- Addressing substances of concern
- Universe of registered substances
- How does the chemical universe mapping work?
How does the chemical universe mapping work?
How does the chemical universe mapping work?
The main source of information for the chemical universe is ECHA’s database, which contains information from the REACH registration process as well as the ongoing, planned and completed regulatory actions under REACH and CLP and the outcomes of these actions.
To make sure that the mapping is based on comprehensive information of all substances, sources in addition to REACH, such as CLP, biocides and plant protection products, and persistent organic pollutants (POPs), are also taken into consideration.
On that basis, each substance is assigned to a pool. If there are multiple processes ongoing on the same substance, this mapping is usually based on the latest action, unless there are already stringent regulatory risk management measures in place. For example, if a substance is on the candidate list but there is further data generation currently under CCH, the current mapping would be based on the existing candidate listing.
A more detailed description of the pools can be found below.
Once a certain regulatory action is completed, the substance may be assigned to a different pool. Hence, many substances will be in different pools in different updates of the chemical universe. Comprehensive and up-to-date information on each substance can be found in the substance infocard. Additional details about the planned regulatory actions, i.e., the basis of the pool assignments, can be seen in the public activities coordination tool (PACT).
The characteristics of the five pools of substances are as follows:
This pool includes a very important group of chemicals, often with confirmed hazards on human health and the environment. For the substances in this pool, regulatory risk management measures have already been put in place. A relevant regulatory approach has been found for most of the substances and will be followed. For most of these substances, additional EU level regulatory actions are not foreseen. However, for some substances in this pool, there may still be significant work required (for example prioritisation on the Authorisation list or restriction proposal for certain PBT/ED substances).
This pool includes, for example:
- substances on the Candidate list of substances of very high concern;
- most substances restricted under REACH (excluding e.g. CMR substances restricted in consumer products);
- active substances in biocides and pesticides;
- persistent organic pollutants (POPs);
- substances subject to prior informed consent (PIC); and
- Substances included on Annex VI to CLP with a harmonised classification as CMR in category 1A or 1B or as Respiratory Sensitisers in any category.
This pool also includes substances that have a harmonised classification on Annex VI to CLP as Carcinogenic, Mutagenic or Reprotoxic in categories 1A or 1B, or as respiratory sensitisers in any category. These classifications are severe and trigger several downstream consequences and therefore, regulatory risk management can be considered ongoing. However, if there are any additional risk management measures under consideration or further data generation ongoing, the substances are mapped in the other pools to highlight this.
This pool includes substances that are currently being considered for regulatory risk management. These are, for example:
- substances for which there is an intention or ongoing proposal for identification as a substance of very high concern (SVHC);
- substances where authorities are preparing or have submitted a proposal for restriction under REACH;
- Substances where authorities are preparing or have submitted a proposal for harmonised classification and labelling under CLP; and
- substances under regulatory management option analysis (RMOA).
This pool also includes those substances where authorities have identified that further regulatory risk management might be needed, but this action has not yet started. These pending cases may come after the outcome of a substance or dossier evaluation, RMOA, PBT/ED assessment, or group assessment by authorities.
For example, a Member State may conclude at the end of a substance evaluation that a substance should be considered for SVHC identification. The substance would be assigned to this pool even if the SVHC identification process has not yet started.
This pool includes substances which require additional information or assessment before it is possible to identify whether further regulatory action should be proposed. This pool includes, for example:
- substances currently under substance evaluation;
- substances currently under dossier evaluation, but excluding testing proposal evaluation and ‘targeted’ compliance checks that focus only on one or a few aspects, e.g. only targeting environment or only targeting substance identity;
- substances under assessment by the PBT and ED experts groups; and
- substances addressed by the Petroleum and Coal stream working group (PetCo) or under the ECHA-Cefic collaboration on dossier compliance.
This pool also includes those substances where authorities have identified the need for further data generation or assessment, but this action has not yet started. These pending cases may come from substance or dossier evaluation, RMOA, PBT/ED assessment or group assessment by authorities.
For example, during group assessment ECHA may propose that a substance should be considered for substance evaluation. The substance would be assigned to this pool even if the substance evaluation process has not yet started.
Once the additional information is generated and assessed, authorities will either consider further regulatory actions or propose that no further action is needed. In the first case, the substance would then be assigned to the 'risk management under consideration' pool and in the latter to the 'currently no further actions proposed' pool.
Authorities review many substances under different regulatory processes and may not identify a need for further regulatory action at that moment. These processes are:
- Substance or dossier evaluation;
- PBT/ED expert group assessment; and
- Group assessment by authorities
This could be due to, for example, low hazard or low potential for exposure, taking into account company-level risk management measures. If the situation changes and, for example, if companies report new uses or new data on the substance’s hazardous properties, or if regulatory priorities change, these substances may be subject to further regulatory actions.
This pool also includes substances where ECHA has received a proposal for harmonised classification and labelling under CLP, and RAC has concluded on a harmonised classification for categories other than CMR 1A/B or Resp. Sens. in any category.
Substances addressed under the Existing Substances Regulation (ESR), which have not been mapped to other pools, are also included here as they were reviewed by authorities.
It is important to recognise that assignment to this or any of the other pools does not in any way relieve registrants’ obligations to keep registrations up to date and that regulatory action may be initiated at any moment.
This pool includes substances that have not yet been assigned to any of the other pools. Substances such as intermediates, unclaimed NONS, and substances for which manufacture has ceased, are usually not prioritised for regulatory action and therefore more likely to be mapped to this pool.
It is important to recognise that if a substance is in this pool, this should not be taken to indicate anything about the compliance of the information contained in the registration dossier. Neither does it indicate whether there might be doubts about the (hazardous) properties of the substance. It merely means that the substance has not yet been assigned to any of the other pools.