Is your substance on the blueprint for next substance evaluation round?
REACH registrants are encouraged to check the European Chemicals Agency's (ECHA) proposal for an update on the substances to undergo substance evaluation in 2016–2018. Plan early contact with the evaluating authority to address any potential concerns you may have.
ECHA has recently published the annual proposal to update the Community Rolling Action Plan (CoRAP). CoRAP is the list of substances that are to undergo substance evaluation by the EU Member States in the following three year period. According to ECHA's proposals, the 2016–2018 list will contain 138 substances, of which 53 are newly included.
Aims at REACH substance evaluation process
The inclusion of a substance on CoRAP does not, in itself, denote that a substance causes risk to human health or the environment. Rather, the REACH substance evaluation process aims at clarifying potential concerns raised by a particular substance. As such, the substance evaluation process is not limited to an individual registrant's dossier but can potentially affect all registrants of a particular substance, as well as any downstream users.
ECHA and the EU Member States select substances for CoRAP and the subsequent substance evaluation with reference to risk-based criteria. These include the substance's intrinsic properties, exposure thereto and its (dispersive) use. Ultimately, the prioritisation of substances for substance evaluation depends on the severity of the risks and the EU Member States' interest and readiness to evaluate a specific substance. To this factors also the propensity to clarify potential concerns through a request for further information.
The evaluating EU Member State may request, by decision, any additional information to clarify potential concerns, including information that goes beyond the standard REACH information requirements.
Finalised CoRAP for 2016–2018 set for March 2016
ECHA will adopt the finalised CoRAP for 2016–2018 in March 2016. The list will identify the substance, the evaluating authority in one or several EU Member States and the initial ground for concern. The EU Member States will have 12 months from the adoption of the annual final CoRAP to evaluate the substances identified for the specific year. This includes issuing any draft decision by which the evaluating national competent authority requests further information to address potential concerns.
Informal contacts with the evaluating competent national authority should be established early in the evaluation process to address any potential concerns identified by the regulators. To this effect, registrants of the same substance are recommended to collaborate during the evaluation process, including in submitting any comments to the evaluating authority. In addition, registrants will have an opportunity to comment the draft decision by which further information is requested before its formal adoption by either ECHA or the European Commission.
Once a final decision has been issued, the registrants will be given a time-limit within which to comply with any request for further information. The decision is subject to a review by either ECHA's Board of Appeal (in case ECHA has adopted the final decision) or the General Court of the European Union (in case European Commission has adopted the final decision).
