What regulatory guidelines apply to Estradiol hemihydrate (CAS: 35380-71-3)?

Estradiol hemihydrate (CAS: 35380-71-3) is classified as an endocrine disruptor under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). It falls under REACH regulations in the European Union, requiring registration, evaluation, and authorization. In the United States, it is regulated by the FDA for pharmaceutical purposes and the EPA for environmental protection. Compliance with these regulations is essential for handling and manufacturing this compound.