Occupational health and safety requirements for the handling of carcinogenic, mutagenic and reprotoxic chemicals

[RT I, 26.03.2015, 5 – entry into force 1 June 2015]

(1) This Regulation sets out the occupational health and safety requirements when working with carcinogenic, mutagenic and reprotoxic chemicals (hereinafter ‘carcinogens’, ‘mutagens’ and ‘reprotoxic substances’).

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) This Regulation shall apply when the substance that is being handled or a substance in the mixture that is being handled is classified as a category 1A or 1B carcinogen, mutagen or reprotoxic substance under Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1), or if the substance or mixture is referred to in Section 2 of this Regulation or is released during the processes listed in Section 2.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) This Regulation shall apply to work performed by radiation workers, subject to the specific provisions of the Radiation Act [ kiirgusseadus ].

(4) This Regulation shall apply to asbestos-related work, but shall not prevent the application of stricter or more specific provisions set out in Government of the Republic Regulation No 224 of 11 October 2007 on the occupational health and safety requirements for asbestos-related work.

[RT I, 26.03.2015, 5 – entry into force 1 June 2015]

The following are processes giving rise to a carcinogenic hazard

1) production of auramine (CAS 492-80-8);

2) processes in which the worker may be exposed to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch;

3) brazing, soldering, welding or other heat treatment of materials containing copper and nickel, during which dusts, fumes and sprays of those metals are produced;

4) strong acid processes in the manufacture of isopropyl alcohol;

5) processes in which the worker may be exposed to hardwood dusts, for example from the processing of beech or oak;

6) processes in which the worker may be exposed to respirable crystalline silica dust;

7) processes which may involve dermal exposure of the worker to mineral oils that have been used before in internal combustion engines to lubricate and cool the moving parts within the engine;

8) processes in which the worker may be exposed to diesel engine exhaust emissions;

9) other processes involving a risk of exposure to carcinogens, mutagens or reprotoxic substances.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(1) For all processes involving a risk of workers being exposed to carcinogens, mutagens or reprotoxic substances, the employer – when assessing the risks in the working environment – must determine the nature, extent and duration of the exposure and consequently assess the risk to workers’ health and safety and take the necessary preventive action.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) When assessing the risks, account shall be taken of all routes of exposure to carcinogens, mutagens or reprotoxic substances, including absorption into the skin or through the skin into the body.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) The employer must pay particular attention to how risk-sensitive workers, such as pregnant women, women who are breastfeeding and workers who are minors, are involved in processes, and must take account of the restrictions imposed by legislation to ensure their safety.

(4) [Repealed – RT I, 17.10.2019, 1 – entry into force 17 January 2020]

(1) If the results of the assessment of risks in the working environment show that carcinogens, mutagens or reprotoxic substances may endanger workers’ health, their exposure to those substances must be prevented as far as possible, by restricting the use of those substances, replacing them with safer chemicals or using safer technologies.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) The employer must ensure that areas involving a health risk are accessible only by workers who, by reason of their work or duties, are required to enter them.

(3) Where it is not technically possible to replace the carcinogens, mutagens or reprotoxic substances with safer chemicals or to use safer technologies, the employer must ensure that, in so far as it is technically possible, they are handled in a closed system.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4) Where it is not technically possible to use a closed system referred to in subsection 3, the employer must ensure that the level of exposure of workers to carcinogens, mutagens or non-threshold reprotoxic substances is reduced to as low a level as possible and that the limit value of the chemical agent concerned is not exceeded in the working environment.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4¹) A non-threshold reprotoxic substance is a reprotoxic substance that is harmful to workers’ health regardless of the level of exposure.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4²) Where it is not technically possible to use or manufacture a threshold reprotoxic substance in a closed system, the employer shall ensure that the risk related to the exposure of workers to that threshold reprotoxic substance is reduced to a minimum.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4³) A threshold reprotoxic substance is a reprotoxic substance that is harmful to workers’ health as of a certain level of exposure.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4⁴) Where a reprotoxic substance is not a substance referred to in subsections 41 or 43, the employer shall proceed on the basis of subsection 42 and take appropriate measures to minimise the risk to workers’ health from exposure to that substance, having regard to the fact that for this reprotoxic substance there may be no level of exposure that is not harmful to workers’ health.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(5) Wherever carcinogens, mutagens or reprotoxic substances are used, the employer must apply the following measures

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

1) limitation of the quantity of a carcinogen, mutagen or reprotoxic substance stored or handled in the working environment to the minimum required;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

2) reducing the number of workers exposed to carcinogens, mutagens or reprotoxic substances to the minimum possible;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

3) design of work processes so as to avoid the release of carcinogens, mutagens or reprotoxic substances into the working environment or, where unavoidable, reduce it to a minimum, in conjunction with the application of control measures;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

4) evacuation of carcinogens, mutagens or reprotoxic substances at source, by means of local extraction, general ventilation or other appropriate methods;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

5) use of monitoring methods for the timely detection of the release of carcinogens, mutagens or reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

6) application of safe working practices and methods, including the use of collective or personal protective equipment;

7) application of appropriate hygiene measures, including regular cleaning of floors, walls and other surfaces;

8) timely and precise information for workers;

9) demarcation of risk areas and use of adequate safety signs, including ‘No smoking’ signs, in areas where workers are exposed or likely to be exposed to carcinogens, mutagens or reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

10) drawing up plans to deal with possible emergencies which may expose workers to large quantities of carcinogens, mutagens or reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

11) storage of the chemicals being handled in hermetically sealed and clearly and visibly labelled vessels;

12) collection of hazardous waste in hermetically sealed and clearly labelled containers;

13) application of safe means of storage, transport and disposal.

(1) For certain activities such as maintenance of equipment, in respect of which it is foreseeable that there is the potential for a significant increase in workers’ exposure to carcinogens, mutagens or reprotoxic substances, and where the standard technical measures to protect the workers are insufficient, the employer shall determine, after consultation with the workers or their representatives, the specific measures necessary to ensure the health and safety of those workers.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) In the case referred to in subsection 1, the workers shall be provided with protective clothing and individual respiratory protective equipment which they must wear as long as the exposure to carcinogens, mutagens or reprotoxic substances persists; that exposure must be kept to the strict minimum amount of time necessary for each worker.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) In the case referred to in subsection 1, the area in which the work is carried out must be clearly demarcated and access by unauthorised persons must be prevented.

(1) The employer must inform the workers and the working-environment representative as quickly as possible of any risk of an accident that has arisen or of any accident that has occurred which is likely to result in the exposure of workers to carcinogens, mutagens or reprotoxic substances, and of the causes thereof, the possible consequences and the safeguards that are to be taken.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) The employer must display written instructions on how to react in the event of an accident and how to prevent any consequences.

(3) Only specially trained workers who are essential to the carrying out of repairs or other necessary work may enter the affected area, and they shall be provided with the necessary protective clothing and respiratory protective equipment. The time spent in the affected area must be kept to a strict minimum.

In order to prevent the possible exposure of workers to carcinogens, mutagens or reprotoxic substances, the employer must take the following occupational hygiene measures

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

1) ban eating, drinking and smoking in areas where there is a risk of contamination by carcinogens, mutagens or reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

2) provide workers with appropriate working clothes and, where necessary, with protective clothing and respiratory protective equipment;

3) ensure that there are separate storage places for working clothes and for street clothes;

4) provide workers with washing facilities equipped with showers and, where necessary, install eyewash stations;

5) ensure that all personal protective equipment that is used is cleaned, checked and stored in a predetermined place at the end of each working day;

6) ensure that working clothes and protective clothing are cleaned and washed or, if they have become unusable, treated in accordance with the requirements laid down in the Waste Act [ jäätmeseadus ].

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(1) The employer is required to inform the Labour Inspectorate at least 30 days before commencing work with carcinogens, mutagens or reprotoxic substances for the first time, by providing the following information in writing or electronically

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

1) the employer’s name and address;

2) a list of the carcinogens, mutagens or reprotoxic substances to be used, together with information identifying them in accordance with the Chemicals Act [ kemikaaliseadus ];

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

3) a list of processes or technologies for which carcinogens, mutagens or reprotoxic substances are used, and the reasons for their use;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

4) the quantities of substances or mixtures manufactured or used which contain carcinogens, mutagens or reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

5) the number of workers exposed to carcinogens, mutagens or reprotoxic substances, the nature of the exposure and the duration of the exposure during the working day or working week;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

6) information on the safety measures to be used, including the personal protective equipment.

(2) Where the employer has ascertained while assessing the risks in the working environment that there is a risk of exposure to carcinogens, mutagens or reprotoxic substances, the employer is required to inform the Labour Inspectorate by providing in writing or electronically not only the information referred to in subsection 1 but also information on cases of the replacement of a carcinogen, mutagen or reprotoxic substance by another carcinogen, mutagen or reprotoxic substance.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(1) The employer must ensure that workers exposed to carcinogens, mutagens or reprotoxic substances receive appropriate training, including in particular the following

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

1) knowledge of the health hazards of carcinogens, mutagens and reprotoxic substances, including the additional health risks when smoking;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

2) safety measures to be taken to prevent exposure to carcinogens, mutagens and reprotoxic substances;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

3) knowledge of the safety signs to be used;

4) the occupational hygiene requirements in the undertaking;

5) the purpose of and rules for using personal protective equipment, including protective clothing;

6) guidelines to follow in the event of a dangerous situation arising.

(1¹) The training shall be adapted to take account of new or changed risks, in particular when workers are or may be exposed to a new carcinogen, mutagen or reprotoxic substance or to a number of carcinogens, mutagens or reprotoxic substances, including substances contained in hazardous medicinal products.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) The training shall be repeated periodically where necessary.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) In healthcare settings, the training shall be provided periodically to workers who are exposed to carcinogens, mutagens or reprotoxic substances, in particular where new hazardous medicinal products containing those substances are used.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(1) The employer shall inform workers of any equipment or containers used in the undertaking and containing carcinogens, mutagens or reprotoxic substances, and ensure that all equipment, containers and packaging containing those substances are clearly and legibly labelled and display clearly visible warning signs.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) The employer must draw up and approve written guidelines for the handling of carcinogens, mutagens and reprotoxic substances and ensure that the guidelines are available to the workers and, where necessary, displayed in a visible place.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(1) The employer must keep a list of workers at risk of exposure to carcinogens, mutagens or reprotoxic substances as a result of their work.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) The list must include the following information about each worker

1) first name and surname;

2) a description of duties;

3) the name of the carcinogen, mutagen or reprotoxic substance to which the worker has been exposed;

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

4) the duration of the exposure to the carcinogen, mutagen or reprotoxic substance.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) The information concerning each worker entered in the list must be kept up to date and then kept for at least 40 years following the worker’s final exposure to the carcinogen or mutagen and for at least 5 years following the worker’s final exposure to the reprotoxic substance.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4) Each worker is entitled to access the information about them which is entered in the list.

(5) Workers and working-environment representatives must have the opportunity to access non-personal statistical data concerning the list.

(6) Occupational doctors, working-environment specialists and labour inspectors are entitled to access the list of workers.

(1) On the basis of the results of the assessment of risks in the working environment, employers shall ensure that workers whose health may be affected by carcinogens, mutagens or reprotoxic substances undergo health surveillance in accordance with the procedure set out in the Occupational Health and Safety Act.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(2) If it is found during health surveillance that a worker is suffering from an abnormality which may be the result of exposure to a carcinogen, mutagen or reprotoxic substance, or if the biological limit value for a substance is found to have been exceeded, the employer shall, on the basis of a decision by an occupational doctor, refer other workers who have been similarly exposed to undergo health surveillance. In that event, a further assessment of the risks in the working environment shall also be carried out.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(3) In cases determined by an occupational doctor, workers must also undergo health surveillance following the end of their exposure to a carcinogen, mutagen or reprotoxic substance.

[RT I, 02.04.2024, 13 – entry into force 5 April 2024]

(4) [Repealed – RT I, 17.10.2019, 1 – entry into force 17 January 2020]

(5) [Repealed – RT I, 17.10.2019, 1 – entry into force 17 January 2020]

[Omitted from this text.]