Thai Ministry of Public Health Introduces Online Registration System for Hazardous Substances

On 29 November 2023, the Thai Ministry of Public Health issued a Draft Notification outlining the registration, issuance, and renewal procedures for hazardous substances. The focus of this initiative is to streamline and improve the registration process through the implementation of an online submission system under the jurisdiction of the Food and Drug Administration (FDA).

Key Points of the Draft Notification:

Electronic Submission Requirement:

Business operators dealing with Type 2 and Type 3 hazardous substances will be required to submit applications and relevant documents through the FDA’s designated electronic system.

The application categories include registration of hazardous substances, permission to manufacture or import samples (for quantities exceeding 5 kilograms or 5 litres), self-certification for smaller quantities, amendment/change of registration information, and renewal of the registration certificate.

In cases where submission through the FDA's electronic system is not feasible, alternative procedures are allowed. These should be submitted to the FDA or to other designated agencies/locations/procedures as specified by the FDA.

Validity of Certificate:

The certificate of registration is valid until the end of the sixth calendar year from the year of issuance. However, officials may specify a different period of validity if necessary.

Change of Registration Details:

Changes to registration details will be noted on the permit or issued in writing. In some cases, a new certificate of registration may be issued.

The primary objective of this initiative is to improve the efficiency of the hazardous substance registration process by introducing an online submission system. This move is in line with global trends in regulatory practices and is expected to simplify procedures for businesses and ensure better compliance with safety standards.

Timeline:

The proposed date of adoption is yet to be determined, and the date of entry into force is set for the day following its publication in the Government Gazette. As per Thailand’s notification to World Trade Organization (WTO), stakeholders and interested parties have a 60-day window from the date of notification to provide their comments on the proposed draft.

Relevant documents:

The Hazardous Substances Act B.E. 2535 (1992)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration B.E. 2552 (2009)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 2) B.E. 2558 (2015)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 3) B.E. 2561 (2018)