The Globally Harmonised System (GHS) of classification and labelling and packaging of chemicals provides a basis for classification of chemicals by types or hazard and a harmonised hazard communication. The first edition of the GHS was adopted in December 2002 and published in 2003. Since then, every two years, the GHS has been revised, updated and improved with a new revised edition being released. Its implementation is on a voluntary basis, but many countries has adopted it into their national regulations.

The United Nations Economic Commission for Europe (UNECE), part of the United Nations (UN), is the intergovernmental organisation who facilitates the GHS.

For more detailed information on the CI’s substance portfolio under GHS classification, please see Classification.

The Basel Convention is a treaty on the control of transboundary movements of hazardous wastes and their disposal. It was adopted on 22 March 1989 and entered into force on 05 May 1992. Hazardous wastes may not be exported to Antarctica, State not part of the Basel convention or parties having banned the import of hazardous wastes. E-waste and batteries waste are in scope of the Basel Convention.

Over the years, discussions have been held to revise and amend specific annexes. Cobalt Institute is following the discussions related to cobalt and cobalt compounds.

Basel Convention official website

Chemical regulations in Europe are largely driven by the REACH (Registration, Evaluation, Authorisation, and Restrictions of Chemicals) framework, under REACH Regulation (EC) No 1907/2006.

Cobalt Institute acts as Secretariat on behalf of the lead registrants for cobalt and certain cobalt substances registered under EU-REACH. Companies needing to comply with EU-REACH can either join the Cobalt Institute or purchase a Letter of Access data-sharing agreement.

Cobalt Institute engages at different levels with all relevant authorities at European or national levels and other associations on chemicals regulatory activities in Europe.

For more detailed information on the CI’s substance portfolio under EU REACH please see EU REACH and CLP.

To clearly communicate the hazards of chemicals to workers and consumers, the Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 aligns requirements across European Union with the Global Harmonised System (GHS) of classification and labelling and packaging of chemicals. Under CLP, two types of classifications are allowed: harmonised classification (as described in Annex VI of CLP for some hazardous chemicals) and self-classification (recommended by registrants).

Recently under CLP in Europe, new hazard classes were introduced, like Endocrine Disruptors (EDs). Cobalt Institute has actively contributed to discussions and workshops to better understand the criteria as applied to metals and metal substances.

Cobalt Institute engages at different levels with all relevant authorities at European or national levels and other associations on chemicals regulatory activities in Europe.

For more detailed information on the CI’s substance portfolio under EU REACH please see EU REACH and CLP.

The European Commission is currently working on implementing an EU-wide Occupational Exposure Limit (OEL) for cobalt and inorganic cobalt compounds. This is a multi-step process involving expert input into scientific, socioeconomic and political discussions. The value(s) that come out of these discussions will impact cobalt workplaces in all steps of the cobalt value chain in Europe.

Cobalt Institute actively engages at different levels with all relevant authorities at European or national levels and other associations on chemicals regulatory activities in Europe.

For more detailed information on the proposed EU-wide cobalt OEL,  please see Risk Management: EU-Wide Occupational Exposure Limits for Cobalt.

CLH (harmonised classification and labelling)

Under the registry of harmonised classification and labelling (CLH), the National Institute for Public Health and the Environment in the Netherlands (RIVM) has submitted an intention for harmonised classification for the following 8 cobalt substances: Cobalt bis(2-ethylhexanoate); cobalt hydroxide oxide; cobalt dihydroxide; cobalt oxide; cobalt trihydroxide; cobalt sulphide; cobalt(2+) propionate; and cobalt acetyl acetonate.

The proposed classification is Carcinogenic Category 1B (H350) and Reproductive Toxin Category 1B (H360FD). 

While waiting for the publication of the CLH dossier, Cobalt Institute is engaging with the authorities to provide expertise during this process. When the public consultation is opened, Cobalt Institute will engage with our members and the wider cobalt value chain to prepare a response.

As part of the Green Deal, several initiatives are taking place in the European Union, like the Batteries Regulation which came into force in August 2023 and is applicable since February 2024. This regulation set rules for the entire lifecycle of batteries: design, production, use, recycling and disposal. In addition to due diligence obligations, recycling and recovery targets are defined for Cobalt. By 2025, recyclers must recover at least 90% of cobalt from waste batteries. By 2031, 16% (average weight of Cobalt metal in a battery) of Cobalt in a new battery must be recycled content and 26% by 2036. Battery manufacturers must disclose the amount and source of cobalt in their material declaration.

In November 2023, the European Commission requested ECHA (European Chemicals Agency) to prepare a study report on substances of concern in batteries. The timeframe to deliver the final report is expected by end of 2026. To support this initiative, Eurometaux, the European non-ferrous metals association, created a working group “ECaBaM”, the Exchange and Capacity-building Group on Battery Materials. Those workshops enable collaboration between regulatory bodies and industry stakeholder. The definition of substances of concern is part of the deliverables of this project.

Cobalt Institute actively participates to those workshops to support Cobalt in this application.

Another initiative to support the Green Deal in the European Union and its “zero pollution ambition by 2050” is the Industrial Emissions Directive (IED). Directive 2010/75/EU aim to prevent and control pollution from large industrial activities in Europe and set strict rules on emission to air, water and soil as well as on waste management. It is amended by Directive 2024/1785 (also known as “IED 2.0”) which will expand the scope and would include batteries manufacturing and metal mining. The Best Available Techniques (BAT) will be reviewed and for the last 2 mentioned, the consultation period could start by 2026. It could take up to 2 years for final adoption and implementation.

As part of the Green Deal, another initiative to support the Chemicals Strategy for Sustainability (CSS) was developed by the European Commission as “Safe and Sustainable by Design”, known as SSdB. A revision of the framework is expected in 2025.

The recommendation (EU) 2022/25110 is a voluntary approach to guide the innovation process for chemicals and materials. The framework consists of 2 stages:

• a (re)design stage: guiding design principles are proposed to support the safe and sustainable design of chemicals and materials.
• an assessment stage: assessment of the safety and sustainability of a chemical or material in relation du hazards, exposure in working places and/or during use, life-cycle assessment.

Under CSS and as defined in the Ecodesign requirements for Sustainable Products (ESPR), a substance of concern would be defined by the hazards associated with a chemicals and fulfil the criteria of:

• SVHC – article 57 of Regulation (EC) No 1907/2006
• Harmonised classification of CLP - Part 3 of Annex VI to regulation (EC) No 1272/2008
• POPs – Regulations (EU) 2019/1021
• Negatively affect the reuse and recycling of materials in the product in which it is present.

Chemical regulations are shaped by both federal and state authorities, such as the Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA). The US federal government provides broad, overarching laws and regulations that apply nationwide, while state governments have the power to implement their own regulations, which may be more stringent or tailored to specific local needs.

Cobalt Institute engages at different levels with the authorities and other associations to monitor developments and to represent cobalt and cobalt substances.

Under EPA, the Toxic Substances Control Act (TSCA) is the one of the key pieces of legislation governing the regulation of chemicals in the USA. Under this program, the prioritisation of existing chemicals and the metal framework are two essential and relevant pillars for cobalt and its compounds.

Links:

• CI response to recent TSCA prioritisation list

Created in 1985, the Integrated Risk Information System (IRIS) program supports the EPA’s mission to protect human health and the environment.

The IRIS process includes 7 steps to cover development, review and finalisation of a chemicals assessment. Each IRIS assessment covers a chemical or a group of related chemicals. An outlook of the program activities is frequently updated and published on the EPA’s website.

For cobalt and cobalt compounds, the IRIS assessment plan and protocol was released on 14 November 2022 and a 30-day public consultation was held, in which Cobalt Institute submitted a response. In addition, a public science meeting was held on 11 January 2023. The timeline for the next step, the public comment draft and the external peer review, is not known at present.

Links:

• CI response to IRIS assessment plan and protocol

Created in 1980, the Agency for Toxic Substances and Disease Registry (ATSDR) focuses on minimising human health risks associated with exposure to hazardous substances. ATSDR is an advisory, non -regulatory agency.

The process to develop a toxicological profile (Tox Profile) includes the selection of a chemical from a substance priority list, the conduct of a comprehensive literature review, the development of health guidance values, the conduct of a comprehensive internal and external review as well as an independent peer review of the profile. Comments on the draft Tox Profile are collected during a public consultation. After a comprehensive review, the final Tox Profile is published on the ATSDR website.

Cobalt institute responded to the public consultation on the Tox Profile for cobalt. The toxicological profile for cobalt was published by ATSDR in October 2024.

Links:

• CI response to draft ATSDR Tox Profile
• COMMENTS ON ATSDR TOXICOLOGICAL PROFILE FOR COBALT (By Stantec ChemRisk)

Chemicals regulations are primarily organised at the federal level under the Canadian Environmental Protection Act (CEPA). Last amended in 1999, CEPA is currently undergoing significant reform with strengthening the management, prioritisation and risk assessments of harmful chemicals.

Cobalt Institute engages at different levels with authorities and other associations to monitor the development and implementation of the reform of CEPA, with a focus on the priority substances list and the watchlist of chemicals.

Links:

• CI comments on HAWPr Tool