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ADD: Ryan Building Room 1123, East 3rd. Ring South Rd. No. 102, Chaoyang District, Beijing, 100021, China
Question
If anhydrous compound A is already in IECSC, but the hydrate compound of A is not in IECSC. Is there still a need to register new chemical substances for A hydrate? If a hydrate of A is already in IECSC, but other hydrates of A are not in IECSC. Is there still need to register new chemical substances for A and its hydrates compound?
Answer
A and its hydrate (any number of crystal water) in the above two cases do not need to be regsitered.
Question
A domestic applicant has registered the new chemical substance A, and after it is imported into the country, it is sold to another company. The company performs simple mixing and processing of the A substance without chemical reaction to produce the new substance. Is new substance registration required when the processed products are exported abroad?
Answer
No need.
Question
If the various additives (antioxidants, heat stabilizers, transparent nucleating agents, slip agents, anti-blocking agents, etc.) contained in produced or imported polymers must be included in the "Inventory of Existing Chemical Substances in China"? it can be used in polymers?
Answer
If the chemical substances contained in additives are not listed in the "Inventory of Existing Chemical Substances in China" , then they are belong to new chemical substances, they should be registered in accordance with the "Registration Measures for Environmental Management of New Chemical Substances".
Question
The guideline clearly states that pharmaceutical raw materials can be exempted, so what supporting materials do the enterprises need to provide? If it is all exported to foreign countries, can the exporting raw material drug certification documents meet the exemption conditions?
Answer
Whether the raw material drug manufacturer is exporting or selling domestically, it needs to meet the supervision and management requirements of drug GMP. Enterprises need to judge whether they meet the exemption conditions by themselves, and the supporting documents provided can withstand verification. In the case of export only, the certificate of exporting raw materials abroad is acceptable.
Question
Can veterinary drugs not listed in the "Inventory of Existing Chemical Substances in China" be exempt from application?
Answer
The "Guidelines for the Environmental Management Registration of New Chemical Substances" clearly indicate medicines (including raw materials), pesticides (including pesticides), veterinary drugs (including raw materials), cosmetics, food, food additives, feed, feed additives, fertilizers, etc. Products are not applicable to the "Measures." However, if the above-mentioned products are changed to other industrial uses, and the raw materials or intermediates used in the production of the above-mentioned products are new chemical substances, the Measures shall apply.
