Guidance on Dermal Absorption

“…10-final (European Commission, 2003), SANCO/10597/2003-rev. 10.1 (European Commission, 2012, Guidance on dermal absorption (EFSA PPR Panel, 2012) and Guidance on the Application of the CLP Criteria (ECHA, 2015).…”

Section: Mammalian Toxicitymentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance copper compounds copper(I), copper(II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper(I) oxide, Bordeaux mixture

Arena¹,

Auteri²,

Barmaz³

et al. 2018

EFS2

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The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Germany, for the pesticide active substance copper compounds are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of copper compounds as a fungicide on grapes, tomatoes and cucurbits. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

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“…10-final (European Commission, 2003a, SANCO/10597/2003-rev. 10.1 (European Commission, 2012, Guidance on dermal absorption (EFSA PPR Panel, 2012) and Guidance on non-dietary exposure (EFSA, 2014a).…”

Section: Mammalian Toxicitymentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance trifloxystrobin

Arena¹,

Auteri²,

Barmaz³

et al. 2017

EFS2

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The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Greece, for the pesticide active substance trifloxystrobin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of trifloxystrobin as a fungicide on apple, pear, quince, grapes and strawberry. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the United Kingdom, and co-rapporteur Member State (co-RMS), Greece, received an application from Bayer CropScience AG for the renewal of approval of the active substance trifloxystrobin. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Greece), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.The RMS provided its initial evaluation of the dossier on trifloxystrobin in the renewal assessment report (RAR), which was received by EFSA on 29 September 2016. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Bayer CropScience AG, for comments on 10 November 2016. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 12 January 2017.Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology.In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether trifloxystrobin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of trifloxystrobin as a fungicide on field application on apple, pear, quince, grapes, and greenhouse and field applications in strawberry, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.Data were submitted to conclude that the ...

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Guidance on Dermal Absorption

Cited by 198 publications

References 8 publications

Request for the evaluation of the toxicological assessment of the co‐formulant POE‐tallowamine

Request for the evaluation of the toxicological assessment of the co‐formulant POE‐tallowamine

Peer review of the pesticide risk assessment of the active substance copper compounds copper(I), copper(II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper(I) oxide, Bordeaux mixture

Peer review of the pesticide risk assessment of the active substance trifloxystrobin

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