Vietnam Releases Draft Decree Detailing Law on Chemicals: Part 3

On September 5, 2025, Vietnam’s Ministry of Industry and Trade published a draft decree titled “Detailed Provisions and Guidelines on the Management of Certain Articles and Hazardous Chemicals in Products and Goods of the Law on Chemicals,” and opened it for public comment. Law on Chemicals (69/2025/QH15) was passed by the National Assembly on June 14, 2025, and will take effect on January 1, 2026. The draft decree sets forth detailed regulations on the management of regulated chemicals, new chemical substances, protection of confidential chemical information, and hazardous chemicals in products and goods.

This Part 3 focuses on the detailed provisions concerning the management of new chemical substances under Articles 20 through 22 of the Law on Chemicals.

Application Documents for Registration of New Chemical Substances

Under Article 20 of the 2025 Law on Chemicals, new chemical substances must be registered with a government agency prior to use or market distribution. Required application documents include:

1. Application form for registration of the new chemical substance
2. Evaluation results of the new chemical substance, including information on its physical and chemical properties and hazardous characteristics (provided by a designated evaluation agency)

However, the draft decree newly stipulates requirements for registering new chemical substances listed in at least two foreign chemical inventories. Applicants (manufacturers or importers) falling under this category must submit:

1. Application form for registration of the new chemical substance
2. Summary evaluation report of the new chemical substance, including its CAS or UN number and clear indication that it is listed in two foreign chemical inventories
3. Information on past manufacturing and transactions

The foreign chemical inventories approved by the Vietnamese government and cited in the draft decree are:

• The chemical inventory established by the European Chemicals Agency (ECHA)
• The TSCA chemical inventory established by the U.S. Environmental Protection Agency (EPA)
• The Existing and New Chemical Substances (ENCS) inventory established by Japan’s Ministry of Economy, Trade and Industry (METI)

Registration and Review Procedures for New Chemical Substances

The Ministry of Industry and Trade is authorized to receive and review registration documents for new chemical substances. Procedures for acceptance and review are stipulated in Article 23(4) of the draft decree, with key points as follows:

• The review and approval period shall be within 90 business days from the date of receipt of complete application documents. The time taken by applicants to prepare supplementary documents is excluded.
• Upon receipt of complete application documents, the Ministry is responsible for conducting the review, which shall be carried out through the New Chemical Substance Evaluation Council.
• The Evaluation Council is established by the Ministry and composed of representatives from review agencies, administrative bodies overseeing relevant fields, and experts in related disciplines. The council shall consist of no fewer than seven and no more than nine members.
• Based on the consensus of the council members, the Ministry shall approve the import or manufacture of the chemical substance. Within seven business days from the date the applicant completes the supplementary documents, the Ministry is responsible for approving the registration of the new chemical substance.

In addition, the draft decree specifies the following responsibilities for the Ministry of Industry and Trade:

• Establish various forms related to the application, review, and approval of new chemical substances
• Develop and submit a national chemical inventory to the government by 2028

Designated Evaluation Agencies for New Chemical Substances

Evaluation agencies for new chemical substances must be capable of conducting evaluations and must comply with the provisions of Decrees 74/2018/ND-CP and 154/2018/ND-CP. Requirements for testing agencies under the draft decree are as follows:

Management of New Chemical Substances

Once registered with a government agency, new chemical substances are subject to the same management regulations as specially controlled chemicals. The management provisions specified in the draft decree are essentially identical to those set forth in Article 22 of the 2025 Law on Chemicals.

Reference

Draft decree on Detailed Provisions and Guidelines on the Management of Certain Articles and Hazardous Chemicals in Products and Goods of the Law on Chemicals:
http://cuchoachat.gov.vn/tin-tuc-su-kien/gop-y-du-thao-ho-so-nghi-dinh-quy-dinh-chi-tiet-mot-so-dieu-cua-luat-hoa-chat.html