Carcinogens, Mutagens and Reprotoxic Substances Legislation

The new Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) (Amendment) Regulations, 2026 (S.I. No. 128 of 2026) update the Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations, 2024 (S.I. No. 122 of 2024). It includes the requirements of EU Directive (EU) 2024/869.

• Scope includes workplace and work activities
• “mutagen” now included in Schedule 4 of the
  Code of Practice
• Update to the Occupational Exposure Limit for inorganic Lead and its compounds. See Schedule 1 of the
  Code of Practice
• Update to the Biological Limit Value for inorganic Lead and its compounds. See Schedule 5 of the
  Code of Practice

The Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations, 2024 (S.I. No. 122 of 2024), were published in 2024. They consolidated the 2001 Carcinogens regulations along with its amendments in 2015 and 2019 and included the requirements of EU Directive (EU) 2022/431.

The 2024 Regulations:

• brought reprotoxic substances under its scope.
• introduced hazardous medicinal products (HMPs).
• revised the limit values for three key carcinogens: benzene, acrylonitrile and nickel compounds. (Now in the 2026 Code of Practice)
• contained the (now superceded) Biological Limit Values for lead (which had been transferred from the Chemical Agents Directive).

The regulations relate to the prevention and reduction of exposure to carcinogens, mutagens and reprotoxic substances at work and places responsibility on all employers whose workplace contains:

• Carcinogens
• Mutagens
• Reprotoxic Substances
• Carcinogenic and Mutagenic Substances, Mixtures and Processes

to assess the risk and lay down measures to ensure the safety and health of employees.(Standard is technically feasible)

The regulations apply to Category 1A & 1B carcinogens , mutagens and reprotoxic substances (as per CLP Regulation) and to Carcinogenic and Mutagenic Substances, Mixtures and Processes as per Schedule 4 of the Code of Practice

The Regulations apply in addition to the Safety, Health and Welfare at Work (Chemical Agents) Regulations (2001 to 2026).See Chemical Agents and Carcinogens - Health and Safety Authority