German agencies attempt to tackle nanomaterials in EU regulation

The Federal Institute for Occupational Safety and Health (BAuA), the Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA) developed the idea for amending the Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) regulation at the suggestion of the country's Federal Environment Ministry.

The agencies said there is a need for better identification and assessment of potential hazards arising from nanomaterials in the future.

They proposed introducing reduced registration requirements for nanomaterials from 100 kg/a with details of the substance identity and a characterisation of the different nanoforms, and uses.

The proposal plans for the rapid developments in nanotechnology, to ensure the precautionary principle will be guaranteed, and to accomodate future insights into possible detrimental effects on humans and the environment, said the group.

Nanoscale form​

If nanoscale forms of a chemical substance exist, they should be registered together with the chemically identical bulk material, they added.

The most important parameters which distinguish nanoforms of substances from the bulk form are morphological properties, water solubility and surface characteristics.

The REACH regulation already covers nanomaterials as chemical substances.

“However, the information that must be provided by the manufacturer or importer as part of the registration process does not address specific additional features of nanomaterials, fibres and powders,“ ​they wrote in the proposal​.

Current methods​

The current required characterisation of substances is insufficient for cases where biopersistent particles or fibres are released, they said.  

“Biopersistent dusts and fibres inhaled at the workplace can, in the long run, lead to chronic diseases of the respiratory tract.​

“Nanomaterials have an enlarged surface and can  exhibit modified chemical and physical properties when compared to conventional (bulk) chemicals.“ ​

Yesterday, a US not-for-profit group released a paper urging industry transparency on nanomaterials and pledged to test products to see if they were in food.

In October, the European Commission said it regards REACH as suitable to regulate nanomaterials.

However, the Commission suggested amendments to the annexes and further explanations for manufacturers and importers of nanomaterials.

The recommendation is to be reviewed by December 2014 to establish whether it should be modified in the light of experience accumulated and scientific and technical development.