Regulations

 

Manufactured nanomaterials were originally covered through existing regulations, before the European Commission agreed a recommended definition on manufactured nanomaterials in 2011 to be used in regulation. In this recommendation a nanomaterial is a material where 50% of the particles by number have a minimum size between 1 and 100 nm. Some materials, such as carbon-based nanomaterials, fullerene, graphene, and single-walled carbon nanotubes are by definition nanomaterials even-though their smallest diameters maybe smaller than 1 nm and lengths (graphene and single-walled carbon nanotubes). You can see more here.

With the proposed EC definition, and as consensus developed on nanomaterials being materials that cannot automatically be assumed to be classified and risk assessed based on chemical composition alone, regulations started to be adapted to ensure that risk assessment covered any additional questions on product safety, with both sector-use and cross-sector chemicals regulations starting to change. Below are some examples of European regulations covering nanomaterials:

Chemicals and mixtures
The EU chemical Regulation, REACH and CLP, now includes a definition of nanoforms (alias manufactured nanomaterials), where nanospecific information requirements and risk assessment is required (REACH and CLP; EC (EU) 2018/1881). Introduction to REACH and CLP and information requirements can be found in this eTool (http://ereach.dhigroup.com/). There are also specific provisions for nanomaterials in sector-specific legislation such as biocides. The intention with REACH and CLP is that all products placed on the EU market should have “no chemical hazard” for the user.

Food and Food-packaging
Regulations associated with food production have a number of nano-specific references now, including food additives (EC) No 1333/2008 , Active and intelligent food contact materials (EC) No 450/2009 provision of food information to consumers (EC) No 1169/2011 , novel foods (EC) 2015/2283, plastic materials and articles for food contact (EC) No 10/2011 and finally, regulation for organic production (EC) 2018/848.

Cosmetics
Within personal care, nanomaterials within cosmetics products are covered, pre-dating the EC definition with a cosmetics-specific definition, within (EC) No 1223/2009 . Medical devices regulation (EC) 2017/745 also now reflects the use of nanomaterials, based on the EC 2011 definition.

Responsibilities of producers and users
As with all products, producers and users of nanomaterials have to comply with the regulations and other market access frameworks that define safety and performance. Employee safety is of critical significance with novel nanomaterials and common good practice is zero exposure systems or materials handled within liquids or solid matrices, to avoid potential exposure via inhalation. As nanomaterials knowledge advances, greater management of materials at the recycling and disposal stages of the life cycle can be planned during early product development.

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