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You can access the latest consolidated version of EU REACH Regulation below in PDF format: EU REACH Regulation PDF What is the EU REACH Regulation? The EU REACH Regulation is a comprehensive regulation governing the manufacture, import, and use of chemical substances within the European Union. REACH stands for: Legal Basis of the EU REACH Regulation Primary Legal Basis: Regulation (EC) No 1907/2006 The direct legal basis of REACH is Regulation (EC) No 1907/2006, adopted by the European Parliament and the Council on 18 December 2006. This Regulation was enacted pursuant to Article 95 of the Treaty establishing the European Community. The main objective of the Regulation is to ensure the free circulation of chemical substances throughout the European Union, improve the functioning of the internal market, and at the same time guarantee a high level of protection of human health and the environment. It also aims to enhance the competitiveness and innovation capacity of the EU chemicals industry. Fundamental Principles of REACH REACH is based on the following principles: Other Relevant Legislation The EU REACH Regulation is closely linked to the following legislation: Fees and Charges Under the EU REACH Regulation, fees are payable for services provided by the European Chemicals Agency, such as chemical registration, requests for confidentiality of information, and updates to registration applications. These fees can be found in the REACH Fee Regulation, or you may contact us for support. Our EU REACH Expertise at Chemleg With its expert team, Chemleg provides consultancy services within the scope of the EU REACH Regulation. Our services include: Contact Us To benefit from our services and operate smoothly in the European Union market, you may contact us by completing the form below.

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.

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.

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.