Carcinogenic, mutagenic and reproductive toxic chemicals

• Substances or mixtures, which is stated in Appendix 1 of the Executive Order.
• Working processes, which is stated in Appendix 2 of the Executive Order.
• Substances or mixtures, which according to the CLP regulation are classified and labeled with:

	H340 May cause genetic defects.	Contains 0,1% or more
	H350 May cause cancer.	Contains 0,1% or more
	H360 May damage fertility or th unborn child.	Contains 0,3% or more

A carcinogenic, mutagenic, or reproduction-toxic chemical MUST NOT be used if it can be removed or replaced by a substance that is not hazardous or is less hazardous.

The same applies if there is a work process in which a carcinogenic, mutagenic, or reproduction-toxic substance or mixture is formed - it is mandatory to use another process that produces non-hazardous or less hazardous substances or mixtures.

A chemical risk assessment must be prepared, which must consist of the following assessment elements:

1. A list of the chemicals in the workplace, with reference to supplier information on safety and health - Safety Data Sheets.
2. The hazardous properties of the substances and materials.
3. All exposure routes, e.g., absorption in or through the skin.
4. The degree of exposure, the type and duration of exposure.
5. The circumstances of working with such substances and materials, including the quantity.
6. The effectiveness of the preventive measures that have been taken or should be taken.
7. Where possible, the conclusion from an conducted occupational health examination.
8. Tresholds set by the Danish Working Environment Authority (Arbejstilsynet).

For the preparation of a chemical risk assessment, the template can be used.

In the risk assessment, any safety and health effects for particularly sensitive workers, e.g., for pregnant and nursing women, should be considered. It should be considered whether these workers can be kept away from areas where they may come into contact with the chemicals.

When multiple chemicals with the above hazardous properties are involved, a comprehensive risk assessment must be conducted.

Provide subsequent training and instruction based on the risk assessment to all employees involved in the work process.
Each individual employee, student, or guest must receive adequate and appropriate training and instruction to perform the work in a hazard-free manner.

Training and instruction must be completed before work begins and must be repeated regularly.

When working with various hazardous chemicals, training and instruction must be verbal and supported by written material.
Written material can be a specific guide, a video, a poster, safety rules, or a safety compendium or similar.

When working with carcinogenic, mutagenic, and reproductive toxic chemicals, training and instruction must at least include the following:

1. Instruction as to where hazardous chemicals are found, as well as an instruction in reading hazard labelling and safety data sheets, including the potential health risk.
2. Instruction in safe handling, use and storage, including any restrictions on use (storage, lock, pregnant etc).
3. Instruction in proper use of safety measures and use of personal protective equipment and their locations in the workplace. An instruction and an explanation for the correct use of e.g. point extraction, fume hoods, safety cabinets, suction cabinets, gas alarms, gloves, disposable suits, respiratory protection, etc., used in the workplace.
4. Instruction on the measures to be taken regarding personal hygiene and cleaning.
5. Instruction in safety measures in case of accidents, e.g. fire, spills, etc. An instruction and an explanation of how to act if, for example, a spill occurs; can it simply be wiped up and cleaned, or should the workplace be evacuated and closed until it has been properly cleaned up?
6. Instruction in the correct disposal of hazardous waste, including used personal protective equipment.
   An instruction in the correct sorting of chemical waste into waste fractions (H1, H2, C1, B2, X1, X2, X3, etc.).
   Including an instruction to read the safety data sheet section 10 regarding reactivity and not to mix one chemical with another chemical in the same container if they can react dangerously with each other!

There are certain chemicals which are listed on the executive order annexes 1 and 2 with §5.

The manufacture and use of the substances, materials, and work processes are not permitted to the extent stated in Annexes 1 and 2 of the Executive Order.

Examples:
Benzidine, 2-naphthylamine, and 4-aminobiphenyl.
If there are special reasons for using the substance or material, the Working Environment Authority (Arbejdstilsynet) may allow deviations from the prohibition, for example for scientific research and experiments, including analyses. The application must contain information specified in the regulation appendix 5.

There are certain chemicals which are listed on the executive order annexes 1 and 2 with §17.

Handling of these chemicals may only be carried out by persons who possess the necessary training and qualification requirements according to the executive order on occupational health and safety education. Search for §17 education and you will find a course provider.

Example:
Work involving exposure to fumes from metal welding (welding fumes)

For many of the carcinogenic, mutagenic and reproduction-toxic chemicals listed in annexes 1 and 2 of the order, Laboratory use § 20 is indicated.

This means that the work process may only take place in a closed facility or in another way that prevents the release of the substances or materials, so that any exposure from this is excluded, to that extent.

A well-functioning* fume hood, where control is performed before use, is annually checked by the operation and has a certificate for completed trace gas measurement, can meet the above conditions.

* Good laboratory practice for fume hoods, such as sash opening, alarms, equipment setup in relation to flow, cleaning, etc. must be followed

Example:
Chloroform, dichloromethane, and formaldehyde.

Work with carcinogenic, mutagenic, and reproductive toxic chemicals may only be carried out in workplaces that are effectively separated from other workplaces.

Only employed persons whose work makes it necessary may have access to these areas.

What are the options for lock?

• Lock on the entire building.
• Lock on a laboratory area.
• Lock on a laboratory or another room or
• Lock on the chemical cabinet.

If, on the basis of the risk assessment, it has been concluded that there is a real risk of exposure to the carcinogenic, mutagenic or reprotoxic chemical(s)
OR

in the event of accidents/incidents where exposure has occurred.

Should it be reported as a work accident and form 2 must be filled out:

The form is filled out by the employee working with the chemical in collaboration with the responsible manager, who then sends it to the local occupational health and safety group.

The form is then sent to AU HR occupational health and safety , which archives the form.

• Regarding carcinogenic and mutagenic substances, information about the individual employee must be kept for 40 years after the risk has ceased.
• Regarding reproductive toxic substances, information about the individual employee must be kept for 5 years after the risk has ceased.
• In the event of company closure, the list must be sent to the Danish Working Environment Authority (Arbejdstilsynet).

For the carcinogenic, mutagenic and reprotoxic chemicals listed in Annexes 1 and 2 of the Order, which state sections 47-50, approval by the Danish Working Environment Authority (Arbejdstilsynet) is required before work can begin.
The application for approval must be made in electronic form or in paper form to the Danish Working Environment Authority and contain information about the following:

1. Intended use and assessment of the safety and health conditions of the work, cf. chapter 4.
2. The justification for why the substance, material, or work process cannot be replaced by a less hazardous substance, material, or work process.
3. Any technical installations and processes.
4. Necessary safety measures.

Examples:
Hexachlorobenzene, p-cresidine, and 1,2-dimethylhydrazine.

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