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Identification of Substances of Very High Concern

The Roadmap for Substances of Very High Concern

The merit of the Roadmap is that it is a first step towards a harmonised approach to be used by Member States and the EU Commission to identify SVHCs

The Roadmap describes how to examine the substances that may be identified as relevant SVHC, by giving priority to those that have been registered and are not used only as a chemical intermediate. Potential SVHCs excluded from this selection could still be considered after 2020. The Roadmap aims to improve planning, predictability, communication and to define responsibilities and deliverables.

The Roadmap clearly stresses that RMO analysis is a voluntary but critical step in the definition of the relevance of the SVHC. The level of detail needed to reach a conclusion in the RMO will be highly dependent on the complexity of the case and the available information.

The Commission underlines the need to consider options beside SVHC identification. The minimal information should include inter alia:

  • What the concern identified for the substance is, including screening evaluation if there are risks that are not adequately controlled
  • If and how the substance is already regulated
  • What the relevant REACH RMOs are
  • What the most suitable RMO is and why
  • What the planned time-schedule is

The EU Commission wants RMOs as early as at the stage of the SVHC identification to try and accelerate the process.

The RMO should then already provide indications on the future options that might be favoured, and which might be other than Authorisation.

A preliminary conclusion could be that there are data gaps which require a Substance Evaluation before finalising the RMO analysis.

From 2009 to 2012, ECHA and Member States have prepared RMOs for around 160 substances and 138 substances were included in the Candidate List. The EU wants to assess 440 substances with an RMO, there will be a need for 55 RMOs per year, which is a huge task.

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