1. ECHA activities relating to Nanomaterials
Plenary meeting of the SSDC and
European Chemical Industry
13 Oct 2015
Jenny Holmqvist

2. Nanomaterials remain strategically important
Not an isolated issue – impact on other groups of substances
The success of REACH is also depending on the effective implementation for “non-conventional” substances
The interest remains high at Member States level (Substance evaluation and CLH proposals)
However, ECHA’s ability to act is hampered by uncertainties
especially due to slow progress in the revision of REACH annexes;
review of NM definition
increase number of appeals on compliance decisions

3. The Road to REACH Difficult to identify and address risks;
Lack of information about marketed chemicals
Burden of proof with public authorities
Limited instrument to control problematic substances efficiently

4. ECHA’s observations
Screening of REACH dossiers for nano-specific information (ECHA and EC) showed:
Limited information provided on nano-specific properties, studies and risk assessments
Room for improvement  recommendations provided for registrants on
Dossiers submitted in e.g. 2010, 1st deadline:
No agreed nano-definition at EU level
no explicit reference to nano-materials in legal text;
 ‘learning curve’ effect causing uncertainties for many registrants

5. ECHA’s 3 year Workplan for Nanomaterials
Even with all the uncertainties, ECHA continues to implement REACH, CLP and BPR to substances in nanoforms
This contributes to the successful implementation of ECHA’s strategic objectives, in an integrated way, to
Improve the quality of data submitted by industry
Address substances of concern
Make continual progress on regulatory science in the field
Enhance transparency around risk and benefits of nanomaterials on the EU market

6. Clarify aspects of existing guidance
Careful prioritisation based on existing legal text has been done;
Nanoform, some aspects of the HH and ENV and read-across
Important to meet the guidance standstill mid 2016 to allow for industry to prepare registrations with a deadline of 2018
Communication outreach to industry – webinar etc.

7. Improve quality of data to enable safe use
Dossier and Substance Evaluation;
Continue compliance check (CCH) on registration dossiers containing nanoforms for
all nanomaterial entries in CoRAP
potentially additional dossier CCH in line with CCH Strategy
After guidance update, a targeted approach of CCH on nanomaterials can be considered
A better use of information gathered at MS level

8. Addressing NM’s of concern – Substance Evaluation
Community Rolling Action Plan (CoRAP);
Silver 2014
SAS 2014
TiO2 2015
ZnO 2016/2017
CeO 2017
MWCNT 2017
Additionally 3 substances have been suggested for the next review
1st proposal for harmonised classification and labelling expected under CLP

9. Synergies with international activities and research
OECD remains highest priority – Test Guideline developments and assessment of the data from the sponsorship programme
UN assessment of the applicability of GHS criteria to NM’s
Generally lower priority is given to research projects than in the past

10. NMWG – the sounding board
ECHA NM Working Group - consists of members from Member States, COM Services and Stakeholders
A unique opportunity for technical discussions at EU level relating to hazard and risk assessment of nanomaterials
The importance of the working group is expected to increase with the actions outlined in the work plan
Two annual meetings foreseen as currently

11. Conclusion
ECHA believes that REACH is the best legal instrument to ensure safe use of nanomaterials on the EU market
Guidance developments needs industry support to ensure all aspects are considered in the process
ECHA encourages a closer collaboration with industry to clarify potentially existing uncertainties in the implementation of REACH and CLP
Would like to further discuss with industry in particular how existing Product Stewardships Programs are implemented for nanomaterials and how these scheme may or may not be affected by changes in the regulatory frameworks, e.i. REACH Annexes?

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