Harmful effect of reprotoxic substances on sexual function and fertility in adult males and females, as well as on the development of their offspring resulted in adopting in 9 March 2022 the Directive (EU) 2022/431 of the European Parliament and of the Council amending the Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. More than two years later, on 29 June 2024, the regulations of the Directive 2022/431 were implemented in the Polish law. The current classification of chemical substances which imposes on the employers the obligation to undertake protective measures includes carcinogenic, mutagenic, and reprotoxic substances – called CMR substances. 

The amendment of the Labour Code gave rise to the issuing of the new Regulation of the Minister of Health of 26 July 2024 on chemical substances, their mixtures, factors and technological processes with carcinogenic, mutagenic or reprotoxic effect in the working environment. A reprotoxic substance has been defined as a chemical substance or a mixture of substances which meets the criteria for classification as toxic for reproduction category 1A (it is known to have produced an adverse effect on reproduction) or 1B (it is presumed to produce an adverse effect on reproduction). Harmful effect on reproduction means that as a result of exposure adverse effect occurs on:

• reproductive functions and fertility, including among other things, changes in reproductive system of adult males and females, the onset of puberty, production and transport of gametes, normal sexual cycle, sexual behaviour, pregnancy and labour, premature ageing of the sexual system or changes in other functions depending on the normal functioning of the reproductive system;
• development of offspring, including among other things, disrupting normal foetal  development in the period of prenatal development or a child from the birth until reaching sexual maturity, including functional disorders, structural defects, or even death of the developing foetus.

Also reprotoxic substances have been classified as those for which no safe level of exposure of employees’ health exists (non-threshold reprotoxic substance) and those for which a safe level of exposure exists (threshold reprotoxic substance).

Measurements and limiting exposure
Employing workers for work the performance of which necessitates exposure to reprotoxic substances imposes on obligation on the employer to perform measurements of these substances in order to determine the level of their concentration.

Preventing the exposure of employees to reprotoxic substances involves mainly replacing them with safe substances or substances less hazardous for the health or safety of an employee. If it is not possible, a reprotoxic substance should be manufactured and used, if technically possible, in a closed system. If for technical reasons the substitution and a closed system are not possible, the employer is entitled to introduce preventive measures limiting the exposure to reprotoxic substances remaining in the working environment and:

• to decrease the employees’ exposure to the lowest technically possible level – in case of a non-threshold reprotoxic substance,
• to ensure limiting to a minimum the risk related to exposure of employees – in case of a threshold reprotoxic substance.

The employer’s measures should always take into consideration current developments in science and technology in the area of its activities, i.e. the use of the latest scientific and technical solutions to the extent allowed by the conditions (including economic conditions) in which the employer operates. Failing to modernise the technological process in spite of having economic means to do so may result in the liability for violation of employees’ rights.

Organisational and registration obligations of an employer
In case of using reprotoxic substances the employer is obliged to:

1. limit the amount of a reprotoxic substance in the workplace,
2. maintain the lowest possible number of employees who are or may be exposed to reprotoxic  substances,
3. design work processes and technical control measures in such a way as to avoid producing reprotoxic substances in the workplace or limit their production to a minimum,
4. remove reprotoxic substances in the place of their origination, to a local fume hood  or a general ventilation system, in an appropriate manner and in accordance with the requirements of health and environmental protection,
5. use appropriate work methods and procedures, including the use of existing procedures of examinations and measurements of reprotoxic substances for an early detection of the risk arising as a result of an unpredictable event or accident,
6. use means of collective protection or – wherever exposure to reprotoxic substances cannot be avoided using other means – personal protective equipment,
7. use hygiene measures, in particular regular cleaning of floors, walls and other surfaces,
8. demarcate areas at risk and use appropriate warning signs, including “no smoking” signs, in places where employees are or may be exposed to reprotoxic substances,
9. establish an action plan for emergencies which may arise from excessive exposure to reprotoxic substances,
10. apply methods of safe storage, handling and transport, in particular by using sealed and clearly and visibly marked containers,
11. apply methods of safe collecting, storage and disposal of waste, including using sealed and clearly and visibly marked containers.

Work in contact with reprotoxic substances must be registered on an on-going basis, as must employees performing such work. Information from the register of work, the performance of which results in the need to remain in contact with reprotoxic substances is forwarded to a relevant state province sanitary inspector and relevant district labour inspector immediately following the commencement of activities and annually, by 15 January for the prior year or at their request. Due to the possible consequences which may become evident many years after the exposure, the period of retaining records is 40 years after the cessation of exposure.

Employers’ obligations to employees and their representatives
The employer also has a number of obligations towards workers employed in exposed conditions. These include:

1. informing about packaging, container and installation containing reprotoxic substances, and about the requirements concerning the labelling and warning signs which should be clear and visible;
2. carrying out periodic training in the area of:
   • health risks that result from the assessment of exposure to reprotoxic substances and additional risk that results from smoking and on the precautions which should be taken in order to reduce this exposure,
   • hygiene requirements to be met in order to reduce the exposure to reprotoxic substances, including no consumption of food and drink in a place where there is a risk of contamination with reprotoxins,
   • the need to use personal protective equipment, including protective clothing, and to leave a separate place for the separate storage of daily and protective clothing,
   • accident prevention measures and actions which should be taken by the employees, including employees on rescue duty, during rescue operations and accidents,
3. providing health checks related to individual employee assessment – in order to determine the state of employee’s health in relation to exposure to reprotoxic substances during work,
4. informing, before entrusting work with reprotoxic substance in case of which the value of concentration limit has been established for certain substances in biological material, of the need to carry out health checks related to these limit values.

It is essential that the training is updated on an ongoing basis as soon as the working conditions change or the regulations concerning individual reprotoxic substances are amended.

Employee representatives, like in case of all activities related to occupational health and safety, should be involved in designing and performance of activities preventing the exposure to reprotoxic substances or limiting this exposure, in particular by participation in consultations on the application of requirements set out in EU and national regulations. The employer is obliged to enable them to monitor the application of the requirements set out in specific regulations and inform them on an ongoing basis about exposure to reprotoxic substances, and in case of exposure resulting from breakdowns and other disturbances in the technological process or as a result of repair and maintenance works and in other circumstances – on reasons for exposure which has arisen and on preventative measures which have been or will be taken in order to remedy the situation.

The consequences of the amendment
The amendment of the Labour Code imposed on the employers using reprotoxic substances a number of obligations, both towards the inspection authorities and employees and their representatives. Employers should remember about them not only because of penalisation of neglecting some actions, which is an offence against employee rights, but also due to a serious social problem related to the harmful effects of reprotoxic substances.

As announced by the State Labour Inspectorate and the State Sanitary Inspectorate, one of the key priorities to be taken into account when performing inspection and supervision tasks in 2025, will be evaluation of risks related to reprotoxic substances.
 

Find more in the PRO HR Year Book 2024.