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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 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(7):3782 [147 pp.]. doi:10.2903/j.efsa.2014.3782 Abstract

Salmonella Enteritidis is considered the only pathogen currently posing a major risk of egg-borne diseases in the European Union (EU). The possible impact of extending the shelf-life of eggs on the risk to consumers posed by S. Enteritidis was estimated by applying a quantitative model and comparing the actual situation regarding the storage of eggs in the EU with different possible scenarios combined, considering the prolongation of the best-before and the sell-by date from 7 to a maximum of 70 days. Extending the sell-by date by one week (from 21 to 28 days), but leaving the best-before date unchanged, is estimated to result in a relative risk of illness of 1.4 and 1.5 for uncooked and lightly cooked egg meals respectively, compared to the current situation. If the best-before date is also extended by one week (from 28 to 35 days), the relative risk would be 1.6 and 1.7. In the worst case scenario considered (sell-by date of 42 days, best before date of 70 days), such figures would be 2.9 and 3.5. It should be noted that the absolute risk is greater for uncooked meals compared to lightly cooked meals. An effective way to minimise any increase in risk during extended storage is to keep the eggs refrigerated both at retail and the household. Regarding egg spoilage, such events strongly depend on the hygienic conditions of egg production and practices of egg handling, including storage times and temperatures. Finally, the impact of the prolongation of storage time on the quality criteria for eggs (3-hydroxybutyric acid and lactic acid) destined for manufacturing of egg products is considered negligible.

31 July 2014 Mail Print Cite

EFSA Scientific Committee Jan Alexander, Diane Benford, Qasim Chaudhry, John Griffin, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Simon More, Alicja Mortensen, Birgit Nørrung, Bernadette Ossendorp, Joe Perry, Josef Schlatter, Vittorio Silano, Kristen Sejrsen EFSA Journal 2014;12(7):3806 [74 pp.]. doi:10.2903/j.efsa.2014.3806 Abstract

Carvone occurs naturally as dextrorotatory (d-) and levorotatory (l-) enantiomers in several food items; these may also be used as a pesticide, food flavouring, feed flavouring, in feed additive, in personal care products and as (veterinary) medicine. In order to improve coherence regarding the risk assessment of carvone in the different food and feed sector areas, EFSA asked its Scientific Committee to establish a single ADI for carvone, estimate the overall exposure of European consumers, and quantify the contribution for each source of exposure to the overall exposure of carvone. Having reviewed the information available the Scientific Committee decided to address d-carvone and l-carvone separately and limit its assessment to the oral intake of d- and l-carvone. The Scientific Committee established an ADI of 0.6 mg/kg bw/day for d-carvone, based on the BMDL10 of 60 mg/kg bw/day for an increase in relative liver weight in the rat 90-day studies and an uncertainty factor of 100. The Scientific Committee could not establish an ADI for l-carvone because of a lack of toxicological data for this enantiomer. The highest level of aggregated exposure to d-carvone is estimated to be 0.60 mg/kg bw/day, i.e. is at the level of the ADI established for d-carvone. The highest level of aggregated exposure to l-carvone is three-fold that of d-carvone. In view of key uncertainties 1) on the toxicity of l-carvone, 2) on the biological relevance of the endpoint selected to establish the ADI for d-carvone and its use as a surrogate for the observed lethality in tested animals, 3) whether d- and l-carvone should be considered together for possible combined effects and 4) in the aggregated exposure assessments to d- and to l-carvone, the Scientific Committee recommended generating additional data to refine the current risk assessment.

31 July 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(7):3784 [46 pp.]. doi:10.2903/j.efsa.2014.3784 Abstract

Surveillance programmes based on active and harmonised sampling are considered the most suitable for food-borne outbreak investigations, hypothesis generation, early detection of emerging pathogen subtypes, attribution modelling and genetic studies of bacterial populations. Currently, prototype molecular databases are not widely linked and contain limited epidemiological data, therefore development of linkage mechanisms is a priority. A key technical requirement is determination of an agreed threshold value for the level of genetic variation amongst isolates that can still be regarded as epidemiologically-related. Molecular typing data should be coupled with a minimum required set of epidemiological data and datasets should be comparable to facilitate joint analyses in conjunction with human case data. Rules for assembling strain collections and associated provenance data should be agreed and introduced as EU standards. The data collection process and the characteristics of the data repository should ensure reproducibility and maximise compatibility and interoperability between different datasets. Molecular bacterial characterisation developments, particularly Whole Genome Sequencing (WGS), should be harmonised with those used for surveillance in the human population and food industry. Reference methods and materials, including sequence data, should be adopted for typing of food-borne pathogens. Upload of molecular data should only be allowed for approved laboratories and should be subject to External Quality Assessment. Ongoing international oversight is required to ensure a consensual ‘one-health’ approach. The establishment of a joint EFSA-ECDC-EU-RLs committee for the support of cross-sectoral molecular surveillance, with a balance of public health and veterinary expertise and including both epidemiologists and microbiologists is strongly recommended. Revision of the legal basis of programmes for pathogen reduction based on historic organism nomenclature may be necessary following the increased use of WGS and the subsequent identification of more biologically relevant groupings of organisms.

31 July 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(7):3781 [155 pp.]. doi:10.2903/j.efsa.2014.3781 Abstract

To assess the effectiveness of the strategies implemented in the European Union (EU) to control Classical scrapie (CS), epidemiological data have been compared in the context of the efforts in terms of control measures applied over time. Official EU surveillance data and results from questionnaire surveys of EU Member States (MSs) have been used along with case studies. A spatio-temporal description of the occurrence of small ruminants TSEs in MSs in the period 2002-2012 is provided, with a particular focus on CS in sheep. Based on information collected from MSs, the potential effectiveness of breeding programmes for resistance to CS (BP-CS) in the dissemination of resistance into the general sheep population has been assessed for those countries for which the CS trend analysis has been performed. CS in sheep was reported in 17 MSs (average prevalence: 8.7 cases/10 000 tests), with heterogeneous trends and geographical distribution: among the 13 countries reporting a consistent number of cases, the trend analysis shows a statistically significant decreasing trend only for six of them. Variations in the implementation of genetic and non-genetic measures for the control of CS may explain the failure to improve the disease situation in the remaining seven MSs. At a national level, a reduction in CS seems to be linked to better-achieving BP-CSs. Control options applied to CS in sheep and goats indicate that a CS eradication policy that relies solely on the detection of infected flocks by post-mortem testing and subsequent depopulation would be unlikely to succeed. A minimum frequency of the ARR allele in a sheep population above which CS may be expected to fade-out could be estimated for each specific national sheep population. Recommendations for additional/alternative measures to control CS in sheep and goats are formulated.

30 July 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(7):3783 [30 pp.]. doi:10.2903/j.efsa.2014.3783 Abstract

Fresh meat intended for the production of minced meat may be contaminated by a range of pathogens including Salmonella spp. and verocytotoxigenic Escherichia coli (VTEC). These may grow if the temperatures are not maintained below 5 °C along the continuum from carcass chilling to mincing. Moreover Listeria monocytogenes and Yersinia enterocolitica will grow at chill temperatures, albeit slowly, but significant growth may occur during prolonged storage. Current legislation (Regulation (EC) 853/2004) requires that red meat carcasses are immediately chilled after post-mortem inspection to not more than 7 °C throughout and that this temperature be maintained until mincing which must take place not more than 6 or 15 (vacuum-packed meat) days after slaughter. The corresponding figures for poultry are 4 °C and 3 days. The impact of storage time between slaughter and mincing on bacterial pathogen growth was investigated using predictive modelling. Storage time-temperature combinations that allow growth of Salmonella, VTEC, L. monocytogenes and Y. enterocolitica equivalent to those obtained under the conditions defined by Regulation (EC) 853/2004 were identified. As the modelling assumed favourable pH and aw for bacterial growth, no microbial competition and no lag phase, the equivalent times reported are based on worst-case scenarios. This analysis suggested, for example, that red meat, vacuum packed beef and poultry could be stored at 2 °C for up to 14, 39 and 5 days, respectively, without more bacterial pathogen growth occurring than that which would be achieved under current legislative conditions. It was therefore concluded that alternative time-temperature combinations for the storage of fresh meat between slaughter and mincing are possible without increasing bacterial pathogen growth, and maximum times for the storage of fresh meat intended for minced meat preparation are provided for different storage temperatures. The impact of spoilage on maximum storage times was not considered.

30 July 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 Opsahl 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(7):3770 [42 pp.]. doi:10.2903/j.efsa.2014.3770 Abstract

Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria.

28 July 2014 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. EFSA Journal 2014;12(7):3768 [51 pp.]. doi:10.2903/j.efsa.2014.3768 Abstract

The ANS Panel provides a scientific opinion re-evaluating the safety of Indigo Carmine (E132). The Panel observed that Indigo Carmine was poorly absorbed and does not raise concern for genotoxicity. No adverse effects in subacute, chronic, reproduction and developmental toxicity studies, and no modifications of haematological and biological parameters in chronic toxicity studies have been identified at doses less than or equal to 500 mg/kg bw/day. The only report of an adverse effect was in testis with a LOAEL of 17 mg/kg bw/day which would give rise to a safety concern if confirmed. The Panel considered that this study has shortcomings since it is not clear to the Panel whether the adverse effects observed were due to the food additive itself or to impurities and/or contaminants present in the material tested and/or to the conduct of the study. The Panel considered that the current ADI of 5 mg/kg bw/day for Indigo Carmine was applicable to a material with the same purity and manufacturing process as material used in studies without adverse effects on testis (93% pure colouring and 7% volatile matter) and concluded that any extension of this ADI to Indigo Carmine of lower purity and/or manufactured using a different process would require new data which would need to address the adverse effects on testis. The Panel noted that at the MPL, exposure estimates of Indigo Carmine would exceed the ADI for toddlers and children at the high level. Exposure estimates using the available usage and analytical data did not show an exceedance of the ADI for any population groups.

25 July 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, Irene Vloutoglou, Wopke van der Werf and Stephan Winter. EFSA Journal 2014;12(7):3777 [30 pp.]. doi:10.2903/j.efsa.2014.3777 Abstract

The Panel on Plant Health performed a pest categorisation of Paysandisia archon for the European Union territory. P. archon is a well-defined pest species attacking many palm species. It is currently present in several southern European Member States (Croatia, Cyprus, France, Greece, Italy, Slovenia and Spain). Malta and Portugal are considered to be very important areas for further spread of the pest. The pest is listed in Annex IIAII of Council Directive 2000/29/EC and special requirements for host plants with respect to P. archon are formulated in Annexes IVAI and IVAII of Council Directive 2000/29/EC. This moth is a strong flier, but its main pathway of spread is via ornamental palms traded from outside the European Union and between Member States. Wherever its hosts are present outdoors in southern Europe, P. archon has the potential to establish. Although P. archon can complete its development in protected cultivation and in private/public indoor plant collections, there is no evidence of establishment. The damage produced by the larvae can cause the death of the plant with consequences for cultivated and native palm trees, and therefore on ecosystem services and biodiversity. At the moment no fully effective chemical or biological control methods are available against spread and impact of P. archon, while the use of glues on the stipe of the palm can be effective but affects the ornamental value of the plant. P. archon meets all pest categorisation criteria for both quarantine pests and regulated non-quarantine pests.

24 July 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, Irene Vloutoglou, Wopke van der Werf and Stephan Winter. EFSA Journal 2014;12(7):3774 [28 pp.]. doi:10.2903/j.efsa.2014.3774 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Diaporthe vaccinii Shear, the fungal agent responsible for twig blight, canker, viscid rot, fruit rot and storage rot of several Vaccinium species. The pest is listed in Annex IIAI of Directive 2000/29EC. D. vaccinii is a single taxonomic entity and methods exist for its discriminative detection. The host is restricted to Vaccinium species, the main cultivated hosts being blueberries and cranberries. Hosts are cultivated throughout Europe, and wild Vaccinium species are common components of forests. Conditions are conducive to disease development in most areas of Europe, but not in all Member States (MSs). The disease is currently present in Latvia with restricted distribution and the pest is under surveillance in The Netherlands. In the one Latvian report, storage losses were observed on cranberry, but these losses were caused by a complex of pathogens, including D. vaccinii, which was isolated with a low incidence. Detection methods are available but cultural and morphological identifications should be confirmed with molecular tools owing to the presence of other Phomopsis species on Vaccinium in Europe. The pathogen can spread via the movement of (asymptomatic) infected or contaminated host plants for planting. No information exists on any methods applied for the control of D. vaccinii in the EU. D. vaccinii does not have the potential to be a quarantine pest as it does not fulfil one of the pest categorisation criteria defined in International Standard for Phytosanitary Measures No 11, that of having a severe impact. Data are not sufficient to conclude on pest categorisation of D. vaccinii based on the criteria of the International Standard for Phytosanitary Measures No 21 because there is no information about the level of potential consequences as a result of the use of infected host plants for planting.

24 July 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, Irene Vloutoglou, Wopke van der Werf and Stephan Winter. EFSA Journal 2014;12(7):3775 [34 pp.]. doi:10.2903/j.efsa.2014.3775 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Phoma tracheiphila, the fungal pathogen responsible for “mal secco” disease of citrus. This pathogen is listed in Annex IIAII of Directive 2000/29/EC. Recently, the pathogen has been reclassified as Plenodomus tracheiphilus (Petri) Gruyter, Aveskamp & Verkley, based on molecular phylogenetic analysis. Plenodomus tracheiphilus is a single taxonomic entity, and sensitive and specific methods are available for its differentiation from other related Plenodomus species. The main host is lemon (Citrus limon L.), but the pathogen has also been reported on other species of the genera Citrus, Fortunella, Poncirus and Severinia and on their hybrids. Host plants are widely grown in the southern EU Member States (MSs) and climatic conditions are conducive to disease development in both orchards and nurseries. The pathogen is present in part of the risk assessment area, being mainly reported on lemon grown in Italy, Greece, Cyprus and France, where it has a serious impact on the citrus industry. There are no obvious ecological/climatic factors limiting the potential establishment and spread of the pathogen in the, so far, non-infested citrus-producing EU MSs (i.e. Spain, Portugal, Malta and Croatia). Short-distance spread of the pathogen occurs via water splash and wind-driven rain, whereas movement of infected host plants for planting, particularly asymptomatic plants, is considered to be responsible for the introduction of the pathogen into new areas. Cultural practices and copper-based fungicide sprays may reduce inoculum sources and prevent new infections but they cannot eliminate the pathogen. P. tracheiphilus fulfils all of the pest categorisation criteria for having the potential to be a quarantine pest and a regulated non-quarantine pest, as those are defined in the International Standards for Phytosanitary Measures No 11 and 21, respectively.

24 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3760 [106 pp.]. doi:10.2903/j.efsa.2014.3760 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the essential composition of infant and follow-on formula. This opinion reviews the opinion provided by the Scientific Committee on Food in 2003 on the essential requirements of infant and follow-on formulae in light of more recent evidence and by considering the Panel’s opinion of October 2013 on nutrient requirements and dietary intakes of infants and young children in the European Union. The minimum content of a nutrient in formula proposed in this opinion is derived from the intake levels the Panel had considered adequate for the majority of infants in the first six months of life in its previous opinion and an average amount of formula consumed during this period. From a nutritional point of view, the minimum contents of nutrients in infant and follow-on formula proposed by the Panel cover the nutritional needs of virtually all healthy infants born at term and there is no need to exceed these amounts in formulae, as nutrients which are not used or stored have to be excreted and this may put a burden on the infant’s metabolism. Therefore, the Panel emphasises that maximum amounts should be interpreted not as target values but rather as upper limits of a range which should not be exceeded.

24 July 2014 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, Thierry Candresse, Gianni Gilioli, Jean-Claude Gregoire, 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, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014; 12(7): 3773 [34 pp.]. doi:10.2903/j.efsa.2014.3773 Abstract

The Panel on Plant Health performed a pest categorisation of Elm phloem necrosis mycoplasma, now renamed Candidatus Phytoplasma ulmi (CPu), for the European Union (EU) territory. CPu is a well-defined phytoplasma species of the genus Candidatus Phytoplasma, for which molecular detection assays are available. CPu is transmitted by grafting and vegetative propagation material as well as by insect vectors. CPu is reported from North America and is present in at least four EU Member States: the Czech Republic, France, Germany and Italy. CPu distribution in Europe is suspected to be underestimated, with high uncertainty since no systematic surveys are carried out. CPu has a host range restricted to Ulmaceae species, and especially to the genus Ulmus, with some variations in susceptibility to the disease. It is listed in Annex IAI of Directive 2000/29/EC. CPu is not expected to be affected by EU ecoclimatic conditions wherever its hosts are present and has the potential to establish largely within the EU territory. Two insect vectors, Macropsis glandacea and Philaenus spumarius, are widely distributed in Europe. The uncertainty about other potential vector species, in which the phytoplasma has been detected, is considered as high. There is a lack of data to fully assess the potential consequences of the disease, with regards to the susceptibility of European elm species and virulence of European CPu strains. Data are not sufficient to reach a conclusion on pest categorisation of CPu and a full risk assessment can be conducted but is unlikely to bring any additional value unless the key additional data gaps on distribution, insect vectors, elm species susceptibility and potential consequences of the pest are filled.

23 July 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, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014;12(7):3772 [22 pp.]. doi:10.2903/j.efsa.2014.3772 Abstract

The Panel on Plant Health performed a pest categorisation of Strawberry vein banding virus (SVBV) for the European Union (EU) territory. SVBV is a well-defined virus species of the genus Caulimovirus for which the entire genome sequence is known and molecular detection assays are available. SVBV is transmitted by vegetative multiplication of infected hosts and through the activity of aphid vectors, the most efficient being Chaetosiphon spp. The virus is reported from all continents and is present in three EU Member States: the Czech Republic, Italy and Slovakia. The host range of SVBV is restricted to cultivated and wild strawberries. It is listed in Annex IAI of Directive 2000/29/EC. SVBV is not expected to be affected by ecoclimatic conditions wherever its hosts are present and has the potential to establish in large parts of the EU territory, and to subsequently spread through the action of its Chaetosiphon fragaefolii vector, which is present in many Member States. SVBV does not cause severe symptoms, and modern cultivars are mostly symptomless if infected with SVBV alone. SVBV can, however, contribute to more severe symptoms when it occurs in mixed infections with other strawberry viruses. Despite this, SVBV is considered a minor problem in strawberry production as a consequence of modern practices including the systematic use of certified planting materials and the use of short crop cycles, which have greatly reduced the impact of strawberry viruses. Overall, SVBV does not have the potential to be a quarantine pest as, given current agricultural practices, it does not fulfil the pest categorisation criteria defined in the International Standards for Phytosanitary Measures No 11 of having a severe impact. However, SVBV has the potential to be a regulated non-quarantine pest because it fulfils all pest categorisation criteria defined in the International Standards for Phytosanitary Measures No 21.

23 July 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, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014;12(7):3771 [22 pp.]. doi:10.2903/j.efsa.2014.3771 Abstract

The Panel on Plant Health performed a pest categorisation of Strawberry latent C virus (SLCV) for the European Union (EU) territory. SLCV is defined only by symptoms in strawberry indicators. It has not been characterised, is not recognised as a valid species, and reliable detection assays are unavailable. SLCV is transmitted by vegetative multiplication of infected hosts and by Chaetosiphon aphid vectors. SLCV has been reported only from USA, Canada and Japan. It is listed in Annex IAI of Directive 2000/29/EC. It infects cultivated and wild strawberries, and there is no other information on its host range. SLCV is not expected to be affected by ecoclimatic conditions wherever its hosts are present, and has the potential to establish in large parts of the EU territory. SLCV can spread through the action of its widely distributed C. fragaefolii vector and through the movement of strawberry plants for planting. However, the existence of efficient and widely adopted certification systems for strawberry constitutes a very strong limitation to SLCV spread. Although latent in many strawberry varieties, SLCV can cause significant damage, in particular when in co-infection with other strawberry viruses. However, the importance and impact of SLCV have both essentially disappeared in North America, most probably as a result of modern practices including the systematic use of certified planting materials and the use of short crop cycles. Such practices are also widely used in the EU and have broadly reduced the impact of strawberry viruses. Overall, SLCV does not have the potential to be a quarantine pest or a regulated non-quarantine pest, because it does not fulfil the following pest categorisation criteria of the International Standards for Phytosanitary Measures (ISPM) No 11/21: clear identity of the pest (ISPM 11/21), presence in the PRA area (ISPM 21) and having a severe impact (ISPM 11).

23 July 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(7):3778 [2 pp.]. doi:10.2903/j.efsa.2014.3778 Abstract Abstract not available

22 July 2014 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. EFSA Journal 2014;12(7):3779 [45 pp.]. doi:10.2903/j.efsa.2014.3779 Abstract

The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) which are authorised as food additives in the EU and have been previously evaluated by the SCF and JECFA. JECFA allocated an ADI “not limited”. The SCF concluded that potassium propionate could be added to the list of preservatives and established an ADI ”not specified”. Propionates are naturally occurring substances in the normal diet. The Panel considered that forestomach hyperplasia reported in long-term studies in rodents is not a relevant endpoint for humans because humans lack this organ. Based on the reported presence of reversible diffuse epithelial hyperplasia in the oesophagus the LOAEL for a 90-day study in dogs was considered by the Panel to be 1 % propionic acid in the diet and the NOAEL to be 0.3 % propionic acid in the diet. The Panel considered that there is no concern with respect to genotoxicity and carcinogenicity. The Panel concluded that the present database did not allow allocation of an ADI for propionic acid - propionates. The overall mean and 95th percentile exposures to propionic acid - propionates resulting from their use as food additives (major contributor to exposure) ranged from 0.7-21.1 and 3.6-40.8 mg/kg bw/day, respectively. The Panel noted that the concentration provoking site of contact effect in the 90-day study in dogs (1 % propionic acid in the diet) is a factor of three higher than the concentration of propionic acid - propionates in food at the highest permitted level and concluded that for food as consumed, there would not be a safety concern from the maximum concentrations of propionic acid and its salts at their currently authorised uses and use levels as food additives.

22 July 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(7):3769 [35 pp.]. doi:10.2903/j.efsa.2014.3769 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate four flavouring substances in the Flavouring Group Evaluation 304, Revision 1 (FGE.304Rev1) using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to a re-evaluation of one flavouring substance N-(2-(pyridine-2-yl)ethyl)-3-p-menthanecarboxamide [FL-no: 16.118], as a 90-day dietary rat study has become available. One of the original five flavouring substances [FL-no: 16.124], for which additional data were requested, is no longer supported by the Industry for use as flavouring substance in Europe and will therefore not be considered any further in FGE.304Rev1. Therefore, FGE.304Rev1 will deal with four flavouring substances. None of the four substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the four substances [FL-no: 16.117, 16.118, 16.123 and 16.125] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all four candidate substances.

22 July 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(7):3790 [13 pp.]. doi:10.2903/j.efsa.2014.3790 Abstract

The additive formaldehyde is an aqueous solution of formaldehyde (34–38 % w/w by specification) and methanol (0.5–15.0 % v/v by specification), with a maximum concentration of formic acid of 0.05 %. It is applied for use as a feed hygiene substance in poultry and pigs. Concerning the safety assessment for target species, consumers, users and the environment, no new relevant data were provided which would lead the FEEDAP Panel to reconsider its two recent opinions on formaldehyde. Therefore, the FEEDAP Panel reiterates its former conclusions on the safety of formaldehyde when used as a feed additive. A safe level for poultry and pigs could not be determined. The proposed use of formaldehyde as a feed additive would not increase consumer exposure and consequently would not pose an additional risk to the consumer. No safe level of exposure of the skin, eyes or respiratory system to formaldehyde could be identified. Formaldehyde is not expected to accumulate in the environment and would therefore not pose a risk to the environment when used in animal nutrition. The additive has the potential to be effective in reducing bacterial growth in an already contaminated feed at a lowest concentration of about 200 mg/kg complete feed; the prevention of recontamination requires considerably higher concentrations. The efficacy data submitted for the additive formaldehyde fulfil the classical requirements for a preservative. The FEEDAP Panel notes that reducing the microbial load in contaminated feed does not reduce the hazards associated with bacterial toxins and endotoxins, which may already be present in feed.

22 July 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(7):3791 [2 pp.]. doi:10.2903/j.efsa.2014.3791 Abstract

Lenziaren is a polynuclear Fe(III) starch–saccharose complex intended to be used in food for adult cats to reduce phosphate absorption in the gastrointestinal tract in order to prevent chronic kidney disease. The recommended minimum and maximum levels are 0.25 and 1.0 g/cat per day, equivalent to 5 000 and 20 000 mg/kg complete feed, respectively. In a previous opinion, the Panel concluded that the minimum effective dose was 1 g/cat per day based on three studies which showed either a significant reduction in serum phosphorus or a reduction in urinary phosphate. Two of these studies showed an effect at 0.25 g/cat per day, while the third one only showed an effect at a level of 1 g/cat per day. The results of a new study submitted in this application showed that overall urine inorganic phosphorus concentrations significantly decreased in cats receiving Lenziaren at 0.25 g/day compared with the control group. Therefore, considering the two previous studies, which showed an effect at 0.25 g/cat per day, and the results of the new study, the FEEDAP Panel considers that Lenziaren has the potential to be efficacious in binding intestinal phosphorus at the minimum recommended dose of 0.25 g/cat per day (equivalent to 5 g/kg complete feed). On balance, the Panel considers that the sex difference seen in the new study is an anomaly, possibly owing, as the applicant suggests, to selective feed intake. However, the Panel notes that sex differences were not explored in the remaining efficacy studies. The Panel still has the reservations expressed in the previous opinion regarding the value of the long-term use of the additive in healthy cats.

22 July 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(7):3795 [14 pp.]. doi:10.2903/j.efsa.2014.3795 Abstract

The product L-valine, feed grade (ValAMINO®), is a feed additive produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (DSM 25202). Neither the production strain nor its recombinant DNA was detected in the final product. Therefore, the final product does not give rise to any safety concerns with regard to the genetic modification. The additive L-valine, feed grade, produced by C. glutamicum (DSM 25202) is safe for all target animals when supplemented in appropriate amounts to feed to compensate for valine deficiency in feedingstuffs. The composition of tissues and products of animal origin will not be changed by the use of L-valine, feed grade, in animal nutrition. Considering the high purity of the product under assessment, no risks to the consumer are expected from its use as a feed additive. In the absence of specific data on user safety for the product under application, it would be prudent to consider it as an irritant to the skin, eyes and mucous membranes and as a potential dermal sensitiser. In the absence of any data on inhalation toxicity, the product is also regarded as potentially harmful by inhalation. The amino acid L-valine is a natural component of proteins of living organisms. Therefore, the use of the highly purified product L-valine, feed grade, in animal nutrition does not pose a risk to the environment. The product L-valine, feed grade, is an efficacious source of supplemented amino acid for all species, but it has a low efficiency in ruminants unless it is used in a protected form.

21 July 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(7):3793 [20 pp.]. doi:10.2903/j.efsa.2014.3793 Abstract

Rovabio® Spiky is an enzyme preparation, available in solid and liquid forms, of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Penicillium funiculosum, one of them genetically modified. The additive is intended to be used as a feed additive for chickens for fattening, chickens reared for laying and other minor poultry species (for fattening and reared for laying). None of the production strains was detected in their respective products. The additive does not give rise to safety concerns with regard to the genetic modification. No recombinant DNA was detected in the product obtained from the genetically modified strain of P. funiculosum. Based on the results of a tolerance trial in chickens for fattening, the FEEDAP Panel concludes that the additive is safe for chickens for fattening under the recommended conditions of use. This conclusion can be extended to chickens reared for laying and can be extrapolated to minor poultry species for fattening or reared for laying. Based on the outcome of the toxicological studies performed with the products of fermentation used to formulate the additive, the additive is of no concern regarding consumer safety. The additive is not irritant to the skin or eyes. In the absence of data, it should be considered a potential skin sensitiser and potentially harmful if inhaled. No risks to the environment are expected from the use of the additive in animal nutrition. Based on the results obtained in three efficacy studies, the FEEDAP Panel concludes that the additive has the potential to be efficacious in chickens for fattening at the minimum recommended dose. This conclusion can be extended to chickens reared for laying and can be extrapolated to minor poultry species for fattening or reared for laying.

21 July 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(7):3797 [7 pp.]. doi:10.2903/j.efsa.2014.3797 Abstract

In 2011 the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of SelenoSource AF 2000 which was inconclusive concerning the safety for target animals and safety for users/workers. In response to this, the applicant submitted additional information. A study supporting tolerance in chickens for fattening was provided; however, no new information on users’ safety was submitted. SelenoSource AF 2000 is considered to be a safe source of selenium for all animal species/categories when used up to the total maximum authorised selenium content in complete feed. In the absence of data, it would be prudent to treat the additive as an irritant to the skin and eyes, as a dermal and respiratory sensitiser and as an inhalation toxicant.

21 July 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 and Ton Van Der Linden EFSA Journal 2014;12(7):3800 [163 pp.]. doi:10.2903/j.efsa.2014.3800 Abstract

Following a request from the European Food Safety Authority, the Panel on Plant Protection Products and their Residues developed an opinion on the science to support the development of a risk assessment scheme of plant (crop) protection products on non-target terrestrial plants (NTTPs). This scientific opinion is largely a literature review on the most up-to-date knowledge of factors influencing phytotoxicity testing and risk assessment of NTTPs. Specific protection goals (SPGs) were defined for off-field, in-field and endangered species. SPGs are closely linked to ecosystem services and functions, and include maintaining provision of water regulation, food web support, aesthetic values, genetic resources and biodiversity. Gaps were identified in standard guidelines currently used in lower tier testing (tier I/II). In these guidelines, tests are conducted at the seedling/juvenile stage using mostly annual crops, and effects are recorded at the juvenile/vegetative stage under greenhouse conditions with plants grown individually or in monoculture. Endpoints measured do not include the overall effect on the whole life cycle (germinating seeds, seedling, juvenile stages, flowering, and seed production and germinability). It is also noted that it is unknown whether the following groups of organisms are covered by the plant risk assessment as it is carried out now: ferns, mosses, liverworts, hornworts, horsetails, lichens or woody species. In terms of exposure, droplet drift is considered to be the most important factor for off-field emissions to non-target areas. Models are available to calculate loadings from spray drift. Higher tier assessment is not required if the risk based on the tier II level can be managed by risk mitigation measures. When required, higher tier tests should be conducted under more realistic conditions. They may include additional laboratory/greenhouse tests (e.g. to measure reproductive endpoints or species interactions), microcosms or field experiments with experimentally or already established species. Other issues were considered, including exposure to mixtures, adjuvants, co-formulants and metabolites. Recommendations for the improvement of current guidelines and the elaboration of new guidelines and risk assessment schemes are provided.

21 July 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(7):3792 [18 pp.]. doi:10.2903/j.efsa.2014.3792 Abstract

Sorbic acid and potassium sorbate are already authorised for use in food and feed as preservatives. Sorbic acid and its potassium salt are safe when used at the maximum proposed dose in feed for pigs, poultry, dogs and cats (2 500 (sorbic acid) and 3 400 (potassium sorbate) mg/kg) and young ruminants (6 700 (sorbic acid) and 9 000 (potassium sorbate) mg/kg). This conclusion is extended to all animal species. The contribution of potassium sorbate to the potassium supply of animals should be considered when formulating diets or when it is included in water for drinking. As no measurable residues of sorbic acid or potassium ion are expected in edible products of food-producing animals, sorbic acid and potassium sorbate are considered safe for the consumers when used up to the maximum proposed level. Sorbic acid and potassium sorbate are skin, eye and respiratory tract irritants. The use of sorbic acid and its potassium salt in animal nutrition would not pose a risk to the environment. As sorbic acid and potassium sorbate are authorised food additives within the EU for use as preservatives, it is reasonable to expect that the effect in food will be observed in feed when it is used at comparable concentrations and under similar conditions. The FEEDAP Panel has reservations about the effectiveness of sorbic acid and its potassium salt as preservatives in complete feedingstuffs with a moisture content of ≤ 12 %. Equivalent concentrations for sorbic acid and potassium sorbate when used as preservatives in water for drinking should be specified.

18 July 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(7):3796 [20 pp.]. doi:10.2903/j.efsa.2014.3796 Abstract

Copper chelate of L-lysinate-HCl, provided as powder and as granulate, is intended for use as a copper source in animal nutrition. Tolerance studies with chicken for fattening and weaned piglets, allowed the FEEDAP Panel to conclude that copper chelate of L-lysinate-HCl is a safe source of copper for all animal species, provided that the maximum copper contents authorised in feed are respected. The supplementation of feeds with copper from copper chelate of L-lysinate-HCl up to the maximum authorised copper levels is not expected to result in a different copper deposition in edible tissues/products than the standard inorganic source cupric sulphate pentahydrate. No concerns for consumer safety will arise from the use of the additive in animal nutrition, provided that the maximum copper contents authorised in feed are respected. The powder form of copper chelate of L-lysinate-HCl should be considered as a risk by inhalation; exposure by inhalation should be minimised. Neither form of the additive is a dermal irritant but the powder form is an eye irritant. In the absence of data, it is considered prudent to regard both forms as potential skin sensitisers. Copper chelate of L-lysinate-HCl is intended to be a substitute for other authorised copper additives; it will therefore not further increase the environmental burden from copper. Copper chelate of L-lysinate-HCl is an efficacious source of copper in meeting animal requirements. The Panel made some recommendations regarding the Description and Conditions of use of the additive and the maximum residue limits established for copper in animal tissues and products.

17 July 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(7):3789 [11 pp.]. doi:10.2903/j.efsa.2014.3789 Abstract

Lactobacillus acidophilus D2/CSL is the trade name for a preparation of a strain of Lactobacillus acidophilus. EFSA was requested to re-evaluate the additive when used in feed for laying hens at a minimum dose of 1 × 109 CFU/kg feed and to assess the safety and efficacy of its use in water for drinking for the same species. The identity of L. acidophilus has been established and no resistance to clinically relevant antibiotics has been detected. The strain satisfies the requirements for the qualified presumption of safety approach to safety assessment and, thus, is presumed safe for the target animals, consumers of products derived from animals fed the additive, and the environment. The additive should be considered to be an eye/skin irritant and a skin/respiratory sensitiser and treated accordingly. On the basis of three studies performed with laying hens, the FEEDAP Panel concludes that Lactobacillus acidophilus D2/CSL has the potential to increase laying intensity and significantly improve the feed-to-egg mass ratio at the proposed dose of 1 × 109 CFU/kg feed. The FEEDAP Panel considers that the results are independent of the mode of administration, provided that exposure is the same and that the equivalent dose in water for drinking would be 3–5 × 108 CFU/L.

17 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3759 [42 pp.]. doi:10.2903/j.efsa.2014.3759 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for niacin. Niacin is a generic term for nicotinic acid and nicotinamide. Niacin can be synthesised in the human body from the indispensable amino acid tryptophan. Approximately 60 mg of tryptophan yields 1 mg of niacin defined as 1 mg niacin equivalent (NE). Long-term inadequate intake of tryptophan and niacin can lead to the development of pellagra. In the absence of new scientific data, the Panel endorses the Average Requirement (AR) for adults of 1.3 mg NE/MJ (5.5 mg NE/1 000 kcal) adopted by the Scientific Committee for Food (1993), based on data on urinary excretion of niacin metabolites as an endpoint. The Population Reference Intake (PRI) of 1.6 mg NE/MJ (6.6 mg NE/1 000 kcal) is derived from the AR assuming a coefficient of variation of 10 %. For infants aged 7-11 months, children and adolescents, as well as for pregnant and lactating women, the Panel considers that there is no evidence that the relationship between niacin requirement and energy requirement differs from that of adults; therefore, the AR and PRI for adults are also applied to these age and life stage groups.

17 July 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Franz Roland, Konrad Grob, Rainer Gürtler, Trine Husoy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(7):3786 [8 pp.]. doi:10.2903/j.efsa.2014.3786 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of polyacrylic acid, sodium salt, crosslinked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry, and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polyacrylic acid, sodium salt, crosslinked is used not in direct contact with food and placed in a pad under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. The Panel also considered that non-crosslinked polymer and the crosslinkers do not raise a concern for genotoxicity. The CEF Panel concluded that the use of the substance polyacrylic acid, sodium salt, crosslinked, does not raise a safety concern when used in absorbent pads in the packaging of fresh or frozen foods. The absorbent pads must be used only under conditions in which the absorption capacity of the active substance is not exceeded and direct contact with food is excluded.

16 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3755 [11 pp.]. doi:10.2903/j.efsa.2014.3755 Abstract

Following an application from Natural Alternative International, Inc. (NAI), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise. The food constituent that is the subject of the claim is beta-alanine, which is sufficiently characterised. The Panel considers that an increase in physical performance during short-duration, high-intensity exercise is a beneficial physiological effect. In weighing the evidence the Panel took into account that only one out of 11 pertinent human intervention studies (including 14 pertinent outcomes) from which conclusions could be drawn showed an effect of beta-alanine on physical performance during short-duration, high intensity exercise. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-alanine and an increase in physical performance during short-duration, high intensity exercise.

16 July 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, Irene Vloutoglou, Wopke van der Werf and Stephan Winter. EFSA Journal 2014;12(7):3776 [35 pp.]. doi:10.2903/j.efsa.2014.3776 Abstract

The Panel on Plant Health performed a pest categorisation of the Lewis spider mite, Eotetranychus lewisi, for the European Union (EU). The Lewis spider mite is a well-defined and distinguishable pest species that has been reported from a wide range of hosts, including cultivated species. Its distribution in the EU territory is restricted to (i) Madeira in Portugal; and to (ii) Poland where few occurrences were reported in glasshouses only. The pest is listed in Annex IIAI of Council Directive 2000/29/EC. A potential pathway of introduction and spread is plants traded from outside Europe and between Member States. The Lewis spider mite has the potential to establish in most part of the EU territory based on climate similarities with the distribution area outside the EU and the widespread availability of hosts present both in open fields and in protected cultivations. With regards to the potential consequences, one study is providing quantitative data on impact showing that the pest can reduce yield and affect quality of peaches and poinsettias, and only few studies describe the general impact of the pest on cultivated hosts. Although chemical treatments are reported to be effective in controlling the Lewis spider mite, it is mentioned as a growing concern for peaches, strawberries, raspberries and vines in the Americas. Overall, Eotetranychus lewisi meets the pest categorisation criteria defined in the International Standards for Phytosanitary Measures No 11 for a quarantine pest and in No 21 for a regulated non-quarantine pest.

16 July 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, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright. EFSA Journal 2014;12(7):3765 [39 pp.]. doi:10.2903/j.efsa.2014.3765 Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) has previously provided a scientific opinion re-evaluating the safety of Sunset Yellow FCF (E 110) as a food additive in the EU and establishing a temporary acceptable daily intake (ADI) of 1 mg/kg bw/day (EFSA ANS Panel, 2009). Following a request by the European Commission, the ANS Panel was asked to assess newly submitted data from a study conducted as a result of the recommendations contained in the 2009 opinion. In addition, EFSA was requested to carry out the refined exposure assessment of Sunset Yellow FCF. The new information assessed comprised an evaluation of the 28-day study report, the data considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in its latest evaluation from 2011, and any additional toxicological information that had become available since the completion of the previous evaluation by the ANS Panel. The ANS Panel has considered that the newly submitted data from the 28-day study and the overall available toxicological database on Sunset Yellow FCF provides a basis to revise the established temporary ADI and concluded that, based on the NOAEL of 375 mg/kg bw/day from the long-term feeding study in rats and an uncertainty factor of 100, a new ADI for Sunset Yellow FCF of 4 mg/kg bw/day can be established, in agreement with the latest evaluation by JECFA. Exposure estimates for Sunset Yellow FCF based both on the currently authorised MPLs and reported use levels provided are well below the new ADI of 4 mg/kg bw/day for all population groups. Overall, the Panel concluded that, using data provided by the food industry and Member States, the reported uses and use levels of Sunset Yellow FCF (E 110) would not be of safety concern.

15 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3757 [35 pp.]. doi:10.2903/j.efsa.2014.3757 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of astaxanthin-rich ingredients AstaREAL A1010 and AstaREAL L10 as novel food ingredients (NFIs) in the context of Regulation (EC) No 258/97. The NFIs are produced from astaxanthin-rich alga Haematococcus pluvialis. Astaxanthin content is 5.0–5.6 % in AstaREAL A1010 powder, 10.0–12.0 % in AstaREAL L10 oil and 2.5–2.7 % in AstaREAL L10 encapsulated oil. Sufficient information was provided regarding the composition, specification, manufacture and stability of the NFIs. The NFIs are intended to be used in fermented liquid dairy products, non-fermented liquid dairy products, fermented soya products and fruit drinks for healthy adults. The applicant recommends a maximum consumption of astaxanthin from the NFIs of 4 mg/day. Mean and high-level (95th percentile) daily intakes of 0.106 mg/kg bw and 0.256 mg/kg bw astaxanthin from the NFIs were estimated, based on European consumption data of the proposed food categories. The consumption of the NFIs is not considered to be nutritionally disadvantageous. There are no safety concerns regarding genotoxicity. There is no indication from the available toxicological data that the NFIs would be more toxic than astaxanthin. Therefore, the Panel bases the evaluation of the NFIs on the acceptable daily intake (ADI) of 0.034 mg/kg bw for astaxanthin derived by the FEEDAP Panel. The Panel notes that the maximum recommended intake of 4 mg astaxanthin per day (0.06 mg/kg bw) and the estimated mean intake based on the use levels in the proposed food categories (0.106 mg/kg bw per day) exceed the ADI by approximately two- and three-fold, respectively. The Panel therefore concludes that the safety of the NFIs at the proposed use and use levels has not been established.

15 July 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(7):3780 [11 pp.]. doi:10.2903/j.efsa.2014.3780 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 “Petra Polimeri”, EC register number RECYC089. The process recycles polypropylene (PP) trays and inserts trays which have been used for the transport, storage and display of whole, fresh fruits and vegetables at room temperature or below. Trays are returned by consumers and collected in specific containers at the point of sale and insert trays originate from a closed loop of distributors. After collection, trays and insert trays are sorted separately. Through this process, sorted trays and/or insert trays are ground into flakes, which are washed, dried and extruded into granules. This recycled material is used up to 30 % with virgin PP to manufacture new trays and insert trays intended for transport, storage and display of whole, fresh fruits and vegetables. The Panel considered the specific use of the recycled trays and insert trays and the management of the input material as a critical process step. The Panel concluded that exposure of consumers to potential contaminants is unlikely and that the recycled PP obtained from the process Petra Polimeri is not of safety concern when i) made with collected trays from specific containers at the point of sale along with a communication and/or insert trays from the retailer, trays and insert trays being collected and sorted separately; the sorting being positive and manual, and leading to more than 99.9 % PP trays and insert trays, and when ii) intended to be used up to 30 % with virgin PP to manufacture new recycled trays and/or insert trays for contact with whole, fresh fruits and vegetables at room temperature or below.

15 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3761 [80 pp.]. doi:10.2903/j.efsa.2014.3761 Abstract

Following a request from the European Commission to address the risks and benefits as regards fish/seafood consumption related to relevant beneficial substances (e.g. nutrients such as n-3 long-chain polyunsaturated fatty acids) and the contaminant methylmercury, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a Scientific Opinion on health benefits of seafood consumption in relation to health risks associated with exposure to methylmercury. In the present Opinion, the NDA Panel has reviewed the role of seafood in European diets and evaluated the beneficial effects of seafood consumption in relation to health outcomes and population subgroups that have been identified by the FAO/WHO Joint Expert Consultation on the Risks and Benefits of Fish Consumption and/or the EFSA Panel on Contaminants in the context of a risk assessment related to the presence of mercury and methylmercury in food as relevant for the assessment. These included the effects of seafood consumption during pregnancy on functional outcomes of children’s neurodevelopment and the effects of seafood consumption on cardiovascular disease risk in adults. The Panel concluded that consumption of about 1‑2 servings of seafood per week and up to 3‑4 servings per week during pregnancy has been associated with better functional outcomes of neurodevelopment in children compared to no consumption of seafood. Such amounts have also been associated with a lower risk of coronary heart disease mortality in adults and are compatible with current intakes and recommendations in most of the European countries considered. These associations refer to seafood per se andinclude beneficial and adverse effects of nutrients and non-nutrients (i.e. including contaminants such as methylmercury) contained in seafood. No additional benefits on neurodevelopmental outcomes and no benefit on coronary heart disease mortality risk might be expected at higher intakes.

14 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3753 [12 pp.]. doi:10.2903/j.efsa.2014.3753 Abstract

Following an application from DSM Nutritional Products and Kemin Foods, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of lutein and zeaxanthin and improved vision under bright light conditions. The Panel considers that the food is sufficiently characterised. Improved vision under bright light conditions is a beneficial physiological effect. The applicant provided a total of 10 published and one unpublished human intervention studies as being pertinent to the health claim. Five studies investigated the effects of lutein and/or zeaxanthin on macular pigment optical density, but did not assess vision, whereas two studies investigated the effects of lutein only. Two further studies had already been evaluated by the Panel in a previous assessment. No conclusions could be drawn from one further small (no effect) study. In a further trial with a large number of missing data owing to drop-out/non-compliance of study subjects, a combination of lutein and zeaxanthin had no effect on any outcomes of visual function in the population of subjects completing the protocol as planned. In weighing the evidence, the Panel took into account that the one study from which conclusions could be drawn did not show an effect of lutein plus zeaxanthin on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lutein and zeaxanthin and improved vision under bright light conditions.

14 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3756 [13 pp.]. doi:10.2903/j.efsa.2014.3756 Abstract

Following an application from Clasado Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bimuno® GOS and reducing gastro-intestinal discomfort. The food constituent that is the subject of the health claim, Bimuno® GOS, which is a mixture of β‑galacto-oligosaccharides produced through conversion of lactose by enzymes from Bifidobacterium bifidum NCIMB 41171, is sufficiently characterised. The claimed effect is reducing gastro-intestinal discomfort and is considered to be a beneficial physiological effect. The applicant did not provide any studies from which data could be used for the scientific substantiation of the claimed effect of reducing gastro-intestinal discomfort. A cause and effect relationship has not been established between the consumption of Bimuno® GOS and reducing gastro-intestinal discomfort.

14 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3752 [8 pp.]. doi:10.2903/j.efsa.2014.3752 Abstract

Following an application from DoubleGood AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate and reduction of post-prandial glycaemic responses. The Panel considers that the food is sufficiently characterised. The target population proposed by the applicant is “adults in the general population wishing to reduce their post-prandial blood glucose responses”. The mechanism proposed by the applicant for the claimed effect is “stimulating insulin release via the insulinogenic properties of the amino acids in the food”. The Panel notes that the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application. The Panel considers that a cause and effect relationship has not been established between the consumption of the food, a combination of L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine plus chromium picolinate, and a beneficial physiological effect for the target population.

14 July 2014 Mail Print Cite

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3754 [14 pp.]. doi:10.2903/j.efsa.2014.3754 Abstract

Following an application from InQpharm Europe Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight individuals. The applicant identified a total of four human intervention studies which investigated the effects of the aqueous extract from white kidney bean on body weight as being pertinent to the claim. No conclusions could be drawn from two of these four studies. In weighing the evidence, the Panel took into account that one human intervention study showed an effect of the standardised aqueous extract from white kidney bean in reducing body weight when consumed for 12 weeks, that the reduction in body weight was mostly through a reduction in body fat and that the effect of the standardised aqueous extract from white kidney bean on body weight was supported by a second study of shorter duration. However, the Panel also took into account that the first study was at risk of bias, that the supportive study suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardised aqueous extract from white kidney bean could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight.

14 July 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 Toldrá and Detlef Wölfle. EFSA Journal 2014;12(7):3762 [2 pp.]. doi:10.2903/j.efsa.2014.3762 Abstract Abstract not available

11 July 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 Toldrá and Detlef Wölfle. EFSA Journal 2014;12(7):3763 [2 pp.]. doi:10.2903/j.efsa.2014.3763 Abstract Abstract not available

11 July 2014 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Edith Authie, Charlotte Berg, Anette Bøtner, Howard Browman, Ilaria Capua, Aline De Koeijer, Klaus Depner, Mariano Domingo, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde, Preben Willeberg and Stéphan Zientara. EFSA Journal 2014;12(7):3745 [18 pp.]. doi:10.2903/j.efsa.2014.3745 Abstract

The European Commission (EC) requested that the EFSA Panel on Animal Health and Welfare (AHAW Panel) delivers a scientific opinion on a study that proposes parameters for poultry electrical waterbath stunning different to those laid down in Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing. The submitted study reports upon the use (mean + SD) of a current of 104.00 ± 3.88 mA, a voltage of 125.86 ± 3.28 V and a frequency of 589.78 ± 0.63 Hz using a square wave in alternating current (AC) with a 50 % duty cycle. These conditions were applied for 15 seconds to chickens under laboratory and slaughterhouse conditions. The submitted study was peer-reviewed by the AHAW Panel in the manner detailed in its ‘Guidance on the assessment criteria for studies evaluating the effectiveness of stunning intervention regarding animal protection at the time of killing’. The methodology and the data reported do not provide conclusive evidence that the combination of the proposed electrical frequency and current induced unconsciousness without exposing the chickens to avoidable pain and suffering. Further, some chickens did not remain unconscious for a sufficient time to prevent avoidable pain and suffering during slaughter. Because the information provided in the study was incomplete and insufficient, it did not pass the eligibility phase of the assessment. In the context of Directive 2010/63/EU on the protection of animals used for scientific purposes, and current scientific evidence, a frequency of 600 Hz with a current of 104 mA does not result in efficient stunning of poultry. Therefore, additional research into these stunning parameters is not recommended.

3 July 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(7):3766 [17 pp.]. doi:10.2903/j.efsa.2014.3766 Abstract

Toyocerin® is a feed additive based on a strain originally defined as Bacillus cereus and now re-assigned to Bacillus toyonensis. It was subject to re-evaluation in 2012. Following the publication of the EFSA opinion and the concerns expressed therein regarding the safety of Toyocerin®, the Commission adopted a Regulation which suspended the existing authorisations of the additive. The applicant was given the possibility to submit supplementary data which might allow a re-consideration of the assessment published by EFSA in 2012. The applicant has therefore submitted further data and arguments. B. toyonensis is resistant to chloramphenicol and tetracycline and harbours catQ and tet(M), known acquired resistance genes to these antibiotics. The role of chromosomal genes coding for chloramphenicol acetyl transferase, the major facilitator superfamily transporter and the plasmid-encoded proteins in the gerICnucB locus, potentially contributing to or enhancing the observed resistance, has not been established. On the basis of the data provided by the applicant, including the latest submissions, the FEEDAP Panel concludes that B. toyonensis poses a risk for the spread of genes coding for resistance to tetracycline and chloramphenicol, antibiotics of human and veterinary importance. B. toyonensis harbours complete nhe and hbl operons, coding for non-haemolytic and haemolytic enterotoxins, with all genes in the correct orientation, and no insertions, deletions or mutations affecting their transcription, translation or secretion detected. The strain can produce and release cytotoxic agents, but less effectively than the B. cereus group strains selected as positive controls and under the conditions tested. B. toyonensis has the capacity to elaborate functional toxins and thus, to pose a risk to humans exposed to the organism. Toyocerin® has the potential to improve performance of weaned piglets at the minimum recommended dose of 0.5 × 109 colony-forming units (CFU)/kg feed. B. toyonensis is compatible with all tested coccidiostats except for salinomycin sodium and semduramycin sodium.

3 July 2014 Mail Print Cite

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen. EFSA Journal 2014;12(7):3758 [7 pp.]. doi:10.2903/j.efsa.2014.3758 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of additional information submitted by the applicant. In its previous opinion of 2010, the Panel concluded that the safety of CMC as an ingredient in food supplements at an intake of 3.3 g per day has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. In 2012, the Commission requested EFSA to review and update its opinion by taking into account a new subchronic 90-day oral toxicity study conducted with “Cetylated Fatty Acid Esters Powder 50 %” in mice. In its opinion of 2013, the Panel considered that a new 90-day study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC. The dossier of this new mandate contains three new references which were not submitted and hence not considered in the previous assessments. The Panel notes that two references do not address the concerns expressed by the Panel in its previous assessments. The third reference provided is a report on an in vitro hydrolysis study demonstrating a low rate of hydrolysis of cetyl myristoleate and cetyl myristate. The Panel notes the low rate of hydrolysis of the two esters found in this in vitro hydrolysis study and therefore reiterates the need for adequate safety information on the unhydrolysed esters contained in CMC as expressed in its opinions of 2010 and 2013. The Panel concludes that, even after considering the newly submitted information, the safety of ‘Cetyl Myristoleate Complex’ has not been established.

15 July 2014 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2014;12(7):3767 [11 pp.]. doi:10.2903/j.efsa.2014.3767 Abstract

Following a Rapid Alert System for Food and Feed (RASFF) notification concerning the use of an unauthorised irradiated colouring agent (brown iron oxide) as coatings of food supplements, the European Commission asked EFSA to assess the scientific validity and robustness of three documents i) two safety assessments from two pharmaceutical companies including information on the manufacturing process of iron oxides, and ii) one safety assessment on gamma irradiated iron oxides in food supplements provided by a consultant. According to the supplier of iron oxides and hydroxides (E 172), the aim of the 60Co-gamma irradiation treatment was to eliminate microbiological contamination. Iron oxides and hydroxides (E 172) are authorised food additives in the EU. EFSA noted that the gamma irradiation of iron oxides (yellow, red, black and brown) has not been previously evaluated by other Scientific Committees dealing with foodstuffs, pharmaceutical products or cosmetics and that the irradiation doses applied to iron oxides in this particular case are higher than the doses currently authorised in the EU for “other food and food ingredients”. EFSA also noted that some evidence is available in the literature demonstrating a reduction of iron(III) to iron(II) due to 60Co-gamma irradiation and, that the food additive black iron oxide, as authorised in the EU, contains iron in both (II) and (III) valence states. Therefore, an increase in the content of divalent iron would not be of safety concern per se. However, EFSA also notes that the information on irradiated iron oxides provided is very limited and insufficient to substantiate the claim that iron oxides are not expected to undergo any chemical transformation upon irradiation. In order to demonstrate the chemical stability of iron oxide during the 60Co-gamma irradiation treatment, EFSA recommends to carry out some further analyses.

4 July 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(7):3787 [96 pp.]. doi:10.2903/j.efsa.2014.3787 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 ethametsulfuron (evaluated variant ethametsulfuron-methyl) are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011 and Article 56 of Regulation (EC) No 1107/2009. The conclusions were reached on the basis of the evaluation of the representative uses of ethametsulfuron-methyl as a herbicide on oilseed rape. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework as well as assessments that could not be finalised based on the available data are listed. Concerns are identified as regards the potential for groundwater contamination by some toxicologically relevant metabolites and the risk assessment for aquatic organisms.

21 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3764 [79 pp.]. doi:10.2903/j.efsa.2014.3764 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 Sweden, for the pesticide active substance sulfosulfuron, 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 sulfosulfuron as a herbicide on winter wheat and spring wheat. 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.

14 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3744 [95 pp.]. doi:10.2903/j.efsa.2014.3744 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State United Kingdom, for the pesticide active substance fenhexamid 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 fenhexamid as a fungicide on grapes, strawberry and tomato. 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.

7 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3741 [20 pp.]. doi:10.2903/j.efsa.2014.3741 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Germany, for the pesticide active substance imidacloprid are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology and ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of imidacloprid as an insecticide on apples, tomatoes and sugar beet. 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. No concerns are identified.

2 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3742 [84 pp.]. doi:10.2903/j.efsa.2014.3742 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 amitrole 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 amitrole as a herbicide in orchards, grapes, olives and non-crop uses. 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.

1 July 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(7):3804 [35 pp.]. doi:10.2903/j.efsa.2014.3804 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 Makhteshim-Agan Holland B.V. to modify the existing MRLs for the active substance bupirimate in apricots, peaches, strawberries, grapes, blackberries, dewberries, cucurbits, herbs and globe artichokes. In order to accommodate for the intended uses, The Netherlands proposed to raise the existing MRLs for bupirimate and for its metabolite ethirimol. 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 provisionally derive MRL proposals for bupirimate of 0.3 mg/kg for peaches, apricots and cucurbits with inedible peel, 1.5 mg/kg for grapes and cane fruit, 2 mg/kg for strawberries, 3 mg/kg for courgettes. No change to the existing MRL for cucumbers is necessary. To cover the uses of bupirimate, an amendment of the MRLs for ethirimol is necessary for cane fruits and cucurbits with inedible peel only, to 0.1 and 0.08 mg/kg respectively. No MRLs are proposed for fresh herbs and globe artichokes. Adequate analytical enforcement methods are available to control the residues of bupirimate and ethirimol in the commodities under consideration. Based on the preliminary risk assessment results, EFSA concludes that the proposed uses of bupirimate on apricots, peaches, grapes, strawberries, cane fruits, courgettes, cucumbers and cucurbits with inedible peel will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.

29 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3803 [35 pp.]. doi:10.2903/j.efsa.2014.3803 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 desmedipham. In order to assess the occurrence of desmedipham 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 all MRL proposals derived by EFSA still require further consideration by risk managers.

28 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3799 [127 pp.]. doi:10.2903/j.efsa.2014.3799 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 boscalid. In order to assess the occurrence of boscalid 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. 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 all MRL proposals derived by EFSA still require further consideration by risk managers

21 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3788 [18 pp.]. doi:10.2903/j.efsa.2014.3788 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for the active substance tepraloxydim in Jerusalem artichoke and radishes. In order to accommodate for the intended uses of tepraloxydim, Belgium proposed to raise the existing MRLs from the limit of quantification of 0.1 mg/kg to 0.4 mg/kg. Belgium drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 0.4 mg/kg for the proposed uses on Jerusalem artichoke and radishes. Study to confirm the stability of tepraloxydim residues under frozen conditions in high water content matrices is however requested. Adequate analytical enforcement methods are available to control the residues of tepraloxydim on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of tepraloxydim on Jerusalem artichoke and radishes will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk.

18 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3785 [18 pp.]. doi:10.2903/j.efsa.2014.3785 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance fenhexamid in cranberries, blueberries, gooseberries and azarole (kiwiberry). In order to accommodate for the uses of fenhexamid under greenhouse conditions, Belgium proposed to raise the MRLs proposed during the review of the existing MRLs under Article 12 of the Regulation (EC) No 396/2005, to 15 mg/kg. Belgium drafted an evaluation report, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to extrapolate the MRL of 15 mg/kg set on currants to azarole (kiwiberry). In contrast, the extrapolation to cranberries, blueberries and gooseberries is not recommended, since the maximum application rate of 1000 g/ha proposed on these crops, is not covered by the trials conducted on currants at a dose rate of 750 g/ha. Adequate analytical enforcement methods are available to control the residues of fenhexamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of fenhexamid on azarole (kiwiberry) will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

14 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3748 [8 pp.]. doi:10.2903/j.efsa.2014.3748 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 indolylbutyric acid. Considering that this active substance is not authorised for use on edible crops within the European Union, that no MRLs are established by the Codex Alimentarius Commission, and that no import tolerances were notified to EFSA, residues of indolylbutyric acid are not expected to occur in any plant or animal commodity. Available data were also not sufficient to derive a residue definition or a limit of quantification (LOQ) for enforcement against potential illegal uses.

7 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3747 [8 pp.]. doi:10.2903/j.efsa.2014.3747 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 indolylacetic acid. Considering that this active substance is no longer authorised within the European Union, that no MRLs are established by the Codex Alimentarius Commission, and that no import tolerances were notified to EFSA, residues of indolylacetic acid are not expected to occur in any plant or animal commodity. Available data were also not sufficient to derive a residue definition or a limit of quantification (LOQ) for enforcement against potential illegal uses.

7 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3750 [54 pp.]. doi:10.2903/j.efsa.2014.3750 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 thiabendazole. In order to assess the occurrence of thiabendazole 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. 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 all MRL proposals derived by EFSA still require further consideration by risk managers.

4 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3746 [23 pp.]. doi:10.2903/j.efsa.2014.3746 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 1 methylcyclopropene. In order to assess the occurrence of 1 methylcyclopropene 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.

2 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3749 [32 pp.]. doi:10.2903/j.efsa.2014.3749 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 pethoxamid. In order to assess the occurrence of pethoxamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.

2 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3751 [17 pp.]. doi:10.2903/j.efsa.2014.3751 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 Bayer CropScience Deutschland GmbH to modify the existing MRL for the active substance trifloxystrobin in cane fruit. In order to accommodate for the intended use of trifloxystrobin Germany proposed to raise the existing MRLfrom the limit of quantification of 0.02* mg/kg to 3 mg/kg. 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 an MRL proposal of 3 mg/kg for the proposed use on cane fruit. Based on the risk assessment results, EFSA concludes that the proposed use of trifloxystrobin on cane fruit will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

1 July 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2014;12(7):3798 [55 pp.]. doi:10.2903/j.efsa.2014.3798 Abstract

Information on the pathogenesis and tissue distribution of Atypical Bovine Spongiform Encephalopathy (BSE) in cattle through the study of field cases and experimental transmission studies is lacking. The latter are limited to transmission of Atypical BSE through intracerebral (i.c.) inoculation of cattle. All data currently available relate to the presence or absence of PrPSc, but do not quantify relative amounts of PrPSc or levels of infectivity. A laboratory protocol for further studies is recommended, to allow the assessment of the relative infectious titre, PrPSc accumulation and prion seeding activity in the tissues of cattle that developed H-BSE or L-BSE (using posterior brainstem as a reference). Tissues to be covered by those studies are categorised in three priorities, based on their inclusion in the list of specific risk material in cattle, on the presence of infectivity, or PrPSc presence, demonstrated in Atypical BSEs or other Transmissible Spongiform Encephalopathies (TSEs) in ruminants, and on the importance in terms of input into the food chain in the EU. The protocol provides details in terms of the minimum number of animals to be tested, processing and preparation of tissues, and methods to be used to identify abnormal PrP and quantify infectivity, also depending on the expected level of infectivity and amount of tissue available for analysis. It is recommended that, through the implementation of the protocol, information should also be obtained on the performance of currently validated rapid tests for TSE active surveillance in cattle/bioassay for detecting H-BSE and L-BSE agents.

21 July 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(7):3737 [182 pp.]. doi:10.2903/j.efsa.2014.3737 Abstract

In accordance with Article 43 of Regulation (EC) No 396/2005, EFSA received a request from the European Commission to provide support for the preparation of the EU position for 46th session of the Codex Committee on Pesticide Residues (CCPR). In 2013, JMPR evaluated 10 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment (diquat, chlorfenapyr, picoxystrobin, benzovindiflupyr, bixafen, fenamidone, fluesulfone, isoxaflutole, tolfenpyrad, and trinexapac) and 31 active substances regarding the setting of Maximum Residue Limits (MRLs) (diquat, malathion, chlorpyrifos methyl, triazophos, glyphosate, propiconazole, bentazone, dithianon, fenpyroximate, fenbuconazole, flutriafol, cyprodinil, fludioxonil, indoxocarb, difenoconazole, pyrimethanil, azoxystrobin, chlorantraniliprole, mandipropamid, spirotetramate, cyproconazole, dicamba, sulfoxaflor, penthiopyrad, cyantraniliprole, imazapic, imazapyr, isoxaflutole, tolfenpyrad and trinexapac).

21 July 2014 Mail Print Cite

Errata/Corrigenda

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, 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(4):3631 [15 pp.]. doi:10.2903/j.efsa.2014.3631 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 SOREPET (EU register No RECYC072). The input to the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % PET from non-food consumer applications. In this process, washed and dried PET flakes are heated to the decontamination temperature and subsequently are further decontaminated in a continuous countercurrent reactor under high temperature and inter gas flow. Having examined the challenge test provided, the Panel concluded that the third step, the decontamination in continuous countercurrent reactor for solid state polymerisation (SSP) is the critical step that determines the decontamination efficiency of the process. The operating parameters to control its performance are the temperature, the inert gas flow and the residence time. The operating parameters of this step 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 the modelled migration of 0.1 μg/kg food. The Panel concluded that recycled PET obtained from the process, intended to be used up to 100 % for manufacture of materials and articles for contact with all type of foodstuffs for long term storage at room temperature, with or without hot fill, is not considered of safety concern.

8 April 2014 18 July 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 Tavares Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. EFSA Journal 2014;12(4):3636 [16 pp.]. doi:10.2903/j.efsa.2014.3636 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 SOREPET GR (EU register No RECYC073) which is based on the EREMA Basic technology. The input to the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles and containing no more than 5 % PET from non-food consumer applications. In this process, washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor is the critical step that determines the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are temperature, pressure and residence time. 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 the 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 recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact materials applications in compliance with the conditions as specified in the conclusion of the opinion.

8 April 2014 18 July 2014 Mail Print Cite

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.

Erratum/Corrigendum

Changes have been made to human data in the Campylobacter chapter where resistance levels to ciprofloxacin in Iceland have been modified in Tables CA2 and CA4. In addition, text revision has been done in text boxes related to the revision of epidemiological cut-off values presented in the Introduction part on page 12, in the E. coli chapter on page 201, and in Materials and methods chapter on page 248. The changes do not affect the main findings and the overall discussion of the report. To avoid any confusion the original version of the output has been removed from the website but is available on request.

25 March 2014 18 July 2014 Mail Print Cite

European Food Safety Authority European Centre for Disease Prevention and Control EFSA Journal 2014;12(2):3547 [312 pp.]. doi:10.2903/j.efsa.2014.3547 Abstract

The European Food Safety Authority and the European Centre for Disease Prevention and Control analysed information submitted by 27 European Union Member States on the occurrence of zoonoses and food-borne outbreaks in 2012. Campylobacteriosis was the most commonly reported zoonosis, with 214,268 confirmed human cases. The occurrence of Campylobacter continued to be high in broiler meat at EU level. The decreasing trend in confirmed salmonellosis cases in humans continued with a total of 91,034 cases reported in 2012. Most Member States met their Salmonella reduction targets for poultry. In foodstuffs, Salmonella was most often detected in meat and products thereof. The number of confirmed human listeriosis cases increased to 1,642. Listeria was seldom detected above the legal safety limit from ready-to-eat foods. A total of 5,671 confirmed verocytotoxigenic Escherichia coli (VTEC) infections were reported. VTEC was also reported from food and animals. The number of human tuberculosis cases due to Mycobacterium bovis was 125 cases, and 328 cases of brucellosis in humans were reported. The prevalence of bovine tuberculosis in cattle increased, and the prevalence of brucellosis in cattle, sheep or goats decreased. Trichinella caused 301 human cases and was mainly detected in wildlife. One domestically acquired human case and one imported human case of rabies were reported. The number of rabies cases in animals increased compared with 2011. A total of 643 confirmed human cases of Q fever were reported. Almost all reporting Member States found Coxiella burnetii (Q fever) positive cattle, sheep or goats. A total of 232 cases of West Nile fever in humans were reported. Nine Member States reported West Nile virus findings in solipeds. Most of the 5,363 reported food-borne outbreaks were caused by Salmonella,bacterial toxins, viruses and Campylobacter, and the main food sources were eggs, mixed foods and fish and fishery products.

Erratum/Corrigendum

Changes have been made to the Salmonella compliance on fresh poultry meat text on page 28, data on category 1.28 in Table SA5 on page 28, and Figure SA4 on page 29. The changes do not affect the overall discussion of the Salmonella chapter and the main findings of the output. To avoid confusion the original version of the output has been removed from the website but is available on request.

19 February 2014 17 July 2014 Mail Print Cite