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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 Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(9):3830 [12 pp.]. doi:10.2903/j.efsa.2014.3830 Abstract

The microbial additive MycoCell is a live preparation of Saccharomyces cerevisiae yeast culture. It is intended to be applied daily, incorporated into a total mixed ration or as a top dressing at the dose of 1 × 1010 colony-forming units (CFU)/head/day. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been established and as the additive essentially consists of only the active agent, safety for the target species, consumer and environment is presumed. The additive is not irritant to the skin or eyes and is a skin sensitiser. Considering that the product has no dusting potential, exposure via the respiratory route is of no concern. Three trials in lactating cows indicate that the additive at the dose of 1 × 1010 CFU/head/day has the potential to improve milk production.

30 September 2014 Mail Print Cite

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. EFSA Journal 2014;12(9):3829 [7 pp.]. doi:10.2903/j.efsa.2014.3829 Abstract

In 2012, the Panel on Additives and Products or Substances used in Animal Feed issued an opinion on the safety and efficacy of 18 strains of Lactobacillus plantarum and of six strains of Pediococcus spp. In those instances the FEEDAP Panel concluded that the strains were safe for target animals, consumers of animal products, users of the additive and the environment when used for the purpose described. In both cases the efficacy of a Lactobacillus plantarum strain and a Pediococcus pentosaceus strain was tested in the presence of the other strain in 8:2 ratio by bacterial count. Although the mixture of the strains showed a potential to improve the production of silage from a similar range of forage species by reducing the pH, the consequences of a more rapid pH reduction for the preservation of nutrients were not shown. The Commission has given the possibility to the applicants to submit complementary information to allow the Panel to reach conclusions on the efficacy of these strains. The further data provided are the subject of the current opinion. In six studies made using forage samples of differing water-soluble carbohydrate content and representing material from the range easy, moderately difficult and difficult to ensile,the strains of P. pentosaceus and L. plantarum used in a mixture with the ratio of 8:2 and delivering a minimum combined dose of 1 × 108 CFU/kg forage, show some potential to improve the preservation of nutrients in silage prepared from easy, moderately difficult and difficult to ensile material.

30 September 2014 Mail Print Cite

EFSA Panel on Plant Health (PLH) Richard Baker, Claude Bragard, Thierry Candresse, Gianni Gilioli, Jean-Claude Grégoire, Imre Holb, Michael John Jeger, Olia Evtimova Karadjova, Christer Magnusson, David Makowski, Charles Manceau, Maria Navajas, Trond Rafoss, Vittorio Rossi, Jan Schans, Gritta Schrader, Gregor Urek, Irene Vloutoglou, Stephan Winter and Wopke van der Werf. EFSA Journal 2014;12(9):3834 [31 pp.]. doi:10.2903/j.efsa.2014.3834 Abstract

The Panel on Plant Health performed a pest categorisation of Ditylenchus destructor, the potato rot nematode. D. destructor is listed in Annex II, Part A, Section II of Council Directive 2000/29/EC as a harmful organism known to occur in the Union and relevant for the entire Union. D. destructor is a distinct taxonomic entity that can be identified in a straightforward way, and which is present in the majority of EU member states, although sporadically (but data from systematic surveys are lacking). Many hosts of D. destructor are present in the RA area and the climatic conditions in the whole risk assessment area are favourable for the completion of the pest life cycle. D. destructor can cause significant damage to the below-ground parts (roots, tubers, bulbs) of host crops such as potato and several ornamental plants. However, during recent decades only minor damage has been reported (except in some Eastern European countries). Plants for planting are a pathway for introduction and spread of D. destructor, which may cause severe impacts on the intended use of the plants for planting.

30 September 2014 Mail Print Cite

EFSA Scientific Committee Jan Alexander, Diane Benford, Qasim Chaudhry, John Griffin, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Simon More, Alicja Mortensen, Birgit Nørrung, Bernadette Ossendorp, Joe Perry, Josef Schlatter, Vittorio Silano, Kristen Sejrsen EFSA Journal 2014;12(9):3808 [10 pp.]. doi:10.2903/j.efsa.2014.3808 Abstract

The European Food Safety Authority (EFSA) asked the Scientific Committee to prepare a guidance document revising the structure and content of EFSA’s scientific opinions and statements, to be implemented across EFSA’s Scientific Committee and Panels. The new structure is proposed herein.

23 September 2014 Mail Print Cite

Statements of EFSA

European Food Safety Authority EFSA Journal 2014;12(9):3820 [8 pp.]. doi:10.2903/j.efsa.2014.3820 Abstract

The European Commission asked EFSA to provide a technical assistance on the request for a modification of the specification on the solubility of the food additive polyvinyl alcohol (E 1203) in ethanol and its possible impact on the safety assessment. Polyvinyl alcohol is authorised as a food additive in food supplements in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Having evaluated the results of the solubility test carried out by the European Commission Joint Research Centre (Institute for Health and Consumer Protection, IHCP) with polyvinyl alcohol and the information provided by the applicant, EFSA considers that the description of the solubility of polyvinyl alcohol (E 1203) in ethanol (> 99.8 %) in the existing technical specifications should be solely modified to “practically insoluble or insoluble”. This modification has no impact on the safety of polyvinyl alcohol (E 1203) as a food additive.

11 September 2014 Mail Print Cite

Conclusions on Pesticide Peer Review

European Food Safety Authority EFSA Journal 2014;12(9):3812 [76 pp.]. doi:10.2903/j.efsa.2014.3812 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 Greece, for the pesticide active substance 2,4-D 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 2,4-D as a herbicide on cereals and maize. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

11 September 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(9):3817 [102 pp.]. doi:10.2903/j.efsa.2014.3817 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 Germany, for the pesticide active substance pymetrozine 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 pymetrozine as an insecticide on tomato, aubergine, potato and oilseed rape. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

9 September 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(9):3814 [248 pp.]. doi:10.2903/j.efsa.2014.3814 Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom and the co-rapporteur Member State France for the pesticide active substance cyantraniliprole and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of cyantraniliprole as an insecticide on various crops in agriculture and horticulture. MRLs were assessed in oranges, mandarins, apples/pears, peaches, apricots, plums, vine grapes, potatoes, tomatoes, cucumber/courgettes, melon, lettuce, beans and olives. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment and the proposed MRLs, 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.

9 September 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(9):3815 [91 pp.]. doi:10.2903/j.efsa.2014.3815 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 Slovakia for the pesticide active substance prosulfuron 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 prosulfuron as a herbicide on maize and sweet corn. 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.

2 September 2014 Mail Print Cite

Reasoned Opinions

European Food Safety Authority EFSA Journal 2014;12(9):3822 [20 pp.]. doi:10.2903/j.efsa.2014.3822 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRL for the active substance fluopicolide in Chinese cabbage. In order to accommodate for the intended use of fluopicolide, Belgium proposed to raise the existing MRL from the value of 0.1 mg/kg to 2 mg/kg. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive an MRL proposal of 2 mg/kg for the proposed use on Chinese cabbage. Adequate analytical enforcement methods are available to control the residues of fluopicolide in Chinese cabbage. Based on the risk assessment results, EFSA concludes that the proposed use of fluopicolide on Chinese cabbage will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

17 September 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(9):3823 [84 pp.]. doi:10.2903/j.efsa.2014.3823 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 abamectin. In order to assess the occurrence of abamectin 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 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.

17 September 2014 Mail Print Cite

European Food Safety Authority EFSA Journal 2014;12(9):3824 [20 pp.]. doi:10.2903/j.efsa.2014.3824 Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from the company Nisso Chemical Europe GmbH to modify the existing MRL for the active substance acetamiprid in bananas. In order to accommodate for the intended use of acetamiprid, Spain proposed to raise the existing MRL from the limit of quantification of 0.01* mg/kg to 0.4 mg/kg. EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive an MRL proposal of 0.4 mg/kg on bananas. Adequate analytical enforcement methods are available to control the residues of acetamiprid. Based on the risk assessment results, EFSA concludes that the proposed use of acetamiprid on bananas will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

12 September 2014 Mail Print Cite

Scientific Reports of EFSA

European Food Safety Authority EFSA Journal 2014;12(9):3821 [186 pp.]. doi:10.2903/j.efsa.2014.3821 Abstract

In May 2013, Germany reported cases of hepatitis A virus (HAV) genotype IA infection in persons with a travel history and Italy reported a national increase in the number of HAV cases and declared an outbreak. Confirmed cases (outbreak strain KF182323) have been reported in Denmark, Finland, France, Germany, Ireland, Norway, the Netherlands, Poland, Sweden and the United Kingdom (331 in total). HAV contamination was detected in frozen mixed berries (14 lots) and mixed berry cakes/pastries (2 lots) in Italy, France and Norway. In Ireland, the Netherlands and Sweden, analysis of food histories and questionnaires identified suspect berries and berry products consumed by confirmed cases. Tracing began with 38 lots/cases from Italy, Ireland and the Netherlands, an additional 5 lots/cases were added from France, Norway and Sweden in spring 2014. The tracing data were exchanged via the European Rapid Alert System for Food and Feed. The final dataset comprises 6227 transactions among 1974 food operators. Bulgarian blackberries and Polish redcurrants were the most common ingredients in the traced lots/cases; however, Poland is the largest producer of redcurrants in Europe, and Bulgaria is a major exporter of frozen blackberries. No single point source of contamination linking all 43 lots/cases could be identified. HAV cases/lots in five countries could be linked to seven Polish freezing processors and/or to five frozen berry suppliers in Bulgaria. This indicates that HAV contamination could be occurring at the freezing processor or in primary production of berries and therefore compliance with Good Hygiene Practice, Good Manufacturing Practice and Good Agricultural Practice is recommended for countries producing berries for freezing. It is possible that contaminated product related to this outbreak could still be circulating in the food chain. Hence, for the public health domain, enhanced surveillance, risk communication, vaccination and further research are recommended.

8 September 2014 Mail Print Cite