New obligations for companies with workers exposed to carcinogens: what changes in 2026

Key data

If your company works with chemical substances, solvents, industrial powders, biological agents or any compound that may affect reproductive health or cause cancer, this directive requires you to act. The Directive (EU) 2026/2450, published on 30 October 2026, amends Directive 2004/37/CE and raises the protection standard across the European Union. It is not a minor update: it expands the catalogue of regulated agents and sets stricter exposure limits than the current ones.

Spain must transpose this directive into national occupational risk prevention legislation, which will result in direct changes to the legislation applicable to Spanish companies. The transposition deadline has not been specified in the publication, but the obligation to adapt is immediate in terms of internal planning.

What does this regulation establish?

Directive 2026/2450 introduces three types of changes to the currently applicable Directive 2004/37/CE:

The key concept introduced by this directive is the category of reprotoxic agents: substances that affect fertility or fetal development. Until now, the base directive focused mainly on carcinogens and mutagens. The expansion to reprotoxics means that many companies that believed they were outside the scope of application are now included.

Occupational exposure limit values (OELVs) are the maximum concentrations of a substance in the air of the workplace to which a worker can be exposed without risk to their health. The directive sets new, lower OELVs for various substances, which requires reviewing whether current working conditions remain compliant.

Economic and operational impact

The economic impact of this directive materializes in four areas of expenditure that companies must anticipate:

• Update of risk assessments: Complete review of workplaces where substances now regulated or with new OELVs are handled or generated. This involves environmental measurements, technical reports and, in many cases, contracting specialized prevention services.
• Technical control measures: Installation or improvement of ventilation systems, local extraction, process encapsulation or substitution of substances with less hazardous alternatives. These are the highest cost investments.
• Personal protective equipment (PPE): Update of PPE provided to workers to adapt to new requirements, including training in correct use.
• Documentary and training management: Update of internal procedures, safety data sheets, exposure records and specific training for affected workers.

The economic risk from non-compliance is twofold: administrative penalties arising from occupational risk prevention regulations and civil or criminal liability for occupational diseases diagnosed in exposed workers. Diseases related to carcinogens have long latency periods, which does not reduce retroactive corporate liability.

Who does it affect?

The directive affects any company that has workers exposed to carcinogenic, mutagenic or reprotoxic agents during their work activity. The sectors with the greatest identified impact in the regulation are:

• Chemical industry: Manufacturing, handling and storage of hazardous chemical compounds.
• Construction: Exposure to silica dust, residual asbestos, paints and solvents.
• Healthcare: Personnel exposed to cytostatic drugs, sterilization agents and laboratory products.
• Agriculture: Use of pesticides, herbicides and other phytosanitary products with reprotoxic or carcinogenic properties.
• Manufacturing: Welding processes, metal treatment, printing and surface finishing.

Companies in sectors such as hairdressing and aesthetics (dyes and chemical products), laboratories, pharmaceutical industry, waste management and industrial cleaning may also be affected.

Practical example

A medium-sized construction company with 35 workers regularly performs demolition and renovation work on buildings prior to 1980, with frequent exposure to silica dust and possible presence of asbestos-containing materials. Until now, its risk assessment considered the OELVs in force under Directive 2004/37/CE.

With the entry into force of Directive 2026/2450, this company must:

1. Review whether the substances to which its workers are exposed are listed in the new expanded list of regulated agents.
2. Check whether the new stricter OELVs mean that current concentrations at its sites exceed permitted limits.
3. If the new limits are exceeded, implement additional technical measures: extraction systems, dust dampening, closed work cabins.
4. Update the PPE of its workers and document the training received.
5. Record the entire process to demonstrate compliance in the event of a labor inspection.

The same scheme applies to a hospital laboratory with personnel exposed to cytostatics, or a chemical company that manufactures solvents with reprotoxic properties.

What should companies do now?

1. Identify the substances used in your company and cross-reference them with the new expanded list of carcinogenic, mutagenic and reprotoxic agents in Directive 2026/2450. If you don't have this inventory updated, this is the first step.
2. Review existing risk assessments for workplaces with exposure to these substances. Check whether the new stricter OELVs mean you need to take additional measures.
3. Plan the technical control measures necessary to ensure that worker exposure does not exceed the new limits. Prioritize substituting the hazardous substance with a less harmful alternative when viable.
4. Update personal protective equipment provided to affected workers and ensure they are trained in correct use.
5. Update preventive documentation: work procedures, safety data sheets, exposure records and emergency plans.
6. Follow the transposition process in Spain to learn the exact adaptation deadlines and specific requirements established by national legislation. When the transposition is published, you must verify whether it introduces additional obligations.
7. Consult with your external or internal prevention service to assess the specific impact on your company and help you prioritize necessary investments.

Non-compliance with occupational risk prevention regulations can result in administrative penalties and direct corporate liability for occupational diseases of exposed workers, even years after exposure occurs.

Official source

Consult complete regulation at official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202602450