Why a Roadmap?
The European Commission has set a political target of including all relevant known SVHC on the Candidate List by 2020; consequently they developed a ‘Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to 2020’. This has received widespread support from Member States.
An implementation plan has now been drawn up by the Member State Competent Authorities, the European Commission and ECHA to effect the Roadmap inside the stipulated timeframe.
What is it?
The SVHC Roadmap foresees the use of screening and selection methods and of Risk Management Option (RMO) analyses to identify relevant SVHCs using information from the ECHA registration database, other REACH and CLP databases and other available relevant sources. The pools of substances to be considered under the SVHC Roadmap are as follows:
- Sensitisers (and other substances of equivalent concern)
- PBTs and vPvBs
- Endocrine disrupters
- Petroleum/coal stream substances with CMR or PBT/vPvB properties.
How will they do it?
The identification of SVHC substances relevant for inclusion on the Candidate List will be performed in three stages:
- A screening phase where substances with SVHC characteristics are identified from the registration (and other REACH/CLP) databases;
- A selection phase, to identify those substances of higher priority for inclusion on the Candidate List;
- An analysis phase, where a case-by case assessment is conducted to conclude whether a substance is a ‘relevant SVHC’ in the context of the SVHC Roadmap.
The identification process for each pool of substances is split into:
- Core Activities: substances which have been registered for non-intermediate uses
- Supplemental Activities: substances which are not registered or have been registered as Intermediates.
The screening phase may show there is uncertainty whether a substance fulfils the SVHC criteria; further work will be carried out using the approaches listed below to determine if that is the case:
- Further assessment by the PBT/Endocrine Disruptor Expert Groups;
- Information generation via dossier or substance evaluation;
- The harmonised classification process for CMRs and Sensitisers;
- Assessment whether the substance is likely to be of equivalent level of concern.
The selection phase will prioritise SVHC substances for inclusion in the Roadmap workflow; suggested criteria for the prioritisation process include:
- High volume
- Uses in the scope of authorisation
- Highest potential of being concluded to fulfil the PBT/vPvB/ED/CMR properties.
- The time needed to obtain the missing information when selecting substances for clarification of properties.
- Structural similarity to:
- substances on the Candidate List
- substances for which there is an intention to identify them as SVHC (i.e. in the Registry of Intention)
- substances in the pool for RMO analysis.
Once a priority SVHC substance is identified, the analysis phase will consider the following aspects when determining whether it is relevant for inclusion on the Candidate List:
- Whether registrations include uses within the scope of authorisation;
- That the known uses are not already regulated by specific EU legislation that provides a pressure for substitution;
- That there is no need or basis for a restriction;
- That there is no ultimate reason as to why substitution is not the desired outcome for the substance.
The aims of the Roadmap are to streamline the SVHC identification process, make it more predictable and introduce transparency into the Risk Management Option process in general. Only time will tell whether this approach is successful.
For further information please feel free to contact us .