News

ECHA shortlists substances for possible regulatory action

ECHA/NA/16/03

The Agency has selected nearly 300 substances from REACH registrations for further scrutiny by the Member State competent authorities. The competent authorities will carry out a manual examination of the dossiers they prioritise to decide whether there is a need for regulatory action.

Helsinki, 27 January 2016 – The shortlisted substances are registered by nearly 1 500 companies in 2 500 registration dossiers. The selection is based on an automated IT screening focusing on substances with potential carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), endocrine-disrupting, sensitising or specific target organ toxicity following repeated exposure (STOT RE) properties.

A subset of substances are then further prioritised based on uses that are likely to lead to exposure to humans or release to the environment. The Member State competent authorities will then prioritise substances for their manual examination.

Companies affected have received or are about to receive a letter from ECHA informing them of the potential examination of their registrations. They are invited to update their dossiers to address any shortcomings as soon as possible. Up-to-date information will help the Member State authorities better assess whether the concern indicated by the screening is confirmed, and whether regulatory action is still needed.

If the Member States or ECHA take actions on a substance, this information will be published on the Agency's website, for example, in the list of substances potentially subject to compliance checks, the Registry of Intentions (RoI), the draft Community rolling action plan for substance evaluation, and the the Public Activities Coordination Tool (PACT), which lists substances under hazard assessment or risk management option analysis. Companies can check the status of their substance through the Search for chemicals available on ECHA's homepage.

Background

ECHA and the Member State competent authorities conduct IT and manual screening annually as part of the common screening approach. The aim of this collaborative effort is to identify substances that pose a risk for human health or the environment and take them forward to the most appropriate REACH and CLP processes to ensure their safe use. The common screening approach is part of the SVHC Roadmap to 2020 implementation plan.

The previous round of IT screening identified around 200 substances for further scrutiny. Of those, Member States manually examined 165 and 76 % were found to require follow-up activities. 67 were proposed for substance evaluation and 36 for compliance check.  17 dossiers were proposed for harmonised classification and labelling and six for risk management option analysis. Additional nine were found to require further assessment or other actions.

The aim of the letters to the registrants is to increase transparency of authorities' work in the early stages of substance selection and to give registrants the possibility to clarify the hazard and use profile of their substances. The improved quality of the registration dossiers will in turn provide authorities a more solid basis for deciding the need for further actions.

ECHA does not make the list of shortlisted substances public as it is purely based on automated selection by IT and manual verification is needed to confirm a potential concern.