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.
Oct-02-2025
The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) has held a public consultation on the Draft Regulation on Certification of Good Manufacturing Practices for Cosmetics (CPKB), as part of ongoing efforts to modernize and strengthen regulatory oversight of the cosmetics sector. Stakeholders were invited to submit written comments until 26 September 2025.
The draft regulation seeks to replace BPOM Regulation No. 33/2021, introducing a risk-based supervision system, streamlining certification procedures, and codifying service-level timelines for verification, inspections, and decisions.
What the Draft Changes
Two certification tracks.
Applications must be submitted online. BPOM will verify documentation
within seven working days. Following payment, inspections are coordinated within
20 days, and decisions are issued within 35 days for cases that do not require
inspection. The process follows a “clock on/off” principle, allowing up to
three data-request cycles of 20 days each.
Administrative changes, such as name or address change without
relocation, can be approved without inspection. Certain technical changes and
renewals may trigger inspection depending on risk level and recent oversight
history. Late renewals must re-apply as new.
Existing CPKB or Aspect certificates and joint-use approvals
remain valid until their expiry date. Floor-plan pre-approvals submitted before
the new rule takes effect will be processed under Regulation 33/2021,
signalling the elimination of this requirement in the new framework. Upon entry
into force, Regulation 33/2021 will be repealed.
Why It Matters for Industry
What Companies Should Do Next
Context and Next Steps
Grounded in Government Regulation No. 28/2024 under the 2023
Health Law, the draft modernizes CPKB governance by emphasizing risk
management, digital administration, and enforceable service levels. With
consultation closed, stakeholders should monitor BPOM for the consolidated
final text and effective date.
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.
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