Search EFSA Journal
Refine your search
Type
All article types
Special Issue Item
Journal Editorial
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Other scientific outputs of EFSA
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Technical Report
Subject
All subjects
Animal health & welfare
Biological hazards
Biological monitoring
Contaminants
Dietary & chemical monitoring
Emerging risks
Feed
Food Ingredients and Packaging
GMO
Nutrition
Pesticides
Plant health
Assessment and methodological support
Scientific Committee
Scientific cooperation
Article ID
Digital Object ID
Sort by:
Publication date
Relevance

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.


Editorials

Schoonjans R and Luttik R EFSA Journal 2014;12(6):e14062 [4 pp.]. doi:10.2903/j.efsa.2014.e14062

10 June 2014 Mail Print Cite

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(6):3725 [33 pp.]. doi:10.2903/j.efsa.2014.3725 Abstract

Astaxanthin is a pigmenting carotenoid naturally occurring in plankton, crustaceans and fish. The FEEDAP Panel considers synthetic astaxanthin safe for salmonids up to 100 mg/kg complete diet. This conclusion is extrapolated to ornamental fish at the same dose. Based on a BMDL10 of 3.4 mg/kg bw per day (calculated for liver hypertrophy in female rat in a carcinogenicity study) and applying an uncertainty factor of 100, it is possible to set an ADI of 0.034 mg ATX/kg bw (equivalent to 2.0 mg ATX per 60 kg person per day). The use of astaxanthin up to the maximum permitted dietary level for salmon and trout is of no concern for the safety of the consumer. Skin or eye exposure to astaxanthin is unlikely to be irritant to workers. Sensitisation is unlikely to occur subsequent to skin exposure. The risk of inhalation toxicity is minimal for the formulation under assessment, but the risk for other formulations cannot be assessed. The FEEDAP Panel considers that the use of synthetic astaxanthin (100 mg astaxanthin/kg fish feed) does not pose a significant additional risk to the environment compared with natural astaxanthin. Astaxanthin is efficacious in colouring the flesh of salmonids and in pigmenting the skin of ornamental fish.

18 June 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(6):3729 [16 pp.]. doi:10.2903/j.efsa.2014.3729 Abstract

Coxiril®, containing 0.5 % diclazuril, is intended for the control of coccidiosis in turkeys for fattening at concentrations between 0.8 and 1.2 mg diclazuril/kg complete feed. The highest proposed use level (1.2 mg diclazuril/kg feed) is considered safe for turkeys for fattening. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the other currently authorised diclazuril. The use of Coxiril® at the highest proposed use level of 1.2 mg diclazuril/kg complete feed in turkeys for fattening is safe for the consumer since Maximum Residue Limits are not exceeded. Coxiril® is considered non-irritant to eyes and skin. It is not a potential skin sensitiser. User exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. Based on a Phase I assessment, the use of diclazuril in turkeys for fattening at the high use level does not pose a risk to the environment. Diclazuril from Coxiril® has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 0.8 mg/kg complete feed. This conclusion is derived from literature data, and from recent studies performed with Coxiril®.

18 June 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(6):3731 [10 pp.]. doi:10.2903/j.efsa.2014.3731 Abstract

In 2011, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sodium bisulphate (SBS) for all species as a preservative and silage additive; for pets and other non-food-producing animals (non-food fur animals) as an acidity regulator; and for pets as a flavouring at a maximum recommended inclusion level for complete feed of 1 %. The Panel concluded that SBS is safe for all animal species at concentrations of 0.8 % in fresh forages for ensiling and for pets and other non-food-producing animals at concentrations of 0.5 % complete feed. The efficacy of SBS as a silage additive could not be demonstrated. The applicant has provided complementary information on the safety and new arguments to support the efficacy of SBS. Based on newly submitted data, the maximum concentration of SBS in complete feed considered safe for chickens for fattening and piglets was 4 000 mg/kg complete feed. Considering also that 8 000 mg SBS/kg fresh ensiling forage is safe for dairy cows, the FEEDAP Panel concluded that 4 000 mg SBS/kg complete feed is safe for all animal species. The concentration of 20 000 mg SBS/kg complete feed recommended for pets and non-food-producing animals was considered safe for cats, with a margin of safety of at least 1.5. For minks, a concentration of 10 000 mg SBS/kg complete feed was considered safe. Since no new data have been presented to demonstrate the efficacy of SBS in improving silage production, the FEEDAP Panel confirmed its previous conclusions that SBS is not efficacious as a silage additive at the concentrations tested (0.4 % and 0.8 %).

18 June 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(6):3724 [35 pp.]. doi:10.2903/j.efsa.2014.3724 Abstract

Astaxanthin is a pigmenting carotenoid occurring naturally in plankton, crustaceans and fish. The astaxanthin under assessment is of synthetic origin. The FEEDAP Panel considers synthetic astaxanthin safe for salmonids up to 100 mg/kg complete diet. The conclusion on the safety of astaxanthin for salmonids can be extrapolated to other fish and ornamental fish at the same dose. Dietary concentrations of up to 100 mg astaxanthin/kg feed are safe for crustaceans. The FEEDAP Panel could not conclude on the safety of astaxanthin for ornamental birds. Based on a BMDL10 of 3.4 mg/kg bw per day (calculated for liver hypertrophy in female rat in a carcinogenicity study) and applying an uncertainty factor of 100, it is possible to set an ADI of 0.034 mg ATX/kg bw (equivalent to 2.0 mg ATX per 60 kg person per day).  The use of astaxanthin up to the maximum permitted dietary level for salmon and trout is of no concern for the safety of the consumer. As some formulations of astaxanthin may be dusty, and in the absence of data on inhalation toxicity, it is prudent to regard astaxanthin-containing additives as being potentially hazardous by inhalation. In the absence of any information on irritancy to skin or eyes or on skin sensitisation, astaxanthin-containing additives should be regarded as hazardous by exposure to skin or eyes. The FEEDAP Panel considers that the use of synthetic astaxanthin (100 mg astaxanthin/kg fish feed) does not pose a significant additional risk to the environment compared with natural astaxanthin. Astaxanthin is efficacious in colouring the flesh of salmonids and the epidermis of crustaceans. Astaxanthin is efficacious in pigmenting the flesh of food-producing fish other than salmonids and the skin of ornamental fish. No conclusion can be made on the efficacy of oral astaxanthin in pigmenting the plumage of ornamental birds.

18 June 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(6):3730 [13 pp.]. doi:10.2903/j.efsa.2014.3730 Abstract

Coxiril®, containing 0.5 % diclazuril, is intended for use in the control of coccidiosis in guinea fowl at concentrations between 0.8 and 1.2 mg diclazuril/kg complete feed. Since diclazuril from Coxiril® is considered safe for turkeys for fattening with a margin of safety of 12-fold the intended dose, this conclusion can be extrapolated to guinea fowl, which is a physiologically similar minor species. Diclazuril at a level of 1.2 mg/kg complete feed is therefore safe for guinea fowl. The safety for the consumer of diclazuril when used as a feed additive for chickens for fattening and turkeys for fattening has been established. The FEEDAP Panel proposed that the same Maximum Residue Limits (MRLs) be applied as established in chickens and turkeys for fattening. A withdrawal time is not considered necessary. In the absence of data on residues of diclazuril in eggs, no conclusion on the potential exposure of the consumer can be made. No specific safety concerns related to the user or the environment were identified in the opinions on Coxiril® for chickens and turkeys for fattening, and the same applies to the use of Coxiril® in guinea fowl, since the conditions of use are similar. Based on the results of one study, in which guinea fowl were artificially infected with Eimeria numidia and Eimeria grenieri, and considering the established efficacy of the additive at the proposed use level compared with other Eimeria species, the FEEDAP Panel concludes that 0.8 mg diclazuril/kg feed has the potential to control coccidiosis in guinea fowl.

18 June 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(6):3706 [95 pp.]. doi:10.2903/j.efsa.2014.3706 Abstract

Berries are a perishable food which can be consumed as fresh or minimally-processed as well as a frozen ingredient added to many foods. Strawberries, raspberries, blackberries and blueberries are the most commonly consumed in the EU. Risk factors for berry contamination by Salmonella and Norovirus were considered in the context of the whole food chain. Available estimates of the prevalence of these pathogens in berries were evaluated together with mitigation options relating to prevention of contamination and the relevance of microbiological criteria. It was concluded that each farm environment represents a unique combination of risk factors that can influence occurrence and persistence of pathogens in berry 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 berry producers. There is currently insufficient evidence to justify the establishment of microbiological criteria for Salmonella for fresh or frozen berries. Outbreaks associated with Norovirus in frozen raspberries and strawberries are an emerging public health risk, although it is not known if in these outbreaks contamination occurred at minimal processing or during primary production. It is currently not possible to assess the suitability of an EU-wide Norovirus Hygiene Criterion at primary production for raspberries and strawberries. Microbiological criteria for Norovirus in berries are useful for validation and verification of food safety management systems, including HACCP-based processes and procedures, and can be used to communicate to food business operators and other stakeholders what is acceptable or unacceptable, however there is insufficient data to provide a risk base for establishing a Process Hygiene and Food Safety Criteria for Norovirus in berries. Collection of appropriate data and subsequent risk-based development of microbiological criteria to support improved control of Norovirus in frozen raspberries and strawberries should be considered as a priority.

18 June 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 Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe. EFSA Journal 2014;12(6):3701 [37 pp.]. doi:10.2903/j.efsa.2014.3701 Abstract

Oilseed rape MON 88302 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 EPSPS protein, which confers tolerance to glyphosate. The molecular characterisation of oilseed rape MON 88302 did not raise safety issues. Agronomic and phenotypic characteristics of oilseed rape MON 88302 tested under field conditions revealed no biologically relevant differences between oilseed rape MON 88302 and its conventional counterpart, except for days-to-first flowering. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein, and no evidence that the genetic modification might significantly change the overall allergenicity of oilseed rape MON 88302. The nutritional value of oilseed rape MON 88302 is not expected to differ from that of non-GM oilseed rape varieties. There are no indications of an increased likelihood of spread and establishment of feral oilseed rape MON 88302 plants or hybridising wild relatives, unless these plants are exposed to glyphosate. It is unlikely that the observed difference in days-to-first flowering would lead to any relevant increase in persistence or invasiveness. Risks associated with an unlikely, but theoretically possible, horizontal transfer of recombinant genes from oilseed rape MON 88302 to bacteria were not identified. The post-market environmental monitoring plan is in line with the intended uses of oilseed rape MON 88302. In conclusion, the EFSA GMO Panel considers that the information available addresses the scientific requirements of the EFSA GMO Panel and the scientific comments raised by the Member States, and that oilseed rape MON 88302, as described in this application, is as safe as its conventional counterpart and non-GM commercial oilseed rape varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

17 June 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(6):3723 [9 pp.]. doi:10.2903/j.efsa.2014.3723 Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of Natugrain® TS/TS L in laying hens. This feed additive contains endo-1,4-beta-xylanase and endo-1,4-beta-glucanase, produced by two genetically modified strains of Aspergillus niger. The product is available in solid (Natugrain® TS) and liquid (Natugrain® TS L) forms. This additive is authorised for use in weaned piglets and pigs for fattening, poultry species and ornamental birds. The applicant is now seeking a modification of the terms of the authorisation to reduce the recommended dose in laying hens from 560 thermostable xylanase units (TXU) and 250 thermostable glucanase units (TGU) per kg feed to 280 TXU and 125 TGU per kg feed. The FEEDAP Panel assumes that the two formulations of the additive are equivalent in terms of efficacy. A total of three trials were provided. Based on the results obtained, the Panel concludes that Natugrain® TS has the potential to be efficacious in laying hens at the dose of 280 TXU and 125 TGU per kg feed.

17 June 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(6):3726 [14 pp.]. doi:10.2903/j.efsa.2014.3726 Abstract

The product L-Threonine is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli. L-Threonine is an essential amino acid for all animal species. It is commonly considered the second and third limiting amino acid in cereal-based diets for pigs and poultry, respectively. It is widely used in the feed industry to optimise dietary protein. The amino acid L-threonine itself is considered safe for the target animals, the consumer and the environment. However, the possible presence of the production strain and its recombinant DNA, including antibiotic resistance genes used in the genetic modification process, in the final product cannot be excluded. Consequently, the FEEDAP Panel cannot conclude on the safety of L-threonine produced by fermentation with such E. coli strain for the target animals, consumers and the environment. Regardless of the assessment of the genetic modification, the FEEDAP Panel has concerns regarding the safety of amino acids, including L-threonine, for target species when administered via water for drinking. From the results provided, it is concluded that there is no concern for users in respect of respiratory toxicity, or skin or eye irritancy. In the absence of any data on sensitisation, it is concluded that the product may have the potential to be a dermal sensitiser. The concerns regarding the safety of the genetic modification may also have implications for the safety of the user. The product L-threonine is an efficacious source of supplemented amino acid which helps to maintain or restore the adequate balance of dietary amino acids for all non-ruminant species. Supplemental L-threonine is degraded by ruminal microorganisms if not given in a protected form.

17 June 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(6):3727 [2 pp.]. doi:10.2903/j.efsa.2014.3727 Abstract

Oralin® is a preparation containing viable cells of Enterococcus faecium. It is currently authorised for use in calves, piglets, chickens and turkeys for fattening and dogs. The applicant is now requesting the re-evaluation of the additive when used in feeds for calves for rearing, piglets, chickens and turkeys for fattening, and dogs at different doses. Oralin® is safe for calves, piglets, cats, and chickens and turkeys for fattening. Since the additive has shown a wide and comparable margin of safety in three major species, it is considered safe for dogs. The Oralin® strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is not resistant to clinically relevant antibiotics. Since no other sources of concern have been identified in the additive, the use of the Oralin® is considered safe for consumers. Oralin® is not irritant to skin or eyes or a skin sensitiser, but in its solid forms should be considered to have the potential to be a respiratory sensitiser. E. faecium is a natural component of gut microbiota and its use as Oralin® in animal feeding would not be expected to pose any risk to the environment. The addition of Oralin® to feed has the potential to improve the performance of calves for rearing, chickens for fattening, turkeys for fattening, suckling and weaned piglets. However, the minimum dose found efficacious was higher that that proposed by the applicant for turkeys for fattening, and that for suckling piglets should be expressed in CFU/piglet/day. Three studies showed a limited but significant improvement of faecal scores in dogs treated with Oralin®. However, such limited improvement in faecal scores is questionable in terms of biological relevance.

17 June 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(6):3728 [23 pp.]. doi:10.2903/j.efsa.2014.3728 Abstract

Coxiril®, containing 0.5 % diclazuril, is intended for use in the control of coccidiosis in chickens for fattening at a dose range of 0.8 to 1.2 mg diclazuril/kg complete feed. The highest proposed use level (1.2 mg diclazuril/kg feed) is considered safe for chickens for fattening, although the value of the tolerance study is limited owing to weaknesses in the design. However, none of the parameters measured showed an adverse effect of the three-fold use level of diclazuril. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the other currently authorised diclazuril. The use of Coxiril® at the highest proposed use level of 1.2 mg diclazuril/kg complete feed in chickens for fattening is safe for the consumer since Maximum Residue Limits are not exceeded. Coxiril® is considered non-irritant to eyes and skin. It is not a potential skin sensitiser. User exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. Based on a Phase I assessment, the use of diclazuril in chickens for fattening at the high use level does not pose a risk to the environment. Diclazuril from Coxiril® has the potential to control coccidiosis in chickens for fattening at a minimum dose of 0.8 mg/kg complete feed. This conclusion is derived from literature data, and from recent studies (five floor pen studies, two field trials and two sensitivity tests) performed with Coxiril®.

17 June 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(6):3722 [13 pp.]. doi:10.2903/j.efsa.2014.3722 Abstract

Rovabio® Excel is a preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase that is intended to be used as a feed additive for lactating sows, at a dose of 1 500 glucanase U and 1 100 xylanase U/kg feed, in order to minimise the mobilisation of body reserves of sows during lactation. The European Food Safety Authority issued an opinion on the safety and efficacy of Rovabio® Excel as a feed additive for chickens and turkeys for fattening, laying hens, piglets (weaned) and pigs for fattening, ducks, guinea fowl, quails, geese, pheasants and pigeons. The full description of the formulations, manufacturing processes, purity, stability and homogeneity of the product is given in that assessment. The FEEDAP Panel considers that the safety aspects, other than for the new target species, are covered in the previous assessment and would not be affected by the extension of use requested. The results of a tolerance study showed that 200-fold the recommended dose was tolerated well by the sows when offered for a period of seven weeks, including gestation and lactation. Therefore, the Panel concludes that the recommended dose is safe in lactating sows. The Panel cannot conclude on the efficacy of Rovabio® Excel from the available efficacy data.

16 June 2014 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, Thierry Candresse, Gianni Gilioli, Jean–Claude Grégoire, Imre Holb, Michael John Jeger, Olia Evtimova Karadjova, Christer Magnusson, David Makowski, Charles Manceau, Maria Navajas, Trond Rafoss, Vittorio Rossi, Jan Schans, Gritta Schrader, Gregor Urek, Johan Coert van Lenteren, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014;12(6):3720 [26 pp.]. doi:10.2903/j.efsa.2014.3720 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform the pest categorisation for Xanthomonas campestris pv. vesicatoria, which is the causal agent of bacterial spot of tomato and pepper. X. campestris pv. vesicatoria is not a single taxonomic entity, and four separate species have been described:    X. vesicatoria, X. euvesicatoria, X. perforans and X. gardneri. These organisms can be accurately identified based on a range of discriminative methods. Detection methods are available for seeds. Among the four species described within X. campestris pv. vesicatoria, all except X. gardneri were reported to be present in the EU territory. The host plants (tomato and pepper) are cultivated throughout Europe and conditions are conducive to disease development in open fields in southern Europe and in greenhouses. The disease causes a range of symptoms on aerial parts of plants including fruits. Contaminated seeds and transplants are responsible for long-distance dissemination of the pathogen. Control is mainly based on prevention and exclusion. Extraction of seeds from fruit debris using fermentation and acid treatments and thermotherapy treatments were shown to be effective in reducing the bacterial load in seed lots. No methods and chemical control agents are available that effectively control xanthomonads in infected crops. Although no recent data are available on economic losses caused by these pathogens in the EU, the organisms are considered important bacterial pathogens of tomato and pepper. Infections resulting in up to 30 % losses have been reported. Xanthomonads causing bacterial spot of tomato and pepper meet all criteria defined in International Standard for Phytosanitary Measures (ISPM) 21 and they also meet all ISPM 11 criteria, although X. vesicatoria, X. euvesicatoria and X. perforans are present in the EU territory.

16 June 2014 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, Thierry Candresse, Gianni Gilioli, Jean-Claude Grégoire, Imre Holb, Michael John Jeger, Olia Evtimova Karadjova, Christer Magnusson, David Makowski, Charles Manceau, Maria Navajas, Trond Rafoss, Vittorio Rossi, Jan Schans, Gritta Schrader, Gregor Urek, Johan Coert van Lenteren, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014;12(6):3721 [29 pp.]. doi:10.2903/j.efsa.2014.3721 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform the pest categorisation for Clavibacter michiganensis subsp. michiganensis (Cmm). The agent responsible for vascular tomato wilt and canker is the clearly defined and valid gram-positive taxon C. michiganensis subsp. michiganensis. This pathogen can be accurately identified based on a range of sensitive and specific methods. Tomato (Solanum lycopersicum) is the main host, but peppers (Capsicum annum and C. frutescens) are also naturally susceptible to Cmm. These host plants are cultivated throughout Europe and conditions are conducive to disease development in open fields in southern Europe and in greenhouses. The disease is present in many EU Member States. Outbreaks are rare but usually severe. It causes a range of symptoms on the aerial parts of plants, including the fruits. Detection methods are available for any type of plant material either presenting symptoms or symptomless. Seed testing has proven to be a good control option by discarding contaminated seed lots. Despite tomato seed production being done under strict sanitation using recommended practices, seed contamination still occurs occasionally. Contaminated seeds and transplants are responsible for long-distance dissemination of the pathogen. Under conducive conditions, even low levels of seed contamination can result in disease outbreaks. Cultivation practices can favour secondary spread of the bacterium and an increase in disease incidence both in greenhouse and in open-field crops. No effective biological or chemical control agents are registered for bacterial canker in Europe. Cmm meets all criteria defined in International Standard for Phytosanitary Measures (ISPM) 21. Cmm meets all ISPM 11 criteria, although it has been observed in 16 EU Member States. The outbreaks are usually severe but sporadic.

16 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldra and Detlef Wölfle. EFSA Journal 2014;12(6):3707 [77 pp.]. doi:10.2903/j.efsa.2014.3707 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 44 simple aliphatic and aromatic sulphides and thiols evaluated by the JECFA at the 53rd and the 68th meeting. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. For 36 substances considered in this FGE the Panel concluded that they would pose “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach For seven substances [FL-no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252 and 12.259] the Panel decided, contrary to the JECFA that these substances could not be evaluated due to absence of a NOAEL from either one of these substances or from a structurally related substance. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 44 substances, the information is adequate. For candidate substance 3-(methylthio)heptenal [FL-no: 12.273], which contains 5 to7 % of an α,β-unsaturated aldehyde, 2-(E)-heptenal, with a possible genotoxic potential, the Panel cannot conclude that the material of commerce for this candidate substance is not of safety concern, until either this component is cleared with respect to a concern for genotoxicity, or this component is removed from the commercial product.

13 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldra and Detlef Wölfle. EFSA Journal 2014;12(6):3710 [62 pp.]. doi:10.2903/j.efsa.2014.3710 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 19 simple aliphatic sulphides and thiols evaluated by the JECFA at the 53rd meeting in 1999 and the 61st meeting in 2003. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. For nine substances [FL-no: 12.088, 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291] considered in this FGE, the Panel concluded that they would pose “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for all nine substances, the information is adequate. Thus, the Panel concluded that nine substances [FL-no: 12.088, 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. For 10 candidate substances in FGE.74Rev3 [FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155, 12.169, 12.241 and 12.280] evaluated through the Procedure, the Panel concluded that additional toxicity data are required.

13 June 2014 Mail Print Cite

EFSA Panel on Genetically Modified Organisms (GMO) Salvatore Arpaia, Nicholas Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare M. Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks, Christoph Tebbe EFSA Journal 2014;12(6):3704 [29 pp.]. doi:10.2903/j.efsa.2014.3704 Abstract

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the post-market environmental monitoring (PMEM) report for the 2012 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel noted that the applicant used a similar methodology as the one previously established for monitoring maize MON 810 in 2009, 2010 and 2011. The EFSA GMO Panel therefore focused its assessment on the novel datasets specific to the 2012 growing season of maize MON 810, and not on the methodology. The data submitted by the applicant in its 2012 PMEM report do not indicate any adverse effects on human and animal health or the environment arising from maize MON 810 cultivation in 2012. However, having already highlighted the poor sensitivity of the methodology followed by the applicant, the EFSA GMO Panel strongly reiterates its previous recommendations for the improvement of the methodology. In addition, the EFSA GMO Panel recommends that the applicant: (1) further investigates effects observed during the monitoring of baseline susceptibility of target pests in Spain; (2) follow-up possible adverse effects of maize MON 810 on rove beetles.

13 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldra and Detlef Wölfle. EFSA Journal 2014;12(6):3708 [32 pp.]. doi:10.2903/j.efsa.2014.3708 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of five epoxides evaluated by the JECFA at the 65th meeting in 2005. This revision is made due to inclusion of one additional substance, beta-ionone epoxide [FL-no: 07.170], cleared for genotoxicity concern and due to additional toxicity data have become available for beta-caryophyllene epoxide [FL-no: 16.043]. Since publication of FGE.82 one substance epoxy oxophorone [FL-no: 16.051] is no longer supported for use as flavouring substances in Europe by Industry and will therefore not be considered any further. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. For four substances [FL-no: 16.015, 16.018, 16.040 and 16.043] the Panel agreed with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For one substance [FL-no: 07.170] additional toxicity data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for four substances, the information is adequate; but for the substance [FL-no: 07.170] further information on stereoisomerism is required.

12 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt †, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldra and Detlef Wölfle. EFSA Journal 2014;12(6):3709 [50 pp.]. doi:10.2903/j.efsa.2014.3709 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided.

12 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(6):3715 [16 pp.]. doi:10.2903/j.efsa.2014.3715 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Phoenix – LNOc process (EU register number RECYC028). The input to the process is hot caustic washed and dried PET flakes originating from collected post-consumer poly(ethylene terephthalate) (PET) bottles and containing no more than 5 % of PET from non-food consumer applications. In this process, washed and dried flakes are grinded into small particle size powder, and then powder is compacted into pellets which fed into a reactor at high temperature under inert gas flow. Having examined the results of the challenge test provided, the Panel concluded that the three steps, the pulverisation, the compaction and the decontamination are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are well defined and are particle size for the pulverisation (step 2), time, pressure and pellet size for the compaction (step 3) and temperature, dry air flow and the residence time for the decontamination (step 4). The operating parameters of these steps in the process are at least as severe as those obtained from the challenge test. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food derived from the exposure scenario for infants and 0.15 μg/kg food derived from the exposure scenario for toddlers. The Panel concluded that the recycled PET obtained from this process is not of safety concern when used to manufacture articles intended for food contact material applications in compliance with the conditions as specified in the conclusion of the opinion.

6 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq (until july 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(6):3718 [9 pp.]. doi:10.2903/j.efsa.2014.3718 Abstract

This scientific opinion of EFSA deals with the safety assessment of perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, CAS No 1190931-27-1, for use as a polymer production aid during the manufacture of fluoropolymers. Specific migration of the substance was not determined. The specific migration of the substance and the two degradation products in polytetrafluoroethylene film were determined and the maximum potential migrations were 0.4 μg/kg food. The CEF Panel concluded there is no safety concern for the consumer if the substance is only to be used as a polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 °C and intended for repeated use in contact with all types of foodstuffs under all contact conditions.

6 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(6):3713 [15 pp.]. doi:10.2903/j.efsa.2014.3713 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Greenfiber (EU register No RECYC108) which is based on the VACUREMA Prime ® technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers, containing no more than 5 % of PET from non-food consumer applications. Through this technology, washed and dried PET flakes are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the challenge test provided, the Panel concluded that the two steps, the decontamination in batch reactors and the decontamination in continuous reactor are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the recycled PET obtained from this process, intended to be used up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET should not be used in microwave and conventional ovens.

5 June 2014 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Rose Martin, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright. EFSA Journal 2014;12(6):3696 [39 pp.]. doi:10.2903/j.efsa.2014.3696 Abstract

Hexamethylene tetramine (HMT) is a food additive, currently only permitted in EU for use in Provolone cheese. The maximum permitted level is 25 mg/kg residual amount, expressed as formaldehyde, the break down product of HMT under acidic conditions. HMT has been previously evaluated by the Joint Expert Committee on Food Additives (JECFA, 1974) who established an ADI of 0.15 mg/kg bw/day based on a reproductive study with a NOEL of 15 mg/kg bw/day. Due to the limitations in the database the Panel could not identify a critical study and therefore to derive an ADI. However, the Panel noted that the exposure to formaldehyde from HMT of high level consumers of Provolone cheese equalled 18 µg formaldehyde/kg bw/day in adults and could be as high as 87 µg formaldehyde/kg bw/day in children according to a theoretical conservative assumption that all ripened cheese consumed was Provolone cheese. Considering the estimated exposure from the very limited permitted use, the toxicological database on HMT, the data from use of HMT therapeutically, the available oral toxicity and toxicokinetic data of formaldehyde and the magnitude of the potential effect on intracellular formaldehyde levels arising from this use of HMT, the Panel concluded that the use of HMT in Provolone cheese at the MPL of 25 mg/kg residual amount, expressed as formaldehyde, would not be of safety concern. However the Panel considered that any increase in the permitted uses of HMT or increases in the MPL of 25 mg /kg residual amount, expressed as formaldehyde would need detailed assessment which might require new toxicity data as well as use levels and/or an evaluation of its impact on formaldehyde levels in vivo.

5 June 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until july 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(6):3714 [9 pp.]. doi:10.2903/j.efsa.2014.3714 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the risk assessment of 5-norbornene-2,3-dicarboxylic anhydride CAS 826-62-0, FCM substance No 978, for a co-monomer in polyester based coatings for metal cans. Based on the residual content of the substance in the final coating, the calculated worst case migration of the two isomers of the substance and their hydrolysis products was 27 µg/kg food. From the same experiment the overall migration was 24 mg/kg food. LMWF was found to make up 8.8 mg/kg food, out of this the LMWF which contains the substance was 1.54 mg/kg food. Based on negative results from two in vivo genotoxicity tests, the Panel considered that the substance and the LMWF oligomers containing the substance moieties are non-genotoxic. The systemic toxicity of the substance-containing LMWF oligomers was assessed in a subchronic oral rat study. The comparison between the NOAEL, derived from this study and a daily intake gives a large margin of safety. The CEF Panel concluded that the substance 5-norbornene-2,3-dicarboxylic anhydride is not of a safety concern for the consumer if it is used as a co-monomer in polyester based can coatings at levels of up to 18.3 weight % of the final dry coating, in contact with all food excluding beverages, at sterilization conditions and long term contact. Migration of the substance and its hydrolysis products should in total not exceed 50 µg/kg food.

4 June 2014 Mail Print Cite

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq (until july 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(6):3712 [7 pp.]. doi:10.2903/j.efsa.2014.3712 Abstract

The substance silicon dioxide, silanated, with FCM substance No 87, is authorised for use as an additive in all types of plastics, without restriction. The re-evaluation of the substance was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nanoform. Information on the basic (untreated) silicon dioxide, the surface treated silicon dioxide, silanated, and a study investigating the migration potential of the silanated silicon dioxide were provided. Having examined the information provided, the CEF Panel concluded that the information provided demonstrates adequately the absence of isolated primary nanoparticles in the basic silicon dioxide and in the silanated silicon dioxide since only aggregates larger than 100 nm along with larger agglomerates were observed using two independent measurement techniques, one of which was transmission electron microscopy (TEM). The particle size range was not affected when the silanated product was incorporated into a low density polyethylene film at 3 % w/w. Furthermore, there was no detectable migration of silicon dioxide, of any particle size, from this film into appropriate food simulants. Therefore at the particle sizes reported, the substance silicon dioxide, silanated, does not raise a safety concern for the consumer in the currently authorised conditions of use.

12 June 2014 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Rose Martin, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright. EFSA Journal 2014;12(6):3697 [11 pp.]. doi:10.2903/j.efsa.2014.3697 Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific statement presenting a conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010. This framework will be used in the evaluation made by the Panel, but the expert judgement of the scientific background, on a case-by-case basis, remains essential to reach a final conclusion. The outcome of the re-evaluation of food additives taking into account all available information is presented in the document, as well as the exposure assessment scenarios to be carried out by the Panel considering the use levels set in the legislation and the availability of adequate usage or analytical data.

5 June 2014 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2014;12(6):3732 [7 pp.]. doi:10.2903/j.efsa.2014.3732 Abstract

Following a request of the European Commission, the European Food Safety Authority (EFSA) evaluated the documentation submitted by Greece in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 for cultivation according to Article 18 of Directive 2002/53/EC. All concerns on the safety of maize MON 810 related to human and animal health or the environment raised by Greece were already addressed in previous outputs of the EFSA or its GMO Panel on maize MON 810 or related Bt maize events expressing Cry1Ab protein. The concern pertaining to co-existence was not considered as this is not in the remit of EFSA. Therefore, EFSA concludes that, based on the documentation submitted by Greece, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 18 of Directive 2002/53/EC and that would invalidate the previous EFSA GMO Panel risk assessments of maize MON 810.

10 June 2014 Mail Print Cite

Guidance of EFSA

European Food Safety Authority EFSA Journal 2014;12(6):3734 [278 pp.]. doi:10.2903/j.efsa.2014.3734 Abstract

Quantitative risk assessments facilitate the decisions of risk managers. In the EU, risk assessment in food and feed safety is the responsibility of the European Food Safety Authority (EFSA). Quantitative risk models should be informed by systematically reviewed scientific evidence, however, in practice empirical evidence is often limited: in such cases it is necessary to turn to expert judgement. Psychological research has shown that unaided expert judgement of the quantities required for risk modelling - and particularly the uncertainty associated with such judgements - is often biased, thus limiting its value. Accordingly methods have been developed for eliciting knowledge from experts in as unbiased a manner as possible. In 2012, a working group was established to develop guidance on expert knowledge elicitation appropriate to EFSA's remit. The resulting Guidance first presents expert knowledge elicitation as a process beginning with defining the risk assessment problem, moving through preparation for elicitation (e.g. selecting the experts and the method to be used) and the elicitation itself, culminating in documentation. Those responsible for managing each of these phases are identified. Next three detailed protocols for expert knowledge elicitation are given - that can be applied to real-life questions in food and feed safety - and the pros and cons of each of these protocols are examined. This is followed by principles for overcoming the major challenges to expert knowledge elicitation: framing the question; selecting the experts; eliciting uncertainty; aggregating the results of multiple experts; and documenting the process. The results of a web search on existing guidance documents on expert elicitation are then reported, along with case studies illustrating some of the protocols of the Guidance. Finally, recommendations are made in the areas of training, organisational changes, expert identification and management, and further developments of expert knowledge elicitation methodology within EFSA.

19 June 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(6):3583 [39 pp.]. doi:10.2903/j.efsa.2014.3583 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 cerevisane (cell walls of Saccharomyces cerevisiae strain LAS117), and the assessment of the proposal for inclusion of the substance in Annex IV of Regulation (EC) No 396/2005, are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of the active substance as a systemic resistance inducer against fungi and bacteria in lettuce and other salad crops. 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. No concerns are identified.

25 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3717 [90 pp.]. doi:10.2903/j.efsa.2014.3717 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 beta-cypermethrin are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of beta-cypermethrin as an insecticide on oilseed rape, wheat and maize. 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 as regards the risk to aquatic organisms, bees and non-target arthropods.

20 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3736 [92 pp.]. doi:10.2903/j.efsa.2014.3736 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 Czech Republic, for the pesticide active substance flumioxazin 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 flumioxazin as a herbicide on winter wheat and sunflower (pre- and post-emergence). 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.

12 June 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(6):3743 [31 pp.]. doi:10.2903/j.efsa.2014.3743 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an import tolerance application from Exponent International Ltd., on behalf of BASF Corporation, to set MRLs for the use of the active substance imazapyr in genetically modified soya bean grown in Brazil, imidazolinone-tolerant lentils, rape and mustard plants grown in Canada and sunflowers in Argentina. The United Kingdom proposed to set MRLs of 5 mg/kg in soya bean, 0.08 mg/kg in sunflower seed, 0.05 mg/kg in rape seed and mustard seed and 0.2 mg/kg in lentils. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 5 mg/kg on soya bean, 0.08 mg/kg on sunflower seed, the limit of quantification (LOQ) of 0.05 mg/kg on rape and mustard seed and 0.3 mg/kg on lentils. In the countries of origin the MRLs are set at 3 mg/kg on soya bean, 0.05 mg/kg on sunflower, rape and mustard seed and 0.2 mg/kg on lentils. Adequate analytical enforcement methods are available to control the residues of imazapyr in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of imazapyr in soya bean, sunflower seed, rape seed, mustard seed and lentils will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.

26 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3740 [49 pp.]. doi:10.2903/j.efsa.2014.3740 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 flonicamid. In order to assess the occurrence of flonicamid 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, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

18 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3739 [25 pp.]. doi:10.2903/j.efsa.2014.3739 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 Bayer CropScience to modify the existing Maximum Residue Level (MRL) for the active substance spirotetramat in olives for oil production. In order to accommodate for the intended use of spirotetramat in southern EU, the EMS proposed to raise the existing MRL from the limit of quantification 0.1 mg/kg to 4 mg/kg. 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 an MRL proposal of 4 mg/kg for olives for oil production. Based on the risk assessment results, EFSA concludes that the proposed use of spirotetramat on olives for oil production will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

17 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3738 [16 pp.]. doi:10.2903/j.efsa.2014.3738 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from the Horticultural Development Council to modify the existing MRL for phenmedipham in lettuce and other salad plants. The United Kingdom proposed to raise the existing MRL on lettuce from the LOQ of 0.05 mg/kg to 4 mg/kg. 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. Although the residue trials according to the intended GAP are sufficient in number, as long as the data gap identified regarding the nature of residues of phenmedipham in leafy crops is not addressed, EFSA does not recommend setting a MRL to accommodate for the intended use in lettuce.

16 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3735 [24 pp.]. doi:10.2903/j.efsa.2014.3735 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Dormfresh Ltd. to include the active substance 1,4-dimethylnaphthalene (1,4-DMN) in Annex IV of the Regulation (EC) No 396/2005. Considering the EFSA conclusion where the inclusion in annex IV was not recommended, the applicant submitted a revised application, in order to rise the MRL for 1,4-DMN in potatoes from the default value of 0.01* mg/kg to 15 mg/kg. The Netherlands drafted a revised 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 15 mg/kg for the post harvest use of 1,4-DMN on potato. For the other plant commodities, it is noted that a default MRL value of 0.01* mg/kg is probably not appropriate to cover the natural background levels of 1,4-DMN in plants. Adequate analytical enforcement methods are available to control residues of 1,4-DMN in potato tubers. In contrast a validated analytical method to enforce 1,4-DMN residues in animal matrices is required. The consumer risk assessment could not be finalised as sufficient information was not provided to derive MRLs for products of animal origin. However, based on the available data, chronic intake concerns are not expected for consumers.

10 June 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(6):3733 [29 pp.]. doi:10.2903/j.efsa.2014.3733 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from Exponet International Ltd. to modify the existing MRLs for the active substance tebufenozide in various crops. In order to accommodate for the intended uses of tebufenozide, Germany proposed to raise the existing MRL in table and wine grapes from 3 mg/kg to 4 mg/kg and to lower the existing MRL in apricots, cherries and plums from 1 mg/kg to 0.03 mg/kg, whereas an amendment of the existing MRL was not proposed for pome fruits and lettuce. Germany 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 0.03 mg/kg for apricots, cherries and plums, a tentative MRL of 0.7 mg/kg for pome fruit and a MRL proposal of 9 mg/kg for lettuce. A risk manager decision should be taken before lowering of the existing MRLs for pome fruit, lettuce and the stone fruit. As the intended uses on grapes are not adequately supported by residue data no MRL proposal can be derived. Adequate analytical enforcement methods are available to control the residues of tebufenozide in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of tebufenozide on apricots, cherries, plums, pome fruits and lettuce will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.

6 June 2014 Mail Print Cite

Errata/Corrigenda

European Food Safety Authority EFSA Journal 2014;12(1):3545 [60 pp.]. doi:10.2903/j.efsa.2014.3545 Abstract

Regulation (EC) No 396/2005 on Maximum Residue Levels of pesticides in or on food and feed of plant and animal origin requires the Member States to monitor pesticide residue levels in food commodities and submit the monitoring results to EFSA and the European Commission. In 2009, EFSA developed the Standard Sample Description (SSD), which is a standardised model for the reporting of harmonised data on analytical measurements of chemical substances occurring in food, feed and water. This document is intended to provide the Member States with specific guidance on how to use the SSD for the reporting of the national results of the pesticide monitoring in the framework of Article 32 of Regulation (EC) No 396/2005. In particular, this document is meant to provide SSD users with support in selecting the appropriate codes for the elements which pertain to pesticide residues monitoring data. This document shall complement the EFSA guidance document “Standard sample description for food and feed”.

21 January 2014 18 June 2014 Mail Print Cite