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      UK REACH Fees effective from April 2025
      News

      UK REACH Fees Effective from April 2025

      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.

      Ukraine C&L Notification Draft was published by the Ministry.
      News

      Ukraine C&L Notification: Draft Notification Has Been Published

      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.

      News

      Data Sharing Guidance Updated

      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.

      Info Database

      Data Sharing Management

      The primary purpose of EU REACH-like regulations is to protect the environment and human health from potential or existing harms caused by chemical substances. In line with this objective, over 20,000 chemical substances have been included in the registration process under chemical regulations similar to EU REACH. The information requirements for the registration process are determined based on the tonnage band of the substances manufactured or imported. To meet these requirements, test studies are conducted with the substances, which include animal tests, in vitro tests, and specific calculations. To reduce animal testing and avoid the repetition of these costly tests, Data Sharing is conducted among similar regulations. General Overview of Registration and Data Sharing Processes The steps required to complete the joint registration process of a substance under the chemical regulatory system are shown in the flowchart above. The most complex step in this flow is the data-sharing process. Examples that illustrate the detailed nature of the process include substance identity inquiries, communication with data holders, separating data costs, and local expenses. The joint registration process in the registration system is completed for a member who has completed the data-sharing process through the “Letter of Access” provided by the Lead Registrant. The cost of data sharing for each substance is determined at the beginning of the process. As the number of members wishing to join the joint registration increases, the cost per member decreases proportionally. After a member completes their process, the cost calculation is updated for other members. This approach ensures fair cost-sharing among joint registration members. Thanks to reimbursements, the rights of members who have completed their processes earlier are protected. In short, Data Sharing Management is defined as the regulations for implementing changes/updates that may occur during and after the data-sharing process of the relevant substance and informing joint registration members about all these aspects. There is a solution to the challenges of data sharing management. Relying on our expertise in the field of Chemical Regulations, we offer the industry a sustainable and innovative solution. LoA-Pro allows you to manage data-sharing processes in an organized and efficient manner. LoA-Pro is a software system that consolidates all REACH-like regulations under one platform, providing efficient data-sharing process management. LoA-Pro is a unique system with various advanced algorithms for calculations, easy data management, flexible and reliable automated processes, and much more.

      Info Database

      Data Sharing Rules

      On April 25, 2023, the Data Sharing Rules Document was published by the Ministry of Environment, Urbanization, and Climate Change of the Republic of Turkey, examining the topics of joint submission of data and data sharing rules under the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK). This document contains general explanations in line with the Updated Data Sharing Guidance and consists of five articles. Its purpose is to promote good management practices for the effective operation of data sharing within the scope of the KKDIK Regulation and to ensure the efficient functioning of agreements related to the sharing of such data.

      Regulatory Blog

      Amendment to the KKDIK Regulation

      The regulation titled “Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK)” was published in the Official Gazette dated 23/12/2023 and numbered 32408. As you know, in November 2023, the Ministry published the “Draft Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK).” With this draft, registration deadlines were extended, and it was stated that matters related to the pre-registration deadline and the joint registration process would be determined within the framework of the Procedures and Principles to be published by the Ministry. With the publication of the “Regulation Amending the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK)” on December 23, 2023, the updates made to the KKDIK Regulation have become official, eliminating any uncertainties for the relevant parties.

      Regulatory Blog

      End of 2024 CLP Updates

      This new regulation significantly updates Regulation (EC) No 1272/2008 (CLP – Classification, Labelling, and Packaging Regulation), tightening the management of chemical substances and mixtures. The main changes introduced are: Strengthening Implementation for Online Sales Classification of Multi-Component Substances and Plant Extracts Endocrine Disruptors, PBTs, and Other Hazard Classifications New Criteria for the Classification of Mixtures Major Changes in Labelling and Packaging Requirements Repackaging of Hazardous Substances and Refill Stations New Obligations for Emergency Health Response Information New Regulations for Advertising and Online Sales Changes in the Classification of Industrial Products Transition Processes and Implementation Schedule These amendments aim to strengthen the management of chemical substances to protect both human health and the environment. Notably, significant innovations have been introduced regarding online sales, endocrine disruptors, and digital labelling. 1.Strengthening Implementation for Online Sales It has become mandatory for an EU-based supplier to be involved in online sales from non-EU suppliers. As a result, non-EU companies selling online must comply with regulations through an EU-based supplier. Previously, Regulation (EC) No 1272/2008 assumed that all economic operators were established within the EU. However, non-EU firms could sell hazardous chemicals directly to EU consumers, making regulatory oversight difficult. Solution:By requiring an EU-based supplier, all market placements, including online sales, will be aligned with regulations. This amendment aligns with: (EU) 2019/1020 Market Surveillance and Compliance Regulation (EU) 2022/2065 Digital Services Act (DSA) (EU) 2023/988 General Product Safety Regulation (GPSR) As a result, non-EU firms will be prevented from selling hazardous chemicals directly to EU consumers, online sales platforms will be responsible for monitoring sellers, and authorities will be able to enforce legal actions through EU-based suppliers. 2.Classification of Multi-Component Substances and Plant Extracts Multi-component substances are not fundamentally different from mixtures in terms of hazard classification. According to Article 13 of the EU REACH Regulation, to minimize animal testing, data on multi-component substances should be generated under the same conditions as for other substances. However, individual component data should only be collected if those components are independently registered substances. Special case for plant extracts:Components that may be hazardous in isolation may not pose risks in the full extract. A temporary exception has been introduced to allow scientific evaluation of whether these substances should be classified as mixtures. The European Commission will reassess this issue within five years. 3.Endocrine Disruptors, PBTs, and Other Hazard Classifications New classifications have been introduced for: Endocrine Disruptors (Hormonal System Disruptors) Persistent, Bioaccumulative, and Toxic (PBT) Substances and Very Persistent and Very Bioaccumulative (vPvB) Substances Persistent, Mobile, and Toxic (PMT) Substances and Very Persistent and Very Mobile (vPvM) Substances Specific timelines have been established for the classification and labelling for substances and mixtures.

      What is the Reimbursement System
      Info Database

      Reimbursement Rules

      In the Data Sharing Process, the registration cost is shared between the lead registrant and joint registrants. To ensure fair sharing of information requirements, calculations are made according to the tonnage bands of the members and the lead. When a member obtains a Letter of Access, their process is completed. However, as the number of members for the registered substance changes, the cost per member is recalculated. A new member who obtains the Letter of Access later pays a lower cost than the members who paid before. As a result, a reimbursement must be made to the previous members, ensuring the registration cost is shared fairly among all members. Summary of the Reimbursement System Why is the Reimbursement System Important? The reimbursement system is one of the most important aspects of ensuring compliance with the principles of fairness and non-discrimination in regulations. With the reimbursement system, each member shares the registration cost fairly according to their tonnage band. The reimbursement system ensures cost-sharing among joint registrants without discrimination. The reimbursement system protects the rights of every member of the joint registration, including the lead. Why is the Reimbursement System Complex and Difficult? When a member completes their process and obtains the Letter of Access, the current fee must be recalculated. When reimbursements are made to members, whether the relevant reimbursement has been made, the amount, and its status must be tracked. Updated fees and reimbursements with each new member completing their process can cause confusion during the cost calculation phase. Tracking documents/invoices becomes quite challenging. When automatic processes are not implemented, the calculation and tracking process becomes quite difficult and time-consuming, especially for substances with a large number of joint registrants, increasing the workload. How to Simplify the Reimbursement System? Special algorithms that automatically calculate and provide accurate and reliable results can speed up your compliance with the reimbursement system and make your processes easier. LoA-Pro is a comprehensive software with an optimized reimbursement system working with every calculation scenario and much more. LoA-Pro performs reimbursement calculations on your behalf and accurately and reliably calculates the current price at every step. Reimbursement with LoA-Pro Traditional Reimbursement System The current fee is automatically calculated for each new member, and the relevant member views their fee through the system. Reimbursements are automatically calculated simultaneously at every stage. Reimbursements for each member are recorded in the system. Amounts and statuses can be easily accessed through the system. Information about the reimbursement status is provided to members via automatic emails, as in every stage of the system. Cost calculation is performed to be valid for a certain period for the relevant tonnage bands. During this period, the determined fees apply to all members who wish to complete their process. At the end of the period, reimbursements are calculated according to the number of members and their tonnages. As a result, reimbursements are made to the members. The process is repeated by starting with cost calculation for each new period. Contact us now to benefit from the advantages of LoA-Pro.

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