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Indonesia Cosmetic Registration

11 月 26, 2025 Registration Insights 0 views

Indonesia Cosmetic Registration (BPOM – Badan POM Indonesia)

1. Regulatory Authority & Framework

Cosmetics in Indonesia are regulated under:

  • BPOM Regulation No. 23/2019
  • ASEAN Cosmetic Directive (ACD)
  • BPOM Online Cek BPOM & e-registration portals
  • Updated ingredient, labeling & GMP provisions from BPOM circulars

Authority:
BPOM – National Agency for Drug and Food Control (Badan POM).

Indonesia uses a pre-market approval system (unlike Malaysia/Vietnam/Thailand) — cosmetics must be registered and approved before they can be imported or sold.

2. Classification of Cosmetics

Indonesia follows the ACD definition:

Cosmetic = applied to external body parts/teeth/oral cavity for cleansing, beautifying, perfuming, conditioning, or altering appearance.

Borderline products may become traditional medicines (jamu), OTC drugs, or quasi-drugs if the claims exceed permitted cosmetic functions (e.g., acne treatment, hair growth, melasma treatment).

3. Registration Type – BPOM Cosmetic Notification (Pre-Market Approval)

Output:

  • BPOM Notification Number (e.g., NA1xxxxxxxxxx)
  • Format: NA + region code + 11 digits
  • Validity: 3 years (renewable)

Important: Indonesia is NOT “instant submission”—BPOM performs a full review before approval.

4. Local Responsible Person (LRP / Company) Requirements

Foreign manufacturers cannot register directly.
A local Indonesian company must act as the Registrant / Notification Holder.

Responsibilities:

  • Submit online registration
  • Ensure compliance with ACD & BPOM regulations
  • Maintain PIF & product samples
  • Handle import permits
  • Manage PMS, AE reporting & recalls
  • Ensure labeling in Bahasa Indonesia
  • Cooperate with BPOM inspections

Changing the local company requires re-registration.

5. Dossier Requirements (BPOM Cosmetic Registration)

Indonesia’s cosmetic dossier is stricter than other ASEAN markets.

A. Administrative Documents

  • Power of Attorney to Indonesian Registration Holder
  • Certificate of Free Sale (CFS) from country of manufacture (legalized)
  • Good Manufacturing Practice (GMP) certificate (ISO 22716 recommended)
  • Company licenses (NIB, API-U, etc.)
  • Copy of brand ownership / authorization
  • Product sample (sometimes requested)

B. Technical Documents (ACD-aligned PIF)

Part I – Administrative Information
Part II – Quality Documentation

  • Full formula (%)
  • Raw material specifications
  • Microbiology & stability test results
  • Heavy metal testing (Pb, As, Hg)
  • Preservative efficacy test (if applicable)

Part III – Safety Assessment

  • Toxicology profile of ingredients
  • Safety assessor’s report
  • Exposure & risk analysis

Part IV – GMP Evidence

  • ISO 22716 essential
  • Manufacturing flowchart, QC procedures

C. Labeling (Must be submitted for approval)

  • Product name
  • Function
  • Ingredient list (INCI)
  • Net content
  • BPOM notification number (after approval)
  • Batch/lot number
  • Manufacturing/expiry date
  • Manufacturer details
  • Name & address of Indonesian Registration Holder
  • Warnings (for restricted ingredients)
  • Language: Bahasa Indonesia (mandatory)

Sticker labels are acceptable for imported products but must follow BPOM rules.

6. Ingredient Rules

Indonesia directly implements ACD Annexes:

  • Annex II – Prohibited ingredients
  • Annex III – Restricted ingredients (AHA, hair dyes, salicylic acid)
  • Annex IV – Allowed colorants
  • Annex VI – UV filters
  • Annex VII – Preservatives

Strict prohibitions:

  • Hydroquinone, tretinoin, steroids
  • Mercury = zero tolerance
  • Whitening claims with medical promises (melasma cure) → prohibited
  • AHA/pH limits enforced strictly

7. Fees & Timelines

Government Fees

  • Approx. IDR 500,000–1,500,000 per product (varies based on category)

Timeline

  • Dossier preparation: 2–4 weeks
  • BPOM review: 1–3 months typical
  • Sometimes extended to 4–6 months depending on product complexity, claims, and ingredient verification
  • Notification validity: 3 years

Indonesia has one of the slowest cosmetic approval systems in ASEAN due to full dossier review.

8. Post-Market Surveillance Requirements

BPOM conducts heavy PMS:

  • Market inspections
  • Random sampling & laboratory testing
  • Halo BPOM consumer reports
  • Advertising monitoring
  • Labeling compliance checks
  • BPOM App and online monitoring

Registrant must:

  • Maintain PIF for minimum 3–5 years
  • Report adverse events
  • Implement recalls if ordered
  • Renew notification before expiry

BPOM frequently suspends products for:

  • Excessive whitening claims
  • Heavy metal contamination
  • Prohibited ingredients
  • False or incomplete labeling
  • Non-compliance with UV filter or preservative limits

9. Borderline Product Clarifications

Cannot be registered as cosmetics:

  • Acne treatment (benzoyl peroxide, medical-grade salicylic acid)
  • Melasma therapy (“treat melasma,” “cure pigmentation”)
  • Hair loss prevention / hair growth
  • Anti-inflammatory creams
  • Antiseptic/sanitizer products
  • Medicated shampoos
  • Products containing steroids, tretinoin, or drug-level actives

These fall under OTC drug or quasi-drug regulations.

10. Consulting Notes for Your Product Portfolio

Product TypeIndonesia StatusNotes
Whitening productsCosmeticAvoid therapeutic claims; strict AHA limits
Anti-acne productsLikely drugSA <2% allowed only as cosmetic; no “treat acne” claims
SunscreensCosmeticMust use Annex VI UV filters; SPF testing required
Sheet masksCosmeticEnsure preservative efficacy test if needed
Hair dyesCosmetic with warningsRequires Indonesian warning phrases
Hair growth productsDrugNot eligible for cosmetic route
Scalp treatment with medical claimsDrug/Traditional medicineNot cosmetic

11. Advantages & Challenges in Indonesia Cosmetic Market

Advantages

  • Large population (270+ million)
  • Strong demand for Korean, Japanese, Chinese skincare
  • ASEAN harmonization (ACD)

Challenges

  • Slow BPOM review
  • Strict labeling & ingredient checks
  • 3-year renewal requirement
  • Local company dependency (registrant owns the license)

Author:Grzan

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