Acknowledging the importance of safety and quality standards for cosmetic products distributed in Indonesia, the National Agency of Drug and Food Control (BPOM) issued Regulation Number 17 of 2023 (Regulation 17/2023), which replaces Regulation Number 14 of 2017 (Regulation 14/2017) concerning the Guidelines for Product Information Documents.
Essentially, Regulation 17/2023 revises various provisions related to details of Product Information Documents (DIP) and audit obligations. Further, this article will specifically explain three main updates and changes in Regulation 17/2023, as follows:
- DIP in general
- Updated administrative documents; and
- DIP audits.
DIP in General
In general, cosmetic industry players entering into production contracts must secure DIP before sending notifications to secure distribution permits. Regulation 17/2023 now covers certain DIP-related information that is subject to relevant BPOM regulations but not covered by Regulation 14/2017, as follows:
- Compliance with technical requirements for cosmetics ingredients that are accompanied by scientific or empirical evidence;
- Compliance with contamination requirements;
- Results of monitoring of the side effects of cosmetics products;
- Compliance with labeling requirements; and
- Compliance with the claim provisions.
Further, DIP is divided into four parts:
- Part I – Administrative Documents
- Part II – Data on the Quality and Safety of Cosmetics Ingredients
- Part III – Data on Cosmetics Quality
- Part IV – Data on Cosmetics Safety and Benefits.
Under Regulation 17/2023, applicants are required to keep DIP at least one year after the expiration dates of their most recent manufactured or imported cosmetics products. Additionally, any applicants who had secured notifications before the enforcement of Regulation 17/2023 are required to make adjustments to the relevant DIP within six months after the enforcement of Regulation 17/2023.
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Updated Administrative Documents
There are some changes and adjustments to the administrative documents required for DIP compared to Regulation 14/2017, and there is one category of cosmetics that is removed from Regulation 17/2023 i.e., licensed cosmetics. The following is the comparison of administrative documents between Regulation 17/2023 and Regulation 14/2017.
| Administrative Documents | Legal Framework | |
| Regulation 14/2017 | Regulation 17/2023 | |
| Domestic Cosmetics | ||
| Copy of a valid cosmetics production license | ✓ | – |
| Copy of a statement letter that addresses the relevant trademark | ✓ | |
| Copy of a valid Good Manufacturing Practices for Cosmetics (CPKB) certificate | ✓ | |
| Imported Cosmetics | ||
| Copy of an Importer Identification Number | ✓ | – |
| Copy of a valid agency appointment letter | ✓ | |
| Copy of a legalized cooperation agreement between the applicant and production contract recipient | ✓ | |
| Copy of a free sale certificate for cosmetics products imported from outside ASEAN countries | ✓ | |
| Copy of a statement letter related to the trademark | ✓ | |
| Copies of valid CPKB certification (for industries located within and outside ASEAN countries) | – | |
| Contract Cosmetics | ||
| Copy of a valid cosmetics production license and CPKB certificate | ✓ | ✓ |
| Copy of legalized cooperation agreement between an applicant and a production contract recipient | ✓ | |
| Copy of a cosmetics-related business license | – | |
| Copy of a statement letter that addresses the relevant trademark | ✓ | |
Aside from adjustments and amendments to Regulation 14/2017, Regulation 17/2023 also introduces a number of additional documents that are subject to the three categories aforementioned, which are summarized in the following table:
| List of Documents | Cosmetic Category | ||
| Domestic Cosmetics | Imported Cosmetics | Contract Cosmetics | |
| Copy of a valid Business Identification Number (NIB) | ✓ | – | – |
| Copy of a license agreement between a trademark owner and an applicant who is appointed as a trademark licensee | ✓ | – | – |
| Copy of a good manufacturing practice certificate | – | ✓ | – |
| Copy of a letter that has been stamped by the directors and/or heads of cosmetics industries affirming their non-involvement in any illicit actions within the cosmetics sector | ✓ | ✓ | ✓ |
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DIP Audits
The provisions regarding DIP as previously stated are implemented in order to ensure that cosmetic products are safe and fulfill the quality standards. Thus, business actors are required to guarantee the availability of DIP and grant audit officers access to DIP. The implementation of auditing is summarized into the following:
DIP Audit Procedures:
- Pursuant to Regulation 17/2023, DIP audits cover regular and/or incidental audits. To carry out the audit process, audit officers should be equipped with official ID Cards and Letters of Duty.
- BPOM has to send a notification letter to the relevant party at least thirty calendar days prior to any regular audit.
- Incidental audits, however, are carried out as follow-ups without any prior notification provided based on the results of supervision and/or indications of violations.
Authority of Officers:
During the audit process, audit officers are authorized to:
- examine administrative documents, including making copies (due to the nature of confidentiality, copies will only be made for the purposes of evaluation and supervision)
- Examine cosmetics marks and claims, including other information that relates to safety, benefits and quality aspects, and which constitutes an integrated part of the primary packaging and/or secondary packaging of cosmetic products, according to the distributed products.
- Take product samples for further analysis.
In conclusion, there are adjustments and changes stipulated under Regulation 17/2023, especially in administrative documents, while the audit process does not experience significant changes compared to that stipulated in Regulation 14/2017. The main idea behind Regulation 17/2023 is still the same as that of Regulation 14/2017, which is to ensure the safety and quality standards of cosmetic products through DIP.
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