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Is it necessary to obtain approval from the relevant authorities for the pilot and pilot-scale tests conducted in the early stages of developing chemical products?

2016-05-18View Original

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As the title suggests, recently the safety supervision authorities visited the company for an inspection, stating that both pilot and scale-up tests for the development of chemical products must be approved, whether they are hazardous or not, due to the use of hazardous substances. I’m not sure which regulation mandates this rule; does anyone here know?
Reply #22016-05-18
Should it be registered with the chemical industry authorities, or with the safety supervision department?
Reply #32016-05-18
There seems to be a problem with this statement: According to Article 29 of the **Regulations on the Safe Management of Chemicals**, chemical enterprises that use **chemicals** in production and whose usage volume reaches a specified level (with the exception of those that are **chemical manufacturers**, the same applies hereafter) must obtain a license for the safe use of **chemicals** in accordance with these regulations.   The quantitative standards for the use of **chemicals as specified in the preceding paragraph shall be determined and published by the department under the State Council responsible for work safety supervision and management, in conjunction with the public security department of the State Council and the department in charge of agriculture.   Article 30: Chemical enterprises applying for a **chemical safety use license shall, in addition to meeting the requirements stipulated in Article 28 of these regulations, also meet the following conditions: (1) They must have professional technical personnel suitable for the **chemicals they use ;   (II) Have a safety management organization and full-time safety management personnel ;   (III) There are emergency response plans for chemical accidents that comply with **relevant regulations**, as well as the necessary emergency rescue equipment and apparatus ;   (IV) A safety assessment was conducted in accordance with the law. These are the regulations in **; according to these regulations, as long as your company’s usage does not reach the specified level, there is no need to file a report. However, it is possible that local regulations are more stringent, so it is advisable to check the local regulations to determine the specific requirements ; However, if your company produces chemicals, it is in accordance with Article 2 of the **Regulations on Chemical Registration**: These regulations 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 registered enterprises). Regardless of the quantity, a **chemical declaration** must be submitted ; Registration shall be carried out in accordance with the following provisions: Chapter 3 Time, Content, and Procedures for Registration Article 10 Newly established manufacturing enterprises shall complete **chemical registration prior to the completion acceptance.   Importing enterprises shall complete **chemical registration prior to their first import.   Article 11: Where the same enterprise produces or imports the same type of **chemical, registration shall be carried out once under the name of the producing enterprise, provided that relevant information on the imported **chemicals is submitted.   When an importing enterprise imports the same type of **chemical** from different manufacturers, it shall register once under the manufacturer from whom the chemical is imported for the first time, but it must submit relevant information regarding the **chemicals** from the other manufacturers as well.   If a manufacturing enterprise or an importing enterprise imports the same type of **chemical** from the same manufacturer on multiple occasions, registration is required only once.   Article 12 **The registration of chemicals shall include the following information: (1) Classification and labeling information, including the hazard category of the chemical, pictograms, hazard statements, precautionary statements, etc ;   (II) Physical and chemical properties, including **the appearance and characteristics of chemicals, physical properties such as solubility, melting point, and boiling point, as well as chemical properties such as flash point, explosion limits, auto-ignition temperature, and decomposition temperature ;   (III) Primary uses, including the legitimate uses of products recommended by enterprises, as well as any uses that are prohibited or restricted ;   (IV) Hazardous characteristics, including **the physical hazards, environmental hazards, and toxicological properties of chemicals ;   (5) Safety requirements for storage, use, and transportation. The safety requirements for storage include specifications regarding building conditions, warehouse conditions, safety measures, environmental hygiene conditions, as well as temperature and humidity levels. The safety requirements for use involve operational conditions during use, protective measures for workers, and hazard control measures at the site of use. The safety requirements for transportation include requirements related to the methods of transport or delivery, ways of conveying hazard information to relevant transport personnel, and safety measures during loading, unloading, and transportation ;   (VI) Emergency response measures in case of dangerous situations, including **emergency handling methods for chemical accidents such as fires, explosions, leaks, poisoning, suffocation, burns, etc., that occur during the production, use, storage, and transportation of chemicals, as well as emergency consultation phone numbers.   Article 13: **The registration of chemicals shall be carried out in accordance with the following procedures: (1) The registering enterprise submits an application through the registration system ;   (II) The registration office shall conduct a preliminary review of the applications submitted by the enterprises seeking registration within 3 working days; if the requirements are met, it shall notify the enterprises through the registration system to proceed with the registration procedures ;   (III) Upon receiving notification from the registration office, the registered enterprise shall fill in the registration details accurately in the registration system in accordance with relevant requirements, and submit the relevant paper-based registration documents to the registration office ;   (IV) Within 20 working days from the date of receiving the registration documents from the enterprise seeking registration, the registration office shall examine each item of the documents and the details of the registration. If necessary, on-site inspections may be conducted; if all requirements are met, the registration documents will be submitted to the registration center ; Those that do not meet the requirements will be notified to the registering enterprise through the registration system, along with the reasons ;   (5) Within 15 working days from the date of receipt of the registration documents submitted by the registration office, the registration center shall examine those documents and the information contained therein; if they meet the requirements, it shall issue a **Chemical Registration Certificate to the registered enterprise through the registration office ; Those that do not meet the requirements shall inform the registration office and the registered enterprise through the registration system, along with an explanation of the reasons.   The time required for an registered enterprise to modify its registration documents and address existing issues is not included within the period specified in the preceding clause.   Article 14: When registering **chemicals, registered enterprises shall submit the following materials and be responsible for the accuracy of their contents: (1) Two copies of the **Chemical Registration Form ;   (II) One copy of the business license of the manufacturing enterprise, and one copy each of the registration form for foreign trade operators of the importing enterprise, the qualification certificate for import and export enterprises of the People’s Republic of China, the approval certificate for foreign-invested enterprises of the People’s Republic of China, or the approval certificate for enterprises invested by persons from Taiwan, Hong Kong, Macao, and overseas Chinese ;   (III) One copy each of the chemical safety data sheet and the chemical safety label that are **consistent with** the chemicals they produce or import and that meet the relevant standards ;   (IV) 1 copy of the emergency consultation service phone number as specified in Article 22 of these measures, or a copy of the authorization letter for emergency consultation services ;   (5) Standards for the **chemical products** to be registered (if **standards** or industry standards are adopted, provide the standard numbers used).   Article 15: During the validity period of the **chemical registration certificate, if a registered enterprise experiences changes in its company name, registered address, registered chemical types, or emergency consultation service phone number, or if new hazardous properties are identified in the **chemicals it produces or imports, it shall submit an application for change to the registration office within 15 working days, and go through the procedures for updating the registration details as follows: (1) Fill out the **chemical registration change application form through the registration system, and submit one copy of the supporting documents related to the changes to the registration office ;   (II) The registration office conducts a preliminary review of the application for registration changes submitted by the enterprise in question. If the requirements are met, it notifies the enterprise to submit the updated registration documents, which are then reviewed; if they meet the standards, they are forwarded to the registration center ; Those that do not meet the requirements will be notified to the registering enterprise through the registration system, along with the reasons ;   (III) The registration center examines the registration materials submitted by the registration office; if they meet the requirements and fall within the scope specified in the **Chemical Registration Certificate**, it issues an updated **Chemical Registration Certificate** to the registered enterprise through the registration office, while recalling the original certificate ; For those that meet the requirements but do not fall under the items specified in the **Chemical Registration Certificate**, a written certification document is provided to the registered enterprise through the registration office.   Article 16: **The validity period of a chemical registration certificate is 3 years. After the expiration of the registration certificate’s validity period, if the registered enterprise continues to engage in the production or import of **chemicals, it must submit an application for reevaluation and renewal of the certificate 3 months before the expiration date, following the procedures outlined below: (1) Fill out the **Chemicals Reevaluation and Renewal Application Form through the registration system ;   (II) The registration office examines the applications submitted by registered enterprises for re-examination and renewal of certificates; if the requirements are met, it notifies the registered enterprise through the registration system to submit the registration documents specified in Article 14 of these regulations ; For those that do not meet the requirements, the registration system is used to inform the registered enterprise along with the reasons ;   (III) Go through the procedures for re-examination and certificate renewal in accordance with items 3, 4, and 5 of Paragraph 1, Article 13 of these measures.   Article 17: **The chemical registration certificate is divided into an original and a copy; the original is of a hanging type, while the copy is of a folded type. The original and the copy have the same legal effect.   **The original and copy of the chemical registration certificate shall specify details such as the certificate number, company name, registered address, nature of the enterprise, registered products, validity period, issuing authority, and issuance date. Among them, the nature of the enterprise should be specified as **chemical manufacturing enterprise**, **chemical importing enterprise**, or **chemical manufacturing enterprise (also engaged in import)**.
Reply #42016-05-19
There are two more questions; 1. The product is not a **chemical – is registration required? 2. Where is the registration office? In Beijing? Is it available at the provincial level? Thank you, moderator!
Reply #52016-05-20
Push it yourself so the post doesn’t sink

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