Indicative list of hazardous medicinal products

Background

The publication of the indicative list of hazardous medicinal products (HMPs) aligns with article 18a of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens, mutagens, or reprotoxic substances at work (CMRD). The process of developing the list was supported by representatives from governments, employers and workers' interest groups, and experts from the European Medicines Agency (EMA) and the European Chemicals Agency (ECHA). It integrates data from existing databases, including the ECHA's harmonised classification information and the EMA's medicinal product database.

Objective

The list aims to improve the quality of risk assessments and raise awareness among employers and workers of the risks associated with HMPs. Although the list offers valuable guidance, it is not legally binding and is intended to supplement, not replace, mandatory workplace chemical risk assessments. It complements the Guidance for the safe management of hazardous medicinal products at work published by the EU Commission in 2023.

Contents

The indicative HMPs list has 2 annexes and 4 tables corresponding to the different information sources:

• Annex 1: lists HMPs with harmonised or self-classified CMR 1 A/B properties which have been identified by NIOSH (2020) and selected by ETUI (2022) according to their presence on the EU market
• Annex 2a: lists HMPs with harmonised CMR 1A/1B classifications
• Annex 2b: lists HMPs with CMR 1A/1B self-classifications submitted in REACH registrations by lead registrants (EU manufacturers or importers)
• Annex 2c: lists HMPs with CMR 1A/1B self-classifications submitted by notifiers having obligations under CLP

The following information is included for each medicinal product:

• active ingredient of the medicinal product
• EC and CAS number
• therapeutic class (e.g. antineoplastic agents, immunosuppressants)
• CMR properties

Publication details

• Published by: European Commission
• Publication date: 20 February 2025