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Our company is a manufacturer of chemical active pharmaceutical ingredients. We produce an organic solvent for use as a raw material, and we also utilize other types of hazardous substances; all of these are purchased from external suppliers. Do we need to obtain the two certificates mentioned above? The company currently has a registration certificate for hazardous substances, but no license for their safe use. No regulatory authorities have ever inspected our company – does this mean that we really don’t need to obtain such certificates? Are there any relevant regulations regarding this? Please help us out, experts.
**Implementation Measures for the License for the Safe Use of Chemicals** Chapter 1 General Provisions Article 2 These measures apply to chemical enterprises that are included in the list of industries subject to the license for the safe use of chemicals, and that use such chemicals in production and reach the specified volume thresholds for their use (with the exception of chemical manufacturing enterprises; hereinafter referred to as enterprises). Enterprises that use **chemicals as fuel are not subject to these regulations. Article 3 Enterprises shall obtain a **Chemical Safety Use License (hereinafter referred to as the Safety Use License) in accordance with the provisions of these measures. **General Provisions of the Measures for the Registration of Chemicals** Article 2 These measures apply to the registration and management of **chemicals** listed in the **Chemical Catalogue**, as produced or imported by **chemical manufacturing enterprises and importing enterprises** (hereinafter collectively referred to as registration enterprises). Article 3 **Implement** a chemical registration system. **The registration of chemicals follows the principles of enterprise application, two-level review, unified certification, and hierarchical management. Whether a certificate is required under the aforementioned regulations depends mainly on whether the amount of hazardous materials used by your company constitutes a major hazard source ;
The hazardous substances used by our company constitute a major hazard source of level three.
In my opinion, it is definitely necessary to go through the procedures; for specific details, you can consult the local authorities