The "Roadmap for SVHC identification and implementation of REACH Risk Management measures from now to 2020" (called the SVHC Roadmap 2020) has the aim of having all relevant currently known substances of very high concern (SVHCs) included in the Candidate List by 2020. The planned steps to achieve this objective are defined in the “SVHC Roadmap implementation plan”:
- Screening to identify new substances of concern;
- Analysing the risk management options (RMOs) appropriate to the particular substance of concern.
The SVHC Roadmap 2020 foresees to cover the following groups of substances:
- Carcinogens, mutagens, reprotoxics (CMR, CLP Categories 1A/1B);
- Persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB);
- Endocrine disruptors (ED);
- Petroleum/coal stream substances that are CMR or PBT.
ECHA reports annually about the general progress of implementing the SVHC Roadmap 2020. Information on specific substances can be found in the Public Activities Coordination Tool (PACT) that lists all substances for which a risk management option analysis (RMOA) or an informal hazard assessment for PBT/vPvB properties or endocrine disruptor properties is either being developed or has been completed since the implementation of the SVHC Roadmap 2020. This allows stakeholders to prepare for possible future requirements well in advance.
The first step of the SVHC Roadmap implementation is the so-called Screening. It aims to identify substances of potential concern for which further information is needed to conclude on the hazards or risks they might pose and/or for which further regulatory action needs to be considered. ECHA and the Member State follow a common screening approach to systematically review available information for substances from the REACH registration dossiers and other databases.
Risk Management Option Analysis (RMOA)
The RMOA was as such not foreseen in the REACH and the CLP Regulations. It was “created” to base a decision on whether to go for a specific regulatory risk management measure on a solid basis. It supports the decision, if such measures are required for a certain substance, and to identify the most appropriate instrument to address a concern. A Member State or ECHA (at the request of the EU Commission) can carry out this case-by-case analysis. In addition to substance properties already addressed in the screening, additional aspects such the uses of the substance are analysed in the RMOA.
The output of the RMOA is summarised in the RMOA conclusion document. An RMOA can determine that there is a need for:
- Compliance check under dossier evaluation;
- Inclusion in the Community rolling action plan (CoRAP) under substance evaluation;
- Potential further regulatory risk management measures under the REACH and CLP regulations:
o Harmonised classification and labelling,
o Authorisation (first step: identification as SVHC),
- Potential further regulatory risk management measures within other EU legislation (e.g. occupational exposure limits),
- No regulatory action is required.
RMOAs and their conclusions are compiled on the basis of available information and may change in the light of new information or further assessment.