Thailand

Thailand has published a draft FDA Notification on data requirements for registering hazardous substances, B.E. XXXX

The draft includes the following key updates:

1. Definitions Added: Clear definitions for “technical grade raw materials,” “semi-finished raw materials,” and “finished products” for easier reference.
2. Expanded Substance List: Updated list of hazardous substances requiring analytical results, aligned with the Bureau of Cosmetics and Hazardous Substances’ expanded analytical capabilities.
3. Certificate of Free Sale (CFS): Clear requirements for CFS included in the draft.
4. Registration Differentiation: Identifies differences between previously registered and unregistered hazardous substances, with added details for clarity.
5. Export-only Registration: Reduced documentation requirements for hazardous substances intended for export, emphasizing self-certification by entrepreneurs.
6. Transitional Provision: Applications submitted before the new announcement will be considered under the new rules.
7. Safety Data Sheets (SDS): Simplified by removing the requirement for a separate hazard classification summary.
8. Physical and Chemical Properties: Eliminates duplication by relying on SDS section 9 for technical grade raw materials.
9. Production Process Documents: No longer required for reference registrations, as these are included in the hazardous substance register.
10. Clearer Information Display: Updated and clarified information presentation, maintaining existing principles for insect and rodent control products.
11. CFS Terms Clarified: Removes the need for CFS certification by the Ministry of Foreign Affairs or Thai Commerce, accepting certifications from relevant government or private agencies.
12. Export-only Application Information: Specifies necessary documentation for export-only registrations, reducing the overall documentation required.
13. Hazardous Substances List: Split into two lists for different product purposes (insect control and disinfection/laundry products) for easier use.
14. Updated Hazardous Substances List: Reflects the expanded analytical capabilities of the Department of Medical Sciences as of January 18, 2024, and March 19, 2024.

These updates aim to streamline the registration process, reduce redundancy, and clarify requirements for hazardous substances.