We offer specialized regulatory consulting for the assessment of risks associated with reprotoxic substances, assisting companies in complying with the latest legislative provisions introduced by DIR (EU) 2022/431. Our team of experts supports businesses in updating their risk assessments by integrating the analysis of reprotoxic agents within the context of exposure to carcinogens and mutagens. We provide assistance in reviewing preventive and protective measures, properly managing documentation, and implementing operational procedures that ensure the safety of workers and compliance with current regulations.
Risk Assessment for Reprotoxic Substances
Regulation (EU) 2022/431 (DIR)
The publication of Regulation (EU) 2022/431 (DIR) has amended the Directive on the management of carcinogenic and mutagenic agents, expanding its scope to also include reprotoxic agents.
In addition to equating the management of reprotoxic agents with that of carcinogenic and mutagenic agents, the Directive introduces several important and specific new features for reprotoxic substances.
Therefore, it is necessary to update your risk assessment to include reprotoxic agents in the context of exposure to carcinogens and mutagens.
Comprehensive compliance support
Normachem can support your company by proposing a structured and comprehensive work plan, consisting of the following phases:
- Risk assessment for carcinogens/mutagens/reprotoxic agents/endocrine disruptors (ED) according to Directive CMD, including analysis of work processes
- Identification of all preventive and protective measures to be implemented
- Definition of a testing strategy for airborne substances, adhering to specific technical standards ensuring robust and representative final data
- Conducting environmental, personal, and surface sampling for exposure assessment as defined in the strategy
- Performing modeling estimates for exposure assessment where necessary
- Analysis of resulting data in accordance with the aforementioned technical standards to determine actual worker exposure
- Revision, if necessary, of all preventive and protective measures (including PPE)
- Drafting of the risk assessment document for carcinogens/mutagens/reprotoxic agents/ED
- Support in drafting the corresponding procedure for managing these substances
- Support in managing obligations stipulated by Chapter II (such as opening the register of exposed workers, communication to RLS and workers, etc.)