Introduction:
Endocrine disruptors (EDs) are substances or mixtures that alter one or more functions of the endocrine system and consequently cause adverse effects in an intact organism, its progeny, populations or subpopulations. Great interest has risen in recent years on EDs given the increased consciousness on their human health toxicity as well as their toxicity for the environment.
According to Article 57(f) of the REACH Regulation, ED substances may be included in the Candidate List of Substances of Very High Concern (SVHC) for Authorization. In 2022 the CLP Regulation has been amended with the introduction of new hazard classes for endocrine disruption for human health and for the environment.
As of today, the REACH Regulation does not provide for specific information requirements for ED properties; nevertheless, many toxicological and ecotoxicological testing Technical Guidelines have been recently updated with the evaluation of toxicological aspects related to the ED properties. Importantly, in the next months the publication of the updated REACH Regulation is expected. Among other revisions, new information requirements for ED properties as well as new risk management measures are foreseen.
This training will provide you with the knowledge on definition of ED in the framework of the REACH and of the CLP Regulation, new hazard classes for ED for the environment and for human health, adaptation of testing Technical Guidelines for the evaluation of ED properties and triggers for ED properties, regulatory aspects for the evaluation of the ED properties of substances under REACH.
Program:
- ED in the CLP Regulation and in the REACH Regulation
- Introduction of Endocrine Disruption properties
- Amendment of the CLP Regulation with the introduction of new hazard classes (Regulation (EU) 2023/707).
- SVHC (Substance of Very High Concern)
- EDs listed in Candidate List
- EDs in Authorization List (Annex XIV)
- Information requirements under REACH for ED properties
- Information requirements under REACH for ED properties
- Update of Testing Technical Guidelines for evaluation related to ED properties
- How to prepare a SDS (Safety Data Sheet) in case of ED substances or mixtures
- Expected revisions of the REACH Regulation with regards to ED properties of substances and mixtures
- Substance and dossier evaluation under REACH with focus on ED properties
- ED Expert Group
- ECHA’s ED assessment list
- PACT (Public Activities Coordination Tool)
- CoRAP (Community rolling action plan)
- Dossier Evaluation
- Substance Evaluation
- Case studies
To whom:
This course is aimed at professionals working in the fields of Regulatory affairs, toxicologists interested in the regulatory aspects of EDs and regulatory consultancies in the framework of the REACH Regulation.
Teacher/Speaker:
Ilaria Geremia
Language:
Italian
(available in English upon request)
Duration:
4 hours
Cost:
400 €/person
