Info session on applications - pesticides - technical meeting with stakeholders on EFSA Guidance on dermal absorption
Parma, Italy – 27 September (pm) and 28 September (am) 2017
EFSA invites stakeholders for an exchange of views on the EFSA Guidance on dermal absorption. The guidance is designed to assist applicants, test facilities and Member States’ authorities on critical aspects related to the setting of dermal absorption values to be used in the risk assessment of active substances in plant protection products (PPPs) reviewed for approval under the regulatory framework. The guidance, originally issued in 2012 by the Panel on Plant Protection Products and their Residues (PPR), has been revised in 2017 by the EFSA Working Group on dermal absorption on the basis of new available data on human in vitro dermal absorption for PPPs and wherever clarifications were needed.
The event aims to increase regular interaction and exchange of views with EFSA’s stakeholders.
In 2015, the European Commission asked EFSA to assess the scientific quality of newly available studies on human in vitro dermal absorption and, based on the evaluation of the studies, to revise the EFSA PPR Panel guidance on dermal absorption.
Data on human in vitro dermal absorption for plant protection products were made available by the European Crop Protection Association (ECPA) and the Bundesinstitut für Risikobewertung (BfR) by submitting study reports and two datasets with extracted information from the in vitro experiments. The evaluation of the scientific quality of the new studies has been described in the EFSA scientific report “Assessment of new scientific studies on human in vitro dermal absorption”.
Data analysis provided the scientific basis for the revision of the guidance on dermal absorption. Among other changes, new default values to be used in the absence of experimental data were set by applying both empirical and model-based approaches for the statistical analysis.
A public consultation and Pesticides Steering Network consultation on the draft EFSA guidance on dermal absorption was conducted from 22nd December 2016 to 24th February 2017.
Objectives of the meeting
The overall aim of this technical meeting is to elucidate the changes versus the guidance document issued in 2012, answer question and collect feedback with regard to this new guidance document.
The topics for discussion in the agenda will include:
- Datasets for revision and statistical analysis;
- Revision of default values and other changes;
- Feedback from the public consultation;
- Case studies from competent authorities of Member States and industry.
Structure of the meeting
The technical meeting will be organised in a way that provides for an interactive exchange of views. Participants will have the opportunity to provide feedback and to participate in the various discussions following the scientific presentations. EFSA will issue a short report collecting and summarising the discussions of the event which will be published on EFSA webpage as along with the presentations given.
Who should attend?
The technical meeting is intended for all interested stakeholders in the field of pesticide regulation.
In order to ensure a thorough discussion, participation is limited to a maximum of 50 participants, including speakers and other experts already identified by EFSA. A further selection will ensure a sufficient representation of the various fields of expertise, as well as representation of small and medium enterprises and geographical balance.
The registration form can be found at: https://ec.europa.eu/eusurvey/runner/Dermalabsorption_2017
Please note that registration may close once the maximum number of participants is reached or at the latest on 24 July 2017.
After closure of registration, potential participants will be informed whether they have been selected for participation.
Travel and accommodation
Selected participants will be asked to make travel arrangements at their own expense. EFSA will facilitate accommodation arrangements by making a block-booking for the night before the meeting. Selected participants will be requested to make their own reservation when participation is confirmed. There is no fee for participation.
Dates and venue
The technical meeting will be held on 27 September (starting at 14:00 and ending at 18:00) and on 28 September (starting at 9:00 and ending at 13:00).The event venue will be in Parma, c/o Hotel NH Parma Viale Paolo Borsellino, 31, Parma (Italy). Further details on the venue and logistics will be communicated to participants upon confirmation of selection.
English is the official language of the EFSA technical meeting. No translation is provided.
Do not hesitate to contact Arianna Chiusolo (scientific information), Virginia Spurio Salvi (organisational matters) and Gabrielle Kubanski (administrative matters) at EFSA_Infosessions [at] efsa.europa.eu - European Food Safety Authority (EFSA), via Carlo Magno, 1/a 43126 Parma, Italy.