BPOM Drafts Amendments to Class B Cosmetics Regulations

The Indonesian Food and Drug Authority (“BPOM”) is preparing the draft amendment to Regulation of BPOM No. 8 of 2021 (“Regulation 8/2021”) on the Forms and Types of Certain Cosmetic Preparations That May Be Produced by Cosmetics Manufacturers Holding a Class B Cosmetics Certificate (“Draft Regulation”).

Dian Putri Anggraweni, Director of Standardization for Traditional Medicines, Health Supplements, and Cosmetics at BPOM, explained that the revisions include adjustments to the forms and types of preparations, the addition of new cosmetic categories, and a change in terminology from ‘produced’ to ‘manufactured.’

“These regulatory changes cover dosage forms, types of preparations, and cosmetic categories, as well as changing the term ‘produced’ to ‘manufactured,’” she said.

The changes also open up opportunities for Class B cosmetics manufacturers to develop product variations. BPOM has added paste formulations for semi-solid forms, compact powders for powder forms, and other solid dosage categories. These additions are intended to accommodate product innovation as long as they meet safety, efficacy, and quality criteria.

In addition, BPOM will clarify a number of definitions in the regulation, including cosmetics, the cosmetics industry, and simple technology. Simple technology is defined as technology with an uncomplicated mechanical structure and operational workflow that does not require a high level of technical expertise.