The European Chemicals Agency (ECHA) has developed a “mapping tool” as part of its Integrated Regulatory Strategy designed to provide a transparent look at the status of registered substances as they are shepherded through the European Union’s chemical risk management processes under the bloc’s chemicals management regulations. In this analysis, we briefly explain ECHA’s Universe of Registered Substances and how companies can use this tool to quickly track their formulations’ constellations in the universe of EU chemicals management and what regulatory implications could await the substances found in their products.
Background: universe of registered substances
- The chemical universe is an inventory of the substances registered under REACH, each of which ECHA has allocated to one of six “regulatory pools.” Essentially, by allocating the substances to one of these categories, the agency aims to clarify their status within the EU’s complex chemicals control scheme and what regulatory risk management (RRM) fate may – or may not – await them.
- In the EU, RRM measures include Annex XVII restrictions and Annex XIV authorization under the REACH Regulation (1907/2006/EC), harmonized classification and labeling (CLH) under the CLP Regulation (1272/2008/EC), and EU-wide actions under other legislation.
- The chemical universe supports ECHA’s Integrated Regulatory Strategy (IRS), providing a straightforward way for authorities, NGOs and industry to track registered substances as authorities assess the adequacy of data about them and whether (further) RRM actions are recommended to deal with any uncontrolled human health or environmental risks the substances are found to pose.
- ECHA created the universe of registered substances “[to help] national authorities, ECHA and the Commission monitor the progress made in identifying substances of (potential) concern and appropriate regulatory actions,” according to the agency’s June 2022 Annual Report on the Integrated Regulatory Strategy. Just as important, ECHA emphasizes, is the tool’s purpose “to improve transparency on the actions of authorities towards industry and other stakeholders.”
- Fundamentally, the chemical universe serves to keep the authorities focused on achieving the objectives of the IRS. These are determining by 2027 which substances registered above one metric ton (1) must be prioritized for RRM; (2) represent a low priority for further regulatory action; or (3) must be prioritized for data generation (i.e., substances for which more data must first be generated before assessments can be made whether they require RRM).
- ECHA explains that most of the information on which the universe is based comes from the agency’s REACH registration databases, as well as information related to “ongoing, planned and completed regulatory actions under REACH and CLP, and the outcomes of these actions,” that is, data relating to RRM, or the REACH restriction and authorization and CLP classification and labeling harmonization (CLH) processes. The mapping of the chemical universe is also supplemented by information taken from other EU chemical regulatory frameworks, including the biocidal products (528/2012/EU), plant protection products (1107/2009/EC), and persistent organic pollutant (2019/1021/EU) regulations.
- ECHA has summarized the state of the chemical universe on its website, providing a snapshot of the data points the agency has captured for the registered chemicals as of December 2021.
Where can you find the chemical universe and what data points does it cover?
- The complete inventory is available for download in excel and CSV file formats at the bottom of ECHA’s webpage dedicated to the chemical universe.
- Updated annually, the latest version of the chemical universe is from December 2021. It includes more than 23,400 entries.
- To access either file, you need to first confirm that you have read the accompanying disclaimer by checking the adjacent check box. It states in part that “…the Chemical Universe is not necessarily comprehensive, complete, accurate, or up to date.” And that the agency “provides the chemical universe mapping for information only.” It also notes that the universe is not part of any formal regulatory process under the EU chemical frameworks (e.g., REACH or CLP), nor can any conclusions be made based solely on the list about whether a substance is hazardous or can be used safely.
- Despite ECHA’s qualifications, the chemical universe can still prove helpful in providing a springboard from where companies can initiate searches for more information about potential status of the chemicals affecting their business.
- The excel file contains one worksheet titled “ChemicalUniverse2021.” Each row in the file represents one chemical entry for which ECHA provides the following seven columns of data (note that these data columns are described below): (1) Substance Name; (2) EC number; (3) CAS number; (4) Registration type; (5) Highest registered tonnage; (6) Position in the chemical universe; and (7) Infocard URL.
Columns 1, 2, and 3: Substance identifiers
- Stakeholders are able to track substances by chemical name, or by their EC or CAS number.
Column 4: Registration type
- Substances are categorized as either (1) belonging to active registrations under REACH; (2) ceased manufacture under REACH; (3) NONS – claimed active (that is, substances for which a registration number has been claimed by a previous notifier under the former scheme (i.e., Dangerous Substances Directive – 67/548/EC), and for which no update has been received under REACH); (4) ceased manufacture – claimed NONS; or (5) unclaimed NONS.
Column 5: Highest registered tonnage
- Substances are divided into two groups by quantities manufactured or imported above or below 100 metric tons per annum. Intermediates are grouped separately, as are those whose tonnage information was not disseminated (for example, for confidentiality reasons, or because substances ceased to be manufactured).
Column 6: Position in the chemical universe
- This data column, arguably the most important of the list, groups the substances into six “regulatory pools,” depending on current status. For a detailed description of the six categories and what they potentially mean, please see the section following this discussion of the data columns.
Column 7: Infocard URL
- For each entry in the chemical universe, a link is provided to its respective “infocard” on ECHA’s website. Substance infocards have been created by ECHA “to make the technical information published from the Agency’s substance databases more accessible.” Each publicly accessible chemical substance includes “a high-level summary of all public information ECHA holds on that substance, as well as links to the full details of the public data.”
Where is your substance in the chemical universe?
- Companies can quickly gain insight into where their substances of interest are under the EU’s chemical regulatory processes by understanding what the six “regulatory pools” are under the sixth column heading of data (i.e., ‘Position in the chemical universe’) in the chemical universe excel file.
- These six pools, one of which ECHA has assigned every universe entry to, are:
- Data generation: indicating a need for additional information to be collected or assessment to be conducted for the substance before the authorities can determine whether it should be subject to further regulatory action.
- Assessment of regulatory needs (ARN): ongoing ARNs by ECHA or member states [for details on what encompasses an ARN, see this earlier piece by AgencyIQ].
- Regulatory risk management (RRM) under consideration: RRM actions – like restriction, CLH, or SVHC identification (i.e., preparation for inclusion on the Candidate List) – that are currently being considered for the substance by EU or member-state authorities.
- Regulatory risk management ongoing: that is, RRM actions that have already been finalized and are in place for the substance; examples of substances allocated to this pool include SVHCs (i.e., substances on the Candidate List), restricted substances, CLP Annex VI-listed substances, substances identified as persistent organic pollutants (POPs), and active substances in biocidal and plant protection products.
- Currently no further actions proposed: indicating that at this time, based on current knowledge, the EU plans no further regulatory action for the entry in question.
- Not yet assigned: meaning the entry in question has yet to be assigned to any of the other pools.
- Pages 12-13 of the June 2022 Annual Report on the Integrated Regulatory Strategy (link provided above) explain important implications of the six pool assignments. For example, the report states that substances assigned to the pool ‘data generation’ include those “currently under compliance check or testing proposal evaluation or under substance evaluation, substances being assessed by the PBT and ED expert groups, and substances addressed by the Petroleum and Coal stream working group (PetCo) or under the ECHA-Cefic collaboration on dossier compliance.”
- Because the chemical universe is updated annually and, thus, may not always be up to date, stakeholders should consult ECHA’s online public activities coordination tool (PACT) in combination with it.
- Part of the IRS, the PACT tool also gives stakeholders a transparent overview of the substance-specific activities that authorities are engaged in under REACH and CLP. Unlike the chemical universe, however, ECHA updates PACT on an ad hoc basis year-round.
- The chemical universe, despite ECHA’s qualifications about its potential shortcomings, provides a useful way for economic operators to keep ahead of regulatory actions in the EU concerning the substances that affect their business.
- Knowing in advance of how substances may be regulated contributes to regulatory predictability and market certainty. Ultimately, it allows more time for companies to prepare for possible regulatory and compliance changes.
- While it’s not a crystal ball that can reveal the exact changes, or the exact timelines along which such changes are set to happen, the chemical universe, in combination with PACT, can provide users a reliable starting point from where they can initiate a more targeted search into potentially affected registered substances.
To contact the author of this item, please email Scott Stephens ([email protected]).
Key Documents and Dates
- European Chemicals Agency’s webpage dedicated to the Universe of registered substances (contains the latest version of the list that, upon acknowledging the disclaimer, is available for download in excel and CSV formats). (December 2021)
- Annual Report on the Integrated Regulatory Strategy (June 2022)