Licensing for Production of Schedule 1 Chemicals

The Licensing for Production of Schedule 1 Chemicals procedure is established to ensure strict management and proper usage of special chemicals, creating a clear legal framework for production activities. When meeting technical standards and production scale requirements, enterprises can operate stably, transparently, and in accordance with specialized management regulations. This article summarizes current regulations and provides specific instructions.

Conditions for granting chemical manufacturing licenses (Table 1)

Based on Clauses 1 and 3, Article 10 of Decree 33/2024/ND-CP, conditions include:

1. Legal Entity: The enterprise is established in accordance with the law.
2. Facilities: Material-technical foundations must meet production requirements.
3. Personnel: The Director, Deputy Technical Director, or technical officer in charge of chemical production must have a university degree or higher in chemicals.
4. Training: Heads of units, production staff, safety officers, supervisors, and workers directly related to chemicals must undergo chemical safety training.
5. Purpose: Schedule 1 chemicals may only be produced for special purposes: analysis, testing, scientific research, medical, pharmaceutical production, crime investigation, and national defense/security protection.
6. Scale Restrictions:
   • Single facility: Reactor capacity must not exceed 100 liters; total capacity of reactors over 5 liters must not exceed 500 liters.
   • Output limits:
     • Defense protection: Total output $\le$ 10kg/year.
     • Research/Medical/Pharma: $\le$ 100g/year per chemical (total $\le$ 10kg/year).
     • Laboratories: Total output $\le$ 100g/year.

>>> See more at: Adjustment of Certificate of Eligibility for Production of Conditional Industrial Chemicals

The competent authority for issuing chemical production licenses (Table 1)

Based on Clause 1, Article 11 of Decree 33/2024/ND-CP (amended by Clause 1, Article 8 of Decree 146/2025/ND-CP), the authority belongs to the Provincial-level People’s Committee where the Schedule 1 chemical production enterprise is headquartered.

Required Dossier to apply for a chemical manufacturing license (Table 1)

According to Clause 2, Article 11 of Decree 33/2024/ND-CP, the dossier includes:

1. Request Form: Request for issuance of Schedule Chemical Production License (Form No. 01, Appendix II, Decree 33/2024/ND-CP).
2. Explanatory Statement: Statement on production conditions (Form No. 05, Appendix II, Decree 33/2024/ND-CP).
3. Degree Copies: Copy of the university degree (or higher) in chemicals of the Director/Technical Deputy/Technical Officer.
4. Safety Training: Copy of the Decision recognizing chemical safety training results.
5. Environment: Copy of the Decision approving or confirming environmental protection documents.
6. Fire Safety:
   • Copy of Approval of Fire Prevention and Fighting acceptance (for facilities subject to design approval).
   • Copy of Fire Safety Inspection Minutes (for others).
7. Commitment: Written commitment to produce Schedule 1 chemicals for special purposes only.

Note: Clients should prepare copies of the applicant’s Citizen ID card and a Power of Attorney (if applicable).

Procedure for granting chemical manufacturing licenses (Table 1)

According to Article 11 of Decree 33/2024/ND-CP:

Step 1: Submission

• Online: Submit via the National Public Service Portal (Code: 1.003820).
• Direct: Submit 01 dossier set to the Provincial People’s Committee.

Step 2: Validity Check Within 03 days from receipt, if the dossier is incomplete, the Provincial People’s Committee notifies the applicant to supplement. This time is not included in the processing time.

Step 3: Appraisal and Licensing Within 16 working days from receiving a complete and valid dossier, the Provincial People’s Committee appraises the dossier and checks actual conditions.

• If eligible: Issue the License (Form No. 03, Appendix II) within 03 working days.
• If ineligible: Issue a written refusal stating the reason within 03 working days.
• Consultation: May consult specialized Ministries (max 5 days).

>>> See more: Chemical Business Conditions [LATEST]

Responsibilities of organizations licensed to manufacture chemicals (Table 1)

According to Article 15 of Decree 33/2024/ND-CP:

• Only produce/trade after being licensed and meeting fire/environmental regulations.
• Maintain conditions throughout operations.
• Tracking Log: Maintain a separate logbook recording: Name, content, volume (export/import/buy/sell/stock), and customer details (name, address, phone, purchase purpose).
• Comply with reporting and inspection regulations.
• Keep the original License at the facility.
• Bear full liability for any loss of Schedule chemicals during transport or at the facility.

Long Phan Consulting provides consulting services for obtaining chemical production licenses (Table 1).

Long Phan Consulting Company provides comprehensive support services:

• Consulting & Evaluation: Assessing the production license dossier.
• Dossier Preparation Support: Assisting in preparing documents (Request, Explanatory Statement, Commitment) according to regulations.
• Representation: Submitting the dossier to the competent state agency.
• Monitoring & Explanation: Tracking progress and working directly with agencies to explain the dossier.
• Supplementation: Handling requests for additional information.

Frequently Asked Questions

Below, Long Phan Consulting provides some frequently asked questions related to the procedures for obtaining a license to manufacture chemicals listed in Table 1. We invite interested clients to refer to this information:

Can I get licensed if the Director doesn’t have a chemical degree?

Yes, provided the enterprise appoints a Deputy Technical Director or technical officer in charge of production who holds a university degree or higher in chemicals. (Legal Basis: Point c, Clause 1, Article 10, Decree 33/2024/ND-CP).

Can I produce Schedule 1 chemicals for general commercial purposes?

No. Production is only allowed for specific special purposes (research, medical, defense, etc.). General commercial production is strictly prohibited. (Legal Basis: Point a, Clause 3, Article 10, Decree 33/2024/ND-CP).

What if I exceed the 100-liter reactor limit?

The enterprise will no longer meet the conditions for producing Schedule 1 chemicals and may be refused licensing or have the license revoked, as single facilities are capped at 100L per reactor and 500L total capacity. (Legal Basis: Point b, Clause 3, Article 10, Decree 33/2024/ND-CP).

What details must the tracking log include?

It must record chemical details (name, content, volume) and specifically customer information (name, address, phone) and their purpose of use. (Legal Basis: Clause 3, Article 15, Decree 33/2024/ND-CP).

What is the liability for losing Schedule 1 chemicals?

The licensed organization bears full legal responsibility (criminal or administrative) for any loss or misplacement of chemicals, whether at the facility or during transport. (Legal Basis: Clause 6, Article 15, Decree 33/2024/ND-CP).

Conclusion

The Licensing for Production of Schedule 1 Chemicals helps enterprises review facilities and ensure legal compliance. Preparing a complete dossier from the start optimizes costs and time. To ensure legal rights and production progress, please contact Long Phan Consulting Company via Hotline 1900636389 for timely and professional legal support.