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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 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 2015;13(1):3988 [32 pp.]. doi:10.2903/j.efsa.2015.3988 Abstract

The Panel on Plant Health performed a pest categorisation of Circulifer tenellus (Ct) and C. haematoceps (Ch) (Hemiptera, Cicadellidae) for the European Union (EU) territory. They are well-defined insect species that can be identified on the basis of external morphology and male genitalia. Ch and Ct are considered to originate from the Old World; Ct is also present in North America and the Caribbean. In the EU, Ch is reported in 11 Member States, mostly in southern or central Europe, and Ct is reported in Spain, France, Italy and Greece. Neither species is harmful by itself, but they are vectors of Spiroplasma citri, the causal agent of, for example, citrus stubborn disease. The major impact of Ct in North America results from the transmission of Beet curly top virus to sugarbeet. Ct also transmits ‘Candidatus Phytoplasma trifolii’ and Ch transmits ‘Ca P. asteris’. There is no transovarial transmission of the pathogens. Ch and Ct are regulated harmful organisms in the EU and listed in Annex II, Part A, Section II, of Council Directive 2000/29/EC together with Spiroplasma citri and with respect to plants of Citrus, Fortunella, Poncirus and their hybrids, other than fruit and seeds, despite the fact that Ct and Ch have a larger host range. Ch and Ct are likely to be disseminated by plants for planting (the eggs are laid into the leaf veins and petioles), they have also been observed to hitch-hike on terrestrial vehicles, and Ct is known for its very high flight capacity. Both species have many hosts, in particular in the Chenopodiaceae, Brassicaceae and Asteraceae. Ecological conditions in the risk assessment area are suitable for the establishment and spread of S. citri, at least where citrus is currently grown.

23 January 2015 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Maged Younes. EFSA Journal 2015;13(1):3980 [30 pp.]. doi:10.2903/j.efsa.2015.3980 Abstract

The complexation product of sodium tartrates and iron(III) chloride (Fe mTA) is proposed for use as an anti-caking agent, only in salt or its substitutes, with a maximum use level of 106 mg Fe mTA/kg salt. Fe mTA can be expected to dissociate into its constituent iron(III) and tartrate components upon ingestion. Studies in rats demonstrated that up to 90 % of ingested DL-tartrate or tartaric acid were absorbed, studies in humans suggested that only 20 % of an ingested dose of tartaric acid were absorbed. There are no ADME (absorption, distribution, metabolism and excretion) data for meso-tartrate. From a 90-day rat study, the lowest calculated BMDLs (Benchmark Dose Level) for Fe mTA were: 75 mg/kg body weight (bw) per day for males (BMDL05 for serum bile acids) and 267 mg/kg bw per day for females (BMDL10 for goblet cells hyperplasia). Several in vitro studies showed that there is no safety concern for genotoxicity. No reprotoxicity and developmental toxicity was reported, however no study was specifically designed for teratogenicity. No long-term or carcinogenicity studies were available. The Panel concluded that the toxicity database was insufficient to establish an ADI (Acceptable Daily Intake) and calculated MoS (Margin of Safety) by comparing the highest intake of Fe mTA of 0.092 mg/kg bw per day for children at the 97.5 percentile with the lowest BMDLs. The resulting MoS were 815 and 2 900 for males and females, respectively. Owing to the conservative assumptions included in the exposure assessment, the Panel concluded that there is no safety concern for the single condition of use and use level of Fe mTA proposed. The Panel noted that this evaluation was based on a limited toxicity database, for a single use resulting in a very low exposure, and therefore concluded that any extension of use and/or use level of Fe mTA, would require a new risk assessment.

22 January 2015 Mail Print Cite

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(1):3978 doi:10.2903/j.efsa.2015.3978 Abstract

This opinion describes the assessment of the risks to public health associated with bisphenol A (BPA) exposure. Exposure was assessed for various groups of the human population in three different ways: (1) external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper); (2) internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA); and (3) aggregated (from diet, dust, cosmetics and thermal paper), expressed as oral human equivalent dose (HED) referring to unconjugated BPA only. The estimated BPA dietary intake was highest in infants and toddlers (up to 0.875 μg/kg bw per day). Women of childbearing age had dietary exposures comparable to men of the same age (up to 0.388 μg/kg bw per day). The highest aggregated exposure of 1.449 μg/kg bw per day was estimated for adolescents. Biomonitoring data were in line with estimated internal exposure to total BPA from all sources. BPA toxicity was evaluated by a weight of evidence approach. “Likely” adverse effects in animals on kidney and mammary gland underwent benchmark dose (BMDL10) response modelling. A BMDL10 of 8 960 μg/kg bw per day was calculated for changes in the mean relative kidney weight in a two generation toxicity study in mice. No BMDL10 could be calculated for mammary gland effects. Using data on toxicokinetics, this BMDL10 was converted to an HED of 609 μg/kg bw per day. The CEF Panel applied a total uncertainty factor of 150 (for inter- and intra-species differences and uncertainty in mammary gland, reproductive, neurobehavioural, immune and metabolic system effects) to establish a temporary Tolerable Daily Intake (t-TDI) of 4 μg/kg bw per day. By comparing this t-TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure or from aggregated exposure. The CEF Panel noted considerable uncertainty in the exposure estimates for non-dietary sources, whilst the uncertainty around dietary estimates was relatively low.

21 January 2015 Mail Print

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, David Caffier, 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 2015;13(1):3987 [26 pp.]. doi:10.2903/j.efsa.2015.3987 Abstract

The Panel on Plant Health undertook a pest categorisation of Spodoptera littoralis (Boisduval) for the territory of the European Union (EU). This insect is morphologically very similar to S. litura but the two species occupy very distinct geographical distributions, with only S. littoralis found in Europe and Africa. S. littoralis is established only in the southernmost parts of Europe where winters are not too cold. Long-distance northward migrations occur and the pest can also be transported throughout the EU with plants for planting. S. littoralis is highly polyphagous and it is an important pest of a very wide variety of outdoor vegetable, salad and ornamental crops in southern Europe. Field crops, such as lucerne, can also be affected, and even football pitches can be damaged. Population densities and damage vary considerably from year to year. Outbreaks also occur in protected crops, particularly ornamentals, throughout the EU. A very large number of insecticides are deployed to control this pest, which is resistant to many compounds. Resistance management and successful control of the pest can be obtained with mass trapping, mating disruption and attract-and-kill methods. S. littoralis is listed in Annex IAII and special requirements for S. littoralisare formulated in Annexes IVAI and IVAII of Council Directive 2000/29/EC to regulate the movement of plants for planting of three ornamental genera (Dendranthema, Dianthus and Pelargonium).

20 January 2015 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, David Caffier, 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 2015;13(1):3990 [26 pp.]. doi:10.2903/j.efsa.2015.3990 Abstract

Following a request from the European Commission, the EFSA Panel on Plant Health (EFSA PLH Panel) was asked to react to a document entitled “Comments on the European Union Food Safety Authority’s Pest Risk Assessment for Phyllosticta citricarpa”, authored by Hattingh et al., which was posted online in August 2014 on the website of Citrus Research International (Pty) Ltd, South Africa. Citrus black spot (CBS), caused by the fungus Phyllosticta citricarpa (McAlpine) Van der Aa, is a fruit-blemishing and leaf-spotting disease affecting citrus. P. citricarpa is not known to occur in the EU territory and is regulated as a quarantine organism in citrus (Council Directive 2000/29/EC). The Panel assessed the comments by Hattingh et al. in the light of the content of the EFSA PLH Panel Scientific Opinion on CBS and the EFSA report detailing responses to comments received during the public consultation on the draft opinion. The Panel stands by the EFSA PLH Panel Scientific Opinion on CBS and considers that the comments by Hattingh et al. have been thoroughly addressed in the EFSA report on the public consultation on the EFSA PLH Panel Scientific Opinion on CBS. A detailed point by point reply to the comments by Hattingh et al. is provided in an Appendix of this Panel statement. Since September 2014, EFSA has written to the lead author of the comments trying to engage in a scientific dialogue concerning the sources of uncertainty related to the risks posed by P. citricarpa to plant health in the EU, so as to identify ways to reduce such uncertainties (e.g. with further research and/or data exchange). The EFSA PLH Panel also remains open to such constructive dialogue in the future.

20 January 2015 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 2015;13(1):3968 [20 pp.]. doi:10.2903/j.efsa.2015.3968 Abstract

Coxiril® containing 0.5 % diclazuril is intended for the control of coccidiosis in rabbits for fattening at concentrations between 1.0 and 1.2 mg diclazuril/kg complete feed. The highest proposed concentration, 1.2 mg diclazuril from Coxiril®/kg complete feed, is safe for does (pregnant and lactating) and rabbits for fattening with a margin of safety of about 2.5. This conclusion is extended to all rabbits. Diclazuril has no substantial antibacterial activity. Diclazuril from Coxiril® is considered toxicologically equivalent to the currently authorised diclazuril. The use of Coxiril® at the maximum proposed use level, 1.2 mg diclazuril/kg complete feed for rabbits, is safe for the consumer, provided a withdrawal time of two days is respected. Coxiril® is considered non-irritant to eyes and skin. It is not a potential skin sensitiser. User exposure to Coxiril® as a result of normal handling is unlikely to cause respiratory or systemic toxicity. Applying the current standards, no risk for the soil ecosystem could be identified. From three tests required for the risk characterisation of the aquatic ecosystem, only the chronic test with algae provided reliable results, and the two others (acute tests with daphnia and zebra fish) failed to derive a reliable Predicted No-Effect Concentration because of the low water solubility of diclazuril. Consequently, a final risk characterisation for the aquatic environment was not possible. Diclazuril from Coxiril® at a concentration of 1 mg/kg complete feed has the potential to effectively control coccidiosis in rabbits.

20 January 2015 Mail Print Cite

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Maged Younes. EFSA Journal 2015;13(1):3981 [20 pp.]. doi:10.2903/j.efsa.2015.3981 Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion evaluating   the safety of the change in the production method for the production of L-glutamic acid (E620), monosodium - L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate (E625). The L-glutamic acid is produced by the genetically modified Corynebacterium glutamicum EA-12 strain. The recipient strain Corynebacterium glutamicum  strain2256  has been recommended for Qualified Presumption of Safety (QPS) status. No antibiotic resistance genes were left in the genome and neither the production strain nor its recombinant DNA were detected in the final product. The Panel considered there were no safety concerns for consumers from the genetic modification. The proposed uses or use levels of L-glutamic acid and its salt derivatives produced with the current strain and the new genetically modified microorganism (GMM) strain will be identical and thus the Panel considered that the exposure to the food additive will remain unaffected. Provided that the L-glutamic acid and its salts both produced with the current strain and with the GMM strain are equal in the specifications and physicochemical characteristics, the biological and toxicological data for the L-glutamic acid and its salts produced with the current strain are considered by the Panel to support the safety of the food additives produced with the GMM strain. The Panel concluded that there are no safety concerns from the  change in the production method of the food additives L-glutamic acid (E620), monosodium L-glutamate (E621), monopotassium L-glutamate (E622), calcium di-L-glutamate (E623), monoammonium L-glutamate (E624) and magnesium di-L-glutamate (E625) meeting their existing specifications.

20 January 2015 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 2015;13(1):3998 [49 pp.]. doi:10.2903/j.efsa.2015.3998 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 (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 30 aliphatic and arylalkyl amines and amides evaluated by JECFA at the 65th meeting in 2005. This revision is required owing to additional available toxicity data on piperine [FL-no: 14.003] and deca-(2E,4E)-dienoic acid isobutyl-amide [FL-no: 16.091]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological thresholds of concern and available data on metabolism and toxicity. The Panel agrees with JECFA’s conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the Maximised Survey-derived Daily Intake (MSDI) approach for all substances considered in this FGE. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 30 substances, the information is adequate.

20 January 2015 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 2015;13(1):3997 [58 pp.]. doi:10.2903/j.efsa.2015.3997 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 (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 22 pyridine, pyrrole and quinoline derivatives evaluated by JECFA (63rd meeting). The revision of this consideration is made since additional toxicity data have become available for 1-furfurylpyrrole [FL-no: 13.134]. The data are intended to cover the re-evaluation of this substance and 2-acetyl-1-ethylpyrrole [FL-no: 14.045] and 2-acetyl-1-methylpyrrole [FL-no: 14.046]. The Panel concluded that for 6-methylquinoline [FL-no: 14.042], the genotoxicity data available do not clear the concern with respect to genotoxicity in vitro and accordingly the substance is not evaluated through the Procedure. For 21 substances [FL-no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 14.045, 14.046, 14.047, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.068, 14.071, 14.072 and 14.164] considered in this FGE, the Panel 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 evaluated, and the information is considered adequate for all the substances.

20 January 2015 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 2015;13(1):3969 [10 pp.]. doi:10.2903/j.efsa.2015.3969 Abstract

Hostazym X is an enzyme preparation of xylanase produced by a non-genetically modified strain of Trichoderma citrinoviride. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of the product as a feed additive for poultry, piglets (weaned) and pigs for fattening. The Panel could not conclude on the safety for the target species, the consumer and the user because the presence of genotoxic activity in the fermentation product could not be excluded. The applicant provided new experimental data to support the safety of the fermentation product used to formulate the additive. The FEEDAP Panel concludes that the fermentation product used to formulate Hostazym X is unlikely to present a genotoxic hazard. Taking also into consideration the findings of the previous opinion, Hostazym X is considered safe for target animals and consumers. With regards to user safety, the previous conclusion that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser, applies.

19 January 2015 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 2015;13(1):3967 [43 pp.]. doi:10.2903/j.efsa.2015.3967 Abstract

Solanum glaucophyllum standardised leaves (PAN) is a mixture of irradiated Solanum glaucophyllum ground leaves and wheat middlings to ensure a concentration of minimum 10  mg glycosylated 1,25-dihydroxycholecalciferol/kg feedingstuff. Glycosylation of the vitamin molecule affected biopotency in poultry and rats, but not in ruminants. Up to 1 000 mg PAN/kg complete diet was considered safe for chickens and piglets. PAN concentrations meeting the chicken’s requirement for vitamin D in diets without supplemental vitamin D3 could not be established. No evidence for an improvement of zootechnical parameters by PAN in diets already supplemented with vitamin D3 was provided for chickens, laying hens and piglets. In dairy cows, PAN had the potential to be efficacious in the prevention of milk fever. However, a feeding regime ensuring its safe use at efficacious doses has not yet been established. No data on safety and efficacy of PAN for other animal species and categories were provided. A water-soluble extract of Solanum glaucophyllum was not genotoxic. A no observed adverse effect level could be not derived from sub-acute toxicity studies in rabbits. A benchmark dose lower confidence limit (BMDL05) based on an increase in plasma calcium in a 28-day repeat dose rat study corresponded to 2 900–3 500 mg PAN/kg diet. Maternal toxicity and fetotoxicity were observed in rats and rabbits at all extract doses tested. An overall safe dose of PAN was not identified from the available toxicological data in laboratory animals. Since PAN did not increase the concentration of 1,25-dihydroxycholecalciferol in animal tissues, the use of PANin animal nutrition is safe for consumers. Inhalation of PAN could be hazardous. PAN was not irritant to skin and eyes and unlikely to cause skin sensitisation. Considering the content of 1,25-dihydroxycholecalciferol in PAN its use in animal nutrition would not pose a risk to the environment.

16 January 2015 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 2015;13(1):3995 [28 pp.]. doi:10.2903/j.efsa.2015.3995 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the flavouring substance spilanthol [FL-no: 16.121] in Flavouring Group Evaluation 303, Revision 1, using the Procedure according to Commission Regulation (EC) No 1565/2000. This revision is made as new 90 days toxicity data have been submitted for spilanthol [FL-no: 16.121]. The substance was considered not to have genotoxic potential. The substance was 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 concluded that spilanthol [FL-no: 16.121] does not give rise to safety concern at its level of dietary intake, estimated on the basis of the Maximum Surveyderived Daily Intake (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.

15 January 2015 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 2015;13(1):3963 [17 pp.]. doi:10.2903/j.efsa.2015.3963 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling processes "Baltija Eco PET", "Eurocast", "Fernholz", "Formas y Envases", and "Klöckner Pentaplast" (EU register numbers RECYC0118, RECYC0111, RECYC0113, RECYC0115 and RECYC0121 respectively), which are all based on the same Starlinger Decon technology. The decontamination efficiency of all these processes was demonstrated using the same challenge test. The input of all the processes is washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % of PET from non-food consumer applications. Through this technology washed and dried PET flakes are pre-heated before being solid state polymerised (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions it was demonstrated that the recycling processes under evaluation, using a Starlinger Decon technology, are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from these processes intended to be used at up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill is not considered of safety concern.

13 January 2015 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 2015;13(1):3957 [52 pp.]. doi:10.2903/j.efsa.2015.3957 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the essential composition of total diet replacements for weight control. Total diet replacements for weight control are intended to induce a substantial energy deficit in overweight or obese adults who wish to lose weight and replace the whole diet in the context of energy-restricted diets for weight reduction. In this opinion, the Panel proposed a minimum protein content based on a Population Reference Intake for protein adjusted for the overweight or obese (75 g/day), a minimum carbohydrate content based on the obligatory glucose demands of the brain (30 g/day) and minimum contents of linoleic acid (11 g/day), α-linolenic acid (1.4 g/day) and micronutrients based on reference values established either by the Panel or by other scientific or authoritative bodies. Derived from the minimum content of macronutrients, the Panel proposed a minimum energy content of total diet replacements for weight control of 2 510 kJ/day (600 kcal/day). The Panel also advised on potential conditions and restrictions of use for these products.

13 January 2015 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 2015;13(1):3979 [8 pp.]. doi:10.2903/j.efsa.2015.3979 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of the substance 1,7-octadiene, CAS No 3710-30-3, FCM No 1034 for use as a crosslinking co-monomer in polyolefins at a maximum use level of 0.9 %. There were no residues of the substance detectable in the polymer (< 16 μg/kg detection limit) and no detectable migration of the substance itself and its two main impurities into appropriate food simulants (detection limits in the range of 1-8 μg/kg). A comparative migration test between low density polyethylene samples made with and without the substance into 95 % ethanol at 10 days/40 °C showed no qualitative difference between the two gas chromatography–mass spectrometry chromatograms (GC-MS). The GC-MS analysis gave complex chromatograms of oligomeric species, from which it was estimated that overall migration was considerably lower than the overall migration limit of 10 mg/dm². Based on the negative results of three in vitro tests, the Panel considered that the substance is not of genotoxic concern. The CEF Panel concluded that the substance 1,7-octadiene is not of a safety concern for the consumer if the substance is only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature and including hot fill conditions and the migration of the substance does not exceed 0.05 mg/kg food. As the polyolefin oligomers and other reaction products containing the co-monomer are likely to strongly vary in amount and composition, depending on the polymerization and manufacturing process used, they were not evaluated by the Panel. Evaluation of these oligomers and reaction products should be conducted case by case by the business operator.

13 January 2015 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 2015;13(1):3971 [20 pp.]. doi:10.2903/j.efsa.2015.3971 Abstract

Glycyrrhizic acid is extracted from the dried and ground rhizome and root portions of the perennial leguminous plant Glycyrrhiza glabra L., native to southern Europe and Central Asia, or other species of the genus Glycyrrhiza. It is currently listed in the register of flavouring substances, allowing its use in food without restriction. Glycyrrhyzic acid ammoniated is safe at the concentration of 1 mg/kg complete feed for all species, except chickens for fattening and laying hens. For these two categories, a safe concentration of 0.3 mg/kg complete feed applies. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the safety of the additive used in water for drinking. The FEEDAP Panel considers that the use of glycyrrhizic acid ammoniated in animal nutrition would not measurably increase consumer exposure. In the absence of data on user safety, the FEEDAP Panel considers it prudent to treat glycyrrhizic acid ammoniated as an irritant to skin, eyes and respiratory tract and as a skin sensitiser. The use of glycyrrhizic acid ammoniated in animal feeds would not pose a risk to the environment. As glycyrrhizic acid ammoniated is used in food as a flavouring, no further demonstration of efficacy is necessary.

13 January 2015 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Klaus Depner, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde, Preben Willeberg and Stéphan Zientara. EFSA Journal 2015;13(1):3986 [73 pp.]. doi:10.2903/j.efsa.2015.3986 Abstract

Lumpy skin disease (LSD) is a viral disease of cattle characterised by severe losses, especially in naive animals. LSD is endemic in many African and Asian countries, and it is rapidly spreading throughout the Middle East, including Turkey. LSD is transmitted by mechanical vectors, but direct/indirect transmission may occur. The disease would mainly be transferred to infection-free areas by transport of infected animals and vectors. In the EU, it could only happen through illegal transport of animals. The risk for that depends on the prevalence in the country of origin and the number of animals illegally moved. Based on a model to simulate LSD spread between farms, culling animals with generalised clinical signs seems to be sufficient to contain 90 % of epidemics around the initial site of incursion, but the remaining 10 % of simulated epidemics can spread up to 400 km from the site of introduction by six months after incursion. Whole-herd culling of infected farms substantially reduces the spread of LSD virus, and the more rapidly farms are detected and culled, the greater the magnitude of the reduction is. Only live attenuated vaccines against LSD are available. Homologous vaccines are more effective than sheep pox strain vaccines. The safety of the vaccines should be improved and the development of vaccines for differentiating between infected and vaccinated animals is recommended. Epidemics are not self-limiting when effective vaccination or culling are not applied. Active surveillance, rapid detection and prompt culling of infected herds are effective measures for LSD control. The role of vectors for LSD transmission should be further investigated in both controlled environments and the field. Awareness-raising campaigns for farmers and veterinary staff to promote recognition of LSD should be considered. The cooperation of the EU with neighbouring countries should be encouraged to prevent transboundary disease spread.

13 January 2015 Mail Print Cite

EFSA Panel on Animal Health and Welfare (AHAW) Charlotte Berg, Anette Bøtner, Howard Browman, Aline De Koeijer, Klaus Depner, Mariano Domingo, Christian Ducrot, Sandra Edwards, Christine Fourichon, Frank Koenen, Simon More, Mohan Raj, Liisa Sihvonen, Hans Spoolder, Jan Arend Stegeman, Hans-Hermann Thulke, Ivar Vågsholm, Antonio Velarde, Preben Willeberg and Stéphan Zientara. EFSA Journal 2015;13(1):3985 [94 pp.]. doi:10.2903/j.efsa.2015.3985 Abstract

Peste des petits ruminants (PPR) is a severe viral disease of small ruminants caused by a Morbillivirus closely related to rinderpest virus. It is widespread in Africa and Asia and is currently also found in Turkey and Northern Africa. PPR is transmitted via direct contact, and the disease would mainly be transferred to infection-free areas by transport of infected animals. In the EU, it could only happen through illegal transport of animals. The risk of that depends on the prevalence in the country of origin and the number of animals illegally moved. The extent of the spread would depend mainly on the time during which it is undetected, the farm density, the frequency and distance of travel of animals. PPR has a high within-herd transmission rate, therefore contacts between flocks, e.g. through common grazing areas, should be avoided when PPR is present. If PPR enters EU areas with dense sheep population but low goat density, it may spread rapidly undetected, since goats are considered more susceptible than sheep. Effective measures in limiting the spread of PPR in the EU include prompt culling of infected herds, rapid detection, movement restriction, and disinfection. Live attenuated vaccines against PPR are available, safe and effective, and have been successfully used to control PPR epidemics, but no method exists for differentiating between infected and vaccinated animals; therefore, the development of one is recommended. Awareness-raising campaigns for farmers and veterinary staff to promote recognition of the disease should be considered. The cooperation of the EU with neighbouring countries should be encouraged to prevent the spread of PPR and other transboundary diseases.

13 January 2015 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernández Escámez, 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 2015;13(1):3940 [95 pp.]. doi:10.2903/j.efsa.2015.3940 Abstract

Raw drinking milk (RDM) has a diverse microbial flora which can include pathogens transmissible to humans. The main microbiological hazards associated with RDM from cows, sheep and goats, horses and donkeys and camels were identified using a decision tree approach. This considered evidence of milk-borne infection and the hazard being present in the European Union (EU), the impact of the hazard on human health and whether there was evidence for RDM as an important risk factor in the EU. The main hazards were Campylobacter spp., Salmonella spp., shigatoxin-producing Escherichia coli (STEC), Brucella melitensis, Mycobacterium bovis and tick-borne encephalitis virus, and there are clear links between drinking raw milk and human illness associated with these hazards. A quantitative microbiological risk assessment for these hazards could not be undertaken because country and EU-wide data are limited. Antimicrobial resistance has been reported in several EU countries in some of the main bacterial hazards isolated from raw milk or associated equipment and may be significant for public health. Sale of RDM through vending machines is permitted in some EU countries, although consumers purchasing such milk are usually instructed to boil the milk before consumption, which would eliminate microbiological risks. With respect to internet sales of RDM, there is a need for microbiological, temperature and storage time data to assess the impact of this distribution route. Intrinsic contamination of RDM with pathogens can arise from animals with systemic infection as well as from localised infections such as mastitis. Extrinsic contamination can arise from faecal contamination and from the wider farm environment. It was not possible to rank control options as no single step could be identified which would significantly reduce risk relative to a baseline of expected good practice, although potential for an increase in risk was also noted. Improved risk communication to consumers is recommended.

13 January 2015 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 2015;13(1):3970 [10 pp.]. doi:10.2903/j.efsa.2015.3970 Abstract

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. This approach requires the identity of the active agent to be established and the absence of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance to be demonstrated. No evidence of toxigenic potential or of resistance to antibiotics of human and veterinary importance was found as judged by the current guidelines. Consequently, the strain of B. subtilis in the additive is presumed safe for target animals, consumers and the environment. This conclusion covers the use of the additive in feed for laying hens and minor poultry species for laying. Use of the additive in feed for laying hens and minor poultry species will not introduce hazards for users not already considered. All four trials made with laying hens showed some evidence of a beneficial effect of the additive on egg production when used at a minimum dose of 1 × 108 colony-forming units (CFU)/kg complete feed, by increasing laying rate or average egg weight. The FEEDAP Panel concludes that Bacillus subtilis PB6 shows some potential to be efficacious in laying hens. This conclusion on efficacy for laying hens can be extended to minor poultry species raised for laying when the additive is used at the same minimum dose.

13 January 2015 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 2015;13(1):3961 [8 pp.]. doi:10.2903/j.efsa.2015.3961 Abstract

This scientific opinion of EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of the additive adipic acid dihydrazide, CAS No 1071-93-8, FCM substance No 987 for use as a crosslinker for acrylic polymer with keto side groups coated on polyolefins and adhesives in laminates made from plastics. The coating is not for direct food contact but used in inner layers of plastics laminates which are intended to be used for all types of foodstuffs at all time-temperature conditions applicable according to the laminate’s properties. Specific migration of the substance was measured from a coated low-density polyethylene (LDPE) film, the substance was not detectable (limit of detection (LOD) 0.019 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. According the in vitro and in vivo studies available the substance is not considered genotoxic. Based on an in vivo micronucleus test, the substance is not considered to be clastogenic/aneugenic under the tested conditions. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as a crosslinker for non-self-supporting coatings on polyolefins and adhesives for laminates not in direct contact with food and its migration does not exceed 0.050 mg/kg food.

13 January 2015 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 2015;13(1):3966 [10 pp.]. doi:10.2903/j.efsa.2015.3966 Abstract

Biomin®C3 is a preparation of strains of Enterococcus faecium, Bifidobacterium animalis and Lactobacillus salivarius. It is currently authorised in the European Union for use in feed for chickens for fattening. Application now has been made for an extension of use to chickens reared for laying and minor avian species other than laying species, for use in water for drinking and for the removal of a maximum dose. A tolerance study using water as the delivery system showed that consumption of 100 times the currently authorised maximum authorised dose in feed did not cause adverse effects in chickens for fattening. Thus, delivery of comparable doses of the additive via water for drinking is considered to be as safe for chickens for fattening as delivery via feed. Inclusion of a dose of 5 × 1012 colony-forming units (CFU)/L in the tolerance study without ill effects indicates that there would be no safety implications if the current maximum dose for chickens for fattening were withdrawn. The conclusions on safety for chickens for fattening, including the need for a maximum dose, would also apply to chickens reared for laying and minor avian species to the point of lay. Biomin®C3 has the potential to improve the performance of chickens for fattening at a minimum dose of 1 × 108< CFU/kg of complete feedingstuffs or the equivalent dose (5 × 107 CFU/L) when delivered in water for drinking. The additive is also considered to have the potential to be efficacious when used in chickens reared for laying and minor avian species to the point of lay at a minimum dose of 1 × 108 CFU/kg of complete feedingstuffs or 5 × 107 CFU/L water for drinking. The additive is compatible with the coccidiostats robenidine hydrochloride, maduramycin ammonium, diclazuril, decoquinate, narasin, nicarbazin and narasin/nicarbazin.

9 January 2015 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 2015;13(1):3903 [25 pp.]. doi:10.2903/j.efsa.2015.3903 Abstract

The active substance of Suilectin™ is a mixture of five phytohaemagglutinin (PHA) isoforms. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the haemagglutination activity (measured by haemagglutinating units (HAUs)) does not reflect the biological activity of the additive in a comprehensive way. The additive is intended only for aqueous suspension in water for drinking or in liquid complementary feed for suckling piglets. The FEEDAP Panel concludes that the additive is safe for suckling piglets when used under the proposed conditions of use of 220 HAU/piglet for three days. The Panel also considers that there are no reasons to expect that the dose of 660 HAU/piglet in a single administration would not be safe. The use of Suilectin in accordance with the conditions of use proposed by the applicant is considered to be of no concern for the health of the consumer. Suilectin is not an irritant to skin or eyes and is not a skin sensitiser. However, considering its physical and toxicological properties, there is a potential hazard by inhalation exposure. Considering that PHAs are immunogenic substances, the additive should be considered to be a respiratory sensitiser. The additive is a natural plant substance and its use will not result in a substantial increase in concentration in the environment. Therefore there are no safety concerns for the environment. The FEEDAP Panel cannot conclude on the efficacy of the additive in suckling piglets.

9 January 2015 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 2015;13(1):3965 [14 pp.]. doi:10.2903/j.efsa.2015.3965 Abstract

The additive L-valine is produced by a strain of Escherichia coli (NITE SD 00066) obtained by chemical mutagenesis. The additive L-valine is safe for all animal target species/categories when used in appropriate amounts to supplement feed to compensate for a valine deficiency in feedingstuffs. The composition of tissues and products of animal origin will not be changed by the use of L-valine in animal nutrition. Considering the high purity of the product under assessment, no risks are expected for the consumer from its use as a feed additive. In the absence of any data, it would be prudent to consider L-valine produced by E. coli NITE SD 00066 to be an irritant to skin, eyes and mucous membranes, a potential dermal sensitiser and potentially harmful by inhalation. The amino acid L-valine is a natural component of plants and animals. The use of the product L-valine under assessment in animal nutrition does not represent a risk to the environment. The product L-valine is considered to be an efficacious source of the amino acid L-valine for all non-ruminant species. Supplementary free amino acid valine is degraded by ruminal microorganisms if it is not given in a protected form.

9 January 2015 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 2015;13(1):3956 [18 pp.]. doi:10.2903/j.efsa.2015.3956 Abstract

Following a request from the European Commission, the EFSA NDA Panel was asked to carry out the additional assessment for ‘pasteurised milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food (NF) in the context of Regulation (EC) No 258/97. Pasteurised or ultra-high-temperature-treated milk is used for the fermentation process with B. xylanisolvens DSM 23964. After fermentation the product is heat treated for one hour at 75 °C to ensure the absence of viable B. xylanisolvens DSM 23964. The Panel considers the information provided on the identity and characterisation of B. xylanisolvens DSM 23964 to be sufficient. The production process encompasses standard techniques used by the dairy industry, is sufficiently described by the applicant and does not give rise to safety concerns. The Panel considers that the information provided on the production process and on the content of vitamins B2 and B12 and furosine in heat-treated fermented milk products does not give rise to concerns regarding disadvantageous nutritional effects. The Panel considers that the microbiological data provided do not give rise to safety concerns. The Panel also notes that a pilot study and a RCT over six weeks with 140 volunteers receiving daily doses of a spray-dried heat-treated fermented milk product containing intakes of up to 1 ´ 1012 inactivated bacterial cells of B. xylanisolvens DSM 23964 were provided. No clinical effects related to the treatment were observed in the two studies. Although no information has been provided to conclude on the risk of allergic reactions caused by the NF, the Panel considers that it is unlikely that its allergenic potential is dissimilar to that of other fermented dairy products. The Panel concludes that the NF ‘heat-treated milk products fermented with B. xylanisolvens DSM 23964’ is safe for the proposed uses and at the proposed use levels.

9 January 2015 Mail Print Cite

EFSA Panel on Biological Hazards (BIOHAZ) Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies, Pablo S. Fernández Escámez, 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 2015;13(1):3939 [131 pp.]. doi:10.2903/j.efsa.2015.3939 Abstract

Eight tools relevant to risk ranking of biological hazards in food were identified and assessed using two case studies. Differences in their performance were observed, related to the risk metrics, data requirements, ranking approach, model type, model variables and data integration. Quantitative stochastic models are the most reliable for risk ranking. However, this approach needs good characterisation of input parameters. The use of deterministic models that ignore variability may result in risk ranking errors. The ordinal scoring approaches in semi-quantitative models provide ranking with more errors than the deterministic approaches. FDA (Food and Drug Administration)-iRISK was identified as the most appropriate tool for risk ranking of microbiological hazards. The Burden of Communicable Diseases in Europe (BCoDE) toolkit can be used in combination with the outputs from FDA-iRISK or as a top-down tool to rank pathogens. Uncertainty needs to be addressed and communicated to decision makers and stakeholders as one of the outcomes of the risk ranking process. Uncertainty and variability can be represented by means of probability distributions. Techniques such as the NUSAP (numeral, unit, spread, assessment and pedigree) approach can also be used to prioritise factors for sensitivity and scenario analysis or stochastic modelling. Quantitative risk ranking models are preferred over semi-quantitative models. When data and time constraints do not allow quantitative risk ranking, semi-quantitative models could be used, but the limitations of these approaches linked to the selection and integration of the ordinal scores should be made explicit. Decision trees should be used only to show how decisions are made about classifying food–pathogen combinations into broad categories. BCoDE and FDA-iRISK, in combination with a network of available predictive microbiology tools, databases and information sources, can form a risk ranking toolbox and be applied based on a “fit for purpose” approach supporting timely and transparent risk ranking.

9 January 2015 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 2015;13(1):3954 [12 pp.]. doi:10.2903/j.efsa.2015.3954 Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of “Arracacia xanthorrhiza”. This novel food (NF) comprises pre-cooked and individually quick-frozen slices, chunks and “other formats” of the roots of Arracacia xanthorrhiza Bancroft (arracacha roots).Arracacia xanthorrhiza var. xanthorrhiza (cultivated) is one of three varieties of this species. In the original application the analytical methods employed for the batch testing of these three lots from 2008 had not been described and certificates regarding the accreditation of the laboratory had been missing. No data on secondary plant metabolites were provided. The applicant provided data on cultivation, production tonnage and human consumption, including information on the preparation and recipes for arracacha used in South American countries. According to the applicant, arracacha is consumed in the same way as other crops such as potato, cassava, yam or carrot. The NF is intended for human consumption in dishes such as “sudados”, soups and stews. EFSA requested the applicant to provide information on potential “other formats” of the NF intended by the applicant, compositional data on a current lot of the NF covering all analyses contained in the specifications of the NF as proposed in the original application and analysed by a certified laboratory and analytical data on the presence of secondary metabolites, in particular of coumarin and monoterpene derivatives. EFSA also asked for details on the two-step steam heating process, in particular time –temperature conditions. As the applicant did not respond to the request by EFSA, the Panel cannot conclude on the safety of the NF.

9 January 2015 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 2015;13(1):3951 [12 pp.]. doi:10.2903/j.efsa.2015.3951 Abstract

Following an application from BENEO-Orafti S.A., submitted pursuant to Article 13.5 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency. The food constituent that is a subject of a claim is “native chicory inulin”. The Panel considers that “native chicory inulin”, a non-fractionated mixture of monosaccharides (< 10%), disaccharides, inulin-type fructans and inulin extracted from chicory, with a mean DP ≥ 9, is sufficiently characterised in relation to the claimed effect. The Panel considers that maintenance of normal defecation by increasing stool frequency (provided that it does not result in diarrhoea) is a beneficial physiological effect. Six studies involving 86 subjects consistently showed that consumption of “native chicory inulin” at an amount of at least 12 g/day increases stool frequency. The Panel also notes the plausible mechanisms by which inulin and inulin-type fructans in “native chicory inulin” could exert the claimed effect. The Panel concludes that a cause and effect relationship has been established between the consumption of “native chicory inulin” and maintenance of normal defecation by increasing stool frequency. The following wording reflects the scientific evidence: “Chicory inulin contributes to maintenance of normal defecation by increasing stool frequency”. In order to obtain the claimed effect, 12 g of “native chicory inulin” should be consumed daily.

9 January 2015 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 2015;13(1):3955 [11 pp.]. doi:10.2903/j.efsa.2015.3955 Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide an update of its exposure assessment on lycopene as a novel food ingredient in the context of Regulation (EC) No 258/97 taking into account the new additional information from the post-marketing monitoring programme imposed by the Commission Decisions authorising the use of synthetic lycopene, lycopene oleoresin from tomatoes and lycopene from Blakeslea trispora as a novel food ingredient in several foodstuffs. The marketing authorisation holders for the use of lycopene as a novel food ingredient jointly prepared and submitted a dossier containing sales data, product launch data, an intake estimate and toxicological information. On the basis of information on sales and new product launch data for the period from July 2009 to June 2012 provided by the lycopene manufacturers, food supplements appear to be the main source of lycopene after intake from natural occurrence. Since no new toxicological studies became available, there is no scientific basis on which the ADI established by EFSA in 2008 could be reconsidered. On the basis of previous intake assessments performed by EFSA and data on sales and product launch data provided for the period from July 2009 to June 2012, the Panel concludes that intakes of naturally occurring lycopene and from its use as a food colouring and as a novel food ingredient at permitted use levels do not lead to intakes above the ADI of 0.5 mg/kg bw/day.

9 January 2015 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 2015;13(1):3952 [9 pp.]. doi:10.2903/j.efsa.2015.3952 Abstract

Following an application from Avesthagen Limited, 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 Teestar™ and a reduction of post-prandial glycaemic responses. The Panel considers that the food, Teestar™, a fenugreek seed extract standardised by its content of galactomannan, is sufficiently characterised. A reduction of post-prandial glycaemic responses might be a beneficial physiological effect. The applicant submitted one unpublished and eight published human studies as being pertinent to the health claim. No conclusions can be drawn from the eight published studies, as they were not carried out with Teestar™ or any other fenugreek seed extract which complied with the specifications of the food which is the subject of the claim. In one unpublished study, the consumption of Teestar™ did not lead to a reduction in mean peak post-prandial blood glucose concentrations, which was the primary endpoint of the study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses.

8 January 2015 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 2015;13(1):3953 [11 pp.]. doi:10.2903/j.efsa.2015.3953 Abstract

Following an application from BASF SE and Stepan Lipid Nutrition, submitted for the authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 an equimolar mixture (marketed under the trade names Clarinol® and Tonalin®) of the two conjugated linoleic acid (CLA) isomers c9,t11 and t10,c12. The Panel considers that the food is sufficiently characterised. The claimed effect is “contributes to a reduction in body fat mass”. In previous assessments on the safety of these equimolar isomeric mixtures of CLA, the NDA Panel considered that the observed increase in plasma and urinary concentrations of isoprostanes, which may indicate an increase in lipid peroxidation, and the increase in some markers of subclinical inflammation associated with CLA consumption, together with the limited data available on the effects of CLA on vascular function, may indicate a potential for vascular damage in the longer term. The Panel considers that the information provided does not establish that a reduction in body fat mass, when accompanied by an increase in markers of lipid peroxidation and inflammation, is a beneficial physiological effect for the target population. The Panel concludes that a cause and effect relationship has not been established between the consumption of an equimolar mixture of the CLA isomers c9,t11 and t10,c12, marketed under the trade names of Clarinol® and Tonalin®, and a beneficial physiological effect.

8 January 2015 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 2015;13(1):3948 [11 pp.]. doi:10.2903/j.efsa.2015.3948 Abstract

Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13.5 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet. The food that is the subject of the claim is fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims. The Panel considers that fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims are sufficiently characterised. The Panel considers that reduction of body and visceral fat mass while maintaining lean body mass in the context of an energy-restricted diet is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided. The Panel concludes that a cause and effect relationship has not been established between the consumption of fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and reduction of body and visceral fat mass while maintaining lean body mass in the context of an energy-restricted diet.

7 January 2015 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 2015;13(1):3949 [11 pp.]. doi:10.2903/j.efsa.2015.3949 Abstract

Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13.5 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet. The Panel considers that the food that is the subject of the claim, fat-free yogurts and fermented milks complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims, is sufficiently characterised. The Panel considers that maintenance of lean body mass in the context of an energy-restricted diet is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided. The Panel concludes that a cause and effect relationship has not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications “fat free”, “low in sugars”, “high protein”, “source of calcium” and “source of vitamin D” for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet.

7 January 2015 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, David Caffier, 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 2015;13(1):3989 [262 pp.]. doi:10.2903/j.efsa.2015.3989 Abstract

The EFSA Panel on Plant Health conducted a pest risk assessment and an evaluation of risk reduction options for Xylella fastidiosa. X. fastidiosa has been detected in olive in the EU with a distribution restricted to the region of Apulia in Italy and is under official control. X. fastidiosa has a very broad host range, including many common cultivated and wild plants. All xylem fluid-feeding insects in Europe are considered to be potential vectors. Philaenus spumarius (Hemiptera: Aphrophoridae), a polyphagous spittlebug widespread in the whole risk assessment area, has been identified as a vector in Apulia. The probability of entry of X. fastidiosa from countries where X. fastidiosa is reported is very high with plants for planting and moderate with infectious insect vectors carried with plant commodities or travelling as stowaways. Establishment and spread in the EU is very likely. The consequences are considered to be major because yield losses and other damage would be high and require costly control measures. The systematic use of insecticides for vector control may create environmental impacts. With regard to risk reduction options, strategies for the prevention of introduction and for the containment of outbreaks should focus on the two main pathways (plants for planting and infectious insect vectors) and combine the most effective options in an integrated approach. For plants for planting, these could be pest-free production areas, surveillance, certification, screened greenhouse production, vector control and testing for infection and, for some plant species, treatments (e.g. thermotherapy). To prevent entry of the infectious vectors, insecticide treatments and inspection of consignments and production sites are required. The Panel has also reviewed the effectiveness of risk reduction options for X. fastidiosa and its vectors listed in Directive 2000/29/EC and in the EU emergency measures. The Panel recommends the continuation and intensification of research on the host range, epidemiology and control of the Apulian outbreak.

6 January 2015 Mail Print Cite

Scientific Opinions: Statements of the Scientific Committee/Scientific Panel

EFSA Scientific Committee Jan Alexander, Diane Benford, Qasim Chaudhry, John Griffin, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Simon More, Alicja Mortensen, Birgit Nørrung, Bernadette Ossendorp, Joe Perry, Josef Schlatter, Kristen Sejrsen and Vittorio Silano EFSA Journal 2015;13(1):3982 [36 pp.]. doi:10.2903/j.efsa.2015.3982 Abstract

Following a request from the European Commission to carry out a risk benefit analysis as regards the risks and benefits to human health of fish/seafood consumption related to methylmercury, the EFSA Scientific Committee used previous work performed by the EFSA Panel on Contaminants in the Food Chain and the EFSA Panel on Dietetic Products, Nutrition and Allergies to create scenarios based on typical fish consumption patterns of population groups at risk of exceeding the tolerable weekly intake (TWI) for methylmercury. The Scientific Committee then estimated how many servings of fish/seafood per week these population groups would need to reach the TWI for methylmercury and the dietary reference value (DRV) for n-3 (Long-Chain) Polyunsaturated Fatty Acid (LCPUFA). When consuming species with a high methylmercury content, only a few numbers of servings (<1–2) can be eaten before reaching the TWI, which may be attained before the DRV. To protect against inter alia neurodevelopmental toxicity of methylmercury and achieve the benefits of fish consumption (effect of fish/seafood consumption during pregnancy on functional outcomes of children’s neurodevelopment and on cardiovascular diseases in adults), which are associated with 1–4 fish servings per week, fish/seafood species with a high content of mercury in the daily diet should be limited. Because a variety of fish species are consumed across Europe, it is not possible to make general recommendations on fish consumption. The Scientific Committee therefore recommends that each country needs to consider its own pattern of fish consumption, especially the species of fish consumed, and carefully assess the risk of exceeding the TWI of methylmercury while obtaining the health benefits from consumption of fish/seafood.

22 January 2015 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2015;13(1):3960 [33 pp.]. doi:10.2903/j.efsa.2015.3960 Abstract

The European Food Safety Authority (EFSA) carried out an exposure assessment of Brilliant Black BN (E 151), taking into account new information on its use as a food additive 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 Brilliant Black BN and concluded that dietary exposure in 1- to 10-year-old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brilliant Black BN of 5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested that EFSA performs a refined exposure assessment for this food colour. Data on the presence of Brilliant Black BN in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for 11 out of 37 food categories in which Brilliant Black is authorised. In addition, 4 337 analytical results were also reported to EFSA, with the majority of values being below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three scenarios were considered: (1) exposure estimates based on Maximum Permitted Levels (MPLs), (2) a refined brand-loyal exposure scenario, and (3) a refined non-brand-loyal exposure scenario. Considering the first scenario, high exposure levels (95th percentile) exceeded the ADI for toddlers and children in four dietary surveys. In comparison with the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, whereas the 95th percentile exposure is lower, particularly in adults. The mean and high-level exposure estimates of Brilliant Black BN are below the ADI for all population groups when considering the refined scenarios (brand-loyal and non-brand-loyal).

9 January 2015 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2015;13(1):3984 [138 pp.]. doi:10.2903/j.efsa.2015.3984 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 Poland, for the pesticide active substance florasulam are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of florasulam as a herbicide on winter and spring cereals, maize and pasture (one season and permanent). 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.

13 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3977 [25 pp.]. doi:10.2903/j.efsa.2015.3977 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 Pepino mosaic virus strain CH2 isolate 1906, and the assessment of the application to include Pepino mosaic virus strain CH2 isolate 1906 in Annex IV of Regulation (EC) No 396/2005, are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Pepino mosaic virus strain CH2 isolate 1906 as a virus inoculation for cross protection of tomatoes under glasshouse application. 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.

9 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3958 [78 pp.]. doi:10.2903/j.efsa.2015.3958 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and the co-rapporteur Member State Denmark for the pesticide active substance triasulfuron are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative use of triasulfuron as a herbicide on winter cereals. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

8 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3932 [43 pp.]. doi:10.2903/j.efsa.2015.3932 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 (3E)-3-decen-2-one and the considerations regarding the proposal for inclusion of the active substance in Annex IV of Regulation (EC) No 396/2005, are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of (3E)-3-decen-2-one as a plant growth regulator on potatoes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

6 January 2015 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2015;13(1):3992 [48 pp.]. doi:10.2903/j.efsa.2015.3992 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 spiroxamine. In order to assess the occurrence of spiroxamine residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the import tolerance and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

22 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3983 [33 pp.]. doi:10.2903/j.efsa.2015.3983 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 metosulam. In order to assess the occurrence of metosulamresidues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. 

19 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3976 [36 pp.]. doi:10.2903/j.efsa.2015.3976 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 mesotrione. In order to assess the occurrence of mesotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

19 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3975 [72 pp.]. doi:10.2903/j.efsa.2015.3975 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 propiconazole. In order to assess the occurrence of propiconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

16 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3994 [25 pp.]. doi:10.2903/j.efsa.2015.3994 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta France SAS to modify the existing MRLs for the active substance isopyrazam in tomatoes, aubergines, cucurbits-edible peel and cucurbits-inedible peel. In order to accommodate for the intended uses of isopyrazam, France proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 0.5 mg/kg for tomatoes and aubergines, from 0.06 mg/kg to 0.4 mg/kg for cucurbits-edible peel and from 0.07 mg/kg to 0.3 mg/kg for cucurbits-inedible peel. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive an MRL proposal of 0.5 mg/kg on tomatoes extrapolated to aubergines and MRL proposals of 0.4 mg/kg and 0.3 mg/kg for cucurbits-edible peel and cucurbits-inedible peel respectively, to cover the proposed indoor and NEU and SEU outdoor uses of isopyrazam. Based on the risk assessment results, EFSA concludes that the proposed uses of isopyrazam on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk.

16 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3974 [50 pp.]. doi:10.2903/j.efsa.2015.3974 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 pirimiphos-methyl. In order to assess the occurrence of pirimiphos-methyl 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. Some information required by the regulatory framework was found to be missing and a possible chronic risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

16 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3993 [19 pp.]. doi:10.2903/j.efsa.2015.3993 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 company ISK Biosciences Europe N.V. to modify the existing MRL for the active substance cyazofamid in aubergines. In order to accommodate for the intended use of cyazofamid, Germany proposed to raise the existing MRL from the limit of quantification of 0.01 mg/kg to 0.2 mg/kg. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive an MRL proposal of 0.3 mg/kg for tomato, extrapolated to aubergines. Adequate analytical enforcement methods are available to control cyazofamid residues in aubergines. Based on the risk assessment results, EFSA concludes that the proposed use of cyazofamid on aubergines will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

16 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3972 [69 pp.]. doi:10.2903/j.efsa.2015.3972 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 diquat. In order to assess the occurrence of diquat 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 (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible chronic risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

15 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3950 [80 pp.]. doi:10.2903/j.efsa.2015.3950 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 glufosinate. In order to assess the occurrence of glufosinate 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 European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. 

8 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3964 [48 pp.]. doi:10.2903/j.efsa.2015.3964 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 tritosulfuron. In order to assess the occurrence of tritosulfuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

8 January 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(1):3946 [48 pp.]. doi:10.2903/j.efsa.2015.3946 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 dodine. In order to assess the occurrence of dodine residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

6 January 2015 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority European Centre for Disease Prevention and Control EFSA Journal 2015;13(1):3991 [162 pp.]. doi:10.2903/j.efsa.2015.3991 Abstract

This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring activities carried out in 2013 in 32 European countries (28 Member States and four non-Member States). Campylobacteriosis was the most commonly reported zoonosis. After several years of an increasing European Union (EU) trend, the human campylobacteriosis notification rate has stabilised. In food and animals no EU trends were observed and the occurrence of Campylobacter continued to be high in broiler meat at EU level. The decreasing EU trend in confirmed human salmonellosis cases observed in recent years continued. Most Member States met their Salmonella reduction targets for poultry. In foodstuffs, the reported EU-level Salmonella non-compliance in fresh poultry meat decreased. Human listeriosis increased further, showing an increasing EU trend in 2009-2013. In ready-to-eat foods Listeria was seldom detected above the legal safety limit. Also during 2009-2013, a decreasing EU trend was observed in confirmed yersiniosis cases. Positive findings for Yersinia were mainly reported in pig meat and products thereof. The number of confirmed verocytotoxigenic Escherichia coli (VTEC) infections in humans increased. VTEC was reported from food and animals. A total of 5,196 food-borne outbreaks, including water-borne outbreaks, were reported in the EU. Most food-borne outbreaks were caused by Salmonella, followed by viruses, bacterial toxins and Campylobacter, whereas in 28.9 % of all outbreaks the causative agent was unknown. Important food vehicles in strong-evidence food-borne outbreaks were eggs and egg products, followed by mixed food, and fish and fish products. The report further summarises trends and sources along the food chain of tuberculosis due to Mycobacterium bovis, Brucella, Trichinella, Echinococcus, Toxoplasma, rabies, Coxiella burnetii (Q fever), West Nile Virus and tularaemia.

28 January 2015 Mail Print Cite