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Grant on supporting EFSA in preparing guidance on endocrine disruptors

03/2017-04/2018

This third-party funded project is conducted in the framework of scientific cooperation.

EFSA grant number: GP/EFSA/PRAS/2017/01

Project homepage: -

Project description:

In a letter addressed to both ECHA and EFSA, the European Commission (EC) requested that both agencies develop a common Guidance Document for the implementation of the hazard-based criteria to identify endocrine disruptors (ED) in the context of Regulations (EC) No 1107/2009 and (EU) No 528/2012.

In accordance with the mandate from the EC, ECHA and EFSA provided the EC with an outline of the Guidance Document that was published in December 2016. The outline includes a detailed plan of the drafting process, timelines, responsibilities, the foreseen consultations with relevant parties and information on the background documents to be compiled during the drafting and consultation processes and to be published after the publication of the guidance document.

According to the mandate, the draft Guidance Document must be produced in a very short time period. In order to fulfil the tasks allocated to EFSA and to ensure that the guidance is produced on time and according to the EFSA principles, the Pesticides unit has identified the need for getting additional support from the BfR regarding two complementary tasks as described below.

BfR parts of the project:

Task A: Scientific support to the drafting group

The group drafting the Guidance Document is composed of scientific staff ECHA, EFSA and the JRC, and includes a BfR expert seconded to EFSA for this specific activity.

When developing the Guidance, best use should be made of available relevant documents/guidance and already developed tools in the context of EDs. Due to the scientific complexity of the issue, the drafting group requires additional support for collecting the available information, assessing recent publications, and integrating the new developments to be considered for drafting the guidance.

Scientific staff from the BfR provides the required support to this task A, which includes the following activities:

1) Compilation and submission of relevant information available at the BfR, including the background documents collected in relation to the International Expert Meeting on Endocrine Disruptors held in 2016 and other relevant recent activities as well as any recent publications already compiled by the BfR.

2) At the specific request of the drafting group, the BfR provides reasoned responses, including reference documents and relevant scientific publications on the issue. The questions from the drafting group cover the different aspects within the scope of the guidance on so-called EATS pathways (Estrogen, Androgen, Thyroid and Steroidogenesis), in the human health area

3) At the specific request of the drafting group, the BfR will provide preliminary assessments on the comments received during the consultations with the ad hoc ECHA/EFSA ED Consultation Group and the public consultation.

The total burden of the requested scientific contributions will be in line with the allocated budget for this task.

Task B: Technical support for managing the project and producing the background documents

Technical scientific support to EFSA and the joint taskforce in preparing the guidance on endocrine disruptors is needed for the scientific coordination of the activity within EFSA, and between EFSA, ECHA and JRC, as well as for the stakeholders’ involvement. This includes compilation of the comments received during the different consultation process, preparation of the background publications described in the scoping paper, and for the reporting and additional activities connected to this project. The needs cover two full-time equivalents (FTEs).- The holders of the positions work for a period of 12 months at EFSA’s premises on activities conducted in Parma with confidential and personal data only available to EFSA. One has a scientific background and knowledge of the pesticides regulation (junior scientific coordinator) and the other has a technical background regarding managing projects. They are organising cooperation activities and events with stakeholders, preparation of the technical reports, archiving documents and supporting requests for public access to documents. At the end of the grant, a short activities report should be prepared and submitted to EFSA mainly outlining the activities and tasks executed by the two experts.

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