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.
Current issue

Just Published: August, 2015

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

Scientific Opinion on a request for a review of a scientific publication concerning the zoonotic potential of ovine scrapie prions

EFSA Journal 2015;13(8):4197 [58 pp.].
doi
10.2903/j.efsa.2015.4197
EFSA Panel on Biological Hazards (BIOHAZ)
Abstract

The factors that modulate the transmissibility of Transmissible Spongiform Encephalopathies (TSE) and the approaches for the study of their zoonotic potential are reviewed. The paper ‘Evidence for zoonotic potential of ovine scrapie prions’ by Cassard et al. (2014) is scientifically appraised, focussing on the experimental design, the results and the conclusions. The paper provides evidence in a laboratory experiment that some Classical scrapie isolates can propagate in humanised transgenic mice and produce prions that on second passage are similar to those causing one form of sporadic Creutzfeldt-Jakob disease (sCJD). It is concluded that the results from the study raise the possibility that scrapie prions have the potential to be zoonotic, but do not provide evidence that transmission can or does take place under field conditions. The conclusions of the 2011 ECDC-EFSA ‘Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans’ are reviewed in the light of the new scientific evidence available since its publication. This supports and strengthens the conclusions of that opinion with regard to the potential for some animal TSE to be zoonotic, but does not provide evidence of a causal link between Classical or Atypical scrapie and human TSE. Current evidence does not establish this link, and no consistent risk factors have been identified for sCJD. The possibility of scrapie-related public health risks from the consumption of ovine products cannot be assessed. Recommendations are formulated on further studies and data that are needed to investigate the zoonotic potential of animal TSE and to estimate the amount of infectivity from TSE-infected products sourced from small ruminants and entering the food chain in the European Union.

5 August 2015

Conclusions on Pesticide Peer Review

Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid considering all uses other than seed treatments and granules

EFSA Journal 2015;13(8):4211 [82 pp.].
doi
10.2903/j.efsa.2015.4211
European Food Safety Authority
Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to perform a risk assessment of neonicotinoids, including imidacloprid, as regards the risk to bees, as a follow up of previous mandates received from the European Commission on neonicotinoids. In this context the conclusions of EFSA concerning the risk assessment for bees for the active substance imidacloprid are reported. The context of the evaluation was that required by the European Commission in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data. The conclusions were reached on the basis of the evaluation of all authorised uses of imidacloprid other than seed treatments and granules in Europe (including the foliar spray uses as referred to in recital 7 of Commission Implementing Regulation (EU) No 485/2013). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the submitted studies and literature data as well as any other relevant data available at national level and made available to EFSA, are presented. Missing information identified as being required to allow for a complete risk assessment is listed. Concerns are identified.

26 August 2015

Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam considering all uses other than seed treatments and granules

EFSA Journal 2015;13(8):4212 [70 pp.].
doi
10.2903/j.efsa.2015.4212
European Food Safety Authority
Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to perform a risk assessment of neonicotinoids, including thiamethoxam, as regards the risk to bees, as a follow up of previous mandates received from the European Commission on neonicotinoids. In this context the conclusions of EFSA concerning the risk assessment for bees for the active substance thiamethoxam are reported. The context of the evaluation was that required by the European Commission in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data. The conclusions were reached on the basis of the evaluation of all authorised uses of thiamethoxam other than seed treatments and granules in Europe (including the foliar spray uses as referred to in recital 7 of Commission Implementing Regulation (EU) No 485/2013). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the submitted studies and literature data as well as any other relevant data available at national level and made available to EFSA, are presented. Missing information identified as being required to allow for a complete risk assessment is listed. Concerns are identified.

26 August 2015

Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin considering all uses other than seed treatments and granules

EFSA Journal 2015;13(8):4210 [77 pp.].
doi
10.2903/j.efsa.2015.4210
European Food Safety Authority
Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to perform a risk assessment of neonicotinoids, including clothianidin, as regards the risk to bees, as a follow up of previous mandates received from the European Commission on neonicotinoids. In this context the conclusions of EFSA concerning the risk assessment for bees for the active substance clothianidin are reported. The context of the evaluation was that required by the European Commission in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data. The conclusions were reached on the basis of the evaluation of all authorised uses of clothianidin other than seed treatments and granules in Europe (including the foliar spray uses as referred to in recital 7 of Commission Implementing Regulation (EU) No 485/2013). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the submitted studies and literature data as well as any other relevant data available at national level and made available to EFSA, are presented. Missing information identified as being required to allow for a complete risk assessment is listed. Concerns are identified.

26 August 2015

Peer review of the pesticide risk assessment for the active substance dodine in light of confirmatory data submitted

EFSA Journal 2015;13(8):4209 [15 pp.].
doi
10.2903/j.efsa.2015.4209
European Food Safety Authority
Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Portugal, for the pesticide active substance dodine are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data in ecotoxicology. The conclusions were reached on the basis of the evaluation of the representative uses as a fungicide on pome fruits and stone fruits. 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. Concerns are identified.  

20 August 2015

Conclusion on the peer review of the pesticide risk assessment of the active substance isoproturon

EFSA Journal 2015;13(8):4206 [99 pp.].
doi
10.2903/j.efsa.2015.4206
European Food Safety Authority
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 isoproturon 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 isoproturon as a herbicide on winter cereals (wheat, barley, rye, triticale) and spring cereals (wheat, barley). 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 August 2015

Peer review of the pesticide risk assessment for the active substance oxyfluorfen in light of confirmatory data submitted

EFSA Journal 2015;13(8):4205 [45 pp.].
doi
10.2903/j.efsa.2015.4205
European Food Safety Authority
Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Spain for the pesticide active substance oxyfluorfen are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding environmental fate and behaviour and ecotoxicology. The conclusions were reached on the basis of the evaluation of the representative uses of oxyfluorfen as a herbicide in grapes, pome fruits and sunflower. 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. Concerns are identified.  

19 August 2015

Peer review of the pesticide risk assessment for the active substance buprofezin in light of confirmatory data submitted

EFSA Journal 2015;13(8):4207 [24 pp.].
doi
10.2903/j.efsa.2015.4207
European Food Safety Authority
Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the United Kingdom, for the pesticide active substance buprofezin are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory residue data. The conclusions were reached on the basis of the evaluation of the representative uses of buprofezin as an insecticide on tomato, lettuce and citrus. 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. Concerns are identified. 

7 August 2015

Reasoned Opinions

Review of the existing maximum residue levels (MRLs) for mepiquat according to Article 12 of Regulation (EC) No 396/2005

EFSA Journal 2015;13(8):4214 [35 pp.].
doi
10.2903/j.efsa.2015.4214
European Food Safety Authority
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

mepiquat . In order to assess the occurrence of mepiquat 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. 
24 August 2015

Modification of maximum residue levels for cyazofamid in hops, globe artichokes, leeks and spring/green onions and Welsh onions

EFSA Journal 2015;13(8):4204
doi
10.2903/j.efsa.2015.4204
European Food Safety Authority
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Belgium, received an application from ISK Biosciences Europe N.V. to modify the existing maximum residue levels (MRLs) for the active substance cyazofamid in hops, globe artichokes, leeks and spring onions/green onions and Welsh onions. In order to accommodate for the intended uses of cyazofamid, Belgium proposed to set the MRL at 0.4 mg/kg for leeks and spring onions/green onions and Welsh onions, at 0.15 mg/kg for globe artichokes and at 20 mg/kg for hops. Belgium 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 derive a MRL of 0.4 mg/kg for spring onions/green onions and Welsh onions and a MRL of 20 mg/kg for hops. An amendment of the MRL is not proposed for globe artichokes and leeks as long as the toxicity of metabolite CCIM observed as the predominant compound of the residues in the hydrolysis study is not addressed and information on the possible residue levels of this compound in the processed food commodities is not provided. Adequate analytical enforcement methods are available to control the residues of cyazofamid on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of cyazofamid on spring onions/green onions and Welsh onions and on hops will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

17 August 2015

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for 1 naphthylacetamide and 1 naphthylacetic acid according to Article 12 of Regulation (EC) No 396/2005

EFSA Journal 2015;13(8):4213 [52 pp.].
doi
10.2903/j.4213
European Food Safety Authority
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 substances 1‑naphthylacetamide and 1‑naphthylacetic acid. In order to assess the occurrence of 1‑naphthylacetamide and 1‑naphthylacetic acid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers.

11 August 2015