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General information, guides and resources about chemical substances and their risks.

Substances prohibited for pregnant and breastfeeding workers


What are they?


Substances prohibited for pregnant and breastfeeding workers are those included in the non-exhaustive list of agents and working conditions to which there may be no risk of exposure for pregnant workers or workers during the period of natural breastfeeding, established in Annexes VII and VIII of Royal Decree 39/1997, of 17 January, approving the Regulation on Prevention Services.


Protection applies when the risk assessment determines that exposure to certain agents or working conditions may endanger the safety or health of the pregnant worker, the foetus, the worker during the period of natural breastfeeding, or the breastfeeding child.



The list is non-exhaustive. Therefore, a substance that is not expressly included in it should not automatically be considered safe during pregnancy or breastfeeding. The risk assessment must take into account the nature, degree and duration of exposure and the characteristics of the job.

Protection of maternity is regulated mainly by Article 26 of Law 31/1995, of 8 November, on Occupational Risk Prevention.


What should be done?


When the risk assessment identifies a risk for a pregnant worker or a worker during the period of natural breastfeeding, the company must adopt the necessary measures to prevent exposure.


Action should be taken in the following order:


  1. Adapt the working conditions or working time to avoid the risk. Where necessary to ensure protection, the adaptation may include not performing night work or shift work.
  2. If adaptation is not possible or is insufficient, assign the worker to a different position or function compatible with their condition, in accordance with Article 26 of Law 31/1995.
  3. When changing the position is not technically or objectively possible, or cannot reasonably be required for justified reasons, the employment contract may be suspended due to risk during pregnancy for the period necessary to protect health or safety.


During natural breastfeeding, when there is a risk that may adversely affect the health of the worker or the breastfeeding child and it is not possible to eliminate the risk through adaptation or a change of position, the employment contract may likewise be suspended due to risk during natural breastfeeding, in accordance with the applicable legislation.


The assessment must take into account the specific characteristics of pregnancy or breastfeeding and the possible routes of exposure, including inhalation, skin contact or accidental ingestion where relevant.


Substances for which there may be no risk of exposure during pregnancy


Annex VIII, Part A, of Royal Decree 39/1997 establishes a non-exhaustive list of agents and working conditions for which there may be no risk of exposure for pregnant workers.

In relation to chemical agents, it includes:


  1. Substances labelled with the hazard statements H360, H360D, H360F, H360FD, H360Fd, H360Df and H370, in accordance with Regulation (EC) No 1272/2008 (the CLP Regulation).
  2. Carcinogenic and mutagenic substances in categories 1A and 1B included in Part 3 of Annex VI to the CLP Regulation.
  3. Lead and its derivatives, insofar as these agents are capable of being absorbed by the human body.


Annex VIII also includes certain physical and biological agents and certain working conditions. These include ionising radiation, certain work in high-pressure atmospheres, Toxoplasma, the rubella virus — unless there is adequate immunisation — and underground mining work.

The complete list can be consulted directly in the current text of Royal Decree 39/1997:


Substances for which there may be no risk of exposure during natural breastfeeding


Annex VIII, Part B, of Royal Decree 39/1997 establishes that there may be no risk of exposure to:


  1. Substances labelled with the hazard statement H362, in accordance with the CLP Regulation.
  2. Carcinogenic and mutagenic substances in categories 1A and 1B included in Part 3 of Annex VI to the CLP Regulation.
  3. Lead and its derivatives, insofar as these agents are capable of being absorbed by the human body.


Annex VIII also includes underground mining work as a working condition for which there may be no risk of exposure during natural breastfeeding.


What do the H360, H370 and H362 hazard statements mean?


The CLP Regulation uses specific hazard statements to communicate certain risks to reproduction and breastfeeding.

  1. H360: May damage fertility or the unborn child.
  2. H360D: May damage the unborn child.
  3. H360F: May damage fertility.
  4. H360FD, H360Fd and H360Df: Combine effects on fertility and/or fetal development.
  5. H370: Causes damage to organs.
  6. H362: May cause harm to breast-fed children.


The CLP classification of a substance must be checked against the current version of the CLP Regulation and its amendments, as classifications may change.

The official database of the European Chemicals Agency (ECHA) can be used to consult substances related to the protection of pregnant and breastfeeding workers. ECHA – Protection of Pregnant and Breastfeeding Workers: Annex I + II


Important: the list is non-exhaustive

The inclusion of a substance in Annex VII or VIII of Royal Decree 39/1997 establishes specific protection, but the absence of a substance from these lists does not mean that it can be considered safe.


Annex VII contains a non-exhaustive list of agents, procedures and working conditions that must be assessed because they may adversely affect the health of pregnant workers or workers during the period of natural breastfeeding, the foetus or the breastfeeding child.

Therefore, the risk assessment must also consider other chemical agents present in the workplace, even when they are not expressly included in Annex VIII.

Preventive measures must be established on the basis of an assessment of the actual exposure conditions, taking into account, among other factors, the route of exposure, the intensity and duration of exposure and the characteristics of the agent.


Protection against carcinogenic, mutagenic and reprotoxic substances


Protection during pregnancy and breastfeeding must be coordinated with the obligations established for occupational exposure to carcinogenic, mutagenic and reprotoxic agents.

The classification of substances under the CLP Regulation is a fundamental element for identifying hazards, but the preventive assessment should not be limited to consulting only the H-statements on the label.


In particular, substances and agents that may present risks due to the characteristics of occupational exposure must be considered, even when there is no classification that automatically determines their inclusion in Annex VIII.


Official reference guidelines and publications

I

NSST – Guidelines for risk assessment and protection of maternity at work. Guidelines for risk assessment and protection of maternity at work

These guidelines provide criteria for identifying and assessing risks to maternity at work and for guiding the selection of preventive measures.

They are a technical publication of the INSST, not a legal regulation. The INSST itself indicates that its guidelines and Technical Prevention Notes (NTPs) are recommendations or good practices, unless a current legal provision establishes their mandatory application.


INSST – NTP 992: Pregnancy and natural breastfeeding: procedure for risk prevention in companies

NTP 992: Pregnancy and natural breastfeeding: procedure for risk prevention in companies

This NTP proposes a procedure for managing risks during pregnancy and natural breastfeeding and can be used to support the organisation of preventive action within the company.


INSST – NTP 993: Pregnancy and natural breastfeeding: the company's role in the occupational risk benefit

NTP 993: Pregnancy and natural breastfeeding: the company's role in the occupational risk benefit

This NTP provides information on managing the benefit for risk during pregnancy and natural breastfeeding and on the company's action when the risk cannot be eliminated through adaptation or a change of position.


INSS – Guide to the Assessment of Occupational Risk during Pregnancy

The National Social Security Institute (INSS) maintains the 3rd edition of this guide, intended for the assessment of occupational risk during pregnancy.

It is particularly useful for complementing RISCTOX information on occupational risk assessment and the benefit for risk during pregnancy. It does not replace the preventive assessment that must be carried out by the company.

INSS – Guide to the Assessment of Occupational Risk during Pregnancy, 3rd edition

INSS – Birth and care of a child, risk during pregnancy and risk during natural breastfeeding: official publications


European Commission – Guidelines for the assessment of hazardous agents during pregnancy and breastfeeding

The European Commission published the Guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of pregnant workers, workers who have recently given birth or workers who are breastfeeding, pursuant to Article 3 of Directive 92/85/EEC.


European Union – Directive 92/85/EEC

Directive 92/85/EEC establishes the European framework for the protection of pregnant workers, workers who have recently given birth or workers who are breastfeeding, and contains non-exhaustive lists of agents, procedures and working conditions that must be taken into account for protection.

The consolidated version available on EUR-Lex should be consulted as a reference for the European framework.


Legislation


  1. Law 31/1995, of 8 November, on Occupational Risk Prevention, particularly Article 26, on protection of maternity.
  2. Royal Decree 39/1997, of 17 January, approving the Regulation on Prevention Services, particularly Annexes VII and VIII.
  3. Royal Decree 298/2009, of 6 March, amending Royal Decree 39/1997 in relation to the application of measures to promote improvements in the safety and health at work of pregnant workers, workers who have recently given birth or workers who are breastfeeding. The content introduced by this Royal Decree is currently incorporated into the current text of Royal Decree 39/1997.
  4. Regulation (EC) No 1272/2008 (CLP), on the classification, labelling and packaging of substances and mixtures, and its current amendments.
  5. Royal Decree 374/2001, of 6 April, on the protection of the health and safety of workers against risks related to chemical agents at work.
  6. Council Directive 92/85/EEC, on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers, workers who have recently given birth or workers who are breastfeeding.


Last updated: August 2026