the National Agency of Drug and Food Control Regulation Number 25 of 2025 was enacted in October 2025 in response to two main factors: developments in the ASEAN Cosmetic Directive (ACD) and advances in global scientific knowledge identifying previously unrecognized hazardous substances.11. This regulation introduces several fundamental changes, including full harmonization with the updated ACD (ACSB 38th), a preventive risk-based supervisory approach, and legal recognition of technically unavoidable traces under Article 10, of the total 1,684 cosmetic business actors in Indonesia, 85 percent (approximately 1,431 units) are Small and Medium Enterprises (SMEs). SMEs differ from large industries in several respects, including limited capital for research and development, absence of in-house laboratories, limited formulation expertise, and dependence on imported raw materials. These characteristics are crucial in assessing the proportionality of the regulation.

The most significant substantive change introduced by the National Agency of Drug and Food Control Regulation Number 25 of 2025 is the addition of 101 new substances to the list of prohibited ingredients (Annex V), including Lilial (Butylphenyl Methylpropional), Styrene, and D4 (Octamethylcyclotetrasiloxane)12. Lilial has been banned in the European Union since 1 March 2022 through Omnibus IV Regulation (EU) 2021/1902, following the Scientific Committee on Consumer Safety (SCCS) Opinion SCCS/1591/17 confirming its reproductive toxicity (CMR category 1B)13. The principle of proportionality in administrative law consists of three sub-principles that must be satisfied.

Table 2. Application of the Principle of Proportionality in the Prohibition of Cosmetic Ingredients

Source: Author’s analysis, 2026.

The reformulation process resulting from the prohibition of substances involves seven technical stages17: a) identification of safe and available alternative ingredients; b) laboratory-scale formulation testing; c) accelerated stability testing (minimum of three months in accordance with ASEAN Guidelines); d) microbiological stability testing; e) skin safety testing (irritation/sensitization); f) revision of the Product Information File (PIF); and g) re-notification through the the National Agency of Drug and Food Control e-Notification system. Kashuri, Ikrar, and Indrayanto (2025), in their study of 50 SME cosmetic enterprises in West Java and East Java, found that the average reformulation time required by SMEs ranges from 15 to 18 months, with the following breakdown:

Table 3. Reformulation Stages, Time Requirements, and Key Constraints for SMEs

Source: Kashuri et al. (2025)18

Article 10 of the National Agency of Drug and Food Control Regulation Number 25 of 2025 recognizes the concept of technically unavoidable traces; however, the phrase “technically unavoidable levels” constitutes a vague norm (vage norm), as it is not accompanied by quantitative threshold values expressed in ppm (parts per million) for each prohibited substance. Best practices in the European Union demonstrate the establishment of specific threshold values, for example, nitrosamines ≤50 ppb. The absence of such quantitative thresholds in the National Agency of Drug and Food Control Regulation Number 25 of 2025 creates legal uncertainty for SMEs and poses a risk of disproportionate enforcement of sanctions.

The prohibition of cosmetic ingredients under the National Agency of Drug and Food Control Regulation Number 25 of 2025 has not fully satisfied the principle of proportionality. While the principle of suitability (geeignetheid) is fulfilled in achieving public health protection, the principle of necessity (noodzakelijkheid) is only partially met due to the absence of less restrictive alternatives, and the principle of proportionality in the strict sense (proportionaliteit sensu stricto) is not satisfied, as the substantial reformulation burden on SMEs is not balanced by supporting instruments such as quantitative thresholds and an early warning system.

Regulation Number 25 of 2025 provides a uniform transition period of 12 months (October 2025 – October 2026) for all business actors to adjust formulations, labeling, and notifications, without differentiation based on the scale of the business19.

Table 4. Application of the Principle of Proportionality in the Transition Period

Source: Author’s analysis, 2026.

A comparison of transition periods across jurisdictions is essential for assessing proportionality:

Table 5. Comparison of Transition Periods across Jurisdictions

Source: European Commission (2019)23, European Union (2021)24, BPOM (2025)25, Kashuri et al. (2025)26

Based on Kashuri, Ikrar & Indrayanto (2025), the reformulation time required by SMEs reaches 15–18 months. With a transition period of only 12 months and without prior notice, technically SMEs are not able to meet the deadline. Accelerated stability testing alone requires a minimum of 3 months in accordance with the ASEAN Guidelines on Stability Testing of Cosmetic Products. Assuming that SMEs receive information on the prohibition during the socialization in November 2025, the remaining time is: October 2026 – November 2025 = 11 months. Subtracting 3 months for stability testing leaves 8 months for the other 6 stages. This condition is practically not feasible for SMEs without in-house laboratories.

If the transition period remains 12 months without revision, there are three main risks (Kashuri, Ikrar & Indrayanto, 2025): a) Legal risk: BPOM may potentially engage in detournement de pouvoir (abuse of power) if it imposes sanctions on SMEs that fail to meet the deadline due to structural technical incapacity rather than bad faith; b) Industrial risk: Most of the 1,431 SMEs are at risk of losing their marketing authorization, potentially leading to contraction in the national cosmetic market and loss of employment; c) Consumer risk: Excessive compliance pressure may push SMEs to switch to cheaper substitute ingredients that have not been adequately tested, creating a regulatory paradox where consumer protection may instead result in less safe products.

The transition period under Agency of Drug and Food Control Regulation Number 25 of 2025 does not satisfy the principle of proportionality. The uniform 12-month transition period does not consider the actual capacity of SMEs, which require 15–18 months, lacks a prior notice/early warning mechanism (unlike EU practice), and ignores the principle of a differentiated regulatory approach as recommended in the ASEAN Cosmetic Directive, to strengthen the proportionality analysis, the following comprehensive comparison is presented:

Table 6. Comparative Analysis with the ASEAN Cosmetic Directive and the European Union

Source: ASEAN Cosmetic Association (2008)27, European Union (2021)28, BPOM(2025)29, OECD (2021)30, European Commission (2013)31

Although not part of the main research questions, it should be noted that Agency of Drug and Food Control Regulation Number 25 of 2025 introduces administrative sanctions in the form of revocation of the Good Cosmetic Manufacturing Practices certificate for serious violations. Firmantoro (2025) finds a significant disparity between the potential sanctions (fines of up to IDR 1 billion) and actual enforcement outcomes (averaging IDR 5–10 million). The strengthening of sanctions through Good Cosmetic Manufacturing Practices revocation should be positioned as an ultimum remedium, preceded by written warnings and temporary suspension.32