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Summary of Questions and Answers on the Webinar on Registration of Intermediates and New Substances and Corporate Compliance Strategies
Release time:
2021-07-20 09:59
In order to further publicize the latest information on the registration of new substances in intermediates and corporate compliance strategies under Decree 12, New Anrun Consulting successfully held a webinar on the registration of new substances in intermediates and corporate compliance strategies on July 15, 2021.
The teacher gave a detailed introduction to the registration of new substances in intermediates and the compliance strategies of enterprises from the aspects of the registration of new substances under China's Decree No. 12, the introduction of the scope and types of registration of new substances, the special regulations and requirements of intermediates, and the compliance strategies of enterprises producing/using intermediates.
We have listed some of the questions answered during the seminar:
1. Under Decree No. 12, is it possible that the registration of new chemical substances will not pass the review and will not be certified?
A: Yes. Under 12 orders, summary registration and regular registration have clear criteria for registration. For simple registration, if the application substance has a cumulative environmental risk or is a PBT substance, it is not registered. Among them, the environmental cumulative risk needs to look at whether the environmental exposure of the same substance in the same area may accumulate. Therefore, it is recommended that customers with simple registration needs register as soon as possible.
2. Under the Decree No.12, the materials obtained for filing will no longer be produced/imported in the later period. How to deal with it? Can the filing be revoked?
A: At present, only simple registration and regular registration can be canceled (canceled) registration certificate. There is no filing. After communicating with MEESCC, the current suggestions are two kinds: 1. Make a change record, the amount of change activity is 02, and do not do any operation. After the later registration, the management activity record can indicate that the substance is no longer imported/produced for random inspection by the regulatory authorities.
3. Is it necessary to prove that the product is indeed used as an intermediate? How to prove that the substance is only used as an intermediate of pesticide, medicine or veterinary drug? Does the manufacturer provide the relevant production process or supervise the subsequent use?
Answer: The substance is only used as an intermediate for pesticides, pharmaceuticals and veterinary drugs and requires enterprise proof. For example, provide processing user information, processing use process, final product information, etc. According to the requirements of post-registration management, researchers, producers, importers, and processing users of registered substances are all within the regulatory system.
What is the difference between the registration of pharmaceuticals, pesticides, veterinary drugs, and other chemical intermediates?
A: The exemptions are different. Non-isolated intermediates in intermediates are exempt and do not require new substance registration. In the separation of intermediates, chemical substances used only as pesticide intermediates, pharmaceutical intermediates or veterinary drug intermediates, health toxicology and ecotoxicology minimum requirements data can only submit basic data. The general isolated intermediates are consistent with the data requirements of other new chemical substances.
5. Is there a difference between small tonnage (10 tons) and large tonnage (1000 tons) intermediate registration?
Answer: There is basically no difference in data requirements for intermediate registration after more than 10 tons. However, because the production or processing of large tonnages of chemical substances often involves greater environmental exposure, if the risk assessment shows that there is an unreasonable environmental risk, supplementary data may be needed to reduce the risk characterization ratio.
What Are Highly Hazardous Chemicals? (See Guidelines)
A: Mainly refers to PBT substances, vPvB, the same environmental or health hazards of high-risk chemical substances, including but not limited to endocrine disruptors (EDCs), very high toxicity (acute or chronic) substances.
7. New use management, is there a list that can be searched or searched online? In addition, for old substances, will the authorities also evaluate and impose new use management?
A: There is no special list for new use management, but substances with new use management requirements will be listed in the list of existing chemical substances in China. For substances that are under the key management of hazardous categories under Order 7, new use management will also be imposed when they are added to the list.
If you are interested in the content of the training, please contact us for information or video content, contact as shown below, thank you.
Contact: Miss Ann
Mobile phone number: 15801695345 (WeChat with the same number)
QQ: 1798064165
Electronic E-mail: nar@china-reach.net
OUR SERVICES
Comprehensive consultation on 1. and regulations and substance novelty search service
(1) Professional regulatory advisory services
(2) New chemical substance search service (IECSC open database query, entrusted new search)
2. New Chemical Substance Registration Agency Services
(1) Registered Agent Services
(2) New chemical substance registration service (filing/simple registration/regular registration)
(3) Registration of the overall program customization
(4) Substance data assessment/gap analysis/exemption analysis
(5) Laboratory test supervision service
(6) Preparation of risk assessment report
(7) Competent department/expert communication and consultation
(8) Translation of regulatory documents and registration materials
3. Registration Agent Maintenance Service
(1) Post-registration services for new chemical substances
(2) Regulatory training services
New Anrun Chemical Regulations Advisory Services:
Declaration of new domestic chemical substances
Registration of hazardous chemicals and business license for hazardous chemicals
SDS/GHS Labeling
Declaration of cosmetic finished products and raw materials
EU REACH, Taiwan REACH, South Korea K-REACH Registration
Pharmaceutical, food contact materials regulatory consultation
Compliance services in countries where epidemic prevention materials are exported
Laboratory Testing Services
Environmental regulations consulting services
Including park environmental protection housekeeper, solid waste and hazardous waste comprehensive solution design, etc.
Contact: Miss Ann
Mobile phone number: 15801695345 (WeChat with the same number)
QQ: 1798064165
Electronic E-mail: nar@china-reach.net
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