Definition of “New Chemical Substance”: A New Chemical Substance refers to a chemical substance that does not exist in IECSC (Inventory of Existing Chemical Substances in China). The inventory of Existing Chemical Substances in China is formulated, adjusted and published by the Ministry of Environment Protection.Production or import of new chemical substances shall be subject to new chemical substance notification according to the Measures for Environmental Management of New Chemical Substances (Order No. 7 of Ministry of Environmental Protection, hereafter referred to as the Measures). The Measures are applicable to raw materials or intermediates for producing medicine, pesticide, veterinary drug, cosmetic, food, food additive, feed additive and other products, which are new chemical substances. The Measures is applicable to new chemical substances contained in intermediate products or finished products with specific functions, such as surfactant, plasticizer, antiseptic, dispersant and flame retardant, regardless of their content.The Measures are applicable to chemical substances with non-unique and uncertain molecular structure such as variable composition substances and complex reaction products and polymers which are new chemical substances.Definition of “Inventory Checking” (or Checking in IECSC)： Inventory Checking means to search whether the chemical intended to produce or import is listed in IECSC. Inventory Checking is the precondition that whether a chemical substance is new and shall be notified.Method of Inventory Checking: Independent Checking and Entrust Checking.1. “Independent Checking” means notifiers can perform the checking through internet query, buying electronic PC version of the inventory. (You can download the PDF version of the inventory by click the button below or email us. We will provide our proffesional help asap.)2. “Entrust Checking” means notifier entrusts the China Solid Waste and Chemicals Management Center of the Ministry of Environmental Protection (MEPSCC) to perform inventory checking. “Entrust Checking” requires notifier to download application software and pay MEPSCC RMB 5,000 for this official inventory checking which would not only search in the publicized inventory but the classified inventory as well. And an official confirmation letter will be issued by MEPSCC after checking. Beijing BoardingCard provides free “Independent Checking” and “Entrust Checking” service. Our experienced and professional employees will help you communicate with MEPSCC and provide you with the most efficient service. Contact Person: Lena Liu Peter WangEmail: lenaliu@bjboardingcard.com peterwangpeng@bjboardingcard.comCall: 86-10-87671126
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China New Chemical Substance Registration (referred to as “China Reach”) includes regular registration, simplified registration and filing.The producer or importer of a new chemical substance shall obtain a new chemical substance environmental management regular registration certificate or a simplified registration certificate or go through a new chemical substance environmental management filing (referred to as "filing") before production or import under China Reach. Those who meet one of the following conditions shall apply for filing: The annual production or import of new chemical substances is less than 1 ton/year;The new chemical substance monomer or reactant content does not exceed 2% of the polymer or belongs to the low concern polymer. Registration:After the applicant submits complete filing materials, the online registration system will automatically send a filing receipt.The applicant can carry out activities related to new chemical substances in accordance with the contents of the filing.Please pay attention: the competent department of ecological environment of State Council organizes its affiliated chemical substance environmental management technical institute to conduct random checks on the compliance of the filing materials. If, after random inspections, it is found that the filing materials submitted by the applicant do not meet the requirements, or are insufficient to determine whether they meet the filing requirements, the applicant shall supplement the relevant materials at one time in accordance with the requirements of the supplementary notice. After random inspections, it is found that the filing materials do not meet the filing requirements and the competent department will cancel the filing. The applicant shall bear the corresponding legal responsibilities stipulated in the "Measures", and apply for a new chemical substance environmental management regular or simplified registration certificate in accordance with the "Measures". Filing application form:Please download in the "Download Center". Post-registration supervisionunder China Reach：1. The filing applicant shall carry out activities in accordance with the filing items.2. Processing users are not allowed to process and use new chemical substances that have not obtained a registration certificate or have not been filed.3. Filing materials and records of new chemical substance activities should be kept for at least three years.For detailed post-registration supervision rules, please refer to Tracking Management Requirements for New Chemical Substances after Registration in Part 7 of the "Guidelines for Environmental Management Registration of New Chemical Substances". Friendly reminder: The requirements for polymer filing are more complicated. If you have any questions about its "exclusions" and specific material requirements, you can call our consultation phone or email for inquiries. Contact Person: Lena Liu Peter WangEmail: lenaliu@bjboardingcard.com peterwangpeng@bjboardingcard.comCall: 86-10-87671126
2025-01-19
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China New Chemical Substance Registration (referred to as “China Reach”) includes regular registration, simplified registration and filing.The producer or importer of a new chemical substance shall obtain a new chemical substance environmental management regular registration certificate or a simplified registration certificate or go through a new chemical substance environmental management filing before production or import under China Reach.. Those who meet the following conditions should apply for simplified registration:If the annual production or import volume of new chemical substances is more than 1 ton but less than 10 tons, the simplified registration of environmental management of new chemical substances (hereinafter referred to as simplified registration) shall be applied. Registration period:Preliminary preparation time: 1 monthTest period: 4-10 monthsRegistration dossier preparation time: 10-20 working daysCompetent department formal review: 5 working days (not counting the time for correction)Technical review by the competent authority: 30 days.If, after technical review, it is deemed that the application materials do not meet the requirements, or the necessity of information protection is not fully explained, the applicant shall supplement the relevant application materials at one time within 6 months as required by the supplementary notice.Approval time: 20+10 working daysThe total time consumption for simplified registration: 7-13 months is estimated based on the material properties and existing data. Simplified registration application materials:It mainly includes application forms, test reports, determination conclusions and evidence for the persistence, bioaccumulation and toxicity of the applied substances. The specific requirements of the test data need to be analyzed on a case-by-case basis based on the characteristics and purpose of the substance. Post-registration supervisionunder China Reach: The holder of the registration certificate shall carry out activities in accordance with the matters stated in the registration certificate.Processing users are not allowed to process and use new chemical substances that have not obtained a registration certificate or have not been filed.The registration certificate is not transferable.Substances that are simplified registered could not be listed the IECSC list.Producers, importers, and processing users of new chemical substances should transmit information about the new substance to downstream users and properly preserve the evidence of information transmission.The holder of the registration certificate shall submit the first activity report of the new chemical substance within 60 days from the date of the first production activity or the first import and transfer to the processing user.The registration materials and new chemical substance activity records and other relevant materials shall be kept for at least ten years.For detailed post-registration supervision rules, please refer to Tracking Management Requirements for New Chemical Substances after Registration in Part 7 of the "Guidelines for Environmental Management Registration of New Chemical Substances. Friendly reminder: Simplified registration is applicable to special forms such as "serial registration" and "joint registration";The designated ecological experiments need to be completed with Chinese test organisms;The determination of bioaccumulation, degradability and toxicity of substances is of guiding significance for the early deployment of the project. It is necessary to analyze the characteristics and purpose of substances in order to give the most efficient combination of test schemes. If you have any questions, you can call our consultation phone or email for inquiriesContact Person: Lena Liu Peterr WangEmail: lenaliu@bjboardingcard.com peterwangpeng@bjboardingcard.comCall: 86-10-87671126
2025-01-19
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The environmental management registration of new chemical substances includes full registration, simplified registration and notification. The producer or importer of a new chemical substance shall obtain a full registration certificate or a simplified registration certificate for the environmental management of the new chemical substance or apply for the notification of the environmental management of the new chemical substance before production or importation. If the following conditions are met, full registration shall be carried out:If the annual production or import volume of a new chemical substance is more than 10 tons, the full registration of a new chemical substance (hereinafter referred to as full registration) shall be completed. Full registration timeline of new chemical substances:Preliminary preparation time: 1-2 monthsTest period: 9-36 monthsRegistration dossier preparation time: 1-2 monthsFormal examination by the competent department: 5 working days (excluding the time for supplementation and correction)Expert technical review: 60 daysIf the technical review finds that the application materials do not meet the requirements, or the necessity of information protection is insufficient, the applicant shall supplement the relevant application materials at one time within 6 months according to the requirements of the supplementary noticeApproval time: 20+10 working daysFull registration of the total timeline: 14-40 months is appropriate according to the substance property, PBT property, available data and use. Full registration application materialsMainly include the application form, test report, environmental risk assessment report, and social and economic benefit analysis report (pertaining to high-hazard new chemical substances). The specific requirements for the test data need to be analyzed on a case-by-case basis according to the characteristics and uses of the substance. Post-registration supervision:The holder of the registration certificate shall carry out activities in accordance with the matters specified in the registration certificate.Processing users shall not process or use new chemical substances that have not obtained a registration certificate or have not been recorded.The registration certificate is non-transferable.The validity of the fulll registration certificate is from the date of issuance until the date the new chemical substance is included in the IECSC list.Producers, importers, and processing users of new chemical substances shall transmit information related to new substances to downstream users and properly preserve evidence of information transmission.The holder of the registration certificate shall submit a report on the first activity of the new chemical substance within 60 days from the date of the first production activity or the date of the first import and transfer to the processing user.If the environmental management requirements on the full registration certificate stipulate the requirements for the submission of annual reports, the holder of the registration certificate or their designated agent shall submit an annual report on the new chemical substance by April 30 of each year starting from the year following the date of registration.Registration materials and records of the activities of new chemical substances and other relevant materials shall be kept for at least 10 years.For detailed post-registration regulatory details, please refer to Part VII of the "Guidelines for Environmental Management and Registration of New Chemical Substances" - Post-registration Follow-up Management Requirements for New Chemical Substances. Friendly Reminder:The full registration of new chemical substances applies to special forms such as 'serial registration' and 'joint registration';The specified ecological tests must be conducted using Chinese test organisms;The preliminary assessment of the basic properties, uses, declared amounts, accumulation, degradability, and toxicity of substances is crucial for the project's deployment, and it is necessary to analyze the characteristics and uses of the substances to provide the most efficient combination of testing solutions. BoardingCard has compiled the following for your reference. If you encounter any issues during the self-assessment, you can call our consultation number or email us for inquiries.
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