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You can click the link below to access the PIC Regulation: EU PIC Regulation (EU) No 649/2012 What Is the PIC Regulation (EU) No 649/2012? The PIC Regulation refers to Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals. It implements within the European Union the procedures established by the Rotterdam Convention for certain hazardous chemicals and pesticides in international trade. What Are the Main Objectives of the PIC Regulation? The PIC Regulation implements the Prior Informed Consent (PIC) procedure for certain hazardous chemicals in international trade. Like other EU chemicals legislation, such as REACH and CLP,, the PIC Regulation aims to protect human health and the environment. By facilitating the exchange of information on the properties of hazardous chemicals, it contributes to the environmentally sound use of these substances. The Regulation covers certain hazardous chemicals that are subject to the PIC procedure or are banned or severely restricted within the European Union. Key Principles of the PIC Regulation Implementation of the Rotterdam Convention: The primary principle of the Regulation is to implement at European Union level the Rotterdam Convention, which establishes the Prior Informed Consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade. Shared responsibility and cooperation: The Regulation promotes shared responsibility and cooperative efforts between exporting and importing countries to protect against potential harm arising from the international movement of hazardous chemicals. Promotion of environmentally sound use: By facilitating the exchange of information on the properties of hazardous chemicals, the Regulation aims to ensure that these substances are used in an environmentally sound manner. Common export notification procedure: A standard export notification procedure applies to chemicals, mixtures or articles that are banned or severely restricted within the EU and are exported to third countries, regardless of whether the importing country is a Party to the Rotterdam Convention. Explicit consent requirement: Before certain hazardous chemicals may be exported, explicit consent must be obtained from the competent authorities of the importing country. This constitutes a critical control for preventing unwanted exports. Information exchange and transparency: The Regulation facilitates the exchange of regulatory, safety and hazard information on hazardous chemicals. It also requires exported chemicals to comply with applicable packaging and labelling requirements. Technical assistance and capacity building: The provision of technical assistance is encouraged, particularly for developing countries and countries with economies in transition, to help them develop the infrastructure and expertise required to manage chemicals properly throughout their life cycles. Product safety and shelf life: Exported chemicals must comply with applicable packaging and labelling requirements and have an adequate shelf life to ensure that they can be used safely and effectively, particularly in developing countries. Obligations of Companies under the PIC Regulation Some of the obligations imposed on companies under the PIC Regulation are as follows: Ensure Compliance with the PIC Regulation with Chemleg Chemleg provides PIC notification services for the European Union and Türkiye. For further information, please visit our service page by clicking here. You can contact our team by filling out the form below.

You can click the link below to access the EU CLP Regulation: EU CLP Regulation (EC) No 1272/2008 PDF What is the EU CLP Regulation (EC) No 1272/2008? The EU CLP Regulation (EC) No 1272/2008 aims to ensure a high level of protection of human health and the environment. It also seeks to guarantee the free movement of substances, mixtures, and certain articles within its scope. CLP stands for: What Is the Scope of the EU CLP Regulation (EC) No 1272/2008)? Which product groups are excluded? The EU CLP Regulation applies to nearly all substances and mixtures, including substances placed on the market or registered via REACH, hazardous polymers and formulations and pesticides and biocides. However, there are some exemptions, which are listed below: What is legally required on packaging and labelling under the EU CLP Regulation? The main obligations introduced by the EU CLP Regulation are summarised below: Classification obligation Substances and mixtures must be classified in accordance with the Regulation. All available information must be collected and assessed for adequacy and reliability before classification. Necessary tests must be carried out to determine hazards; testing on animals must be used only as a last resort. Classifications must be updated without undue delay where required.   Labelling obligation The packaging of a substance or mixture classified as hazardous must include supplier details, product identifiers, hazard pictograms, signal words, hazard statements, and precautionary statements. The label must be written in the official language(s) of the Member State where the product is placed on the market. Labels must be updated without undue delay when necessary. Packaging obligation Packaging must be designed to prevent the contents from escaping and must be made of durable materials. For hazardous products supplied to the general public, packaging must not have designs that may attract children. Certain hazard classes require child-resistant fastenings and tactile warnings of danger. Notification obligation Manufacturers and importers must notify the classification and labelling information of substances they place on the market to ECHA within one month after placing the product on the market. Retention and submission of information Suppliers must retain all information used for classification and labelling purposes for at least 10 years after the last supply of the product. Upon request by competent authorities of Member States or ECHA, suppliers must provide this information. Provision of information for emergency health response Importers and downstream users must submit harmonised information on the composition of mixtures they place on the market to the bodies appointed by Member States, in accordance with CLP Article 45 and Annex VIII. This includes the obligation to submit information via the Poison Centre Notification (PCN) portal and to ensure that a Unique Formula Identifier (UFI) is included as part of the submission and on the product label. Cooperation in the supply chain Suppliers must cooperate with one another to ensure compliance with classification, labelling, and packaging requirements. Relationship Between the EU CLP Regulation (EC) No 1272/2008 and REACH The EU CLP Regulation and the REACH Regulation are two complementary pillars of EU chemicals legislation. These two legal frameworks operate in direct connection at many technical and administrative levels. For example, substances subject to registration or notification under REACH, even if not placed on the market, must be classified according to the criteria of the CLP Regulation. Furthermore, where manufacturers and importers have already submitted classification and labelling information as part of a REACH registration dossier, a separate notification under CLP is not required. When performing hazard assessments under CLP, the general rules and existing data referred to in Annex XI of the REACH Regulation are also taken into account. The terminology used for identifying substances or mixtures must be fully consistent between the CLP label and the Safety Data Sheet (SDS) prepared in accordance with Article 31 of REACH. These examples illustrate the close interrelation between the two Regulations. To achieve full legal compliance, it is advisable to work with expert consultancy firms specialised in both legal frameworks. EU CLP Regulation (EC) No 1272/2008 Compliance Process with Chemleg If you are an exporter to the European Union, an importer, an Only Representative, or a formulator, you may have obligations under the EU CLP Regulation. Chemleg can support you in this process with the following services: You can contact our team by filling out the form below.

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.