Author name: bilgi@chemleg.com

On 3 October 2025, the European Commission adopted new measures restricting the use of PFAS in firefighting foams. PFAS use is one of the major sources of environmental pollution in the European Union. To protect human health and the environment, the Commission introduced new measures to restrict the use of PFAS (per- and polyfluoroalkyl substances) under the REACH Regulation. This restriction aims to minimise PFAS emissions and prevent the release of approximately 470 tonnes of PFAS into the environment each year. According to the Commission’s announcement, this measure will help reduce soil and water contamination while also protecting firefighters from exposure to PFAS-containing foams. Based on the scientific assessment of the European Chemicals Agency’s (ECHA) committees, the restriction includes specific transition periods to allow industry to switch to PFAS-free alternatives, which are stated in the related Regulation. The new regulation will officially enter into force 20 days after its publication in the Official Journal of the European Union. It will become applicable following transition periods ranging from 12 months to 10 years, depending on the use, providing sufficient time for the replacement with safer and more effective alternatives. You can review the Comission Regulation (EU) 2025/1988 below. Click here to access the official source of the news.

At its September meeting, which took place on 9–11 September 2025, the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) adopted four opinions on active substances and six on Union authorisations. Adopted Opinions on Active Substances Regarding carbon dioxide, ECHA made the following statement: “Supporting the amendment of the inclusion of Carbon dioxide (CO₂) in Annex I of the Biocidal Products Regulation (BPR). This inclusion in Annex I is restricted to: ‘Only for use in ready-for-use gas canisters functioning together with a trapping device.’” At the meeting, a request was made to revise the existing restrictions on CO₂, upon which the BPC proposed the following: “For product authorisations it shall be ensured that the exposure for professional users remains below the acceptable exposure concentration (AEC): 1.5% v/v carbon dioxide for the STEL (short-term exposure limit) 15 minutes, and 0.5% v/v carbon dioxide for the TWA (time-weighted average) 8 hour.” ECHA stated that this new restriction would enable broader authorisation of CO₂-based products while ensuring safe use within the defined exposure limits. Non-approval of Poly(dimethyloctadecyl[3-(trihydroxysilyl)propyl]ammonium chloride) Poly(dimethyloctadecyl[3-(trihydroxysilyl)propyl]ammonium chloride) generated from di-methyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride (DMOAP)was proposed for use in the following product-types: Product-type 2 – Disinfectants and algaecides not intended for direct application to humans or animals, Product-type 7 – Film preservatives, Product-type 9 – Fibre, leather, rubber and polymerised materials preservatives. However, the BPC recommended non-approval for all three product types, as no safe use was identified. Six Union Authorisations Supported At the September BPC meeting, the following Union authorisations were supported: A biocidal product containing active chlorine generated from sodium chloride by electrolysis for product-types 2 and 4 (food and feed area); A biocidal product containing Alkyl (C12–16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12–16)) and Glutaral (Glutaraldehyde) for product-types 3 (veterinary hygiene) and 4; A biocidal product containing Peracetic acid for product-type 2; A biocidal product family containing L-(+)-lactic acid for product-types 2 and 4; A biocidal product family containing Peracetic acid for product-types 2, 3 and 4; and A biocidal product family containing Glutaral (Glutaraldehyde) for product-types 6, 11 and 12. Decisions and Competent Authorities The ECHA annex provides information on Commission decisions and competent authorities. These are summarised in the table below: Topic Product-Types Decision Rapporteur Member State Opinion on approval of DMOAP 2, 7, 9 Not approved Spain CO₂ Annex I inclusion – Approved Netherlands Biocidal product containing active chlorine generated from sodium chloride by electrolysis 2, 4 Approved (simple majority) France Biocidal product containing ADBAC/BKC and Glutaraldehyde 3, 4 Approved Belgium Biocidal product containing Peracetic acid 2 Approved Germany Biocidal product family containing L-(+)-lactic acid 2, 4 Approved Germany Biocidal product family containing Peracetic acid 2, 3, 4 Approved (simple majority) Netherlands Biocidal product family containing Glutaraldehyde 6, 11, 12 Approved Netherlands Questions on the risks of exposure of workers to corrosive particles during the use of biocidal products by coarse spraying – Approved France and Belgium Examination of alternatives to cholecalciferol and its possible use by the general public 14 Approved (simple majority) Sweden The opinions discussed and adopted at the meeting will be published on ECHA’s website. ECHA also announced that the next meeting will be held on 24–28 November 2025. For questions on this topic or to receive support with your biocidal products, you can contact us. This article was originated from ECHA. Contact with our experts

On 24 July 2025, the European Commission published a Commission Implementing Regulation (EU) in the Official Journal. This regulation amends Regulation (EU) No 564/2013 to adjust ECHA’s fees in line with inflation. According to Article 17 of Commission Implementing Regulation (EU) No 564/2013, fees must be reviewed annually based on inflation. In this context, a cumulative inflation rate of 19.5% was determined by taking into account the average annual inflation rates for the years 2021, 2022, and 2023, and a decision was made to increase the fees accordingly. What does the fee update cover? The amendment solely concerns the adjustment of fees based on inflation and affects the fees related to applications for the placing on the market and use of biocidal products. The new fees will also apply within the European Economic Area starting from 14th August. New Fees Effective from August The updated fees, as determined by the European Commission, are as follows: In Annex I, Table 1 is replaced with the following: Table 1: Standard Fees General description of task; relevant provision in Regulation (EU) No 528/2012 Specific condition or task description Fee (EUR) Approval of an active substance; Article 7(2) Fee for the first product-type for which that active substance is approved 143 400 Additional fee per additional product-type 47 800 Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 23 900 Fee for the amendment of an approval, other than the addition of a product-type 23 900 Renewal of an approval; Article 13(3) Fee for the first product-type for which renewal of that active substance is sought 17 925 Additional fee per additional product-type 1 793 Additional fee for the first product-type for which renewal of that active substance is sought in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 29 875 Additional fee per additional product-type in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 2 988 Additional fee per product-type (for both the first product-type and any additional product-type) if the active substance is a candidate for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 23 900 Inclusion in Annex I of an active substance; Article 28 Fee for the first inclusion in Annex I of an active substance 11 950   Fee for the amendment of an inclusion of an active substance in Annex I   Notification in accordance with Article 17(4) of Commission Delegated Regulation (EU) No 1062/2014 Fee per substance/product-type combination. The fee for the notification shall be deducted from the subsequent application for approval 11 950 In Annex II, Table 1 is replaced with the following: Table 1: Standard Fees General description of task; relevant provision in Regulation (EU) No 528/2012 Specific condition or task description Fee (EUR) Granting of Union authorisation, single product; Article 43(2) Fee per product not identical with (one of) the representative product(s) assessed for the purpose of the substance approval 95 600   Fee per product identical with (one of) the representative product(s) assessed for the purpose of the substance approval 47 800   Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 47 800   Additional fee per product when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 11 950 Granting of Union authorisation, biocidal product family; Article 43(2) Fee per family 179 250   Additional fee per family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 71 700   Additional fee per family when the requested authorisation is provisional in accordance with Article 55(2) of Regulation (EU) No 528/2012 17 925 Notification to the Agency of an additional product within a biocidal product family; Article 17(6) Fee per additional product 2 390 Union authorisation of a same biocidal product; Article 17(7) Fee per product constituting a ‘same product’ within the meaning of Commission Implementing Regulation (EU) No 414/2013  (2) 2 390 Major change of an authorised product or product family; Article 50(2) Fee per application 47 800 Minor change of an authorised product or product family; Article 50(2) Fee per application 17 925 Administrative change of an authorised product or product family; Article 50(2) Fee per notification 2 390 Recommendation on the classification of a change of an authorised product or product family; Article 50(2) Fee per request in accordance with Commission Implementing Regulation (EU) No 354/2013 (3) If the recommendation is to classify the change as an administrative or minor change, the fee for the request shall be deducted from the subsequent application or notification in accordance with Implementing Regulation (EU) No 354/2013 2 390 Renewal of Union authorisation, single product; Article 45(3) Fee per product 5 975   Additional fee per product in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 17 925   Additional fee per product when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 47 800 Renewal of Union authorisation, biocidal product family; Article 45(3) Fee per product family 8 963   Additional fee per product family in case a full evaluation is found necessary in accordance with Article 14(1) of Regulation (EU) No 528/2012 26 888   Additional fee per product family when comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 is required 71 700 ANNEX II ‘ANNEX III Other fees General description of task; relevant provision in Regulation (EU) No 528/2012 Specific condition or task description Fee (EUR) Technical equivalence; Article 54(3) Fee, when difference between the active substance sources is limited to a change in manufacturing location, and application is based solely on analytical data 5 975 Fee, when difference between the active substance sources goes beyond a

The UK Department for Environment, Food & Rural Affairs (DEFRA) is considering postponing the transitional registration deadlines for chemical substances under UK REACH. A public consultation, launched on 14 July 2025 and open until 8 September 2025, is currently gathering stakeholder feedback on the proposed changes. As is well known, UK REACH (the United Kingdom’s chemical registration system) requires the registration of chemical substances placed on the GB market. However, following the UK’s departure from the European Union, the chemical data sets collected under EU REACH were not transferred to the UK’s Health and Safety Executive (HSE). As a result, many chemical substances on the GB market still require registration under UK REACH. The government continues to work on a new model called the Alternative Transitional Registration model (ATRm). Preliminary drafts of the ATRm were shared with the public during a previous consultation in 2024. However, since the details of the model have not yet been finalized, it remains unclear what data must be submitted and when. According to DEFRA, the government does not anticipate that the data requirements will exceed those proposed in 2024. Given that the legislation needed to implement the ATRm will not be in force in time, it will not be feasible to meet the current registration deadlines of October 2026, October 2028, and October 2030. Therefore, three alternative sets of new deadlines have been proposed for public consultation: Option 1 is the government’s preferred choice as it provides an estimated two-year transition period for finalizing the ATRm and allowing industry time to adapt. Additionally, shortening the gap between registration deadlines from two years to one would still offer adequate time for data collection and submission, while enabling regulators to access information more rapidly and efficiently. The consultation also includes a proposal to extend the deadlines for compliance checks that HSE is required to conduct on 20% of incoming registration dossiers, as stipulated in Article 41(5) of UK REACH. Click here to access DEFRA’s official statement and related documents. For any questions regarding UK REACH, please fill out the form.

On 5 June 2025, the draft Resolution of the Cabinet of Ministers and the accompanying Rules for Joint Submission of Information in Registration Applications under Ukraine REACH were published. These rules were prepared in accordance with Article 38 of the Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products” (LCS). According to the announcement published on the MEPR website, the aim of this draft regulation is to establish the procedure for the joint submission of information in registration applications for the same chemical substance under UA REACH. For details, you can visit the announcement page by clicking here. What Does “Draft Rules for Joint Submission of Information” Introduce? Would You Like to Submit Feedback? The Ministry invites feedback from companies, NGOs, academics, experts, and other stakeholders regarding the published draft regulation. All submitted comments will be considered in the preparation of the final version of the text, and revisions may be made accordingly. You can submit your feedback on the draft rules published under UA-REACH to info@mepr.gov.ua by 5 July 2025. Do You Have Questions? For any inquiries on the topic, you may contact info@chemleg.com. Related Services UA REACH Only Representation UA REACH Pre-registration and Registration UA CLP Stewardship

ECHA announced the inclusion of the following substances in the Candidate List on 25 June 2025: Substance name EC number CAS number Reason for inclusion Examples of uses 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane 241-867-7 17928-28-8 Very persistent and very bioaccumulative, vPvB (Article 57e) Used as a laboratory reagent, in cosmetics and personal care products, and in perfumes and fragrances Decamethyltetrasiloxane 205-491-7 141-62-8 Very persistent and very bioaccumulative, vPvB (Article 57e) Used in cosmetics and personal care products, in lubricants and greases, and in automotive care products Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate; Reactive Brown 51 466-490-7 – Toxic for reproduction (Article 57c) Used in textile treatment products and dyes *Click here for the source. As with other substances on the Candidate List, these newly added substances are not eligible for the EU Ecolabel award under the EU Ecolabel Regulation. Besides, if they are later included in the Authorisation List, companies will not be allowed to use them unless they apply for authorisation and the European Commission grants permission for continued use. What Does Inclusion in the Candidate List Mean? According to the REACH Regulation, inclusion of a substance on the Candidate List—whether on its own, in mixtures, or in articles—triggers certain legal obligations for companies. For articles containing these substances at concentrations above 0.1%, suppliers must inform consumers about the safe use of their products. ECHA has stated that importers and manufacturers must notify ECHA about any products containing these substances within six months from 25 June 2025. Safety data sheets (SDS) must also be updated accordingly. Chemleg is here to support you in the authorisation and restriction processes under EU REACH. Contact us for assistance. Related Services

On 2 June 2025, the European Commission adopted Regulation (EU) 2025/1090. This regulation introduces new restrictions on the use of N,N-dimethylacetamide (DMAC) (CAS No. 127-19-5, EC No. 204-826-4) and 1-ethylpyrrolidin-2-one (NEP) (CAS No. 2687-91-4, EC No. 220-250-6). With this regulation, Annex XVII (Restriction List) of the EU REACH Regulation has been amended. About the Newly Added Substances N,N-dimethylacetamide (DMAC) DMAC is classified as a Category 1B reproductive toxicant and a Category 4 acute toxicant. The new update introduces the following restriction for DMAC: 1.Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 13 mg/m3 for long-term exposure by inhalation and 1,8 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. 3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 23 June 2029 in relation to placing on the market for use, or use, as a solvent in the production of man-made fibres. 1-ethylpyrrolidin-2-one (NEP) 1-ethylpyrrolidin-2-one (NEP) is classified as a Category 1B reproductive toxicant. The following restriction applies to NEP: 1. Shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, derived no-effect levels (DNELs) relating to exposure of workers of 4,0 mg/m3 for long-term exposure by inhalation and 2,4 mg/kg bw/day for long-term dermal exposure. 2. Shall not be manufactured, or used, as a substance on its own, as a constituent of other substances, or in mixtures in a concentration equal to or greater than 0,3 % after 23 December 2026 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1. When Will the Regulation (EU) 2025/1090 Enter into Force? Regulation No (EU) 2025/1090 will enter into force on 23 June 2025, and companies are advised to begin preparations accordingly. In this regard, you can find the roadmap we have prepared for companies below. Roadmap for Companies Companies should identify whether DMAC and NEP are used in their products and create an inventory accordingly. For each product or process, it should be checked whether the concentration exceeds 0.3%, and updated SDSs should be requested from upstream manufacturers and importers. Chemical Safety Reports (CSRs) and SDSs should be updated to include the correct DNEL values, and exposure scenarios should be prepared. Necessary personal protective equipment (PPE) should be determined with occupational safety experts. Technical measures such as ventilation, closed systems, gloves, and masks should be implemented in production processes to reduce worker exposure below DNELs. Training documents and work instructions should be revised, and updated SDSs should be shared with customers and distributors. From 23 December 2026, the placing on the market and use of products containing ≥0.3% DMAC or NEP will be prohibited unless DNEL-compliant SDSs, CSRs, and exposure control measures are in place. Companies are strongly advised to be prepared. For companies using DMAC as solvents in the production of man-made fibres, the obligations described above will apply from 2029. For all other sectors, the transition period ends in 2026. Plan Your Compliance Process with Chemleg At Chemleg, we support companies with DNEL calculations, CSR updates, REACH-compliant SDS preparation, and more. You can schedule a meeting with us and start your compliance process immediately. Click here to fill out the form. Related Services

The European Chemicals Agency (ECHA) has redesigned the Classification and Labelling (C&L) Inventory within its chemicals database, ECHA CHEM. The updated inventory is now accessible to users. What is ECHA CHEM? To briefly remind, ECHA CHEM is a platform created by the European Chemicals Agency to improve the use of the largest database in the European Union. Due to the sheer volume of information, users have increasingly found the former database difficult to navigate. To improve usability and accessibility of a database that receives over 30 million views, ECHA developed ECHA CHEM. For more information about ECHA CHEM, you can read this article. What Has Been Updated in ECHA CHEM? To facilitate easier access to classification information for users, the user interface has been improved. Additionally, current and upcoming harmonised classifications at the EU level have been clarified. This aims to support companies in preparing for and implementing necessary safety measures. The C&L Inventory, which includes more than 4,400 harmonised classifications and classifications notified or included in REACH registrations, contains data on approximately 350,000 substances in total. According to ECHA, the updated inventory has been adapted in line with recent legislative changes and designed with future developments in mind. How to Use ECHA CHEM? The video below provides information on how to use ECHA CHEM. For more detailed information about your chemicals, feel free to contact us.  

The Ministry of Environmental Protection and Natural Resources (MEPR) of Ukraine has launched the pre-registration process for chemical substances manufactured and imported at ≥ 1 ton on January 26, 2025. As part of this process, manufacturers, importers, and suppliers are now required to submit information about their chemical substances to the relevant authorities until January 26, 2026. These obligations are being implemented under the Technical Regulation on the Safety of Chemical Products. The aim is to ensure that chemical substances potentially hazardous to human health and the environment are systematically monitored and officially registered. To facilitate a standardized and efficient registration process for all stakeholders, the Ministry has developed a unified pre-registration form, which is now available on the official MEPR website. Companies are instructed to complete this form and send their chemical substance pre-registrations to reach@mepr.gov.ua. For any questions regarding this matter, please feel free to contact us. You can also click here to learn more about our Ukraine REACH registration services.