Global REACH: What’s on the horizon in 2025?
Although 2025 is not a registration year, there are plenty of changes on the horizon for REACH-like regulations. Below we summarise the key trends around the globe.
Ukraine
Ukraine REACH (Technical Regulations on safety of chemical products) is the REACH equivalent regulation in Ukraine. Ukraine REACH was approved in 2024 and took effect on 26 January, 2025. Ukraine REACH mirrors the REACH requirements that chemical substances with annual import/manufacture of ≥1 tonne/year must be registered.
The pre-registration window is from January 2025 to January 2026 to enable existing supply chain benefit from a grace period with the following registration deadlines:
26 January 2026: Carcinogenic, mutagenic, or toxic for reproduction (CMR) substances (Categories 1A and 1B) at ≥1 tonne per year and Substances very toxic to aquatic organisms at ≥100 tonnes per year.
1 October 2026: Substances manufactured or imported at ≥1,000 tonnes per year.
1 June 2028: Substances manufactured or imported at 100–1,000 tonnes per year.
1 March 2030: Substances manufactured or imported at 1–100 tonnes per year.
Turkey
In January 2025, the 2nd version of the draft “Principles and Procedures” document was released. According to the latest draft document, the following changes are expected to be implemented :
Pre-registration deadlines: All potential registrants must complete the pre-registration by 30/06/2025. If there is a new substance which will enter the market after 30/06/2025, the pre-registration deadlines are set as 31/12/2027 for 100-1000 t/y and 31/12/2029 for 1-100 t/y.
Lead Registrant Selection: Lead Registrant (LR) selection for pre-registered substances must be completed by 30/09/2025. The LR candidate must inform potential registrants of their candidacy and obtain approval from at least 70% of those who respond within 30 days. If the LR is not determined (there is no candidate and/or no agreement between potential registrants), the Union of Chambers and Commodity Exchanges of Turkey (TOBB) and MoEUCC will appoint the LR. The three criteria that TOBB and MoEUCC will consider in the selection of LR are: data ownership, company size and the intended tonnage band.
Data Sharing Model Agreement: The selected LR must share the information regarding the registration such as data gap assessment plan, registration tonnage band, data sharing plan with the potential registrants. And again, LR needs to receive 70% approval from potential registrants for the introduced plan. If the agreement is not achieved, a new LR will be selected.
Scope for New Lead Registrant Selection: The procedure introduced in Principles and Procedures document will also apply to the current LRs who have not submitted their dossier yet.
Temporary Registration: In the draft document, a new procedure called “temporary registration” is introduced. Lead registrants can apply for temporary registration by providing a basic level of information (Section 1, 2, 3, 4 and 11 must be provided) by 31/12/2025. Upon Lead Registrant’s temporary registration, joint registrants can also complete their registration until 30/06/2026.
Registration Deadline: If potential registrants are not able to provide the data by the given deadline due to the issues regarding the data purchase rights, the LR will inform the MoEUCC about the situation and will make an extension request. The MoEUCC will make a decision for these requests. As stated in the draft document, the maximum extension will be 2 years from the relevant deadline. Also, it is emphasized that for substances with a registration deadline of 31/12/2030, an extension request cannot be made.
Kindly note that the draft Principles and Procedures document is currently non-binding and is subject to revision. The summary provided herein is likewise subject to change.
United Kingdom
In May 2024, DEFRA published their proposed Alternative Transitional Registration model (ATRm) for UK REACH. The public consultation on the ATRm closed on 25th July 2024.
The aim of the proposed ATRm is to reduce the costs to businesses whilst upholding existing human health and environmental protections by:
Reducing the hazard data required for UK REACH registrants of transitional substances (i.e. those subject to DUIN, grandfathered and NRES)
Enhancing information requirements for use and exposure
Introducing Transitional Evaluation which would require registrants to submit supporting hazard information in certain circumstances
Speeding up decision-making processes, such as the restriction process.
From 1 April 2025, UK REACH registrants will be charged a flat fee of £2,222 per registration (with reduced fees for SMEs), regardless of tonnage band.
South Korea
K-REACH
From 1 January 2025, the registration threshold for new chemical substances changed to ≥ 1 tonne per year. Below 1 t/y new substances must be notified.
K-OSHA
SDS and hazard labels products must be prepared following the updated Korean GHS Standard (MoEL Notice 2020-130). Companies must submit SDS to the MoEL by the following deadlines:
16 January 2025: 1-10 tonnes
16 January 2026: <1 tonne
For products that have not yet been placed on the South Korean market, SDS Submission must be approved before import/manufacture.
United States
TSCA
In October 2023, the EPA enacted a final rule on perfluoroalkyl and polyfluoroalkyl substances (PFAS) under TSCA. The rule requires manufacturers (including importers) of a perfluoroalkyl or polyfluoroalkyl substance (PFAS) in any year since January 1, 2011, to submit a report to EPA and keep records for 5 years.
The PFAS reporting window was supposed to start in November last year, but the EPA announced they will delay the beginning of the reporting period to July 2025 due to budgetary constraints.
China
MEE Order 12 / China REACH
Companies that have registered new substances ≥ 1 tonne/year (Regular Registration) under MEE Order 12 (“China REACH”) need to submit the annual report to the MEE. The Annual Report deadline is 30 April 2024 and the report must include the annual tonnage of the previous calendar year.
China GHS
A new mandatory standard GB 30000.1-2024 Rules for classification and labelling of chemicals - Part 1 was published on 24 July 2024. It is not yet in force but will take effect on 1 August 2025.
Draft Law on Safe Management of Hazardous Chemicals
In December 2024, the People’s Republic of China published the Law on Safe Management of Hazardous Chemicals for public consultation. This is expected to replace Decree 591, which is the current regulation on hazardous chemicals in China.
Like Decree 591, there are registration and licensing requirements, but the draft Law introduces potential registration exemptions for substances supplied in low volumes or with low release. The draft Law places a greater focus on regulatory roles and responsibilities, safety management systems, education and training for employees, use of electronic identification and full life cycle information management and monitoring, and use of information technology to conduct investigations and spot checks. Warehouses storing hazardous chemicals will also need to establish a hazardous chemical export and import database.
Canada
CEPA
Following Section 71 of the Canadian Environmental Protection Act (CEPA), Health Canada issued a mandatory PFAS notice. The reporting deadline was January 29, 2025. The notice applied to entities who, in 2023:
Manufactured >1000 g of a substance listed in Schedule 1;
Imported >10 g of a substance listed in Part 1 of Schedule 1, or >100 kg of a substance listed in Part 2 or Part 3 of Schedule 1, whether the substance was alone, or at a concentration equal to or above 1 ppm in a mixture or in a product or at a concentration equal to or above 1 ppm in one of the categories of manufactured items;
Imported >100 kg of any substance listed in Schedule 1 at a concentration equal to or above 1 ppm in a manufactured item NOT listed in the categories of manufactured items;
Used >10 g of a substance listed in Schedule 1, whether the substance was alone, or at a concentration equal to or above 1 ppm in a mixture or in a product, in the manufacture of a mixture, a product or a manufactured item.
Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5) received royal assent on 13 June 2023. The Bill requires the Ministers of the Environment and Health to develop an implementation framework to set out how the right to a healthy environment will be considered in the administration of CEPA, within two years of receiving royal assent (i.e. by 13 June 2025). The draft implementation framework can be found here.
Chile
Decree 57
Chile’s Decree 57 aims to enhance chemical safety and ensure proper hazard communication. Under the Decree, manufacturers and importers of hazardous substances and mixtures in Chile must fulfil GHS and notification requirements by the deadlines below.
Notification Requirements: Initial Notification: Entities that manufactured or imported hazardous substances in quantities exceeding 1 tonne per year during 2022 or 2023 were required to submit a notification by August 30, 2024. Notifications must be submitted biannually.
GHS Implementation Deadlines: Industrial use mixtures were required to comply with GHS by February 9, 2025.
Brazil
Law 15.022 of 2024
On 13 November 2024, "Brazil REACH" was signed into law.
The main requirements under the regulation are:
National Inventory of Chemical Substances: To establish an inventory, the law requires notification of chemicals on the Brazilian market with tonnage >1t/y.
New substance registration: Once the inventory is established (3 years from the enactment of the regulation), chemicals not on the inventory with tonnage >1t/y must be registered
Priority Substance Assessment and Risk Control: the authority will request further data from the industry for priority substances: e.g. highly toxic chemicals; PBT substances; EDC’s
Colombia
Colombia's Decree 1630 of 2021, is a comprehensive framework for managing industrial-use chemical substances.
Manufacturers/importers/representatives appointed by foreign manufacturers of industrial chemicals and mixtures with classifications according to Decree 1496 (which implements UN GHS Revision 6) and imported or manufactured at > 100 kg/y, must register the hazardous substances by 30 May 2025.
Required information includes:
company identification, annual production or import quantities for 2021–2023
chemical identification (including CAS numbers)
hazard classification per Decree 1496 of 2018
identified uses.
Substances already regulated under specific laws are exempt. After the deadline, unregistered chemicals will be considered new and must be notified within six months if manufactured or imported above 100 kg/year.
