Italy’s national institute for insurance against workplace accidents, INAIL, has published a fact sheet with a practical decision tree for assessing and managing exposure to reproductive toxicants in the workplace. Reproductive toxicants are chemical substances that can harm the fertility of men and women or adversely affect pregnancy. The fact sheet focuses on reproductive toxicants that are not also carcinogenic or mutagenic. The scheme is based on Italian legislation, but that legislation stems from EU rules that apply in all member states. This also makes it a useful example for employers and prevention officers elsewhere in Europe when carrying out a chemical risk assessment.
How the decision tree works
INAIL’s scheme first distinguishes between two categories of reproductive toxicants: substances for which a threshold value has been set, and substances for which this is not the case. The scheme is based on article 235 of the Italian occupational health and safety law D.Lgs. 81/2008, which sets out the employer’s obligations, and on annex XLIII of that law, which lists the substances with an established threshold value. Depending on that classification, the employer follows a different route to assess the risk. The procedure also takes into account exposure to a single substance, and does not rule out including reproductive toxicants together with carcinogenic or mutagenic substances in a single assessment, taking into account the properties of those substances.
Legal framework: from Italy to the EU
The fact sheet ties in with a broader development within the European Union. Reproductive toxicants were added relatively recently to the European protection regime for hazardous substances at work: Directive (EU) 2022/431 extended the EU directive on carcinogens and mutagens at work, generally referred to as the CMRD (Directive 2004/37/EC), to cover reproductive toxicants. Italy transposed that extension through legislative decree D.Lgs. 135/2024, which added reproductive toxicants to the Italian occupational health and safety law. As a result, employers must now treat these substances in the same way as carcinogens and mutagens: first replacing them with less hazardous alternatives where possible, otherwise limiting exposure as much as possible through technical and organisational measures, followed by health surveillance of workers who are still exposed.
Context
The European Agency for Safety and Health at Work (EU-OSHA) points to the wider impact of this risk in a summary report on reproductive toxicants. Reprotoxicants are found in, among other things, certain pesticides and medicines, and besides affecting the fertility of men and women they can also lead to miscarriages and birth defects. According to EU-OSHA, reproductive risks at work have traditionally been associated mainly with women – particularly pregnant workers – even though they affect both men and women. INAIL had previously also worked, through a multidisciplinary working group of its Dimeila department, on a broader handbook on carcinogens, reproductive toxicants and hazardous medicines in the workplace, with substitution, technical and organisational measures, training and health surveillance as prevention measures. The new fact sheet with the decision tree builds on that as a more compact tool for workplace risk assessment.
Source: Sostanze tossiche per la riproduzione: diagramma decisionale per la valutazione del rischio (Certifico.com; on the INAIL fact sheet of 22-23 October 2026)
Additional sources consulted: EU-OSHA, Summary: State-of-the-art report on reproductive toxicants, Edotto.com on the INAIL handbook on reproductive toxicants (23 May 2024)
