Regulatory Update: BPOM’s Latest Rules on Cosmetics Labeling and Advertising
The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, “BPOM“) Regulation Number 18 of 2024 concerning the Labeling, Promotion, and Advertising of Cosmetics or Peraturan BPOM Nomor 18 Tahun 2024 tentang Penandaan, Promosi, dan Iklan Kosmetik (“PerBPOM 18/2024”) brings important updates to the cosmetics industry in Indonesia, including the introduction of mandatory halal labeling, along with the reinforcement and enhancement of existing provisions on 2D barcodes, refillable cosmetics, and the supervision and administrative sanctions. These updates also consolidate three previous regulations, which simplify compliance and ensure better governance. The regulation mandates business actors to update their operations to comply with the new requirements within 12 months starting from November 15, 2024.
BPOM recently introduced an important regulatory development for the cosmetics industry. On November 15, 2024, BPOM officially enacted PerBPOM 18/2024. This regulation not only introduces a new framework but also repeals and replaces three previous regulations:
- BPOM Regulation Number 30 of 2020 concerning Technical Requirements for Cosmetic Labeling or Peraturan BPOM Nomor 30 Tahun 2020 tentang Persyaratan Teknis Pelabelan Kosmetik (“PerBPOM 30/2020”);
- BPOM Regulation Number 32 of 2021 concerning Supervision of Cosmetic Advertising or Peraturan BPOM Nomor 32 Tahun 2021 tentang Pengawasan Iklan Kosmetika (“PerBPOM 32/2021”); and
- BPOM Regulation Number 12 of 2023 concerning Supervision of Cosmetic Production and Distribution or Peraturan BPOM Nomor 12 Tahun 2023 tentang Pengawasan Produksi dan Distribusi Kosmetik (“PerBPOM 12/2023”).
As an institution authorized to supervise the circulation of cosmetic products in Indonesia, BPOM issued PerBPOM 18/2024 to protect the public from cosmetic products that do not meet the required standards. This includes tackling the rampant circulation of illegal cosmetics, which lack permits and may contain harmful substances, posing health risks to consumers and threatening the domestic market by undermining fair business competition, particularly for manufacturers who have adhered to the applicable legal and regulatory requirements.
What are the new provisions and the reinforced requirements introduced by PerBPOM 18/2024? And how do they impact the cosmetics industry, particularly for business actors?
A. New Requirements Introduced in PerBPOM 18/2024
The new provisions introduced in PerBPOM 18/2024 address aspects that were previously not regulated under the three revoked regulations.
Halal Labeling Requirements
The new provision introduced by PerBPOM 18/2024 is the requirement for business actors to include a halal label on cosmetic products. This provision stipulates that:1
- The halal label may only be included on cosmetic products after the business actor obtains halal certification.2
- The halal certification is issued by an institution established by the government to implement halal product assurance in accordance with the applicable regulations.3
- The Inclusion of a halal label must adhere to the format and guidelines outlined in the applicable legal and regulatory requirements.4
As is known, the demand for halal cosmetics continues to rise, aligning with the global trend of rapid growth in the halal product market, especially in Indonesia. According to available data, Indonesia is one of the largest consumers of halal cosmetics globally, making it a strategic market for businesses seeking to expand their customer base. Due to the rising demand for halal cosmetics, BPOM sees that the obligation to include halal label on cosmetics, along with BPOM approval, can provide consumers with confidence that the products are safe. This also aligns with BPOM’s vision to ensure safe, high-quality, and competitive cosmetics products in Indonesia.
Top 5 Halal Cosmetics Consuming Countries in the World (2020)
Source: databoks
Business actors need to consider strategic steps to ensure that their products meet the halal standards as governed in Halal Product Assurance (“HPA”) Law. This interrelated law requires business actors to comprehensively evaluate raw materials, production processes, and distribution chains as a whole. Furthermore, maintaining transparency and consistency in product labeling is essential to building consumer trust and reducing risks that may impact a company’s operations and reputation.
B. Updated and Expanded Provisions in PerBPOM 18/2024
Many of the provisions in PerBPOM 18/2024 are not entirely new, but they are further detailed in PerBPOM 18/2024, providing greater clarity and strengthening existing rules to ensure better compliance across the industry. Some of these provisions include:
- 2D Barcode Another update in PerBPOM 18/2024 that requires attention is the mandatory inclusion of 2D barcodes on cosmetic labeling or packaging. As outlined in Article 3 Letter (k) of PerBPOM 18/2024, the 2D barcode is a mandatory element of cosmetic product labeling. This requirement is further clarified in Article 4 Paragraph (2), which states that the application of 2D barcode information must comply with related BPOM regulations, namely BPOM Regulation Number 22 of 2022 concerning the Application of 2D Barcodes for the Supervision of Drugs and Food or Peraturan BPOM Nomor 22 Tahun 2022 tentang Penerapan 2D Barcode Dalam Pengawasan Obat Dan Makanan (“PerBPOM 22/2022”).
Article 3 of PerBPOM 22/2022 defines a 2D barcode as a graphical representation of digital data in a two-dimensional format that optical devices can read. It is used for product identification, tracking, and tracing purposes. The barcode must provide information such as notification numbers, batch numbers, and other essential data to track products throughout the distribution chain.5This provision marks a significant update compared to previous regulations. For instance, PerBPOM 30/2020 only listed the 2D barcode as one of the elements in cosmetic labeling without detailing data-based tracking and supervision mechanisms. Meanwhile, PerBPOM 22/2022 stipulated technical standards for 2D barcode implementation, which was limited to pharmaceutical and food products. Subsequently, with the enactment of PerBPOM 18/2024, this technology-based mechanism is now mandatory for all cosmetics, providing a more integrated regulatory framework for supervision. - Refillable Cosmetics
Under the previous regulation, PerBPOM 12/2023—which has now been revoked—refillable cosmetics were mainly regulated with a focus on facility requirements, including sanitation, hygiene, and technical procedures. Additionally, refillable cosmetics were restricted to certain categories, such as liquid soap and shampoo, while baby cosmetics were explicitly prohibited from being made refillable.In contrast, PerBPOM 18/2024 expands the scope by focusing on the labeling requirements for refillable cosmetics. Business actors are required to include at least the following information on refillable cosmetic products:6- Name of the cosmetic product;
- Notification number;
- Batch number;
- Name and address of the refill facility;
- Refill date; and
- Expiry date.PerBPOM 18/2024 introduces a consumer-centric approach by prioritizing the availability of information through labeling. This ensures that refillable cosmetics are not only produced in compliant facilities but also offer transparency to consumers through complete product information on labels.
- Supervision and Administrative Sanctions
PerBPOM 18/2024 reinforces the importance of effective supervision and the enforcement of administrative sanctions for violations in cosmetic labeling, promotion, and advertising. This regulation strengthens the supervisory framework by integrating provisions from previous regulations, creating a more comprehensive approach to ensuring the safety and quality of cosmetic products in Indonesia.
Enhanced Supervision
The supervision under PerBPOM 18/2024, as detailed in its provisions, includes two main approaches:7
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- Routine inspections, which are conducted periodically to ensure compliance with applicable provisions.
- Incidental inspections, which are conducted based on reports of alleged violations or findings from previous inspections.
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This supervision include the monitoring of labeling, promotion, and advertising activities, as well as inspections of production and distribution facilities. Officers conducting the supervision are required to carry official identification and assignment letters to ensure compliance with legal procedures.8
Administrative Sanctions
In the event of violations, BPOM has the authority to impose administrative sanctions, which include:9
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- Written warnings;
- Temporary suspension of product distribution for up to one year;
- Product recalls;
- Destruction of products;
- Temporary suspension of business activities;
- Revocation of cosmetic notifications, and/or;
- Public disclosure of violations.
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Additionally, BPOM may recommend the revocation of business licenses to relevant ministries or agencies for consistent violators.10 This provision underscores the significant pressure on business actors to prioritize compliance with the regulations.
Conclusion
In one hand, PerBPOM 18/2024 simplifies the provisions of the three revoked regulations, but it essentially introduces significant changes aimed at improving compliance and strengthening governance in the cosmetics sector. With new provisions such as halal labeling requirements, 2D barcodes, refillable cosmetics regulations, and stricter supervision, business actors should adjust their operations to ensure compliance and business sustainability.
Business actors need to note that those who already held cosmetic notification numbers before the enactment of this regulation must align with the new provisions within 12 months from November 15, 2024, to ensure full compliance.
For further information or consultation regarding compliance, please contact us at ADCO Law.
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