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March 2, 2020

Germany Publishes English Translation of TRGS 527: Activities with Nanomaterials

Lynn L. Bergeson Carla N. Hutton

The Federal Institute for Occupational Safety and Health (BAuA) issues Technical Rules for Hazardous Substances (TRGS), which reflect the state of technology, occupational safety and health, and occupational hygiene, as well as other verified scientific knowledge relating to activities involving hazardous substances, including their classification and labeling.  BAuA has published an English translation of TRGS 527:  “Activities with nanomaterials.”  TRGS 527 contains rules for protection of employees at the workplace during activities with substances, mixtures, and products consisting of or containing nanomaterials.  It includes provisions on:

  • The scope of application;
  • Definition of terms;
  • Identification of risks;
  • Risk assessment;
  • Protective measures;
  • Effectiveness testing; and
  • Working instructions and provision of information to employees, documentation.

TRGS 527 defines nanomaterials to include nanoforms of substances registered under the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, as well as non-registered nanoforms according to Annex VI of Regulation (EC) No. 1907/2006, as amended by (EU) 2018/1881.  TRGS 527 notes that the European Commission (EC) does not distinguish between established and new materials.  It does not apply to:

  1. Natural nanomaterials if no activities are carried out with them;
  2. Nanomaterials created as a result of work processes (g., weld fumes, diesel particles) if they are not handled as products. For activities such as welding, cutting, and similar procedures involving metal materials, TRGS 528:  “Welding work” applies.  For activities in work areas in which diesel exhaust gases may occur, TRGS 554:  “Exhausts of diesel engines” applies; and
  3. TRGS 527 amends the rules for hazardous substances regarding the risks caused by nanomaterials and in particular TRGS 400: “Risk assessment for activities involving hazardous substances.”

TRGSs specify, within their scope of application, the requirements of the German Hazardous Substances Ordinance.  If an employer complies with TRGSs, that employer may assume that the relevant requirements of the Ordinance have been met.  If the employer chooses a different solution, that solution must achieve at least the same level of safety and health protection for employees.  BAuA notes that the English translation is an unofficial version.  Only the original German text has legal effect.