Legal Framework (incl. Occupational Safety)

Employers are responsible for protecting the safety and health of their employees during the handling of nanomaterials. Information, definitions and ordinances support businesses in implementing occupational safety and health (OSH).

Use in the workplace

In the field of OSH, the fundamental statutory rules place the responsibility for protecting workers' health on the employer (at the national level: Safety and Health at Work Act (ArbSchG) and Hazardous Substances Ordinance (GefStoffV); at the European level: Framework Directive 89/391/EEC on the safety and health of workers at work and 98/24/EC on health and safety from the risks related to chemical agents at work).
However, especially in small and medium-sized enterprises, deficits have been observed in the handling of chemicals. There are no special regulations in place that cover nanomaterials. The workplace risk assessment must take account of the special "nanoproperties". If not enough is known about these properties, the precautionary principle must be followed and the measures must be defined based on an assumed hazard in accordance with the lack of knowledge.

Further information can be found in the Technical Rule for Hazardous Substances 527 "Activities with nanomaterials" (TRGS 527) and in the "Guidelines for risk assessment of tasks involving nanomaterials at the workplace" by BAuA/VCI. In May 2015, the Committee on Hazardous Substances (AGS) adopted an assessment criterion (reference value) for granular biopersistent particles without known significant specific toxicity (nanoscaled GBP) (respirable dust) generated from manufactured ultrafine particles.

Placing on the market

As nanomaterials (in this context, especially nanoparticles, nanotubes, nanoplatelets, nanofilaments, etc., including their aggregates and agglomerates) usually have the same CAS number as larger objects made of the same base material, the nanoscale fraction was not specifically evaluated in the previous set of substance-specific, statutory regulations (Chemicals Act, Existing Substances Regulation) for the placing of substances on the market. In the past, there was no statutory, substance-specific obligation to conduct studies specifically in relation to nanomaterials. Fullerenes are one exception to this, as they are not an EINECS substance, have been assigned their own CAS number, and are subject to comprehensive testing requirements above a certain tonnage threshold. In April 2018, the REACH Regulatory Committee adopted the amendment to REACH Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) with regard to the uniform registration of nanomaterials. Above all, this amendment provides for adaptation of the information requirements for nanomaterials, which are regulated in the annexes to the regulation. Thus, under REACH, a binding and above all uniform regulation for nanomaterials will be made.

Regulation (EU) 2018/1881 of 03.12.2018 (OJ L 308, 04.12.2018, p. 1-20) has now adopted the amendments to Annexes I, III and VI to XII of REACH Regulation (EC) No 1907/2006. They apply from 1 January 2020.

Regulation (EU) 2020/878 of 18 June 2020 amending Annex II to REACH Regulation (EC) No. 1907/2006 introduces specific requirements for safety data sheets for substances with nanoforms. They apply from 1 January 2021. By way of derogation, safety data sheets not complying with the Annex to the Regulation (EU) 2020/878 may continue to be provided until 31 December 2022.

The EU Biocidal Products Regulation No 528/2012 governs the "placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product". Nanomaterials are included in the scope of this Regulation. If products contain nanomaterials, the environmental risks they pose must be considered separately and the products must be labelled accordingly.

Further Information

EU-Commission's Links