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


Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

EFSA Panel on Animal Health and Welfare (AHAW) 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(4):4075[76 pp.]. doi:10.2903/j.efsa.2015.4075 Abstract

 This Scientific Opinion presents a characterisation of canine leishmaniosis (CanL) in Europe and its potential for spreading. The efficacy of available preventative measures to protect dogs against CanL was assessed, with the objective of mitigating the probability of introduction of CanL into free areas in the European Union through movement of infected dogs. Several systematic reviews (SRs) of literature were carried out to evaluate the efficacy of vaccines, topically applied insecticides and prophylactic medication. Additionally, SRs on the sensitivity of diagnostic tests and treatment efficacy were carried out to evaluate the possibility of testing and excluding or treating infected dogs to mitigate the risk of introduction into free areas. The probability of introduction and establishment of CanL in a non-endemic region with competent sandflies was estimated, using a stochastic simulation model. The probability of establishment defined as the local transmission of L. infantum from vector to host and vice versa, was very high. The most effective mitigation measure to reduce the probability of introduction and establishment of CanL was topically applied insecticide. Vaccination had only limited effect on the probability of establishment in a non-endemic region. Testing dogs before their introduction into a non-endemic area is of limited value if applied too soon after exposure to infected sandflies, because it takes several months to obtain a positive result after exposure. Test and treatment in the endemic area, prior to movement into a non-endemic area, does not appear to be an efficient and realistic option to mitigate the probability of introduction of CanL, as no treatment against CanL can guarantee to prevent future transmission. It was concluded that the main limitation to CanL spread is represented by the vectors. This reinforces the need for knowledge on the vectorial competence, distribution and abundance of potential vectors of CanL in the EU.

28 April 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, Wopke van der Werf and Stephan Winter. EFSA Journal 2015;13(4):4079[48 pp.]. doi:10.2903/j.efsa.2015.4079 Abstract

The EFSA Panel on Plant Health was requested by the European Commission to assess the risk to plant health in the European Union if the Australian bud-galling wasp Trichilogaster acaciaelongifoliae was released for the control of the invasive alien plant Acacia longifolia in Portugal. T. acaciaelongifoliae feeds on A. longifolia and A. floribunda. In South Africa, following its intentional introduction in 1982 and 1983, the wasp is now present throughout the range of A. longifolia in that country, with most plants showing galls and seed set reductions of, initially, up to 95 %. Climatic conditions in the EU are largely suitable for establishment wherever A. longifolia and A. floribunda are present. T. acaciaelongifoliae is moderately likely to establish and spread in the EU, by natural means, but particularly if it is intentionally moved to control populations of A. longifolia other than those present in Portugal. The effects on native biodiversity and ecosystems resulting from invasive populations of A. longifolia are likely to be reduced by the wasp. A. longifolia is grown as an ornamental plant in some EU countries. A. floribunda is not an invasive plant in the EU and is cultivated as an ornamental plant on a small scale in France, Greece and Italy. Any effects on cultivated ornamental A. longifolia and A. floribunda are rated as moderate, although likely to be transient, as the industry could switch to the cultivation of other Acacia spp. For plant species other than A. longifolia and A. floribunda, consequences are expected to be minor, with low uncertainty except for A. retinodes and Cytisus striatus, where further investigation is required. No risk-reducing options in the plant health context are considered necessary, except for monitoring, sentinel planting, and care with regard to quarantine facilities and release protocols to prevent accidental release in situations and locations other than those intended.

23 April 2015 Mail Print Cite

EFSA Panel on Contaminants in the Food Chain (CONTAM) Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael DiNovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Anne-Katrine Lundebye, Manfred Metzler, Antonio Mutti (as of 6 October 2014), Carlo Stefano Nebbia, Michael O’Keeffe, Annette Petersen (as of 6 October 2014), Ivonne Rietjens (until 2 May 2014), Dieter Schrenk, Vittorio Silano (until 21 July 2014), Hendrik van Loveren, Christiane Vleminckx, and Pieter Wester. EFSA Journal 2015;13(4):4074[76 pp.]. doi:10.2903/j.efsa.2015.4074 Abstract

Following a request from the European Commission, the risks to animal and human health and the environment related to the presence of nickel (Ni) in feed were assessed by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel). The presence of Ni in feed can arise from both natural and anthropogenic sources. Additionally, certain feed materials contain metallic Ni, since it is used as a catalyst in their production. Based on the differences observed between the Ni exposure levels estimated for different animal species and identified no observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs), the CONTAM Panel concluded that any adverse impact of Ni via feed to cattle, pigs, rabbits, ducks, fish, dogs, chickens, horses, sheep, goats and cats is unlikely. Concerning the assessment of human health risks from the presence of Ni in food of animal origin, the CONTAM Panel concluded that in the average population the current levels of chronic exposure to Ni, considering only foods of animal origin, might be of potential concern in the young population, in particular in ‘Toddlers’. In the highly exposed population (95th percentile), the concern also extends to the age class ‘Other children’. Regarding acute dietary exposure, the CONTAM Panel concluded that Ni-sensitized individuals are also at risk of developing eczematous flare-up skin reactions through the consumption of food of animal origin. The contribution of food of animal origin to human dietary exposure to Ni should therefore not be underestimated, particularly in age classes with high dietary exposure to Ni. Release to the environment from manure, resulting from its presence in animal feed, is not a major contributor of Ni deposited onto agricultural soils or to the environment. 

20 April 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, 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(4):4065[15 pp.]. doi:10.2903/j.efsa.2015.4065 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling processes Coveris and Envaplaster (RECYC0117 and RECYC0120, respectively), which are based on the same EREMA Basic technology. The input to these processes is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consumer PET bottles containing no more than 5 % PET from non-food consumer applications. In this technology, washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor (step 2) is the critical step that determines the decontamination efficiency of the processes. The operating parameters to control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling processes under evaluation are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the processes is not of safety concern when the final thermoformed trays and containers manufactured with the recycled pellets and not used for packaging water contain up to 90 % recycled post-consumer PET for Envaplaster, and up to 100 % recycled post-consumer PET for Coveris.

13 April 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, 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(4):4064[17 pp.]. doi:10.2903/j.efsa.2015.4064 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 process PET-M (EU register No RECYC062). The input material for the process is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing less than 5 % of PET from non-food consumer applications. In this process, post-consumer washed and dried PET flakes are heated and dried in a mixing reactor, followed by mixing with a modifier, before being extruded under vacuum into pellets. Having examined the challenge test provided, the Panel concluded that steps 2 (heating and drying under air flow) and 4 (extrusion under vacuum and pelletisation) are the critical steps for the efficiency of decontamination. The operating parameters which control the performance of these steps are temperature, residence time and air flow, for step 2, and temperature, time and pressure, for step 4. It was demonstrated that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food derived from the exposure scenario for infants and 0.15 μg/kg food derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process PET-M is not of safety concern when it is used up to 60 % to manufacture bottles and up to 90 % to manufacture thermoformed trays and containers not used for packaging water.

13 April 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, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(4):4069[115 pp.]. doi:10.2903/j.efsa.2015.4069 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 14 flavouring substances in the Flavouring Group Evaluation 25, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances was considered to have a genotoxic potential. This revision is made due to the inclusion of new toxicity data on the supporting substances β-caryophyllene [FL-no: 01.007] and myrcene [FL-no: 01.008] considered in FGE.78Rev2 to cover the assessment of 4(10)-thujene [FL-no: 01.059], 2,6-dimethylocta-2,4,6-triene [FL-no: 01.035], cis-3,7-dimethyl-1,3,6-octatriene [FL-no: 01.064] and 1-octene [FL-no: 01.070]. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all 14 substances [FL-no: 01.001, 01.027, 01.028, 01.033, 01.034, 01.035, 01.038, 01.039, 01.046, 01.054, 01.057, 01.059, 01.064, 01.070] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity and identity criteria for the materials of commerce have been provided for all 14 candidate substances.

13 April 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, 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(4):4063[9 pp.]. doi:10.2903/j.efsa.2015.4063 Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of zinc oxide, nanoparticles, uncoated (FCM No 1050) and coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 1046), for use as a transparent ultraviolet light absorber in all polyolefins at a maximum content of 2 % and 3 % for the uncoated and the coated species, respectively. The substance is used as a powder in nanoform. In the final polymer, nanoparticles are still present but largely aggregated. The specific migration of the substance was tested from low-density polyethylene films, containing the maximum use level of the substance, into 3 % acetic acid and 10 % and 50 % ethanol for 10 days at 60 °C. Data from a stress test with iso-octane for 10 days at 20 °C was provided. Migration values into the different simulants and the microscopic analysis of swollen polymers demonstrate that there is no mass transfer of the zinc oxide in nanoform. In 2003 the Scientific Committee on Food established for zinc a no observed adverse effect level of 50 mg/day and an upper limit of 25 mg/person per day was recommended. The CEF Panel concluded that zinc oxide, nanoparticles, uncoated or coated with [3-(methacryloxy)propyl]trimethoxysilane, does not migrate in nanoform, and therefore the safety evaluation focuses on the migration of soluble ionic zinc. Available migration data for ionic zinc coming from the intended application are in compliance with the current specific migration limit (SML), but in combination with the dietary exposure from other sources the upper limit of 25 mg/person per day could be exceeded. For use of the coated form of zinc oxide, migration of [3-(methacryloxy)propyl]trimethoxysilane should be within the existing SML for this substance of 0.05 mg/kg.

13 April 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, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn. EFSA Journal 2015;13(4):4066[105 pp.]. doi:10.2903/j.efsa.2015.4066 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 41 flavouring substances in Flavouring Group Evaluation 21, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision was carried out because of the inclusion of the assessment of new toxicity data on the candidate substances, 5-ethylthiophene-2-carbaldehyde [FL-no: 15.074] and 2-pentylthiophene [FL-no: 15.096]. These data on 5-ethylthiophene-2-carbaldehyde [FL-no: 15.074] should cover 2-acetylthiophene [FL-no: 15.040] and 2-propionylthiophene [FL-no: 15.097]. These data on 2-pentylthiophene [FL-no: 15.096] should cover 2-butylthiophene [FL-no: 15.045], 2-hexylthiophene [FL-no: 15.076] and 2-octylthiophene [FL-no: 15.093]. For two of the substances [FL-no: 15.060 and 15.119] the Panel concluded that additional genotoxicity data are required. The remaining 39 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel concluded that the 39 flavouring substances [FL-no: 15.038, 15.039, 15.040, 15.044, 15.045, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.074, 15.076, 15.078, 15.079, 15.080, 15.082, 15.084, 15.085, 15.086, 15.087, 15.089, 15.093, 15.096, 15.097, 15.098, 15.108, 15.115, 15.116, 15.118 and 15.135] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the Maximised Survey-derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all 41 candidate substances.

13 April 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, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn EFSA Journal 2015;13(4):4067[72 pp.]. doi:10.2903/j.efsa.2015.4067 Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns 21 aromatic, aliphatic and alicyclic hydrocarbons [FL-no: 01.002, 01.003, 01.004, 01.005, 01.006, 01.007, 01.008, 01.009, 01.010, 01.016, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] evaluated by the JECFA in 2005. FGE.78Rev1 considered 24 substances, but 4-methyl-1,1'-biphenyl (JECFA-no: 1334) and biphenyl (JECFA-no: 1332) [former FL-no: 01.011 and 01.013] are no longer supported by Industry for use as a flavouring substance in Europe. Moreover 1-methylnaphthalene [FL-no: 01.014] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β-caryophyllene [FL-no: 01.007] and 90-day studies in rats on β-caryophyllene [FL-no: 01.007] and myrcene [FL-no: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons [FL-no: 01.002-01.010, 01.016-01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.

13 April 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(4):4058[45 pp.]. doi:10.2903/j.efsa.2015.4058 Abstract

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has assessed seven zinc compounds in the current application: zinc acetate, dihydrate; zinc chloride, anhydrous; zinc oxide; zinc sulphate, heptahydrate; zinc sulphate, monohydrate; zinc chelate of amino acids, hydrate; zinc chelate of glycine, hydrate. These compounds are safe sources of zinc for all animal species/categories when used up to maximum authorised zinc levels in feed; the simultaneous use of both feed and water supplemented with zinc should be avoided. No concerns for consumer safety are expected from the use of the zinc compounds under application when used up to the maximum authorised levels in feed. Zinc acetate, zinc sulphate (heptahydrate and monohydrate), zinc chelate of amino acids, hydrate, and zinc chelate of glycine, hydrate, are irritant to the skin, eyes and mucosae. Zinc sulphate may cause skin sensitisation. Zinc chloride, anhydrous, is extremely corrosive to skin, eyes and mucosae. Zinc chelate of amino acids, hydrate, may induce sensitisation by inhalation and should be considered a skin sensitiser. Zinc oxide is not irritant to skin or eyes or skin sensitiser. The Panel considers that all the additives under application should be treated as hazardous by inhalation. The use of the zinc compounds under assessment does not pose an immediate concern for the agricultural soil compartment. However, there is a potential environmental concern related to drainage and the runoff of zinc to surface water, with acidic sandy soils being the most vulnerable; for a final conclusion, further refinements to the assessment of zinc-based additives in livestock need to be considered, and additional data are required. The adoption of the newly proposed maximum zinc contents in feeds would greatly reduce the risk to the environment from zinc-containing additives. The zinc compounds under assessment are efficacious in meeting animal requirements.

7 April 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(4):4057[51 pp.]. doi:10.2903/j.efsa.2015.4057 Abstract

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has assessed seven copper compounds in the current application: cupric acetate, monohydrate; basic cupric carbonate, monohydrate; cupric chloride, dihydrate; cupric oxide; cupric sulphate, pentahydrate; cupric chelate of amino acids, hydrate; cupric chelate of glycine, hydrate. These compounds are safe sources of copper for all animal species/categories when used up to maximum authorised copper levels in feed. The use of copper compounds in water for drinking is considered unsafe for ovine and certain breeds of dogs and cats; for all other animal species/categories the simultaneous application of copper compounds via feed and water for drinking should be avoided. No concerns for consumer safety are expected from the use of the copper compounds under application in animal nutrition when used up to the maximum EU-authorised levels in feed. The additives under assessment should be treated as irritant to the skin and eye and skin sensitisers, and should be considered as hazardous by inhalation. Copper chelate of amino acids, hydrate, should also be considered a sensitiser by inhalation. The presence of nickel in the additives may induce contact dermatitis in workers; because of its nickel content, cupric sulphate, pentahydrate, would represent an additional hazard by inhalation to users. Potential risks to soil organisms have been identified after the application of piglet manure; there might be a potential concern related to sediment contamination with copper. Drawing final conclusions would need further model validation and refinement to the assessment of copper-based additives in livestock. The use of copper compounds in aquaculture is not expected to pose a risk. The extent to which copper-resistant bacteria contribute to the overall antibiotic resistance situation cannot be quantified at present. The copper compounds under assessment are efficacious in meeting animal requirements.

1 April 2015 Mail Print Cite

Scientific Opinions: Guidance 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 Journal2015;13(4):4080[11 pp.]. doi:10.2903/j.efsa.2015.4080 Abstract

To increase transparency and harmonisation, EFSA asked the Scientific Committee for advice on how cross-cutting guidance documents should be used across EFSA, reviewed and kept up-to-date. The Committee examined 23 documents that should be applied consistently across EFSA sectors to set a common assessment framework, and identified two categories of compliance: unconditional, with a requirement to follow; and conditional, with a requirement to follow if the recommended approach is chosen. The Committee recommends that each guidance document identifies its target audience and addresses the level of obligation to follow. The Committee concludes that the cross-cutting guidance documents must be regularly screened for their up-to-date scientific relevance, and recommends that this should be done every three years. Prioritisation criteria for updating/revising the guidance documents were identified to allow suitable planning of adequate resources and the availability of expertise necessary for the revisions of cross-cutting guidance. The Scientific Committee concluded that the principle of regular review and subsequent revision should also be extended to all guidance documents produced by EFSA’s Panels and Units thus including the sectoral guidance documents specific to EFSA’s domains of activity.

16 April 2015 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2015;13(4):4073[34 pp.]. doi:10.2903/j.efsa.2015.4073 Abstract

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for Ponceau 4R (E 124) taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Ponceau 4R (E 124) used as a food additive. In that opinion, the Panel concluded that, at the maximum levels of use, intake estimates for adults at the high percentile (97.5th) and for 1- to 10-year old children at the mean and high percentiles (95th/97.5th) were generally above the Acceptable Daily Intake (ADI), even for the refined intake estimates. Consequently, Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission regarding the conditions of use of Ponceau 4R (E 124), applicable as from 1 June 2013. Many Maximum Permitted Levels (MPLs) of Ponceau 4R (E 124) were withdrawn (n = 24) or decreased by a factor 1.2 to 200 (n = 29), depending on the food category. Following this, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as analytical data submitted to EFSA by Member States, combined with food consumption data of the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided for three out of the 31 food categories for which Ponceau 4R (E 124) is authorised as a food additive; while analytical data from Member States were provided to EFSA for 18 food categories. Using MPLs and these new data, none of the exposure estimates exceeded the ADI of 0.7 mg/kg bw per day in any population.

21 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4082[13 pp.]. doi:10.2903/j.efsa.2015.4082 Abstract

Following the publication of the Scientific Opinion by EFSA’s PLH Panel which assessed the risk to plant health posed by Xylella fastidiosa in the EU territory and evaluated risk reduction options, EFSA received a request for an urgent response to scientific and technical information provided by an Italian non-governmental organisation (NGO). The NGO claimed that X. fastidiosa is not the cause of olive tree decline in Lecce Province in Southern Italy, but only an endogenous element present in the trees that is not active or aggressive unless a series of fungi infect the plants and create the right conditions for the development of X. fastidiosa. The NGO also claimed that treatment possibilities do exist to treat such fungi including pruning of infected plants and soil treatment. EFSA has reviewed the submitted documentation and held a hearing with an expert on tracheomycotic fungi associated with olive decline in Apulia. EFSA concluded that currently there is no scientific evidence that tracheomycotic fungi are the primary causal agents of olive quick decline syndrome. EFSA recommended further research – based on pest biology and using replicated and well-designed field experiments – to provide insight into the sustainable management of this complex problem.

17 April 2015 Mail Print Cite

Guidance of EFSA

European Food Safety Authority EFSA Journal 2014;13(4):4094[102 pp.]. doi:10.2903/j.efsa.2015.4093 Abstract

This EFSA guidance document provides guidance for the exposure assessment of soil organisms to plant protection products (PPPs) and their transformation products in accordance with Regulation (EC) No 1107/2009  of the European Parliament and the Council. This guidance was produced by EFSA in response to a question posed by the European Commission according to Art. 31 of Regulation (EC) No 178/2002  of the European Parliament and of the Council. Guidance is provided for all types of concentrations that are potentially needed for assessing ecotoxicological effects, i.e. the concentration in total soil and the concentration in pore water, both averaged over various depths and time windows. The current guidance is restricted to annual field crops under conventional and reduced tillage. The recommended exposure assessment procedure consists of five tiers. To facilitate efficient use of the tiered approach in regulatory practice, user-friendly software tools have been developed. In higher tiers of the exposure assessment, crop interception and subsequent dissipation at the crop canopy may be included. The models that simulate these processes were harmonised. In addition, an easy-to-use table for the fraction of the dose reaching the soil has been developed, which should be used at higher tiers in combination with the simple analytical model. With respect to substance-specific model inputs, this guidance generally follows earlier documents; however, new guidance is included for some specific substance parameters.

28 April 2015 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2015;13(4):3056[55 pp.]. doi:10.2903/j.efsa.2015.3056 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Sweden, for the pesticide active substance Trichoderma atroviride strains IMI-206040 and T11, are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004 as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of Trichoderma atroviride strains IMI-206040 and T11 as a fungicide on tomatoes (T11), strawberries and ornamental trees (IMI-206040), however it should be noted that a Good Agricultural Practice (GAP) table for the strain T11 is not available. 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.

30 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4092[33 pp.]. doi:10.2903/j.efsa.2015.4092 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France for the pesticide active substance Trichoderma atroviride strain SC1 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 Trichoderma atroviride strain SC1 as a fungicide on established grape vines and in grape vine nurseries. 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.

29 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4077[153 pp.]. doi:10.2903/j.efsa.2015.4077 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 Netherlands, for the pesticide active substance bentazone 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 bentazone as a herbicide on a variety of crops in the EU. 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.

20 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4060[82 pp.]. doi:10.2903/j.efsa.2015.4060 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, Ireland, and the co-Rapporteur Member State, Italy, for the pesticide active substance iprovalicarb 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 iprovalicarb as a fungicide on grapes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

14 April 2015 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2015;13(4):4189[61 pp.]. doi:10.2903/j.efsa.2015.4189 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 bifenthrin. In order to assess the occurrence of bifenthrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, 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 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.

23 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4084[20 pp.]. doi:10.2903/j.efsa.2015.4084 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience to modify the existing maximum residue levels (MRLs) for the active substance propamocarb in onions, garlic, shallots and leeks. In order to accommodate for the intended uses of propamocarb, The Netherlands proposed to raise the existing MRLs to 3 mg/kg in onions, garlic and shallots and to 30 mg/kg in leek. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission (EC) and forwarded to EFSA. According to EFSA the data are sufficient to propose a MRL of 2 mg/kg for the intended uses on garlic and shallots, without amending the existing MRL of 2 mg/kg for onions. The MRL proposal of 30 mg/kg is derived for the intended uses on leeks. Adequate analytical methods are available to control the residues of propamocarb on the crops under consideration. Based on the risk assessment results, EFSA concludes that the intended uses of propamocarb on onions, garlic and shallots are unlikely to pose a public health concern. In contrast, a potential acute exposure cannot be excluded for leeks. Risk managers should decide whether the cooking factor derived for leafy crops is applicable to stem crops and whether the margin of safety might be considered sufficient to protect consumers.

23 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4091[29 pp.]. doi:10.2903/j.efsa.2015.4091 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 BASF to modify the existing MRLs for the active substance tebufenpyrad in citrus fruits, plums, strawberries, tomatoes, aubergines, peppers, melons, watermelons and gherkins. 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 residue data were sufficient to derive MRL proposals for all crops under consideration. Based on the risk assessment results, EFSA concludes that the intended use of tebufenpyrad on peppers might result in an acute consumer intake concerns and therefore shall not be authorised. The intended uses of tebufenpyrad on citrus fruits, plums, strawberries, tomatoes, aubergines, gherkins, melons and watermelons will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

23 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4078[19 pp.]. doi:10.2903/j.efsa.2015.4078 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 BASF SE to set a MRL for the active substance metrafenone in hops (dried). In order to accommodate for the intended use of metrafenone, Germany proposed to raise the existing MRL from the limit of quantification of 0.05mg/kg to 80 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 a MRL proposal of 80 mg/kg for the proposed use on hops (dried). Adequate analytical enforcement methods are available to control the residues of metrafenone on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of metrafenone on hops (dried) will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

13 April 2015 Mail Print Cite

European Food Safety Authority EFSA Journal 2015;13(4):4076[56 pp.]. doi:10.2903/j.efsa.2015.4076 Abstract

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received from the European Commission (EC) a mandate to update its previous review of the maximum residue levels (MRL) for metalaxyl, taking into account new information provided in the Renewal Assessment Report for metalaxyl-M and taking into account previous MRL assessments for metalaxyl-M. EFSA is providing a reasoned opinion combining the MRL reviews of metalaxyl and metalaxyl-M and taking into consideration the additional data. Based on the assessment of the available data, one set of MRL proposals was derived for metalaxyl and metalaxyl-M (using the OECD calculator) 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 require further consideration by risk managers.

2 April 2015 Mail Print Cite

Errata/Corrigenda

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 glufosinateresidues 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. 

Erratum/Corrigendum

The Reasoned Opinion has been amended to take into account the omitted CXL for soya bean, derived by JMPR (FAO, 1998). The original Reasoned Opinion is available on request as is a version showing all the changes made. 

8 January 2015 9 April 2015 Mail Print Cite