EU REACH and CLP
The safe use of cobalt in various industries is a top priority for Cobalt Institute, ensuring that exposure risks are minimised for both workers and the general population.
Through comprehensive regulations like the EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation and responsible industry practices, we strive to protect human health and the environment.
EU REACH
The EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation is the main piece of legislation in the EU to manage the risks that chemicals can pose to human health and the environment. Under this framework, the responsibility to generate relevant data to ensure safe use of substances placed on the EU market was placed on industry.
The Cobalt Institute has long supported the cobalt industry in meeting its obligations under the REACH and CLP regulations.
From 2007 to 2022, this role was carried out through a wholly owned subsidiary, the Cobalt REACH Consortium Ltd. (CoRC), which served as Secretariat on behalf of Consortium members. CoRC has since been fully integrated into the Cobalt Institute.
Today, the EU REACH Group within the Cobalt Institute serves as the Secretariat, managing key functions for its members – including budget planning, strategic direction, scientific coordination, and data sharing.
Registration
Under REACH, all manufacturers and importers of chemical substances in the EU—including cobalt and its compounds—must submit a registration dossier to the European Chemicals Agency (ECHA) if they handle quantities exceeding one tonne per year.
To comply, companies must identify and manage the risks associated with their substances, demonstrate how these substances can be used safely, and communicate appropriate risk management measures (RMMs) to downstream users.
While downstream users are not required to register substances under REACH, it is important that they provide details about their uses to the Cobalt Institute. This information supports the safe use of cobalt-containing substances across all applications.
The Cobalt Institute is responsible for maintaining and updating the registration dossiers for more than 20 cobalt substances. These updates ensure the dossiers reflect the latest scientific knowledge and regulatory requirements.
| List of registered substances | ||
| Substance | EC/List number | CAS number |
| Cobalt | 231-158-0 | 7440-48-4 |
| Tricobalt tetraoxide | 215-157-2 | 1308-06-1 |
| Cobalt carbonate | 208-169-4 | 513-79-1 |
| Cobalt dichloride | 231-589-4 | 7646-79-9 |
| Cobalt dihydroxide | 244-166-4 | 21041-93-0 |
| Cobalt dinitrate | 233-402-1 | 10141-05-6 |
| Cobalt sulphate | 233-334-2 | 10124-43-3 |
| Cobalt sulphide | 215-273-3 | 1317-42-6 |
| Cobalt hydroxide oxide | 234-614-7 | 12016-80-7 |
| Cobalt oxide | 215-154-6 | 1307-96-6 |
| Cobalt lithium dioxide | 235-362-0 | 12190-79-3 |
| Cobalt di(acetate) | 200-755-8 | 71-48-7 |
| Cobalt(2+) propionate | 216-333-1 | 1560-69-6 |
| Cobalt bis(2-ethylhexanoate) | 205-250-6 | 136-52-7 |
| Neodecanoic acid, cobalt salt | 248-373-0 | 27253-31-2 |
| Cobalt, borate propionate complexes | 295-033-2 | 91782-61-5 |
| Cobalt, borate 2-ethylhexanoate complexes | 295-032-7 | 91782-60-4 |
| Cobalt, borate neodecanoate complexes | 270-601-2 | 68457-13-6 |
| Cobalt oxalate | 212-409-3 | 814-89-1 |
| Cobalt(II) 4-oxopent-2-en-2-olate | 237-855-6 | 14024-48-7 |
| Stearic acid, cobalt salt | 237-016-4 | 13586-84-0 |
| Resin acids and rosin acids, cobalt salts | 273-321-9 | 68956-82-1 |
| Reaction mass of cobalt and copper and iron | 912-664-7 | – |
| Reaction mass of cobalt sulphide and nickel sulphide and trinickel disulphide | 910-663-6 | – |
Evaluation
Once a registration is submitted, ECHA and EU Member States may evaluate the information provided in the dossier—particularly if data gaps are identified or if the registrant seeks approval to conduct vertebrate animal testing.
As part of the Evaluation process, registrants may be required to provide additional data or clarification.
REACH outlines three key areas of Evaluation:
- Compliance checks of registration dossiers
- Assessment of testing proposals submitted by registrants
- Substance evaluation by Member States to address potential risks
Cobalt Institute coordinates the scientific and budgetary activities associated with any Evaluation procedures related to registration dossiers under its responsibility.
Authorisation and Restriction
Authorisation and Restriction are key regulatory processes under EU REACH designed to limit the use of substances that pose unacceptable risks to human health or the environment.
Substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) category 1A or 1B, Persistent, Bioaccumulative and Toxic (PBT), or of equivalent concern may be placed on the Candidate List of Substances of Very High Concern (SVHCs). These substances can then become subject to Authorisation requirements under REACH.
The Restriction process limits or bans the manufacture, placing on the market, or use of a substance if its risks cannot be adequately controlled.
The Cobalt Institute, along with the former Cobalt REACH Consortium and downstream users across the cobalt value chain, played an active role in past Authorisation and Restriction discussions involving cobalt-containing substances. Their input was critical in demonstrating that these regulatory tools were not the most appropriate means of managing workplace exposure to cobalt.
This contribution helped steer the focus toward developing EU-wide occupational exposure limit values (OELs) for cobalt and inorganic cobalt compounds—a process that is currently in the political decision-making phase.
Classification
Under EU Regulation No. 1272/2008 on the classification, labelling, and packaging of substances and mixtures (EU CLP), companies are required to ensure the safe use of substances by clearly identifying and communicating their hazards.
Cobalt Institute plays an active role in supporting the appropriate classification of cobalt and cobalt-containing substances. This includes generating scientific and regulatory evidence, engaging with regulatory authorities, and developing position papers when necessary to ensure that classifications are scientifically justified and proportionate.
An overview of the classification and concentration limits under CLP of the substances under the Institute’s portfolio is available via the CI Secretariat (please email REACHinfo@cobaltinstitute.org). Please note that the information in the overview will apply only to pure substances and targets CLP requirements. Therefore, it only applies to the European Union territory.
For an overview of the classification of these substances under GHS, please contact the CI Secretariat (REACHinfo@cobaltinstitute.org).
For the substance cobalt (EC 231-158-0, CAS 7440-48-4) in powder form, a particle-size based classification is used. In order to determine the respirable fraction of any cobalt powder, the “Size Weighted Respirable Fraction” (SWeRF) is calculated, taking into account the particle size distribution and the probability that the particles reach the alveoli, and using cumulative particle size distribution.
This particle-size based classification can be overruled by an in vivo testing result on an individual powder only.
If you have any questions on cobalt and cobalt compound EU CLP classifications, please contact the CI Secretariat (REACHinfo@cobaltinstitute.org).
Safe use
Cobalt Institute promotes the safe production and use of cobalt and cobalt-containing compounds.
Under REACH, companies are required to report the uses of the substances they place on the market, indicate the appropriate risk management measures per use and communicate this information throughout the supply chain.
Cobalt Institute coordinates the generation of:
- Exposure Scenario Documents: These cover the identified uses of the cobalt substances and provide risk management measures per substance. They are also appended to the registration dossiers;
- Exposure Scenarios For Communication (SDS ES): These are included in the Extended Safety Data Sheets to ensure that downstream users are informed of risks and best use practices.
Data sharing
There are several options available to meet the needs of both EU and non-EU industry companies, as well as for the downstream users of cobalt substances:
- Membership to the EU REACH Group of the Cobalt Institute
- Letter of Access (LoA)
- License to Use (LtU)
The list of the cobalt substances managed by Cobalt Institute can be found here.
EU REACH Group membership
The EU REACH Group oversees the strategic and budgetary management of substance registrations under the Cobalt Institute’s REACH portfolio (view list). All members of the EU REACH Group are also members of the Cobalt Institute.
Scientific and technical input into the EU REACH dossiers is provided through Technical Working Groups and Task Forces, which are open to Cobalt Institute members who opt into the Chemicals Management Option.
Companies interested in registering multiple cobalt substances are encouraged to join the Cobalt Institute and become part of the EU REACH Group as regular members.
Benefits of EU REACH Group membership
Data-sharing
- Opportunities for wider cost-sharing.
Cobalt Institute’s Secretariat provides management and coordination of the whole process in a timely and cost-effective way. - Members can license the access or use of the studies/data to third parties (prior written agreement required from Cobalt Institute).
- Secretariat will prepare the necessary data-sharing and/or data license agreements.
- Access to Legal advice on REACH issues and associated agreement templates on a cost-sharing basis.
Regular members can receive copies of the studies/data that goes into the core part of the dossiers (data ownership).
Participation
- Regular membership covers participation of legal Affiliates.
- Avoidance of duplication of effort by working within a larger group.
- Builds a consensus approach to the overall work programme.
- Representation in decision making processes (one company = one vote).
- Involved in detailed review and decisions regarding proposals for studies/testing programme and associated costs, as well as review/approval of the overall consortium budgets.
Technical Aspects
- Participation in the technical discussions of the Working Groups/Task Forces.
Access to knowledge on REACH and associated requirements. - Technical support regarding cobalt substances, use of read-across, classification and labelling, GHS, etc.
Support with each part of the implementation of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). - Involvement in the update and maintenance of the core part of the Registration Dossiers.
- Technical knowledge gained through participation can assist companies with preparing their own part of their submission.
If you would like to join the EU REACH Group, whether you are already a member of the Cobalt Institute or not, please contact the CI Secretariat (REACHinfo@cobaltinstitute.org).
Letter of access
Companies interested in data ownership and active involvement in data collection and registration dossier development are encouraged to join the Cobalt Institute’s EU REACH Group.
Alternatively, the Letter of Access (LoA) option offers a less intensive form of participation. By sharing costs and relying on a dedicated team of experts to maintain the dossiers, this option provides an attractive choice for companies seeking to comply without direct involvement in dossier management.
However, the LoA option does not grant ownership of any data or studies produced or obtained by the Cobalt REACH Consortium/Cobalt Institute, nor does it allow access to view or use these materials. Instead, the LoA simply grants the company the right to reference the dossier as a Co-registrant in accordance with REACH Article 10(a).
The cost-sharing mechanism associated with the LoA option is outlined in the Funding Structure Document.
Licence to Use
Cobalt Institute encourages the global use of its data. Companies may request access to EU REACH data for read-across purposes or for uses beyond the EU REACH framework (i.e., outside the EU). In such cases, a Licence to Use (LtU) agreement is required. Four scenarios are possible:
Case A:
Use of Cobalt Institute data for read-across to a cobalt substance not covered by the Consortium, for the purpose of REACH registration within Europe.
Case B:
Use of Cobalt Institute data within the EU for purposes other than REACH.
Case C:
Use of Cobalt Institute data outside the EU for registrations or authorisations in other jurisdictions (e.g., Korea REACH, KKDIK) by Cobalt Institute members.
Case D:
Third-party requests to use or purchase Cobalt Institute data for EU or non-EU registrations or authorisations (e.g., Korea, China).
All companies—including EU REACH members and holders of Letters of Access—should contact the Secretariat at REACHinfo@cobaltinstitute.org to discuss their specific case and next steps. Since each request may vary, the Institute prepares tailored agreements for each company. The cost-sharing mechanism associated with the LtU option is outlined in the Funding Structure Document.