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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 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(5):4120[15 pp.]. doi:10.2903/j.efsa.2015.4120 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Terrachim (EU register number RECYC122), which is based on the VACUREMA Prime® technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers and containing no more than 5 % PET from non-food consumer applications. Through this technology, washed and dried PET flakes are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the challenge test provided, the Panel concluded that the decontamination in the batch reactors and in the continuous reactor are the critical steps that determine the decontamination efficiency of the process. The operating parameters which control the performance of these critical steps are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling process under evaluation 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 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.

Erratum/Corrigendum

28 May 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(5):4119 doi:10.2903/j.efsa.2015.4119 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the recycling process Evertis Iberica (EU register number RECYC0123), which is based on the EREMA Multi-Purpose Reactor (MPR) technology. The input to this process is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consumer PET containers and containing no more than 5 % PET from non-food consumer applications. In this technology, post-consumer washed and dried PET flakes are heated in a continuous reactor under vacuum. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency. The operating parameters which control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 µg/kg food, derived from an exposure scenario for toddlers. The Panel concluded that the recycled PET obtained from the process Evertis Iberica is not considered of safety concern when used for the manufacture of thermoformed trays and containers made with up to 100 % recycled post-consumer PET, and used for contact with all types of foodstuffs, except packaged water, for long-term storage at room temperature, with or without hotfill. Thermoforming trays are not intended to be used, and should not be used, in microwave and conventional ovens.

28 May 2015 Mail Print

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) 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(5):4117 doi:10.2903/j.efsa.2015.4117 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from FGE.19 subgroup 4.4, in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups: subgroup 4.4a containing [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded that for the substances in subgroup 4.4b there is no concern for genotoxicity. In FGE.220, Revision 2, the Panel evaluated genotoxicity studies on two representative substances of subgroup 4.4a: 2,5-dimethylfuran-3(2H)-one [FL-no:13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. Based on the submitted data the Panel concluded that 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] does not give rise to concern with respect to genotoxicity. For 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] the concern for genotoxicity could not be ruled out, therefore the Panel requested a repetition of the submitted micronucleus study in the presence of S9-mix, or a combined in vivo micronucleus and Comet assay, including analysis of the liver. The Flavour Industry has tested again 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in an in vitro micronucleus assay as was requested by the Panel. This new study is evaluated in FGE.220, Revision 3, where the Panel concluded that [FL-no: 13.175] does not give rise to concern with respect to genotoxicity and can be evaluated using the Procedure. This is also applicable to other two substances in subgroup 4.4a: 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl4-ethoxyfuran-3(2H)-one [FL-no:13.117]. Based on the available data the substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

28 May 2015 Mail Print

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(5):4116 doi:10.2903/j.efsa.2015.4116 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 22 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212. Based on available genotoxicity data and new genotoxicity data submitted by the Industry, the Panel concluded that genotoxic potential could be ruled out for the six carvone derivatives [FL-no: 02.062, 07.146, 07.147, 09.143, 09.215 and 09.870], the 11 isophorone derivatives [FL-no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the five substances [FL-no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 in FGE.212, FGE.212Rev1 and FGE.212Rev3, respectively. Two substances previously included in FGE.212Rev2, vetiverol and vetiveryl acetate [FL-no: 02.214 and 09.821], are no longer supported by Industry. Based on the available data, all 22 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

28 May 2015 Mail Print

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(5):4118 doi:10.2903/j.efsa.2015.4118 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 29 flavouring substances in the Flavouring Group Evaluation 18, as laid down in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have a genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. This revision deals with new toxicity data on the supporting substance myrcene [FL-no: 01.008], providing an appropriate NOAEL for the evaluation of candidate substance [FL-no: 02.146]. The Panel concluded that all 29 substances [FL-nos: 02.041, 02.052, 02.054, 02.120, 02.123, 02.129, 02.140, 02.146, 02.144, 02.147, 02.149, 02.150, 02.168, 02.171, 02.181, 02.184, 02.197, 02.203, 02.206, 02.219, 02.226, 02.230, 02.253, 09.171, 09.356, 09.614, 09.617, 09.671 and 09.808] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for all candidate substances except [FL-no: 02.146] more reliable intake data are required for a re-evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For four substances [FL-nos: 02.129, 02.147, 02.168, 02.197] additional information on purity criteria and/or stereoisomeric composition is required.

28 May 2015 Mail Print

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) 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(5):4115 doi:10.2903/j.efsa.2015.4115 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of 28 furan-substituted compounds evaluated by the JECFA. This revision of FGE.67 is due to new data on toxicity for 3-(-methyl-2-furyl) butanal [FL-no: 13.058] providing an appropriate NOAEL for the evaluation of candidate substance [FL-no: 13.058]. The Panel concluded that 11 substances [FL-nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for these eleven candidate substances, except [FL-no: 13.058], more reliable intake data are required for a re-evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered, which for all candidate substances are adequate.  For 17 substances [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] a concern for genotoxicity was raised and therefore these were not evaluated using the Procedure. The Panel noted further that for 7 of these 17 substances [FL-nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.069 and 13.083], use levels have not yet been submitted.

28 May 2015 Mail Print

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(5):4113[24 pp.]. doi:10.2903/j.efsa.2015.4113 Abstract

This opinion concerns the authorisation for a new use of formic acid, ammonium formate and sodium formate used as feed hygiene agents for all animal species. Studies performed with formic acid or its salts are considered equivalent when these agents are used on an equimolar basis. Conclusions of the previous opinion on formic acid and its safety for target species, consumers and the environment are reiterated. No adverse effects are anticipated when formic acid is used at the maximum proposed dose (pigs 12 000 mg/kg, all other animal species 10 000 mg/kg formic acid equivalents/kg complete feed). For ammonium formate, the inevitable presence of formamide is considered insufficient to guarantee the protection of reproduction animals from developmental toxicity. Evidence of carcinogenic potential argues for avoiding its use in reproducing animals and non-food-producing animals. The use of formic acid and sodium formate in animal nutrition is safe for consumers. Use of ammonium formate in dairy animals and laying poultry gives rise to concerns because of the potential exposure of consumers to formamide. Formic acid and its salts are corrosive and skin sensitisers. Sodium formate is mildly irritating to the eyes. Ammonium formate is considered an irritant for skin and eyes. The exposure via inhalation is considered to present a risk to unprotected workers handling the additive. The use of formic acid and its salts in animal nutrition is safe for the environment. Formic acid, at recommended concentrations, is effective at inhibiting or reducing the numbers of bacterial pathogens in feed, fulfilling the classical requirements of a preservative additive. Limited data are available to demonstrate the effects of formate salts in feed. Decreasing the number of viable microbial cells in contaminated feed does not eliminate the potential hazards associated with bacterial toxins and endotoxins that may be present in feed.

27 May 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(5):4101 doi:10.2903/j.efsa.2015.4101 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies derived Dietary Reference Values for calcium. These include Average Requirement (AR), Population Reference Intake (PRI) and Adequate Intake (AI). For adults, data were analysed from a number of balance studies undertaken in North America and the mean value at which calcium intake equals excretion was calculated as 715 mg/day in adults ≥ 25 years. An allowance for dermal calcium losses (not included in the balance data) of 40 mg/day was added to derive an AR of 750 mg/day. The upper bound of the 95 % prediction interval at the estimated population mean at null balance (which represents the 97.5th percentile of the distribution of the individual predictions for each calcium intake level) was 904 mg/day, and when dermal losses are added this gives a PRI of 950 mg/day for adults ≥ 25 years. For infants (7–11 months), an AI was derived by extrapolating the average amount of calcium absorbed by exclusively breast-fed infants (120 mg/day) using isometric scaling and assuming an absorption of 60 %, and was calculated as 280 mg/day. The AR for children was derived using the factorial approach. The total quantity of calcium required for bone accretion and replacement of endogenous losses was adjusted for percentage absorption to derive PRIs for children aged 1–3, 4–10 and 11–17 years of 450, 800 and 1 150 mg/day, respectively. The PRI for young adults (18–24 years), who still accumulate calcium in bones, is 1 000 mg/day. This is the intermediate value between children aged 11–17 years and adults. Taking into consideration adaptive changes in calcium metabolism that occur during pregnancy and lactation, the PRI for non-pregnant women also applies to pregnant and lactating women of the same age group.

27 May 2015 Mail Print

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(5):4102 doi:10.2903/j.efsa.2015.4102 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on the safety of caffeine, providing advice on caffeine intakes, from all dietary sources that do not give rise to concerns about adverse health effects for the general healthy population and subgroups thereof. Possible interactions between caffeine and other constituents of so-called “energy drinks”, alcohol, p-synephrine and physical exercise should also be addressed. Single doses of caffeine up to 200 mg (about 3 mg/kg bw for a 70-kg adult) do not give rise to safety concerns. The same amount does not give rise to safety concerns when consumed < 2 hours prior to intense physical exercise under normal environmental conditions. Other constituents of “energy drinks” at typical concentrations in such beverages (about 300–320, 4 000 and 2 400 mg/L of caffeine, taurine and d-glucurono-γ-lactone, respectively), as well as alcohol at doses up to about 0.65 g/kg bw, would not affect the safety of single doses of caffeine up to 200 mg. Habitual caffeine consumption up to 400 mg per day does not give rise to safety concerns for non-pregnant adults. Habitual caffeine consumption up to 200 mg per day by pregnant women does not give rise to safety concerns for the fetus. Single doses of caffeine and habitual caffeine intakes up to 200 mg consumed by lactating women do not give rise to safety concerns for breastfed infants. For children and adolescents, the information available is insufficient to derive a safe caffeine intake. The Panel considers that caffeine intakes of no concern derived for acute caffeine consumption by adults (3 mg/kg bw per day) may serve as a basis to derive single doses of caffeine and daily caffeine intakes of no concern for these population subgroups.

27 May 2015 Mail Print

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2015;13 (5):4112[2 pp.]. doi:10.2903/j.efsa.2015.4112 Abstract

The product under consideration is vitamin B12 (cyanocobalamin) produced by Ensifer adhaerens. There are uncertainties regarding the genetic basis of the antibiotic resistance found in the production strain and regarding the possible presence of its DNA in the product. However, the product under assessment is extensively purified ensuring that the active substance represents more than 99 % on a dry matter basis and that the remainder is almost exclusively attributable to substance-related impurities. Taking into account the extensive purification process, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers it unlikely that any remnants of DNA from the production strain would remain in the final product to an extent that would give rise to any safety concerns. The use of vitamin B12 produced by E. adhaerens as a nutritional additive is safe for the target animals. Its use in animal nutrition does not give rise to safety concerns for consumers. In the absence of data, the FEEDAP Panel considers it prudent to assume that vitamin B12 is an irritant to skin and eyes, is a skin sensitiser and is hazardous by inhalation. The use of vitamin B12 produced by E. adhaerens in animal nutrition does not pose a risk to the environment. Vitamin B12 produced by E. adhaerens is regarded as effective in meeting animals’ requirements when administered orally.

22 May 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(5):4111[7 pp.]. doi:10.2903/j.efsa.2015.4111 Abstract

Fecinor® and Fecinor® plus are preparations of a single strain of Enterococcus faecium. In a previous opinion on Fecinor® and Fecinor® plus, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the efficacy of these additives when used in feed for weaned piglets owing to insufficient evidence. The European Commission requested that the European Food Safety Authority re-evaluate the efficacy of Fecinor® and Fecinor® plus when used as zootechnical additives (functional group: gut flora stabilisers) in diets for weaned piglets at a minimum dose of 1 × 109 colony-forming units (CFU)/kg complete feedingstuffs. In the present application, the results from a new efficacy study performed with weaned piglets showed significant increases in final body weight and average daily gain in Fecinor®-treated animals. Taking into account the two positive trials from the initial application, the FEEDAP Panel concludes that Fecinor® has the potential to improve performance of weaned piglets when added to feed at 1 × 109 CFU/kg complete feedingstuffs. The Panel considers that this conclusion applies to both formulations when used to deliver the same dose of the active agent.

21 May 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(5):4110[18 pp.]. doi:10.2903/j.efsa.2015.4110 Abstract

The product L-valine is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli (NITE BP-01755). Neither the production strain E. coli NITE BP-01755 nor its recombinant DNA was detected in the final product. The product does not give rise to any safety concern associated with the genetic modification of the production strain. L-Valine, feed grade, is safe for all target species when used to meet the animals’ nutritional requirements. As the composition of tissues and products of animal origin will not be changed by the use of the product in animal nutrition, and considering its high purity, no risks are expected for the consumer from the use of the product as a feed additive. L-Valine produced by E. coli NITE BP-01755 is not considered irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, acute toxicity by this route is not expected. Since the estimated total exposure to endotoxins by inhalation is below the provisional occupational exposure limits, no risk from the exposure to endotoxins for people handling the additive is expected. The amino acid L-valine is a natural component of the proteins of living organisms. Therefore, the use of the product does not pose a risk to the environment. The product is considered an efficacious source of the amino acid L-valine for all animal species. For the supplemental L-valine to be as efficacious in ruminant as in non-ruminant species, it requires protection against degradation in the rumen.

21 May 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(5):4114[2 pp.]. doi:10.2903/j.efsa.2015.4114 Abstract

The additive complexation products of sodium tartrates with iron(III) chloride (Fe-TA), which is a an equilibrium mixture of sodium tartrates with iron(III) chloride, is intended to be used as an anticaking agent in salt (sodium chloride) for all animal species and categories. The proposed inclusion levels vary between 3 and 12 mg iron/kg salt, equivalent to 26 to 106 mg Fe-TA/kg salt (on a dry matter basis). Fe-TA is intended to be dripped onto salt in the form of a 1:8 water solution. The use of Fe-TA at the maximum recommended supplementation rate for common salt (106 mg Fe-TA dry matter/kg) is considered safe for all animal species and categories. There is no indication that the use of Fe-TA in animal nutrition would result in a measurable exposure of the consumer to Fe-TA or its constituents tartrate, iron and oxalate. Therefore, no concerns for the safety for the consumer would arise from the use of Fe-TA, provided that the conditions of use recommended by the applicant are respected. Users are unlikely to be exposed to the additive by inhalation. Fe-TA is not irritant to skin and eyes, is not a skin sensitiser and is of low acute dermal toxicity. No risk to the environment is expected from the use of Fe-TA in animal nutrition. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive has the potential to be efficacious as an anticaking agent when used in salt at the minimum proposed concentration of 3 mg iron/kg salt (equivalent to 26 mg Fe-TA/kg salt, on a dry matter basis).

21 May 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 (5):4109[31 pp.]. doi:10.2903/j.efsa.2015.4109 Abstract

Iron from iron-containing additives is safe in feed up to a maximum content of 250 mg/day for piglets up to one week before weaning, 450 mg/kg for bovines and poultry, 500 mg/kg for ovines, 600 mg/kg for pets and 750 mg/kg for other species/categories, except horses and fish. It was not possible to derive a maximum safe iron concentration in feed for horses or fish; as a provisional measure, the current value (750 mg/kg) could be maintained. Iron from ferrous carbonate is unlikely to modify iron concentration in edible tissues/products of animal origin; therefore, no concern for consumer safety was identified resulting from the use of ferrous carbonate in animal nutrition, provided the maximum iron content in complete feedingstuffs is respected. Owing to the presence of nickel, the additive should be regarded as a dermal and respiratory sensitiser. Ferrous carbonate should be considered as irritant to skin and eyes and to the respiratory tract. The handling of this additive is considered to be a risk by inhalation. Ferrous carbonate is generally less bioavailable than ferrous sulphate; whilst for adult animals ferrous carbonate might be efficacious, it would be insufficiently bioavailable for young animals—which require a highly efficacious iron source for a rapid response in haemoglobin synthesis. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) recommends that the currently authorised maximum iron content in feed be reduced for bovines and poultry from 750 to 450 mg Fe/kg, and for pets from 1250 to 600 mg Fe/kg. The Panel proposes the name of Iron(II) carbonate (siderite) to reflect the mineral nature and variability in composition and bioavailability of the ferrous carbonates from ores.

21 May 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(5):4108[15 pp.]. doi:10.2903/j.efsa.2015.4108 Abstract

Indigo carmine (E 132), an authorised food colourant, is intended to be used as a feed additive for dogs, cats and ornamental fish without a maximum content. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concludes that indigo carmine (purity of at least 93 % colouring matter) is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1 000 mg/kg complete feed. Users may be at risk of inhalation exposure to dust from indigo carmine. In the absence of information on the inhalation toxicity, such exposure is regarded as hazardous. Indigo carmine is not an irritant to skin and eyes. Indigo carmine should be considered as a potential skin and respiratory sensitiser in humans. Indigo carmine is effective in adding colour to feedingstuffs for dogs, cats and ornamental fish.

19 May 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(5):4107[11 pp.]. doi:10.2903/j.efsa.2015.4107 Abstract

The additive AGal-Pro BL/BL-L is a preparation of alpha-galactosidase produced by a genetically modified strain of Saccharomyces cerevisiae and of endo-1,4-beta-glucanase produced by a non-genetically modified strain of Aspergillus niger. The additive is intended for use in laying hens and minor poultry species for laying (e.g. ducks, goose, quail, turkey, etc.). This product is currently authorised for use in chickens for fattening as a zootechnical additive, functional group of digestibility enhancers. Aspects other than the safety and the efficacy for laying hens and minor poultry species for laying have been addressed in previous opinions and therefore the present assessment addresses these aspects for the new target species only. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that AGal-Pro BL/BL-L is safe and efficacious for laying hens at the maximum recommended dose of 100 units of alpha-galactosidase/kg feed and 570 units endo-1,4-beta-glucanase/kg feed equivalent in 100 mg/kg feed. These conclusions are extrapolated to minor poultry species for laying at the maximum recommended dose. The data submitted do not allow any conclusions to be drawn on efficacy at the minimum proposed dose of 50 mg/kg feed.

19 May 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(5):4106[9 pp.]. doi:10.2903/j.efsa.2015.4106 Abstract

Rovabio® Spiky is an enzyme preparation, available in solid and liquid forms, of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Penicillium funiculosum, one of which is genetically modified. The additive is intended to be used as a feed additive for turkeys for fattening and minor poultry species for fattening or reared for laying or breeding. Aspects other than the safety and efficacy for turkeys have been addressed in the previous opinion on the safety and efficacy for chickens for fattening, chickens reared for laying and other minor poultry species. The current assessment addresses these aspects for the new target species only. Based on the results of a tolerance trial in turkeys for fattening, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for turkeys for fattening under the recommended conditions of use. Based on the results obtained in three efficacy studies, the FEEDAP Panel concludes that the additive has the potential to be efficacious in turkeys for fattening at the minimum recommended dose (1 100 U/kg xylanase and 760 U/kg glucanase). Both conclusions are extended to turkeys reared for breeding. The FEEDAP Panel confirms the previous conclusions that the additive is safe and efficacious in minor poultry species for fattening, reared for laying and reared for breeding at the same conditions of use.

19 May 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. In line with EFSA’s policy on declarations of interest, Panel member Anders Sjödin did not participate in the development and adoption of this scientific output. EFSA Journal 2015;13(5):4095[12 pp.]. doi:10.2903/j.efsa.2015.4095 Abstract

Following an application from Synbiotec S.r.l., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation. The Panel considers that the food, SYNBIO®, which is the subject of the health claim, is sufficiently characterised. Maintenance of normal defecation is a beneficial physiological effect. The applicant identified three human intervention studies which investigated the effect of SYNBIO® on outcome measures (i.e. frequency of defecations, faecal bulk and stool consistency) related to the claimed effect. The Panel notes that no evidence was provided that the tools used to assess changes in bowel habits in response to an intervention were valid. Therefore, no conclusions could be drawn from these studies for the scientific substantiation of a claim on SYNBIO® and maintenance of normal defecation. In the absence of evidence for an effect of SYNBIO® on the maintenance of normal defecation in humans, studies which investigated the presence of L. rhamnosus IMC 501® and L. paracasei IMC 502® in the faeces of participants who consumed foods enriched with these strains were not considered by the Panel. The Panel concludes that a cause and effect relationship has not been established between the consumption of SYNBIO® and maintenance of normal defecation.

13 May 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(5):4098[12 pp.]. doi:10.2903/j.efsa.2015.4098 Abstract

Following an application from WILD-Valencia SAU, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, 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 FRUIT UP® and a reduction of post-prandial blood glucose responses. The Panel considers that the food, FRUIT UP®, and the food (i.e. glucose, sucrose) that FRUIT UP® should replace in foods or beverages are both sufficiently characterised in relation to the claimed effect. A reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) is a beneficial physiological effect. In weighing the evidence, the Panel took into account that in the human intervention studies, from which conclusions could be drawn, FRUIT UP® decreased post-prandial blood glucose responses compared with glucose but not compared with sucrose, and that this effect may be explained by the partial replacement of glucose by fructose. The Panel concludes that a cause and effect relationship has not been established between the consumption of FRUIT UP® and a reduction of post-prandial glycaemic responses over and above the well-established effect of fructose on reducing post-prandial glycaemic responses when replacing glucose in foods.

13 May 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(5):4094[9 pp.]. doi:10.2903/j.efsa.2015.4094 Abstract

Following an application from Lallemand Health Solutions, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract. The food constituent that is the subject of the claim is B. bifidum CNCM I-3426. The Panel considers that B. bifidum CNCM I-3426 is sufficiently characterised. The Panel considers that defence against pathogens in the upper respiratory tract is a beneficial physiological effect. The applicant provided one published human intervention study, one unpublished human intervention study (which was published during the evaluation of the claim) and one in vitro study as pertinent to the claimed effect. The Panel considers that no conclusions can be drawn from either of the human studies for the scientific substantiation of the claim. In the absence of evidence of an effect of B. bifidum CNCM I3426 on defence against pathogens in the upper respiratory tract in humans, the results of the in vitro study submitted cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract.

13 May 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(5):4099[12 pp.]. doi:10.2903/j.efsa.2015.4099 Abstract

Following an application from Tchibo GmbH, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the 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 coffee C21 and reduction of DNA damage by decreasing spontaneous DNA strand breaks. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. Coffee C21, a coffee standardised by its content of caffeoylquinic acids, trigonelline and N-methylpyridinium (NMP), which is the subject of the health claim, is sufficiently characterised. Reduction of DNA damage by decreasing spontaneous DNA strand breaks is a beneficial physiological effect. In weighing the evidence, the Panel took into account that one human intervention study showed that daily consumption of coffee C21 (750 ml/day) for four weeks decreased spontaneous DNA strand breaks in habitual coffee drinkers after coffee withdrawal over the previous four weeks, but that no other human studies in which these results have been replicated were provided, and that no evidence was provided for a mechanism by which coffee (including coffee C21) could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of coffee C21, a coffee standardised by its content of caffeoylquinic acids, trigonelline and NMP, and a reduction of DNA damage by decreasing spontaneous DNA strand breaks.

13 May 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(5):4096[7 pp.]. doi:10.2903/j.efsa.2015.4096 Abstract

Following an application from VAB-nutrition, 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 contribution to the normal function of the immune system. The Panel considers that vitamin D is sufficiently characterised. Contribution to the normal function of the immune system is a beneficial physiological effect for children. The Panel had previously assessed a claim on vitamin D and contribution to the normal function of the immune system with a favourable outcome. The target population was the general population. The Panel considered that vitamin D plays a regulatory role in the functioning of the immune system. The Panel considers that the role of vitamin D in the functioning of the immune system applies to all ages, including children. 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 children from 3 to 18 years of age.

Erratum/Corrigendum

13 May 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(5):4097[16 pp.]. doi:10.2903/j.efsa.2015.4097 Abstract

Following an application from Nerthus ApS, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, 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 a combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase in the number of motile spermatozoa in semen. The Panel considers that the food is sufficiently characterised. An increase in the number of motile spermatozoa in semen is a beneficial physiological effect. In weighing the evidence, the Panel took into account that one human study showed an increase in the number of motile spermatozoa in semen when the combination of pomegranate pomace extract and greater galangal rhizome powder was consumed for three months, that no other human studies in which these results have been replicated were provided, 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 the combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase in the number of motile spermatozoa in semen.

13 May 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 Younes Maged. EFSA Journal 2015;13(5):4085[42 pp.]. doi:10.2903/j.efsa.2015.4085 Abstract

Chlorophyllins (E 140(i)) are obtained by saponification of a solvent extract from sources, such as grass, lucerne, and nettle, that could not be regarded as edible plant material or food for humans. Chlorophyllins represent 90 % of the colouring matter in the food additive E 140(ii); the remaining part consists of other pigments, such as carotenoids, together with oils, fats and waxes derived from the source material. The Panel noted that the material used in many studies, identified as “chlorophyllins”, was quite often, if not always, a copper complex of chlorophyllins (E 141(ii)). There are no data regarding the absorption, distribution, metabolism and excretion (ADME) and toxicity of chlorophyllins (E 140(ii)). Considering the available data on chlorophylls (E 140(i)), the Panel concluded that chlorophyllins are not metabolites of chlorophylls in humans and owing to their differences in physico-chemical properties, it was not possible to support read-across for toxicity data between these two compounds. The Panel considered that it is necessary to carefully review the definition and identity of E 140(ii) in order to adequately characterise the food additive E 140(ii)) as used in the market. This will also allow proper assessment of its safety when relevant studies of the compound to which consumers are actually exposed become available. Considering the absence of relevant ADME and toxicity data, and because chlorophyllins (E 140(ii)) are neither natural constituents of the regular diet nor metabolites of chlorophylls in humans, the Panel concluded that it was not possible to assess the safety of chlorophyllins (E 140(ii)) as food additives.

7 May 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 Younes Maged. EFSA Journal 2015;13(5):4089[51 pp.]. doi:10.2903/j.efsa.2015.4089 Abstract

Chlorophylls (E 140(i)) were previously evaluated by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1969 and the Scientific Committee on Food (SCF) in 1975 and 1983 and, in relation to special medical purposes, for young children in 1996. Neither of the Committees established a numerical Acceptable Daily Intake (ADI). Specifications should be updated to adequately cover chlorophylls (E 140(i)), as currently up to 90 % of the extract is unidentified and chlorophylls (E 140(i)) may be obtained from sources that could not be regarded as regular edible plant materials or foods (grass, lucerne, nettle) for humans. Based on the origin of chlorophylls (E 140(i)), the Panel also concluded that data on pesticides, mycotoxins and other components with biological activity (e.g. phytoestrogens, phytotoxins and allergens) should be included in the specification and kept as low as possible to avoid any potential adverse effects (allergenicity, endocrinal effects). The few biological data available indicate that chlorophylls are poorly absorbed by humans and are not metabolised to chlorophyllins (the dephytylated form of chlorophylls). The Panel considered that the few toxicological studies available for chlorophylls were limited and did not comply with the Organisation of Economic Co-operation and Development (OECD) guidelines or current regulatory requirements, and therefore did not allow for an ADI to be established. The Panel concluded that the available database for chlorophylls was inadequate for risk assessment. However, chlorophylls are natural dietary constituents, which are present at relatively high concentrations in a number of foods. In addition, the exposure resulting from the use of chlorophylls (E 140(i)) as food additives is lower than the exposure to chlorophylls from the regular diet. Therefore, the Panel concluded that, at the reported use levels, chlorophylls (E 140(i)) are not of safety concern as regards their current use as food additives.

7 May 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(5):4090 [22 pp.]. doi:10.2903/j.efsa.2015.4090 Abstract

Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat-based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re-evaluation of the safety of extracts of rosemary (E 392) as a food additive performed by EFSA in 2008. In that previous opinion, it was noted that, whilst the data were insufficient to establish a numerical ADI, the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels was not of safety concern. In providing a scientific opinion on the safety of the proposed extensions of use, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of extracts of rosemary. The Panel concluded that, since the two additional uses for rosemary extracts in fat-based spreads would not change the estimated exposure to the food additive compared with the already approved permitted uses in any part of the population, the conclusions made by the AFC Panel in 2008 regarding safety remain valid. Therefore, the Panel considered that it is unlikely that there is a safety concern with the current permitted uses together with the additional proposed extension of uses compared with the current permitted uses alone. The Panel recommends that a refined exposure assessment is carried out to decrease the existing uncertainties arising from its conservative estimates based on current MPLs.

7 May 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(5):4087[124 pp.]. doi:10.2903/j.efsa.2015.4087 Abstract

The EFSA Panel on Food additives and Nutrient Sources added to Food (ANS Panel) provides a scientific opinion re-evaluating the safety of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives. The use of ascorbic acid and its salts as food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Ascorbic acid is absorbed from the intestine by a sodium-dependent active transport process and, at low doses, the absorption is almost complete until a saturation point, after which increasing amounts of unabsorbed substance are excreted. Ascorbic acid and its salts have very low acute toxicities, and short-term tests in animals showed little effect, and even so only at high doses. The Panel concluded that there is no genotoxicity concern for ascorbic acid, sodium ascorbate or calcium ascorbate. Long-term carcinogenicity tests with ascorbic acid did not show any chronic toxicity, even at high doses, and also showed no signs of carcinogenicity. Prenatal developmental studies did not show adverse developmental effects. The Panel estimated the combined exposure to ascorbic acid (E 300), calcium ascorbate (E 301) and sodium ascorbate (E 302). The Panel concluded that, given the fact that adequate data on exposure and toxicity were available and no adverse effects were reported in animal studies, there is no safety concern for the use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives at the reported uses and use levels and there is no need for a numerical ADI for ascorbic acid and its salts.

Erratum/Corrigendum

6 May 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(5):4083[29 pp.]. doi:10.2903/j.efsa.2015.4083 Abstract

Maize 5307 was developed by Agrobacterium tumefaciens-mediated transformation to express two proteins: eCry3.1Ab, conferring resistance to certain coleopteran pests, and phosphomannose isomerase (PMI), used as selection marker. The molecular characterisation showed relevant similarities between the amino acid sequence of PMI and a known allergen, and between the amino acid sequence of eCry3.1Ab and a potential toxin. Some agronomic and phenotypic differences between maize 5307 and its conventional counterpart were observed (higher ‘heat units to 50 % pollen shed’, grain moisture, plant height, grain yield); however, the EFSA GMO Panel considered that these do not give rise to food/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 PMI protein. The EFSA GMO Panel could not conclude on the safety of the eCry3.1Ab protein due to the inadequate 28-day toxicity study provided. The outcome of a broiler feeding study with maize 5307 was not assessed by the EFSA GMO Panel, due to study weaknesses. There are no indications of an increased likelihood of the establishment and spread of feral maize plants. Interactions with the biotic and abiotic environment were not considered to be a relevant issue. Risks associated with the unlikely but theoretically possible horizontal gene transfer of recombinant genes from maize 5307 to bacteria were not identified. The post-market environmental monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, in the absence of an appropriate assessment of eCry3.1Ab, the EFSA GMO Panel is not in a position to complete its food/feed risk assessment of maize 5307. However, the EFSA GMO Panel concludes that the maize 5307 is unlikely to have any adverse effect on the environment in the context of its scope.

5 May 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(5):4056[24 pp.]. doi:10.2903/j.efsa.2015.4056 Abstract

This opinion concerns the re-authorisation of ammonium, calcium and sodium formates as preservatives in feed for all animals and the use of ammonium and sodium formates as silage additives. Conclusions of the previous opinion on formic acid establishing safety for target species, consumer and environment are reiterated and extended to cover the calcium and sodium salts. No adverse effects are anticipated when these salts are used at the maximum proposed dose (pigs 12 000 mg; all other animal species 10 000 mg formic acid equivalents/kg feed or an equivalent dose in water for drinking). For ammonium formate, the presence of formamide is considered insufficient to guarantee the protection of reproduction animals. Evidence of its carcinogenic potential argues to avoid using ammonium formate in non-food-producing animals. The use of formic acid and sodium formate in animal nutrition is safe for the consumer. Use of ammonium formate in dairy animals and laying poultry raises concerns due to the potential exposure of consumers to formamide. Calcium and sodium formates are non-irritant to skin, but mildly irritant to eyes and respiratory irritants with a potential for sensitization. Liquid preparations of sodium formate/formic acid and ammonium formate/formic acid can act as preservatives in feed, with a potential to control growth of fungi and aerobic bacteria. However, the Panel has reservations about the effectiveness of organic acids as preservatives in feedingstuffs with a typical moisture content of ≤ 12 %. Pure calcium or sodium formate had no discernible effects on microbial numbers in the feed materials examined. A preservative effect of the three formate salts in water for drinking was not demonstrated.  Sodium formate has a potential to improve the preservation of nutrients in silage prepared from easy, moderately difficult and difficult to ensile material. Efficacy of ammonium formate as silage additive was not demonstrated.

5 May 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(5):3794[17 pp.]. doi:10.2903/j.efsa.2015.3794 Abstract

AviMatrix® is a granulated preparation of benzoic acid, calcium formate and fumaric acid encapsulated in a lipid matrix. The additive is intended to be used as a zootechnical additive in feedingstuffs for chickens for fattening, chickens reared for laying, minor avian species for fattening and minor avian species reared to point of lay with a minimum content of 250 mg/kg complete feed and no maximum content. Tolerance studies in chickens for fattening tested the effects of high ingestions of the additive on the birds’ health and performance. The available tolerance data are considered insufficient to draw conclusions on the safety of AviMatrix® at the proposed use level for the target species. Consumer exposure to the active substances (benzoic acid, calcium formate and fumaric acid) or other ingredients of the additive is not expected to be increased by the use of AviMatrix® as a feed additive under the conditions of use proposed by the applicant. Given the particle size distribution and low dusting potential of AviMatrix®, the exposure of workers by inhalation and the subsequent health risks are expected to be low. AviMatrix® is not considered to be a skin/eye irritant or a skin sensitiser. The use of AviMatrix® in animal nutrition will not pose a risk to the environment. Given the limited and inconsistent evidence of efficacy that has been provided, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is not in a position to draw a definitive conclusion on the efficacy of the additive.

5 May 2015 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Panel members: 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, Maged Younes. EFSA Journal 2015;13(5):4086[39 pp.]. doi:10.2903/j.efsa.2015.4086 Abstract

The EFSA ANS Panel was asked to deliver a scientific opinion re-evaluating dodecyl gallate (E 312) as a food additive. The Panel considered that whilst from theoretical considerations dodecyl gallate could be metabolised to dodecyl alcohol and gallic acid, there were insufficient data to demonstrate the rate and extent of dodecyl gallate metabolism in vivo. Having reviewed the data on the toxicokinetics (rate and extent of metabolism) of propyl, octyl and dodecyl gallate in a previous EFSA evaluation of propyl gallate, the Panel concluded that the available metabolism data on gallates were insufficient to provide a basis for the read-across of systemic toxicity data on propyl, octyl and dodecyl gallate to be valid. The Panel noted the absence of concern for genotoxicity and the lack of increase of tumours in the long-term study. However, owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with dodecyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of dodecyl gallate. The Panel noted that there was no indication for overt toxicity in the available studies; however, owing to the limitations of these studies, the Panel was unable to identify any NOAEL. Overall, the available database was too limited to either establish an ADI or serve as a basis for a margin of safety approach to be applied with confidence. The Panel concluded that although there was unlikely to be a safety concern from the single use for which usage and analytical data were provided, an adequate assessment of the safety of dodecyl gallate as a food additive would require a sufficient toxicological database in line with its current guidance for submission for food additives evaluations.

5 May 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(5):4088[21 pp.]. doi:10.2903/j.efsa.2015.4088 Abstract

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of an amendment to specifications for the food additive hydroxypropyl methyl cellulose (HPMC, E 464). It is requested that the limit of the sum of the two isomers (1-chloro-2-propanol and 2-chloro-1-propanol) of propylene chlorohydrin (PCH) in HPMC be raised from 0.1 mg/kg to 1.0 mg/kg, in order to align it with the limit defined by the Joint FAO/WHO Expert Committee on Food Additives in 2011. The ANS Panel received a dossier from the applicant and subsequently requested additional data. The ANS Panel noted that not all information was made available and that exposure to PCH is likely to be underestimated, since data were provided only for a limited number of authorised uses and that other sources of PCH were not included. The Panel also noted that the available data, for both PCH isomers, were indicative of a genotoxic hazard and that the results available from preliminary studies were deemed insufficient to make any conclusion regarding developmental toxicity. In addition, because no carcinogenic effects were observed in relevant chronic/carcinogenicity studies at the same time, it was impossible to derive a lower benchmark dose level. A margin of exposure approach to impurities, as suggested by EFSA guidance in 2012, was also not possible. Moreover, when considering a threshold of toxicological concern approach to genotoxic effects, the Panel was unable to make any conclusion regarding the absence of risk. Finally, analytical data provided for a total of 12 different batches of HPMC showed that PCH levels were in compliance with current specifications. The Panel concluded that the data available are insufficient to support a change in specification from 0.1 to 1 mg PCH/kg HPMC.

5 May 2015 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2015;13(5):4100[72 pp.]. doi:10.2903/j.efsa.2015.4100 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance mandestrobin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of mandestrobin as a fungicide on oilseed rape. 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.

5 May 2015 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2015;13(5):4105[20 pp.]. doi:10.2903/j.efsa.2015.4105 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), United Kingdom, received an application from Bayer CropScience S.A.S. to modify the existing maximum residue level (MRL) for the active substance prothioconazole in shallots. In order to accommodate for the intended use of prothioconazole, United Kingdom proposed to set the MRL at the limit of quantification (LOQ) of 0.05 mg/kg. According to EFSA the data are sufficient to derive a MRL proposal of 0.05 mg/kg (LOQ) for the intended use on shallots in northern Europe. Adequate analytical enforcement methods are available to control the residues of prothioconazole-desthio in the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of prothioconazole on shallots will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, the consumer risk assessment should be regarded as provisional since the possible contribution of the triazole derivative metabolites (TDMs) in the consumer risk assessment was not taken into consideration.

13 May 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(5):4103[26 pp.]. doi:10.2903/j.efsa.2015.4103 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, both France, hereafter referred to as the evaluating Member State (EMS-FR), and the Netherlands, hereafter referred to as the evaluating Member State (EMS-NL) received an application from ISK Biosciences Europe N.V. to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in peas without pods, cotton seeds and rye (EMS-FR) and peppers, Brussels sprouts, barley and oat (EMS-NL). France and the Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 0.3 mg/kg for peppers (indoor uses), 0.6 mg/kg for Brussels sprouts, 0.7 mg/kg for peas without pods, 0.2 mg/kg for cotton seeds, 0.4 mg/kg for barley and oat. The extrapolation to rye of the current MRL of 2 mg/kg set on wheat in the EU legislation and recommended during the Article 12 review of the existing MRLs is confirmed. Sufficient data were not provided to support the outdoor use of flonicamid on peppers. Adequate analytical methods are available to control the residues of flonicamid and its metabolites TFNG and TFNA in the crops under consideration. Based on the risk assessment results, EFSA concludes thatthe proposed uses of flonicamid on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

5 May 2015 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2015;13(5):4124[14 pp.]. doi:10.2903/j.efsa.2015.4124 Abstract

Different organisations have undertaken risk assessments of dioxins resulting in the issuance of a range of health-based guidance values. This report examines the approaches taken by the Scientific Committee on Food (SCF), the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the United States Environmental Protection Agency (US EPA) and how these differing approaches impact on the final derivation of a numerical value. SCF and JECFA concluded that the critical studies for derivation of a health-based guidance value (HBGV) were animal studies, whereas the US EPA selected the human data, as their preference is to use human data where available. SCF and JECFA applied a body burden one-compartment kinetics approach to derive a HBGV from rat data, whereas US EPA applied physiologically based pharmacokinetic modelling of blood levels estimated from epidemiology studies. An uncertainty factor of 3 was applied by SCF and JECFA as the lowest-observed-adverse-effect level (LOAEL) was close to the no-observed-adverse-effect level (NOAEL) (observed in another animal study), as opposed to the US EPA applying their default uncertainty factor of 10 for extrapolation from a LOAEL in the absence of a NOAEL. This resulted in the reference dose set by US EPA being 3-fold lower than the tolerable weekly intake (TWI)/provisional tolerable monthly intake (PMTI). In view of the different approaches used in the most recent assessments undertaken by the authorities, it would appear appropriate to undertake a comprehensive risk assessment on the risks for animal and human health related to the presence of dioxins and dioxin-like polychlorinated biphenyls (dl-PCBs) in feed and food.

29 May 2015 Mail Print Cite

Errata/Corrigenda

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Poças, Fidel Toldra and Detlef Wölfle. EFSA Journal 2014;12(2):3584[44 pp.]. doi:10.2903/j.efsa.2014.3584 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 24 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212, Revision 2. The Panel concluded in FGE.212, that the genotoxic potential could be ruled out for d-carvone [FL-no: 07.146] together with the structurally related l-carvone [FL-no: 07.147] as well as carveol and the carvyl derivatives [FL-no: 02.062, 09.143, 09.215 and 09.870].  Based on available genotoxicity data and new submitted genotoxicity data from the Industry, the Panel concluded that the genotoxic potential could be ruled out for the 11 isophorone derivatives [FL-no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the two vetiveryl derivatives [FL-no: 02.214 and 09.821] in FGE.212Rev1 and FGE.212Rev2, respectively. For the remaining five substances [FL-no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 there is still a genotoxicity concern and additional data are required.

19 February 2014 29 May 2015 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernández Escámez, John Griffin, Tine Hald, Arie Havelaar, Kostas Koutsoumanis, Roland Lindqvist, James McLauchlin, Truls Nesbakken, Miguel Prieto Maradona, Antonia Ricci, Giuseppe Ru, Moez Sanaa, Marion Simmons, John Sofos and John Threlfall. EFSA Journal 2015;13(1):3940[95 pp.]. doi:10.2903/j.efsa.2015.3940 Abstract

Raw drinking milk (RDM) has a diverse microbial flora which can include pathogens transmissible to humans. The main microbiological hazards associated with RDM from cows, sheep and goats, horses and donkeys and camels were identified using a decision tree approach. This considered evidence of milk-borne infection and the hazard being present in the European Union (EU), the impact of the hazard on human health and whether there was evidence for RDM as an important risk factor in the EU. The main hazards were Campylobacter spp., Salmonella spp., shigatoxin-producing Escherichia coli (STEC), Brucella melitensis, Mycobacterium bovis and tick-borne encephalitis virus, and there are clear links between drinking raw milk and human illness associated with these hazards. A quantitative microbiological risk assessment for these hazards could not be undertaken because country and EU-wide data are limited. Antimicrobial resistance has been reported in several EU countries in some of the main bacterial hazards isolated from raw milk or associated equipment and may be significant for public health. Sale of RDM through vending machines is permitted in some EU countries, although consumers purchasing such milk are usually instructed to boil the milk before consumption, which would eliminate microbiological risks. With respect to internet sales of RDM, there is a need for microbiological, temperature and storage time data to assess the impact of this distribution route. Intrinsic contamination of RDM with pathogens can arise from animals with systemic infection as well as from localised infections such as mastitis. Extrinsic contamination can arise from faecal contamination and from the wider farm environment. It was not possible to rank control options as no single step could be identified which would significantly reduce risk relative to a baseline of expected good practice, although potential for an increase in risk was also noted. Improved risk communication to consumers is recommended.

Erratum/Corrigendum

On page 31, in the header row of Table 6 the text ‘Concentration distribution log10 CFU/mL (minimum, most likely, maximum)’ was corrected to ‘Concentration distribution log10 CFU/L (minimum, most likely, maximum)’ and the two sentences following Table 6 were adapted accordingly. The original version is available on request as is a version showing all the changes made.

13 January 2015 8 May 2015 Mail Print Cite