Documents Germany. Federal Institute for Risk Assessment 2 results

"The workshop was hosted by the German Federal Institute for Occupational Safety and Health (BAuA) in co-operation with the German Federal Institute for Risk Assessment (BfR). It was meant to present and discuss stakeholder views on possible Article 57(f) requirements for non-endocrine disrupting human health hazards as a first step towards a harmonised concept for SVHC identification via the Article 57 (f) route. The workshop was attended by 40 participants from different European Member State Competent Authorities, the European Commission, the European Chemicals Agency, industry and non-governmental organisations including the European Trade Union Confederation. In the course of the workshop, presentations were given on the following issues:
• the legal framework around Article 57(f);
• general requirements for an Annex XV dossier proposing SVHC identification via the Article 57(f) route;
• ideas and examples for a general concept to apply Article 57(f) to non-endocrine disrupting human health hazards;
• (preliminary) views on individual human health hazards regarding their appropriateness to fulfil Article 57(f) requirements.
In summary, the workshop proved to be a useful platform to exchange and discuss different opinions at a European level. The majority of the workshop participants agreed that in principle respiratory sensitisers meet Article 57(f) requirements. Nevertheless, additional work is still needed until a comprehensive and harmonised concept for SVHC identification via the Article 57(f) route will be available.
The workshop report includes an executive summary and summarizes the essential contents of the presentations and discussions. The agenda of the workshop, the list of participants and the slides of all presentations are also enclosed to the report."

"Chemical substances with a potential to modulate the hormonal system may have harmful effects on human or animal health, if they are included in plant protection products. Consequently, the new EU plant protection regulation (EC) No 1107/2009 names as one of the cut-off criteria that an active substance, safener or synergist shall only be approved if it is not considered to have endocrine disrupting properties that may cause adverse effects in humans, unless the exposure of humans under realistic proposed conditions of use is negligible. However, the new regulation fails to provide measures concerning specific scientific criteria for the assessment and decision on substances with endocrine disrupting properties. Specific criteria are to be presented by the European Commission within four years.
To address this need, the German Federal Institute for Risk Assessment (BfR) hosted an expert workshop to establish assessment and decision criteria in human health risk assessment for substances with potential endocrine disrupting properties. It was strongly recommended by a majority of workshop participants to replace the preliminary interim criteria implemented in the regulation (EC) No 1107/2009 in the decision making process by specific scientific criteria at the earliest time possible. Prior to the workshop, a conceptual framework for evaluating potentially adverse endocrine effects and their relevance for humans under realistically proposed exposure conditions was presented by the BfR. Central aspects considered and discussed within this conceptual framework for a tiered decision process included the analysis of adversity of effects on the endocrine system, of mechanistic data to establish a mode or mechanism of action in animals, and of relevance of such effects to humans. The proposal was modified and considered useful as a starting point for the development of measures to be adopted in accordance with the regulatory procedure."