CMR substances
According to the CLP Regulation (EC) No 1272/2008, CMR classified chemical products are assigned the following hazard codes:
• H350: May cause cancer
• H340: May cause genetic defects
• H360: May damage fertility or the unborn child
The abbreviation CMR stands for: Carcinogenic – Mutagenic – Reproductive toxic substances and substances that contain any of these hazard codes may only be handled if there is a documented investigation that shows that it is not technically possible to replace the product with other chemical products that are less harmful and thus pose less risk, a so-called CMR investigation. Such an investigation must be attached to the risk assessment that must be carried out before work begins. The procedure already exists if you do the risk assessment in KLARA.
Employees exposed to levels of carcinogenic and mutagenic substances that pose a risk to health must be registered and the data must be saved for 40 years. For substances that disrupt reproduction, the register must be kept for 5 years. The unit manager is responsible for establishing the register.
Link to risk assessment procedure at Linnaeus University: General information about environmental safety at Linnaeus University
The Swedish Work Environment Authority's provisions and general guidance (AFS 2023:10) on risks in the work environment: https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/afs-202310/
In AFS 2023:10 section V you can read more about the regulations:
https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/afs-202310/#avdelningv-kemiskariskkallor
About substitution
Read about substitution on the page General information about environmental safety at Linnaeus University, under the heading "About substitution".
Working with CMR substances
Carcinogenic, mutagenic or reproductive toxic substances are called CMR substances and are classified with the following risk phrases: H350: Carcinogenic, H340: Mutagenic and H360: Toxic for reproduction.
The easiest way to find out if a department or unit has CMR products is by searching for them in the KLARA database. Instructions for this are provided in a separate manual.
Employees who have authorisation in KLARA can see their possession of chemicals and also obtain lists from KLARA of all CMR products, i.e. chemical substances, mixtures and kits that are classified as CMR products and that are available in the department or unit in question. This applies provided that all products in the department or unit are inventoried in the system.
CMR-classified chemical products may not be used if it is technically possible to replace them. Do a substitution investigation!
A documented investigation must be conducted to demonstrate that substitution is not possible. Use the Substitution investigation form which is then attached to the risk assessment in KLARA.
CMR-classified chemical products should be handled in a closed system if technically possible – if a closed system is not possible:
- Equipment and methods are selected and designed to minimise exposure and avoid splashes or spills.
- Contaminated air is handled through process ventilation (e.g. fume cupboards).
- Protective clothing and gloves are worn if there is a risk of contact with the chemical product.
- You should be aware of situations where there is a risk of contact with the chemical product and when/what personal protective equipment is required.
- Spills are cleaned up as quickly and safely as possible (avoid creating dust if it is a powder, for example).
- Surfaces that may have been contaminated are cleaned daily and when a task has been completed.
- The chemical product and waste from its handling are stored and transported safely.
- Written handling and safety instructions are available for the entire handling chain, from purchasing and storage, use and cleaning to waste disposal etc.
Risk assess work with CMR
Risk assessment is an important part of ensuring that CMR products are used as safely as possible. The handling must also be monitored so that deviations that entail increased risk can be detected at an early stage. Monitoring may involve the organisation regularly checking that all concerned are working in accordance with the handling and protection instructions developed for working with CMR products. This review should take place regularly at local workplace meetings or equivalent within the relevant unit and also in connection with the annual safety inspection.
The ability to measure the concentration of the risk source in the air is limited to a few substances. If process ventilation is required for the work, there must be a control system that indicates if there is a fault in the ventilation efficiency.
The results of the risk assessment and the decisions on measures to be implemented must be documented. For CMR products, the following information must be stated with particular clarity:
- In which locations and areas CMR products may be present and what measures can be taken to ensure that only employees/students/other personnel who are needed for the work are present there. These measures must also be documented.
- What protective measures are necessary to ensure that exposure is minimal
- Equipment and methods are selected and designed to minimise air pollution and avoid spraying or splashing.
- Contaminated air must be handled through process ventilation (e.g. fume cupboards).
- Spills should be cleaned up as quickly and safely as possible (for example, avoid creating dust if it is a powder).
- Surfaces that may have been contaminated must be cleaned daily and when a task has been completed.
- The chemical product and waste from its handling must be stored and transported safely.
- In which situations personal protective equipment is required and what type of protective equipment (e.g. protective clothing, protective gloves, protective goggles if there is a risk of contact with the chemical product)
- How the handling and functioning of equipment, processes or ventilation should be monitored so that deviations that could entail increased risk can be detected at an early stage.
Employees/students who have been exposed to carcinogenic or mutagenic substances must be registered in an exposure register.
According to AFS 2023:10 section V chapter 8 (20), employers must keep a register of employees who have been exposed to chemical products that meet the criteria for labelling with hazard statements H350 (carcinogenic substances), H340 (mutagenic substances), H360 (reproductive toxicity) or for the following work and activities/work involving exposure to:
- dust from deciduous trees
- respirable crystalline quartz dust
- dust containing asbestos
- diesel exhaust fumes
- polycyclic aromatic hydrocarbons in soot, tar or pitch from coal
- dust, fumes or spatter arising from the smelting and electro-refining of copper-nickel mattes
- skin exposure to mineral oils previously used to lubricate and cool moving parts in an engine
- production of auramine
- processes involving strong acids in the production of isopropyl alcohol (AFS 2020:7)
The requirements entail clarified requirements for risk assessment and written handling and protection instructions, as well as requirements to register employees or students if they have been exposed to high levels of a carcinogenic substance as described above, so that there is a risk of ill health in the form of cancer or genetic defects.
If an employee/student has had a high level of exposure, the employer must enter this in an exposure register. It is important to keep in mind that cleaning staff, service staff and others who have been in the premises may also be exposed.
A form should be used for registration and archived according to the instructions on the form. Linnaeus University has a common form Exposure Register – Template Linnaeus University. The register must be kept for 40 years for carcinogenic and mutagenic substances and 5 years for substances that disrupt reproduction and can be used to investigate whether there is a connection between work and an illness. The person responsible for ensuring that the report is made to the exposure register is the head of department/equivalent or manager to whom work environment responsibility has been delegated. The completed form should be sent to registrator@lnu.se and for information to Linnaeus University's coordinators for sustainable development.
The official requirement for a CMR investigation does not contain a lower limit for the quantity for which an investigation is required. An investigation aims to show what alternatives exist for using a certain chemical product intended for a certain purpose.
Group A and B substances
For certain CMR products there are prohibitions (Group A substances) or permit requirements (Group B substances) Some substances in Group B are not CMR products but are instead allergenic (sensitising). Substances requiring a permit can also be searched for in KLARA.
Some CMR products have hygienic limit values
Exposure to CMR products must always be limited as much as reasonably possible. Some chemicals classified as CMR products have hygienic limit values. If the exposure is below the limit value, you are considered to be protected against ill health. Information about these limit values can be found in the Swedish Work Environment Authority's provisions on hygienic limit values. The requirements do not apply if the content in the product is below the classification limit.
Handling and protection instructions must be written and apply to all aspects of handling, including maintenance, cleaning, waste disposal, spillage collection etc.
For other processes where CMR products are created, the regulations are not mandatory, but it is still appropriate to use them as guidance when deciding on measures.