Chemical Regulatory Services in Indonesia

Overview

Cleaning and disinfectant products are called, identified, and regulated very differently across countries and regions making it very challenging for the industry to place these products in different markets.

Chemical products like detergents, cleaners (laundry preparations) and disinfectants, and antiseptic preparations products (for example - intended to be used on inanimate surfaces and hard surfaces) fall under the ambit of Regulation of the Minister of Health Number 1190/MENKES/PER/VIII/2010 and classified as Household Health Products (HHP) (Perbekalan Kesehatan Rumah Tangga) abbreviated as PKRT, where they are further classified as per the degree of risk as mentioned below:

  • Low-risk - Class I
  • Moderate risk - Class II
  • High-risk - Class III

Further hazardous and toxic chemicals (B3 chemicals) are regulated by the Ministry of Environment and Forestry (MoEF), which requires such chemicals to be registered before placing in the market. Chemicals for limited use (B3) or imported for the first time require notification before importation. All chemicals are required to be labeled as per the Globally Harmonized System (GHS). A GHS is applicable in Indonesia for the classification & labeling of chemicals & chemical products, and SDS preparation.

Summary Table

 

Categories

Biocide/ Disinfectant

Detergents

/Cleaning Products

General Consumer Products

Chemicals

Chemical Regulation

 

Minister of Health Number 1190/MENKES/PER/VIII/2010

 

 

 

Hazardous and toxic substance management [Bahan Berbahaya dan Beracun (abbreviated as B3)]

 

Hazardous and toxic substance management [Bahan Berbahaya dan Beracun (abbreviated as B3)]

MoEF Regulation 36/2017 on Registration and Notification Procedures for Hazardous and Toxic Substances

KEP NO. 187/MEN/1999 (Handling of hazardous chemicals at work)

Regulation of the Minister of Industry No. 87 of 2009 concerning the Globally Harmonized System of Classification and Labeling of Chemicals

Registration/Notification Requirement

Yes

No

Yes (only for hazardous/toxic chemicals)

Process Brief

Application submission for PKRT online through  http://regalkes.kemkes.go.id/

Only product compliance is required to ensure the safety and quality of the product.

Application submission through PTSP online system

Local Representative

Yes (Sole agent in case of the overseas manufacturer)

N/A

Yes (could be importer)

Key Data Requirements
  1. Product details (category, HS code, description, shape, color, packaging, and net)
  2. Details of the overseas company that authorizes a sole agent to register
  3. A copy/scan of the original power of attorney as the sole agent or sole distributor authorized to register PKRT products with the Ministry of Health from the principal/factory of origin, which has been legalized by the Indonesian Embassy (Import)
  4. The certificate has been circulated in the country of origin for imported products
  5. SIUP and NPWP (imported products)
  6. Letter of cooperation/relationship/appointment/license between the factory and the owner brand
  7. Statement letter that the uploaded document/data is original and correct
  8. Formula/components and manufacturing procedure
  9. Laboratory test certificates and materials used
  10. Packaging information
  11. Finished product analysis certificate
  12. Product stability test results
  13. Efficacy test results
  14. Purpose of use, instructions for use, warnings, cautions, and other information (in Indonesian)

N/A

Documents required for B3 chemical registration:

 

  1. B3 Registration form
  2. Photo of the B3 storage warehouse
  3. Photo of the B3 packaging
  4. Photo of the B3 storage arrangement
  5. Safety Data Sheet (LDK)
  6. Certificate of Analysis (CoA)
  7. Other additional documents related to the importer
Expertise

Freyr Expertise

  • Product Classification and Regulatory Guidance
  • Regulatory Strategies for Market Access/Product Launch
  • Develop Product Notification/Registration Strategies
  • Regulatory Applicability Review and Interpretation
  • Prepare Technical Data Files (specification, MSDS, etc.) including Registration/ Notification dossiers
  • Application Preparation and Submission for Relevant Introductions and Renewals
  • Sustainability and Packaging Solutions
  • Regulatory Intelligence (RI)
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate the complexities of Regulatory authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in the multi-market scenario
  • Quick turnarounds and faster time-to-market