Thailand FDA Updates Hazardous Substance Safety Handling Requirements

On 21 October 2022, Thailand's Food and Drug Administration (FDA), under the Ministry of Public Health (MoPH), published Notification of the Ministry of Public Health on Criteria and Methods of Production, Import, Export, and Transit and Having in Possession for Contracting Use of Hazardous Substances Under the Authority of the Food and Drug Administration, B.E. 2565 (2022), dated 29 September 2022, in the Royal Thai Gazette.

The regulation took effect on 22 October 2022.

3E Review

The 2022 notification repeals and replaces the existing rules under the 2011 notification, Notification of the Ministry of Public Health Re: Criteria and Methods of Production, Import, Export, and Transit and Having in Possession for Contracting Use of Hazardous Substances Under the Authority of the Food and Drug Administration, B.E. 2555 (2012), dated 15 May 2012.

The 2022 changes focus on improving the safety criteria and procedures for entities handling hazardous substances. Specifically, the rules will apply to the manufacturers, importers, exporters, and possessors of household and public health chemicals controlled by the FDA/MOPH under the Hazardous Substances Act B.E. 2535 (1992) (HS Act) and the List of Hazardous Substances (HS List). These include chemicals used in products such as disinfectants, cleaning products, and pesticides.

Once the notification, registration, and licensing procedures are completed, manufacturers and importers of types 1, 2, and 3 hazardous substances must comply with the following obligations:

• Annual chemical data reporting must be done by importers and manufacturers, which must submit chemical data to FDA/MOPH before 31 January of the following year. The required information includes total imported and manufactured quantities and registration and license certificate details.
• Import declaration (for importers only) is required once before importation. The information must be submitted to the FDA Import and Export Inspection Division.
• Companies must keep records for inspection (minimum two years of record).
• Proper hazard communication is required, including having GHS compliance labeling and a safety data sheet in place.
• Other safety measures are required, including chemical production establishment, devices, equipment, personal protection, chemical incident prevention, and emergency response plan.

Background

Under Article 18 of the HS Act, chemicals and chemical products in Thailand are classified into four types/classes via the HS List. There are six Thai authorities (ministries) involved in controlling these substances based on these types. The following requirements must be met before manufacturing, importing, exporting, transporting, or possessing hazardous substances:

• Type 1 requires notification of volume and product information.
• Type 2 requires notification and product registration.
• Type 3 requires notification, product registration, and licenses (permit).
• Type 4 is prohibited from all activities (with certain exceptions).

3E Analysis

Manufacturers and importers of affected products should consult the details of the regulation to ensure that their products are in compliance with the new requirements. Since each regulator has different requirements for notification, registration, and licensing procedures, businesses are strongly advised to follow the specific steps that are required by the control regulators as prescribed under regulations, such as ministry notification(s) and ministerial regulations. The regulation sets out the details for the types of required forms and documentation.