Overview of the regulatory work on PFASs under REACH and CLP

Johanna Peltola-ThiesEuropean Chemicals Agency

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REACH/CLP machinery

See for descriptions of each processhttp://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern

The time aspect - some of the building blocks

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Harmonised classification and labelling (CLH)Approximately 3-4 years*

Identification of Substances of Very High Concern (SVHC) 6 months**

RestrictionApproximately 3 years*

Substance evaluationEvaluation, 1 year(stops here if no further information needed)

Decision making stage ca. 1 year

Testing: ca. 1-3 years depending on the case

Follow-up evaluation, 1 year

* The minimum process time in ECHA and the EU Commission decision process + the normal waiting time for entry into force. Excluding the preparation of the dossiers for these processes.** For the high priority SVHCs the process to recommend and include them into Annex XIV of REACH takes minimum 3 years (steps as described in *). Authorisation application process takes ca. 2 years for substances listed in Annex XIV.

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Collaboration on PFASs

Informal collaboration focusing on PFASs in the regulatory work started 2014

BE, DE, DK, NL, NO, SE, The European Commission, ECHA Purpose to gain efficiency in handling PFASs of (potential) concern

PFASs are one of the substance categories to which ECHA and the REACH Member State Competent Authorities pay particular attention currently

ECHA supports and facilitates the work of the Member States

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Drivers

Group –wise work -approach: to gain efficiency and to ensure coherent approach

-An “arrow head” substance (terminal degradation product)

-Precursors of the “arrow head” substance

-High number of substances*

-Substitution within the category -(import in) articles -> global challenge-REACH registration standard information and current assessment approaches do not sufficiently address concerns of this group

≥C5-PFASs: > 20 registrations, ca. 100 CLP notificationsOther PFASs: > 100 registrations; >> 1000 CLP-notifications

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The approach – for PFASs of concern

Assess “arrow head” subst.

• Substance evaluation, where needed• Harmonised classification and labelling, where needed• PBT/vPvB assessment outside Substance evaluation

Assess precursors

• Identify potential precursor groups• Provide evidence on (slow or fast) degradation of the precursors to “arrow head”

substance (use Substance evaluation, if necessary)• Estimate degradation rate roughly (cf. DecaBDE, PFOA precursors)

• Where relevant, submit assessment of “arrow head” substance and its precursors in one dossier OR as several dossiers

• The group of the identified precursors and the “arrow head” substance subjected to one restriction proposal (e.g., PFOA group entry). Restriction needed in particular where articles involved in causing exposure.

SVHC-identification

Restriction

State-of-play

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Subgroup Arrowhead group RMOA Assessment CLH/SVHC Restriction

Long-chained PFCAs

PFOA √ √ √ / √ √ (ECHA opinion)

PFNA √ √ √ / √ -

PFDA On-going √ √ / - -

C11-C14-PFCAs - √ - / √ -

Short-chained PFCAs

C7-PFCA - On-going ? ?

C6-PFCA - On-going ? ?C4-PFCA, etc. - Scheduled ? ?

Short-chained PFSAs

PFHxS On-going On-going ? ?

C4-PFSA On-going - ? ?

Work addressing multiple PFASs’ needs

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1. Mass screenings

2. Gaining understanding of degradation paths of precursors

3. Hazard assessment approach development topics E.g., use of toxicokinetic data; efficient ways to evaluate effects/toxicity of short-chained PFASs: read across or testing

4. Risk management option analysis (RMOA) –work

Further activities needed: Information review/gathering of uses of specific PFASs groups in (imported) articles, work on fluoropolymers    

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Conclusions

Several coordinated activities on-going in the Member States and in ECHA

• In formal REACH- processes• As preparatory activities

Yet it should be noted:• PFASs are a significant challenge (many substances and many approach

issues to tackle)• The gap between info we get from registration/notification –dossiers and

monitoring observations needs to be closed –responsible stakeholders need to be identified for collaboration

• No fast solutions

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Remarks

Link to the global activities and activities in non-EU countries essential for progress

• Some topic -based –collaborations initiated• Information generation on imported articles needs intensive collaboration at

global level – not yet established – ANY IDEAS ON THE WAY FORWARD?

Uses also cover other regulatory frameworks (e.g., food contact materials, medicinal products)

• Need to ensure coherence of the work within the EU, globally among different authorities/organisations

 

Thank you!

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johanna.peltola-thies@echa.europa.eu