Nanomaterials: Industrial Policy and Legislation

Otto LinherDG Enterprise and IndustryEESC, 9 September 2015

European Commission

•„Nanomaterial“means a […] material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm

Nanomaterials are not necessarily new and innovative

Not all innovative nanotechnology contains nanomaterials.

Nanomaterials – Myths and Reality

•Nanomaterial properties are not as unknown as often reported

• 20 years of focused research is not without results

• Nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not: the dosis is decisive

Nanomaterials – Myths and Reality

•Global market (excluding pigments) annually around 11 million tonnes (market value around 20 bn €)

French nanomaterial registry: around 500000 tonnes for France

•Global market value of products containing nanomaterials around 2 trillion €

•Direct number of jobs in the EU in the area of nanotechnology around 300 000 to 400 000

Nanomaterials on the Market

Market for Selected NanomaterialsNanomaterial Second Regulatory

Review (global, t/a)Nano registry

France (t/a)

Carbon black 9 600 000 270 000

Synthetic amorphous silica 1 500 000 150 000

Aluminium oxide 200 000 2000

Yellow pigment/iron oxide … 540

Titanium dioxide 10 000 15 000

Cerium oxide 10 000 110

Zink oxide 8 000 290

Carbon nanotubes and nanofibres Several hundreds to thousands

unclear

Nanosilver 20 0,0001-0,001

Food additives (Anticoagulants)

Fillers (e.g. paper, plastics, tyres)

UV-filters in sun creams

Antibacterial applications

Paints, varnishes, adhesives

Catalysts

Batteries, solar cells

Medicine, medical devices, tumour therapies

Nanoelectronics (mostly nanostructured materials, and not nanomaterials)

Examples of Applications of Nanomaterials and Nanotechnology

• Nanotechnology is one of 6 Key Enabling Technologies for innovation

• Example for high-tech material: Graphene

integrated circuits, transistors, transparent conductive electrodes

solar cells, energy storage, gas sensors

medicine

ethanol destillation

• Nanoelectronics

Role of Nanomaterials/Nanotechnology in Industrial Policy

Legislation on Nanomaterials: Overview• Horizontal themes/legislation

• Nanomaterial definition• REACH• Worker Protection• Discussion on possible transparency measures

• Product specific legislation with explicit provisions on nanomaterials• Cosmetics• Food safety• Biocides

• Other instruments with relevance for nanomaterials• Electrical and electronic equipment, environmental legislation,

(Waste, eco-label etc.),• Medical products• Plant protection products

• Get to terms with the discrepancy between public discussion and economic reality of nanomaterials and nanotechnology

• Fair and proportionate treatment of nanomaterials in terms of safety regulation, taking into account existing knowledge on:

• hazards and risks of nanomaterials

• likelihood and seriousness of potential incidents.

Nanomaterial legislation: Perspectives

• Key instruments :

• Adapting REACH Annexes in a cost-efficient way, i.e.:

• requiring clarity of REACH dossiers and additional information where it is needed

• taking into account the cost of generating new information

• Finding the right instrument to increase transparency on nanomaterials on the market, which :

• Is cost-efficient in terms of developing key information at a low administrative burden to authorities and companies

• Can contribute to a better understanding and prioritisation of nanomaterial safety issues at regulatory and risk assessment level

• Is accessible and understandable for consumers and workers

Nanomaterial legislation: Perspectives

• If any, which nanomaterials are particularly toxic due to their particle size (as opposed to chemical identity)? – "Drivers of toxicity"

• Risk assessment of examples of nanomaterials – substance evaluation under REACH

• Is there indeed bioaccumulation in realistic exposure scenarios? – Epidemiological studies on workers

• Improving REACH-dossiers and Safety Data Sheets

• Better risk assessment for ultrafine particles in air

Where else are information gaps?

Thank you for your attention!