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New Carcinogens, Mutagens and Reprotoxic Substances legislation and Code of Practice published

The new Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations 2024, have been published. They consolidate the 2001 Carcinogens regulations along with its amendments in 2015 and 2019 and includes the requirements of EU Directive (EU) 2022/431. It is available for download from the Irish Statute Book here .

The Health and Safety Authority has also published the 2024 Code of Practice for the Safety, Health and Welfare at Work (Chemical Agents) Regulations (2001-2021) & the Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations (2024). The new COP is available for download here.

The 2024 regulations along with the Code of Practice have transposed Directive (EU) 2022/431 which is the fourth update to Directive 2004/37/EC (Carcinogens and Mutagens Directive (CMD)). This Directive brings reprotoxic substances under its scope and introduces hazardous medicinal products (HMPs). Both the regulations and Code will not introduce any new or additional national measures other than what is required from Directive (EU) 2022/431.

The Directive revises the limit values for three key carcinogens: benzene, acrylonitrile and nickel compounds. The Biological Limit Values for lead have also been transferred from the Chemical Agents Directive to the CMR Directive. These binding occupational exposures limit values and biological limit values have been included in the 2024 Code of Practice. The limit values have different transition periods.

Further information will be available on the HSA website.

Joint Summit: Preventing occupational exposure to Hazardous Medicinal Products (HMPs)

The Health and Safety Authority participated in a joint Summit on preventing occupational exposure to Hazardous Medicinal Products (HMPs). The Summit was held at Fórsa’s office in Dublin on the 30th of January 2024, hosted by Fórsa, the European Biosafety Network (EBN), the Hospital Pharmacists Association of Ireland (HPAI), and the National Association of Hospital Pharmacy Technicians (NAHPT).

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Lead

Directive (EU) 2024/869 as regards the limit values for lead and its inorganic compounds and for diisocyanates has been adopted.

The adopted directive contains the following provisions for lead:
• Reduction of occupational exposure limit from 0.15mg/m3 to 0.03mg/m3,
• Reduction of biological limit value from 70µg/100ml of blood
      o To 30μg Pb/100 ml blood (until 31 December 2028)
      o And To 15µg/100ml (from 1 January 2029)
      o If exposure occurs before these dates and a declining trend is established, these workers can continue to work involving                    exposure to lead
• Notation of lead as a non-threshold reprotoxic substance
• Medical surveillance is carried out
     o if exposure to a concentration of lead in air is greater than 0,015 mg/m3, calculated as a time-weighted average over 40 hour per week,
     o or a blood lead level greater than 9 μg Pb/100 ml blood is measured in individual workers.
     o with regard to female workers of childbearing age whose blood lead level exceeds 4,5 μg Pb/100 ml blood.


We have 2 years to implement these via an update to out Code of Practice.


However, please note that under the Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations 2024, the level of exposure of employees to lead must be reduced to as low a level as is technically possible.

Chemical Agents Webpage updated

The Chemical Agents Webpage has been updated to include a section on Diisocyanates. This includes information on the Restriction, training requirements and resources including posters in several languages.

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The EU Commission has published new ‘Guidance for the Safe Management of Hazardous Medicinal Products ‘’HMPs’’ at Work

HMPs are defined as medicinal products that contain one or more substances that meet the criteria for classification in accordance with Regulation (EC)No 1272/2008 (the CLP Regulation). This includes medicinal products for both human and veterinary use. The guidance on the use of HMPs is presented in a simple and reader friendly way by using graphics, photos and special training documents. It is a non-binding document designed to be used by workers, employers, public authorities and safety experts.  Link to Guidance 

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Risk Assessment Page Updated

The Chemicals Risk Assessment webpage has been reorganised and updated. It now includes examples of assessments that Inspectors have seen during inspections and investigations. They are in different formats because different formats suit different types of activities involving chemicals. The examples have been reviewed and comments included on how they should be improved. They illustrate how you can improve the compliance of your risk assessments.

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How to achieve best outcomes for occupational hygiene monitoring in your business

Occupational Hygiene is the discipline of anticipating, recognising, evaluating and controlling health hazards in the working environment. It is not just about the air quality at the workplace. It includes inhalational exposure (air), dermal exposure (skin, contaminated surfaces) and inadvertent ingestion. It applies to measurements of chemicals, noise and vibration in the workplace.

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Training Requirement for Products Containing diisocyanates

From 24 August 2023, all workers (employed or self-employed), using mixtures containing diisocyanates (e.g. insulation and filler foams used in construction and vehicle repair), must undergo training. All employers must keep a record of successful completion and ensure its renewal every five years. The suppliers of these products must already ensure that the labelling includes the statement; “As from 24 August 2023 adequate training is required before industrial or professional use.” The suppliers, from the 24 August 2023, must check training information is available.

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