Cosmetics Notification in ASEAN: A Comprehensive Guide to the Regulatory Process  

Introduction

The Association of Southeast Asian Nations (ASEAN) has established a regulatory scheme, the ASEAN Harmonised Cosmetic Regulatory Scheme, to improve the quality and safety of cosmetics in the region. This scheme includes the ASEAN Cosmetic Directive (ACD), which allows cosmetics produced or sold in one member state to enter the market of another member state, provided they comply with the directive.

In this article, we provide a comprehensive guide to the notification process for cosmetics in ASEAN countries and the documents required for compliance.

Regulatory Overview

The Association of Southeast Asian Nations (ASEAN) is comprised of 11 member states, including Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Laos, Singapore, Indonesia, the Philippines, Brunei, and Timor-Leste.

In September 2003, the ASEAN countries signed the Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme, which includes the ASEAN Cosmetic Directive (ACD), and the ACD was fully implemented in all member states on January 1, 2008. The purpose of this scheme and directive is not only to improve the quality and safety of cosmetics in the ASEAN region but also to allow cosmetics produced or sold in one member state to enter the market of another member state, provided they comply with the directive.

However, there is currently no mutual recognition among member states, and cosmetic companies must complete separate notifications in each ASEAN country before their products can be marketed. The basic information required for product notification includes formula, labeling, authorization letter, GMP compliance, free sale certificate, and local company business license, with different requirements in each country.

Definition of Cosmetics in ASEAN

Cosmetics are defined as products used on any external part of the human body (skin, hair, nails, lips, and external genitalia), or teeth and oral mucosa, primarily for the purpose of cleaning, perfuming, or protecting, to achieve good condition, beauty, or elimination of body odor. The definition of cosmetics in ASEAN is similar to that of the European Union.

Notification Process Overview

Each ASEAN country adopts a post-market surveillance system for cosmetics, and the notification process is similar in most countries.

Here is an overview of the notification process for each of the six ASEAN countries:

1. Cosmetic Notification in Indonesia

Country Regulatory Authority Notification Process Completion Time
Indonesia Badan Pengawas Obat dan Makanan (BPOM) 1.document inspection

2.manufacturer registration

3.cosmetic notification

 3-4 months

Note:

  1. The Certificate of Free Sale and Good Manufacturing Practices must be notarized and certified before use in Indonesia.
  2. Product functions, usage instructions, and warnings/precautions must be written in Indonesian.

Documents required for document inspection:

  1. Certificate of Free Sale (CFS) notarized and certified
  2. Good Manufacturing Practices (GMP) notarized and certified
  3. Authorization letter and contract manufacturing agreement between brand and manufacturer
  4. Business license of the manufacturing company
  5. Other necessary documents

After notification is completed, a Product Information File (PIF) must be prepared, including:

  1. Administrative documents (importing company: importer identification number, power of attorney, manufacturer information of the country of origin, importer information, cosmetic product/brand name, release date, delegated agent validity period, contract manufacturing agreement, notarized and certified Certificate of Free Sale and Good Manufacturing Practices)
  2. Quality and safety data of cosmetic ingredients
  3. Quality data of cosmetic finished products (formula, manufacturing process, analysis methods, stability data, etc.)
  4. Safety assessment and claims.

2. Cosmetic Notification in Singapore

Country Regulatory Authority Notification Process Completion Time
Singapore Health Sciences Authority (HSA) of Singapore

1. formula and packaging review

2. submission of product information via an online system

3. completion of notification

 1-2 months

After the notification is completed, a Product Information File (PIF) must be prepared, including:

  1. Administrative documents and product information summary
    1. Administrative documents (product notification number, company business license, other documents required by the government)
    2. Full ingredient list of the cosmetic product
    3. Product photos and labeling
    4. Good Manufacturing Practices (GMP)
  2. Quality specification data for ingredients
    1. Specifications and analytical methods for raw materials
    2. Safety data for raw materials (provided by the manufacturer or publicly available data from CIR, SCCP, ACSB, etc.)
  3. Quality specification data for finished products
    1. Quantitative product formulation
    2. Production process
    3. Product quality specifications and testing methods
    4. Product stability report
  4. Safety and efficacy data
    1. Safety assessment
    2. Adverse reaction data
    3. Product efficacy report

3. Cosmetic Notification in Malaysia

Country Regulatory Authority Notification Process Completion Time
Malaysia National Pharmaceutical Regulatory Agency (NPRA) of Malaysia

1. formula and packaging review

2. online submission

3. completion of notification

3-4 weeks

 

 Documents required for submission:

  1. Product details, including product name, product type, usage, and product appearance
  2. Manufacturer\’s name and address (if applicable)
  3. Name, address, and valid contact phone number (and email address) of the license holder
  4. Personal information of the individual representing the license holder, including valid contact phone number
  5. Importer\’s name and address (if applicable)
  6. Complete product ingredient list (restricted ingredient content must be declared, i.e. percentage)
  7. Authorization letter/declaration letter/contract manufacturing agreement (if applicable)
  8. Product labeling

After notification is completed, a Product Information File (PIF) must be prepared, including:

  1. Qualitative and quantitative composition of the product
  2. Specifications for ingredients and finished products
  3. Production methods that comply with the Good Manufacturing Practices (GMP) specified in the guidelines
  4. Safety evaluation: including safety of finished products, ingredients, chemical structures, and exposure levels to human health
  5. Existing data on adverse effects of using cosmetics on human health
  6. Supporting data for cosmetic efficacy claims must be provided.

4. Cosmetic Notification in Thailand

Country Regulatory Authority Notification Process Completion Time
Thailand Thai Food and Drug Administration (Thail FDA)

1. formula and packaging review

2. online submission

3. completion of notification

3-4 weeks

 

Note: The label on the outer packaging must be in Thai.

Documents required for submission:

  1. Product name in English and Thai
  2. Manufacturer\’s name and address
  3. Authorization letter
  4. Complete the formula and content
  5. Product information, including:

1) brand name, 2) usage instructions, 3) application site, 4) intended use, 5) method of use, 6) product appearance, 7) packaging appearance, and 8) product image or packaging

  1. Thai language label

5. Cosmetic Notification in Vietnam

Country Regulatory Authority Notification Process Completion Time
Vietnam
  • Ministry of Health (MoH)
  • Drug Administration of Vietnam (DAV)

1. formula and packaging review

2. preparation of Vietnamese labeling

3. online submission

4. completion of notification

 2-3 months

Note: Usage instructions, notification entity, and precautions on the label must be written in Vietnamese.

Documents required for submission:

  1. Brand and product name
  2. Product type
  3. Usage
  4. Manufacturer information
  5. Country of origin
  6. Certificate of Free Sale
  7. Complete ingredient list
  8. Authorization letter.

6. Cosmetic Notification in the Philippines

Country Regulatory Authority Notification Process Completion Time
Philippines
  • Food and Drug Administration of the Philippines (FDA PH)
  • Center for Cosmetics Regulation and Research (CCRR)

1. obtain a CCRR account

2. formula and packaging review

3. online submission

4. completion of notification

 2-3 months

Note: The Philippine government will also check overseas official websites to compare product information submitted.

Documents required to apply for a CCRR account:

  1. Authorization letter or contract or distribution agreement
  2. Good Manufacturing Practices (GMP) or ISO certificate or production license
  3. Contract manufacturing agreement (if applicable)
  4. Product list

Documents required for product notification:

  1. Full ingredient list of the product
  2. Clear and visible packaging or labeling information
  3. Product photo

After the notification is completed, a Product Information File (PIF) must be prepared, including:

  1. Quantitative product formulation
  2. Product label
  3. Good Manufacturing Practices and batch coding system
  4. Product safety evaluation
  5. Adverse reaction data
  6. Product efficacy report

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