Q&A info

They will be available on our website in PACT or via the assessment of regulatory needs list.

You can see from the ECHA PACT website or via the assessment of regulatory needs list  if there is a group assessment report for your substance. If yes, you can download ECHA’s report on the assessment of regulatory needs, which includes a list of substances within this group. Note that the assessment is done within a short time period; it is iterative and for most of the groups an updated report will be published for instance after the generation of additional hazard information, where needed. Note also that this is preparatory work for the existing formal regulatory processes; any assessment in one of the formal processes will be communicated on ECHA’s website as usual in accordance with the respective procedures.
 

No, ECHA will not publish a list of the groups as such and their member substances. ECHA will publish the assessment of regulatory needs done on each group and ECHA’s reports include the list of the substances covered in each group. They will be available on our website in PACT or via the Assessment of regulatory needs list.
 

For its assessments of regulatory needs, ECHA forms and selects groups according to several criteria, including among others the known or suspected hazards of some group members, or the position of the substances in the chemical universe [see also Q&A 1869]. Normally, it is not foreseen that ECHA forms and selects groups on request; in case of concrete suggestions/ questions, however, please contact ECHA. 

In most cases, compliance check is proposed as the first action and when that has started for a substance you find further information on the status under Dossier Evaluation on ECHA’s website. In case a compliance check has been opened for your registration, ECHA also informs you via REACH-IT.   
PACT will also show when any of the other REACH/CLP processes has started, and also sometimes when an authority has submitted an intention (e.g. for harmonised classification).

Registrants can find ECHA’s group assessment reports on the ECHA PACT website or via the assessment of regulatory needs list. This report gives an overview of the assessment for the group, including if there is (no) action planned for the moment for any substance within the group. When ECHA updates the assessment, a new report will be published.
 

The initial grouping is done primarily using IT-based algorithms and following two broad, complementary methods:

• structural similarity, which uses the substance identity information in registration dossiers and C&L notifications; and
• associations made by the registrants between substances through read-across and category approaches as well as category associations from external sources (e.g. OECD categories).

The algorithmically generated groups are verified by chemists and group membership is reconsidered through the group assessment.

Structurally similar substances are identified within the universe of registered substances around pre-selected substances known as ‘seeds’. Examples of seeds are substances in Annex VI to the CLP Regulation, in the Candidate List or listed in the CoRAP, for which there is already an identified or potential hazard. Another starting point for grouping could be a substance that has a certain type of use or function with a potential for exposure.

Note that these methods are different from grouping as defined in Section 1.5 of Annex XI to REACH and therefore do not constitute validated read-across and category information according to that requirement. 

ECHA utilises all available information for grouping substances. The algorithms use all available identifiers in all registrations, compositions and reference substances in IUCLID dossiers. Hence, it is quite likely that all structurally related substances are identified, to the extent that the submitted information allows to do so. However, for certain substances, such as inorganic UVCBs, substance grouping may be less accurate and may require additional manual effort for fine tuning the approach and manually verifying the accuracy of the results.

Substance grouping by ECHA is designed to be inclusive and is robust to the extent that is possible. E.g. small differences in molecular structure that are considered insignificant for grouping can be toxicologically relevant. The assessment of the regulatory needs of the group may include such considerations, in which case it is possible that the group will be split in smaller subgroups, or the substances will be assessed individually. Hence, the robustness of the group depends on the process/stage we are at and at the level of certainty this stage requires. Therefore, group membership is reconsidered throughout the iterative group assessments. 

Groups are formed based on similarity of chemical structures and cover both substances with known/ likely hazards and substances not currently known or suspected to be hazardous. ECHA may address (potentially) hazardous substance earlier than substances with unlikely hazards, but the systematic grouping of the chemical universe will address all REACH registered substances eventually.

Registrants cannot influence ECHA’s initial grouping based on structural similarity. The purpose of ECHA’s grouping based on structural similarity is mainly to facilitate and speed up the assessment of substances. However, up-to-date information in registration dossiers will be taken into account during any potential follow-up regulatory action as well as at later iterations of the assessment of regulatory needs of the group. Also any changes in read-across or category adaptations by the registrants will be taken into account by ECHA in later iterations of the assessment of regulatory needs.

See also Q&A 1878 on the benefits of updating registration dossiers.

ECHA’s assessment of regulatory needs is mainly based on the information provided in the REACH registration dossiers. A (foreseen) need for regulatory risk management under REACH, CLP and other EU legislations depends on the potential hazards identified, the uses and potential for exposure or releases identified. The assessment of regulatory needs is an iterative process that can start from a low level of information and high uncertainty on the best way forward, moving to data generation and to proposing more definitive regulatory management options for the (groups of) substance(s). Note that the assessment of regulatory needs is iterative: the foreseen regulatory actions may therefore change based on new information, further assessment or change in policy. 

EU regulatory risk management actions are expected for many assessed substances. However, most of these substances may require further data generation and confirmation of their hazards before the need for planned actions can be confirmed or actions can be initiated.

Regulatory risk management actions can be initiated either by Member States and/or ECHA (upon request by the Commission) through the formal processes.

ECHA is mainly using the information on uses (e.g. life cycle stages, type of products, use description) reported in the REACH registration dossiers (IUCLID) as a proxy for assessing the potential for exposure to humans and releases to the environment. The potential for release/exposure is generally considered high for “widespread” uses, i.e. professional and consumer uses and uses in articles. For these uses, normally happening at many places, the expected level of control is, in theory, considered limited. No quantitative exposure assessment is performed at this stage and so the chemical safety reports are normally not consulted. In some cases, public information can also be used.

The potential for exposure is then considered together with the (potential) hazard to assess the regulatory needs for the (group of) substance(s).

The initial grouping by ECHA provides a useful starting point for assessing substances. However, it does not necessarily mean that the same regulatory needs will be identified for all substances within a group or that the full group will be progressed towards the same regulatory action by authorities. Actions proposed as outcome of our assessments can be on the entire group, subgroup(s), or individual substance(s). For instance, ECHA may propose restriction or CLH for one substance, a sub-set of substances in the group or for the entire group. 

We take ongoing actions into account in the assessment of regulatory needs of the group however the assessment will not impact the ongoing regulatory actions. We check whether there are any planned or ongoing activities with the substances in the group before the assessment of regulatory needs is done on the group. 

A formal assessment of registrant’s read-across /category approach is only done in the context of the relevant formal processes (e.g. compliance check); ECHA does not formally accept or confirm the registrant’s read-across in its assessments of regulatory needs. See also Q&A 1868 on how the grouping is done by ECHA.

When "currently no need for further EU RRM action" is proposed based on available information, this may be because of several considerations e.g. on hazard, registration status, existing legislations, uses, potential for exposure or combinations of those. Therefore, if new information becomes available (e.g. on hazard, uses) this conclusion will need to be revisited.

A conclusion on “Currently no need for further EU RRM action” based on the current registered uses and hazard information doesn’t necessarily mean the substance is safe for all future new uses. In addition, in some specific situations where “Currently no need for further EU RRM action” is foreseen, reference is made to company level risk management and the responsibility of registrants and downstream users to ensure safe use of the substances in any case. For instance, registrants and downstream users are expected to adequately (self) classify their substances and implement the necessary risk management measures and operational conditions to ensure the safe use of the substances.

One of the aims of the publication of the ECHA group assessment reports is to increase transparency of authorities' work in the early stages of the assessment and to give registrants the possibility to clarify the potential hazard and use profile of their substances. The improved quality of the registration dossiers will in turn provide authorities a more solid basis for deciding on the need for further actions. Therefore, if we have in registration dossiers accurate information on hazards and uses this will impact the way substances are proceeding to further processes. 

It is in the interest of both authorities and industry that we focus on hazardous substances for which uses are of relevance from a regulatory risk management perspective.

If you consider that the information in your registration is not up-to-date, or that you have additional data that may assist with the assessment of your substance, ECHA recommends updating your dossier as soon as feasible for you. The updated information will be taken into account during the ongoing or future group assessment or during any potential follow-up regulatory action. In any case, you as a registrant have the obligation to keep your dossiers up to date with the latest available information.   

In the context of the assessments of regulatory needs of groups of substances, ECHA does not foresee direct interaction with the registrants. We highly recommend that registrants update their registrations proactively on hazards, uses and volumes information as soon as possible and preferably before the planned regulatory actions would start. The information provided in the update will be taken into account by ECHA in the following formal processes and when updating the assessment of regulatory needs. In case of additional questions we would recommend to contact ECHA.

Once an assessment of regulatory needs for a group of substances is published, we encourage registrants to consult them and to consider the concern identified (if any) and the proposed next steps. 

Whenever a formal process is initiated on a substance, the information is available on our website, along with the contact details of the authority initiating the action. We also encourage industry to contribute to the consultations foreseen in the different regulatory processes.