ECHA activities relating to Nanomaterials

Jenny Holmqvist

Plenary meeting of the SSDC and European Chemical Industry 13 Oct 2015

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

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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

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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 http://echa.europa.eu/chemicals-in-our-life/nanomaterials

• 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

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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

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.

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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

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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

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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

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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

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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?

Thank you!

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