Article

REACH: SVHCs and Authorisation

Posted on: January 8, 2014

By Jamie Lin Sehrer

Q: How are Substances of Very High Concern (SVHCs) identified?

A: A substance may be identified as an SVHC when EU Member States or the European Chemicals Agency (ECHA) complete an Annex XV dossier to propose that a substance be identified.  Once a substance has been identified as a SVHC, it is added to the Candidate List on the ECHA website.  Currently the Candidate List contains 151 substances.

Substances that are identified as SVHCs are those that meet the following criteria given by Article 57 of Regulation (EC) 1907/2006 (REACH):

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR), as identified in Directive 67/548/EEC (DSD) or Regulation (EC) 1272/2008 (CLP).
  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to REACH Annex XIII.
  • Substances identified to cause serious effects to human health and the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

Q: Can the public provide comments on identified SVHCs?

A: The Annex XV reports that are prepared by ECHA or an EU Member State are available on the ECHA website for review.  Interested parties may provide comments during the 45 days following publication.  Comments can be in regard to the identification of a substance as SVHC and any relevant information regarding use, exposure, risks and available alternative substances.  Comments will not be accepted in regard to SVHCs that have been identified based upon harmonized classifications published in Annex VI of the CLP Regulation.

Q: If a substances is listed on REACH Annex XIV, how long can I continue to use the substance without Authorisation?

A:  Substances listed on Annex XIV have an application date and a sunset date. All applications for Authorisation of certain uses must be submitted prior to the application date.  However, should you choose not to submit an application, a manufacturer or importer can only continue to use the substance until the sunset date.

After the sunset date, an Authorisation will be required before placing the substance on the EU market for a particular use.

Q: If a substance is on the Candidate list of SVHCs, do I have to fill out an application for Authorisation?

A: Substances are placed on the Candidate list of SVHCs after an Annex XV dossier has been completed and the substance has been identified as meeting the criteria of a Substance of Very High Concern.  An application for Authorisation is not required until the substance has made its way onto the REACH Annex XIV list of substances subject to Authorisation.  However, if a substance is on the Candidate list, there is an obligation to communicate down the supply chain when a product contains an SVHC in a concentration greater than 0.1% by weight.  Also, if manufactured or imported in quantities of 10 metric tonnes or more per year, there are obligations to complete a chemical safety assessment and submit a notification to ECHA.  Special attention is required for products that are considered Articles without intended release of substances.

Q: Where can I find more information about ECHA’s future plans to add more substances to the Candidate List and REACH Annex XIV?

A: ECHA recently added a new section to its website which will provide stakeholders and the general public regularly updated information on how ECHA, the EU Commission and the EU Member States plan to implement the SVHC Roadmap all the way to 2020.

References

Candidate List of SVHCs

http://echa.europa.eu/web/guest/candidate-list-table

ECHA – Addressing Chemicals of Concern: Authorisation

http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation

ECHA – Support: Authorisation – SVHC Identification

http://echa.europa.eu/web/guest/support/authorisation/substances-of-very-high-concern-identification

ECHA – Applying for Authorisation

http://echa.europa.eu/web/guest/applying-for-authorisation

ECHA SVHC Roadmap

http://www.echa.europa.eu/view-article/-/journal_content/title/monitor-progress-on-the-implementation-of-the-svhc-roadmap-on-echas-website

ECHA webinar and workshop website:

http://www.echa.europa.eu/web/guest/support/training-material/webinars

ECHA Helpdesk:

http://www.echa.europa.eu/web/guest/support/helpdesks/echa-helpdesk

EU Member State National Helpdesks:

http://www.echa.europa.eu/web/guest/support/helpdesks/national-helpdesks


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