:10.2903/j.efsa.2015.4127 Abstract

Using mathematical modelling, the EFSA GMO Panel has previously quantified the risk to non-target (NT) Lepidoptera of conservation concern, potentially occurring within protected habitats, associated with the ingestion of Bt-maize pollen deposited on their host plants. To reduce the estimated larval mortality to a negligible level, an isolation distance of 20 and 30 m was recommended between protected habitats and the nearest fields of maize MON 810/Bt11 and 1507, respectively. Here, the EFSA GMO Panel refines its model predictions, accounting for newly reported information on maize pollen deposition over long distances. For its calculations, the EFSA GMO Panel considered three exposure scenarios at a range of isolation distances, at two protection levels and for a range of lepidopteran species, including hypothetical ones, with a wide spectrum of sensitivities to Bt toxins. An analysis of various sources of uncertainties affecting the exposure of NT Lepidoptera to Bt-maize pollen was conducted, in order to provide quantitative estimates of realistic exposure levels. The EFSA GMO Panel therefore provides risk managers with a tool to estimate and mitigate the risk for NT Lepidoptera of conservation concern. In contrast to its previous outcomes obtained for unrealistically large levels of exposure that would not be expected in practice, the EFSA GMO Panel reports here mortality estimates for a more realistic level of exposure. The EFSA GMO Panel concludes that its previous recommendation for a 20 m isolation distance around protected habitats, within which maize MON810/Bt11 should not be cultivated, remains valid. New calculations show that the previously recommended isolation distance of 30 m from the nearest maize 1507 field would still protect NT Lepidoptera with known levels of sensitivity, including the ‘highly-sensitive’ Plutella xylostella. Should hypothetical species with greater sensitivities exist, larger isolation distances would be needed to ensure the desired level of protection.

1 July 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(7):4147[13 pp.]. doi:10.2903/j.efsa.2015.4147 Abstract

Following an application from Han-Asiabiotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal®, which is the subject of the health claim, and the food, table salt, which Symbiosal® should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect for people who want to lower their blood pressure. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with methodological limitations showed a decrease in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study and that no evidence was provided for a mechanism by which the food could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal® instead of table salt and lowering of blood pressure.

1 July 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(7):4148[16 pp.]. doi:10.2903/j.efsa.2015.4148 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to carry out the additional assessment for UV-treated bread as a novel food (NF) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The NF is bread to which a treatment with UV radiation is applied after baking in order to convert ergosterol, which is present in bread as a result of yeast fermentation, to vitamin D2. The provided compositional data, the specifications (i.e. vitamin D2 content of 0.75–3 μg/100 g in the UV-treated bread, 1–5 g/100 g of yeast in the dough) and the data from batch testing do not give rise to safety concerns. The data provided on the production process are sufficient and do not give rise to safety concerns. The Panel considers that even if it is conservatively assumed that all consumed breads are UV-treated and contain the maximum proposed amount of 3 µg vitamin D2/100 g, it is highly unlikely that tolerable upper intake levels for vitamin D, established by EFSA for various age groups, will be exceeded. The NF is not nutritionally disadvantageous. Under certain conditions, UV treatment may result in reactions of biomolecules. However, the levels of potential reaction products that may be formed under the employed conditions are low compared with the reactions induced by the baking process. Therefore, the Panel considers that it is not necessary to perform additional analyses and that the absence of toxicological studies with the novel food is acceptable. The risk of allergic reactions to the NF is not dissimilar to that associated with conventional bread. The Panel considers that bread enriched with vitamin D2 through UV treatment is safe under the conditions of use as specified by the applicant.

1 July 2015 Mail Print Cite

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

EFSA Panel on Plant Protection Products and their Residues (PPR) Alf Aagaard, Theo Brock, Ettore Capri, Sabine Duquesne, Metka Filipic, Antonio F. Hernandez-Jerez, Karen I. Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Matthias Liess, Alberto Mantovani, Colin Ockleford, Bernadette Ossendorp, Robert Smith, Paulo Sousa, Ingvar Sundh, Aaldrik Tiktak and Ton van der Linden. EFSA Journal 2015;13(7):4175[54 pp.]. doi:10.2903/j.efsa.2015.4175 Abstract

The European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues to prepare a scientific opinion on the Food and Environment Research Agency guidance proposal ‘Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments’. The Panel concluded that the experimental and modelling approaches described in the proposed guidance are reasonable compromises between the required effort and what is desirable from a theoretical point of view. However, the Panel has concerns about the interpretation of the experiments and how the results of the experiments should be used in the leaching assessment. The Panel investigated options for improvement, but could not complete its evaluation on these two topics because underlying data to test these options were not made available to the Panel. For this reason, the Panel prepared a statement instead of a scientific opinion. Therefore, the Panel cannot recommend the use of the guidance for the time being.

13 July 2015 Mail Print Cite

Guidance of EFSA

European Food Safety Authority EFSA Journal 2015;13(7):4195[61 pp.]. doi:10.2903/j.efsa.2015.4195 Abstract

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin Member States have to monitor pesticide residue levels in food commodities and submit the monitoring results to EFSA and the European Commission. Since 2009 the Standard Sample Description (SSD) is the data model used for the reporting of data on analytical measurements of chemical substances occurring in food, feed and water. This document should provide Member States with specific guidance on how to use the SSD for the reporting of the national results of the pesticide residue monitoring in the framework of Article 32 of Regulation (EC) No 396/2005. In particular, this document describes the codes to be used for the SSD data elements which pertain to the data collection on pesticide residues monitoring of the calendar year 2014.

13 July 2015 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2015;13(7):4201[144 pp.]. doi:10.2903/j.efsa.2015.4201 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom, for the pesticide active substance thifensulfuron-methyl are reported.  The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of thifensulfuron-methyl as a herbicide on spring cereals (wheat, barley, oat, rye), winter cereals (wheat, barley, oat, rye, triticale), corn/maize and soybeans. 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.

23 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4194[116 pp.]. doi:10.2903/j.efsa.2015.4194 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 United Kingdom, for the pesticide active substance famoxadone, 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 famoxadone as a fungicide on grapes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. 

16 July 2015 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2015;13(7):4202[21 pp.]. doi:10.2903/j.efsa.2015.4202 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), France, received an application from Syngenta Agro S.A.S. to modify the existing maximum residue levels (MRLs) for the active substance fenoxycarb in peaches and olives. In order to accommodate for the intended uses of fenoxycarb, France proposed to raise the value of the existing MRL of 1 mg/kg (both peaches and olives) to 1.5 mg/kg in peaches and 3.0 mg/kg in table olives and olives for oil production. 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 MRL proposals of 1.5 mg/kg for the intended use on peaches and 3.0 mg/kg for the intended use on table olives and olives for oil production. Adequate analytical enforcement methods are available to control the residues of fenoxycarb in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of fenoxycarb on peaches, table olives and olives for oil production will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

22 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4203[49 pp.]. doi:10.2903/j.efsa.2015.4203 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 acrinathrin. In order to assess the occurrence of acrinathrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 as well as the European authorisations reported by Member States (incl uding the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Furthermore, only few authorisations reported by Member States were compliant with the current approval restrictions of acrinathrin. Hence, the consumer risk assessment is considered indicative only, all MRL proposal s derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

22 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4191[18 pp.]. doi:10.2903/j.efsa.2015.4191 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Belgium, compiled an application to modify the existing maximum residue level (MRL) for the active substance thiacloprid in Jerusalem artichokes. In order to accommodate for the intended use of thiacloprid Belgium proposed to raise the value of the existing MRL from the limit of quantification (LOQ) of 0.02 mg/kg to 0.05 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. EFSA concludes to derive a MRL proposal of 0.05 mg/kg on Jerusalem artichokes by extrapolation of data from carrots. Adequate analytical enforcement methods are available to monitor the residues of thiacloprid on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of thiacloprid on Jerusalem artichokes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

17 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4179[18 pp.]. doi:10.2903/j.efsa.2015.4179 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the United Kingdom, received an application from the UK Agriculture and Horticulture Development Board to modify the existing maximum residue level (MRL) for the active substance metalaxyl-M in gooseberries. In order to accommodate for the intended use of metalaxyl-M, the United Kingdom proposed to raise the existing MRL from the limit of quantification to 0.3 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 0.3 mg/kg for the proposed use on gooseberries. Adequate analytical enforcement methods are available to control the residues of metalaxyl-M in gooseberries. Based on the risk assessment results, EFSA concludes that the proposed use of metalaxyl-M on gooseberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a health risk to consumers.

16 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4189[27 pp.]. doi:10.2903/j.efsa.2015.4189 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 Syngenta Crop Protection AG to modify the existing maximum residue levels (MRLs) for abamectin in various crops. The EMS proposed to raise the existing MRLs in all crops, except scarole. 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. EFSA concludes on MRL proposals of 0.02 mg/kg on pome fruits, 0.04 mg/kg on cucurbits with edible peel and 0.05 mg/kg on Chinese cabbage and celery. For beans and peas with pods, an amendment of the MRL of 0.03 mg/kg proposed under the Article 12 review is not necessary. No MRL can be proposed for the intended uses on the groups of lettuces and other salad plants and spinaches and similar leaves. Enforcement methods are available, however none of them is sufficiently validated and the proposed MRLs should be associated with the submission of the data as requested under the Article 12 MRL review. EFSA concludes that the residues of abamectin resulting from the intended uses on pome fruits, cucurbits with edible peel, Chinese cabbage, beans and peas with pods and celery will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern. However, the risk assessment is indicative pending the submission of the confirmatory data requested under the Article 12 MRL review

16 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4196[24 pp.]. doi:10.2903/j.efsa.2015.4196 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 Agro S.A.S. to modify the existing maximum residue levels (MRLs) for the active substance tefluthrin in beetroots, celeriacs, radishes, swedes, turnips, garlic, onions, shallots, herbal infusions from roots, root and rhizome spices, sugar beet and chicory roots. In order to accommodate for the intended uses of tefluthrin, France proposed to raise the existing MRLs from 0.05 mg/kg to 0.1 mg/kg for radishes, 0.09 mg/kg for beetroots, swedes, turnips, herbal infusions from roots, root and rhizome spices, sugar beet and chicory roots, 0.15 mg/kg for celeriacs and onions and 0.4 mg/kg for garlic and shallots. 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 an MRL proposal of 0.08 mg/kg for beetroots, celeriacs, swedes and turnips, of 0.1 mg/kg on radishes, of 0.07 mg/kg on garlic, onions, sugar beet and chicory roots, of 0.3 mg/kg on shallots and of 0.7 mg/kg on herbal infusions from roots and root and rhizome spices in northern and southern Europe.

Adequate analytical enforcement methods are available to monitor the residues of tefluthrin on the commodities under consideration. Based on the risk assessment results, EFSA concludes thatthe proposed use of tefluthrin on beetroots, celeriacs, radishes, swedes, turnips, garlic, onions, shallots, herbal infusions from roots, root and rhizome spices, sugar beet and chicory roots will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

15 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4192[39 pp.]. doi:10.2903/j.efsa.2015.4192 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 carbetamide. In order to assess the occurrence of carbetamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

13 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4193[21 pp.]. doi:10.2903/j.efsa.2015.4193 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands, received an application from the Cranberry Marketing Committee USA to set an import tolerance for the active substance chlorothalonil in cranberries from import country USA at the proposed level of 10 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. Although no consumer risk was identified related to the MRL proposed by the applicant, EFSA concluded that the setting of an MRL for chlorothalonil in cranberries at a higher level than 5 mg/kg, the MRL from the origin country, is not appropriate. Adequate analytical enforcement methods are available to control the residues of chlorothalonil and its metabolite SDS-3701 in cranberries.

10 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4190[31 pp.]. doi:10.2903/j.efsa.2015.4190 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 triflusulfuron. In order to assess the occurrence of triflusulfuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

7 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4166[11 pp.]. doi:10.2903/j.efsa.2015.4166 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 cinidon-ethyl . Considering that this active substance is no longer authorised within the European Union, that MRLs are not established by the Codex Alimentarius Commission, and that uses authorised in third countries were not reported to EFSA, residues of cinidon-ethyl are not expected to occur in any plant or animal commodity. Nevertheless, available data allowed EFSA to propose a residue definition and limit of quantification (LOQ) for enforcement against potential illegal uses.

6 July 2015 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2015;13(7):4208[178 pp.]. doi:10.2903/j.efsa.2015.4208 Abstract

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to provide support for the preparation of the EU position for 47th session of the Codex Committee on Pesticide Residues (CCPR). In 2014 JMPR evaluated 15 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment (aminocyclopyrachlor, benzovindiflupyr, cyflumetofen, dichlobenil, emamectin benzoate, fenamidone, fluensulfone, flufenoxuron, imazamox, mesotrione, metrafenone, myclobutanil, pymetrozine and triforine) and 32 active substance regarding the setting of Maximum Residue Limits (MRLs) (aminocyclopyrachlor, benzovindiflupyr, buprofezin, chlorantraniliprole, chlothianidin, cyflumetofen, dichlobenil, dimethomorph, dithiocarbamates (mancozeb), emamectin benzoate, fenamidone, fenpropathrin, fluensulfone, flufenoxuron, fluopyram, glufosinate, imazamox, mesotrione, metrafenone, myclobutanil, phosmet, propamocarb, propiconazole, prothioconazole, pymetrozine, pyraclostrobin, sedaxane, spirodiclofen, sulfoxaflor, thiamethoxam, triadimenol and triforine). The relevant findings that should serve as the basis for deriving the EU position for the CCPR meeting are summarised in this report.

31 July 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(7):4162[48 pp.]. doi:10.2903/j.efsa.2015.4162 Abstract

Relevant hazards associated with pre-packed fresh fishery products were identified through a literature search. The main temperature-dependent hazards identified are histamine formation, Listeria monocytogenes, Clostridium botulinum, and Yersinia enterocolitica. To assess bacterial growth and histamine production during storage and transport at retail level and to evaluate different storage scenarios, published predictive microbiology growth models were used assuming favourable growth conditions. Compliance with the legislative temperature requirement can only be assessed by translating the requirement into an objective measure, which, in this instance, is assumed to be 0 °C. Any assessment of temperature and its effect on histamine production or bacterial growth can be meaningful only in the context of a time period. The modelling results showed that packaged fresh fishery products can be stored at refrigeration temperatures above 0 °C (e.g. 3–5 °C) and be compliant with the current EU and international rules. For histamine, the modelling results showed that, for a fishery product with certain characteristics subject to the current temperature requirement, histamine formation would be 100 ppm (lower limit m of the safety criterion in EU Regulation (EC) No 2073/2005) at the end of its shelf-life. Thus, an equivalent condition to the above baseline scenario is any combination of storage temperature, shelf-life and CO2 concentration in the package that leads to histamine formation of 100 ppm at the end of shelf-life. For example, for a retail temperature of 3 °C, 100 ppm would be reached under the following conditions: (1) shelf-life of 6 days and 0 % CO2 in the packaging headspace, (2) shelf-life of 7 days and 20 % CO2 in the packaging headspace or (3) shelf-life of 8 days and 40 % CO2 in the packaging headspace. Similar estimates are provided for the other hazards identified.

1 July 2015 Mail Print Cite