the regulatory framework from the industries’ … regulatory framework from the industries’...

The Regulatory Framework from the Industries’ Perspective Sao Paulo, 27th November 2012 © Nanotechnology Industries Association (2012)

Seminário Regulação, Inovação e Desenvolvimento da Nanotecnologia Sao Paulo, 27th November 2012

The Regulatory Framework from the Industries’ Perspective


… the sector-independent, responsible voice for the industrial nanotechnologies supply chains; … it proactively supports the ongoing innovation and commercialisation of the next generation of technologies and promotes their safe and reliable advancement.

Nanotechnology Industries Association (NIA)


Manufacture of (Nanomaterials &) nanoenabled Products

NIA Membership

[source: Oxonica]

Trade & Manufacture of intermediate nanoenabled Products

Retail of nanoenabled Products

Instrumentation & Services: Characterisation , Analysis, Detection

Associated Support Services (Insurance, Legal Representation, etc.)

[source: Intrisiq]

[source: Beneq]

[source: BASF

[source: UMICORE]

[source: Naneum]

[source: RAS Materials]

[source: RAS Materials]


Nano-specific Policy & Regulation

Nano-specific Regulation, Policy, and supporting Recommendations (in chronological Order):

1. June 2008: European Commission Regulatory Review “Regulatory aspects of

nanomaterials”: • Current legal framework is adequate to cover nanomaterials

2. December 2008: Food Additives Regulation ((EC) No 1333/2008): „A food additive

[…] should be submitted for evaluation by the Authority [, if it is] „significantly different‟ [such as through] a change in particle size, including the use of nanotechnology.‟

3. March 2009: adoption of EU Cosmetics Regulation recast: • Labelling: „nano‟ in brackets behind the ingredient name • Notification: six months prior to market launch of a nanomaterial -containing cosmetic

4. April 2009: European Parliament „Own Initiative Paper‟: „no data, no market‟(-

reporting) PLUS: • Labelling (of all consumer products) • Notification (… Commission responded with the ‘2nd Regulatory Review’ (3rd October 2012))



(… continued) Nano-specific Regulation, Policy, and supporting Recommendations

(in chronological Order): 5. January 2010: EU Plastics Directive: Enforcement of Positive List of additives:

• „Prohibition‟ of nano-Silver and nano-Clay

6. December 2010: Australia: 'Guidance on New Chemical Requirements for Notification of Industrial Nanomaterials'

7. January 2011: EU Food-Contact Plastics (EU) No 10/2011 • Novelty specifications (ANNEX I)

8. March 2011: US National Organic Program Ban on Engineered Nanomaterials

9. April 2011: EU Novel Food Regulation recast: … failed to reach agreement, due

to differences over cloned meat, but it had previously been agreed to regulate: • Labelling of nanomaterials • Notification of nanomaterial content




(in chronological Order): 10.June 2011: US FDA Draft Guidance for Industry - Considering whether an FDA

Regulated Product involves the Application of Nanotechnology

11.June 2011: US FDA Centre for Drug Evaluation and Research (CDER) mandates „Reporting Format for Nanotechnology-Related Information in CMC Review‟

12.June 2011: US EPA Policy on nanoscale Material in Pesticide Products 13.July 2011: US EPA Test Rules for selected Nanomaterials

14.May 2011: EU EFSA Guidelines on Nanomaterials Risk Assessment (takes into

consideration data on non-nano form)

15.July 2011: EU ROHS Directive: • Prohibition of carbon nanotubes and nano-Silver • Requires „special safety consideration‟ for nanomaterials

… cf. WEEE Directive




(in chronological Order): 16.October 2011: Adoption of Regulation on Food Information to Consumers

17.October 2011: European Commission Recommendation of a Definition of the

Term ‘Nanomaterial’:

18.January 2012: Adoption of Biocidal Product Regulation recast: • Requires „special safety consideration‟ for nanomaterials (i.e. exclude the

use of nanomaterials unless the „the risk to human health, animal health and the environment has been assessed separately‟)

• Labelling: „the name of all nanomaterials contained in the biocidal products, followed by the word "nano" in brackets.

19. January 2012: France: Mandatory Reporting of Nanomaterials

20.February 2012: REACH Implementation Plans on Nanomaterials (RIPoNs): ECHA adapting Guidance, …. leading to … REACH Text Amendments?! (REACH Review expected November 2012)




(in chronological Order): 20. September 2012: EU Medical Device Directive Recast (Commission Proposal):

• Classification of all nanomaterial-containing medical devices under Class III • Labelling of nanomaterial-containing devices

21.September 2012: Denmark announces development of a database on products

containing „nano‟

22.September 2012: SAICM (ICCM3) suggests a number of „measures relating to nanotechnologies and manufactured nanomaterials‟ • The EU called for establishing a register of nanomaterials, encouraging

information exchange, and establishing public-private partnerships to ensure environmentally sound management of nanomaterials.'

23.October 2012: European Commission publishes 2nd Regulatory review on

Nanomaterials • Changes of REACH Annexes will be investigates • Changes of registration or CSR threshold are not foreseen • … investigations continue


… in Europe (since 18th October 2011):

We have DEFINITION

Nano-specific Policy & Regulation: DEFINITION


Which nano-specific Regulation will apply?



Which nano-specific Regulation will apply?

Nano-specific Policy & Regulation:DEFINITION


Particle Mass model Particle Number model

100nm

Compliance with the EU Definition - Mass vs Number Distribution



… EU Definition: expected Next Steps & Follow-Ups: • Implementation by Member States & Agencies (but not all MS agree with

the recommendation)

• JRC Reference Report on Methods available to measure/detect nanomaterials (according to the EU Definition)

>>>> published in September 2012:



Nano-specific Policy & Regulation JRC reference Report on „Requirements on measurements for the implementation of the EC Definition of the term „nanomaterial‟


PROSPECT Publications • Cerium Oxide Literature Review

• Zinc Oxide Literature Review

• Protocol for Nanoparticle Dispersion

• Guidelines and Protocol for Sampling

• Evaluation and Assignment of

Nanoparticle Dispersion/Characterisation Methodologies, to be developed under PROSPECT

• Video: Dispersion Protocol

NIA Activities - OECD WPMN Sponsorship Programme


NIA Activities - OECD WPMN Sponsorship Programme

OECD RMNs Lead sponsor(s)

Co-sponsor(s) Contributor

Fullerenes(C60) Japan, US Denmark, China

SWCNTs Japan, US BIAC (NIA), EC Germany, Canada, France, China, EC

MWCNTs Japan, US Korea, BIAC, BIAC (NIA), EC Germany, Canada, France, China, EC, BIAC(NIA)

Nano-Silver US, Korea Germany, Canada, Australia, Nordic Council of Ministers

BIAC (NIA), EC, France, China, Netherland

Iron nanoparticles China BIAC Canada, US, Nordic Council of Ministers

Titanium dioxide France, Germany Austria, Canada, Spain, BIAC, Korea, US, EC China, Denmark, Japan, UK

Aluminium oxide Germany , US, Japan

Cerium oxide UK/BIAC(NIA), US(EPA)

Australia, Spain Denmark, Netherlands, Germany, EC, Switzerland, Japan

Zinc oxide UK/BIAC(NIA) BIAC(CEFIC), Australia, US(FDA), Spain Denmark, Germany, Canada, Japan

Silicon dioxide France, EC Belgium, BIAC(CEFIC), Korea Denmark, Japan

Dendrimers Spain, US

Nanoclays BIAC (NIA) EC US, Denmark, EC

Nano-Gold South Africa EC, US, BIAC (NIA)

BIAC: Business and Industry Advisory Committee to the OECD

PROSPEcT Project: Industrial contribution: £1840840 Government contribution: £1840767 Total: £3681607 Start date: 1st January 2009 Duration: 3 years (36 months)

RefNanoCLAYM Project: Industry contribution: ~ EURO 245000 Start date: 1st September 2010 Duration: 1 Year (provisional)

Global-NanoMaPPP: current conf. contributions: EURO 4.7 Million Start date: September 2012 Duration: 2 Years

NIA Projects:


OECD WPMN Representative Manufactured Nanomaterial (RMN) Series & the European Reference Nanomaterial Repository

[Image courtesy JRC, European Commission]

OECD WPMN – Global Results for Policy Makers


NIA Activities – Global Results – available Data


Europe: 2nd Regulatory Review of Nanomaterials


… worrying Results


… worrying Results

When filtered by a whether the respondent had heard stories about nanoparticles in sunscreens Question 12, “Not using sunscreen at all is less risky to my health than using sunscreens that include nanoparticles.” reported that 24% “Disagree” with the statement that not using sunscreen at all is less risky and 20% “Strongly Disagree ”.


Contact: Dr Steffi Friedrichs Director General Nanotechnology Industries Association t: +32 2300 5933 f: +32 2300 5938 m: +32 493 158 959 e: [email protected] w: www.nanotechia.org Brussels: Nanotechnology Industries Association (aisbl) 101 Avenue Louise 1050 Brussels Belgium

Thank you!

London: Nanotechnology Industries Association (ltd) Lion House Red Lion Street London, WC1R 4GB United Kingdom


* 50:50 public-private-partnership with the UK Government to support the OECD Sponsorship Programme on Manufactured Nanomaterials: £3.7 Million for in-depth characterisation, ecotoxicology testing and detection prototyping of nano-ZnO and nano-CeO2: PROSPECT – „Ecotoxicology Test Protocols for Representative Nanomaterials in Support of the OECD Sponsorship Programme‟ (January 2009 – December 2011)

* Industry-funded contribution to the OECD Sponsorship Programme on Manufactured Nanomaterials: EURO 245 000 for in-depth characterisation and ecotoxicology testing of nano-Clay: RefNanoCLAYM – „Lead-Sponsorship, Characterisation and Testing of Reference NanoClay Materials within the OECD Sponsorship Programme‟ (September 2010 – September 2011)

* Global 50:50 public-private-partnership with the Govmts of German, UK, South Africa (...) in support and advancement of the OECD Sponsorship Programme on Manufactured Nanomaterials: (EURO 4.6 Million) for a Global-NanoMaPPP – „Global PPP for the Integrated Measurement and Testing of Representative NanoMaterials‟ (July 2011 – June 2013)

[* NIA-initiated and led]

The OECD WPMN Sponsorship Programme - supported by NIA PPPs

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