Nanomaterials

Risks and characteristics of nanomaterials

• Size and behavior. Nanoparticles remain suspended in the air for a long time, are deposited in the alveolar region, and can translocate to the blood, nervous system, and other organs.
• Reactivity and surface area. The high specific surface area increases reactivity and toxicity per unit mass, so mass concentration does not accurately describe the risk.
• Shape and solubility. Long, biopersistent fibers (some carbon nanotubes) and insoluble materials raise greater concerns; aggregation and coating modify behavior.
• Toxicological uncertainty. Information is incomplete for many nanomaterials, and safety data sheets do not always describe nanoforms, requiring the application of the precautionary principle.
• Absence of specific limit values. There are no occupational exposure limits for most nanomaterials, and measurements require special instrumentation and strategies (particle number, surface area, microscopy).
• Safety risks. Some metallic and carbon nanopowders present a higher risk of fire and explosion, and nanoparticles can act as catalysts.

Applicable regulatory framework

Law 31/1995 mandates the assessment of risks from all agents present in the workplace, and Royal Decree 374/2001 applies the following to nanomaterials as chemical agents: hazard identification, exposure assessment, hierarchy of measures (substitution, closed systems, extraction, organization, personal protective equipment), information and training, and health surveillance. When the nanomaterial or its base substance is classified as a Category 1A or 1B carcinogen or mutagen, the enhanced regime of Royal Decree 665/1997 applies, requiring the reduction of exposure to the minimum technically possible, registration of exposed persons, and long-term health surveillance.

Within the European Union, the REACH Regulation, since January 1, 2020, following the amendment of its annexes by Regulation (EU) 2018/1881, requires registrants to characterize the nanoforms of substances and provide specific information on their properties and hazards, thus progressively improving the content of safety data sheets. The 2022 Commission Recommendation updates the definition of nanomaterial for use in legislation, and the CLP Regulation governs classification and labelling. The INSST (National Institute for Safety and Health at Work) offers NTP 1172 on preventive measures, NTP 877 on risk assessment using simplified methodologies (control banding), and a thematic portal with documentation and frequently asked questions.

Recommended preventive measures

• Planning. Consult the safety data sheets and supplier information on nanoforms, specific procedures for each task, and delimited work areas, if possible under negative pressure.
• Avoid dispersion. Preference for liquid suspensions over powders, closed systems, minimal transfer distances, and avoid aerosolization.
• Technical controls. Localized extraction with booths and cabinets, high-efficiency filtration (HEPA) in the extracted air and in the cleaning, and adequate general ventilation.
• Organizational measures. Reduction of the number of people and exposure time, restricted access, registration of exposures and signage.
• Personal protection. Respiratory protection with high-efficiency particle filters, chemical-resistant gloves, eye protection and particle-protective clothing, with procedures for donning and doffing.
• Cleaning and waste. Wet cleaning or cleaning with HEPA filter vacuums, prohibition of sweeping and compressed air, and management of waste as hazardous.
• Health surveillance. Monitoring of respiratory function and other parameters according to the nanomaterial, with recording of exposure.

Organizational application: how to manage nanomaterials

1. Inventory the nanomaterials present (raw materials, intermediate products, waste), collect information from suppliers and safety data sheets on nanoforms, and classify the processes by release potential.
2. Evaluate the risk per task using simplified control band methodologies (NTP 877) and, where possible, with specific concentration measurements by number and surface area carried out by competent personnel.
3. Apply the hierarchy of measures: substitution or use of less dispersible forms (suspensions, granules), closed systems, localized extraction with HEPA filtration and work organization.
4. Define individual protection for each task, wet cleaning procedures and waste management, and delimit and mark the areas.
5. Inform and train exposed persons, record exposures and, when the nanomaterial is carcinogenic or mutagenic, apply the regime of Royal Decree 665/1997.
6. Establish specific health surveillance and retain exposure records for the required periods.
7. Review the assessment with the new toxicological information, process changes and the updated regulations and INSST guidelines.

Preventive management software allows maintaining the inventory of nanomaterials and their data sheets, linking them to the evaluated positions and tasks, recording exposures and measurements, managing personal protection, training and health surveillance, and preserving the traceability required by the precautionary principle in the face of a risk with evolving evidence.

Limits and common mistakes

1. Treat nanomaterials like the conventional material of the same name and apply their mass limit values ​​without considering size and reactivity.
2. Relying on safety data sheets that do not describe nanoforms or their specific hazards.
3. Handle nanopowders in the open, clean with sweeping or compressed air, and manage waste as conventionally.
4. Use respiratory protection without high-efficiency filters or proper fit, or as the sole measure instead of closed systems and extraction.
5. Failure to record exposures or establish health surveillance due to the absence of specific limit values.
6. Forgetting the fire and explosion risks of certain nanopowders.

Scientific evidence on nanomaterials is evolving; this fact sheet is for informational purposes and should be supplemented with specific information for each material.

Regulatory and reference framework

• Royal Decree 374/2001, of April 6. Protection against risks related to chemical agents during work.
• Royal Decree 665/1997, of May 12. Protection against exposure to carcinogenic agents during work.
• Regulation (EC) 1907/2006 (REACH) . Registration, evaluation, authorization and restriction of chemicals.
• Regulation (EU) 2018/1881 . Amends the annexes to the REACH Regulation to include nanoforms of substances.
• NTP 1172. Nanomaterials: preventive measures . Technical, organizational and protective measures against nanomaterials.
• NTP 877. Risk assessment for exposure to nanoparticles using simplified methodologies . Control band methods for nanomaterials.
• INSST. Nanomaterials . Thematic portal with documentation and frequently asked questions.

The definition of nanomaterial is set out in the European Commission Recommendation of 2022 on the definition of nanomaterial, which updates the 2011 one cited in the Prevention Technical Notes.