Occupational exposure to reproductive toxicant: risk assessment, health surveillance and prevention under Directive (EU) 2022 / 431 and Legislative Decree No. 135 / 2024

This thesis examines the practical implications of recent regulatory reforms on reproductive toxicants for workplace prevention strategies in the European Union, with particular attention to the Italian transposition of Directive (EU) 2022/431 through Legislative Decree No. 135/2024. The study adopts an interdisciplinary and literature-based methodology integrating legal analysis, occupational health doctrine, toxicological evidence and comparative regulatory models. The analysis demonstrates that the inclusion of Category 1A and 1B reproductive toxicants within the Carcinogens, Mutagens and Reprotoxicants Directive (CMRD) represents a significant strengthening of the legal architecture of worker protection, marking a transition from a predominantly risk-based approach toward a hazard-oriented and precautionary regulatory model. This shift introduces reinforced obligations for substitution, exposure minimisation, health surveillance and exposure traceability, redefining the standard of care in occupational settings. However, the findings also show that this regulatory advancement remains only partial. The persistence of a two-tier regulatory structure—whereby suspected reproductive toxicants (Category 2) remain governed by the more flexible framework of Directive 98/24/EC—creates a structural gap that is difficult to reconcile with current scientific evidence. Reproductive toxicity emerges as a multifactorial, latency-driven and uncertainty-based domain, characterised by low-dose effects, endocrine 3 disruption, mixture exposure and long-term or transgenerational outcomes, which challenge traditional threshold-based regulatory models. The study further highlights the limitations of occupational exposure limits as primary tools of protection, as well as the insufficient integration of gender-specific and life-stage vulnerabilities into risk assessment processes. In this context, effective protection depends not only on formal legal transposition but also on the integration of scientific evidence, institutional capacity and operational risk assessment practices. Comparative analysis confirms that the practical effectiveness of Directive (EU) 2022/431 varies significantly across Member States, with more advanced systems combining binding exposure limits, technical guidance and precautionary approaches, while the Italian system—although significantly strengthened—remains in a transitional phase of development. The thesis argues that a further evolution toward an adaptive, science-informed and precautionary regulatory model is required. This includes stronger management of scientific uncertainty, enhanced protection of vulnerable workers, improved integration of biomonitoring and exposome-based approaches, and closer alignment between occupational and environmental exposure assessment. The study concludes that the effectiveness of Directive (EU) 2022/431 ultimately depends on its operational translation into workplace practice and on the progressive alignment between legal frameworks and evolving toxicological knowledge.