Harmonizing Regulatory Frameworks: An Evaluation of Divergent Technical Responsible Person Requirements and Their Impact on Indonesia's Cosmetic Import Notification Efficiency

Abstract

This study analyses the disparities in technical competence requirement for responsible person regarding cosmetic notification applicants in Indonesia specified in Regulation No. 12 of 2023 by the Indonesian National Agency of Drug and Food Control (BPOM) and Regulation No. 17 of 2024 by the Ministry of Health of the Republic of Indonesia.  Regulation BPOM No. 12 of 2023 stipulates that the technical supervisor for cosmetic importers must possess a bachelor's degree in medicine, biology, or chemistry, whereas Regulation of the Ministry of Health No. 17 of 2024 necessitates that the technical supervisor holds relevant qualifications as a chemist.  The study seeks to assess the influence of these varying restrictions on the volume of re-application submissions by enterprises, namely within the Cosmetic Wholesale Trade for Humans (cosmetic importers).  The data employed consists of notification application records from the Jakarta BPOM Main Office for the years 2022 and 2023.  The results demonstrate that these inconsistencies have resulted in a rise in re-applications, with around 35.75% of total submissions being re-applications due to problems such as the non-issuance of standard certificates through the Online Single Submission (OSS) RBA system, consequently hindering further processing.  As a result, this circumstance has generated regulatory ambiguities for cosmetic importers and extended the registration timeline for cosmetic items.  In light of these findings, it is advisable to undertake a reevaluation of Regulation BPOM No. 12 of 2023 to alleviate conflicts with other pertinent regulations.