On March 14, 2022, the Food and Drug Monitoring Agency (BPOM) of Indonesia published a draft regulation to partially amend BPOM Regulation No.23 of 2019 on Technical Requirements for Cosmetic Ingredients and solicited comments. The draft regulation proposes to amend the list of substances to be regulated and to add regulations on nanomaterials.
The original text of the draft regulation can be downloaded from the following URL.
The original text of the BPOM Regulation No. 23 of 2019 can be downloaded from the following URL.
Proposed amendments to the list of regulated substances
This draft regulation specifies the following five lists of regulated substances, all of which replace the Appendices to Regulation No.23 of 2019.
Appendix I: List of ingredients permitted for use subject to restrictions and conditions of use
Appendix II: List of colorants permitted for use in cosmetics
Appendix III: List of preservatives permitted for use in cosmetics
Appendix IV: List of UV inhibitors permitted for use in cosmetics
Appendix V: List of ingredients not permitted for use in cosmetics
The main amendment is that the substances included in the list of Appendix V has been increased from 1375 substances in Regulation No.23 of 2019 to 1605 substances in this draft regulation. In addition to the names and CAS RNs of the regulated substances, the list also includes the regulation number under the ASEAN Cosmetic Directive (ACD). However, the serial number assigned to each substance in the draft regulation does not correspond to the regulation number under the ACD.
Note that some substances not regulated by the ACD (e.g., plastic microbeads in Appendix V) have already been regulated in Indonesia by Regulation No.23 of 2019.
Regulations on nanomaterials
Under the current Regulation No.23 of 2019, substances that do not satisfy the restrictions and conditions in Appendix I or are not listed in Appendices II-IV are permitted for use if they are natural ingredients. However, this draft regulation would require that a separate recommendation letter for quality policy be obtained from the authorities for natural ingredients. To obtain the recommendation letter, in addition to data on safety and efficacy, technical documents on nanomaterials shall be submitted. The term “nanomaterial” in the draft regulation refers to “a material that is intentionally manufactured, insoluble or biopersistent, and has one or more external dimensions or internal structures that are 1-100 nm, or that exceed 100 nm but have very different properties from the original material.”