The focus of the European Chemicals Agency (ECHA) and Member States is on substances for which concerns have not yet been clarified. Currently, new data is being generated or assessed on 750 substances. Substances are increasingly addressed in groups based on structural similarity. ECHA has published its annual report describing the progress in implementing the SVHC Roadmap. For several years, Member States and ECHA have been scrutinising substances of concern by systematically screening the information available in the REACH registration dossiers and in other databases. The focus of this screening has shifted towards looking at groups of substances with similar hazardous properties. This will enhance the coherence of regulatory action of similar substances and help to avoid regrettable substitution of substances of very high concern (SVHCs). This will also allow well-informed decisions to be made on a higher number of substances in a shorter period of time compared to if they were examined one-by-one. The compliance check and substance evaluation processes generate further information on substances and mainly focus on the most crucial hazard properties for protecting human health and the environment, such as carcinogenicity, mutagenicity and reprotoxicity, endocrine-disrupting properties and persistent, bioaccumulative or toxic properties. Currently, new data is being generated or is under assessment on 750 substances. The report provides further details on the number and type of substances that authorities are working on to clarify their priority for further information generation and for further regulatory action. The generated data will enable authorities to confirm or refute the identified concerns and to initiate regulatory risk management where needed. The report also gives an overview of the current situation in harmonised classification, the different steps of the authorisation process, and restriction. The report also contains an analysis of the regulatory status of all currently known SVHCs. SVHCs consist of substances that are persistent (or very persistent), bioaccumulative (or very bioaccumulative) and toxic (PBT/vPvB), endocrine disruptors (EDs) and/or carcinogenic, mutagenic or toxic for reproduction (CMR). The report concludes that all these substances have been or are being scrutinised and put forward to the relevant regulatory risk management processes, such as inclusion in the Candidate List, authorisation, restriction, and harmonised classification and labelling. Alternatively, concerns regarding a substance have or are being addressed under other EU legislation. Some substances are also considered not to require further regulatory risk management action at present. ECHA, together with the Member States and the European Commission, will now focus on all remaining substances that have been registered above 100 tonnes per year and will aim to clarify whether these are of concern or not. This work will be done by incorporating REACH and CLP processes into the Integrated Regulatory Strategy, which will continue the work started by the SVHC Roadmap.
The Integrated Regulatory Strategy aims to:
- efficiently select substances that raise potential concern, generating the necessary information for assessing their safety to subsequently be addressed through the most suitable regulatory risk management instrument;
- ensure appropriate and timely intervention from all actors; and
- enhance confidence among stakeholders and the public that registrants meet REACH information requirements, followed up by improved communication on safe use in the supply chain.
Further information is available at:
- Roadmap for SVHC identification and implementation of REACH risk management measures – Annual Report 2017
- Annex to the report – Analysis of all relevant currently known substances of very high concern (SVHCs)
- SVHC Roadmap to 2020
- Integrated Regulatory Strategy
ECHA, 17 April 2018 ; http://echa.europa.eu