Author name: bilgi@chemleg.com

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.

DEFRA (UK’s Department for Environment, Food & Rural Affairs) has announced updates to certain registration and authorisation fees under UK REACH. The new fees came into effect on 1 April 2025. According to UK authorities, this update is based on the price indices and fee structures proposed by HSE. The updated fee schedule was published on 10 March 2025 under the name The REACH Fees and Charges (Amendment of Commission Regulation (EC) No 340/2008) Regulations 2025. Updated UK REACH Fees Registration Fees Fees for full registrations and intermediate-only registrations have been revised as follows: 1. Standard Fees Tonnage Band Individual Submission Joint Submission All Tonnage Bands £2,222 £2,222 2. Reduced Fees for SMEs Tonnage Band Medium (Ind.) Medium (Joint) Small (Ind.) Small (Joint) Micro (Ind.) Micro (Joint) All Tonnage Bands £740 £740 £399 £399 £57 £57 The lack of tonnage differentiation in standard fees means the base registration cost is the same whether 1 tonne or 1000 tonnes of a substance is manufactured. It is a different approach compared to the EU REACH regulation. However, the reduced fees can help SMEs. A micro-enterprise may pay up to 97% less than a large company for the same registration. Update Fees To maintain transparency and oversight in UK REACH processes, fees for updates under Article 22 have also been revised: Tonnage Band Updates 1. Standard Fees Type of Update Individual Submission Joint Submission All Updates £2,222 £2,222 2. Reduced Fees for SMEs Type of Update Medium (Ind.) Medium (Joint) Small (Ind.) Small (Joint) Micro (Ind.) Micro (Joint) All Updates £1,249 £1,249 £672 £672 £96 £96 Identity Change Identity change fees apply in cases such as mergers, name changes, etc. 1. Standard Fees Type of Change Fee Change in identity of the registrant involving a change in legal personality £290 2. Reduced Fees for SMEs Type of Change Medium Small Micro Change in identity of the registrant involving a change in legal personality £261 £232 £72 Other Changes 1. Standard Fees Type of Update Individual Submission Joint Submission Degree of purity and/or identity of impurities or additives £4,271 £3,203 Relevant tonnage band £1,424 £1,068 A study summary or a robust study summary £4,271 £3,203 Information in the safety data sheet £2,847 £2,135 Trade name of substance £1,424 £1,068 IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 £1,424 £1,068 IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development £1,424 £1,068 2. Reduced Fees for SMEs Type of Update Medium (Ind.) Medium (Joint) Small (Ind.) Small (Joint) Micro (Ind.) Micro (Joint) Degree of purity and/or identity of impurities or additives £2,776 £2,082 £1,495 £1,121 £214 £160 Relevant tonnage band £925 £694 £498 £374 £72 £53 A study summary or a robust study summary £2,776 £2,082 £1,495 £1,121 £214 £160 Information in the safety data sheet £1,851 £1,388 £996 £747 £142 £107 Trade name of the substance £925 £694 £498 £374 £72 £53 IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 £925 £694 £498 £374 £72 £53 IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development (not specified)           PRORD Fees Under Article 9 of the UK REACH Regulation, the fees for PRORD notification and PRORD exemption extension are as follows: PRORD Notification Standard fee £751 Reduced fee for medium enterprise £308 Reduced fee for small enterprise £166 Reduced fee for micro enterprise £24 PRORD notification fees are relatively low compared to other categories, which supports research and development activities. Fees for Extension of PRORD Exemption Standard charge £751 Reduced charge for medium enterprise £617 Reduced charge for small enterprise £332 Reduced charge for micro enterprise £47 Authorisation Application and Review Fees Authorisation Application 1. Standard Fees Application Type Fee Base Fee £57,689 Additional Fee Per Substance £11,538 Additional Fee Per Use £51,920 2. Reduced Fees for SMEs Application Type Medium Small Micro Base Fee £43,267 £25,960 £5,769 Additional Fee Per Substance £8,653 £5,192 £1,154 Additional Fee Per Use £38,940 £23,364 £5,192 Authorisation Review 1. Standard Charges Review Type Fee Base Charge £57,689 Additional Charge Per Substance £11,538 Additional Charge Per Use £51,920 2. Reduced Charges for SMEs Review Type Medium Small Micro Base Charge £43,267 £25,960 £5,769 Additional Charge Per Substance £8,653 £5,192 £1,154 Additional Charge Per Use £38,940 £23,364 £5,192 Authorisation and review fees are notably high, representing a significant cost for companies dealing with SVHCs. Firms are advised to support their applications with thorough justification and explore safer alternatives. Strategic Recommendations • Cost PlanningCompanies are advised to prepare annual budgets that consider costly processes like authorisation and review. • SME DeclarationTo benefit from reduced fees, companies must complete their SME declarations accurately and on time. • Alternatives to SVHCsWhere possible, firms should prioritize substitution of SVHCs to avoid the authorisation process. • Consultancy SupportErrors in these processes may lead to serious financial consequences; expert guidance is strongly recommended. How Chemleg Consultancy Can Help At Chemleg, we support companies in navigating UK REACH registration, notification, and authorisation processes, including: • Development of compliance strategies• Accurate SME declarations• Technical dossier and IUCLID preparation• Data sharing management for lead registrants and obtaining Letter of Access (LoA) for co-registrants with LoA-Pro. Learn more about our UK REACH registration services.

The Ministry of Environmental Protection of Ukraine has prepared a draft notification form in accordance with the requirements of the Technical Regulations on Classification, Labelling, and Packaging of Chemical Products. This draft aims to ensure consistency in the forms completed and submitted to the Ministry at the email address clp@mepr.gov.ua, in the process of Ukraine C&L notification. According to the Ministry of Environmental Protection and Natural Resources (MEPR) website, before chemical products are placed on the market in Ukraine: It is recommended to use this draft form in relevant notifications. Click here to access the draft. You can simplify the legal compliance process for your company by using our Ukraine C&L notification service.

The Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK) requires existing and/or potential registrants to make every effort to reach an agreement on data sharing and to ensure that the cost of sharing the information required for registration is determined fairly, transparently, and in a non-discriminatory manner. The rules necessary to ensure the efficient implementation of existing obligations regarding joint submission and data sharing are included in the Data Sharing Guidance. Update Content Summary of Key Aspects Explained in the Data Sharing Guidance The key aspects explained in the Data Sharing Guidance are summarized below: The Data Sharing Guidance ensures that the information required for the registration process is shared fairly, transparently, and in a non-discriminatory manner. This guidance outlines the obligations related to agreements and the management of data and cost-sharing required under KKDIK. Fundamentally, under KKDIK, a registrant or potential registrant must: The rules required to ensure the efficient implementation of existing obligations regarding joint submission and data sharing by registrants or potential registrants are provided in this guidance. The relevant guidance states that both administrative costs and costs related to information requirements must be shared transparently among only the registrants concerned and clarifies the mandatory elements that must be included in each agreement. Data Sharing Agreement According to the Data Sharing Guidance, a data-sharing agreement must be established. The parties are free to agree on the format of the data-sharing agreement within the scope of contractual freedom. However, regardless of the chosen format, the fundamental principles of fairness, transparency, and non-discrimination outlined in the KKDIK Regulation must be upheld.In any case, data sharing is designed not to generate profit for the data owner(s) but to share the actual costs incurred. The following mandatory elements must be included:a) A list of the data to be shared and associated costs,b) A list and justification of administrative costs,c) A cost-sharing model that must include a reimbursement mechanism; the inclusion of potential future data needs in the cost-sharing model should also be considered. Each registrant must be the legal owner of the study report or have permission to refer to the study report for the study summary and/or robust study summary submitted for registration. Joint registrants should have access to all the information submitted on their behalf in the joint registration dossier that they need for registration and have paid for. By paying for access to the joint submission, joint registrants should have access to at least the endpoint conclusions they have paid for, or if available, a copy of the robust study summary and study summary. Regarding the content of the dossier and the type of access obtained through the agreed cost-sharing, the following elements should be clear and understandable for all parties in the data-sharing agreement: In the event of a data-sharing dispute under the KKDIK Regulation, the Ministry will consider whether the parties have acted in accordance with the obligations specified in the guidance. During data-sharing negotiations, the parties are obligated to make every effort to reach an agreement on data sharing in a fair, transparent, and non-discriminatory manner.