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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, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(11):3909[9 pp.]. doi:10.2903/j.efsa.2014.3909 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, CAS No 287916-86-3, food contact materials substance No 871 for use as a polymeric antistatic additive in hydrophobic plastics (mainly polyethylene and polypropylene) at a maximum used level up to 20 % w/w. The additive is a self-standing polymer and all starting substances used for its manufacture have already been evaluated from the toxicological point of view and they are listed in the Annex I of Regulation (EU) No 10/2011. Migration tests using food simulants 10 % ethanol and poly(2,6-diphenyl-p-phenylene oxide), at test conditions of 10 days at 40 °C, gave no detectable migration of the oligomeric fraction < 1000 Da (limit of detection ca. 18 μg/6 dm2). Considering the absence of genotoxicity of the starting substances used and of the additive itself, the additive does not give rise to safety concerns. The CEF Panel concluded that the substance dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and propene, is not of safety concern if it is used as an additive in polyolefins at levels of up to 20 weight %, in contact with dry foods as represented by simulant E (poly(2,6-diphenyl-p-phenylene oxide) in Regulation (EU) No 10/2011. The contact conditions should be at ambient temperature or below. Migration of the low molecular weight oligomeric fraction less than 1000 Da should in total not exceed 50 µg/kg food.

25 November 2014 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 2014;12(11):3905[11 pp.]. doi:10.2903/j.efsa.2014.3905 Abstract

The additive under assessment, Avi-Deccox® 60G, contains the same active substance (decoquinate) in the same concentration (6 %) as the already authorised Deccox®. The differences between the two formulations are their different diluents (calcium sulphate dihydrate in Avi-Deccox® 60G, wheat middlings in Deccox®) and their physical forms (granulated product for Avi-Deccox® 60G, powder for Deccox®). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the differences in carriers and physical form between Avi-Deccox® 60G and Deccox® will not affect the safety for the target species, consumer, user and environment with respect of Deccox®. No in vivo bioequivalence study for decoquinate in Avi-Deccox® 60G has been provided. Instead, in vitro studies simulating gastric juice and measuring the release of decoquinate were submitted. The release of decoquinate from the granulated product was slower than from the powdered form. However, considering the transit time of feed from the crop to the small intestine, the FEEDAP Panel concludes that the observed differences are of no biological relevance and that Avi-Deccox® 60G is equivalent to decoquinate contained in Deccox® in terms of the capacity of the additives to control coccidiosis in chickens. It is noted that the current assessment applies only to the time period for which the Deccox® is authorised.

20 November 2014 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 2014;12(11):3893[59 pp.]. doi:10.2903/j.efsa.2014.3893 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for folate. The Panel concludes that an Average Requirement (AR), as well as a Population Reference Intake (PRI) assuming a coefficient of variation (CV) of 15 % to account for the additional variability associated with the higher requirement for folate in individuals with the methylene-tetrahydrofolate reductase (MTHFR) 677TT genotype, can be derived from biomarkers of folate status. Several health outcomes possibly associated with folate intake/status were also considered, but data were found to be insufficient to establish DRVs. For adults, the AR is determined from the folate intake required to maintain folate adequacy characterised by serum and red blood cell folate concentrations of ≥ 10 and 340 nmol/L, respectively. An AR of 250 µg dietary folate equivalents (DFE)/day and a PRI of 330 µg DFE/day are derived. For infants aged 7–11 months, an Adequate Intake (AI) of 80 µg DFE/day is derived by extrapolating upwards from the estimated folate intake in exclusively breast-fed infants. For children, ARs are extrapolated from the AR for adults using allometric scaling and growth factors and considering differences in reference weights. PRIs ranging from 120 µg DFE/day for 1–3 year-old children to 330 µg DFE/day for boys and girls aged 15–17 years are derived. For pregnant women, an AI of 600 µg DFE/day is derived based on a study on maintenance of serum and red blood cell folate concentrations in pregnancy. For lactating women, an additional intake of 130 µg DFE/day is considered to cover folate losses via breast milk; this figure is added to the AR for non-lactating women and a PRI of 500 µg DFE/day is derived.

20 November 2014 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 2014;12(11):3904[15 pp.]. doi:10.2903/j.efsa.2014.3904 Abstract

Friedland clay is typically composed of the major constituents montmorillonite, illite, quartz and kaolin. Based on a series of studies in chickens for fattening, sows, dairy cows and cattle for fattening, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that 20 000 mg Friedland clay/kg complete feed is safe for these target species/categories and extends this conclusion to all animal species. A margin of safety cannot be determined. The use of Friedland clay as an additive in animal nutrition would not give rise to safety concerns for consumers. When handling the product, users may be exposed to harmful substances in Friedland clay (crystalline silica), particularly by inhalation. Measures must be taken to limit exposure of users to dust. In the absence of data on the effects on skin and eyes, it is prudent to consider Friedland clay as an irritant to skin and eyes and as a potential dermal sensitiser. The mineral components occurring in Friedland clay are ubiquitous in the environment. Therefore, it is not expected that its use as a feed additive would adversely affect the environment. Friedland clay has the potential to improve pellet hardness by acting as a binder. The FEEDAP Panel considers that insufficient evidence was provided to establish the binding and anticaking properties of Friedland clay.

20 November 2014 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 2014;12(11):3906[11 pp.]. doi:10.2903/j.efsa.2014.3906 Abstract

Cylactin® is a product consisting of viable cells of Enterococcus faecium NCIMB 10415. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed a tolerance study conducted with chickens for fattening, in which Cylactin® was included in diets at concentrations up to 100 times the recommended dose of 3 × 108 CFU/kg complete feed. No adverse effects were seen in this study and so the FEEDAP Panel concluded that the additive is safe when used at the recommended dose. This conclusion is extended to chickens reared for laying and extrapolated to minor poultry species for fattening and minor poultry species reared for laying. The potential of Cylactin® to be efficacious was previously demonstrated in chickens for fattening at 3 × 108 CFU/kg complete feed. This conclusion is extended to chickens reared for laying. Because it can be reasonably assumed that the mode of action in chickens for fattening would be the same in minor poultry species, the conclusion regarding chickens for fattening can be extrapolated to minor poultry species for fattening and minor poultry species reared for laying when the additive is used at the same dose. Cylactin® is compatible with lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin.

20 November 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(11):3899[16 pp.]. doi:10.2903/j.efsa.2014.3899 Abstract

The additive cassia gum, the ground, purified endosperm of the seeds of Cassia tora and Cassia obtusifolia, is intended to be used as a technological additive (functional group: gelling agents) in feedingstuffs for all dogs and cats. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that only purified semi-refined cassia gum that meets the specifications of cassia gum as a food additive (< 0.5 mg anthraquinones/kg) can be considered safe for cats and dogs, at a maximum content of 13 200 mg/kg complete feed. Cassia gum is regarded as a skin and respiratory sensitiser and as a potential irritant to skin and eyes. It would be prudent to assume that cassia gum has the potential to harm workers who might be exposed via skin, eyes or inhalation. The dusting potential of the additive and the particle size distribution in dust mean that there is a high probability of inhalation exposure of unprotected workers handling the dry additive. The FEEDAP Panel concluded that cassia gum used alone, in accordance with the conditions of use, is not efficacious as a gelling agent. However, the FEEDAP Panel noted that cassia gum has the potential to be effective as a gelling agent when used together with carrageenan in feeds with moisture content higher than 20 %.

19 November 2014 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 2014;12(11):3892[8 pp.]. doi:10.2903/j.efsa.2014.3892 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted 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 prunes and contribution to normal bowel function. The food constituent, prunes, which is the subject of the health claim, is sufficiently characterised. Contribution to normal bowel function is a beneficial physiological effect without the occurrence of diarrhoea for infants and young children from six months to three years of age. No evidence was provided by the applicant to substantiate the effect of prunes on bowel function without the occurrence of diarrhoea for infants and young children. The Panel concludes that a cause and effect relationship has not been established between the consumption of prunes and contribution to normal bowel function without the occurrence of diarrhoea for infants and young children from six months to three years of age.

19 November 2014 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 2014;12(11):3890[8 pp.]. doi:10.2903/j.efsa.2014.3890 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 selenium and protection of DNA, proteins and lipids from oxidative damage. The Panel considers that selenium is sufficiently characterised. Protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage is a beneficial physiological effect. The Panel has previously assessed a claim on selenium and protection of DNA, proteins and lipids from oxidative damage with a favourable outcome. The target population was the general population. The Panel considers that the role of selenium in the protection of DNA, proteins and lipids from oxidative damage 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 selenium and protection of DNA, proteins and lipids from oxidative damage. The following wording reflects the scientific evidence: “Selenium contributes to the protection of DNA, proteins and lipids from oxidative damage”. The target population is infants and children up to three years of age.

19 November 2014 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 2014;12(11):3891[8 pp.]. doi:10.2903/j.efsa.2014.3891 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted 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 zinc and normal growth. The food constituent, zinc, which is the subject of the health claim, is sufficiently characterised. Normal growth is a beneficial physiological effect for infants and young children. The Panel considers that the role of zinc in normal growth is well established. Growth retardation is one of the clinical manifestations of severe zinc deficiency. Zinc supplementation has been reported to stimulate growth and development in zinc-deficient infants and young children. The Panel concludes that a cause and effect relationship has been established between the dietary intake of zinc and normal growth. The following wording reflects the scientific evidence: “zinc contributes to normal growth”. The target population is infants and children up to three years of age.

19 November 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(11):3901[15 pp.]. doi:10.2903/j.efsa.2014.3901 Abstract

The additive cassia gum, the ground, purified endosperm of the seeds of Cassia tora and Cassia obtusifolia, is intended to be used as a technological additive (functional groups: thickeners and gelling agents) in feedingstuffs for all dogs and cats. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that only purified semi-refined cassia gum that meets the specifications of cassia gum as a food additive (< 0.5 mg anthraquinones/kg) can be considered safe for cats and dogs, at a maximum content of 13 200 mg/kg complete feed. Cassia gum is regarded as a skin and respiratory sensitiser and as a potential irritant to skin and eyes. It would be prudent to assume that cassia gum has the potential to harm workers who might be exposed via skin, eyes or inhalation. The FEEDAP Panel could not conclude on the efficacy of cassia gum used as a gelling agent and thickener in feedingstuffs for dogs and cats.

19 November 2014 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 2014;12(11):3889[8 pp.]. doi:10.2903/j.efsa.2014.3889 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 “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin” and “increase in calcium absorption”. The scope of the application was proposed to fall under a health claim referring to children’s development and health. The food constituents that are proposed by the applicant to be the subject of the health claim are “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”. Upon requests by EFSA for clarification on the food constituent, the applicant did not clarify the food constituent that is the subject of the health claim. The Panel considers that the food constituents, “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”, which are the subject of the health claim, are not sufficiently characterised. The Panel concludes that a cause and effect relationship cannot be established between the consumption of “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin” and a beneficial physiological effect.

19 November 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(11):3902[16 pp.]. doi:10.2903/j.efsa.2014.3902 Abstract

The additive cassia gum, the ground, purified endosperm of the seeds of Cassia tora and Cassia obtusifolia, is intended to be used as a technological additive (functional group: gelling agents) in feedingstuffs for all dogs and cats. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that only purified semi-refined cassia gum that meets the specifications of cassia gum as a food additive (< 0.5 mg anthraquinones/kg) can be considered safe for cats and dogs, at a maximum content of 13 200 mg/kg complete feed. Cassia gum is regarded as a skin and respiratory sensitiser and as a potential irritant to skin and eyes. It would be prudent to assume that cassia gum has the potential to harm workers who might be exposed via skin, eyes or inhalation. The dusting potential of the additive and the particle size distribution in dust mean there is a high probability of inhalation exposure of unprotected workers handling the dry additive. The FEEDAP Panel concluded that cassia gum used alone, in accordance with the conditions of use, is not efficacious as a gelling agent, thickener, emulsifier or stabiliser. However, the FEEDAP Panel noted that cassia gum has the potential to be effective as a gelling agent and thickener when used together with carrageenan and xanthan, and to stabilise the effects of other emulsifiers in feed with a moisture content higher than 20 %.

19 November 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(11):3900[15 pp.]. doi:10.2903/j.efsa.2014.3900 Abstract

The additive cassia gum, the ground, purified endosperm of the seeds of Cassia tora and Cassia obtusifolia, is intended to be used as a technological additive (functional groups: thickeners and gelling agents) in feedingstuffs for all dogs and cats. The Panel on Additives and Products used in Animal Feed (FEEDAP) concluded that only purified semi-refined cassia gum that meets the specifications of cassia gum as a food additive (< 0.5 mg anthraquinones/kg) can be considered safe for cats and dogs, at a maximum content of 13 200 mg/kg complete feed. Cassia gum is regarded as a skin and respiratory sensitiser and as a potential irritant to skin and eyes. It would be prudent to assume that cassia gum has the potential to harm workers who might be exposed via skin, eyes or inhalation. The FEEDAP Panel could not conclude on the efficacy of cassia gum used as a gelling agent and thickener in feedingstuffs for dogs and cats.

19 November 2014 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 2014;12(11):3896[17 pp.]. doi:10.2903/j.efsa.2014.3896 Abstract

Crina® Poultry Plus is a preparation of benzoic acid, thymol, eugenol, piperine, benzyl salicylate, isoamyl salicylate and trans-anethole. In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for chickens for fattening, the consumer or the environment, or on its efficacy. Based on the results from a new tolerance study, the FEEDAP Panel concluded that Crina® Poultry Plus is safe for chickens for fattening at the maximum recommended dose (300 mg/kg). This conclusion can be extended to chickens reared for laying and extrapolated to minor species for fattening/reared for laying with the same maximum dose. New data on the metabolism of eugenol and on residues of eugenol and piperine indicated that exposure of consumers to residues of these substances when consuming edible tissues from chickens for fattening receiving the additive would not be expected. Therefore, the use of Crina® Poultry Plus in chickens for fattening and minor poultry species for fattening is of no concern for consumers. The FEEDAP Panel concluded that the use of Crina® Poultry Plus in chickens for fattening, chickens reared for laying and minor species for fattening/reared for laying is of no concern for the environment. Three out of ten studies showed some beneficial effect on zootechnical parameters of Crina® Poultry Plus at a dose of 300 mg/kg complete feed. The Panel concluded that the additive has some potential to be efficacious in chickens for fattening at a dose of 300 mg/kg complete feed. This conclusion can be extended to chickens reared for laying and extrapolated to include the minor poultry species for fattening and reared for laying at the same dose.

18 November 2014 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 2014;12(11):3895[20 pp.]. doi:10.2903/j.efsa.2014.3895 Abstract

L-Lysine is an essential amino acid for all animal species. The products, concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride (HCl) and L-lysine HCl technically pure, as sources of the amino acid L-lysine, are produced by fermentation with a genetically modified strain of Escherichia coli (FERM BP-11355). Neither the production strain nor its recombinant DNA was detected in the final products. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure, manufactured by fermentation with E. coli FERM BP-11355, do not give rise to any safety concern with regard to the genetic modification of the production strain. The additives under assessment are considered safe for target species when supplemented in appropriate amounts. Use of concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure produced by E. coli FERM BP-11355 in animal feed do not give rise to safety concerns for the consumer. The products under application are not considered to have the potential to cause respiratory toxicity, skin or eye irritation or skin sensitisation, but respiratory sensitisation cannot be excluded. L-Lysine is a substance naturally occurring in bacteria, plants and animals. The use of the products under application as feed additives does not represent a risk to the environment. The products concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure produced by E. coli FERM BP-11355 are regarded as efficacious sources of the essential amino acid L-lysine for all non-ruminant species. Supplemental free amino acid L-lysine is degraded by ruminal microorganisms, if not given in a protected form.

18 November 2014 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 2014;12(11):3897[11 pp.]. doi:10.2903/j.efsa.2014.3897 Abstract

The additive AGal-Pro BL-L is a liquid 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 authorised in its solid form for use in chickens for fattening, chickens reared for laying and minor poultry species for fattening as a zootechnical additive in the functional group digestibility enhancers. The applicant seeks the authorisation of the liquid form as a feed additive for chickens for fattening at the same authorised dose range. Taking into account the information provided on the characterisation and manufacturing process of the additive in its liquid form, AGal-Pro BL-L, and the previously submitted data on the solid formulation of the same additive, the FEEDAP Panel concludes that AGal-Pro BL-L is safe and efficacious for the target species at the dose range currently authorised for the product and is safe for the consumer and the environment. The additive is irritant to skin and eyes and a dermal sensitiser and should be considered a respiratory sensitiser.

18 November 2014 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 2014;12(11):3898[2 pp.]. doi:10.2903/j.efsa.2014.3898 Abstract

This opinion concerns the re-evaluation of calcium formate for use as a preservative in feed for all animal species and categories. Calcium formate is currently authorised for use as a preservative in feed for all animal species, but is not authorised as a food additive in the EU. Considering the results of the tolerance studies with chickens for fattening and cattle for fattening, and other published studies, no adverse effects on target animals safety are anticipated when calcium formate is used at the maximum proposed dose in feed for pigs, poultry, fish and ruminants (15 000 mg calcium formate/kg complete feed, equivalent to 10 000 mg formic acid/kg complete feed). However, no margin of safety can be established. This conclusion can be extrapolated to other animal species provided the maximum dose applied does not exceed 15 000 mg calcium formate/kg complete feed. The contribution of calcium formate to the calcium supply of animals should be considered when formulating diets. Considering that the turnover of formate is rapid, with no evidence of accumulation in body tissues, neither calcium nor formate concentrations will increase in the edible tissues of animals maintained on feed with calcium formate added and, therefore, the use of calcium formate as a feed additive in all animal species is considered safe for the consumer. Calcium formate is non-irritant to skin but causes severe adverse effects in eyes. It is likely that handling the additive could result in skin reactions and in the production of respirable dust that could present a risk to unprotected workers. The use of calcium formate in animal nutrition is safe for the environment. Data submitted do not provide convincing evidence of the efficacy of the additive when used as a preservative for compound feed or feed materials.

18 November 2014 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, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(11):3887[34 pp.]. doi:10.2903/j.efsa.2014.3887 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate a flavouring substance,cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide [FL-no: 16.115] in the Flavouring Group Evaluation 300, Revision 1 (FGE.300Rev1) using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to a re-evaluation of the flavouring substance, cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide [FL-no: 16.115], as a 90-day dietary study in rats has become available. The substance was not considered to have genotoxic potential. The substance was 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 Panel concluded that the substance [FL-no: 16.115] does not give rise to safety concern at its levels of dietary intake estimated on the basis of the Maximised Survey-derived Daily Intake MSDI approach. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.

14 November 2014 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, Pagona Lagiou, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2014;12(11):3883[24 pp.]. doi:10.2903/j.efsa.2014.3883 Abstract

Following a request from the European Commission, a set of assessment criteria was developed to support the selection of existing environmental surveillance networks for post-market environmental monitoring (PMEM) of genetically modified plants (GMPs). In compliance with these criteria, some networks and associated programmes were identified as being of potential use subject to further case-by-case analysis. When considering PMEM of GMPs, the approach would also require comparing sites monitored by the networks and the locations where GMPs are cultivated. The reporting of the sites surveyed by networks and locations of cultivated GMPs should thus follow the same standards in order to ensure interoperability and to potentially establish a causal link between a change observed and the GMPs. In this respect, technical support might be required by networks to transform their data records into workable standards. Moreover, the EFSA GMO Panel was asked by the European Commission to examine the sensitivity of statistical analyses used by the networks to detect change. A decision tree is provided for selecting the optimal method for statistical analysis based on the study design and the datasets from networks. Sufficient statistical power needs to be ensured to detect an effect for a particular indicator. Sample size is one of the main contributing factors in determining the power of any network to detect an effect of a product release into the environment. Increasing the sample size implies variable extra-costs depending on whether data are collected by volunteers or professionals. A more powerful statistical analysis can also be achieved by pooling datasets collected by different networks; this needs further investigation because of important covariates leading to differentiated responses. In general, PMEM would benefit from a move towards ‘open data’ policies for re-analysis or pooling data collected by different networks.

14 November 2014 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Edith Authie, 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 and Stéphan Zientara. EFSA Journal 2014;12(11):3885[122 pp.]. doi:10.2903/j.efsa.2014.3885 Abstract

Sheep pox (SPP) and goat pox (GTP) are viral diseases of sheep and goats characterised by severe losses, especially in naive animals. SPP and GTP are endemic in many African, Middle Eastern and Asian countries, with recurrent epidemics in Greece and Bulgaria, as in 2013–2014. The main mode of SPP/GTP transmission is direct contact between animals, but, since the virus can survive in the environment, indirect transmission may also occur through fomites such as human movement, vehicles, wildlife and trade of hides when insufficiently treated. According to a model developed to evaluate the spread of SPP, the probability of spread of the infection in south-eastern Europe is <1 %, while, if introduced in the Iberian Peninsula, the probability that SPP would spread is more than 50 %. The long-term survival of the SPP virus in the environment enhances the likelihood of SPP endemicity; however, this can be reduced by extensive cleaning and disinfection, and with a waiting period before re-stocking culled herds. Early detection and notification, prompt movement restriction of animals, an extension of duration and size of the protection zone and culling affected herds, based on clinical signs, are effective and time-saving control measures recommended by the AHAW Panel. Only live attenuated vaccines are available for SPP/GTP, which are not licensed within the EU and without principle for differentiating infected from vaccinated animals. The AHAW Panel recommends further investigation of potential SPP/GTP transmission through arthropods and wildlife, the survival of SPP/GTP viruses in grazing sites and in animal feed and hides and the development of inactivated vaccines. Sentinel animals could be used prior to re-stocking culled herds. Awareness-raising campaigns for farmers and veterinary staff to promote recognition of the disease should be considered. The cooperation of EU with neighbouring countries should be encouraged to prevent transboundary disease spread.

13 November 2014 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, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(11):3888[60 pp.]. doi:10.2903/j.efsa.2014.3888 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 11 flavouring substances in the Flavouring Group Evaluation 11, Revision 3, using the Procedure 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 Revision of FGE.11, FGE.11Rev3, is prepared due to the evaluation of genotoxicity data, which have been requested in the previous version of FGE.11, for 3-methylnona-2,4-dione [FL-no: 07.184]. Additionally, new information on the stereoisomerism of [FL-no: 07.184 and 07.260] has become available. Based on the new data received the Panel concluded that all 11 flavouring substances [FL-no: 02.133, 07.071, 07.097, 07.152, 07.165, 07.167, 07.168, 07.184, 07.238, 07.248 and 07.260] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all candidate substances.

13 November 2014 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 2014;12(11):3878[9 pp.]. doi:10.2903/j.efsa.2014.3878 Abstract

The European Commission asked the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to address the objections of Cyprus to the placing on the market of the genetically modified (GM) carnation SHD-27531-4. The GM carnation cut flowers, with a modified petal colour, are intended to be imported and distributed in the European Union for ornamental use only. The EFSA GMO Panel responded to the objections of Cyprus, taking into account the limited intended use of carnation SHD-27531-4 and the information available. First, the EFSA GMO Panel concludes that the propagation of carnation SHD-27531-4 by individuals cannot be excluded. However, should this occur, carnation SHD-27531-4 would not show any potential for increased survival, fitness or weediness compared with its parental line. Second, the EFSA GMO Panel is of the opinion that the potential spread of pollen of the GM carnation SHD-27531-4 by Lepidoptera to wild Dianthus species cannot be eliminated but is highly unlikely to occur and, if it did occur, it is very unlikely that viable hybrids would be produced, survive and result in adverse environmental effects. Third, considering the very low potentials for hybridisation and/or seed production of (GM) carnations, the EFSA GMO Panel concludes that plant-to-plant gene transfer of the introduced genes is very unlikely and, if it did occur, it is unlikely to result in viable seed production leading to adverse environmental effects.

10 November 2014 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 2014;12(11):3886[15 pp.]. doi:10.2903/j.efsa.2014.3886 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 processes Roxane Nord and Stute (EU register number RECYC017 and RECYC104, respectively) which are based on the KRONES® technology. The input to the processes is washed and dried poly(ethylene 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, washed and dried PET flakes are transferred by two heated conveyors under atmospheric pressure into a reactor where they are decontaminated at high temperature under vacuum. Having examined the results of the challenge test provided, the Panel concluded that three steps, the pre-heating and the heating in the conveyors and the decontamination in the vacuum reactor, are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control the performance of these critical steps are temperature, residence time, and, for the vacuum reactor, also pressure. Under these conditions, it was demonstrated that the recycling processes are able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from these processes when 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 should not be used in microwave and conventional ovens.

6 November 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(11):3880[57 pp.]. doi:10.2903/j.efsa.2014.3880 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, Spain, and co-rapporteur Member State the Netherlands, for the pesticide active substance thiabendazole 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 use of thiabendazole as a post-harvest fungicide on seed potato, apple and pear, and citrus. 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.

6 November 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(11):3881[82 pp.]. doi:10.2903/j.efsa.2014.3881 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France, for the pesticide active substance flupyrsulfuron (evaluated variant flupyrsulfuron-methyl-sodium) 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 flupyrsulfuron-methyl-sodium as a herbicide on cereals. 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. 

6 November 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(11):3873[125 pp.]. doi:10.2903/j.efsa.2014.3873 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 esfenvalerate, 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 esfenvalerate as an insecticide on cereals, potatoes and 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. 

3 November 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2014;12(11):3884[25 pp.]. doi:10.2903/j.efsa.2014.3884 Abstract

Several animal species were found to harbour Zaïre Ebola virus (ZEBOV), mainly non-human primates and fruit bats. The risk for persons in Europe linked to the transmission of ZEBOV via handling and preparation (by consumers or staff handling the food in kitchens immediately prior to consumption), and consumption of bushmeat illegally imported from Africa was assessed. The outcome was the probability for at least a single human case of ZEBOV in Europe due to transmission via bushmeat. This probability results from a combination of several steps: 1) the bushmeat has to be contaminated with ZEBOV; 2) the bushmeat has to be (illegally) introduced into the EU; 3) the imported bushmeat needs to contain viable virus when it reaches the person; 4) the person has to be exposed to the virus; and 5) the person needs to get infected following exposure. Due to lack of data and knowledge, which results in very high uncertainty, it is not possible to estimate this risk. Considering all these elements, and based on: (i) the limited number of outbreaks confirmed to date in Africa in spite of the routine consumption of bushmeat in that continent, (ii) the handling of bushmeat in Europe not involving high risk practices such as hunting and butchering, and (iii) the assumed low overall consumption of bushmeat in Europe, it can be assumed that the potential for introduction and transmission of ZEBOV via bushmeat in Europe is currently low. The public health consequences of such an event would be very serious given the high lethality and potential for secondary transmission. Hardly any information on ZEBOV infectivity is available on the effect of salting, smoking or drying of meat. Therefore, a conclusion cannot be reached regarding the effectiveness of these methods for virus inactivation. Thorough cooking (100 °C) will destroy the virus.

4 November 2014 Mail Print Cite