Registration Criteria for Hazardous Substances under Responsibility of Department of Agriculture B.E. 2552 - Thailand

Thailand B.E. 2552 - Determination of Details, Criteria and Procedure for Registration, Issuance and Extension of Hazardous Substances Registration Certificate under the Responsibility of Department of Agriculture sets the registration data requirements and process for agricultural pesticides in Thailand.

The regulation specifies that the registration of pesticides (hazardous substances) consists of three phases:

• Phase 1 - Trials Clearance for knowing the efficacy and information on acute toxicity. In this respect, production or importation of hazardous substance sample in a limited quantity is allowed for the efficacy or residue test, as the case may be.

• Phase 2 - Provisional Clearance for demonstrating the usage and knowing information on sub-acute toxicity, chronic toxicity relating to teratogenicity, reproductive effect, mutagenicity, toxicity to nervous system, oncogenicity and carcinogenicity (if any) and toxic residues. In this respect, production or importation of hazardous substance sample in limited quantity for demonstration of usage in the limited area is allowed.

• Phase 3 - Final evaluation for full registration by evaluating the results of experiments and various information in order to know efficacy and safety to human and the environment sufficiently if it is for use, including long term chronic toxicity (2 years) to testing animal. The applicant may not apply for phase 2 (Provisional Clearance) in the case that he/she has the complete information required for phase 3 (Full registration).

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