Chemicals & Raw Materials

NIA Service for Chemicals and raw MaterialsThe annual quantity of raw nanoscale materials is estimated to be around 11.5 million tonnes, where carbon black and amorphous silica accounts for about 9.6 million tonnes (85 %) and 1.5 million tonnes (12 %) respectiely. The remaining 3 % are nanomaterials made from e.g. aluminium oxide, barium titanate, titanium dioxide, cerium oxide and zinc oxide. Carbon nanotubes, graphene and fullerenes have annual production amounts in the hundred tonnes range. Nanosilver is estimated to be produced in about 20 tonnes per year.  

The EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals – REACH (Regulation (EC) No. 1907/2006) is the European integrated approach for managing chemicals. Under REACH, industry is responsible for both assessing and managing the risks posed by chemicals, and for providing appropriate safety information to users.

Nanomaterials are classified as chemical substances under REACH. Therefore manufacturers, importers and downstream users of nanomaterials have to comply with the REACH requirements.


Support for NIA Members:

NIA has a number of activities in relation to Chemicals and Raw materials. For more information go to NIA Support in Chemicals and Raw Materials or to the NIA REACH-nano Representation

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News & Alerts

US FDA publishes Draft Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials

The United States Federal Drug Administration has published a draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials on 18 December 2017.

This Guidance for Industry outlines potential risk factors for drugs containing nanomaterials. It also provides recommendations on quality aspects, environmental impact as well as guidance for both non-clinical and clinical testing.

The document is now open for public comments for a period of 90 days, closing on 19 March 2018.

Sweden requires registration of nanomaterials

The Swedish Chemical Agency (KEMI) today published their rules requiring companies to register information about nanomaterials to the Swedish Products Register.

The rules enter into force on 1 January 2018, and consequently, information will need to be provided to the Products Register by February 2019, for products on the Swedish market in 2018.

KEMI claims the reason for requiring registration is to collect information about nanomaterials on the Swedish market.

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