Integrated Regulatory Strategy
Based on the first years of experience in implementing REACH and CLP regulatory processes, ECHA developed an integrated regulatory strategy, which coherently brings all the processes together to achieve the aims of these Regulations, as well as contributing to meeting the 2020 goals of the World Summit on Sustainable Development.
The integrated strategy ultimately aims to achieve the following impact:
- efficiently select substances that raise potential concern, generating the necessary information for assessing their safety through a compliance check or other means so that any remaining concerns can subsequently be addressed through the most suitable regulatory risk management instrument;
- ensure appropriate and timely intervention from all actors (ECHA, Member States, industry and the European Commission) within the different REACH and CLP processes so that chemicals of concern are addressed as soon as possible through the regulatory risk management measures
- provide confidence amongst stakeholders and the public that registrants meet REACH information requirements, followed up by improved communication on safe use in the supply chain;
The basis for all activities is the REACH registrations. Several activities address the quality of dossiers already before a submission, at the completeness check phase and after a submission is approved.
Together with the Member States, ECHA developed a common screening process, which identifies substances that have the greatest potential for adverse impacts on human health and the environment. The common screening allows a conclusion to be reached on which substances need to undergo further compliance check and/or substance evaluation and which substances can be directly earmarked for EU level risk management measures.
Under the compliance check process, priority is given to full registrations of chemicals produced in volumes over 100 tonnes per year. The main focus is on the higher tier human health and environment endpoints which are relevant for identifying CMR (carcinogenic, mutagenic and reprotoxic) and PBT/vPvB ((very) persistent, bioaccumulative and toxic) substances.
If the concern is confirmed in the evaluation, a risk management option analysis (RMOA) process will usually follow to check which risk management process is most suitable. The generation of new information can also lead to the conclusion that a substance is currently of no, or low concern.
ECHA’s ambition by 2020 is to have mapped the ‘universe of registered substances’ above 100 tonnes through a number of actions. These actions are intended to reduce the pool of substances of potential concern and conclude for as many substances as possible the need for specific action or that they are currently of low priority for further work.
The work is carried out in collaboration with industry sectors, and companies can proactively contribute by updating their dossiers and by providing better use and exposure information, when they are informed of the results of the common screening. This level of coordination will also be instrumental in making sure that all relevant currently known SVHCs are on the Candidate List by 2020 with the best risk management options identified as provided by the SVHC Roadmap.