The process of registering pesticide products in Myanmar has been slowed significantly by regulatory challenges since the enactment of the Pesticide Law in 2016. In some cases, the whole process can take almost three years. Nonetheless, this stringent and time-consuming process has been functioning smoothly, and Tilleke & Gibbins has successfully received approvals from the Pesticide Registration Board (PRB) despite the ongoing COVID-19 pandemic and state of emergency in the country.
Overview
Since its enactment, the Pesticide Law of 2016 has governed the regulation of local and imported pesticides under the oversight of the Plant Protection Division (PPD) and the joint secretary of the PRB. All foreign and domestic companies (including subsidiaries and joint ventures) looking to have their agricultural or household pest control products imported into Myanmar must first provide the products’ complete formulas and lists of active ingredients to the PPD, and apply for a pesticide registration certificate. Applications should be supported by a letter of consent from the manufacturer and various other technical documents and requirements. Experts at the PRB will review the technical dossier and inform the applicant if any re-submissions are required.
Key Considerations
One common cause of delay in the registration process is the requirement to submit both English and Myanmar translations of proposed labels to the PRB. Because the PRB takes a restrictive view of these labels and their translations, having the labels initially reviewed by a local regulatory expert familiar with the requirements will streamline the process by flagging potential issues for correction before submission to the PRB.
After document submission is complete, the next stage of the process is further lab testing according to requirements set out by the Myanmar Pesticide Law. Applicants will need to supply the formulated product in an amount sufficient for carrying out supervised trials and quality control tests. There are also detailed technical specifications regarding the necessary laboratory testing, sample analysis, and certification of the product and its active ingredients. In order to import the necessary products to conduct these laboratory tests, the applicant must obtain a recommendation letter from the Laboratory Department of the PPD and pay the required laboratory fees. Applicants should also create the label at this time. Typically, a label should include hazard pictograms (symbols) along with usage directions, the names of the manufacturer and distributor, and the expiry date—all in the Myanmar language. This label must be approved by the PPD.
Upon completion of the laboratory tests, the PPD assists with evaluation of the technical documents, corresponding test results, and reviewed labels. The results of the PPD’s evaluation will then be submitted to the PRB, which will finally decide whether to approve the application and grant the applicant experimental, provisional, or full registration. Upon payment of the registration fees, an experimental registration is valid for two years, a provisional registration is valid for five years, and a full registration is valid for ten years. Some applications are rejected after PRB meetings due to a lack of required documentation, use of a banned active ingredient (aldrin, arsenic compounds, binapacryl, etc.), or a determination that the product is hazardous for the country’s agriculture.
Outlook
Though it is time consuming and laborious, the registration process for pesticide products in Myanmar has proved to be effective and functional. Moreover, the stringent application of the requirements has shown that Myanmar takes the issue of pesticides seriously, and will take time to scrutinize the introduction of new pest control substances for agricultural and household use. The PPD recently announced an online application system that will expedite the final evaluation process by eliminating some bottlenecks caused by the current reliance on physical documents and in-person procedures. Altogether, the encouraging indications—including Tilleke & Gibbins’ repeated success in the registration process, and the authorities’ diligence in following the registration process—signal that companies looking to make their pesticide products available in Myanmar have a viable avenue for doing so safely and responsibly.
