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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 Animal Health and Welfare (AHAW) Edith Authie, Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Klaus Depner, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde and Preben Willeberg EFSA Journal 2014;12(10):3877 [68 pp.]. doi:10.2903/j.efsa.2014.3877 Abstract

In the last decade, many porcine epidemic diarrhoea (PED) outbreaks have been reported by several countries in Asia whereas only a few Member States of the European Union (EU) have reported PED clinical cases and/or PED virus (PEDV)-seropositive animals. This alphacoronavirus was first reported in the USA in May 2013, followed by rapid spread throughout the country and outbreaks reported by several countries in the Americas. The recent PEDV-EU isolates have high level of sequence identity to PEDV-Am isolates. Based on nucleotide sequencing, multiple variants of PEDV are circulating in Europe, the Americas and Asia but any difference in virulence and antigenicity is currently unknown. Serological cross-reactivity has been reported between PEDV isolated in Europe and in the Americas; however no data regarding cross-protection are available. The impact of different PEDV strains is difficult to compare between one country and another, since impact is dependent not only on pathogenicity but also on factors such as biosecurity, farm management, sanitary status or herd immune status. However, the clinical signs of PEDV infections in naive pigs are similar in different countries with mortalities up to 100% in naive newborn piglets. The impact of recently reported PED outbreaks in Asia and the USA seems to be more severe than what has been described in Europe. Infected animals, faeces, feed and objects contaminated with faeces are matrices that have been reported to transmit PEDV between farms. Infectious PEDV has been detected in spray-dried porcine plasma (SDPP) in one study but the origin of the infectious PEDV in SDPP is not clear. Detection of porcine deltacoronavirus (PDCoV) has been reported in a few countries but only limited testing has been done. Based on the currently available information, it seems that PDCoV would have a lower impact than PEDV.

31 October 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(10):3858 [36 pp.]. doi:10.2903/j.efsa.2014:3858 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation for Ceratocystis fimbriata f. sp. platani Walter, the fungal pathogen responsible for the “canker stain” disease of plane trees. C. fimbriata f. sp. platani is listed in Annex IIAII of Directive 2000/29/EC. Recently, the pathogen has been reclassified as Ceratocystis platani (Walter) Engelbrecht et Harrington, based on intersterility studies, progeny analysis and the morphology of isolates from different hosts. C. platani is a single taxonomic entity and sensitive and reliable methods are available for its detection and differentiation from other related fungal species. The only known hosts are Platanus occidentalis, Platanus orientalis and Platanus × acerifolia. The last two plane species are the most susceptible to C. platani and are widely grown in most of the European Union Member States. C. platani is a wound pathogen causing canker and wilt and eventually death of plane trees. It is currently present in part of the risk assessment area (Greece, France, Italy), where it causes serious consequences on P. orientalis and P. × acerifolia trees grown in natural stands, coppices, and public and private gardens in both rural and urban environments. There are no obvious ecological/climatic factors limiting the potential establishment and spread of the pathogen in the non-infested part of the risk assessment area where hosts are present. C. platani has multiple natural and human-assisted means of spread, including waterways, root anastomosis, contaminated pruning tools, insects, contaminated insect frass and sawdust. The movement of infected host plants for planting and wood is considered to be responsible for the introduction of the pathogen into new areas. Cultural practices and sanitary and chemical measures applied in the infested areas may reduce inoculum sources but they cannot eliminate the pathogen. Plane accessions resistant to C. platani are available in the European market.

21 October 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(10):3859 [42 pp.]. doi:10.2903/j.efsa.2014:3859 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Cryphonectria parasitica (Murrill) Barr, the fungal pathogen responsible for chestnut blight, a highly destructive disease that kills trees through bark cankers. The pathogen is listed in Annex IIAII of Directive 2000/29/EC. Its identity is clearly defined as C. parasitica (Murrill) Barr and methods exist for its discriminative detection. Several hosts are known, but the main hosts are species of Castanea and Quercus, particularly C. sativa and Q. petraea. These two host species are present in all the EU Member States and the disease has been recorded in most parts of the risk assessment area. C. parasitica is absent in Denmark, Estonia, Finland, Ireland, Malta, Iceland and Norway. No information is available on the presence of the pathogen in Latvia, Lithuania or Luxembourg. In the Czech Republic and Poland, C. parasitica has been eradicated. There are no recognised ecological or climatic factors limiting the potential establishment of the pathogen in the EU Member States where the pathogen is not known to occur. The pathogen can spread by propagules (mainly conidia, but also ascospores and mycelium) that are dispersed by wind, rain or vectors, as well as via the movement of infected or contaminated host plants for planting and bark, particularly asymptomatic ones. Control methods used against C. parasitica include exclusion and eradication, chemical control, host genetic resistance and biological control (hypovirulence). The most successful control methods of C. parasitica in the EU are exclusion and eradication, and hypovirulence. Potential consequences of the damage caused by C. parasitica include yield losses of fruit and wood, reduction in biodiversity and habitat loss for associated organisms.

21 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(10):3864 [41 pp.]. doi:10.2903/j.efsa.2014.3864 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 19 bicyclic secondary alcohols, ketones and related esters evaluated by the JECFA at the 63rd meeting in 2004. This revision of FGE.87 is made due to inclusion of two additional substances Nookatone [FL-no: 07.089] and 4,4a,5,6-tetrahydro-7-methylnapthalen-2(3H)-one [FL-no: 07.136] cleared for genotoxicity concern in FGE.213 Rev1. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all substances considered in this FGE and for 18 substances the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For one substance [FL-no: 07.136], a production volume for Europe is not available, which precludes the finalisation of the evaluation by EFSA of this substance. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for all 19 substances, the information is adequate.

20 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(10):3863 [8 pp.]. doi:10.2903/j.efsa.2014.3863 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol, β3,β3,β9,β9-tetramethyl- (SPG), CAS No 1455-42-1, FCM No 1052, for use as a co-monomer in polyesters. The polyesters are intended for contact with all food types for long-term storage at room temperature including hot-fill/sterilisation conditions. Migration of the substance into 10 % ethanol was 0.009 mg/kg food and no migration was detected (<0.003 mg/kg food) in 3 % acetic acid. No migration of the oligomers was detectable (< 0.2 mg/kg food). Based on three negative in vitro tests, the Panel considered that the substance does not raise a concern related to genotoxicity, while from a 90-day oral toxicity study in rats not providing a dose-response relationship of the incidental changes, it was concluded that the NOAEL is 2000 mg SPG/kg b.w. per day, the highest dose tested. The substance does not raise concern for accumulation in man. The Panel concluded that the use of the substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (SPG) as a monomer in the production of polyesters, does not raise a safety concern for the consumer when the migration of the substance itself does not exceed 5 mg/kg food and the migration of the oligomers of less than 1000 Da does not exceed 50 µg/kg food (expressed as SPG).

20 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(10):3866 [8 pp.]. doi:10.2903/j.efsa.2014.3866 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the substance furan-2,5-dicarboxylic acid (FDCA) with CAS No 3238-40-2 and FCM substance No 01031, for use as a monomer with ethylene glycol to produce polyethylene furanoate polyesters.  Final articles are intended to be used in contact with all types of foodstuffs and storage under any condition of time and temperature. Based on the residual content in the plastic, specific migration of the substance was calculated to be up to 0.12 mg/kg food when assuming total mass transfer. Concerning the migration of oligomers, the sum of all species that had a low molecular weight, contained the FDCA unit, and migrated into food simulants under test conditions of 10 days at 60 °C, was estimated to be 1.5 mg/kg food (into 95 % ethanol), 0.54 (50 % ethanol), 0.060 (20 % ethanol), 0.021 (10 % ethanol) and 0.011 mg/kg (3 % acetic acid). Out of all these migration values the results from the 20 % ethanol test is considered representative but still conservative for the intended use. Based on three negative in vitro tests, the Panel considered that there is no concern with respect to genotoxicity. From a 90-day oral toxicity study in rat, it was concluded that the NOAEL was 300 mg FDCA/kg bw/day. The substance does not raise concern for accumulation in man. The Panel concluded that the substance furan-2,5-dicarboxylic acid does not raise a safety concern for the consumer when used as a monomer in the production of polyethylene furanoate polymers (PEF) and the migration of the substance itself does not exceed 5 mg/kg food and migration of the oligomers less than 1000 Da does not exceed 50 µg/kg food (expressed as FDCA).

20 October 2014 Mail Print Cite

EFSA Panel on Contaminants in the Food Chain (CONTAM) Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael DiNovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye, Manfred Metzler, Carlo Stefano Nebbia, Michael O’Keeffe, Ivonne Rietjens (until 2 May 2014), Dieter Schrenk, Vittorio Silano (until 21 July 2014), Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester. EFSA Journal 2014;12(10):3869 [106 pp.]. doi:10.2903/j.efsa.2014.3869 Abstract

The European Food Safety Authority (EFSA) received a request from the European Commission for a scientific opinion on perchlorate in food, in particular fruits and vegetables. Perchlorate is a contaminant released into the environment from both natural and anthropogenic sources. The use of natural fertilisers and perchlorate contaminated irrigation water may lead to substantial concentrations in leafy vegetables. Water disinfection with chlorinated substances that potentially degrade to perchlorate could be another potential source of contamination. EFSA received analytical results for 4 731 samples submitted by six Member States, mainly for fruits, vegetables, and fruit and vegetable products. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) performed estimates of both chronic and ‘short-term’ exposure considering the available dataset, and data from the literature on the levels of perchlorate in fruit juices, alcoholic beverages, milk, infant formulae and breast milk. The CONTAM Panel established a tolerable daily intake of 0.3 µg/kg body weight per day, based on the inhibition of thyroid iodine uptake in healthy adults. Amongst the vulnerable subpopulations, potential acute effects of perchlorate have been suggested for fetuses and infants. The CONTAM Panel noted that a single acute exposure to perchlorate at levels found in food and water is unlikely to cause adverse effects on human health, including the more vulnerable groups of the population, and concluded that the establishment of an acute reference dose for perchlorate is not warranted. Overall, the CONTAM Panel concluded that the chronic dietary exposure to perchlorate is of potential concern, in particular for the high consumers in the younger age groups of the population with mild to moderate iodine deficiency. Furthermore, it is possible that short-term exposure to perchlorate is of concern for breast-fed infants and small children with low iodine intake.

17 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn EFSA Journal 2014;12(10):3865 [78 pp.]. doi:10.2903/j.efsa.2014.3865 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 21 flavouring substances in the Flavouring Group Evaluation 9, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revision of FGE.09 includes the assessment of one additional flavouring substance, 2,6,6-trimethylcyclohex-2-en-1,4-dione [FL-no: 07.109]. None of the 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 21 substances [FL-no: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all candidate substances.

17 October 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(10):3851 [31 pp.]. doi:10.2903/j.efsa.2014.3851 Abstract

The Panel on Plant Health performed a pest categorisation of Grapevine Flavescence dorée, also known as Flavescence dorée phytoplasma (FDP), for the European Union (EU) territory. FDP has not yet been defined as a phytoplasma species of the genus Candidatus Phytoplasma.  Routine molecular detection assays are available. FDP is transmitted by grafting and vegetative propagation material as well as by insect vectors. FDP is only reported in Europe. Within Europe it is present in Serbia, in Switzerland and in 10 out of 21 countries of the grapevine producing EU countries. Besides grapevine, FDP is also commonly found in other hosts such as Ailanthus, Alnus and Clematis. FDP is included in the annexes II/A/II and II/B of the Council Directive 2000/29/EC. Grapevine, the main host plant, is included into annexes III, IV and V of the Directive 2000/29/EC. FDP 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. The specific leafhopper vector of FDP, Scaphoideus titanus, is an invasive insect that was introduced in Europe. It is only in areas where FDP and Scaphoideus titanus are associated that the direct and indirect impacts are considered to be high: yield reduction, death of grapevine plants, costs for disease and vector management procedures. Additional insect vectors are known, but are not directly associated with FDP epidemics. A major outcome of this pest categorisation has been to emphasise the role of S. titanus. Uncertainty lies mostly in the knowledge on specific FDP strain transmissibility, susceptibility of specific grapevine varieties and distribution in alternate hosts. It is not fully known how far the invasive vector insect S. titanus is still enlarging its distribution within the risk assessment area.

16 October 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(10):3849 [22 pp.]. doi:10.2903/j.efsa.2014.3849 Abstract

The Panel on Plant Health performed a pest categorisation of Prunus necrotic ringspot virus (PNRSV) for the European Union (EU) territory. PNRSV is a well-defined virus species of the genus Ilarvirus for which the entire genome sequence and molecular detection assays are available. It is transmitted by vegetative multiplication of infected hosts and also via seeds and pollen (both horizontally and vertically) in some of its hosts. PNRSV has a somewhat restricted natural host range, which contains Prunus spp., hops, roses and Rubus ellipticus (yellow Himalayan raspberry). It is listed on plants of Rubus for planting in Annex IIAI of Directive 2000/29EC, probably as a result of confusion with the closely related Apple mosaic virus. PNRSV is widely present in the EU, but there are no records on its regulated hosts. It is not expected to be affected by ecoclimatic conditions wherever its hosts are present, and it has the potential to establish in large parts of the EU territory. PNRSV can spread through efficient seed- and pollen-mediated transmission mechanisms and through the movement of vegetatively propagated plants for planting. However, the existence of efficient and widely adopted certification systems for Prunus spp. constitutes a limitation to PNRSV spread. Although the virus alone or when in mixed infection can cause significant diseases in some hosts, the actual impact of PNRSV appears to be limited.

16 October 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(10):3848 [23 pp.]. doi:10.2903/j.efsa.2014.3848 Abstract

The Panel on Plant Health performed a pest categorisation of Cherry leafroll virus (CLRV) for the European Union (EU) territory. CLRV is a well-defined virus species of the genus Nepovirus, for which the entire genome sequence and molecular detection assays are available. CLRV is transmitted by vegetative multiplication of infected hosts and is also seed- and pollen-transmitted (both horizontally and vertically) in many of its hosts. There is, however, evidence that interspecific transmission by the pollen-mediated mechanism is very limited. CLRV has a wide host range, which contains both woody and herbaceous hosts, many of which are largely present in natural environments. It is listed on plants of Rubus spp. for planting in Annex IIAI of Directive 2000/29/EC. CLRV is widely present in the EU but there are very few records on its regulated hosts. It 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. CLRV can spread through efficient seed- and pollen-mediated transmission mechanisms and through the movement of vegetatively propagated plants for planting of numerous hosts. However, the existence of efficient and widely adopted certification systems for some of these hosts constitutes a limitation to CLRV spread. Although the virus alone or when in mixed infection can cause significant disease in some hosts, the actual impact of CLRV is very difficult to evaluate but generally appears to be limited.

16 October 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(10):3853 [29 pp.]. doi:10.2903/j.efsa.2014.3853 Abstract

The Panel on Plant Health of the European Food Safety Authority performed a pest categorisation of Aculops fuchsiae, a mite listed in Annex II, Part A, Section I of Council Directive 2000/29/EC as a harmful organism not known to occur in the community. A. fuchsiae is, however, established in France and the UK and it was also reported as transient in Belgium and Germany (but systematic surveys are lacking). A. fuchsiae is a distinct taxonomic entity. The known hosts of A. fuchsiae are Fuchsia spp. This exotic plant genus is naturalised in several areas of Europe and is widely present in the risk assessment area, both in the open field and under protected cultivations, as well as in gardens. The impact in terms of quality loss on fuchsia plants caused by the pest has been described in the European Union. However, no quantitative data on these losses have been reported yet. Plants for planting are the main pathway for introduction and spread of A. fuchsiae, which may cause severe impacts on the intended use of the plants for planting. In Europe, the climatic conditions do not seem to be the key limiting factor for establishment and spread in the open field and under protected conditions. Establishment and spread could occur provided that suitable hosts (Fuchsia spp.) are present. Further spread is anticipated from the areas where the pest is currently present, mainly by movement of plant material through trade and exchange.

16 October 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(10):3852 [36 pp.]. doi:10.2903/j.efsa.2014.3852 Abstract

The European Commission requested that the EFSA Panel on Plant Health perform a pest categorisation for Radopholus similis and Radopholus citrophilus. R. similis is regulated in Annex II, Part A, Section II of Council Directive 2000/29/EC as a harmful organism known to occur in the European Union (EU). R. citrophilus is regulated in Annex II, Part A, Section I of Council Directive 2000/29/EC as a harmful organism not known to occur in the EU. This pest characterisation applies only to R. similis, because R. citrophilus has been recognised as an invalid species designation and is considered as a junior synonym of R. similis. R. similis is a distinct taxonomic entity that is absent in the field production sites (citrus, bananas) of the risk assessment area and can cause significant losses in citrus production. Moreover, various susceptible hosts other than citrus species are present in the EU under climatic conditions that are suitable for the development of R. similis. The pest has a sporadic presence on ornamental plants (under protected cultivation) in a few EU countries. Plants for planting are a pathway for introduction and spread of R. similis. The pest is observed to cause impacts on ornamentals in some MSs and further impacts are expected should further spread happen in the EU.

16 October 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(10):3856 [30 pp.]. doi:10.2903/j.efsa.2014.3856 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation for Xanthomonas campestris pv. phaseoli. In reaching its conclusions, the Panel considered four parameters to be of critical importance in the risk assessment area: (i) the presence and distribution of X. campestris pv. phaseoli in the risk assessment area and its potential for spread; (ii) the existence and the distribution of the main host plants throughout the European Union (EU); (iii) the potential for damage to crops grown in Europe; and (iv) the implementation of pest control strategies and cultural measures. The organisms formerlyidentified as X. campestris pv. phaseoli have proven to be genetically diverse and are currently known as Xanthomonas fuscans subsp. fuscans and Xanthomonas axonopodis pv. phaseoli. Based on its analysis, the Panel concluded that the identity of these pathogens is clearly defined and their distribution involves limited areas or regions in the EU, although with a medium uncertainty. The main dispersal pathway for these pathogens is contaminated seeds. In addition, the Panel noted that host plants are widely cropped throughout the EU, common bean Phaseolus vulgaris being of  great commercial importance, not only for consumption—fresh, canned, deep frozen and dried—but also for the seed industry. Currently, the impact of common bacterial blight is limited in the EU as a consequence of seed testing. Finally, the Panel concluded that moderate to high consequences, in terms of yield and quality losses, are expected for beans, especially if weather conditions are conducive to disease and seed inoculum no longer contained.

16 October 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(10):3854 [27 pp.]. doi:10.2903/j.efsa.2014.3854 Abstract

The Panel on Plant Health undertook a pest categorisation of Rhagoletis cingulata for the European Union (EU). This pest is a member of a complex of five North American species, of which Rhagoletis indifferens is the only other crop pest. The two pest species have morphologically distinct adults, but similar larvae and both attack cherries. R. cingulata is currently present in eight Member States but its presence in eastern North America from Mexico to Canada implies that all the risk assessment area where its hosts occur is suitable for establishment. Adults have a limited capacity for flight, and spread is mainly by larvae present in traded fruit and pupae in soil. R. cingulata attacks all cultivated and wild cherries but is particularly damaging to late-maturing varieties, especially sour cherries. Even small infestations can cause losses because the quality requirements for marketing of cherry fruits indicate a threshold below 4 % for “worm-eaten” fruit in accordance with Commission Regulation 214/2004. The limited control measures available are similar to those for the native cherry fruit fly, R. cerasi, and are primarily based on insecticide sprays timed to kill adults, along with some cultural methods (e.g. netting and trapping). R. cingulata is listed in Annex IAI of Council Directive 2000/29/EC and its hosts are regulated in Annex IIIA with prohibitions for introduction in the Member States, in Annex IVAI with special requirements on soil and dwarfed plants that need to be considered and in Annex V indicating that host plants intended for planting are subject to plant health inspection before entry or movement within the EU.

16 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(10):3867 [10 pp.]. doi:10.2903/j.efsa.2014.3867 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and ProcessingAids (CEF) deals with the risk assessment of N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide, CASNo 42774-15-2, FCM No 1051, for use as an additive in poly(ethylene terephthalate) (PET), in polyamide (PA)inner layer in multilayers, and in the ethylene vinyl alcohol (EVOH) layer in polypropylene (PP)/EVOH/PP andpolyethylene (PE)/EVOH/PE laminates. Migration tests for the substance were performed in food simulants:acetic acid 3 %, ethanol solutions (10, 20 and 50 %) and olive oil, at time/temperature testing conditionsrepresenting the intended use. The results show migration less than 5 mg/kg. Comparison between thechromatograms of solvent extracts of films of PA, PET and two multilayer structures of PP and PE containingEVOH, each with and without the substance as reference films, do not show significant differences. Based onnegative results from five in vitro genotoxicity tests, the Panel concluded that the substance does not raise aconcern related to genotoxicity. Based on the [removed for confidentiality reasons] at the highest dose levels in asubchronic and subacute studies an overall 'No Observed Adverse Effect Level' NOAEL is set to [removed for confidentiality reasons] mg/kg bw..Based on a consideration of the structure of the molecule along with the low log Pow value of 1.12, thesubstance does not give rise to concern for accumulation in man. The CEF Panel concluded that the substanceN,N'-Bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide is not a safety concern for the consumer if used as anadditive in plastics and its migration does not exceed 5 mg/kg food.

16 October 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(10):3847 [20 pp.]. doi:10.2903/j.efsa.2014.3847 Abstract

The Panel on Plant Health performed a pest categorisation of Beet leaf curl virus (BLCV) for the European Union (EU) territory. BLCV mainly infects Beta spp., as well as Spinacia spp., Tetragonia tetragonioides and the common weeds Atriplex spp. and Chenopodium spp. This putative Rhabdovirus is not a recognised virus species; it is only defined by particle morphology and by its circular propagative transmission by the lace bug Piesma quadratum. No efficient diagnostic assay is available for BLCV, which was reported in only Germany and Turkey. With a few exceptions, there is no record of BLCV after 1983. BLCV is listed in Annex IIAII of Directive 2000/29/EC. The virus itself is not expected to be affected by ecoclimatic conditions and its P. quadratum vector is widely distributed in the EU; thus, BLCV has the potential to establish and spread over large areas of the EU and cause significant damage in sugarbeet. However, it appears to have caused sporadic outbreaks in only some years, possibly associated with high vector populations. It does not appear to have had any significant impact in recent years, and it may now no longer be significantly present in agricultural production systems. This situation is possibly a consequence of current intensive sugarbeet crop management practices and of the ensuing reduction in vector populations. Owing to the very limited literature available on BLCV, a full pest risk assessment is highly unlikely to provide clearer insight into the risks associated with this virus than the present pest categorisation.

15 October 2014 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2014;12(10):3862 [33 pp.]. doi:10.2903/j.efsa.2014.3862 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 18 alicyclic alcohols, aldehydes, acids and related esters and one phenethyl ester evaluated by the JECFA at their 59th and 63rd meetings. This revision is made due to consideration of one additional substance, beta-ionyl acetate [FL-no: 09.305] cleared for genotoxicity concern in FGE.213Rev1. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 19 substances [FL-no: 02.114, 02.141, 05.098, 05.104, 05.112, 05.119, 05.123, 08.034, 08.060, 08.067, 09.028, 09.034, 09.289, 09.305, 09.488, 09.534, 09.536, 09.615 and 09.712] considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all substances, the information is adequate.

15 October 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(10):3850 [27 pp.]. doi:10.2903/j.efsa.2014.3850 Abstract

The Panel on Plant Health performed for the European Union (EU) territory a pest categorisation of Tomato yellow leaf curl virus (TYLCV) and three related viruses, Tomato yellow leaf curl Sardinia virus (TYLCSV), Tomato yellow leaf curl Axarquia virus (TYLCAxV) and Tomato yellow leaf curl Malaga virus (TYLCMaV), which collectively cause the tomato yellow leaf curl disease (TYLCD) in Europe. The viruses are well-defined species of the genus Begomovirus, are exclusively transmitted by members of the Bemisia tabaci species complex and have tomato, as well as a few other crops or weeds, as their hosts. TYLCV is listed on tomato plants for planting, other than seeds, in Annex IIAII of Directive 2000/29/EC. While establishment and local spread rely on the Bemisia vector, the viruses can also be disseminated over long distances by movement of infected plants for planting or by consignments of non-host plants carrying viruliferous whiteflies. Establishment outdoors and spread are limited to regions with ecoclimatic conditions suitable for the establishment of vector populations in the open. Outbreaks can nevertheless occur in other regions under protected cultivation conditions. Because of the very high potential impact of TYLCD, tomato production in affected regions requires intensive crop management efforts to reduce impact. TYLCV appears to be present in almost all EU regions with suitable ecoclimatic conditions for its establishment in open fields, while the other three viruses do not appear to have reached their full establishment potential. All four viruses are absent from other regions of the EU but have the potential to cause temporary outbreaks there.

15 October 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(10):3857 [25 pp.]. doi:10.2903/j.efsa.2014.3857 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation for Xanthomonas campestris pv. pruni which has been renamed Xanthomonas arboricola pv. pruni. In reaching its conclusions, the Panel considered four parameters to be of critical importance in the risk assessment area: (i) the presence and distribution of X. campestris pv. pruni in the risk assessment area and its potential for spread; (ii) the existence and distribution of the main host plants throughout the European Union (EU); (iii) the potential for damage to crops grown in Europe; and (iv) the implementation of pest control strategies and cultural measures. Based on its analysis, the Panel concluded that the identity of the pest is clearly defined and its distribution involves limited areas or regions in the EU, although with a medium uncertainty. The pathogen may have a serious impact on horticultural production. Yield and quality losses have been observed on peach, nectarine and Japanese plum genotypes, especially if weather conditions are conducive to disease and minimal damage to crops is expected on cherry and European plum genotypes. The Panel noted that host plants are widely distributed throughout the EU and most of them are of great commercial importance. The pathogen is present but not widely distributed and not fully under official control by means of specific certification and other control measures. Planting material is the main pathway of pathogen dissemination.

14 October 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(10):3855 [26 pp.]. doi:10.2903/j.efsa.2014.3855 Abstract

The European Commission requested the EFSA Panel on Plant Health to perform the pest categorisation for Pseudomonas syringae pv. persicae (P. s. pv. persicae). The agent is responsible for bacterial die-back in peach, nectarine, Japanese plum and, possibly, myrobalan plum. The disease is caused by a genetic clade within genomic species 3 of P. syringae, but there is only limited knowledge of the diversity of the causative agent. The host plants are cultivated throughout Europe, although it is only in southern European countries that the production of peaches and/or nectarines is of economic importance, and the cultivation of Japanese plums is restricted to some parts of southern Europe. Outbreaks are rare and currently the disease occurs only sporadically in Portugal, France and Germany. P. s. pv. persicae causes symptoms on the bark, shoots, leaves and fruit. Detection is based on symptomatology and isolation; no DNA amplification (polymerase chain reaction) protocols are available. The pathogen can be identified on the basis of disease symptoms, including shoot die-back and leaf spots, and on the basis of distinct biochemical and genetic properties. No effective management strategies are available, although disease incidence and severity can be somewhat reduced by disinfection of tools, machines and materials, the use of planting material from disease-free areas, and the avoidance of conditions favouring disease expression. Initial infections may be due to the use of (latently) infected plant material, but infections may also occur from the environment. No effective biological or chemical control agents are registered for bacterial die-back in Europe. The outbreaks, although they occur sporadically, are usually severe and can result in the loss of entire orchards.

14 October 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(10):3844 [76 pp.]. doi:10.2903/j.efsa.2014.3844 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values for zinc, using a two-stage factorial approach and reference values for body weight. The first stage of estimating physiological requirements used studies that had physiologically plausible data, specifically related to faecal excretion of endogenous zinc. Adult physiological requirements were closely related to body size, and sex differences were not detectable after adjustment for body weight. Average Requirements (ARs) for dietary zinc necessary to meet physiological requirements were estimated using saturation response modelling, taking into account the inhibitory effect of dietary phytate on zinc absorption. Estimated ARs and Population Reference Intakes (PRIs) are provided for phytate intake levels of 300, 600, 900 and 1 200 mg/day, which cover the range of mean/median intakes observed in European populations. ARs range from 6.2 to 10.2 mg/day for women with a reference weight of 58.5 kg and from 7.5 to 12.7 mg/day for men with a reference weight of 68.1 kg. PRIs were derived from the zinc requirement of individuals with a body weight at the 97.5th percentile for reference weights for men and women and range from 7.5 to 12.7 mg/day for women and from 9.4 to 16.3 mg/day for men. ARs for infants from seven months of age and for children were estimated factorially, based on extrapolation from estimates of adult losses plus zinc needs for growth, and range from 2.4 to 11.8 mg/day. PRIs for infants and children were derived by assuming a coefficient of variation of 10 %, and range from 2.9 to 14.2 mg/day. For pregnancy and lactation, additional zinc requirements related to fetal and maternal tissues and transfer of zinc into breast milk, respectively, were considered and additional PRIs of 1.6 and 2.9 mg/day, respectively, were estimated.

10 October 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(10):3846 [67 pp.]. doi:10.2903/j.efsa.2014.3846 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for selenium. The levelling off of plasma selenoprotein P (SEPP1) concentration was considered indicative of an adequate supply of selenium to all tissues and to reflect saturation of the functional selenium body pool, ensuring that selenium requirement is met. This criterion was used for establishing DRVs for selenium in adults. Evidence from human studies on the relationship between selenium intake and plasma SEPP1 concentration was reviewed. Given the uncertainties in available data on this relationship, they were considered insufficient to derive an Average Requirement. An Adequate Intake (AI) of 70 µg/day for adults was set. A review of observational studies and randomised controlled trials that investigated the relationship between selenium and health outcomes did not provide evidence for additional benefits associated with selenium intake beyond that required for the levelling off of SEPP1. No specific indicators of selenium requirements were available for infants, children or adolescents. For infants aged 7–11 months, an AI of 15 µg/day was derived by extrapolating upwards from the estimated selenium intake with breast milk of younger exclusively breast-fed infants, taking into account differences in reference body weights. For children and adolescents, the AIs for selenium were extrapolated from the AI for adults by isometric scaling and application of a growth factor. AIs range from 15 µg/day for children aged one to three years to 70 µg/day for adolescents aged 15–17 years. Considering that adaptive changes in the metabolism of selenium occur during pregnancy, the AI set for adult women applies to pregnancy. For lactating women, an additional selenium intake of 15 µg/day was estimated to cover the amount of selenium secreted in breast milk, and an AI of 85 µg/day was set.

10 October 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(10):3845 [25 pp.]. doi:10.2903/j.efsa.2014.3845 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) considered the evidence for setting Dietary Reference Values for chromium. Trivalent chromium (Cr(III)) has been postulated to be necessary for the efficacy of insulin in regulating the metabolism of carbohydrates, lipids and proteins. However, the mechanism(s) for these roles and the essential function of Cr(III) in metabolism have not been substantiated. The criteria for the essentiality of a trace element were considered. It was noted that attempts to create chromium deficiency in animal models have not produced consistent results, and that there is no evidence of essentiality of Cr(III) in animal nutrition. Evaluating the possibility of Cr(III) as an essential element for humans, the evidence from reported improvements associated with chromium supplementation in patients on total parenteral nutrition was considered to be the most convincing, but overall data do not provide sufficient information on the reversibility of the possible deficiencies and the nature of any dose–response curve in order to identify a dietary requirement for humans. The Panel concludes that no Average Requirement and no Population Reference Intake for chromium can be defined. Several studies assessed the effect of chromium supplementation on glucose and/or lipid metabolism. In the only study for which information on total chromium intake was available, there was no difference in parameters of glucose metabolism of normoglycaemic subjects between the placebo and chromium-supplemented periods. The Panel considered that there is no evidence of beneficial effects associated with chromium intake in healthy subjects. The Panel concluded that the setting of an Adequate Intake for chromium is also not appropriate.

9 October 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(10):3843 [17 pp.]. doi:10.2903/j.efsa.2014.3843 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 an extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is already authorised for use in a range of foodstuffs at specified maximum levels. The applicant requests an extension of use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult population, excluding pregnant and lactating women. In a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults. Based on estimations of high intake of DHA and EPA from the NFI which are considered to be conservative, the Panel considers that this level will not be exceeded by the use of the NFI. The conclusion that there are no safety concerns for the NFI is supported by a 90-day study in which no adverse effect was observed at the highest dose tested of 5 %, equivalentto 3.149 and 3.343 g NFI/kg body weight per day for male and female rats. Following a request from a Member State, the Panel reviewed the evidence for an association between DHA and/or EPA intake and risk of prostate cancer. The Panel considers that, on the basis of available data, there is no evidence for a role of EPA and/or DHA intake in the development of prostate cancer. The Panel concludes that the NFI is safe under the proposed extension of use.

9 October 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(10):3838 [10 pp.]. doi:10.2903/j.efsa.2014.3838 Abstract

Following an application from Olygose, 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 AlphaGOS® and a reduction of post-prandial glycaemic responses. Non-digestible carbohydrates, including α-galacto-oligosaccharides in AlphaGOS®, are resistant to hydrolysis and absorption in the small intestine and therefore do not contribute to post-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) which should replace sugars in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non-digestible carbohydrates, which is the subject of the health claim, and the food constituent (i.e. sugars) that non-digestible carbohydrates should replace in foods or beverages are both sufficiently characterised in relation to the claimed effect. The Panel considers that a reduction of post-prandial glycaemic responses might be a beneficial physiological effect. A claim on non-digestible carbohydrates and reduction of post-prandial glycaemic responses has already been assessed by the Panel with a favourable outcome. The previous evaluation, including the proposed wording and the conditions of use, also applies to this application. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates and a reduction of post-prandial glycaemic responses as compared with sugar-containing foods/beverages.

8 October 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(10):3841 [8 pp.]. doi:10.2903/j.efsa.2014.3841 Abstract

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-galactosidase from Streptococcus thermophilus and reduction of gastrointestinal discomfort. According to the applicant, the food constituent which is the subject of the claim is beta-galactosidase from Streptococcus thermophilus. Streptococcus thermophilus is added to infant formulae in the production process for fermentation purposes and the live organisms are inactivated after the fermentation process. The Panel considers that the food constituent, beta-galactosidase from Streptococcus thermophilus, under the conditions of use proposed by the applicant, is sufficiently characterised. The claimed effect proposed by the applicant is “reduction of gastro-intestinal discomfort”. The target population proposed by the applicant is infants and young children. The Panel considers that reduction of gastrointestinal discomfort is a beneficial physiological effect. No human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-galactosidase which is produced by Streptococcus thermophilus (subsequently inactivated) during fermentation of an infant formula and reduction of gastrointestinal discomfort.

8 October 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(10):3839 [9 pp.]. doi:10.2903/j.efsa.2014.3839 Abstract

Following an application from Roquette Italia S.P.A., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutriose®06 and a reduction of post-prandial glycaemic responses. Non-digestible carbohydrates, including resistant dextrin in Nutriose®06, are resistant to hydrolysis and absorption in the small intestine and therefore do not contribute to post-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch), which should replace glycaemic carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent, non-digestible carbohydrates, which is the subject of the health claim, and the food constituent (i.e. glycaemic carbohydrates) that non-digestible carbohydrates should replace in foods or beverages are both sufficiently characterised in relation to the claimed effect. The Panel considers that a reduction of post-prandial glycaemic responses might be a beneficial physiological effect. A claim on non-digestible carbohydrates and reduction of post-prandial glycaemic responses has already been assessed by the Panel with a favourable outcome. The previous evaluation, including the proposed wording and the conditions of use, also applies to this application. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates and a reduction of post-prandial glycaemic responses as compared with foods/beverages containing glycaemic carbohydrates.

8 October 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(10):3840 [8 pp.]. doi:10.2903/j.efsa.2014.3840 Abstract

Following an application from DSM Nutritional Products, submitted for authorisation of a health claim pursuant to Article 14 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 docosahexaenoic acid (DHA) and contribution to normal brain development. The Panel considers that DHA is sufficiently characterised, and that contribution to normal brain development is a beneficial physiological effect for infants and children. The Panel has already assessed a claim on DHA and maintenance of normal brain function with a favourable outcome. The Panel noted the well-established role of DHA in brain function. The Panel considers that the role of DHA in normal brain function applies to all ages, including brain development in infants and children. The Panel also notes that the developing brain accumulates large amounts of DHA, particularly during the first two years of life, but also later and throughout childhood. The Panel concludes that a cause and effect relationship has been established between the consumption of DHA and contribution to normal brain development. The following wording reflects the scientific evidence: “DHA contributes to normal brain development”. In order to bear the claim, foods for older infants and young children below the age of 24 months should provide a daily intake of 100 mg DHA in one or more servings, while foods for children from 2 to 18 years should provide a daily intake of 250 mg DHA in one or more servings.

8 October 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(10):3837 [11 pp.]. doi:10.2903/j.efsa.2014.3837 Abstract

Following an application from Oy Karl Fazer AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, 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 high‑fibre sourdough rye bread and a reduction of post-prandial glycaemic responses. The Panel considers that the food, high-fibre sourdough rye bread, and its “comparator”, glucose, are sufficiently characterised in relation to the claimed effect. A reduction of post-prandial glycaemic responses might be a beneficial physiological effect. The Panel notes that in the four human intervention studies submitted as pertinent to the health claim the consumption of high-fibre sourdough rye bread induced a significant reduction of post-prandial blood glucose responses when compared with glucose. The Panel also notes that, when comparable amounts of available carbohydrates from different carbohydrate-containing foods are tested, almost any carbohydrate-containing food would induce a reduction of post-prandial blood glucose responses compared with glucose. In addition, foods containing low amounts of, or no available carbohydrates, will also induce lower post-prandial blood glucose responses when compared with glucose. The Panel concludes that a cause and effect relationship has been established between the consumption of almost any food and a reduction of post-prandial blood glucose responses as compared with glucose. However, the Panel considers that solid foods, including high-fibre sourdough rye bread, are generally not considered as an alternative to glucose solutions. In this context, conditions of use cannot be established for this health claim.

8 October 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(10):3825 [14 pp.]. doi:10.2903/j.efsa.2014.3825 Abstract

The product L-threonine, intended for use as a feed additive, is produced by fermentation with a genetically modified strain of Escherichia coli (FERM BP 11383). Neither the production strain nor its recombinant DNA were detected in the product. The product does not raise safety concerns with regard to the genetic modification. L-threonine, technically pure, produced by E. coli (FERM BP-11383) is considered safe for the target species when used to meet the animals’ nutritional requirements. As the composition of tissues and products of animal origin will not be changed by the use of the product in animal nutrition, and considering its high purity, no risks are expected for the consumer from the use of the product as a feed additive. The product is considered not irritating to the skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is no evidence of acute toxicity by the inhalation route. The use of the product as a feed additive does not represent a risk to the environment. The product is considered as an efficacious source of the amino acid L-threonine for all animal species. Supplemental L-threonine is degraded by ruminal microorganisms if not given in a protected form.

3 October 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(10):3826 [13 pp.]. doi:10.2903/j.efsa.2014.3826 Abstract

L-Tryptophan, technically pure, is a feed additive produced by a genetically modified Escherichia coli strain (FERM BP-11354). Neither the production strain nor its recombinant DNA were detected in the final product. l‑Tryptophan manufactured by fermentation with E. coli FERM BP-11354 does not give rise to any safety concern for the genetic modifications of the production strain. The L-Tryptophan product produced by E. coli (FERM BP-11354) is considered safe for non-ruminant target species when used to supplement the diet in appropriate amounts. The use of unprotected L-Tryptophan in ruminants’ feed should be avoided. L-Tryptophan will be incorporated into proteins of the body of the target animal and any potential excess will be metabolised and excreted. Considering the high purity of the product under assessment, no risks are expected for the consumer from the use of L-Tryptophan produced by E. coli (FERM BP-11354) as a feed additive. Safety is further ensured by the low levels (less than 10 mg/kg additive each) of 1,1¢-ethylidene-bis-L-Tryptophan (EBT) and 1-methyl-1,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA), previously seen to cause eosinophilia–myalgia syndrome in humans. The FEEDAP Panel considers that the product is not an irritant to the skin or eyes and it is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is no evidence of acute toxicity by the inhalation route. L-Tryptophan is a naturally occurring amino acid and its use in animal nutrition is not expected to be of concern to the environment. The additive L-Tryptophan is regarded as an effective source of the amino acid L-Tryptophan. Supplemental L-Tryptophan is degraded by ruminal microorganisms if not given in a protected form.

3 October 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(10):3832 [75 pp.]. doi:10.2903/j.efsa.2014.3832 Abstract

Tomatoes may be minimally processed to obtain ready-to-eat products, and these steps include selection, washing, cleaning, stem removal, cutting, packaging and storage. Epidemiological data from the EU have identified one salmonellosis outbreak and one Norovirus outbreak associated with tomato consumption between 2007 and 2012. Risk factors for tomato contamination by Salmonella and Norovirus were considered in the context of the whole food chain. Available estimates of the Salmonella and Norovirus occurrence in tomatoes were evaluated together with mitigation options relating to prevention of contamination and the relevance of microbiological criteria. It was concluded that each farm environment represents a unique combination of risk factors that can influence occurrence and persistence of pathogens in tomato production. Appropriate implementation of food safety management systems including Good Agricultural Practices (GAP), Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP), should be primary objectives of tomato producers. The current lack of data does not allow the proposal of a Hygiene Criterion for E. coli at primary production of tomatoes and it is also not possible to assess the suitability of an EU-wide E. coli Process Hygiene Criterion. There are Food Safety Criteria for the absence of Salmonella in 25 g samples of ready-to-eat pre-cut tomatoes as well as in unpasteurised tomato juice placed on the market during their shelf life. A Food Safety Criterion for Salmonella in whole tomatoes could be considered as a tool to communicate to producers and processors that Salmonella should not be present in the product. Testing of tomatoes for Salmonella could be limited to instances where other factors indicate breaches in GAP, GHP, GMP or HACCP programmes. It is currently not possible to provide a risk base for establishing a Norovirus Food Safety Criterion for these foods.

2 October 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(10):3831 [77 pp.]. doi:10.2903/j.efsa.2014.3831 Abstract

Melons and watermelons are ready-to-eat foods, with an internal pH of 5.1 to 6.7 and can be consumed whole, as fresh-cut products or as fresh juices. Epidemiological data from the EU identified one salmonellosis outbreak associated with consumption of both pre-cut and whole melon between 2007 and 2012. Risk factors for melon and watermelon contamination by Salmonella were considered in the context of the whole food chain, together with available estimates of Salmonella occurrence and mitigation options relating to prevention of contamination and the relevance of microbiological criteria. It was concluded that each farm environment represents a unique combination of risk factors that can influence occurrence and persistence of Salmonella in melon and watermelon production. Appropriate implementation of food safety management systems including Good Agricultural Practices (GAP), Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP), should be primary objectives of producers. It is currently not possible to assess the suitability of an EU-wide E. coli Hygiene Criterion at primary production. The existing Process Hygiene Criterion for E. coli in pre-cut melons and watermelons aims to indicate the degree to which GAP, GHP, GMP or Hazard Analysis and Critical Control Points (HACCP) programmes have been implemented. There are Food Safety Criteria for the absence of Salmonella in 25g samples placed on the market during their shelf life of ready-to-eat pre-cut melon and watermelon and unpasteurised melon and watermelon juices. A Food Safety Criterion for Salmonella in whole melons and watermelons could be considered as a tool to communicate to producers and processors that Salmonella should not be present in the product. Since the occurrence of Salmonella is likely to be low, testing of whole melons or watermelons for this bacteriumcould be limited to instances where other factors indicate breaches in GAP, GHP, GMP or HACCP programmes.

2 October 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(10):3827 [16 pp.]. doi:10.2903/j.efsa.2014.3827 Abstract

This opinion concerns the re-authorisation of formic acid for use as a preservative in feed and water for drinking and as a silage additive in feed for all animal species and categories. No adverse effects are to be anticipated when formic acid is used at the maximum proposed dose in feed for pigs (12 000 mg formic acid/kg complete feed), poultry or ruminants (10 000 mg formic acid/kg complete feed). A margin of safety could not be identified. These conclusions are extrapolated to other animal species at a maximum dose of 10 000 mg formic acid/kg complete feed. Considering that the turnover of formic acid is rapid, with no evidence of accumulation in body tissues, its use in animal nutrition is not expected to contribute to consumer exposure. Therefore, the use of formic acid as a feed additive in all animal species is considered safe for the consumer. Formic acid at concentrations greater than 10 % is considered to be corrosive to skin and eyes. The acid is volatile, and exposure via inhalation for those handling the additive, as well as exposure to skin and eyes, is considered to present a risk to unprotected workers. The FEEDAP Panel considers that the use of formic acid in animal nutrition is safe for the environment. Formic acid at the recommended concentrations inhibits bacterial growth in feedingstuffs and water for drinking, and is recognised as an efficacious silage additive.

2 October 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(10):3842 [13 pp.]. doi:10.2903/j.efsa.2014.3842 Abstract

Following an application from E-piim production Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Estonia, 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 “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type “heart cheese” of Harmony™” and maintenance of normal blood pressure (BP). The food constituent L. plantarum TENSIA®, which is the subject of the health claim, is sufficiently characterised. The Panel considers that the maintenance of normal blood pressure is a beneficial physiological effect. The applicant provided 47 references which did not address the effects of L. plantarum TENSIA® on BP. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim. Two human randomised, double-blind, placebo-controlled, intervention studies investigated the effect on BP of L. plantarum TENSIA® consumed in Edam-type cheese for three and eight weeks. In weighing the evidence, the Panel took into account that only one human intervention study with important methodological limitations showed a BP-lowering effect of L. plantarum TENSIA® consumed in the Edam-type “heart cheese” of Harmony™ when consumed daily for eight weeks, and that no evidence was provided for a mechanism by which L. plantarum TENSIA® in the Edam-type “heart cheese” of Harmony™ could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum TENSIA®in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure.

1 October 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(10):3836 [8 pp.]. doi:10.2903/j.efsa.2014.3836 Abstract

Following an application from the British Specialist Nutrition Association 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 carbohydrate solutions and maintenance of physical performance during endurance exercise. The food, which is proposed by the applicant to be the subject of the health claim, is “carbohydrate solutions including sports ‘gels’ (to be consumed with water) which will either be able to maintain endurance performance for longer or improve performance relative to plain water or water/electrolyte placebo”. The Panel notes that, whereas carbohydrate solutions, the food which is the subject of the health claim, and one of the proposed comparators, water, are sufficiently characterised, no specifications have been provided for the other comparator, “water/electrolyte placebo”. Therefore, the Panel considers that a cause and effect relationship between the consumption of carbohydrate solutions and maintenance of physical performance during endurance exercise as compared to “water–electrolyte solutions” cannot be established on the basis of the information provided. Maintenance of physical performance during endurance exercise is a beneficial physiological effect. Three meta-analyses of human intervention studies were provided by the applicant for the scientific substantiation of this health claim. The Panel considers that these meta-analyses cannot be used to substantiate a claim on the effect of carbohydrate solutions on the maintenance of physical performance during endurance exercise as compared to water. The Panel concludes that a cause and effect relationship has not been established between the consumption of carbohydrate solutions and maintenance of physical performance during endurance exercise as compared to water.

1 October 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(10):3828 [18 pp.]. doi:10.2903/j.efsa.2014.3828 Abstract

Tannic acid is a synonym for hydrolysable tannins, which are widely distributed in nature. The use of tannic acid as a feed additive up to 15 mg/kg feed is safe for all animal species. The use of tannic acid as a feed additive under the proposed conditions of use presents no safety risk to consumers. In the absence of data, it would be prudent to regard the additive as potentially hazardous to workers by exposure to the skin, eyes and mucous membranes or by inhalation exposure. Tannic acid is naturally present in many plant species. The use of tannic acid as a feed additive is considered safe for the environment. Tannic acid is recognised as a food flavouring agent and is included in the European Union list of food flavourings. As its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

1 October 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(10):3833 [28 pp.]. doi:10.2903/j.efsa.2014.3833 Abstract

The Panel on Plant Health undertook a pest categorisation of Helicoverpa armigera for the European Union territory. The taxonomy of H. armigera and related species worldwide is complex but, in Europe, only H. armigera is present. Although it has been recorded in all Member States, it persists throughout the year only in the southernmost parts of Europe where winters are not too cold. From these areas and from North Africa, long-distance northward migrations of up to 1 000 km can occur. In most of Europe, only transient populations are found outdoors. Nevertheless, damage to outdoor crops has been recorded as far north as the Netherlands. H. armigera also damages crops produced under protected conditions, with outbreaks related to the import of plants for planting. It is highly polyphagous, with over 180 host species recorded from more than 45 families, and it is particularly hard to detect and difficult to control because the larvae bore into reproductive structures with few visible external symptoms. Damage is especially severe in hot summers. Insecticide resistance is common and a wide range of insecticides may be applied. It is listed in Annex IIAII, and special requirements for H. armigera are formulated in Annexes IVAI and IVAII of Council Directive 2000/29/EC to regulate the movement of plants for planting of Solanaceae and three ornamental genera.

1 October 2014 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2014;12(10):3876 [43 pp.]. doi:10.2903/j.efsa.2014.3876 Abstract

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for curcumin (E 100) taking into account additional information on its use in foods. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of curcumin (E 100) used as a food additive. In that opinion, the Panel concluded that at the maximum levels of use, intake estimates for 1 to 10-year old children at the mean and the high level can be above the Acceptable Daily Intake (ADI) of 3 mg/kg body weight per day in some European countries. Following this conclusion, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as monitoring data from Member States submitted to EFSA and the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided to EFSA for 52 out of the 57 food categories in which curcumin is authorised as a food additive. Analytical results provided to EFSA from Member States were all below the limit of detection (LOD) except for four samples of the food category edible ices. Using the reported use levels, exposure estimates for adolescents, adults and the elderly were below the ADI both at the mean and at the high level (95th percentile) of exposure. This was also true for the mean exposure estimates for toddlers and children. High level estimates were at the level of the ADI in these two population groups, with exceedance of the ADI in one survey each. In comparison to the previous assessment of 2010, the current exposure estimates based on reported use levels and consumption data at individual level were lower.

23 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3871 [25 pp.]. doi:10.2903/j.efsa.2014.3871 Abstract

The European Food Safety Authority mandated its GMO Unit to prepare a statement supporting the application of the EFSA Scientific Committee ‘Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed’ in the frame of Implementing Regulation (EU) 503/2013, which requires a 90-day study in rodents for the risk assessment of genetically modified (GM) plants. This statement illustrates two possible scenarios for 90-day studies, based on the identification (scenario 1) or not (scenario 2) of hazards in previous analyses, and provides information on the study design, conduct and interpretation accordingly. Considerations on the type and source of the test materials and on preparation of test diets are also provided, with illustrative examples. Detailed analytical characterisation of the test and control materials and diets are recommended, including the detection of the genetic event and, if appropriate, quantification of the newly expressed protein(s). The selection of dose levels is discussed, with a maximum incorporation rate (high dose level) proposed for various crops. The selection of one dose level only (the high dose) is proposed as an option and discussed for scenario 2. The preferred test species is the rat; it should be socially housed, single housing needing justification. Limitations for the identification of appropriate sample sizes are discussed for both scenarios. Technical details for endpoints selection and data collection are provided. Strategies for integrated study interpretation are presented and areas for further scientific development are discussed.

9 October 2014 Mail Print Cite

Guidance of EFSA

European Food Safety Authority EFSA Journal 2014;12(10):3874 [55 pp.]. doi:10.2903/j.efsa.2014.3874 Abstract

Regulation (EC) No 1107/2009 ensures that the residues of plant protection products (PPPs), consequent to application consistent with good plant protection practice and having regard to realistic conditions of use, shall not have any harmful effects on human health. In 2010, the EFSA Panel on Plant Protection Products and their Residues (PPR) prepared a Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders”, which highlighted some inconsistencies between the approaches adopted by regulatory authorities. Therefore, the PPR Panel proposed a number of changes to those practices in use (e.g. routine risk assessment for individual PPPs should continue to use deterministic methods, and a tiered approach to exposure assessment remains appropriate; there is a need to introduce an acute risk assessment for operators, workers and bystanders where PPPs are acutely toxic; for acute risk assessments, exposure estimates should normally be based on 95th percentiles of relevant datasets, whereas, for longer term risk assessments, the starting point should be a 75th percentile). To prepare a Guidance Document, an ad hoc working group was established to revise all available data and procedures to perform the operator, worker, resident and bystander risk assessment. In addition to the data reported in the PPR opinion, further data were made available to the working group which were analysed and considered. The opinion also identifies those scenarios for which exposure estimates are least satisfactory, and makes recommendations for further research that would reduce current uncertainties. An exposure calculation spreadsheet, reflecting the Guidance content, is annexed to this Guidance Document, to support stakeholders in performing the assessment of exposure and risk.

23 October 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(10):3835 [49 pp.]. doi:10.2903/j.efsa.2014.3835 Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to perform an evaluation of imidacloprid as regards the risk to aquatic organisms. In this context the conclusions of EFSA concerning the risk assessment for aquatic organisms for the active substance imidacloprid are reported. The context of the evaluation was that required by the European Commission in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data. The conclusions were reached on the basis of the evaluation of the representative uses of imidacloprid authorised at the time of approval of the substance. The proposed endpoints concluded as being most appropriate for use in regulatory risk assessment, derived from the submitted studies and literature data, are presented. Missing information identified as being required to allow for a complete risk assessment is listed.

13 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3868 [39 pp.]. doi:10.2903/j.efsa.2014.3868 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 Belgium for the pesticide active substance COS-OGA are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of COS-OGA as an elicitor to control powdery mildew (Sphaerotheca fuliginea) on cucurbits grown under glasshouses. An application for inclusion of COS-OGA in Annex IV of Regulation (EC) No 396/2005 was assessed. 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.

13 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3816 [41 pp.]. doi:10.2903/j.efsa.2014.3816 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 Netherlands for the pesticide active substance terpenoid blend QRD-460 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of terpenoid blend QRD-460 as an insecticide on tomato, melon, cucumber and pepper. 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 October 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(10):3882 [26 pp.]. doi:10.2903/j.efsa.2014.3882 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 the Landwirtschaftskammer Nordrhein-Westfalen plant protection service to modify the existing maximum residue limits (MRLs)for the active substance difenoconazole in lettuce and other salad plants including Brassicaceae. Furthermore, Belgium, referred also to as the evaluating Member State (EMS), received an application from the Belgian Federal Public Service Health, Food chain safety and Environment to modify the existing MRL for the active substance difenoconazole in basil (mint). According to EFSA the data are sufficient to derive MRL proposals of 0.7 mg/kg for the proposed uses on lettuce and scarole, 7 mg/kg on lamb's lettuce, 1.5 mg/kg on rucola/rocket and 15 mg/kg on basil (mint). Adequate analytical enforcement methods are available to control the residues of difenoconazole in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of difenoconazole on lettuce, scarole, lamb's lettuce, rucola and mint will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

31 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3879 [17 pp.]. doi:10.2903/j.efsa.2014.3879 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the EMS, received an application from BASF SE to modify the existing maximum residue level (MRL) for the active substance ametoctradin in hops. In order to accommodate for the intended use of ametoctradin, Germany proposed to raise the existing MRL from the value of 15 mg/kg to 100 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 of 100 mg/kg for the proposed use on hops. However, EFSA is of the opinion that the analytical method is not fully validated for dried hops and therefore, additional data have to be provided to confirm that the proposed analytical method is suitable to enforce ametoctradin residues in dried hops. Based on the risk assessment results, EFSA concludes that the proposed use of ametoctradin on hops will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

28 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3872 [19 pp.]. doi:10.2903/j.efsa.2014.3872 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, United Kingdom (UK) hereafter referred to as the evaluating Member State (EMS), received an application from Horticulture Development Company (HDC), to modify the existing maximum residue levels (MRLs) for the active substance pyraclostrobin in swedes and turnip. In order to accommodate for the intended uses of pyraclostrobin in northern Europe (NEU), UK proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.02* mg/kg to 0.09 mg/kg. UK drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive the MRL proposals of 0.09 mg/kg for the proposed uses on swedes and turnips. Based on the risk assessment results, EFSA concludes thatthe proposed uses of pyraclostrobin on swedes and turnips will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

16 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3870 [15 pp.]. doi:10.2903/j.efsa.2014.3870 Abstract

In accordance with Article 16 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), compiled an application to set an MRL for copper compounds in wild game. Since the default MRL of 0.01 × mg/kg would not be sufficient to cover the natural background level of copper compounds in wild game, Germany proposed to set an MRL of 4 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 sufficient to derive an MRL proposal of 4 mg/kg for copper in order to cover the natural background levels of copper in wild game. Adequate analytical enforcement methods are available to control the residues of total copper on the wild game. Since the contribution of the proposed MRL to the total consumer exposure to copper is negligible (0.7 % of the ADI, IE adult), EFSA recommends the setting of an MRL of 4 mg/kg for copper compounds in wild game.

9 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3860 [22 pp.]. doi:10.2903/j.efsa.2014.3860 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Makteshim-Agan UK Ltd to modify the existing MRLs for the active substance clofentezine in several commodities. In order to accommodate for the intended uses of clofentezine, the United Kingdom proposed to raise the existing MRL in cucurbits with edible peel to 0.2 mg/kg and in tomatoes and aubergines to 0.5 mg/kg. No MRL was proposed for cherries as the data were insufficient. The United Kingdom drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to propose a MRL of 0.2 mg/kg on cucurbits with edible peel. An amendment of the MRL is not proposed on cherries as the data were not sufficient and on tomatoes, aubergines and courgettes as long as the toxicity of the metabolites observed in the hydrolysis study is not addressed and information on their possible residue levels in the processed food commodities provided. Adequate analytical enforcement methods are available to control the residues of clofentezine in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of clofentezine on cucumbers and gherkins will not result in a consumer exposure exceeding the toxicological reference value for clofentezine. However, the overall risk assessment in the framework of this opinion should be considered as provisional pending the conclusion on the toxicology of the metabolite 2-chlorobenzonitrile.

7 October 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(10):3861 [60 pp.]. doi:10.2903/j.efsa.2014.3861 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 haloxyfop-P. In order to assess the occurrence of haloxyfop-P 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 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 for the European authorisation, 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. Moreover, when considering the MRLs established by the Codex Alimentarius Commission, a possible chronic risk to consumers was identified. Consequently, EFSA concluded that CXLs should not be included in the EU legislation.

1 October 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2014;12(10):3875 [44 pp.]. doi:10.2903/j.efsa.2014.3875 Abstract

This report provides an analysis and critical assessment of the sampling strategy, the data collected, and the detection methods used in the Echinococcus multilocularis surveillance carried out in Finland, Ireland, Malta and the United Kingdom (UK) and reported in 2014 in the context of Regulation (EU) No 1152/2011 regarding preventive health measures for the control of E. multilocularis infection in dogs. The surveillance aims at detecting the parasite, if present in any part of those Member States. The 2014 surveillance reports of the four Member States were assessed by checking the description of the surveillance system for completeness against the relevant elements that need to be addressed in assessing the quality of E. multilocularis surveillance reports in the context of Regulation (EU) No 1152/2011. The data reported on individual samples were assessed using the raw data submitted by the Member States via the EFSA Data Collection Framework (DCF). Descriptive statistics were calculated to check whether the requirements of Regulation (EU) No 1152/2011 had been fulfilled. None of the four Member States who are operating an E. multilocularis-specific surveillance programme aimed at detecting the parasite, if present in any part of those Member States, has detected E. multilocularis through the surveillance activities reported in 2014. Under the assumption of unbiased representative sampling (in the case of Finland, Ireland and the UK) and unbiased risk based sampling (in the case of Malta) and considering the sensitivity of the tests applied, all four MS have fulfilled the requirement of Regulation (EU) No 1152/2011 to the effect that the surveillance activities should detect a prevalence of E. multilocularis of 1 % or less at a confidence level of at least 0.95.

27 October 2014 Mail Print Cite