In Indonesia the so-called negative list approach is employed for chemicals control. Hazardous and toxic chemicals are regulated by making lists of specified hazardous chemicals to be controlled. Indonesia does not have a risk-based chemical control approach to regulated chemicals based on assessment results of their hazards and exposure as is employed in for example EU-REACH. However, the Indonesia government is working to improve the current method of chemical control. Indonesian government published the Chemical Substance Bill that aims to regulate from import/export, production, transportation, usage to disposal in 2012. As of 2018 the Bill has not been promulgated but is still under consideration.
Sep-01-2025
Indonesia’s Ministry of Trade has issued Regulation No. 20
of 2025 on the import of chemicals, hazardous substances, and certain minerals,
replacing Regulation No. 36 of 2023 (as amended). The rule was promulgated on 30
June 2025 and took effect on 29 August 2025.
Scope and Coverage
The regulation establishes import controls for the following
categories:
Legal Basis and Key Dates
Import Licensing and Verification
Importers must hold appropriate business permits and import
approvals before goods enter Indonesia’s customs territory, using the regime
defined in the regulation:
The regulation also formalizes verification/technical
tracing by authorized surveyors and the issuance of Laporan Surveyor (LS) where
required. Definitions for IT, IP, PI and LS are standardized in Article 1.
Electronic Realisation Reporting
Holders of PI or LS must submit electronic import
realisation reports, covering both realised and unrealised volumes, in
accordance with the trade licensing framework administered by the Ministry of
Trade. Non-compliance triggers administrative sanctions.
Treatment in Special Regimes (FTZ/SEZ/Bonded)
The regulation distinguishes the treatment of goods entering
Free Trade Zones (KPBPB), Special Economic Zones (KEK), and Bonded Warehouses
(TPB):
Transitional Provisions
Existing IT/IP/PI documents remain valid until expiry and
may be amended or extended under the new framework. However, previously issued PI
for Certain Chemicals (BKT) under API-P/API-U are expressly revoked via the
INATRADE system. Surveyor (LS) documents issued under prior rules remain valid
through completion of the relevant importation.
Compliance Actions for Industry
Assess zone strategy: imports routed via TPB/KPBPB/KEK may obtain warehousing efficiencies, but domestic release will trigger full import controls; certain categories are regulated at all stages including entry.
Aug-01-2025
On 30 July 2025, Indonesia’s National Agency of Drug and Food Control (BPOM) released a draft five-year strategic plan (2025–2029) to enhance regulatory compliance in product safety and labelling, with a particular focus on the cosmetics sector and small and medium-sized enterprises (SMEs). The initiative seeks to transition from reactive enforcement to a proactive, risk-based oversight model supported by artificial intelligence and intersectoral collaboration.
Addressing Root Causes of Non-Compliance in Cosmetics
The strategy builds on BPOM’s analysis of widespread labelling violations observed during the 2020–2024 period, especially among SMEs in the cosmetics sector. Investigations revealed that inaccurate or misleading labelling—largely due to the absence of pre-market label evaluations—was a leading cause of non-compliance. This regulatory gap had a negative impact on national compliance metrics, as cosmetics are monitored within the same framework as pharmaceutical products.
Microbial contamination, particularly in traditional and herbal cosmetic lines, was another recurring issue. In response, BPOM expanded its post-market surveillance, conducting over 188,000 inspections and increasing product sampling from 27,000 units in 2020 to more than 43,000 in 2024.
Improved Compliance Among SMEs
BPOM reported significant progress in SME compliance rates, which rose from 73.11% in 2022 to 93.26% by 2024. The agency attributes this improvement to increased self-reliance in sourcing cosmetic raw materials and intensified outreach efforts, including regulatory education, technical assistance, and incentives aimed at elevating production standards.
Strategic Focus Areas for 2025–2029
The new strategic plan outlines several core priorities to sustain and build on recent gains:
a. Expanded technical support and training for SMEs in the cosmetics sector.
b. Development of digital platforms to facilitate regulatory updates and industry guidance.
c. Standardisation of facilitator competencies to improve local advisory services.
d. Promotion of raw material independence, particularly for locally sourced cosmetic ingredients.
These measures are designed to support a more consistent and scalable compliance culture, particularly among smaller manufacturers navigating regulatory complexities.
A Shift Toward Proactive, Technology-Driven Oversight
Central to BPOM’s strategy is the deployment of a proactive, AI-enabled risk-based monitoring system, which aims to identify potential violations before products reach consumers. This forward-looking approach will be supported by greater coordination between government agencies, industry stakeholders, and academic institutions.
Implications for Industry Stakeholders
Cosmetics producers—especially SMEs—are advised to prepare for more sophisticated compliance expectations and closer integration with digital regulatory systems. Firms should consider:
a. Investing in regulatory training for staff.
b. Reviewing labelling processes in light of upcoming pre-market evaluation requirements.
c. Engaging with BPOM’s digital platforms and public-private initiatives.
Public consultation on the draft strategic plan closed on 5 July 2025, with final adoption anticipated later this year. The plan signals a continued commitment to strengthening Indonesia’s product safety framework while supporting the sustainable growth of its domestic cosmetics industry.
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