The Second Regulatory Review on Nanomaterials

Otto Linher DG Enterprise and Industry Enterprise Policy Group SG REACH 30 November 2012

European Commission

•Global market evaluated at around 11 million tonnes (roughly 20 bn €)

• Products underpinned by nanotechnology: 2 trn € by 2015 (including total value of products containing nm)

• direct employment in nanotechnology 300 000 to 400 000 jobs (figures from KETs report)

Takes into account commonly known nanomaterials (i.e. those known to have a particle size between 1-100 nm)

All figures to be taken with caution but rough dimension is correct

Nanomaterials on the market

Global market size – selected nanomaterials

Carbon black 9 600 000

Synthetic amorphous silica 1 500 000

Aluminium oxide 200 000

Barium titanate 15 000

Titanium dioxide 10 000

Cerium oxide 10 000

Zinc oxide 8 000

Carbon nanotubes and nanofibres Hundreds or a few thousand

Nanosilver 20

• Three main types

Commodity materials (e.g. carbon black or synthetic amorphous silica) – more than 95% of market, used for decades, including in high exposure situations

Newly developed medium volume substances (e.g. nano-TiO2, carbon nanotubes etc.) – some of them under discussion for safety aspects

Newly developed low volume substances (a large variety of substances) – most of them used in technical applications such as catalysts, batteries, solar cells etc.

Nanomaterials on the market

• Key statement by SCENIHR 2009

Potential toxic effects of nanomaterials for man and the environment

Not all nanomaterials induce toxic effects. Some have already been in

use for a long time (e.g., carbon black, TiO2) showing low toxicity

The hypothesis that smaller means more reactive, and thus more toxic,

cannot be substantiated

Nanomaterials are similar to normal chemicals/substances in that

some may be toxic and some may not.

Case-by-case approach for the risk assessment of nanomaterials is

still warranted

Hazards and risks of nanomaterials

•Toxicological knowledge about nanomaterials is improving continuously

•Experimental data are generated with high doses

Most common effects: oxidative stress, inflammatory responses, genotoxic effects, tumours

•At low doses, most nanomaterials show little effects

Conclusions on hazardousness depend crucially on whether the experimental data are considered representative for real life conditions.

Hazards of nanomaterials

•Certain nanomaterials can penetrate into the body and reach certain organs and tissues

•Lack of epidemiological studies

except one on carbon black workers, which is considered inconclusive because of inconsistent epidemiological evidence

Toxicokinetics and epidemiology

•Very few measured data and available exposure models

•Distinction between manufactured and incidental or natural nanoparticles difficult

•Exposure aspects can be mainly addressed through general considerations and assumptions

•Question marks on waste stage and fate in the environment

Exposure to nanomaterials

•SCENIHR

while risk assessment methodologies are generally applicable to nanomaterials

specific aspects related to nanomaterials still require further development

Very similar conclusions by OECD, EFSA, EMA

Risk assessment methods

•Main uses: 73% tyres, 19% other rubber, rest pigments, plastics, cosmetics, paper etc.

•Hazards: at high dosis inflammation, cytotoxicity and tissue damage; IARC: possible carcinogen on the basis of experimental data; epidemiological data considered to be inconclusive

• REACH: registered, obviously relating to nanoform (which is more than 90% of the market), in one out of three registrations classified as suspected carcinogen, others not classified

Carbon black

•Main uses: “a bit of everything”: Paper, CMP-slurries, coatings, paints, inks, adhesives, food, plastics, photography, surface treatment, catalysis, textiles, leather, building, tyres, footwear, rubber, batteries, toothpastes, detergents, cosmetics, pharmaceuticals

•Hazards: at high dosis inflammation, cytotoxicity, tissue damage; low dosis: no effects (contrary to bulk crystalline silica)

• REACH: registered, obviously relating to nanoform, not classified as hazardous

• EFSA, in food supplements up to 1500 mg/day no safety concern

Synthetic Amorphous Silica

•Main uses: UV-filter and photocatalytic applications: sunscreens (around 5%), plastics, metals, varnishes, textiles, catalysis, self-cleaning products (windows, cement, tiles etc), tribological coatings in engines, scratch-resistant coatings, solar cells

•Hazards: at high dosis inflammogenic, oxidative and genotoxic pulmonary responses; IARC carcinogenic 2B (i.e. possibly carcinogen)

• REACH: registered, no specific differentiation between bulk and nano, not classified as hazardous

Titanium dioxide

•Main uses: Optical devices, polishing agent, anti-corrosion material, diesel fuel additive

•Hazards: at high dosis inflammatory responses

• REACH: registered, differentiated between bulk and nano, neither form classified as hazardous

Cerium dioxide

•Main uses: mainly antimicrobial uses in textiles and medical applications; small quantities in anti-odour applications, electronics, printing, catalysis, photovoltaics, displays, fuel cells

•Hazards: Highly ecotoxic, at high dosis pulmonary oedemas

• REACH: registration for silver explicitly states that nanoform is not covered; (bulk) silver has been classified for aquatic toxicity and chronic aquatic toxicity

• SCENIHR has been mandated to assess potential effects and role in microbial resistance

Nanosilver

•Main uses:

carbon nanotubes: largest use is electrical conductivity for plastic materials; polymer addititive, paints and coatings, fuel cells, batteries

carbon nanofibres: lithium ion batteries (by far biggest use)

•Hazards: Variations between forms (some causing mesothelioma); at high dosis inflammation and cytotoxicity (single walled often to be shown to be more toxic; longer length more pathogenic)

• REACH: separate registration – not classified as hazardous; another registration under graphite: eye and respiratory irritation

Carbon nanotubes and carbon nanofibres

•Graphene: many new applications

•Quantum dots: potentially strong growth in technical applications

•Nanoclays: quite widespread?

• Pigments, a wide range of food additives, sea sand: nanomaterials under the Community definition?

Others

Again Others...

Diamond Nanoparticles Gallium Nitrate Nanopowder

Dysprosium Nanoparticles Germanium Nanoparticles

Dysprosium Oxide Nanopowder Germanium Nanoprisms

Erbium Nanoparticles Gold Nanoparticles

Erbium Oxide Nanopowder Gold Nanoprisms

Europium Nanoparticles Gold Oxide Nanopowder

Europium Oxide Nanopowder Graphite Nanofibers

Gadolinium Nanoparticles Hafnium Oxide Nanopowder

Gadolinium Oxide Nanopowder Hafnium Nanoprisms

Gallium Nanoprisms Holmium Nanoparticles

• As of February 2012:

Voluntary tickbox “nanomaterial” ticked in 7 registrations and 18 notifications

Further registered substances are obviously nanomaterials or have nanomaterial forms

registrants recognized nanomaterials (8 dossiers /5 substances);

substances exist only as nanomaterial (12/9)

assessors identified nanomaterials on the basis of the particle size distribution (5/5)

• ECHA analysis is annexed to SWP

Nanomaterials in REACH registration and CLP notification dossiers

•Nanomaterial Regulatory Review concludes

REACH sets the best possible framework for the risk management

of nanomaterials when they occur as substances or mixtures but

more specific requirements for nanomaterials within the

framework have proven necessary.

However, many registration dossiers are unclear in whether and

how they cover nanoforms of substances

Overall, risk assessment methods are applicable but some

aspects may need more detailed requirements in REACH Annexes

Therefore, the Commission envisages modifications in some of

the REACH Annexes and encourages ECHA to further develop

guidance for registrations after 2013

Nanomaterials and REACH/CLP

•Worker protection: Ongoing study on nanomaterials in the workplace will be input

to deciding whether changes to worker protection legislation will be necessary

EU-OSHA publications and website review is annexed to SWP

• Consumer product safety legislation:

Overview of latest developments on cosmetics, novel food, medicines, medical devices, food contact legislation

• Ingredient labelling

• Environmental legislation

Other relevant health, safety and environmental legislation

• Standardisation: Commission Mandate to CEN Description of other relevant standardisation activities in ISO

and CEN

•OECD Working Party on Manufactured Nanomaterials Working Party on Nanotechnologies

• SAICM

• Research on Nanomaterial Safety

Other areas

• SWP contains a lot of information on individual nanomaterials and their uses, as well as their safety

• Existing databases analysed in the SWP Product databases such as Woodrow Wilson, Nanowerk etc. REACH-IT Other databases linked to use of nanotechnology such as

OECD Database on Research into Safety of Manufactured

Nanomaterials, JRC nanohub, etc.

Information needs and databases

•Do we need a Community nanomaterial registry? French legislation Commission announces a web platform for 2013, with

references to all relevant information sources, including registries on a national or sector level, where they exist.

Impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes

Information needs and databases

• Communication and SWP have been transmitted to European Parliament, the Council and the EESC Own initiative report by EP? Council conclusions? EESC report?

Next steps

Thank you!