CMR products

The simplest way to find out is with the aid of the chemicals management system KLARA.

People who have login to KLARA with authorisation to see which chemical products that are available for example chemical inventory staff, can obtain lists from the KLARA system of all CMR products (i.e. both chemical substances and mixtures, kits, etc., that have been classified as CMR products) used at the relevant division or unit. This only applies provided that all products at the division or unit have been included in the inventory kept in KLARA.

Chemical products that have been classified as CMR products may not be used if it is technically possible to replace them.

• A documented investigation must have shown that it is not possible to replace these substances. Use the "Form for the investigation of CMR-products".

Chemical products that have been classified as CMR products must be handled in a closed system if this is technically possible

If it is not possible to use a closed system, the following must be observed:

• Equipment and methods are to be selected and designed to minimize air contaminants and avoid sprays and splashes.
• Contaminated air is to be managed through process ventilation (e.g. fume cupboard).
• Protective clothes and protective gloves must be used if there is a risk of contact with the chemical product.
• Spillages are to be collected as rapidly and safely as possible (for example, avoiding the formation of dust if a powder has been spilled).
• Surfaces that may have become contaminated are to be cleaned every day and at the end of a work task.
• The chemical product and waste from its handling must be stored and transported safely.

Written handling and safety instructions are to be available for the complete chain of handling (i.e. storage, use, waste management, etc.)

• Risk assessment is an important part of ensuring that CMR products are used in as safely as possible.

The handling is to be monitored such that deviations that lead to increased risk are discovered at an early stage

• The monitoring may mean that the operational unit (or similar) regularly check that everyone affected is working according to the handling and safety instructions that have been drawn up for work with CMR products. This check should take place regularly at local workplace meetings or similar, within the operational unit under consideration. It should also be carried out in association with the annual safety inspection (checklist for laboratory safety or equivalent).
• The possibility of measuring the levels of sources of risk in air is limited to a few substances.
• If process ventilation is required for the work, a control system must be in place that demonstrates whether the efficiency of the ventilation is defective. See the provisions of the Swedish Work Environment Authority.

Co-workers and students who are exposed to carcinogenic or mutagenic substances must be registered

• If a co-worker or student is subject to a high exposure of a carcinogenic or mutagenic product such that a risk of ill-health in the form of cancer or genetic defects arises, the university is to record this in an exposure register.
• A carcinogenic or mutagenic product has the hazard statement H350 (May cause cancer) or H340 (May cause genetic defects)
• It is important to remember that also cleaning service staff, service personnel and others who have been on the premises may be exposed.
• A LiU form is to be used for the registration, and it must be archived as specified in the instructions on the form. (The form will be available here, soon.)
• The register is to be preserved for 40 years and is to be available for use in investigating whether there is a correlation between work and a disease.

Stricter regulations are also valid for certain operations, such as those in which there is exposure to hardwood dust

More information is available on the Swedish Work Environment Authority's theme page Chemical risks and airborne particles.

A documented investigation must be carried out that demonstrates that it is not technically possible to replace the CMR product with another chemical product that poses a lower risk for ill-health or accident. A form is available at LiU to help with this investigation "Form for the investigation of CMR-products". It is a good idea to complete the form electronically, since the fields for free text then expand and provide sufficient space for the required descriptions.

Hint! Use the chemical management system KLARA to keep track of the products that have been investigated and when a new investigation needs to be done. You can add this type of information in the “Comments" field.

The requirement for an investigation applies without any lower limit of the amount to be used. An investigation is to show which alternatives are available to the use of a certain chemical product intended for a certain purpose.

The use of certain CMR products (Group A) is prohibited, while the use of others (Group B) requires a permit. Certain substances in Group B are not CMR products, but are allergenic (sensitizing).

Certain CMR products have limit values

Exposure to CMR products must always be limited as much as is reasonably possible. Exposure limit values have been set for some chemicals that have been classified as CMR products. If the exposure lies below the limit value, it is considered that the exposed person is not at risk of ill-health. Information about these exposure limit values is given in the provisions about occupational exposure limit values published by the Swedish Work Environment Authority.

The requirements are not applicable if the level in the product lies under the limit for classification.

In the case of a carcinogenic or mutagenic substance, the limit, unless otherwise specified, is that a chemical product must contain at least 0.1% of the substance for the product to be given the same classification as the substance. The equivalent limit for substances toxic to reproduction is 0.3%, unless otherwise specified.

Special concentration limits have been set for certain substances. Since December 2022, a new harmonized classification and labeling of boric acid applies within the EU, which means that boric acid is now classified as toxic to reproduction at 0.3% and not as previously at 5.5%.

Information about the classification of various substances is available from the European Chemicals Agency, ECHA. The agency also provides documents with supporting information for classification as CMR.

Handling and safety instructions must be in written form, and cover all aspects of the handling, including maintenance, cleaning, removal of waste, cleaning spillage, etc.

Further information is to be documented during the assessment of risk

The manager to whom responsibility for the work environment has been delegated is to take decisions about measures for the complete chain of handling, such that he or she can take responsibility that no-one will suffer ill-health as a result of the work, provided that the stipulated procedures are followed. These measures are to be documented. This involves both protective measures that the co-worker or student who carries out the work is to take, and the installations that are to be available.

For the measures that have been assessed as being necessary to ensure that the exposure is safe, the employer is also to take a decision about how to monitor that work is performed as intended, and to document that this is the case. The documents are to show what, how, when and by whom the checks are to be made, i.e. how the handling is to be monitored.

The result of the risk assessment and decisions about measures to take are to be documented. The following information is to be specified with particular clarity for CMR products:

• The locations and places at which CMR products may be found and the measures that can be taken to ensure that only co-workers, students and other personnel who need to be in these locations for the work are there. These measures are also to be documented.
• The protective measures that are necessary to ensure that exposure is minimal
  • Equipment and methods are to be selected and designed to minimize air contaminants and avoid sprays and splashes.
  • Contaminated air is to be managed through process ventilation (e.g. fume cupboard).
  • Spillages are to be collected as rapidly and safely as possible (for example, avoiding the formation of dust if a powder has been spilled).
  • Surfaces that may have become contaminated are to be cleaned every day and at the end of a work task.
• The chemical product and waste from its handling must be stored and transported safely.
• The situations in which personal protective clothing and which type of protective equipment is required (such as that protective clothes, protective gloves, protective goggles must be used if there is a risk of contact with the chemical product)
• How the handling and function of equipment, processes and ventilation are to be monitored such that deviations that may lead to increased risk can be detected at an early stage.

There are special requirements for work and operations that involve exposure to:

• wood dust from hardwood trees
• respirable crystalline quartz dust
• dust that contains asbestos
• diesel exhaust
• polycyclic aromatic hydrocarbons in soot, tar or carbon pitch, or
• dust, fumes or splashes that arise during the roasting and electro-refining of copper-nickel mattes.

These requirements also apply to:

• Work and operations that involve skin exposure to mineral oils that have been used to lubricate and cool moving parts in a combustion engine. (These requirements do not apply to new, unused mineral oils.)
• The production of auramine
• During processes in which strong acids are used for the manufacture of isopropyl alcohol.

The requirements involve:

• clearly expressed requirements on risk assessment and written handling and protection instructions, with a requirement that co-workers and students are registered if they are exposed to high levels of a carcinogenic substance according to the information above, such that the risk of ill-health in the form of cancer or genetic defects arises. The regulations are not compulsory for other processes in which CMR products are formed, but it even so appropriate to use them as guidance when taking decisions about measures.

For other processes where CMR products are formed, the regulations are not mandatory, but it is still appropriate to use them as guidance when deciding on measures.

Co-workers and students who are exposed to carcinogenic or mutagenic substances must be registered

• If a co-worker or student is subject to a high exposure of a carcinogenic, mutagenic or reprotoxic product such that a risk of ill-health in the form of cancer or genetic defects arises, the employer is to record this in an exposure register.
• A carcinogenic, mutagenic or reprotoxic product has the hazard statement H350 (May cause cancer), H340 (May cause genetic defects) or H360 (May damage fertility or the unbordn child).
• It is important to remember that also cleaning service staff, service personnel and others who have been on the premises may be exposed.
• A LiU form is to be used for the registration, and it must be archived as specified in the instructions on the form. Contact the coordinator for laboratory safety at LiU to gain access to the form (contact details are given in the right column).
• The register is to be preserved at least for 40 years and is to be available for use in investigating whether there is a correlation between work and a disease. For products classified as toxic to reproduction the register is to be preserved for at least 5 years.

Remember that an incident or an accident that has occurred is also to be reported according to LiU’s procedures for incidents and accidents.

Registration mainly becomes an issue in cases where it is discovered that someone has been working in air that has higher levels (higher than the exposure limit value, if this has been defined for the substance).

The causes of the high exposure may be that:

• An accident, such as a spillage, has occurred.
• The ventilation has not been satisfactory.
• Personal protective clothing or equipment for the work has not been used or has been insufficient.
• Handling and safety instructions have not been followed.

If the work has not been planned and monitored, and if the co-workers have not been informed of the hazardous nature of the substances, there is reason to suspect an increased risk of cancer or genetic defects. This is the case even if the conditions for the permit to handle Group A and Group B substances have not been followed.