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Reproductive Toxicants – List, Regulations and New Requirements: Everything You Need to Know!

ByAgnieszka Kuźmicka

Reproductive toxicity refers to a hazard associated with adverse effects on human reproduction. Substances classified as reproductive toxicants (reprotoxicants) are defined as follows:  

“Toxic to reproduction means adverse effects on sexual function and fertility in adult men and women, as well as developmental toxicity in the offspring, resulting from exposure to a substance or mixture.” 

Given the seriousness of the risks arising from exposure to reproductive toxicants, a systematic approach to their monitoring and control is essential. As with carcinogens and mutagens, reproductive toxicants raise particular concern due to the severe and irreversible health effects they can cause.

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New Regulations 

On 24 July 2024, the Polish Minister of Health published a regulation amending the regulation on testing and measurement of factors harmful to health in the work environment (Dz.U. 2024, item 1110 – Polish Journal of Laws). Under Article 3 of this regulation, it entered into force on 28 July 2024. On 26 July, the Journal of Laws (Dz.U.) also published a regulation of the Minister of Health on chemical substances, their mixtures, factors or technological processes with carcinogenic, mutagenic or reprotoxic effects in the work environment (Dz.U. 2024, item 1126). 

The provisions of the new regulations are intended to implement Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. 

What Is Changing? 

The new regulations extend the scope of mandatory testing and measurement of harmful workplace factors to include reproductive toxicants. Until now, this scope covered only carcinogenic and mutagenic substances. 

Under Article 2 of the new regulation, employers are required to ensure that testing and measurement of reproductive toxicants is carried out within one month of the regulation’s entry into force. 

Definitions – Directive (EU) 2022/431 of the European Parliament and of the Council and Regulation (EC) 1272/2008 (CLP) 

EU legislation provides the following definitions for reproductive toxicants: 

  • reproductive toxicant (reprotoxic substance) – means a substance or mixture that meets the classification criteria for reproductive oxicity, category 1A or 1B, as set out in Annex I to Regulation (EC) No 1272/2008; 
  • non-threshold reproductive toxicant – means a reproductive toxicant for which no safe level of exposure for workers’ health can be established; 
  • threshold reproductive toxicant – means a reproductive toxicant for which a safe exposure level exists, below which there is no risk to workers’ health. 

Under Regulation (EC) 1272/2008 (CLP), reproductive toxicants are further divided into: 

  • Category 1 (Repr. 1A and Repr. 1B) – substances known to cause, or presumed to cause, harm to human reproduction; 
  • Category 2 (Repr. 2) – substances suspected of causing harm to human reproduction; 
  • Category LACT (Lact.) – substances affecting lactation or causing harm to breastfed children. 

And the corresponding hazard (H) statements: 

  • H360 – May damage fertility or the unborn child   
  • H360F – May damage fertility. 
  • H360D – May damage the unborn child. 
  • H360FD – May damage fertility. May damage the unborn child. 
  • H360Fd – May damage fertility. Suspected of damaging the unborn child. 
  • H360Df – May damage the unborn child. Suspected of damaging fertility. 
  • H361 – Suspected of damaging fertility or the unborn child. 
  • H361f – Suspected of damaging fertility. 
  • H361d – Suspected of damaging the unborn child. 
  • H361fd – Suspected of damaging fertility. Suspected of damaging the unborn child. 
  • H362 – May cause harm to breast-fed children. 

It is therefore worth carefully reviewing which substances are used in your workplace and paying attention to the presence of reproductive toxicants, so as to respond in time and ensure both employee safety and compliance with applicable regulations. It should also be remembered that these provisions will also apply to mixtures which, due to the presence of reproductive toxicants, are classified as reprotoxic category 1A or 1B. 

Employer Obligations 

As noted above, young workers, as well as pregnant and breastfeeding women, are most at risk from exposure to reproductive toxicants. This is reflected in the law, as these two groups of workers are prohibited from working under exposure to reprotoxic substances or mixtures: 

  • Regulation of the Council of Ministers of 3 April 2017 on the list of arduous, dangerous or harmful work for pregnant and breastfeeding women (Dz.U. 2017, item 796) 
  • Regulation of the Council of Ministers of 19 June 2023 on the list of work prohibited for young workers and the conditions for their employment in certain such work (Dz.U. 2023, item 1240) 

As for the additional tasks imposed on employers in connection with the use of reproductive toxicants, the regulation specifies a number of obligations. Employers are therefore required to: 

  • limit the quantity of reproductive toxicants present in the workplace;  
  • keep the number of workers who are or may be exposed to reproductive toxicants as low as possible;  
  • design work processes and technical control measures to avoid the generation of reproductive toxicants in the workplace, or to reduce it to a minimum;  
  • remove reproductive toxicants at the point of generation, to a local exhaust system or general ventilation, in a proper manner and in accordance with health and environmental protection requirements; 
  • apply appropriate work methods and procedures, including the use of existing testing and measurement procedures for reproductive toxicants set out in regulations issued under Article 227 § 2 of the Labour Code, in order to detect excessive risk arising from an unforeseen event or accident at an early stage;  
  • use collective protection measures or – where exposure to reproductive toxicants cannot be avoided by other means – personal protective equipment;  
  • apply hygiene measures, in particular regular cleaning of floors, walls and other surfaces;  
  • demarcate hazardous areas and use appropriate warning signs, including “no smoking” signs, in places where workers are or may be exposed to reproductive toxicants; 
  • define an emergency action plan for incidents that may result from excessive exposure to reproductive toxicants;  
  • apply safe methods of storage, handling and transport, in particular through the use of tightly sealed containers, clearly and visibly labelled;  
  • apply safe methods of collecting, storing and disposing of waste, including the use of tightly sealed containers, clearly and visibly labelled. 

Register of Work and Workers 

Employers should also maintain a register of work whose performance requires contact with chemical substances, their mixtures, factors or technological processes with reprotoxic effects. The regulation specifies detailed requirements for this register. 

In addition, employers are required to maintain a register of employees engaged in the work referred to above. This register should include: 

  • the date of entry in the register;  
  • the employee’s first and last name and job position; 
  • the PESEL number (Polish national identification number), or, if unavailable, the number of an identity document. 

The register concerning reproductive toxicants that are not also carcinogens or mutagens must be kept for 5 years after exposure has ended. 

List of Reproductive Toxicants 

Since the regulation refers to the definition set out in the CLP regulation in order to determine what constitutes a reproductive toxicant, it unfortunately does not provide a specific list of reprotoxic substances. Employers must therefore assess the substances present at their workplace based on this definition. Safety Data Sheets (SDS) for chemical substances and mixtures will certainly prove useful here. 

The list below can serve as general guidance, although it is neither closed nor exhaustive (it is also worth checking Annex VI to the CLP Regulation): 

  • metals and/or certain metal compounds: chromium, nickel, cadmium, cobalt, gallium (gallium arsenide), lead, tin (organic compounds), mercury and methylmercury, tellurium and tellurium oxide; 
  • boron compounds (diboron trioxide, boric acid, borates) and sodium perborate (+hydrates); 
  • carbon disulphide; 
  • carbon monoxide; 
  • phthalates; 
  • formamide and its N-methyl derivatives (N-methylformamide) 
  • dimethylformamide; 
  • certain pesticides and biocides; 
  • organic solvents, e.g.  toluene, n-hexane, 2-methoxyethanol and 2-ethoxyethanol, and their acetates; 
  • imidazole and certain of its derivatives (1-vinylimidazole, 2-methylimidazole, 4-methylimidazole); 
  • phenolphthalein; 
  • certain acrylates and methacrylates; 
  • N-methylpyrrolidone and N-ethylpyrrolidone. 

A look at the C&L Inventory maintained by the European Chemicals Agency (ECHA) shows that at least several hundred substances are classified as reproductive toxicants. However, a precise assessment should always be carried out by reviewing the substances used at the workplace and having them thoroughly evaluated by a specialist.