Recently, the Indonesian Food and Drug Authority (BPOM) issued an announcement revoking the distribution permits of 34 cosmetic products. The revocation was due to the presence of harmful and/or prohibited ingredients in these products, which may pose serious health risks to consumers.
CIRS reminds relevant enterprises to closely monitor Indonesia’s regulatory requirements regarding restricted and prohibited substances in cosmetics. The use of any unapproved or explicitly banned ingredients is strictly prohibited. Companies are also advised to strengthen the verification of raw material sources and enhance quality control of finished products to ensure full compliance with local regulatory standards in terms of formulation, labeling, and other aspects.
Sampling and testing confirmed that all these products contained hazardous and/or prohibited ingredients that could pose health risks to consumers. The prohibited and/or hazardous ingredients found included mercury, retinoic acid, hydroquinone, lead, Methanyl yellow dye, and steroids. The health risks posed by hazardous and/or prohibited ingredients in cosmetics vary widely, ranging from mild to severe.
Among other things, mercury can cause skin discoloration in the form of dark spots, allergic reactions, skin irritation, headaches, diarrhea, vomiting, and even kidney damage. Retinoic acid can cause dry skin, burning sensations, and changes in the shape or function of fetal organs in pregnant women. Furthermore, hydroquinone in cosmetics can cause hyperpigmentation, exogenous ochronosis, and discoloration of the cornea and nails. Lead in cosmetics may impair the functions of organs and body systems. Methanyl yellow, a prohibited dye, is carcinogenic and can damage the liver, nervous system, and brain.
Compliance Requirements in Indonesia
Indonesia adopts the ASEAN Cosmetic Directive (ACD) as the basis for its cosmetic-related regulations, which it then formulates in accordance with national conditions. These include the Cosmetic Manufacturing License (No. 1175/Menkes/Per/VIII/2010), Cosmetic Notification Requirements (No. 1176/Menkes/Per/VIII/2010; BPOM Regulation No. 21/2022), Product Information File Guidelines (BPOM Regulation No.17/2023), Cosmetic Technical Requirements (BPOM Regulation No.30/2020), and Adverse Event Monitoring Regulations.
In Indonesia, all cosmetics (including imported and locally manufactured) must be notified to the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan, BPOM) before being marketed. In addition, cosmetics sold in Indonesia are also required to obtain Halal certification (this requirement has been effective since October 17, 2021, with a 5-year transition period). The Halal Product Assurance Organizing Agency (Badan Penyelenggara Jaminan Produk Halal, BPJPH) is responsible for overseeing Halal certification for cosmetics in Indonesia.
Cosmetic compliance in Indonesia must meet the following main requirements:
- Cosmetics must be manufactured in facilities certified with Good Manufacturing Practices (GMP)
- Cosmetics must comply with all safety and quality requirements set by BPOM
- Cosmetics must be labeled in the Indonesian language
- Cosmetics must be accompanied by a Product Information File (PIF/DIP) in Indonesian or English
Our Services
- Indonesian Company License Holding Service
- BPOM Account Registration in Indonesia
- Formula and Packaging Review
- Cosmetic Product Notification in Indonesia
- Preparation and Compilation of PIF/DIP Files
- Product Testing Services
- Logistics and Customs Clearance
- HALAL Certification
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.