- Addressing substances of concern
- Universe of registered substances
- How does the chemical universe mapping work?
How does the chemical universe mapping work?
The main source of information for the chemical universe are ECHA’s REACH and CLP databases, which contain information from the registration and notification processes as well as the ongoing, planned and completed regulatory actions 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 and CLP, such as 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 a substance is addressed with different regulatory actions and could be assigned to several pools at the same time, it is only assigned to one pool according to the following order:
- Regulatory risk management ongoing.
- Regulatory risk management under consideration.
- Data generation.
- Currently no further actions proposed.
- Not yet assigned.
Once a regulatory action moves forward, the substance may be assigned to a different pool. 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 been put in place. A relevant regulatory approach has been found for most of the substances and will be followed. Additional assessments or measures are usually not foreseen and therefore, for the purposes of the chemical universe mapping they are considered as low priority for additional EU level regulatory action. 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;
- certain substances restricted under REACH;
- active substances in biocides and pesticides;
- persistent organic pollutants (POPs); and
- substances subject to prior informed consent (PIC).
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 restrictions under REACH; 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 from substance or dossier evaluation, RMOA, PBT/ED assessment, manual screening or a preliminary assessment by ECHA.
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.
Once the regulatory risk management measures are identified, the substance would normally be assigned to the above 'Regulatory risk management ongoing' pool.
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:
- all substances currently under dossier or substance evaluation;
- substances under assessment by the PBT and ED experts groups; and
- substances addressed by the Petroleum and Coal stream working group (PetCo).
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, manual screening or a preliminary assessment by ECHA.
For example, ECHA may conclude at the end of a dossier evaluation 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 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
- Manual screening by Member States or preliminary assessment by ECHA
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.
Substances addressed under the Existing Substances Regulation (ESR), which have not been mapped to other pools, are also included here.
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 are currently registered under REACH and have not yet been assigned to any of the other pools.
Note: 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 ECHA still needs to assign the substance to one of the other pools.