What are Carcinogens and Mutagens ?
(a) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council (CLP Regulations)
(b) a substance, mixture or process referred to in Annex I to the Directive (CMD as amended) as well as a substance or mixture released by a process referred to in that Annex (CMD Annex 1 consolidated)
- a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No. 1272/2008 (CLP).
How are they classified?
Carcinogenic and mutagenic substances are classified into a number of categories under the CLP Regulations:
- A category 1A (Carc1A) carcinogen is a substance known to have carcinogenic potential for humans, classification is largely based on human evidence.
- A category 1B (Carc1B) is a substance which is presumed to have carcinogenic potential for humans, classification is largely based on animal evidence
- A category 1A mutagen (Muta1A) is a substance known to induce heritable genetic mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. The classification is based on positive evidence from human epidemiological studies.
- A category 1B mutagen (Muta1B) is a substance known to induce heritable genetic mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. The classification is based on positive mutagenicity test results on cells in humans.
How do I know if the substance, mixture or process is a ‘carcinogen’ or "mutagen"?
- Check the label and safety data sheet (SDS) for the substance or mixture to determine whether or not the material is carcinogenic or mutagenic. Look out for the following:
Classification Code Hazard Statement
Carc 1A, 1B H350 May cause cancer
Carc 1A, 1B H350i May cause cancer by inhalation
Muta 1A, 1B H340 May cause genetic defects
- Check Annex 1 to CMD (CMD Annex 1 consolidated) to determine if any substances, mixtures or process in your business are included.
Are there any other categories?
A third category of carcinogen/mutagen exists and while these fall outside the specific scope of the carcinogen regulations they must still be risk assessed under the Chemical Agents Regulations and the Safety. Health and Welfare at Work Act, 2005
- Category 2 carcinogens are suspected human carcinogens. This is based on evidence obtained from human and/or animal studies but which is not sufficient for a Category 1 classification
- Category 2 mutagens cause concern for human owing to the possibility that they may induce heritable mutations in the germ cells of humans.
Category 2 substances and mixtures will be labelled:
- Classification Code Hazard Statement
- Carc 2 H351 Suspected of causing cancer
- Muta 2 H341 Suspected of causing genetic defects.
What do I need to do if I am using a carcinogen or mutagen or have a process listed in Annex 1?
You will need to review the applicable legislation and comply with it. Consult the Safety, Health and Welfare at Work (Carcinogens) Regulations, 2001 and Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations, 2015 and Safety, Health and Welfare at Work (Carcinogens) (Amendment) Regulations, 2019.
- It is the duty of the employer to assess any risk to any employee's health or safety resulting from any activity likely to involve a risk of exposure to carcinogens or mutagens.
- Determine the nature, degree and duration of exposure.
- Include all routes of exposure.
- Are there any employees at particular risk? It is desirable to not have such employees present in areas where they may be exposed.
- Apply the Hierarchy of Control.
- Lay down the resulting measures to be taken to ensure the safety and health of employees.
- Update the risk assessment whenever there is a change in conditions.
Hierarchy of Control
- Prevent exposure to the carcinogen or mutagen.
- Reduce the use of the carcinogen or mutagen (in so far as is technically possible) by a substance, mixture or process which eliminates or reduces the risk?
- Use the carcinogen or mutagen (in so far as is technically possible) in a closed system.
- Reduce exposure to as low as is technically possible.
- Ensure exposure shall not exceed the limit value.
- In areas where there is a risk, only employees who must work in the area are permitted to enter.
- All containers, packages and installations containing carcinogen or mutagen are clearly labelled and display clearly visible warning and hazard signs.
Schedule 3 of the Regulations requires the following measures:
- Limit the quantities.
- Keep the number of employees exposed or likely to be exposed as low as possible.
- Design work processes and engineering control measures to avoid or minimise release into the place of work.
- Use appropriate systems to extract the carcinogen or mutagen at source.
- Use appropriate procedures for measurement in particular fro the early detection of abnormal exposures resulting from an accident.
- use suitable working procedures and methods.
- Use collective protective measures.
- Use hygiene measures, in particular regular cleaning of floors, walls and other surfaces.
- Provide information to employees.
- Demarcate risk areas and use adequate warning and safety signs, including "no smoking" signs.
- Draw up plans to deal with emergencies.
- Have means for safe storage, handling and transportation.
- Have means for safe collection, storage and disposal of waste.
The legislation also set out the requirements for:
- Information to be made available to the HSA (on request).
- Arrangements for Unforeseen Exposure.
- Arrangements for foreseeable increase in exposure.
- General measures regarding no eating, drinking or smoking and personal protective equipment.
- Measures to ensure employees receive appropriate training and information.
- Consultation of employees or their Safety Representative.
- Health Surveillance
Please note that the Carcinogens and Mutagens Directive (CMD) is currently undergoing further review at EU level.