# Global Product Compalince (GPC) Group > Global Chemical Registration Consultant > Admin Email: keith@kr.gpcregulatory.com ## Pages ### Norway REACH [rank_math_breadcrumb] Norwegian Chemical Regulation Norway REACH What is Norway REACH? Producers and importers of hazardous substances and mixtures to the Norwegian market have to follow the Regulations on declaration of chemicals to the product register (declaration regulations), enforced on June 1, 2015. Applicants need to submit information to Norwegian Environment Agency (NEA) before they place the products. Applicants also have the duty to notify (PCN) to the European Chemical Agency (ECHA). Registration Requirements Businesses producing or importing 100 kg or more of a chemical substance are to declare their products, where the registration must take place by the latest when manufacture, market placement, or professional use begins in Norway. Companies need to provide the following information for registration: Company information unambiguous chemical name for all chemical substances in the substance mixture; CAS no. and EC No.; code for hazard class and hazard category as well as code for hazard statements according to CLP; the amount of each component expressed as % weight. The annual deadline for the quantities report is May 20, 2022, applicants need to report annual quantities of chemicals processed the previous year, including chemicals discontinued during the previous year. Do you want to know more about Norwegian Chemical Regulation? Explore more about Norway REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Norway REACH Check out our Norwegian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### Thank You Thank You! Your details have been successfully submitted. We appreciate you taking the time to provide us with your information.What Happens Next?Our team will review your submission shortly.If needed, we’ll contact you using the details you provided.Expect a response within 5 to 6 business daysWhat Would You Like to Do Next?🔹 Return to Homepage – Explore more about us.🔹 Browse Our Services – See how we can help you.🔹 Contact Us  – Have another question?Need Immediate Help?For any urgent inquiries, feel free to contact us at:📧 Email: info@gpcregulatory.com📞 Phone: (+46) 46 211 4615Thanks again for reaching out—we’re excited to assist you!     ### Ukraine REACH [rank_math_breadcrumb] Ukraine Chemical Regulation UA REACH UA REACH Registration & Only Representative (OR) Services in Ukraine – Ensure Full Compliance and Market Access Expanding into Ukraine’s chemical market requires compliance with the new UA REACH regulation. Many global companies struggle with complex registration rules, data preparation, and communication with authorities. GPC simplifies Ukraine REACH registration by acting as your Ukraine REACH Only Representative, managing all submissions, reports, and updates to ensure smooth market access. What Is Ukraine REACH (UA REACH)? Ukraine REACH, officially known as the Ukrainian Technical Regulation on the Safety of Chemical Products, entered into force on 26 January 2025. Commonly called UA REACH, it creates a comprehensive regulatory framework aligned with the European Union’s REACH Regulation (EC No 1907/2006). The regulation governs the registration, evaluation, authorization, and restriction of chemical substances manufactured, imported, or sold in Ukraine. It applies to all chemicals exceeding one tonne per year, requiring companies to identify hazards, assess risks, and ensure safe use. In essence, Ukraine REACH is the country’s version of the EU REACH system, protecting human health and the environment while supporting fair trade with the EU. Regulatory Authority The Ministry of Economy, Environmental and Agriculture of Ukraine (MEEA) is responsible for overseeing the enforcement of and compliance with the UA REACH Regulation. The Ministry is tasked with managing the registration process, evaluating compliance, and ensuring that chemical products meet the required safety standards. In addition, the Ministry has the authority to impose sanctions or corrective actions on companies that fail to meet regulatory requirements. Why Appoint a Ukraine REACH Only Representative Foreign companies cannot register directly under UA REACH. A Ukraine-based Only Representative (OR) must handle registration, pre-registration, and official communication with MEEA. Working with an experienced partner like GPC ensures: Legal representation and full regulatory compliance in Ukraine Seamless market access without local incorporation Efficient management of UA REACH registration and reporting GPC serves as a reliable Ukraine REACH representative company, guiding global manufacturers through every stage of UA REACH compliance. Book Consultation with GPC'S Ukraine OR Expert Mandatory Registration and Key Provisions Under UA REACH, any company involved in the import, production, or sale of chemical substances in Ukraine must comply with the following provisions: 1. Mandatory Registration All chemicals ≥ 1 t/y must be registered. Technical dossiers must describe substance identity, uses, and risk-management measures. Failure to register can result in penalties or market suspension (“no data, no market”). 2. Chemical Safety Report (CSR) Required for ≥ 10 t/y. Must include hazard and exposure assessments throughout the life cycle. Add nanomaterial information where applicable. 3. Hazardous Chemicals Substances classified as CMR (Carcinogenic, Mutagenic, Reprotoxic) or harmful to aquatic life undergo stricter assessment. 4. Pre-Registration (26 Jan 2025 – 26 Jan 2026) Transitional phase for existing substances. Late pre-registration available for new entries introduced before subsequent deadlines. 5. Registration Deadlines Deadline Category Jan 2026 CMR 1A/1B ≥ 1 t/y or aquatic toxicity ≥ 100 t/y Oct 2026 ≥ 1 000 t/y Jun 2028 100 – 1 000 t/y Mar 2030 1 – 100 t/y Update: On 22 October 2025, Ukraine’s Ministry of Economy, Environment and Agriculture published a draft resolution proposing to extend the pre-registration and registration deadlines under UA REACH. The draft is currently open for a 30-day public consultation 6. Simplified Registration Substances already registered under EU REACH may follow a simplified   UA REACH procedure if data sharing requirements are met. UA-REACH Compliance Process Step 1 – Technical Dossier Submission Submit via EcoSystem Service, including: IUPAC name and CAS number Restrictions on use Purity and molecular structure details Nano-form information (if applicable) Step 2 – Chemical Safety Report Provide hazard control measures, exposure scenarios, and risk assessment results. Step 3 – Classification and Labelling Ensure compliance with UA CLP (Classification, Labelling and Packaging) rules. Who Must Comply Manufacturers and Importers placing substances on the Ukrainian market. Authorized Representatives / UA Only Representative acting for foreign companies. Downstream Users employing substances in industrial processes and maintaining safety records. Penalties and Enforcement Non-compliance with UA REACH can result in a range of penalties, from administrative fines to criminal sanctions, depending on the severity of the violation. Companies found to be in violation of registration requirements or safety standards may face market restrictions or revocation of their registration Request Pre-Registration Assistance UA REACH Compliance & OR Services Provided by GPC as Ukraine REACH representative company As a leading provider of Ukraine REACH registration support, GPC offers end-to-end Ukraine OR services for international manufacturers seeking compliance under UA-REACH. Our local team in Kyiv delivers expert guidance and regulatory management for smooth market entry. 1. Representation and Compliance Management Serve as your official UA OR services partner for all UA REACH obligations. Maintain legal responsibility for documentation and liaison with MEEA. Enable compliance without the need to establish a local entity. 2. Pre-Registration Support Manage pre-registration of existing substances (2025 – 2026). Handle late pre-registrations for new market entries. Ensure correct data submission through the EcoSystem Platform. 3. Exemption Assessment and Certification Determine eligibility for UA REACH exemptions. Prepare and issue official certificates confirming status for audits and inspections. 4. Full Registration Management Oversee the entire UA REACH registration workflow from data collection to dossier submission. Compile technical dossiers with usage profiles and risk-management measures. Represent clients directly before MEEA as their UA Only Representative. 5. Spectral Analysis and Verification Conduct spectral and spectroscopic testing to confirm composition of substances or mixtures. Analyse and validate client data for accurate registration records. 6. Member Dossier Preparation Develop member dossiers for joint registrations and data-sharing arrangements. Protect confidential information while ensuring regulatory consistency. 7. Chemical Safety Report (CSR) Preparation Create comprehensive CSRs covering hazard classification, exposure scenarios, and lifecycle controls. Align with both UA REACH and EU REACH best practice standards. 8. Study Management and Monitoring Coordinate physicochemical, toxicological, and ecotoxicological studies. Supervise laboratory quality and data validation to ensure reliable results. 9. Regulatory Monitoring and Updates Provide ongoing updates on UA REACH and UA CLP changes. Alert clients to deadline extensions or new obligations. Support strategic planning for long-term portfolio compliance. Why Choose GPC as Your Ukraine REACH Representative Company Over 15 years of global REACH experience (EU, UK, Turkey, Korea, Ukraine) Local Kyiv office with dedicated regulatory specialists Trusted by 1500 + international clients for representation and compliance Recognized among reputable Ukrainian REACH representative companies offering reliable regulatory support 📍 Office 3/5, 11 Myrnoho Panasa Street, Kyiv 01011, Ukraine 📞 +38 099 089 11 06 ✉️ uareach@gpcregulatory.com Get in Touch with Our Regulatory Expert Contact US Conclusion UA REACH aligns Ukraine’s chemical safety standards with the EU framework, ensuring protection of health and the environment. By partnering with GPC, a leading Ukraine REACH Only Representative, you gain expert compliance guidance, efficient registration management, and secure market access in Ukraine. Do you want to know more about Ukraine Chemical Regulation? Explore more about Ukraine REACH Contact US Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Discover more regulations... VIEW ALL REACH EU Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### UK Cosmetic Product Notifications UK Cosmetic Product Notifications [rank_math_breadcrumb] GPC Service UK Cosmetic Product Notifications Cosmetic Product Notifications Service is a streamlined and professional solution for ensuring compliance and safety in the cosmetic industry. This service offers a straightforward process for notifying regulatory authorities about cosmetic products. By simplifying the notification procedure, we assist businesses in meeting regulatory requirements efficiently. Our unique approach not only ensures compliance but also emphasizes the importance of safety and quality in cosmetic products. Do you want to know about EU cosmetic regulation service? Click here What are Cosmetic Product Notifications? Cosmetic Product Notifications are a crucial aspect of regulatory compliance. At its core, this process involves notifying OPSS (GB Cosmetics Notification Portal ) about your cosmetic products, a step essential for ensuring consumer safety. By providing OPSS with detailed information, you contribute to the ongoing monitoring of product safety, enabling prompt action if necessary. Cosmetics Product Information File: The Blueprint for Notifications The Cosmetics Product Information File (PIF) serves as the foundational document for Cosmetic Product Notifications. This comprehensive file must include key details:Product name and categoryName and address of the responsible personList of all ingredients, with INCI names and CAS numbersSafety assessment of the productRelevant safety information, including warnings and precautions Cosmetic Product Information Checklist: Key Components for Compliance When preparing your Cosmetic Product Notifications, ensure you incorporate the following essential information into your checklist:Product name and categoryName and address of the responsible personList of all ingredients, with INCI names and CAS numbersSafety assessment of the productRelevant safety information, including warnings and precautionsImage of the product labelPhotograph of the cosmetic product packaging How GPC Group Facilitates Cosmetic Product Notifications At GPC, our comprehensive services cover all aspects of Cosmetic Product Notifications, including:Preparing the PIF: Our experts ensure that your Cosmetics Product Information File is thorough and compliant.Submitting Notifications to OPSS: We take care of the submission process, ensuring accuracy and completeness.Liaising with OPSS: Our team communicates with OPSS on your behalf, addressing any queries or concerns.Expert Guidance: We provide advice and guidance throughout the Cosmetic Product Notifications process, ensuring a smooth experience. Benefits of Being a GPC Client for Cosmetic Product Notifications Service As a valued GPC client, you enjoy a range of benefits: Access to Experienced Regulatory Experts: Our team brings a wealth of regulatory expertise to ensure your compliance. Personalized Service: We tailor our services to meet your specific needs, providing a personalized and attentive approach. Peace of Mind: With GPC Group, you can rest assured that your Cosmetic Product Notifications are in full compliance with all applicable regulations. Get in Touch with us for Cosmetic Product Notification If you're keen on learning more about our Cosmetic Product Notifications service, don't hesitate to reach out. Contact us today, and we'll be delighted to discuss your needs and offer a complimentary consultation. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Regulatory Compliance Assessment Regulatory Dossier Study Management Safety Data Sheet (SDS) Authoring Chemical Substance Safety Assessment ### Colombia REACH [rank_math_breadcrumb] Colombian Chemical Regulation Colombia REACH (THE DECREE 1630) What is Colombia REACH? In 2017, Colombia updated its national profile of chemical substances and issued the National Profile of Chemical Substances: Volume II. The document provided information on chemicals and the amount that circulated in the country. Also in the document, the Colombian authoritiescompiled a list of prioritized chemical substances based on the GHS 6th revision. THE DECREE 1630 On the 30th of November 2021, the Ministry of Environment and Sustainable Development of Colombia published Decree 1630/2021 on chemicals management requiring the registration of industrial chemicals (as such or in mixtures) that are identified as hazardous under UN GHS – if they are manufactured in or imported into Colombia in quantities above 100 kilograms per year. Consequently, and as a step forward, Colombia’s Ministry of Commerce has launched this year an online registration system for industrial chemicals – known as RSQUI – that will initially require manufacturers and importers to submit the following information: Identity of the manufacturer or importer of the chemical substance for industrial use Annual production or import of the chemical substance for industrial use (as such or in mixtures). Chemical substance identity, including CAS number (where applicable) Hazard classification, according to the sixth revision of GHS, which Colombia adopted in 2018 -Decree 1496; and Identified uses. EXEMPTIONS FROM DECREE 1630 Those chemical substances that have a specific regulation for their use, as well as those that in the future will have such regulation [e.g., pesticides, cosmetics, cleaning products, food additives, etc.] Substances of unknown or variable composition, complex reaction products or biological materials – UVC Articles. Impurities. Substances of natural origin without chemical processing. Substances that result from a chemical reaction as a consequence of exposure to environmental factors (air, humidity, sunlight, microbial organisms) or from storage of another product, during the end use of other products that have not been manufactured, imported or marketed as such. Substances that are not manufactured, imported or marketed as such resulting from a chemical reaction. By-products that have not been imported or marketed as such. Hydrates of a substance or hydrated ions. Polymers, including monomeric units and additives that are part of the polymers. Substances in customs transit. Non-isolated intermediates. Samples of no commercial value. If you are not otherwise exempt, you must register. NOTIFICATION OBLIGATIONS Registration is all done online in Spanish. Once registered as a reporting entity, the registrant has access to the instructions detailing what information is required to register a chemical. Here's what will be required according to Decree 1630/2021: Identity of the manufacturer/importer. Annual production or import quantity of the chemical from the years 2021, 2022 and 2023. Identification of the chemical substance, including CAS number (when applicable). Substance’s hazard classification according to Decree 1496 of Aug. 6, 2018. Identified uses. THE NATIONAL CHEMICAL INVENTORY After the first notification deadline, authorities are expected to consolidate the gathered information and publish an official Chemical Inventory. This Chemical Inventory is a database that allows the identification of each chemical substance produced or imported into the country with the purpose of associating the respective quantities, identified uses, and hazardousness. Manufacturers and importers have the duty to keep the data up-to-date and submit information to the portal whenever new information is available. Updates on produced or imported substances are mandatory once a year. What is the deadline? The final deadline for providing the information is May 30, 2025. The first National Inventory of Industrial Chemical Substances (Inventario Nacional de Sustancias Químicas de Uso Industrial) will be created on May 31, 2025, based on the chemicals registered over the next three years. If your chemicals are not registered before the May 31, 2025 cut-off, they will be considered “new substances” and subject to additional hurdles. How can Foreign Manufacturers register their products? Foreign manufacturers can register their product, but the local importer must be involved. They can use an Exclusive Representative Abroad (Representante Exclusivo del Exterior or “REE”) to protect confidential business information (CBI) from their local importer and/or customers. The REE allows the foreign manufacturer to share confidential information with the government through the encrypted database while ensuring the customer/importer in Colombia does not have access to that information. Do you want to know more about Colombian Chemical Regulations? Explore more about Colombia REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Colombia REACH Check out our Colombian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL BRAZIL Brazilian Chemical Regulation CHILE Chilean Chemical Regulation ARGENTINA Argentinian Chemical Regulation MEXICO Mexican Chemical Regulation ### Brazil REACH [rank_math_breadcrumb] Brazilian Chemical Regulation Brazil REACH What is Brazil REACH? In Brazil, there are specific laws that apply to pharmaceutical products, cosmetics, pesticides, sanitizing products, and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, the National Chemicals Safety Commission (Comitê Nacional Sobre Segurança Química, or CONASQ), along with the Ministry of Environment (Ministério do Meio Ambiente, or MME), published a Preliminary Bill for the Inventory, Evaluation, and Control of Chemical Substances. The draft law sets provisions for the creation of a national existing chemical substance inventory and for the evaluation and control of chemical substances. It also makes GHS mandatory for industrial chemicals at the workplace. Draft Chemical Law (Bill 6120/2019) On 21 November 2019, the draft Chemical Law (Bill 6120/2019) was presented in the Chamber of Deputies.  Bill 6120/2019 would require manufacturers, exporters, and importers of chemicals to report the volume of chemical substances annually produced and imported. Furthermore, Safety Data Sheets (SDSs) would have to prepared in accordance with GHS, including recommended uses, hazard classifications, and chemical risk assessment analysis studies for recommended uses. The draft law was approved by the Economic Development, Industry, Trade, and Commercial Services (CDEICS) on 23 November 2022. Now the measure is under consideration by the Commission on Constitution, Justice, and Citizenship (CCJC). The most important aspects of Bill 6120/2019 are: The notification data requirements include substance identity, CAS number, recommended uses, safety data sheet, classification information, and risk assessment analysis for all substances in the Inventory. The bill adopts GHS as the mandatory classification system. Data related to hazard and risk are not confidential, but substance identity can be confidential in special circumstances. Chemicals of unknown or variable composition (UVBCs) must be registered as a single chemical. Candidate substances for prioritization include Carcinogenic, Mutagenic and Reprotoxic (CMR), Persistent, Bioaccumulative, and Toxic (PBT) and Endocrine Disruptors. In addition substances that are covered by international agreements or conventions can also be prioritized. Manufacturers, exporters, and importers of chemical substances are obliged to provide information to the National Inventory of Chemical Substances. Animal testing should be the last resort to determine the hazard of a chemical. Non-compliance of the law is subject to administrative sanctions. The government is responsible for setting up an Assessment Committee to assess the risks of the substances and recommend risk management measures. The draft law, Bill 6120/2019, applies to industrial chemical substances on their own, in mixtures or in articles in volumes above 1 TPA. According to Article 3 of the draft law, the following chemical substances are out of scope as they are regulated by other specific laws and regulations: Pesticides Pharmaceuticals and medical gases Cosmetics, toiletries, and perfumes Disinfectants Products for veterinary uses Food and food additives Products used for animal feed Fertilizers The draft law is pending on Senate and it is the final steps to be enacted. (Last update: 15April2024) Do you want to know more about Brazil REACH? Explore more about Brazil REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Mexico REACH Check out our Mexican Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL CHILE Chilean Chemical Regulation COLOMBIA Colombian Chemical Regulation ARGENTINA Argentinian Chemical Regulation MEXICO Mexican Chemical Regulation ### Argentina REACH [rank_math_breadcrumb] Argentinian Chemical Regulation Argentina REACH What is Argentina REACH? In 2018, a memorandum of understanding and cooperation for the management of chemicals was signed between Argentina and Brazil. Among its objectives, the memorandum aimed to exchange information (including the Brazilian study on chemical management) and to strengthen collaboration in the design of policies, regulations, and regulatory instruments for the management of chemical substances. The National Law for the Management of the Risk of Chemical Substances was published in June 2019 with the purpose to create a harmonized inventory at the national level of all chemical substances produced or introduced in the territory and to strengthen the mechanisms for evaluating and managing their risk. The system is similar to the one proposed in Brazil: it will be implemented in phases; the Ministry of Environment and Sustainable Development is the main agency in charge; chemicals will be evaluated by a special committee that will create a hazardous chemical list (and will be prioritized for risk management); a 3 years adaptation time; and manufacturers’ and importers’ mandatory annual updates to the system will follow. The local government issued Resolution 192/2019, which created a national list of existing, restricted, and prohibited chemical substances, and is continuously being populated. Moreover, Decree 504/2019 was closely published, implementing an interministerial group responsible for coordinating different governmental areas to guarantee national management of chemical substances, fulfilling the national and international commitments assumed. The draft law of national chemical legislation was presented to public discussion in September 2019, right before the country’s election in October. In the end, the change in government affected further progress and the draft was withdrawn by Argentina’s executive power. Meanwhile, an improved version is ready to be published, but not to be presented to Congress since the new election is scheduled for October 2021. Adoption of GHS Argentina officially adopted GHS 5th version in 2017 through Resolution 801/2015, which was amended twice by Resolution 3.359/2015 and Resolution 155/2016. Altogether, GHS became mandatory for substances on January 1st, 2017, and for mixture from June 1st, 2017. In Argentina, the GHS is supplemented by the Argentine Institute of Standardization and Certification (IRAM) norms 41.400/2013 (SDS) and IRAM 41.401/2020 (Labels). Resolución 801/2015 (GHS-workplace) Resolución 195/97 (GHS-transport) Decreto 779/95 (GHS-transport) Do you want to know more about Argentinian Chemical Regulation? Explore more about Argentina REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Mexico REACH Check out our Mexican Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL BRAZIL Brazilian Chemical Regulation CHILE Chilean Chemical Regulation COLOMBIA Colombian Chemical Regulation MEXICO Mexican Chemical Regulation ### Chile REACH [rank_math_breadcrumb] Chilean Chemical Regulation Chile REACH (THE DECREE 57) WHAT IS THE DECREE 57 ABOUT? Chile enacted, on February 2021, a new regulation on the classification, labeling, and notification of hazardous substances and mixtures. Decree 57 establishes criteria and obligations that manufacturers and importers of hazardous substances must meet in order to introduce or maintain their products on the market. The new regulation was developed jointly by the Ministry of Health and the Ministry of Environment. WHAT IS THE SCOPE? Decree 57 applies to substances and mixtures that are not regulated by specific laws and are classified as hazardous. Examples of substances not considered for Decree 57 application are nuclear substances, intermediaries, substances in warehouses, substances used in scientific research and development, pharmaceutical, veterinary, and cosmetic products, fertilizers, articles containing dangerous substances or mixtures, and food products. WHAT IS CONSIDERED A HAZARDOUS SUBSTANCE? In August 2021, the Ministry of Health approved an official list of classification of substances by Resolution 777. The list is known to be the minimum reference for manufacturers and importers when classifying their substances. Hazard substances are those containing hazard classes identified by GHS revision 7, with some exceptions. Hazard categories not considered in Decree 57 include: the flammable gases (category 1b) flammable liquids (category 4) desensitized explosives acute toxicity (category 5) skin irritation (category 3) eye irritation (category 2b) aspiration hazard (category 2) acute hazards to the aquatic environment (categories 2 and 3) The list is not extensive, and in the case where a chemical is not present in the list, manufacturers and importers must identify, classify, and label the substances according to their hazardous status before marketing or use. It is desirable to use existing data from trials, data centers, clinical studies, and scientific literature. If further tests are still required, these should be preferably performed according to the OECD guidelines and carried out by laboratories certified according to the ISO 17025 standard. Animal tests are the last resort. WHO SHOULD NOTIFY? The manufacturers and importers of substances classified as hazardous substances present in mixtures will have to notify the Chilean government when dealing with amounts ≥ 1 ton per annum. Substances contained in mixtures only requires notification when presenting such hazardous characteristics and are over cutoff values as displayed below. WHAT INFORMATION IS REQUIRED FOR NOTIFICATION? The environmental authority is establishing an electronic portal for chemical reporting where the notifier will be able to submit all requested information. The information to be provided should include: Notifier information Name, address, phone, and email of the notifier, legal representative, and contact person. Manufacturers must indicate the address of the manufacturing plant. Data about the substance Substance names (IUPAC, commercial, common, etc.) CAS number Hazard classification (with hazard class and category) Manufactured or imported amounts per annum (expressed in mass) Substance intended uses Attach the substance SDS (in Spanish) The notification must be made every two years, with a deadline of August 30, considering what was manufactured or imported in the previous two calendar years. The first notification window is scheduled for February – August 2024. IMPLEMENTATION TIMELINE Decree 57 implementation will be gradual with several deadlines along the way. The image below best summarizes important deadlines. Do you want to know more about Chilean Chemical Regulation? Explore more about Chile REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Chile REACH Check out our Chilean Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL BRAZIL Brazilian Chemical Regulation COLOMBIA Colombian Chemical Regulation ARGENTINA Argentinian Chemical Regulation MEXICO Mexican Chemical Regulation ### Regulatory Dossier Study Management [rank_math_breadcrumb] GPC Service Regulatory Dossier Study Management Regulatory Dossier Study Management Services offer expert support in navigating complex regulatory requirements. These services efficiently handle the preparation, organization, and submission of regulatory dossiers, ensuring precision and compliance. With a focus on optimizing strategies and adhering to evolving regulatory frameworks, professionals in this field streamline processes for successful interactions with regulatory authorities, contributing to overall business success. What is Dossier Preparation and Regulatory Procedures Management ? A Regulatory Dossier is like a complete report containing all the important details about a product. It's sent to government agencies to get permission to sell the product.Think of it like an official product handbook that has been painstakingly created. Regulatory dossier acts as a guide to make sure the product conforms with all applicable regulations and is safe for users.Dossier preparation is a process of creation of a comprehensive file that contains all the detailed  information about a chemical product. To convey a product's safety and effectiveness this information is essential, as it acts as a proof. It is a final report that will be presented to the authorities for their approval.On the other hand, regulatory procedures management involves keeping track and performing all the necessary steps and tasks to ensure the chemical product complies with the established rules and regulations. Regulatory process management guarantee that the chemical product meets safety and legal requirements from initial to final stage. The Significance of Dossiers in Regulatory Affairs Dossiers are like super-organized files filled with data that prove our chemical product is safe and works well.  Without a good dossier, getting our product approved is really hard.Product Safety and Effectiveness is what we need to show. Dossiers have multiple details, which involves  testing, how the chemical is made, and proof of how the product is safe for people and the environment. The authorities check all details to make sure it is safe. Key Steps in Regulatory Dossier Submission 1. Data Compilation The journey begins with the collection and compilation of data. This data compilation cover in depth details related to research results, safety profiles, and manufacturing documentation. All of this must be meticulously organized and presented. 2. Regulatory Strategy A well-thought-out strategy is essential. Regulatory strategy is very important to handle possible upcoming challenges, and estimating a clear timeline for submitting the dossier. 3. Document Authoring Experienced writers play a vital role in creating clear, concise, and compliant documents. This step is combination of scientific and regulatory knowledge. 4. Quality Control Quality control is crucial to ensure that the dossier is accurate and complete. Multiple reviews and revisions are conducted to eliminate errors or inconsistencies. 5. Submission and Follow-Up Submitting the dossier to regulatory agencies is a milestone. Resolving inquiries and calls for more information frequently requires close coordination with regulatory bodies. The Role of GPC in Dossier Preparation The Expertise and ExperienceWith an extensive amount of knowledge and experience, GPC is a pioneer in the regulatory affairs sector. We have teams of regulatory professionals with extensive experience in dossier preparation to satisfy legal specifications.Tailored SolutionsEvery product is distinct, as is every regulatory submission. GPC creates customized strategy to fulfill client's specific needs as well as ensuring that the dossier matches the characteristics of the product.Speed and EfficiencyTimelines are often tight in regulatory matters. GPC is an excellent partner in projects with short timelines since they understand the importance of efficiency and speed in dossier preparation. How GPC Group Can Manage a Regulatory Dossier Study Comprehensive Study ManagementManaging a regulatory dossier study involves a wide range of activities, from planning to execution. GPC oversees the entire process, ensuring that each aspect is meticulously managed.Regulatory IntelligenceStaying up-to-date with ever-changing regulations and guidelines is essential. GPC notifies businesses via regulatory portal, newsletters and other sources to help clients to be up to date and adapt evolving requirements.Risk MitigationIdentifying and mitigating risks is a crucial aspect of dossier management. GPC employs proactive strategies to minimize potential hurdles in the approval process. Get in Touch with GPC for Efficient Dossier Preparation Ensuring the success of regulatory submissions is no small task. GPC has a track record of excellence in preparing dossiers that meet the highest standards of quality and compliance. For efficient dossier preparation that paves the way for product approvals, don't hesitate to get in touch with GPC. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Chemical Classification and Labeling Chemical Registration and Notification Chemical Safety Report (CSR) Chemical Toxicological Assessment ### Chemical Regulatory Compliance Assessment [rank_math_breadcrumb] GPC Service Chemical Regulatory Compliance Assessment Chemical regulatory compliance assessment services are essential for businesses that manufacture, import, or use chemicals. These services help businesses to identify and address potential compliance issues before they become problems, reducing the risk of legal and financial penalties, protecting human health and the environment, and maintaining market access. What is Chemical Regulatory Compliance Assessment? A chemical regulatory compliance assessment is an evaluation of a company's compliance with the applicable chemical regulations in the jurisdictions in which it operates. This assessment helps to identify any potential gaps in compliance and to develop corrective actions to ensure that the company is meeting its legal obligations. Why Chemical Regulatory Compliance Assessment is Important Chemical regulatory compliance is important for several reasons:Protecting human health and the environment: Chemical regulations are designed to protect human health and the environment from the harmful effects of chemicals. By complying with these regulations, companies can help to reduce the risk of exposure to hazardous chemicals.Avoiding legal and financial penalties: Non-compliance with chemical regulations can result in significant legal and financial penalties. A chemical regulatory compliance assessment can help to identify and address potential compliance issues before they become problems.Maintaining market access: Chemical regulations can vary from country to country. By ensuring that they are compliant with all applicable regulations, companies can maintain access to global markets. How Chemical Regulatory Compliance Assessment is Done The assessment process encompasses the following key steps:Identification of Applicable Regulations: Professionals at GPC assist in identifying federal, state, and local regulations pertinent to the company's products and activities.Review of Company Procedures: A comprehensive examination of company procedures is conducted to ensure alignment with identified regulations. This includes a scrutiny of the chemical inventory, labeling, packaging, and waste disposal practices.Facility Audits: In some cases, facility audits may be necessary to verify compliance with chemical regulations. These audits are essential in identifying and addressing any gaps in compliance.Preparation of Detailed Reports: The process culminates in the preparation of a comprehensive report summarizing findings. This report identifies potential compliance issues and provides recommendations for corrective actions. How GPC's Compliance Assessment Services Add Value Enlisting GPC's chemical regulatory compliance assessment services provides companies with several advantages, including the ability to: Identify Applicable Regulations: Professionals assist in identifying the myriad federal, state, and local regulations that apply to a company's products and activities. Review Company Procedures: The assessment involves a comprehensive review of company procedures to ensure alignment with identified regulations, covering aspects such as chemical inventory, labeling, packaging, and waste disposal. Conduct Audits: When necessary, professionals conduct facility audits to verify compliance with regulations, helping to identify and address any gaps. Prepare a Detailed Report: The services culminate in the preparation of a comprehensive report summarizing findings, highlighting potential compliance issues, and recommending corrective actions. Benefits of Opting for GPC's Chemical Regulatory Compliance Assessment Services The advantages of utilizing these services include:Reduced Risk of Non-Compliance: Professionals proactively address compliance issues, minimizing the risk of non-compliance.Enhanced Regulatory Knowledge: Staying abreast of regulatory changes ensures businesses remain informed and adaptable to evolving requirements.Improved Audit Readiness: Companies are better prepared for regulatory audits, addressing potential gaps before they become problematic.Peace of Mind: Knowing that the business is compliant instills confidence, allowing for an unwavering focus on core operations. Get in Touch with GPC Group for Expert Chemical Compliance Assessment At GPC, we offer expert chemical regulatory compliance assessment services designed to help businesses proactively manage compliance challenges. Our experienced team can assist in developing and implementing effective compliance strategies, safeguarding your business from legal and financial repercussions while prioritizing human health, environmental protection, and global market access. Schedule a plan with us today for a personalized consultation tailored to your specific needs. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Chemical Classification and Labeling Chemical Registration and Notification Chemical Safety Report (CSR) Chemical Toxicological Assessment ### Lead Registrant (LR) & SIEF Management [rank_math_breadcrumb] GPC Service LR & SIEF Management Effective Substance Information Exchange Forum (SIEF) Management Services are crucial for streamlining collaborative efforts among companies sharing the same substance. These services play a vital role in facilitating communication, data exchange, and efficient collaboration within regulatory frameworks like the European Union's REACH. By optimizing the registration process, SIEF Management Services contribute to resource efficiency, avoidance of redundant testing, and enhanced compliance, ensuring businesses can navigate regulatory complexities with precision and collaboration. What is SIEF (Substance Information Exchange Forum) ? Within the complex realm of chemical regulatory compliance, the Substance Information Exchange Forum (SIEF) stands as a pivotal hub for manufacturers and importers, facilitating the seamless exchange of vital data in strict adherence to REACH regulation. The concept of Consortia Management, intimately linked with SIEF, underscores the industry's collaborative commitment to sharing data efficiently, ensuring a cohesive approach to regulatory compliance. Uniquely within the Korean context, SIEF is alternatively recognized as CICO (Chemicals Information Center for International Communication), embodying its distinctive role in fostering international communication and information exchange for Korean enterprises. These nuanced frameworks not only epitomize industry collaboration but also exemplify the adaptability required to navigate diverse global regulatory landscapes with finesse. What is SIEF Composed Of? A SIEF typically consists of various companies or entities that manufacture or import the same chemical substance in the European Union. This group can range from a few participants to a larger consortium, depending on the substance's complexity and the number of registrants involved. SIEF members play a primary role in exchange of data, studies, and other relevant information. What does a SIEF Manager do? Functions performed by SIEF Managers include:Coordinate communication within the Substance Information Exchange Forum (SIEF).Streamline the registration process under regulations like the European Union's REACH.Minimize redundancy in testing efforts.Resolve disputes and oversee the functionality of the collaborative platform.Ensure efficient collaboration among companies sharing data on the same substance.Contribute to the smooth operation of SIEF, promoting effective compliance within the chemical regulatory landscape. The Creation of a SIEF and Preliminary Steps Creating a SIEF is a fundamental step in the REACH registration process. It involves finding more possible registrants for the same chemical and getting in touch with them in order to begin collaborating together.. The preliminary steps leading up to the creation of a SIEF include: 1. Substance Identification: Accurately identifying the chemical substance.Determining the substance's EC number and CAS number. 2. Data Sharing: Identifying existing data on the substance.Sharing data with other potential registrants. 3. Contacting Potential Registrants: Reaching out to other manufacturers and importers of the same substance. The Role of Lead Registrant (LR) The Lead Registrant (LR) is a pivotal figure within the SIEF. This individual or entity takes the responsibility of coordinating and managing the registration process for the entire group. The LR is important when it comes to data exchange, cooperative registration, dossier submission, and correspondence with authorities.  How GPC Group Can Help You with LR and SIEF Management Navigating the intricacies of SIEF management and serving as a Lead Registrant can be a daunting task. This is where expert regulatory consulting firms like GPC come into play.GPC can provide necessary guidance, support, and services to facilitate the smooth management of your SIEF and LR responsibilities. Our expertise & experience can make a significant difference in your compliance needs.GPC has supported over 800 clients for LR and SIEF Management since 2008. Benefits of Being GPC Client for SIEF management service Benefit from streamlined collaboration, minimizing redundancies and optimizing resources for efficient substance registration. Rely on GPC's mediation excellence, ensuring a cooperative SIEF platform. Rest easy with comprehensive compliance under regulations like the European Union's REACH, supported by GPC's operational brilliance. Stay informed with GPC's up-to-date intelligence on regulatory changes and industry insights. Enjoy tailored solutions and peace of mind, letting GPC handle SIEF management while you focus on core business activities. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Regulatory Compliance Assessment Regulatory Dossier Study Management Safety Data Sheet (SDS) Authoring Chemical Substance Safety Assessment ### Only Representative (OR) Service [rank_math_breadcrumb] GPC Service Only Representative (OR) Service REACH Only Representative (OR) Services help non-EU manufacturers and importers to comply with the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. REACH requires all non-EU manufacturers and importers of chemicals to register their substances with the European Chemicals Agency (ECHA). However, non-EU companies cannot register their substances directly with ECHA. They must appoint an OR, which is a legal entity established in the EU, to act on their behalf. What is the Only Representative in the EU REACH ? The European Union's REACH regulation offers an extensive framework to govern the use and export of chemicals within the EU.​ Companies worldwide that manufacture or import chemicals into the EU must comply with REACH. For entities based outside the EU, designating a REACH Only Representative (OR) can be a strategic decision with numerous benefits. What Is the Role & Services of a REACH Only Representative? 1. Data Collection and Submission Your OR collects and compiles the necessary data for REACH registrations, ensuring accuracy and completeness. They additionally verify applications that have been recently submitted to the relevant EU agencies. 2. Communication with EU Agencies Your OR serves as the point of contact between your business and EU regulatory agencies. They keep track of data requests, transfers, and connections. 3. Compliance Monitoring A REACH OR keeps your company up-to-date with regulatory changes and ensures ongoing compliance with evolving EU regulations. Advantages of Designating a REACH Only Representative (OR) Designating a REACH Only Representative offers several advantages, making it a valuable choice for non-EU-based businesses: 1. Regulatory Compliance One of the primary benefits is ensuring compliance with the complex REACH regulation. An OR serves as your legal entity in the EU, handling all REACH-related obligations, including registrations, data submissions, and communication with EU authorities. 2. Market Access Having a REACH OR allows your products to access the vast EU market without the need to establish a physical presence in the region. 3. Expertise and Guidance A reputable REACH OR possesses in-depth knowledge of EU chemical regulations. To assist you in avoiding costly errors, Only Representative (OR) offers guidance on labeling, categorization, and other compliance-related concerns. 4. Confidentiality ORs protect your company's confidential information and property rights by managing confidential information on your behalf. Who Requires REACH-Only Representation? Not every business that deals with chemicals in the EU needs REACH-Only Representation. You should consider designating a REACH OR if:1. Your Business is Non-EU BasedIf your company is not physically located in the EU, designating an OR is often necessary to meet REACH obligations.2. You Export Chemicals to the EUExporters to the EU must have an EU-based OR to fulfill their REACH obligations. This is applicable to most of the firms worldwide.3. Complex Supply ChainsIf your supply chain involves various manufacturers and distributors, a REACH OR can simplify compliance and communication with EU authorities. How to Replace Your REACH-Only Representative? In some cases, you may need to replace your existing REACH OR. This may happen for a number of reasons, including a shift in the OR's performance or the requirements of the business. The process typically involves:Identifying a New OR: Choose a suitable replacement with the required expertise and capabilities.Formal Notification: Notify the relevant EU authorities about the change and provide the necessary information.Data Transfer: Ensure a smooth transition of data and responsibilities from the previous OR to the new one.Compliance Continuity: Maintain ongoing compliance during the transition to avoid disruptions in your business operations. Benefits of GPC Client Status for EU REACH Only Representative Services Expert Guidance: Benefit from the in-depth knowledge and experience of our regulatory experts, ensuring accurate interpretation and application of EU REACH regulations. Tailored Solutions: GPC Group crafts personalized solutions to address the unique needs of your business, providing a bespoke approach to EU REACH Only Representative services. Efficient Handling: Our team streamlines the complex process of compliance, offering efficient and meticulous management of REACH obligations, saving you time and resources. Peace of Mind: As a GPC client, enjoy peace of mind knowing that your REACH Only Representative needs are in the hands of seasoned professionals, dedicated to ensuring your compliance success. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Regulatory Compliance Assessment Regulatory Dossier Study Management Safety Data Sheet (SDS) Authoring Chemical Substance Safety Assessment ### OECD & GLP Study Management [rank_math_breadcrumb] GPC Service OECD & GLP Study Management OECD & GLP Study Management Services provide a professional and unique approach to overseeing studies in accordance with Organization for Economic Cooperation and Development (OECD) guidelines and Good Laboratory Practices (GLP). It includes streamlining study management with simplicity and efficiency, ensuring adherence to rigorous international standards. These services not only facilitate compliance but also prioritize the unique aspects of each study, tailoring  approaches to meet specific requirements. What is Chemical Registration and Notification? Chemical Registration and Notification involve the processes of formally registering and notifying chemicals to regulatory bodies, ensuring compliance with safety and environmental regulations. For instance, EPA pesticides registration falls under this category, emphasizing the importance of adhering to specific guidelines to guarantee the safety of both users and the environment. What Are GLP Study Practices? Good laboratory practice (GLP) is a quality system of management controls for research laboratories and organizations that are conducting non-clinical health and environmental safety studies. GLP is designed to ensure the generation of high-quality and reliable test data that can be used for regulatory decision-making. Total Testing involved in GLP Study Service The total testing involved in GLP study services varies depending on the specific purpose of the study. However, most GLP studies typically include the following steps:Study design: The study design is developed in consultation with the regulatory authorities to ensure that it meets all applicable requirements.Test material preparation: The test material is prepared and characterized in accordance with GLP standards.Test system preparation: The test system (e.g., animal models, cell cultures, etc.) is prepared and characterized in accordance with GLP standards.Study conduct: The study is conducted in accordance with the approved study design and GLP standards.Data collection and analysis: Data is collected and analyzed in accordance with GLP standards.Study reporting: A final study report is prepared in accordance with GLP standards. Which chemicals or chemical products fall under the OECD Principles of GLP? The OECD Principles of GLP apply to all non-clinical health and environmental safety studies that are conducted for regulatory purposes. This includes studies on pesticides, herbicides, pharmaceuticals, industrial chemicals, and other chemical products. What are Good Laboratory Practice Guidelines? Good laboratory practice guidelines are a set of standards and procedures that are designed to ensure the quality and reliability of non-clinical health and environmental safety studies. The OECD Principles of GLP are the most widely accepted set of GLP guidelines in the world. How do governments ensure that a study conducted at a test facility adheres to the OECD Principles of GLP? Governments typically ensure that studies conducted at test facilities adhere to the OECD Principles of GLP through a process of inspection and accreditation. Inspection teams are sent to test facilities to evaluate their compliance with GLP standards. Test facilities that meet the GLP standards are accredited by the inspection team. What does GLP Compliance Monitoring involve? GLP compliance monitoring involves the ongoing evaluation of a test facility's compliance with GLP standards. This includes monitoring the test facility's personnel, procedures, and equipment. GLP compliance monitoring can be conducted by the test facility itself, by a government agency, or by a third-party auditor. How GPC Group can help for OECD & GLP Study Management Services? GPC has a team of experienced regulatory experts who can help you to ensure that your OECD and GLP studies are conducted in accordance with all applicable requirements. We can also help you to develop and implement a GLP compliance monitoring program. GPC can help you with all aspects of OECD and GLP study management services, including:Study designTest material preparationTest system preparationStudy conductData collection and analysisStudy reportingGLP compliance monitoring Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Regulatory Compliance Assessment Regulatory Dossier Study Management Safety Data Sheet (SDS) Authoring Chemical Substance Safety Assessment ### EU Cosmetic Product Notifications (CPN) [rank_math_breadcrumb] GPC Service European Cosmetic Product Notifications (CPN) EU Cosmetics Regulations services are vital for ensuring compliance, market access, and consumer safety. They help manufacturers navigate complex regulations, mitigate legal risks, and uphold product quality and transparency. Ultimately, these services are essential for maintaining consumer trust and competitiveness in the cosmetics industry. Do you want to know about UK cosmetic regulation service? Click here What is EU Cosmetics Product Regulation? The EU Cosmetics Product Regulation (EU CPR) sets out the rules and regulations for the manufacture, labeling, and sale of cosmetic products within the European Union. It aims to ensure the safety of cosmetic products for consumers while harmonizing regulations across EU member states. What is the process of Cosmetic Product Notification Portal (CPNP) The Cosmetic Product Notification Portal (CPNP) is an online system established by the European Commission to facilitate the notification of cosmetic products before they are placed on the market within the European Union (EU). Here's a brief overview of the process: Registration: Before using CPNP, companies must register with the system. This involves providing basic company information and receiving access credentials. Product Notification: Once registered, companies can submit notifications for their cosmetic products through the CPNP platform. This includes details such as product name, category, composition, function, packaging, and labeling information. Safety Assessment: Companies are responsible for ensuring the safety of their cosmetic products. They must conduct safety assessments, including evaluation of ingredients and potential risks, in accordance with EU regulations. Notification Submission: After completing the necessary safety assessments, companies upload their product notifications to the CPNP system. Notifications must be submitted before the product is placed on the market in the EU. Validation and Publication: The information provided in the notification undergoes validation by the competent authorities. Once validated, the product details are published in the CPNP database, accessible to relevant authorities across the EU. Market Placement: With a validated notification in CPNP, companies can proceed to place their cosmetic products on the market within the EU member states. Ongoing Compliance: Companies are required to keep their product information in CPNP up-to-date. Any changes to product formulations or other relevant details must be promptly notified through the portal.Overall, CPNP serves as a central repository for cosmetic product information, facilitating regulatory compliance and ensuring the safety of cosmetic products placed on the market within the European Union. Cosmetic Product Information Checklist (EU) Refer to the Cosmetic Product Information Checklist (EU) below:Product IdentificationProduct DescriptionProduct CompositionFunctionalitySafety AssessmentProduct ManufacturingPackaging and LabelingProduct ClaimsProduct TestingNotification and ComplianceProduct Information Updates Services Under EU Cosmetics Product Regulation GMP (Good Manufacturing Practices) Certification : Ensuring your manufacturing processes meet the highest standards of quality and safety.Cosmetics Testing : Conducting rigorous testing to ensure product safety and efficacy.Cosmetic Safety Assessments : Evaluating the safety of cosmetic ingredients and formulations.Cosmetics Ingredient Profiles : Documenting and assessing the safety and functionality of cosmetic ingredients.Product Information Files (PIFs) : Compiling comprehensive documentation to demonstrate product safety and compliance.Part A Cosmetic Product Safety Information  and  Part B Cosmetic Product Safety Assessment : Providing detailed safety information and assessments for cosmetic products.Regulatory Compliance Support : Offering guidance and support to ensure compliance with EU cosmetics regulations.Regulatory Consulting : Providing expert advice on navigating EU cosmetics regulations and requirements.Product Notifications : Assisting with the notification process for cosmetic products placed on the EU market.Clinical Studies for Claim Substantiation : Conducting studies to support cosmetic product claims.Design, Placement, and Monitoring : Assisting with the design and placement of cosmetic products on the market and monitoring compliance.Product Labeling Review and Support : Reviewing product labels to ensure compliance with EU labeling requirements and providing support in label creation. Why Choose GPC Group for Cosmetic Product Notifications Service? At GPC Group, we offer a comprehensive suite of services to help cosmetics manufacturers navigate the complex landscape of EU regulations. Our team of experts has extensive experience in regulatory compliance and works closely with clients to ensure their products meet all necessary requirements. With our commitment to excellence and dedication to client success, we are your trusted partner in achieving compliance and success in the EU cosmetics market. Get in Touch with us for EU Cosmetic Product Notification Ready to ensure compliance and success in the EU cosmetics market? Contact GPC GroupUn today to learn more about our services and how we can help you navigate EU cosmetics regulations with confidence. Let us be your partner in achieving regulatory compliance and success in the dynamic cosmetics industry. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Regulatory Compliance Assessment Regulatory Dossier Study Management Safety Data Sheet (SDS) Authoring Chemical Substance Safety Assessment ### Chemical Safety Report (CSR) [rank_math_breadcrumb] GPC Service Chemical Safety Report (CSR) Creation The Chemical Safety Report (CSR) Service stands as a cornerstone in ensuring safety within the chemical landscape. This professional service meticulously analyzes and communicates potential hazards associated with chemical products. Through comprehensive reports, it provides a clear understanding of risks, enabling businesses to navigate the chemical terrain with confidence. The CSR Service goes beyond mere compliance, offering a unique blend of simplicity and effectiveness. What is Chemical Safety Report (CSR) ? A Chemical Safety Report (CSR) stands as an indispensable document, mandated for substances manufactured or imported in quantities surpassing 10 tonnes per year under the REACH Regulation (Article 10).Understanding and guaranteeing the safe and responsible use of chemicals is greatly aided by this research. The Unique Role of Chemical Safety Report (CSR) In its distinctive capacity, the Chemical Safety Report (CSR) serves a multitude of purposes, each contributing to the broader goal of chemical safety and responsible usage: 1. REACH Regulation Compliance At its core, the CSR is a legal prerequisite established by the REACH Regulation, designed to safeguard human health and the environment. Large-scale imports or manufacturing of substances fall under this category.  Ensuring that these substances are managed in a way that effectively minimizes potential hazards is the main objective of the CSR. 2. Exposure Assessment and Risk Characterization A paramount function of the CSR is the inclusion of an exposure assessment and risk characterization, especially for substances classified as hazardous or meeting the criteria for being persistent, bioaccumulative, or toxic (PBT) as outlined in REACH Article 14(4). In order to address all of the identified risks related to the chemical, this complete evaluation is required 3. Tailored Exposure Scenarios The Chemical Safety Report is unique the way it covers exposure scenarios. For each distinct use of the chemical, as documented in IUCLID Section 3.5, a corresponding exposure scenario within the CSR is essential. These scenarios are essential for ensuring the chemical is used safely in a wide range of applications. 4. Contribution to Safety A unique facet of the CSR is the inclusion of contributing scenarios. These scenarios align with the contributing activities reported in IUCLID Section 3.5, which are segmented into three vital categories:Environment: This category encompasses the environmental release category (ERC), focusing on the substance's interactions with the environment.Workers: The process category (PROC) caters to the safety of workers involved in the handling of the chemical.Consumers: This segment concentrates on the article category (AC) and/or product category (PC), ensuring the chemical's safe utilization by consumers. 5. Detailed and Comprehensive Information Particularly, every scenario that contributes captures minute information about usage characteristics, operational constraints, and risk control strategies. Additionally, exposure estimates are given for each relevant route and compartment. The risk characterization ratios for individual pathways, compartments, and combination pathways support these. 6. Holistic Environmental Considerations The CSR exceptionally broadens its scope by including ecological variables. Environmental contributing scenarios comprise soil, air, and water releases at the local level which provide an ecosystem-wide view on the impacts of the chemical. 7. Tonnage and Health Considerations The careful assessment of tons with respect to human and environmental exposure is one of the CSR's unique features. Notably, substances exceeding 1,000 tonnes per year or those classified as toxic to specific target organs from repeated exposure (STOT RE) 1, carcinogens, mutagens, or toxic to reproduction (categories 1A or 1B) warrant special attention within the CSR. 8. Completeness and Transparency Intriguingly, if any element within the CSR is absent, the report necessitates a thorough justification for its omission. This unique aspect ensures that the CSR strives for the utmost comprehensiveness and transparency in its mission.In summary, the Chemical Safety Report (CSR) is a truly unique and indispensable instrument in the realm of chemical safety and regulatory compliance. It uniquely combines legal requirements, tailored exposure scenarios, risk assessments, and environmental considerations, all contributing to the protection of both human health and the environment. How GPC Group Can Help you for the creation of Chemical Safety Report (CSR) GPC offers a comprehensive Chemical Safety Report (CSR) service that can assist you in fulfilling your regulatory obligations and ensuring the safety of your chemical products. Here's how GPC can help you:Expertise and Experience: GPC possesses a team of highly qualified and experienced professionals who have a deep understanding of chemical safety regulations and the intricacies of CSR preparation. They can guide you through the entire process, from data gathering and analysis to report writing and submission.Streamlined Process: GPC utilizes a streamlined approach to CSR preparation, ensuring that the process is efficient, cost-effective, and compliant with all relevant regulations. They leverage their expertise to identify potential challenges early on and provide proactive solutions.Comprehensive Support: GPC provides comprehensive support throughout the CSR preparation process, addressing your queries and concerns promptly. They maintain open communication channels to ensure you are fully informed and involved in every step. Benefits of Being a GPC Client for Chemical Safety Report (CSR) Service: Reduced Risk of Non-Compliance: GPC's expertise helps you avoid costly mistakes and ensure your CSR meets all regulatory requirements. Enhanced Product Safety: GPC's comprehensive assessment process identifies potential hazards and helps you implement appropriate risk management measures. Accelerated Time to Market: GPC's streamlined approach expedites the CSR preparation process, allowing you to bring your products to market faster. Improved Reputation: By demonstrating your commitment to chemical safety through a well-prepared CSR, you can enhance your brand reputation and gain customer trust. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Cosmetic Product Notifications (CPN) OECD & GLP Study Management Only Representative (OR) Service Lead Registrant (LR) & SIEF Management ### Chemical Toxicological Assessment [rank_math_breadcrumb] GPC Service Chemical Toxicological Assessment Chemical toxicological assessment services are crucial for safeguarding human health and the environment from the dangers of hazardous chemicals. These services analyze potential hazards, evaluate the relationship between dose and response, estimate likely exposure levels, and characterize the overall risk. This information is instrumental in developing safe handling procedures and informs regulatory decisions. Importance of toxicological risk assessment of chemicals A toxicological risk assessment of chemicals is important to evaluate the potential health risks of a chemical to humans and the environment. This information can be used to develop safe handling and use procedures for chemicals, as well as to inform regulatory decisions. The four principles of toxicological risk assessment Hazard identification: This step involves identifying the potential hazards of a chemical, such as its toxicity, carcinogenicity, and mutagenicity.Dose-response assessment: This step involves evaluating the relationship between the dose of a chemical and the severity of its effects.Exposure assessment: This step involves estimating the amount of exposure to a chemical that is likely to occur.Risk characterization: This step involves combining the hazard and exposure information to estimate the risk posed by the chemical. Methods of Hazard Identification Hazard identification can be conducted using a variety of methods, including:Literature review: This involves reviewing the scientific literature to identify any known hazards associated with the chemical.Structure-activity relationship (SAR) analysis: This involves comparing the structure of the chemical to the structure of known hazardous chemicals.In vitro testing: This involves testing the chemical in a laboratory setting to assess its toxicity. Studies we conduct Under Chemical Toxicological Assessment The following are some of the studies that we conduct under chemical toxicological assessment:Epidemiologic studies: These studies involve examining the relationship between exposure to a chemical and the occurrence of human disease.Animal studies: These studies involve testing the chemical in animals to assess its toxicity.In vitro studies: These studies involve testing the chemical in a laboratory setting to assess its toxicity. The services provided under chemical toxicology risk assessment Hazard identificationDose-response assessmentExposure assessmentRisk characterizationRisk management recommendations How GPC Group can help you for toxicology assessment of chemicals GPC can help you with all aspects of chemical toxicology risk assessment, including: Identifying the applicable regulatory requirements Developing a study plan Conducting the necessary studies Analyzing the data Preparing a report Benefits of Being GPC Client for Chemical Toxicological Assessment Service As a GPC client, you will benefit from the following:Access to a team of experienced toxicologistsService tailored to your specific chemical toxicological assessment needsPeace of mind knowing that your chemical toxicology risk assessment is being conducted in accordance with the latest scientific principles and regulatory requirements Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Cosmetic Product Notifications (CPN) OECD & GLP Study Management Only Representative (OR) Service Lead Registrant (LR) & SIEF Management ### Chemical Registration and Notification [rank_math_breadcrumb] GPC Service Chemical Registration and Notification Chemical registration and notification services are essential for ensuring compliance and safety in handling chemicals. GPC specializes in these services, providing expertise in REACH registration, including support for global REACH alike (K-REACH, UK REACH, Türkiye REACH) regulations. Choosing GPC ensures efficient compliance and expert assistance in navigating regulatory complexities for effective chemical management. Importance of Chemical Registration and Notification Effective chemical registration and notification are vital for safeguarding human health, the environment, and ensuring legal compliance. It establishes a systematic approach to manage chemicals, reducing potential risks, and providing transparency across the supply chain. How Chemical registration works? Chemical registration is a meticulous process involving the formal submission of data and information about a chemical substance to regulatory authorities. In the context of REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals), companies are required to provide detailed data on the properties, uses, and potential hazards of their substances. This information is then evaluated by regulatory bodies to ensure compliance with safety and environmental standards. How Does Registration Work in REACH? REACH registration mandates that manufacturers and importers submit comprehensive data on substances produced or imported in quantities exceeding one ton per year. This includes details on the substance's properties, uses, exposure scenarios, and risk management measures. The submitted data undergoes rigorous assessment by the European Chemicals Agency (ECHA), forming the basis for regulatory decisions. The services comes under Chemical Registration and Notification Our chemical registration and notification services encompass various crucial aspects:Training and Auditing: Offering educational programs and audits to enhance understanding and compliance.Supply Chain Management: Ensuring efficient and secure chemical handling through the entire supply chain.Government Relations: Facilitating communication with regulatory bodies for seamless compliance.Inventory Verification and Nomination: Verifying inventories and nominating chemicals appropriately.Scientific and Regulatory Assistance for Pesticides: Providing specialized support in the realm of pesticide regulation.Worldwide Chemical Notification: Enabling global compliance through comprehensive notification services.Comprehensive Regulatory Support: Offering extensive support to navigate complex regulatory landscapes.Technical Support Services: Providing technical expertise to address specific challenges. Check the registration and reporting requirements and roles in different countries. Global Chemical Regulations How GPC Group Can Help in Regulatory Chemical Registration and Notification Services? At GPC, our skilled team is here to simplify the process of  chemical registration and notification for your company. Here's how we can help:Regulatory Roadmap: We'll identify the rules you need to follow, making it easy for you to understand the regulatory landscape.Paperwork Made Easy: GPC will handle the paperwork, preparing all the necessary documents with precision.Smooth Submission: We'll submit your documents to the right authorities, ensuring everything is in order and compliant.Talking to Authorities: Let us do the talking. We'll liaise with regulatory bodies on your behalf, making the process hassle-free for you.Expert Advice: Beyond the paperwork, we're here to provide ongoing advice, keeping you informed and compliant with the latest regulations.When you choose GPC, you're choosing a partner dedicated to making your  chemical registration journey straightforward and stress-free. GPC Group can help companies with all aspects of REACH registration, including: Determining whether a substance is subject to REACH registrationPreparing the required documentationSubmitting the documentation to the European Chemicals Agency (ECHA)Liaising with ECHA on behalf of their clientsProviding advice and guidance on REACH registration compliance Get in Touch with Us for Chemical Registration and Notification Services If you seek reliable and professional chemical registration and notification services, contact GPC Group today. We offer expertise in REACH and Global REACH alike registration services, ensuring a compliant and efficient approach to chemical management. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Cosmetic Product Notifications (CPN) OECD & GLP Study Management Only Representative (OR) Service Lead Registrant (LR) & SIEF Management ### Chemical Classification and Labeling [rank_math_breadcrumb] GPC Service Chemical Classification and Labelling Chemical classification and labelling services are vital for ensuring safety and regulatory compliance in the chemical industry. These services categorize and label chemicals accurately, meeting standards and communicating essential information. Investing in these services reflects a commitment to safety and environmental responsibility. The precise classification and labelling also promote clear communication, mitigate risks, and support international trade. Overall, these services are essential for maintaining operational integrity and meeting regulatory requirements in the complex chemical sector. What is Chemical Classification and Labelling? Chemical classification and labelling are like a safety manual for everyone, providing vital information about chemicals through labels and safety data sheets (SDSs). They serve as a shield to protect workers and the environment from dangerous substances. In the world of chemical safety, it's not just a rule; it's a strategic fortification, ensuring a safe path forward. For businesses dealing with chemicals, it’s not merely following rules; it’s a smart move to keep things safe, informed, and eco-friendly. What is the Globally Harmonised System? The Globally Harmonized System (GHS) is a standardized framework adopted by over 70 countries for classifying and labeling chemicals. It provides consistent criteria for categorizing chemicals based on their hazards, ensuring uniform hazard communication elements like labels and safety data sheets (SDSs). This global approach streamlines chemical safety practices, establishing a universal language for risk assessment and communication across borders. For businesses, GHS compliance isn't just a requirement; it's a strategic necessity for navigating global markets and maintaining clear communication on chemical hazards. What is CLP? CLP stands for Classification, Labeling and Packaging. It is the European Union's implementation of the GHS. CLP is a regulation that requires manufacturers and importers of chemicals to classify, label, and package their products in accordance with the GHS. What is the Hazard Identification and Classification Process? Identify the chemical substances and mixtures present in the product. This information can be obtained from the product’s formulation or from the suppliers of the individual ingredients.Gather information about the physical and chemical properties of the chemical substances and mixtures. This information can be obtained from safety data sheets, technical data sheets, or scientific literature.Identify the potential hazards of the chemical substances and mixtures. This can be done by evaluating the physical and chemical properties of the substances and mixtures, as well as any available toxicological data.Classify the chemical substances and mixtures according to the GHS criteria. The GHS criteria are based on the potential hazards of the substances and mixtures, such as flammability, toxicity, and corrosivity. How GPC can help in Chemical Classification and Labelling GPC can help you with all aspects of chemical classification and labelling, including:Identifying the applicable regulatory requirementsGathering the necessary information about your productsClassifying your products in accordance with the GHSLabeling your products in accordance with the GHSPreparing safety data sheets for your products Benefits of Being GPC Client for Chemical Classification and Labelling Services As a GPC client, you will benefit from the following:Access to a team of experienced regulatory expertsA personalized service tailored to your specific needsPeace of mind knowing that your products are classified, labeled, and packaged in accordance with all applicable regulatory requirements Get in Touch with us for Chemical Classification and Labelling If you would like to learn more about our chemical classification and labelling services, please contact us today. We would be happy to discuss your needs and provide you with a free consultation. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Cosmetic Product Notifications (CPN) OECD & GLP Study Management Only Representative (OR) Service Lead Registrant (LR) & SIEF Management ### Scientific Chemical Substance Safety Assessment [rank_math_breadcrumb] GPC Service Chemical Substance Safety Assessment Scientific chemical substance safety assessment services (CSSA) are a comprehensive evaluation of the risks posed by a chemical substance to human health and the environment. CSSA services typically include hazard identification, exposure assessment, risk characterization, and risk management. CSSA services are essential for businesses that want to comply with regulatory requirements and operate safely and responsibly. How chemicals can be harmful Chemicals can be harmful in a variety of ways, including:Acute toxicity: Acute toxicity is the ability of a chemical to cause harm after a single exposure. Examples of acute toxicity include poisoning, skin burns, and respiratory irritation.Chronic toxicity: Chronic toxicity is the ability of a chemical to cause harm after repeated exposure. Examples of chronic toxicity include cancer, birth defects, and neurological damage.Environmental hazards: Chemicals can also be harmful to the environment. For example, chemicals can pollute water and soil, and they can harm wildlife. What are the steps involved in Chemical Substance Safety Assessment A chemical substance safety assessment (CSSA) is a process for evaluating the risks posed by a chemical substance to human health and the environment. The steps involved in a CSSA typically include:Hazard identification: This step involves identifying the potential hazards of the chemical substance, such as its toxicity, flammability, and corrosivity.Exposure assessment: This step involves estimating the amount of exposure to the chemical substance that is likely to occur.Risk characterization: This step involves combining the hazard and exposure information to estimate the risk posed by the chemical substance.Risk management: This step involves developing and implementing measures to reduce the risk posed by the chemical substance, if necessary. Principles of Chemical Substance Risk Assessments The principles of chemical substance risk assessments are based on the following:The dose-response relationship: This principle states that the severity of an effect caused by a chemical substance is related to the dose of the substance that is received.The threshold concept: This principle states that there is a threshold dose below which no adverse effects will occur.The interspecies variability: This principle states that different species have different sensitivities to chemical substances.The intraspecies variability: This principle states that there is variability in sensitivity to chemical substances within a single species. How GPC Group can help with Scientific Chemical Substance Safety Assessment Services GPC can help you with all aspects of chemical substance safety assessment, including:Identifying the applicable regulatory requirementsGathering the necessary information about your chemical substanceConducting a hazard identificationConducting an exposure assessmentConducting a risk characterizationDeveloping and implementing risk management measures Benefits of Being GPC Client for Scientific Chemical Substance Safety Assessment Services As a GPC client, you will benefit from the following:Access to a team of experienced regulatory expertsA personalized service tailored to your specific needsPeace of mind knowing that your chemical substance safety assessment is being conducted in accordance with the latest scientific principles and regulatory requirements Get in Touch with us for Scientific Chemical Substance Safety Assessment Services If you would like to learn more about our scientific chemical substance safety assessment services, please feel free to contact us. We would be happy to discuss your needs and provide you with a free consultation. Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Chemical Classification and Labeling Chemical Registration and Notification Chemical Safety Report (CSR) Chemical Toxicological Assessment ### Safety Data Sheet (SDS) Authoring [rank_math_breadcrumb] GPC Service Safety Data Sheet (SDS) Authoring Safety Data Sheet (SDS) Authoring Services ensure compliance with regulatory standards, offering clear and accurate documentation for chemical products. OECD & GLP Study Management Services streamline adherence to international guidelines for rigorous study oversight. Cosmetic Product Notifications Services simplify regulatory compliance in the cosmetic industry, emphasizing safety and quality. Chemical Toxicological Assessment Services are vital for identifying hazards, evaluating dose-response, and informing risk management, ensuring safety in handling hazardous chemicals. Each service plays a crucial role in maintaining safety, compliance, and quality within its domain. What is a safety data sheet (SDS)? An SDS is a document that provides information about the hazards and safe handling of a chemical product. SDSs are required by law in many countries, and they are an essential tool for employers and workers to protect themselves from the risks posed by hazardous chemicals. Who writes a product's SDS? The manufacturer or importer of a chemical product is responsible for writing the product's SDS. However, many companies choose to outsource the task of SDS authoring to experienced regulatory experts like GPC Group. What details must be included in a safety data sheet? The specific details that must be included in an SDS are determined by the regulatory requirements of the country in which the product is being sold or distributed. However, all SDSs must include the following information:The product's identity and compositionThe product's physical and chemical propertiesThe product's health and environmental hazardsThe product's safe handling, storage, and disposal procedures Ideal steps for the creation of SDS The ideal steps for the creation of an SDS are as follows:Identify the applicable regulatory requirements.Gather the necessary information about the product, including its identity, composition, physical and chemical properties, and health and environmental hazards.Write the SDS in a clear and concise manner, ensuring that all of the required information is included.Review the SDS to ensure that it is accurate and compliant with all applicable regulatory requirements. How GPC Group can help in Safety Data Sheet (SDS) Authoring GPC can help you with all aspects of SDS authoring, including:Identifying the applicable regulatory requirementsGathering the necessary information about your productsWriting accurate and compliant SDSsReviewing SDSs to ensure that they are accurate and compliant Benefits of Being GPC Client for Safety Data Sheet (SDS) Authoring Services We have successfully completed over 400 Safety Data Sheets with a commitment to timeliness and accuracy, achieving a 100% client satisfaction rate.As a GPC client, you will benefit from the following:Access to a team of experienced regulatory expertsA personalized service tailored to your specific needsPeace of mind knowing that your SDSs are accurate and compliant with all applicable regulatory requirements Do you want to know more about our services? Schedule a call Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you About Us Our Professions GPC Team GPC Partners GPC Brochure GPC Service Discover more GPC services... VIEW ALL Chemical Classification and Labeling Chemical Registration and Notification Chemical Safety Report (CSR) Chemical Toxicological Assessment ### Work with us Work with us Why work with us GPC Internship [rank_math_breadcrumb] Why work at GPC? GPC has an amazing, diverse, and creative work environment. This is a forward-thinking company that creates a friendly environment for its employees. At GPC, we promote diversity, equity, and inclusion. Working with GPC is a great opportunity you shouldn’t miss.  "Reasons you should work with us" International Work Environment & diversity GPC has an international work environment where we have a team of different backgrounds, cultures, and disciplines. Each employee has grown to understand among other things, the value of cultural sensitivity and respect of others’ perspectives. This also helps our employees to get more educated about other cultures and values. We have a team from about 10 countries, all of whom have their unique languages. Flexible Working Hours Flexible working hours at GPC means employees can begin their work earlier or later than the standard 9 am to 5 pm. GPC values its employees and affords them the opportunity to manage their time as suitable. This is aimed at reducing work stress and ensuring work satisfaction in the company. Independent working, learning and growth opportunity We provide an environment that is favourable for interpersonal growth, and we encourage the team to develop new skills to grow within the organization and not stay at the same level throughout their entire career. So far, this has helped employees build confidence and motivation in their respective work projects. GPC indeed provides the adequate platform needed for learning and growing. Working in global leading company GPC is a global leading company in the regulatory field and the employees are proud to be part of an organization that contributes to the safety and protection of the environment. Compliance with regulatory laws is a foundational step towards the environmental sustainability, being part of a company that is at the forefront of it is something to be proud of. Job openings Are you interested in working with us?​ Current openings Linkedin GPC Internship A GPC internship is your gateway into the company. GPC offers real-world experience in the compliance field that you can’t get anywhere else. You’ll work alongside our business development and regulatory teams, and we like to invest in your development and give you feedback to help you grow and improve. We offer a range of sought-after internships for those interested in Circular Economy, Business Development, IT, and more. Click to check our internship offers below to see further details. Internship ### Chemical Regulations Chemical Regulations [rank_math_breadcrumb] Global Chemical Regulations ⊙ Chemical Regulations in Asia Australia China India Korea Taiwan Vietnam ⊙ Chemical Regulations in Europe EU Eurasia Türkiye Norway UK ⊙ Chemical Regulations in Latin America Argentina Brazil Chile Colombia Mexico Newsletter Would you like to receive the latest global regulatory information? Subscribe Also check out the latest regulatory updates! Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you ### India BIS [rank_math_breadcrumb] Bureau of Indian Standards India BIS What is Bureau of Indian Standards (BIS)? BIS stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.  The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards. Moreover, BIS aims to link Quality Control Orders with Indian Standards Institution (ISI). BIS certification BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. Product certification includes two schemes: Product Certification Schemes: Scheme 1 – Indian Standards Institution (ISI) Scheme 2 – Compulsory registration scheme (CRS) The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.  Who can apply for BIS Certification?​​ Registration Process for Indian Companies Registration Process for non-Indian Companies How to obtain the BIS certification? For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including: Required documentDocumentation and application submission Factory inspection by Indian auditorProvision of test samples by the AIR and execution of the testsMarking and labelling of products with the standard or ISI marks for BIS certificationIn addition to above-mention rules, a number of chemicals are regulated under the BIS schemes. BIS stands for the Bureau of Indian Standards, the National Standards Body established based on the Bureau of Indian Standards Act 2016. The Act has enabling provisions for the Government to bring under compulsory certification regime any goods or article of any scheduled industry, process, system or service which it considers necessary in the public interest or for the protection of human, animal or plant health, safety of the environment, or prevention of unfair trade practices, or national security. There are two types of product certification schemes: Scheme 1 – Indian Standards Institution (ISI) and Scheme 2 – Compulsory Registration Scheme (CRS).Since 2018, 63 chemicals have been added to the BIS list with individual timelines for implementation via the publication of Quality Order Controls (QOCs). This means that manufacturers or importers of chemical substances that are on the BIS list need to apply for the certification before their business activities and get a BIS licenses. For non-Indian manufacturers to comply with BIS certification, they can appoint an Authorized Indian Representative (AIR) to submit the application. Do you want to know more about Bureau of Indian Standards? Explore more about BIS Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you BIS (India) Check out our Bureau of Indian Standards Document! Download Actionable summary Discover more regulations... VIEW ALL CMSR Indian Chemical Regulation REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation ### Norway REACH [rank_math_breadcrumb] Norwegian Chemical Regulation Norway REACH What is Norway REACH? Producers and importers of hazardous substances and mixtures to the Norwegian market have to follow the Regulations on declaration of chemicals to the product register (declaration regulations), enforced on June 1, 2015. Applicants need to submit information to Norwegian Environment Agency (NEA) before they place the products. Applicants also have the duty to notify (PCN) to the European Chemical Agency (ECHA). Registration Requirements Businesses producing or importing 100 kg or more of a chemical substance are to declare their products, where the registration must take place by the latest when manufacture, market placement, or professional use begins in Norway. Companies need to provide the following information for registration: Company information unambiguous chemical name for all chemical substances in the substance mixture; CAS no. and EC No.; code for hazard class and hazard category as well as code for hazard statements according to CLP; the amount of each component expressed as % weight. The annual deadline for the quantities report is May 20, 2022, applicants need to report annual quantities of chemicals processed the previous year, including chemicals discontinued during the previous year. Do you want to know more about Norwegian Chemical Regulation? Explore more about Norway REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Norway REACH Check out our Norwegian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### Mexico REACH [rank_math_breadcrumb] Mexican Chemical Regulation Mexico REACH What is Mexico REACH? There is no chemical regulation in Mexico today. In 2019, the General Health Council (CGS) proposed the Comprehensive National Policy for the Management of Chemical Substances. CHS’s proposal intended to put the burden of proof on companies to show that substances are safe; enable authorities to impose restrictions and bans on chemicals after an assessment; to impose obligations on producers or importing companies to provide regular information, etc. Expected to be submitted to Congress in 2020 and be approved by 2021, the bill is delayed. *Política Nacional Integral para la Gestión de Sustancias Químicas Inventory In 2009, the first step towards a national chemical inventory occurred in Mexico. In total, the inventory has 5.852 chemicals present and is based on 2009 as the reference year.  The inventory was more characterized as a catalog since it did not impose any obligation on the national market, it was the initial step for a pilot project to be established. In 2018, the National Institute of Statistics and Geography (INEGI) published the Guidelines for the use of the National Catalog of Chemical Substances for statistical and geographic purposes. The document considered information provided by the national chemical industry and importers, in addition to being a homologation tool for substances collected so far. In December 2020, National Chemical Industry Association (ANIQ) proposed changes to the national chemical substance inventory, which includes the possibility to improve the management of chemicals by assessing the substance through its life cycle. According to ANIQ’s proposal, the suggested inventory would serve as a basis for future chemical regulation advancement, support a better decision-making process, and contribute to the national industry. It is predicted that the agencies are working together to strengthen and streamline the proposal implementation process, presenting a project that does not only control but also promotes and develops the industry’s production. Neither ANIQ nor CGS have made changes available to the public (until this publication date). Adoption of GHS In 2015, the norm NOM-018-STPS-2015* was responsible for incorporating GHS standards 5th version in Mexico, with a transitional period of 3 years, which entered into force in October 2018. Do you want to know more about Mexican Chemical Regulations? Explore more about Mexico REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Mexico REACH Check out our Mexican Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL BRAZIL Brazilian Chemical Regulation CHILE Chilean Chemical Regulation COLOMBIA Colombian Chemical Regulation ARGENTINA Argentinian Chemical Regulation ### Korea REACH [rank_math_breadcrumb] Korean Chemical Regulation Korea REACH (K-REACH) What is K-REACH (Korea REACH)? The Ministry of Environment of Korea (MoE) published the Act on Registration and Evaluation, etc. of Chemical Substances on January 1, 2015. The Act is also known as K-REACH. The recent amendment was published on April 13th, 2021. The Act on Registration and Evaluation of Chemical Substances (known as K-REACH) was published on January 1, 2015. K-REACH aims to protect public health and the environment, which is achieved through four procedures, namely notification or registration, evaluation, authorization, and restriction of chemicals. Under K-REACH, depending on if a substance is listed in the inventory, chemical substances can be divided into 3 categories, which are existing substances, new substances, and Priority Existing Chemicals (PEC) substances. Compliance procedures differ according to the substance categories and tonnage band. There are 2 types of exemptions: confirmation required exemption and no action required exemption. The proof of exemption should be submitted for the confirmation required exemption. Types of registration under K-REACH New Substance Manufacturers or importers of a new chemical substance need to register the substances prior to manufacture or import. For substance less than 100 Kg/year, it only requires notification and does not need to go through hazard evaluation. PEC Substance Manufacturers or importers of a PEC (Priority Existing Chemicals) substance need to register the substances prior to manufacture or import. Pre-registration of PEC substance is not possible as the transition period has already passed. Existing Substance For existing substances above 1 Tonne Per Annum (TPA) (excluding exempt substances), they must be registered within given grace periods. Only companies that carried out pre-notification can be entitled to the grace periods.  The deadline for existing substance registration varies based on tonnage band. After the deadline for each tonnage band, existing substances within the tonnage band cannot be pre-registered, and it should be registered prior to placing the substances in Korea. Deadline for existing substance registration: 1000+ tpa: 2021.12.31 100-1000 tpa: 2024.12.31 10-100 tpa: 2027.12.31 1-10 tpa: 2030.12.31 K-REACH Registration Process Other related regulations K-BPR The Consumer Chemical Products and Biocide Safety Management Law (known as K-BPR) concerns the placing on the market and use of hazardous consumer chemical and biocidal products, which aims to protect public health and environment from these chemicals and products.  K-BPR was taken into force on January 1, 2019, and its recent amendment was promulgated on March 24, and May 26, 2020. Its enforcement will start on January 1, 2021. Cosmetic Act The Cosmetic Act in South Korea aims to develop the cosmetics industry and improve public health. It has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020. KOSHA & MSDS MSDS is one part of Occupational Safety and Health Act (KOSHA). The purpose of this Act is to maintain and promote the safety and health of people providing labour by establishing stands on industrial safety and health. Do you want to know more about Korean Chemical Regulation? Explore more about K-REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Korea REACH Check out our Korean Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### Australia REACH [rank_math_breadcrumb] Australia Chemical Regulation Australia REACH What is AICIS (Australian Industrial Chemicals Introduction Scheme) ? The Industrial Chemicals Act 2019 established the Australian Industrial Chemicals Introduction Scheme (AICIS) to regulate the importation and manufacture (introduction) of industrial chemicals in Australia. AICIS replaced the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1 July 2020. The AICIS regulates chemicals (including polymers) introduced for an industrial use, such as in inks, paints, adhesives, solvents, cosmetics and personal care products, cleaning products, as well as in manufacturing, construction, and mining applications and to promote the safe use of industrial chemicals in order to protect human health and the environment. Who is affected? Importers and manufacturers (introducers) of industrial chemicals for commercial purposes need to register their business under this scheme. All industrial chemical introducers must categorise their chemical importation or manufacture (introduction) into the following categories i.e., Listed introduction, exempted introduction, reported introduction, assessed introduction, commercial evaluation before placing into Australian territory. If the introduction is listed in the Australian Inventory of Industrial Chemicals (the Inventory), then it is categorized as Listed introduction, and can be placed in the market in complying with the regulatory obligations (if any). If the introduction is not in the listed category, then it must be authorized into any one of the other categories. Annual Declaration Regardless of introduction category, one must submit an annual declaration at the end of every registration year (between August 1 and November 30). This declaration is to make about the industrial chemicals imported or manufactured in the previous registration year and confirms that introductions were authorised under Australian laws. Introduction categories for chemicals Importers and manufacturers (introducers) of industrial chemicals for commercial purposes need to register their business under this scheme. All industrial chemical introducers must categorise their chemical importation or manufacture (introduction) into the following categories i.e., Listed introduction, exempted introduction, reported introduction, assessed introduction, commercial evaluation before placing into Australian territory. If the introduction is listed in the Australian Inventory of Industrial Chemicals (the Inventory), then it is categorized as Listed introduction, and can be placed in the market in complying with the regulatory obligations (if any). If the introduction is not in the listed category, then it must be authorized into any one of the other categories. It is important for Non-Australian introducers to register their business and meet compliance & reporting requirements for uninterrupted exports to Australia. Australian Registered Business Number (ARBN) is mandatory for the same. Non-Australian introducers can also appoint an Australian agent for compliance requirements if they are unable to obtain Australian Registered Business Number (ARBN). Do you want to know more about Australian Chemical Regulation? Explore more about Australia REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Australia REACH Check out our Australian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation UK REACH UK Chemical Regulation ### Vietnam REACH [rank_math_breadcrumb] Vietnamese Chemical Regulation Vietnam REACH What is Vietnam REACH? The main chemical law in Vietnam is the Law on Chemicals 06/2007/QH12 issued in Nov. 2007. The Chemical Law provides regulations on chemical handling, safety in chemical handling, right and obligations of organizations and individuals engaged in chemical handling, and state management of chemical handling. The main authority in charge of chemical management is the Ministry of Industry and Trade (MOIT). The chemical law in Vietnam is supported by various decrees. The Decree No. 113/2017/ND-CP Specifying and providing guidelines for implementation of certain articles of the law on chemicals in which updated on 2017 provides detailed regulations on chemical lists on licenses, classification, plans/measures for chemical incident, safety training, declaration, etc. The Circular 32/2017/TT-BCT provides forms and guidelines of labeling, MSDS, declaration, reports, license application, plans/measures, etc. National Chemical Inventory (NCI) Vietnam began to compile the national chemical inventory (NCI) in 2012. Substances that are not listed on the inventory will be considered as new substances and require registration before they can be used, imported, or produced in Vietnam. So far, there are 5 times where companies can nominate substances to the inventory. The inventory contains about 40,000 substances. The new deadline for substance submission is April 15th, 2021. The final draft of the inventory is expected to be released by the end of this year. Nominating Substance to the NCI Nominating Substances to the NCI requires the following information:Chemical Name (IUPAC)CAS No.Safety Data Sheet (SDS) – as per Vietnamese Decree No. 113/2017/ND-CP and Circular no. 04/2012/TT-BCT in Vietnamese languageDocument that showing the chemicals are being used in Vietnam (such as purchase contract, invoices, etc)The Vietnamese authority will evaluate the substances and decide if they should be included in the inventory. Steps for Nominating Substances to the NCI Identify substances that export to Vietnam and check if it is listed in the NCIPrepare information (CAS No.) and documents for substance nomination to the NCICheck if the SDS is updated and prepare SDS in VietnameseConsult with regulatory compliance companies to fulfill your responsibilities as manufacturers and suppliers and ensure the access to the Vietnamese market Do you want to know more about Vietnamese Chemical Regulation? Explore more about Vietnam REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Vietnam REACH Check out our Vietnamese Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation ### UK REACH [rank_math_breadcrumb] UK Chemical Regulation UK REACH What is UK-REACH? The EU REACH Regulation was brought into UK law, as amended by the REACH (EU Exit) Regulations 2019, on 1st January 2021 and is now known as UK REACH. UK REACH will now regulate the market access to Great Britain (GB) i.e. England, Scotland and Wales. UK REACH has been described as mirroring its EU counterpart. With the aim of assisting the many exporters likely to be affected by the repeal of EU REACH in the Great Britain, UK REACH provides comprehensive transitional arrangements. Such arrangements concern both EU/EEA and non-EU/EEA based exporters dealing with substances which are already registered under EU REACH and now wishing to maintain access to the GB. Transitional provisions are, however, not applicable to those who will place the substances for the first time in the GB market. In order to secure your access to the GB market, you should consider getting in touch with a GB-based OR without delay. GPC Group has already set up a UK-based OR, to support our existing and new clients, in addressing the challenges posed by Brexit on substance exports to the UK.  Brexit Current Status EU REACH has ceased to apply in Great Britain on January 1st 2021, as a consequence of the United Kingdom’s effective withdrawal from the European Union. GB manufacturers, importers, distributors and downstream users of chemical substances must now comply with UK REACH, the UK regulation adopted in replacement of EU REACH. Who is concerned? Companies seeking to export an EU-registered substance to the GB market, who also placed that substance on the GB market in 2019-2020: Such exporters may submit a Downstream User Import Notification (DUIN) to HSE. By notifying their substance via DUIN, exporters will maintain access to the GB-market while deferring the registration of their substance by 2, 4 or 6 years (depending on the tonnage band and risk profile of the substance). To submit a DUIN, non-GB based exporters need to appoint a GB-based Only Representative. The deadline for DUIN expired on 27 October 2021, however late-DUINs can still be submitted. Companies seeking to export an EU-registered substance to the GB market for the first time These exporters may benefit form a simplified registration process named New Registration of an Existing Substance (NRES). NRES requires exporters to: Submit an Inquiry Pay HSE’s registration fee Submit a simplified registration dossier (which does not need to include the LoA) Once these steps have been completed the substance can be placed on the GB-market. The full registration dossier will have to be submitted within 2, 4 or 6 years form 27 October 2021 (depending on the tonnage band and risk profile of the substance) Please note that NRES only applies to substances that were registered under EU REACH before 31st December 2020. Exporters of a non-EU-registered substance wishing to access the GB market: Exporters who do not qualify for DUIN or NRES must register their substances under UK-REACH before they may place that substance on the GB-market. Non-GB based exporters must appoint a GB-based OR to complete the full registration of the substance. To register, exporters need to Submit an Inquiry Pay HSE’s registration fee Submit a full registration dossier (including the LoA) Which procedure applies to your business? Actionable Summary for Chemical Businesses Identify the substances to be placed in the GB market in qty. ≥ 1 tpa​ apart from the EU exports earlier Check- if the substance is already registered in EU-REACH as EU Registered substances make you eligible for DUIN Check- if the substance will be placed in the GB for the first time – Submit inquiry and registration dossier as soon as possible Early submission means possibility to be a part of substance group so prioritise substances for inquiry submission immediately after DUIN Check- if the SDS is updated or not – the substance classification should be as per the new GB CLP Identify the competent OR to take responsibilities towards your UK-REACH compliances. Be transparent to your OR and give complete information to avoid any non-compliances Do you want to know more about UK Chemical Regulation? Explore more about UK REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you UK REACH Check out our UK Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation ### Turkey REACH [rank_math_breadcrumb] Turkish Chemical Regulation Türkiye REACH (KKDIK) What is KKDIK (Türkiye REACH) ? KKDIK came into force as a result of the EU Adaptation policy. The first phase of pre-registration ended on December 31st, 2020. The registration phase then officially started the next day (January 1st, 2021). By complying with KKDIK, exporters can ensure their access to the Turkish Market. Exporters who wish to enter the Turkish market but missed the pre-registration should pre-register as soon as possible to be able to benefit from the advantages of joint registration. KKDIK (aka Türkiye REACH) came into force on the 23rd of June 2017 and has replaced three existing regulations on chemicals and mixtures to regulate the chemical inventory, enforce secure usage, and risk management on hazardous substances, and promote alternatives to hazardous substances or procedures. The regulation provides the means of registration, evaluation, authorization, and restrictions of chemicals and safeguarding human health and the environment. It also encourages using alternative methods for evaluating the hazard of substances such as decreasing the number of animal tests and encouraging innovation so that the competitiveness of the Turkish chemical industry will be enhanced. KKDIK Timeline consists of 3 main phases: Pre-registration (Deadline has passed) Registration (Different deadlines for different tonnage bands) Post-registration Türkiye Reach (KKDIK) Registration Phase Began! It is strongly recommended for exporters to Türkiye to submit late pre-registrations (LPR) as soon as possible to secure business if not done already before 31st December 2020. Pre-registration carries crucial importance to be able to actively participate in SIEF activities for joint registrations. KKDIK allows only pre-registered substances to be placed in the Turkish market from the 1st of January 2021 and onwards. Pre-registration is a simple activity without major compliance requirements that also allows GPC to represent your best interest within the SIEF. KKDIK is a comprehensive regulation. However, some substances are exempted from registration either because they are covered by specific regulations such as radioactive waste or regarded as less risky such as polymers. The registration process is not the same for every substance for instance under some conditions, registration of on-site or transported isolated intermediates is relatively easy. Registration requirements change depending on the exported tonnage of the substance. When the tonnage increases, additional information is needed. For instance, when the tonnage of a substance is 10-100 tons per annum, a chemical safety report should be provided. Therefore, the best and easiest action would be to e-mail us your substance details and we will provide you with your customized complete obligations under Türkiye REACH. Current Deadlines The Ministry of Environment, Urbanization, and Climate Change of Türkiye announced new KKDIK deadlines for the registration process. Pre-registration under the KKDIK needs to be completed according to the timeline soon to be published by the Ministry in a circular or similar official communication. The tonnage bands for registration are like EU REACH (1-10; 10-100; 100-1000 and 1000+ tons/year for full registration and <1000 or >1000 tons/year for intermediate registration). The deadline for the final registration within KKDIK depends on the tonnage band and substance classification: 31st December 2026: 1000+ tons/year, 100+ tons/year if the substance is aquatic chronic/acute 1, 1+ tons/year if the substance is CMR 1A/B 31st December 2028: 100+ tons/year 31st December 2030: 1+ tons/year Joint Registration Joint registration aims to decrease the cost of registration by splitting the fee etc. and reduce the number of animal tests. Lead registrants, who are appointed by the SIEF members for each substance, prepare and submit the joint registration dossier on behalf of the SIEF. GPC can undertake the lead registrant role upon your request. Having managed approximately 1200 registration dossiers including 400 lead registrations in EU REACH, GPC is the holder of data for many substances and thus, we offer you the advantage of having a much faster & cost-effective registration process for the SIEFs that we are the lead of. Do you want to know more about Turkish Chemical Regulation? Explore more about KKDIK Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Türkiye REACH Check out our Turkish Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### Taiwan REACH [rank_math_breadcrumb] Taiwanese Chemical Regulation Taiwan REACH (TCCSCA) What is TCCSCA (Taiwan REACH)? The recent chemical regulation in Taiwan is called Toxic Chemicals and Concerned Substances Control Act (TCCSCA) and it enforced one January 1, 2020. The supplementing regulation for regulating substance registration, Regulation on New and Existing Chemical Substances, was published on March 11 2019. Manufacturers exporting to Taiwan have to comply with the TCCSCA. The compliance obligations are depending on types of substance and its quantity. Phase One Registration Manufacturers / Importers, who manufacture/import existing chemical substances in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacture/import. Standard Registration Taiwan’s EPA announced the first batch of Priority Existing Chemical (PEC) in which contains 106 substances. Companies manufacturing/importing PECs with a quantity above 1 TPA need to submit Standard Registration: Before December 31, 2024 (if the Phase One Registration Number received before January 1, 2020) Before December 31, 2025 (if the Phase One registration Number received after January 1, 2020). Registration for New Chemicals New Chemical Substances can be registered in three types: Standard registration (above 1 TPA), Simplified registration (between 100 kilograms to 1 TPA) and Small quantity registration (less than 100 kilograms). Companies need to submit their application 90 days before manufacturing or importing. Non-Taiwanese manufacturers not willing to disclose their product information to their Taiwanese clients (Importers) can ask the importers to nominate a Representative to fulfil their compliance and annual reporting obligations. Do you want to know more about Taiwanese Chemical Regulation? Explore more about TCCSCA Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Taiwan REACH Check out our Taiwanese Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation ### India REACH [rank_math_breadcrumb] Indian Chemical Regulation India REACH (CMSR) What is ICMSR (India REACH)? The Indian Chemicals (Management and Safety) Rules (ICMSR) are a proposed set of rules replacing the current framework for chemicals management in India. As an overarching regulation, the ICMSR will regulate the production, import and market placement of Substances, Substances in Mixtures, Substances in Articles and Intermediates. Current status of ICMSR India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR is expected to be notified to WTO in 2022 and come into force after a process of legal vetting and ministerial feedback. Who is concerned? Indian manufacturers and importers are required to comply with the ICMSR, which also contains some obligations for Downstream Users. Foreign entities wishing to place products in the Indian market should appoint an Authorized Representative (AR) to act and comply with the ICMSR on their behalf. Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in “Priority Substances Required to be Registered” in Schedule II of the ICMSR need to be registered. What are the main obligations under ICMSR? Notification Notification is required for all substances placed in Indian Territory in quantities above 1 TPA. The ICMSR will include an Initial Notification Period (INP) where manufacturers, importers and Authorised Representatives should notify their substances. The current Draft provides for an INP of 180 days, counting from the entry into force of the ICMSR. Substances notified during the INP will be considered Existing Substances. Substances not notified during the INP will be considered as New Substances. If placed in the Indian market in quantities above 1 TPA, they must be notified at least 60 days prior to being placed in Indian Territory. Registration In addition to Notification, some substances will require Registration if placed in Indian Territory in quantities above 1 TPA. These substances will also require Registration when present in Articles from which they are intended or likely to be released in quantities greater than 1 tonne per producer or importer and year. The ICMSR adopts a listing approach to Registration. All substances listed in Schedule II must be Registered within the 18 months following their inclusion in the Schedule. Intermediates – substances that are manufactured for, consumed in, or used in chemical processing to be transformed into other substances – also incur Registration obligations, which vary according to their quantity and whether they are stored or transported. Reporting The information submitted at the time of Notification and Registration must be regularly updated. An annual report must be set for all notified substances during the first 60 days of the calendar year. This report must include any changes to the information submitted at the time of notification, as well as the actual quantity of substances placed in Indian Territory (including any applicable fee changes). Changes to the information submitted at the time of a Registration must, if they affect hazard or risk management, be notified within the 60 days after the registerer has become aware of the changes. Compliance Strategies In order to prepare for upcoming obligations under the ICMSR, businesses can: Set up a regulatory team Prepare an Inventory of substances being handled Identify the quantity placed in India Initiate communication with downstream users Update SDS in accordance with GHS Rev. 8 Stay updated on the ICMSR Hold internal training activities on the ICMSR Follow up on the relevant Schedules of the ICMSR substance list: Substances to be Registered (Schedule II), Restricted or Prohibited Substances (Schedule VI) and Hazardous Chemicals (Schedule X, XI, XII) Do you want to know more about Indian Chemical Regulation? Explore more about CMSR Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you India REACH Check out our Indian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL BIS Bureau of Indian Standards REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation ### Eurasia REACH [rank_math_breadcrumb] Eurasian Chemical Regulation Eurasia REACH (TR041) What is TR041 (EURASIA REACH)? The Eurasian Economic Union (EAEU) Council consists of five member states, that are, Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. EAEU approved a regulation on March 3, 2017, and it is expected to come into force on November 30, 2022. The regulation, known as ‘Technical Regulation of Eurasian Economic Union on Safety of Chemical Products- TR EAEU 041/2017, establishes requirements for chemical substances, mixtures, and other chemical products that will be placed on the EAEU market. TR EAEU 041/2017 is also known as Eurasian REACH. It covers all chemicals except the ones listed in Annex I of the regulation. According to the regulation, there are different requirements and processes for new and existing substances. Existing substances are those nominated into the Russian inventory while new substances are the chemicals that are absent from the Russian inventory. Existing substances will require simplified registrations while new substances will require standard registrations. Non-EAEU companies that export or want to export chemicals to the EAEU are required to appoint Nominated Representative located in the EAEU to carry out their importer obligations. What are the compliance requirements of TR041? The compliance assessment with the requirements of the TR 041 is carried out in one of the following ways: 1) Notification Registration For substances that are listed (e.g. notified) in the Eurasian chemical inventory: that do not do not contain prohibited and (or) restricted to use chemicals and mixtures. that contain restricted to use chemicals and mixtures in concentrations below the established limit, according to Appendix N 4. *Document requirements: Application form (in accordance with Appendix 5); SDS  in accordance with paragraphs 36-43 of TR 041/2017; Protocols of studies (tests) carried out in test  laboratories, and (or) documents containing information obtained from official information sources. NOTE: Research protocols are not required if the chemical product is already listed in the register of chemicals and mixtures of the Union. The registration certificate is provided online and has no expiration date. 2) Permissive registration For substances that are NOT listed in the Eurasian register of chemical substances and mixtures. New chemical products Chemical products that contain chemicals and mixtures (included in the register of chemical products) limited to use on the territory of the Union, in concentrations, exceeding the limits established in Appendix 4. *Document requirements: Application form (in accordance with Appendix 5); SDS  in accordance with paragraphs 36-43 of TR 041/2017; Protocols of studies (tests) carried out in test  laboratories, and (or) documents containing information obtained from official information sources. NOTE: Research protocols are not required if the chemical product is already listed in the register of chemicals and mixtures of the Union. Information required in paragraph 48; a) chemical safety report in accordance with the structure in accordance with Appendix N 3; b) the name of the chemical according to the IUPAC nomenclature, including in English; c) the structural formula of a chemical substance; d) CAS number; d) data of instrumental analysis of a chemical substance; e) the degree of purity of the chemical; g) the intended uses of the chemical; h) proposed methods of disposal (processing) of a chemical substance; i) a method of transporting a chemical substance and measures to prevent and eliminate emergencies; j) analytical methods of control; k) physicochemical data of a chemical substance; l) toxicity data for the chemical; m) data on the ecotoxicity of the chemical; n) copies of data (protocols) of studies (tests) of a chemical substance for the determination of bioaccumulation, carcinogenicity, mutagenicity, toxicity, carried out in laboratories (centers), recognized by the authorized body in accordance with the principles of good laboratory practice in accordance with the legislation of the Member State ( research (testing) in other laboratories (centers) within 2 years from the date of entry into force of this technical regulation). NOTE: The permissive registration is valid for 5 years ( If the product complies with the TR 041 and the resposible institution has no remarks, the permission is automatically prolonged after 5 years) 2) Chemical Safety Report (> 10 ton per year) Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment; Exposure Scenario is required if classified as dangerous or PBT/vPvB;  operational conditions and risk management measures for each use; exposure estimation Do you want to know more about Eurasian Chemical Regulation? Explore more about Eurasia REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you Eurasia REACH Check out our Eurasian Chemical Regulation Document! Download Actionable summary Discover more regulations... VIEW ALL REACH EU Chemical Regulation KKDIK Turkish Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### EU REACH [rank_math_breadcrumb] EU Chemical Regulation EU REACH What is REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) ? REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users. If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007. How does REACH work? REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance. ECHA receives and evaluates each registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess whether the risks of substances can be managed. Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation. REACH Timeline Post 31st  May’2018, Deadline all chemicals are treated equally and chemicals which were not registered within REACH with European Chemical Agency will not be allowed to be marketed or manufactured within EU. REACH Registration Process To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The main principle of REACH is “one substance, one registration”. During joint submission process, one of the member among the manufacture of same chemicals nominate himself as lead registrant and the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co- registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID6. REACH Registration Dossier A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report. 1) Technical Dossier Identity of manufacturer/importer; Identity, volume and identified uses of substance; Classification and labelling; Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, ); Testing proposal; Statement whether tests have been carried out on vertebrate animals; 2) Chemical Safety Report (> 10 ton per year) Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment; Exposure Scenario is required if classified as dangerous or PBT/vPvB;  operational conditions and risk management measures for each use; exposure estimation Do you want to know more about EU-REACH? Explore more about EU-REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you EU REACH Check out our EU REACH Document! Download Actionable summary Discover more regulations... VIEW ALL KKDIK Turkish Chemical Regulation K-REACH Korean Chemical Regulation CMSR Indian Chemical Regulation UK REACH UK Chemical Regulation ### China REACH [rank_math_breadcrumb] Chinese Chemical Regulation China REACH (MEE Order 12) What is MEE Order (China REACH)? In 2003, Chinese Ministry of Ecology and Environment (MEE) introduced the regulation on the registration of New Chemical Substances (MEP Order No.7). In 2010, this regulation was revised for the first time and the Inventory (IECSC) was introduced under Order No.7. After 9 years’ implementation of Order No.7, MEE called for the second revision of Measures for the Environmental Management Registration of New Chemical Substances, which was finally approved on February 12, 2020 (MEE Order No.12). This new regulation has come into force on January 1, 2021 and replaced the previous regulation (Order No.7). Under the provisions of this regulation, companies shall submit registration application if manufactured/imported substance is not listed in the Inventory. All activities including research, production, importation and processing have to comply with the regulation requirements as long as the chemical substances are under the scope of this regulation. Business activities are not allowed until a certificate is granted. Who should register? Chinese manufacturers or importers Chinese processing users Foreign companies selling New Chemical Substances to China can register via Only Representative (OR) Chinese domestic companies can submit the application by themselves. Overseas applicants can appoint a Chinese agent (OR) who will share the legal responsibility with them to fulfill the registration and post-registration obligations. The OR should have a legal entity in China. Registration Type Registration Document Inventory The Inventory of Existing Chemical Substances in China (IECSC) was introduced in 2013. The list has been regularly updated since then. Currently, there are 46,192 listed chemical substances as of the latest updates (Latest reference date 2020-11-17). Substances in the inventory are presented as category names, neither CAS number nor molecular structure is given. Substances that are not listed in the Inventory are considered New Chemical Substance. The Inventory consists of two parts (public and confidential). Currently, there are 3,270 confidential substances. Companies must submit a formal enquiry in order to check if a substance is listed in the confidential part. China Solid Waste and Chemicals Management Center (SCC), a division of MEE, then will issue a letter of confirmation (usually within 2 weeks) and a 3 000 RMB fee will be charged. GPC can assist the enquiry on the customer’s behalf. Despite all monomers being listed in the inventory, polymers are still required for registration. Annual Report First activity report Certificate holders or their ORs, regardless of registration types, have to submit the first activity reports within 60 days since the first activity (manufacture and import/transfer to downstream user) of concerning chemical substances. The report should contain the following information: Domestic importing or producing company’s information Time, place, volume of the first activity Transferred user’s information Environmental risk control measures Implementation of environmental management requirements Annual Report Regular registration certificate holders or their ORs of those noted with Annual Report obligation on their certificates have to submit Annual Reports before 30 April from the second year of registration. Annual report should include the following information: Record of new chemical substance’s activities from last year, including the production or importation volume, transferring history and processing users’ information Record on information communication Emission into environment Environmental risk control measures Implementation of environmental management requirements Note: processing users are obliged to assist the certificate holders to fulfil the annual report obligation.  Do you want to know more about Chinese Chemical Regulation? Explore more about China REACH Get in Touch with Our Regulatory Expert Contact us Share the page! Other websites that may be useful for you [rank_math_breadcrumb] China REACH Check out our Chinese Chemical Regulation Document! Download Actionable summary Discover more regulations... 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SSS Europe (renamed GPC Europe w.e.f 6th May 2020), a familiar name in chemical regulatory and compliance services now formally belongs under the umbrella of GPC Holding Sweden. Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance service providers with Representation services in Europe, Asia, and Middle East for respective chemical regulations. Our over 1,500 Happy Clients are a testimony to the great rapport we share with them and the fine quality that we offer in our services. This is also reflected in the fact that we have about 99% customer retention (Client loyalty) and we have had over 200 companies opting to switch over to us from other service providers, for better and cost-effective services. 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Our regulatory compliance services started with EU REACH, and we have now ventured into every new regulation that emerged over the past few years like Korea and Turkey REACH, and the regulations in the UK, Eurasia, Australia, Taiwan, Japan, China, USA, Canada, Latin America etc. including cosmetics regulations in EU, India, and the USA. Learn more>> Established in 2008, Global Product Compliance (GPC) is one of the earliest OR services and compliance support company. We specialize in Global Regulatory Compliance Solutions across global sectors. Our regulatory compliance services started with EU REACH, and we have now ventured into every new regulation that emerged over the past few years like Korea and Turkey REACH, and the regulations in the UK, Eurasia, Australia, Taiwan, Japan, China, USA, Canada, Latin America etc. including cosmetics regulations in EU, India, and the USA. 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