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


Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, 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(3):3609 [11 pp.]. doi:10.2903/j.efsa.2014.3609 Abstract

Pediococcus pentosaceus is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony-forming units (CFU)/kg fresh material. The P. pentosaceus strain was found to be resistant to tetracycline by an unidentified mechanism and thus may pose a risk for the spread of genes coding for resistance to an antibiotic of human and veterinary importance. Thus, the additive containing this strain is not considered safe for the target animals and consumers of products from animals fed the treated silage. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. Since the P. pentosaceus strain carries an uncharacterised resistance to tetracycline, the FEEDAP Panel cannot conclude on its safety for the environment. A total of four studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. Although the additive showed a tendency to increase lactic acid production and reduce pH in the ensiled material, overall there was insufficient evidence of a beneficial effect on the preservation of nutrients.

31 March 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(3):3610 [12 pp.]. doi:10.2903/j.efsa.2014.3610 Abstract

Pediococcus pentosaceus is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony-forming units (CFU)/kg fresh material. The P. pentosaceus strain was found to be resistant to tetracycline by an unidentified mechanism and thus may pose a risk for the spread of genes coding for resistance to an antibiotic of human and veterinary importance. Thus, the additive containing this strain is not considered safe for the target animals and consumers of products from animals fed the treated silage. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. Since the P. pentosaceus strain carries an uncharacterised resistance to tetracycline, the FEEDAP Panel cannot conclude on its safety for the environment. A total of seven studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage.

31 March 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(3):3611 [11 pp.]. doi:10.2903/j.efsa.2014.3611 Abstract

Lactobacillus paracasei is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. paracasei is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage.

31 March 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(3):3613 [11 pp.]. doi:10.2903/j.efsa.2014.3613 Abstract

Pediococcus acidilactici is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 ×  108 colony-forming units (CFU)/kg fresh material. The bacterial species P. acidilactici is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 ×  107 and 1 ×  108 CFU/kg forage.

31 March 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(3):3612 [11 pp.]. doi:10.2903/j.efsa.2014.3612 Abstract

Lactobacillus plantarum is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage.

31 March 2014 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernandez Escamez, 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 2014;12(3):3600 [118 pp.]. doi:10.2903/j.efsa.2014.3600 Abstract

Leafy greens eaten raw as salads are minimally processed and widely consumed foods. Risk factors for leafy greens contamination by Salmonella spp. and Norovirus were considered in the context of the whole food chain including agricultural production and processing. Available estimates of the prevalence of these pathogens (together with the use of Escherichia coli as an indicator organism) in leafy greens were evaluated. Specific mitigation options relating to contamination of leafy greens were considered and qualitatively assessed. It was concluded that each farm environment represents a unique combination of numerous characteristics that can influence occurrence and persistence of pathogens in leafy greens production. Appropriate implementation of food safety management systems, including Good Agricultural Practices (GAP), Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP), should be primary objectives of leafy green producers. The relevance of microbiological criteria applicable to production, processing and at retail/catering were considered. The current legal framework does not include microbiological criteria applicable at primary production which will validate and verify GAP and GHP. It is proposed to define a criterion at primary production of leafy greens which is designated as Hygiene Criterion, and E. coli was identified as suitable for this purpose. A Process Hygiene Criterion for E. coli in leafy green packaging plants or fresh cutting plants was considered and will also give an indication of the degree to which GAP, GHP, GMP or HACCP programs have been implemented. A Food Safety Criterion for Salmonella in leafy greens could be used as a tool to communicate to producers and processors that Salmonella should not be present in the product. Studies on the prevalence and infectivity of Norovirus are limited, and quantitative data on viral load are scarce making establishment of microbiological criteria for Norovirus on leafy greens difficult.

27 March 2014 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernandez Escamez, 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 2014;12(3):3601 [81 pp.]. doi:10.2903/j.efsa.2014.3601 Abstract

Salmonella spp., verocytotoxigenic Escherichia coli (VTEC), Listeria monocytogenes and Yersinia enterocolitica are the most relevant microbial pathogens when assessing the effects of beef, pork and lamb carcass chilling regimes on the potential risk to public health. Moreover, as most bacterial contamination occurs on the surface of the carcass, only the surface temperature is an appropriate indicator of bacterial growth. The growth of these four pathogens (using E. coli models for VTEC) during different time-temperature chilling scenarios was estimated using commercial slaughterhouse data and published predictive microbiology models. The outputs suggest it is possible to apply slaughterhouse carcass target temperatures higher than the currently mandated 7 °C throughout the carcass (including the core) in combination with different transport durations without obtaining additional bacterial growth. Combinations of maximum surface temperatures at carcass loading and maximum chilling and transport times, that result in pathogen growth equivalent or less than that obtained when carcasses are chilled to a core temperature of 7 °C in the slaughterhouse are provided.

27 March 2014 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernandez Escamez, 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 2014;12(3):3599 [60 pp.]. doi:10.2903/j.efsa.2014.3599 Abstract

Studies evaluating the safety and efficacy of solutions, containing peroxyacetic acid (PAA) as the active ingredient, in mixtures with acetic acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) and possibly octanoic acid and peroxyoctanoic acid, for reduction of pathogens on poultry carcasses and meat were assessed. Treatments at ambient temperature consisted of dipping in short term baths, in chiller baths or spraying. On the basis of the previous EFSA exposure scenarios including short term baths that were not evaluated previously, no toxicity concerns were identified with regard to residues of peroxyacids, to HEDP and to possible reaction products of hydrogen peroxide and peroxyacids with lipids and proteins of the poultry carcasses. A relevant reduction of PAA treatment on E. coli and coliforms was demonstrated by dipping warm carcasses, but few data were available for pathogens (Salmonella and Campylobacter). Spraying appeared to be less effective than dipping in reducing indicator organisms than dipping. When dipping chilled carcasses, reduction of indicator organisms and pathogens was evident, although only in low or medium strength of evidence studies. In chiller bath application, there was a relevant impact on E. coli, but less effect on coliforms, and little data was available on reduction of pathogens. The emergence of acquired reduced susceptibility to biocides and/or resistance to therapeutic antimicrobials following the use of PAA was considered unlikely. There were no concerns for environmental risk of peroxyacids, acetic acid and octanoic acid. On the basis of a conservative preliminary guideline for surface water quality, the emission of HEDP from a poultry plant into the environment could not be considered safe a priori. It was recommended that HACCP plans should include monitoring of the concentration of HEDP and of the decontaminating substance in the working solution and post-marketing surveillance for resistance in both pathogenic and commensal bacteria.

26 March 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(3):3607 [2 pp.]. doi:10.2903/j.efsa.2014.3607 Abstract

Ferrous sulphate monohydrate is safe when supplied up to a maximum iron content per kilogram complete feedingstuff of 450 mg for bovines and poultry, 500 mg for ovines, 600 mg for pets, and 750 mg for other species/categories, except horses and fish; for piglets up to one week before weaning a maximum of 250 mg Fe/day is considered safe. Because of insufficient data on horses and fish, as a provisional measure, the current value (750 mg Fe/kg) could be maintained. The values for total dietary iron for pigs, ovines, horses, fish and other species/categories (except poultry, bovines and pets) are in line with those currently authorised. Iron from ferrous sulphate monohydrate is unlikely to modify the iron concentration in edible tissues and products of animal origin. Consumer exposure in the EU is not associated with a risk of excess iron intake to the general population. Therefore, the FEEDAP Panel does not foresee any concern for consumer safety resulting from the use of ferrous sulphate monohydrate in animal nutrition, provided that the maximum iron content in complete feedingstuffs is respected. Ferrous sulphate monohydrate is irritant and corrosive to the skin, eyes and respiratory tract. The additive contains up to 109 mg Ni/kg. Nickel is a dermal and respiratory sensitiser, and inhalation may cause lung cancer. Thus, handling the additive poses a risk to the user/worker. Considering the high concentration of iron and sulphur in soil and water, the supplementation of feed with the additive is not expected to pose an environmental risk. Ferrous sulphate monohydrate is an effective iron source for all animal species and categories. The FEEDAP Panel recommends that the currently authorised maximum iron content in complete feed be reduced for bovines and poultry from 750 to 450 mg Fe/kg, and for pets from 1250 to 600 mg Fe/kg.

26 March 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(3):3606 [14 pp.]. doi:10.2903/j.efsa.2014.3606 Abstract

The flavours included in this assessment are widely present in nature as the building blocks of DNA and RNA. In the absence of any information on the microbial strains or substrates used for the production of the additives, and with little information on the manufacturing process, the FEEDAP Panel is unable to ascertain whether the manufacturing process introduces any safety concerns. Disodium 5′-guanylate and disodium 5′-inosinate and their mixture are considered to be safe for the target animals and the consumer. However, considering the lack of information on the production process, these conclusions apply only to the compounds ‘per se’ and their extrapolation to any feed additive containing these compounds is not possible. In the absence of any data related to hazard to the user, it would be prudent to regard disodium 5′-guanylate and disodium 5′-inosinate and their mixture as potentially hazardous to workers by skin or inhalation exposure. The compounds under assessment are naturally present in feed materials; therefore, no risk to the safety for the environment is foreseen. Since these compounds are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

25 March 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(3):3608 [18 pp.]. doi:10.2903/j.efsa.2014.3608 Abstract

5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one and 3-hydroxy-4,5-dimethylfuran-2(5H)-one belong to chemical group 13 (furanones and tetrahydrofurfuryl derivatives) and are authorised for use as flavours in food. These additives are safe at concentrations of 0.05 mg/kg feed for poultry and pigs and 0.08 mg/kg feed for cattle, salmonids and non food-producing animals. The concentration of the additives should be appropriately reduced if used in water for drinking. If used simultaneously in feed and water for drinking, the total intake should not exceed the maximum dose resulting from the use of the flavourings in feed alone. At the levels safe for target animal species these products are safe for the consumers of animal products. The FEEDAP Panel considers it prudent to treat the compounds under assessment as irritant to skin, eyes and the respiratory tract and as skin sensitisers. The proposed concentration of 0.08 mg flavouring compound/kg feed is unlikely to have detrimental effects on the environment except when used in feed for fish in sea cages, in which case the safe concentration would be 0.047 mg/kg. Since both compounds are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

25 March 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, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf EFSA Journal 2014;12(3):3603 [10 pp.]. doi:10.2903/j.efsa.2014.3603 Abstract

Miya-Gold® is the trade name for a feed additive based on a single strain of Clostridium butyricum. EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product Miya-Gold® when used with turkeys for fattening and turkeys reared for breeding at a dose of 1.25 × 108 colony-forming units (CFU)/kg feed. The product was characterised in a previous opinion on chickens for fattening. At that time, safety for the consumers, users of the product and the environment was assessed and found not to give rise to concerns. Subsequently, new data based on the analysis of whole genome sequence have been provided. As a consequence, the present opinion considers the elements of safety assessment related to the new genomic data, the new target species and the efficacy of the product when used with turkeys for fattening and turkeys reared for breeding. The extension of use for turkeys and the new data on the whole genome sequence of the C. butyricum strain do not raise issues which would lead to revision of the conclusions on the safety of the product for consumers, users and the environment reached in previous opinions. Miya-Gold® is safe for turkeys for fattening at the recommended dose of at 1.25 × 108 CFU/kg feed. Safety established in turkeys for fattening applies to turkeys reared for breeding. A meta-analysis pooling data from four trials showed significant improvement in daily weight gain and feed to gain ratio when Miya-Gold® was supplemented at the minimum recommended dose of 1.25 × 108 CFU/kg feed. The FEEDAP Panel concludes that the additive has the potential to improve performance in turkeys for fattening at the recommended dose. This conclusion can be extended to turkeys reared for breeding.

25 March 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(3):3602 [2 pp.]. doi:10.2903/j.efsa.2014.3602 Abstract

The additive Oralin® is a preparation containing viable cells of a single strain of Enterococcus faecium. It is currently authorised for use in calves, piglets, chickens for fattening, turkeys for fattening and dogs. The applicant is now requesting the authorisation of the additive when used for cats at a minimum dose of 1 × 109 and a maximum dose of 1 × 1010 colony-forming units (CFU)/kg feed. Safety of the additive for the target species at the proposed dose range was shown by the results of a tolerance study in which no adverse effects were seen when a 100-fold overdose of the maximum recommended dose of the additive was administered to cats. Oralin® is not irritant to skin or eyes or a skin sensitiser. The dusting potential of the preparation tested indicated that moderate exposure of users/owners to the dust from the additive is possible. Considering this together with the proteinaceous nature of its active agent, the FEEDAP Panel concludes that the additive should be treated as a respiratory sensitiser. Three studies showed a limited but significant improvement of faecal scores in Oralin®-treated animals. However, such limited improvement in faecal scores is questionable in terms of biological relevance.

25 March 2014 Mail Print Cite

EFSA Scientific Committee Jan Alexander, Diane Benford, Qasim Chaudhry, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Bernadette Ossendorp, Simon More, Alicja Mortensen, Birgit Nørrung, Joe Perry, Iona Pratt†, John Sofos, Josef Schlatter, Kristen Sejrsen EFSA Journal 2014;12(3):3593 [38 pp.]. doi:10.2903/j.efsa.2014.3593 Abstract

The Qualified Presumption of Safety (QPS) approach, initially developed for the assessment of microorganisms referred to EFSA and added to the food chain is equally applicable to the assessment of botanicals or botanical preparations. Using the principles to establish the suitability of a botanical preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications of the assessment scheme to related botanicals or different botanical preparations obtained from the same plant variety can allow a QPS status to be derived for specific groupings. However, the particularity of botanicals that may be presented in a wide variety of forms or whose morphology and chemical composition may be markedly affected by geographical and environmental factors, makes the possibility to establish QPS status at high taxonomic levels quite limited. Still, the above-mentioned structured approach for the assessment of botanicals and botanical preparations represents a considerable advancement in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements.

13 March 2014 Mail Print Cite

EFSA Panel on Contaminants in the Food Chain (CONTAM) Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael DiNovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye, Manfred Metzler, Carlo Stefano Nebbia, Michael O’Keeffe, Ivonne Rietjens, Dieter Schrenk, Vittorio Silano, Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester EFSA Journal 2014;12(3):3595 [261 pp.]. doi:10.2903/j.efsa.2014.3595 Abstract

EFSA received a request from the Hellenic Food Authority for a scientific opinion on estimation of the risk to human health from the presence of chromium (Cr) in food, particularly in vegetables, and Cr(VI) in bottled water. The CONTAM Panel derived a TDI of 0.3 mg/kg b.w. per day for Cr(III) from the lowest NOAEL identified in an NTP chronic oral toxicity study in rats. Under the assumption that all chromium in food is Cr(III), the mean and 95th percentile dietary exposure across all age groups were well below the TDI and therefore does not raise concerns for public health. In the case of drinking water, the Panel considered all chromium in water as Cr(VI). For non-neoplastic effects the lowest BMDL10 for diffuse epithelial hyperplasia of duodenum in female mice and the lowest BMDL05 for haematotoxicity in male rats in a 2-year NTP study were selected as reference points. The MOEs indicate that for non-neoplastic effects the current exposure levels to Cr(VI) via drinking water are of no concern for public health. For neoplastic effects, the CONTAM Panel selected a lowest BMDL10 for combined adenomas and carcinomas of the mouse small intestine as the reference point. Overall, the calculated MOEs indicate low concern regarding Cr(VI) intake via drinking water (water intended for human consumption and natural mineral waters) for all age groups when considering the mean chronic exposure values with the exception of infants at the upper bound (UB) exposure estimates. MOEs below 10 000 were calculated at the UB 95th percentile exposure estimates, particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’, which were highly influenced by the relatively high occurrence values under the UB assumption. To improve the risk assessment, there is a need for data on the content of Cr(III) and Cr(VI) in food and drinking water.

13 March 2014 Mail Print Cite

EFSA Panel on Plant Protection Products and their Residues (PPR) Alf Aagaard, Theo Brock, Ettore Capri, Sabine Duquesne, Metka Filipic, Antonio F. Hernandez-Jerez, Karen I. Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Matthias Liess, Alberto Mantovani, Colin Ockleford, Bernadette Ossendorp, Daniel Pickford, Robert Smith, Paulo Sousa, Ingvar Sundh, Aaldrik Tiktak, Ton Van Der Linden EFSA Journal 2014;12(3):3589 [92 pp.]. doi:10.2903/j.efsa.2014.3589 Abstract

The Panel has interpreted the Terms of Reference as a stepwise analysis of issues relevant to both the development and the evaluation of models to assess ecological effects of pesticides. The regulatory model should be selected or developed to address the relevant specific protection goal. The basis of good modelling practice must be the knowledge of relevant processes and the availability of data of sufficient quality. The opinion identifies several critical steps in order to set models within risk assessment, namely: problem formulation, considering the specific protection goals for the taxa or functional groups of concern; model domain of applicability, which drives the species and scenarios to model; species (and life stage) selection, considering relevant life history traits and toxicological/toxicokinetics characteristics of the pesticide; selection of the environmental scenario, which is defined by a combination of abiotic, biotic and agronomic parameters to provide a realistic worst-case situation. Model development should follow the modelling cycle, in which every step has to be fully documented: (i) problem definition; (ii) model formulation, i.e. design of a conceptual model; (iii) model formalisation, in which variables and parameters are linked together into mathematical equations or algorithms; (iv) model implementation, in which a computer code is produced and verified; (v) model setup, including sensitivity analysis, uncertainty analysis and comparison with observed data, that delivers the regulatory model; (vi) prior to actual use in risk assessment, the regulatory model should be evaluated for relevance to the specific protection goals; (vii) feedback from risk assessor with possible recommendations for model improvement. Model evaluation by regulatory authorities should consider each step of the modelling cycle: the opinion identifies points of particular attention for the use of mechanistic effect models in pesticide risk assessment. It is recommended that models be documented in a complete and transparent way, that a feedback platform be established involving risk assessors and model developers, and that a set of agreed models be made available.

7 March 2014 Mail Print Cite

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

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 Opsahl Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks, Christoph Tebbe EFSA Journal 2014;12(3):3591 [6 pp.]. doi:10.2903/j.efsa.2014.3591 Abstract

In this statement, the EFSA GMO Panel responds to a request from the European Commission (EC) to complement its partially inconclusive scientific opinion on cotton MON 88913 taking into consideration updated bioinformatic analyses submitted by the applicant after the adoption. Similarity searches assessed the identity of the genomic sequences flanking the MON 88913 insert, the potential of creating open reading frames (ORFs) showing similarity to known allergens or toxins and the similarity of the newly expressed CP4 EPSPS protein to known allergens or toxins. Having assessed these searches, the EFSA GMO Panel did not identify interruptions of known cotton genes or any safety issue arising from the identified ORFs including the newly expressed CP4 EPSPS protein. In conclusion, the EFSA GMO Panel considers that cotton MON 88913, as assessed in the scientific opinion on application EFSA-GMO-UK-2007-41 and in the supplementary bioinformatic dataset, is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.

13 March 2014 Mail Print Cite

Guidance of EFSA

European Food Safety Authority EFSA Journal 2014;12(3):3615 [43 pp.]. doi:10.2903/j.efsa.2014.3615 Abstract

EFSA was asked by the Commission to prepare an EFSA Guidance document on clustering and ranking of emissions of active substances of plant protection products (PPPs) and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments. This EFSA Guidance Document provides guidance for users on how to assess these emissions when performing risk assessments according to Regulation EC no 1107/2009 of the European Parliament and the Council.

20 March 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(3):3353 [81 pp.]. doi:10.2903/j.efsa.2014.3353 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 Italy, for the pesticide active substance orthosulfamuron are reported. The context of the peer review was that required by Commission Regulation (EC) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of orthosulfamuron as a herbicide on rice. 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, that with the available information, the risk assessments to consumers, soil dwelling organisms except soil micro-organisms and aquatic organisms could not be finalised. In addition there is the concern that the exposure assessment to groundwater could not be finalised.

13 March 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(3):3627 [36 pp.]. doi:10.2903/j.efsa.2014.3627 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience to set import tolerances for fenamidone in various root and tuber vegetables, bulb vegetables, fruiting vegetables, broccoli, Chinese cabbage, lettuce and other salad plants, spinach and similar (leaves), herbs, cardoons, celery, fennel and rhubarb. In support of the authorized uses of fenamidone in the United States, the EMS proposed to raise the existing MRLs in all crops under consideration. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals for fenamidone in all crops under consideration. The proposed residue data extrapolations are supported. Based on the risk assessment results, EFSA concludes thatthe import tolerances of fenamidone on the crops under consideration will not result in a chronic consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a public health concern.

31 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3618 [24 pp.]. doi:10.2903/j.efsa.2014.3618 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Agro SAS to set new MRLs for the active substance penconazole in blackberries and raspberries. In order to accommodate for the intended uses of penconazole, France proposed to raise the existing MRLs in blackberries and raspberries from the limit of quantification of 0.05 mg/kg to 0.1 mg/kg. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 0.1 mg/kg for the proposed uses on blackberries and raspberries. Adequate analytical enforcement methods are available to control the residues of penconazole on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the intended uses of penconazole on raspberries and blackberries will not result in a consumer exposure exceeding the toxicological reference values of the parent compound and therefore are unlikely to pose a consumer health risk. The consumer risk assessment should be regarded as provisional and does not take into consideration the triazole derivative metabolites (TDMs).

26 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3619 [25 pp.]. doi:10.2903/j.efsa.2014.3619 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Austria, hereafter referred to as the evaluating Member State (EMS), received an application from Sumitomo Chemical Agro Europe S.A.S to modify the existing MRLs for the active substance fenpyrazamine in stone fruits. In order to accommodate for the intended uses of fenpyrazamine Austria proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 5 mg/kg in apricots, 4 mg/kg in cherries and 3 mg/kg in plums and from 4 mg/kg to 5 mg/kg in peaches. Austria 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 the following MRL proposals: 5 mg/kg for apricots, 4 mg/kg for cherries and 3 mg/kg for plums. For peaches, no amendment of the existing MRL of 4 mg/kg is necessary; however, as alternative option the higher value of 5 mg/kg, derived by extrapolation from a combined dataset on apricots and peaches may be considered by risk managers. An adequate analytical enforcement method is available to control the residues of fenpyrazamine in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of fenpyrazamine on apricots, cherries, peaches and plums will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

26 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3617 [111 pp.]. doi:10.2903/j.efsa.2014.3617 Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance thiacloprid. In order to assess the occurrence of thiacloprid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

21 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3614 [40 pp.]. doi:10.2903/j.efsa.2014.3614 Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance amidosulfuron. In order to assess the occurrence of amidosulfuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, some MRL proposals derived by EFSA still require further consideration by risk managers.

14 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3596 [23 pp.]. doi:10.2903/j.efsa.2014.3596 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Gowan Comercio Internacional e Servicos Ltd. to modify the existing MRL for the active substance formetanate in strawberries. In order to accommodate for the intended use of formetanate, Italy proposed to raise the existing MRL to 0.4 mg/kg. Italy drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on strawberries. Adequate analytical enforcement methods are available to control the residues of formetanate in strawberries. Based on the risk assessment results, EFSA concludes that according to the internationally agreed methodology for estimation of the consumer exposure, the intended use of formetanate on strawberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. However, the safety margin for the acute exposure as regards formetanate residues on strawberries is very narrow.

3 March 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority European Centre for Disease Prevention and Control EFSA Journal 2014;12(3):3590 [336 pp.]. doi:10.2903/j.efsa.2014.3590 Abstract

The antimicrobial resistance data among zoonotic and indicator bacteria in 2012, submitted by 26 European Union Member States, were jointly analysed by the EFSA and the ECDC. Resistance in zoonotic Salmonella and Campylobacter isolates from humans, animals and food and resistance in indicator Escherichia coli,as well as data on methicillin-resistant Staphylococcus aureus, in animals and food were addressed. Resistance in human isolates was mainly interpreted using clinical breakpoints, while microbiological resistance in animal and food isolates was assessed using epidemiological cut-off values. Resistance was commonly found in isolates from humans, animals and food, although marked disparities in resistance were frequently observed between Member States. In Salmonella from humans, high resistance levels were recorded to ampicillin, sulfonamides and tetracyclines, while resistance to third-generation cephalosporins and fluoroquinolones remained low. In Salmonella and Escherichia coli isolates from fowl, pigs, cattle and meat thereof, microbiological resistance to ampicillin, tetracyclines and sulfonamides was commonly detected, while microbiological resistance to third-generation cephalosporins was generally low. High to very high microbiological resistance to (fluoro)quinolones was observed in Salmonella isolates from turkeys, fowl and broiler meat. In Campylobacter from humans, resistance to ampicillin, ciprofloxacin, nalidixic acid and tetracyclines was high, while resistance to erythromycin was low to moderate. High to extremely high microbiological resistance to ciprofloxacin, nalidixic acid and tetracyclines was observed in Campylobacter isolates from fowl, broiler meat, pigs and cattle, whereas much lower levels were observed for erythromycin and gentamicin. Increasing trends for ciprofloxacin resistance was observed in Campylobacter isolates from humans, broilers and/or pigs in several Member States. Multi-resistance and co-resistance to critically important antimicrobials in both human and animal isolates were presented, and for the first time, multi-resistance patterns in Salmonella serovars. Very few isolates from animals were co-resistant to critically important antimicrobials. A minority of isolates from animals belonging to a few Salmonella serovars (notably Kentucky and Infantis) were resistant to high levels of ciprofloxacin.

25 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3616 [23 pp.]. doi:10.2903/j.efsa.2014.3616 Abstract

This scientific report has been prepared in response to a request for urgent scientific and technical assistance under Art 31 of Regulation (EC) No 178/2002, in relation to possible mitigation measures to prevent introduction and spread of African swine fever virus (ASFV). It was requested to assess the feasibility to drastically reduce the wild boar population by hunting or by the use of traps, and to assess if prevention of movement of wild boars by feeding or by artificial physical barriers reduces the risk of spread of ASFV. No evidence was found in scientific literature proving that wild boar populations can be drastically reduced by hunting or trapping in Europe. The main reasons are the adaptive behaviour of wild boar, compensatory growth of the population and the possible influx of wild boar from adjacent areas. Thus, drastic hunting is not a tool to reduce the risk for introduction and spread of ASFV in wild boar populations. Furthermore, wild boar density thresholds for introduction, spread and persistence of ASFV in the wild boar populations are currently impossible to establish, due to the uncertainty regarding the extent of the spread and maintenance of ASFV, the biases in population datasets, the complex population structures and dynamics. Furthermore, attempts to drastically reduce wild boar populations may even increase transmission and facilitate progressive geographical spread of ASFV, since intensive hunting pressure on wild boar populations leads to dispersion of groups and individuals. Artificial feeding of wild boar might increase the risk of ASFV spread. Fencing can restrict wild boar movements, however further knowledge of the ASF epidemiology and spatial distribution of wild boar is required to identify the areas where fencing could be used as one possible element of a control programme and to assess the feasibility of its implementation.

17 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3598 [25 pp.]. doi:10.2903/j.efsa.2014.3598 Abstract

In the analyses of the reported data on food-borne outbreaks at the European Union level it is important to address the relevance of different food categories as outbreak vehicles and the causative agents most frequently associated with these food vehicles. This report includes an update of the technical specifications for harmonised reporting of food-borne outbreaks to the European Union, to allow for the better achievement of their objectives. Member States shall report all food-borne outbreaks which meet the definition in the Directive 2003/99/EC. A distinction has been made between food-borne outbreaks supported by ‘weak’ evidence and those supported by ‘strong’ evidence, based on the strength of evidence implicating a particular food vehicle. The same dataset is used for both weak- and strong-evidence outbreaks. This includes the number of outbreaks per causative agent, and the number of human cases, hospitalisations, and deaths. In addition, other information can be reported by Member States, including the nature of the evidence supporting the suspicion of implicated food vehicles and data on the causative agents, food vehicles, and the factors in food preparation and handling that contributed to the food-borne outbreaks.

17 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3594 [102 pp.]. doi:10.2903/j.efsa.2014.3594 Abstract

This report reviews recent work on bee health carried out by EFSA, Member States (MSs) and the European Commission (EC). It identifies data and knowledge gaps and provides research recommendations that may facilitate the transition towards an integrated environmental risk assessment of multiple stressors on bees. The report was produced by the EFSA Bee Task Force (TF), involved representatives from six different Scientific Units, and was coordinated by the Scientific Committee and Emerging Risks Unit (SCER). The TF consulted experts from MSs and the Bee Interservice Group of the EC. Additional scientific exchanges with experts were promoted by SCER through the organisation of a scientific colloquium on bee health in May 2013. The review identified a total of 220 research projects on bee health at EU level (EFSA, 19; MSs, 181; EC, 20), and 33 additional projects from other international organisations dealing with general aspects, non-research-focused, of bee issues. A quantitative assessment of the retrieved projects revealed that research projects on multiple stressors on bees and projects on bees other than honeybees were missing, especially with regard to monitoring and testing. EFSA projects were predominantly in the area of risk assessments of pesticides on bees. Research projects on in-hive treatments and bee exposure to chemicals funded at the EC level were scarce, as were those focusing on protection goals, bee diversity and pollination services at the MS level. The qualitative assessment of the retrieved projects revealed knowledge gaps at each step of the risk assessment, which led to several recommendations for future scientific work at EFSA and research to be undertaken in the framework of Horizon 2020. Additional recommendations are given for research coordination, planning and knowledge sharing with MSs and the EC. At EFSA level, further communication, internal collaborations and training on bee health are suggested.

13 March 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(3):3597 [68 pp.]. doi:10.2903/j.efsa.2014.3597 Abstract

Arsenic is a ubiquitous metalloid present at low concentrations in rocks, soil and natural ground water. A total of 103 773 food samples (including drinking water) were used to calculate dietary exposure to inorganic arsenic (iAs). Of these, 101 020 were based on total arsenic (tAs) and 2 753 on iAs. Among the reported results on tAs, 66.1 % were below the limit of detection or quantification (left-censored); for the reported data on iAs the percentage of left-censored data was 41.9 %. Most of the data (92.5 %) reported as tAs were converted to iAs using different approaches before calculating dietary exposure to iAs. The EFSA Comprehensive European Food Consumption Database was used to estimate chronic dietary exposure to iAs using 28 surveys from 17 European countries. According to the scenarios used for the treatment of left-censored data, mean dietary exposure among infants, toddlers and other children ranged from 0.20 to 1.37 μg/kg b.w. per day, while the 95th percentile dietary exposure estimates ranged from 0.36 to 2.09 μg/kg b.w. per day. Mean dietary exposure among the adult population (including adults, elderly and very elderly) ranged from 0.09 to 0.38 μg/kg b.w. per day, and 95th percentile dietary exposure estimates ranged from 0.14 to 0.64 μg/kg b.w. per day. For all the age classes except infants and toddlers, the main contributor to dietary exposure to iAs was the food group ‘Grain-based processed products (non rice-based)’, in particular, wheat bread and rolls. Other food groups that were important contributors to iAs exposure were rice, milk and dairy products (main contributor in infants and toddlers), and drinking water. The most important sources of uncertainty in the present assessment are related to the heterogeneity of the food consumption data, the conversion of tAs into iAs and to the treatment of the left-censored data.

6 March 2014 Mail Print Cite

Errata/Corrigenda

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Georges Bories, Paul Brantom, Joaquim Brufau de Barberà, Andrew Chesson, Pier Sandro Cocconcelli, Bogdan Debski, Noël Dierick, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, Joop de Knecht, Lubomir Leng, Sven Lindgren, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Carlo Nebbia, Walter Rambeck, Guido Rychen, Atte von Wright and Pieter Wester doi:10.2903/j.efsa.2009.1039 Abstract Abstract not available Erratum/Corrigendum

Data on the resistance of the active agent to aminoglycoside antibiotics present in the original dossier but not reported in the opinion were included.

27 April 2009 25 March 2014 Mail Print