In the original draft released on the ECHA website, 96 substances were selected for evaluation by the Member States in 2019, 2020 and 2021.
However a subsequent modification was made to the draft list on October 24 2018 (ECHA press release ECHA/NR/18/60) with the addition of 4 substances. Therefore the CoRAP plan for 2019-2021 now contains 100 substances. Of these substances, 31 are currently planned for evaluation in 2019. Although existing data on the substances were used as the basis of the prioritisation and inclusion of the substances on the CoRAP 2019-2021 list, authorities granted under REACH for substance evaluation empowers member states and ECHA to request new information to fill data gaps on these substances, thus improving the understanding about the risks these substances pose to humans and the environment. In fact the REACH Regulation calls for the compiling of a draft Community Rolling Action Plan to include “substances that could potentially pose a risk to human health or the environment. In developing the draft 2019-2021 list, ECHA and the Member states used the hazard selection and risk criteria to prioritise substances for substance evaluation (2011 CoRAP selection criteria):
The 2011 CoRAP hazard selection criteria include:
- Suspected Persistent, Bioaccumulative and Toxic substances (PBTs), Very Persistent and very Bioaccumulative substances (vPvB) and PBT-like substances.
- Known PBTs/vPvB substances
- Suspected endocrine disruptors (e.g. based on reproductive effects and/or on structural similarities)
- Suspected Carcinogenic, Mutagenenic and Reprotoxic substances (CMRs) (e.g. based on structural similarities)
- Known CMRs: category 1A, 1B and category 2 according to Regulation 1907/2006 (The CLP Regulation)
- Suspected sensitizers (e.g. based on structural similarities)
- Known sensitizers (skin and especially respiratory sensitizers)
The 2011 CoRAP exposure related criteria include:
- Wide dispersive use (number of sites of use, pattern and amount of releases/exposure, the number and type of reported uses and exposure scenarios from different registrants, the substance is incorporated into mixtures or articles used by the public, the potential size of the exposed population
- The number of using sites if emission due to industrial use
- Consumer use and exposure of sensitive subpopulations such as children
- Aggregated tonnage
The 2011 CoRAP risk related criteria include:
- The risk assessment in the chemical safety report shows that risk characterisation ratio is not well below to 1.
- Cumulative exposure from structurally related substances with critical hazardous properties
The 2019-2021 draft CoRAP substances were selected in many cases based on concerns related to PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive use or consumer uses. At this stage some changes to the plan are still possible. The final updated plan will be adopted in March 2019. As such, it is anticipated that member states will submit draft substance evaluations for the 2019 batch of CoRAP substances (currently 31 substances) one year after the publication of the CoRAP update by ECHA.
After submission of the drafts by the Member States, ECHA will forward them to registrants of the substances to provide them with an opportunity to comment. Any decisions to require development of more information will be made public as well as the final evaluations. The final decision of the evaluation in principle may be that no further action is needs to be requested, or that could lead to a decision requesting further information from the registrant in order to clarify the concerned; however evaluation may also lead to the introduction of new risk management measures.
Title VI, Chapters 2 and 4 of in the REACH regulation indicates that substance evaluation is designed to ensure evaluation has a reliable and consistent basis, that requests for further information are consistent, legislative deadlines and the rights of registrants are respected, and that the responsibilities of the Member States Competent Authorities (MS-CA) and ECHA are clearly defined. However, CoRAP (via substance evaluation) also reinforces the basic concept in REACH Article 5 “No data, no market”.
Under CoRAP, ECHA and MS-CA assumes that a substance with insufficient information is potentially a hazard or a risk to the environment or human health. A suspected property is considered by default under CoRAP 2011 criteria to be more important than a known property since this allows MS-CA and ECHA to request additional information to fill data gaps. Registrants with substances in the 2019-2021 CoRAP list are advised to contact the evaluating Member State Authority to coordinate their actions. More especially for the 31 substances planned to be evaluated in 2019, it is important that the use and exposure scenarios as well as exposure estimations are up to date and clearly documented in the Chemical Safety Reports since the relevant dossier updates should be made before March 2019. Of the 31 substances proposed for evaluation in 2019 (See Table), Germany (DE) and Spain (ES) will act as evaluating member state for 5 each, France (FR) and Italy (IT) will evaluate 4 each, The Netherlands (NL) 3, Latvia (LV) 3, Belgium (BE) 2 and Poland (PL), Portugal (PT) and Hungary (HU) 1 each.
About The Author
Dr. Erick Nfon is a Regulatory Scientist at Smithers Viscient, with particular experience in environmental fate modeling and regulatory affairs. Erick has spent 14 years working in Academia, Industry and at European Contract Research Organisations and regulatory consultancies. His responsibilities include environmental risk assessments, dossier preparation and submission, and the provision of scientific expertise and advice to support registration programmes for plant protection products, biocides, pharmaceuticals, and general industrial chemicals.
You can contact Smithers Viscient via email at info@smithersviscient.com