Ethicolegal Analysis of Safety Assesor Aspect on the Application of Ministry of Health of Cosmetic Notification Regulation

摘要

Background: Indonesia is a last country implemented Asean notification of cosmetic which was declared by Permenkes Nomor 1176/Menkes/Per/VIII/2010 about notification of cosmetic started at 1st January 2011. The consequance is every industry has to prepare a safety assessor that to be responsible for quality, beneficial and safety of cosmetic producted. The aims of this research are to analyse ethicolegal aspect of profesionalism of safety assessor, to investigate the willingness of producer in the utility of safety assessor, and to investigate the availability of the safety assessor in implementing notification of cosmetic. Method: Design of this research is cross sectional qualitative approach. Sampling is selected purposively in four provinces namely DKI Jakarta, Jawa Tengah, Jawa Timur, and Bali. In every province 9 industries are choosen (clasified by 2 big industries, 3 middle industries, and 4 small industries). Collecting data was conducted by indepth interview, document analyze, and round table discussion. Result: Research results are firstly all producer confessed the notification registering system are easier and faster than the old registration system. Secondly the qualification and profesionalism or independency of safety assessor has not been mentioned clearly by goverment so it may create etico legal conflict in every side. Thirdly the ministry of health cq health regional offices side do not have roles in applying the Permenkes (exp.in capacity building and controlling). Conclusion: Notification cosmetic regulation has been implemented and the method iseasier compare to registration prosedure. Recommendation: The mechanism of controlling by BPOM and Balai POM have to be informed transparancy to the industries, and the role of Ministry of Health and Health Regional Offices in notificationof cosmetic should be arranged and implemented clearly.