Author name: bilgi@chemleg.com

With Commission Regulation (EU) 2025/2573 dated 18 December 2025, the test methods applicable under the REACH Regulation have been updated. Under this amendment: Human Health, Ecotoxicity, and Nanoforms Structural and Technical Amendments To improve efficiency, additional explanatory notes for certain test methods have been removed. Instead, the updated tables in Part 0 and references to international standards have been adopted as the basis. Updates and Additions Six new OECD test guidelines have been introduced, as listed below: The following test guidelines have been updated: In addition, Commission Regulation (EU) 2025/2573 introduces four new test methods related to the dustiness endpoint (for nanoforms of a substance): Furthermore, A.13 (Pyrophoric Solids and Liquids) in Part A, B.2 (Acute Inhalation Toxicity) in Part B, and B.70 (Estrogen Receptor Binding Assay) in Part B have been deleted. Date of Entry into Force The Regulation will enter into force in all EU Member States on 8 January 2026. For further information and support, you may contact us by completing the form below.

On 26 November 2025, the European Parliament and the Council formally adopted Regulation (EU) 2025/2439. This Regulation introduces critical amendments to Regulation (EU) 2024/2865, specifically regarding the dates of application and transitional provisions. The primary objective of this postponement is to reduce administrative burdens and simplify implementation for companies, aligned with the findings of the 2024 Draghi Report on European competitiveness. The Commission identified that certain requirements, such as those for fuel dispensers at filling stations, were impractical and costly without providing significant health or environmental benefits. New Application Timeline Based on the updated Regulation, the new application dates for the various provisions are as follows: Application Date Provisions and Requirements 1 July 2026 Formatting of labels (Article 1(17)), refill stations (Article 1(18)), specific concentration limits and M-factors (Article 1(22)), and specific sections of Annex I and II. 1 January 2027 Information requirements for poison centres (Article 1(9)), Member State responsibilities (Article 1(24)), and Annex IV. 1 January 2028 Information requirements for advertisements (Article 1(14)), distance sales offers (Article 1(15)(c)), and relabelling requirements (Article 1(26) and (27)). Transitional Provisions (Voluntary Application) To ensure legal clarity, economic operators are permitted to apply the new rules on a voluntary basis before the mandatory deadlines. The derogation periods are structured as follows: Provisions of Regulation (EU) 2024/2865 that are not related to formatting or administrative burdens, and which ensure a high level of protection for human health and the environment, remain unchanged in their original application schedule. This Regulation shall enter into force on the twentieth day following its publication in the Official Journal. Any questions? For detailed information and support on this matter, please submit the form below.

As you may already know, the UK Department for Environment, Food & Rural Affairs (DEFRA) opened a public consultation on 14 July 2025, which remained open until 8 September 2025. On 22 December 2025, DEFRA published the outcome of the consultation on its official website. Accordingly, the government has decided to proceed with the dates set out as Option 1 in the consultation. It stated that the additional time provided under Option 1 will help reduce the burden on small and micro-enterprises and downstream users. At the same time, this approach will ensure that data are available at an appropriate point in time. As stated in the official announcement, the UK government intends, subject to the consent of the Scottish and Welsh Ministers, to bring forward legislation extending the UK REACH submission deadlines to the dates specified under Option 1. The new UK REACH deadlines are as follows: Deadline Tonnage 27 October 2029 1,000 tonnes or more per year 27 October 2030 100 tonnes or more per year 27 October 2031 1 tonne or more per year According to the announcement, the government also intends, subject to the consent of the Scottish and Welsh Ministers, to legislate to align the statutory compliance check dates under Article 41(5) with the new submission deadlines. The new legislation will be brought forward in 2026 following the ordinary parliamentary procedure, ensuring that the revised deadlines and compliance arrangements enter into force in good time before the first extended deadline in October 2029. To access the official announcement, please click here. For updates on UK REACH, you may follow us on our LinkedIn account, or complete the form below to receive support from our team.

At its meeting in November, ECHA’s Biocidal Products Committee (BPC) adopted four opinions on active substances and three opinions on Union authorisations. Opinions Adopted on Active Substances Opinions Adopted on Union Authorisations Biocidal products or biocidal product families must be authorised by the European Commission in order to be made available on the market and used within the European Union and the  European Economic Area. In this context, the biocidal product families for which a Union authorisation opinion was adopted in November are as follows: Opinions Adopted on Post-Authorisation Data What Should Companies Do? The European Commission, together with the EU Member States, will take the final decisions on these opinions. Please stay tuned for updates. Further information on the Committee’s decisions is available on ECHA’s website. Click here to reach.

The European Chemicals Agency (ECHA) has introduced a new tool called B-Risk to facilitate the assessment of risks that biocidal products may pose to bees. The tool is aligned with ECHA’s 2024 Bee Guidance, which will apply as of February 2026. It should be noted that this will not apply to active substances in the review programme. According to ECHA, B-Risk was developed in line with the “one substance, one assessment” approach. It is essentially an extension of the European Food Safety Authority (EFSA), originally designed for plant protection products, but adapted to meet the specific requirements of biocidal products, particularly insecticides. What Does B-Risk Do? With B-Risk, users can carry out the environmental risk assessments required under the Biocidal Products Regulation (BPR). The tool is particularly valued for its contribution to protecting bee health and supporting the EU’s biodiversity goals. Key features of B-Risk for biocides include: How Can You Access B-Risk? B-Risk is accessible via ECHA’s Support page. From there, users are directed to EFSA’s R4EU platform, where the tool is hosted. B-Risk operates entirely online. To access it, users must register on R4EU and accept EFSA’s terms of use. Click here to access the original source and learn more.

As you may know, the EU-wide restriction on microplastics, which entered into force in October 2023, prohibits the intentional use of microplastics in products such as cosmetics, detergents, and certain agricultural products, as well as in some processes where these microplastics are released into the environment. According to ECHA, the Regulation introduces reporting obligations for manufacturers, importers, downstream users, and suppliers placing SPMs or products containing SPMs on the market for certain exempted uses, with the aim of helping monitor and reduce microplastic emissions. Reporting Process for SPMs Has Opened In an article published on its website, ECHA announced that companies can now begin reporting their annual releases under the microplastics restriction. This obligation applies to exempted uses of synthetic polymer microparticles (SPMs), and the deadlines for submitting reports are specified as follows: for manufacturers and industrial downstream users of SPMs in the form of pellets, flakes and powders, used as raw material in plastic production at industrial sites; and 31 May 2026 for all other manufacturers and industrial downstream users of SPMs at industrial sites, as well as for suppliers placing products containing SPMs on the market for the first time for specific exempted uses by professionals or the public   31 May 2027 ECHA notes that examples of exempted SPM uses include veterinary and human medicinal products, food additives, in vitro diagnostic devices, and certain uses at industrial sites. Who is subject to the obligation? The obligation applies to manufacturers, importers, and downstream users alike. In addition, suppliers of SPMs and products containing SPMs are subject to the requirements under certain conditions, particularly when placing such products on the market for the first time. How should the reports be prepared? Companies must prepare annual release reports in IUCLID format and submit them to ECHA via REACH-IT. It should be noted that for now, only initial submissions are possible in REACH-IT. Updates will be allowed from Q2 2026. During this process, companies may use ECHA’s guidance and informational materials, as well as the IUCLID dataset prepared to support users. Click here to access the relevant documents and the source of the news.

On 5 November 2025, the following substance was added to the Candidate List of Substances of Very High Concern (SVHC): Substance name 1,1′-(ethane-1,2-diyl)bispentabromobenzene (DBDPE) EC number 284-366-9 CAS number 84852-53-9 Reason for inclusion Very Persistent and Very Bioaccumulative, vPvB (Article 57e) Example uses Flame retardant Substances added to the Candidate List may also be included in the Authorisation List in the future. If a substance appears on this list, companies can only continue using it after applying for and obtaining authorisation from the European Commission. What should companies do? According to the European Chemicals Agency (ECHA), the following obligations apply to companies: Click here to reach the Candidate List. For more information and to benefit from our registration services, you may fill out the form below:

The European Commission has adopted a revised REACH Fee Regulation, introducing significant changes to chemical registration and authorisation procedures. The new regulation includes innovations such as a mandatory pre-verification for SMEs and increased fees for large companies. The regulation will enter into force 20 days after its publication in the Official Journal of the EU. The ex-ante verification system will become applicable 15 months after the entry into force. Until that date, the current SME verification procedure will remain valid. Fee Increase According to the revised REACH Fee Regulation, standard fees and charges for large companies will increase by 19.5%. This increase is based on the average annual inflation rate in Europe for 2021–2023 and applies only to large enterprises to preserve the competitiveness of SMEs. The updated fees will take effect on 5 November 2025. While reflecting overall economic conditions, the fee increase also aims to reduce the financial burden on smaller businesses. This approach maintains SMEs’ market position while increasing the expected contribution rate from large companies. New Requirements for SMEs Starting from 5 February 2027: The new pre-verification system will clarify a company’s status in advance, simplifying ECHA’s evaluation process and reducing administrative burdens caused by incorrect declarations. Validity and Renewal of SME Status This system eliminates the need for SMEs to submit extensive documentation for each application, saving both time and costs. To facilitate the transition to the new system, ECHA will gradually publish guidance documents to support companies in preparing for the SME verification process. These guides are expected to provide practical information on required documentation, timelines, and common mistakes.  You can review the REACH Fee Regulation here. Fill out the form to start preparing your documentation. Related Services REACH Registration Product Stewardship Only Representation

On 22 October 2025, a draft titled “On Amendments to the Resolutions of the Cabinet of Ministers of Ukraine of May 10, 2024, No. 539 and of July 23, 2024, No. 847” was published. In the draft that is published by Ministry of Economy, Environment and Agriculture (MEEA) the amendments primarily extend timelines to align with the phased for giving industry additional time for dossier preparation and labelling updates. Please note that these amendments are still draft and not in force. The main amendments introduced by this draft regulation are as follows: Process Previous Deadline Updated Deadline UA REACH Pre-registration Deadline 26 January 2026 26 January 2027 UA REACH Registration Deadlines     Substances classified as CMR (Cat. 1A and Cat. 1B) in quantities of ≥ 1 ton/year Substances classified as H400 and H410 (Cat. 1) in quantities of ≥ 100 ton/year 26 January 2026 1 October 2028 Substances manufactured or imported ≥ 1000 tonnes/year 1 October 2026 1 October 2029 Substances manufactured or imported between 100–1000 tonnes/year 1 June 2028 1 June 2031 Substances manufactured or imported between 1–100 tonnes/year 1 March 2030 1 March 2033 Please note that in this draft, A six-month extension could be assumed for C&L Notification, potentially indicating a new deadline around 15 May 2026. Since the currently in-force deadline remains 15 November 2025, preparing a C&L Notification in advance would be an important step to ensure regulatory compliance and market safety. The draft has been published on the official website of the Ministry of Economy, Environment and Agriculture of Ukraine for public consultation, and the approval process of the decree has not yet been finalized. Click here to access the official announcement and share your comments on the draft. Don’t forget to subscribe to our newsletter for future updates on the subject. You can review the related documents through the links below: Related Services Only Representation UA REACH Pre-registration UA C&L Notification