Nanomaterials underREACH

ECHA Workshop on nanomaterials, 30-31 May 2012, Helsinki

Maila Puolamaa and Andrej Kobe

Overview

• REACH – aims and legal basis• CA/59/2008 : Nanomaterials in REACH

• Activities at EU level• CARACAL and CASG Nano

• EU Recommendation on the definition

• RIPoN 1,2&3

• Regulatory review of nanomaterials

• REACH Review 2012

• Conclusions and next steps

Slide 2

EU Approach to Nanotechnologies

- Safe: ensure a high level of protection of human health and the environment

- Integrated: simultaneous development of competitiveness and safety aspects in nanotechnologies

- Responsible: managing the evolving development of nanotechnologies in a scientifically sound manner

Slide 3

REACH – aims (Article 1.1)

- - to ensure a high level of protection of human health and the environment

- - including the promotion of alternative methods for assessment of hazards of substances

- - as well as the free circulation of substances on the internal market

- - while enhancing competitiveness and innovation

Slide 4

REACH Coverage of nanomaterials• REACH requirements apply to nanomaterials (NMs),

even though there are no specific provisions for NMs.

• Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

• This covers in principle (CA/59/2008):• Nanomaterial, substance at the nanoscale• Nano form vs. bulk form• Agglomerates and aggregates

Slide 5

REACH applicability to nanomaterialsREACH implementation issues such as

• Substance identification• Registration of nanomaterials• Chemicals Safety Assessment• Risk management measures• Communication in the supply chain• Current and evolving nanoapplications • Information needs

Other issues of relevance• Test methods and test guidelines (JRC, FPs, OECD-WPMN)• Member State activities• Other

CASG Nano Mandate, March 2008

Slide 6

Tbd

RIPoN 2, Spring 2011

Nov 2011

June 2012

June 2012

June 2012

14. Advice on REACH guidance

15. Advice on testing strategies for NM

16. Recommendations for further research

Open (ES in RIP-oN3)

Dec 2010

Dec 2010

Dec 2010

12. Risk management measures

13. Alternative testing methods for NM

RIPoN 2, Spring 2011

RIPoN 2, Spring 2011

Dec 2010

Dec 2010

10. Testing – Ecotoxicity Environment

11. Testing – Fate, Degradation, Aq. Env.

RIPoN 3, Spring 2011

RIPoN 2, Spring 2011

open

Dec 2010

Dec 2010

open

7. CSA of NM

8. Testing – Human health toxicity

9. ?Annex XIV - Authorisation of NM-SVHC

Dec 2011

RIPoN 2, Spring 2011

Dec 2010

Dec 2010

5. Communication in the supply chain

6. Testing – Physico-chemical properties

Dec 2008

Oct 2009

RIPoN1, Spring 2011

Dec 2011

Nov 2009

Dec 2008

Jan 2009

Jan 2009

Dec 2010

Dec 2010

0. Nanomaterials in REACH

1. Carbon and graphite in Annex IV and V

2. Substance Identification

3. Registration of NM

4. Advice on C&L of NM

4th CASG-Nano

Dec 2009, Rev 1

1st CASG-Nano,

July 2008

CASG Nano Advice

CASG Nano WP 2008-2012

Slide 7

Substance ID (RIPoN 1)

• Characterizer or identifier?

• Common agreement that phys-chem parameters such as size and surface treatment of a nanomaterial affect intrinsic properties of a substance

• No agreement on whether they are characterisers or identifiers (or may trigger new identifiers)

• Agreement found on approach to carbon nanotubes (CNT)

Insufficient evidence to create general solutions at present, indication thatsome flexibility may be required.

• CA/58/2011• Further practice needs to be developed on developing rules on how size should

be used as a characterizer and when it could be used as an identifier. If specific substance identification rules for nanomaterials will be developed they must be consistent with practices for substances in general.

• Registrants can should adequately motivate their approach to ID of the registered nanomaterials either as a substance or a nanoform of a substance.

• Data sharing should be considered as important driver for these decisions.

Slide 8

Information Requirements and Chemical Safety Assessment (RIPoN 2&3)

• Principal findings• REACH approach overall suitable

Recall: all identified uses, registered substance may be present in several forms

• No new endpoints identified at present• Test methods generally applicable, adaptations may be

required (e.g. sampling)Read-across possible if scientifically justifiedLack of validated alternative methods

• Importance of phys-chem characterisation (granulometry)• Still scarce evidence base, field in development

• Broad support on RIPoN 2&3 findings from stakeholders

• ECHA has already taken the recommendations in an update to the Guidance on IR and CSA

Slide 9

European Parliament resolution on NMs

• No regulatory void, further actions on guidance and implementation as well as R&D needed

• EP Resolution on Regulatory aspects of NMs, 2009• Disagrees with Commission that « current legislation covers

risks of nanomaterials »• Lack of NM definition and information about NMs on market• Special evaluations needed in core legislative areas, incl. REACH

• Commission Response to the Parliament, July 2009• 2nd Regulatory review of nanomaterials, including information

on nanomaterial types and uses, including safety aspects in 2011

1st NM Regulatory Review, June 2008

Slide 10

Definition of nanomaterial

• Commission Recommendation 2011/696/EU• science-based, broadly applicable

• Default : 1-100nm, >50% (constituent) particle number size distribution

• Facilitate coherent approach across different regulatory regimes; application to be considered individually

• REACH: COM asked ECHA to consider how to best take the EU recommendation into account

Slide 11

REACH Review 2012• Different aspects of REACH will be looked at to inform

the 2012 review process

• Several thematic studies address issues which may provide inputs to the Commission services in the review

• Inputs to the Commission analysis will also emerge from other review activities going on independently from the REACH exercise but almost in parallel from a time prospective such as:

• Review of regulatory aspects of nanomaterials

• Review of EU legislation addressing risks from exposure to

multiple chemicals from different sources and pathways

Slide 12

Conclusions and next steps

• Competitiveness, innovation and high level of protection fundamental for the EU• Uncertainties influence consumer trust and investment decisions • Key to increase certainty on sustainability and safety

• Legislative reviews on nanomaterials and REACH to steer towards the above

• REACH and CLP regulations cover in principle nanomaterials• Present task : effective implementation

• NM issues addressed in CASG Nano and in the new ECHA Nano-WG

• Close cooperation with the Member States, Industry and NGOs.

• Efficient use of results from OECD-WPMN & ISO/CEN and R&D

Slide 13

Thank you!

• Further info:

http://ec.europa.eu/enterprise/sectors/chemicals/index_en.htm

• http://ec.europa.eu/environment/chemicals/nanotech/index.htm