Comprehensive Guide to the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS)

Before 2008, cosmetics companies hoping to expand across Southeast Asia often faced a fragmented regulatory landscape. Each country had its own standards, definitions, and approval timelines. To standardize cosmetic product registration in Southeast Asia, ASEAN member states signed the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS) in 2003 (implemented fully by 2008).

Whether you’re an importer, manufacturer, or a cosmetic product distributor, you need to understand the core principles of the ASEAN Cosmetic Directive (ACD). In this article, we will cover what is the AHCRS and its core pillars and how it affects cosmetic product registration.

The AHCRS Vision for Borderless Compliance

Before you enter any Southeast Asian market, you need to register your cosmetics to the local food and drug authorities. To do so, you need to adhere to the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS).

The goal of the AHCRS is to eliminate technical barriers to trade while ensuring consumer safety across all signatories in Southeast Asia. These include countries such as Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. For example, if you want to register cosmetics in Thailand, you can use a similar dossier for registering in Indonesia or the Philippines. 

The most significant shift was moving the region from a "pre-market approval" system (where you wait months for a government license) to a "post-market surveillance" model. Under the current scheme, you notify the authorities of your intent to sell, and the burden of safety and compliance rests entirely on the company placing the product on the market.

Understanding the ASEAN Cosmetic Directive (ACD)

The ACD is the legal backbone of the AHCRS that harmonizes technical requirements for cosmetic products. It provides a unified set of rules that all 10 member states follow. To successfully navigate the region, you must master its five core pillars.

1. What is Considered ‘Cosmetic’?

The ACD defines ‘cosmetic’ as any substance or preparation intended to be placed in contact with the various external parts of the human body (skin, hair, nails, lips, etc.). This also applies to other areas such as teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting them or keeping them in good condition.

Note: If your product makes therapeutic claims (e.g., "cures eczema" or "treats acne"), it is no longer a cosmetic. It will likely be classified as a drug or "quasi-drug" depending on the specific country's local laws, requiring a far more rigorous registration process.

2. The Ingredient Annexes

ASEAN maintains a harmonized "Negative List" and "Positive Lists" that all signatories adopt into their national law. These are updated regularly by the ASEAN Cosmetic Committee (ACC). The following table summarizes the key regulatory classifications for ingredients:

Regulatory update in 2025: Approved on December 12, 2025, the ASEAN Cosmetic Scientific Body (ACSB), added new prohibited substances in Annex II and tightened restrictions in Annex III and VII. These substances include petroleum derivatives, camphors, and miconazoles. 

Ask our local compliance experts for more information about Ingredients Annexes and new regulations. 

3. Harmonised Labelling Standards

To sell in any ASEAN signatory state, your packaging must speak the language of the law. Indonesia serves as a prime example of localized requirements within this harmonised framework. While the AHCRS allows for English, BPOM mandates that certain information must be provided in Bahasa Indonesia. This specifically includes the product's function, usage instructions, and safety warnings.

The AHCRS mandates that all consumer-facing information must be legible and indelible. These requirements are non-negotiable, as labeling is the primary tool for post-market surveillance and consumer safety. Mandatory requirements include:

• Product Name and Function: The name must not be misleading, and the function must clearly align with the ASEAN cosmetic definition (e.g., "moisturizing lotion" rather than "skin repair treatment").
• Instructions for Use: Clear directions for the consumer to ensure the product is used safely and effectively. This includes specific warnings for products like hair dyes or chemical exfoliants.
• Full Ingredient Listing: Ingredients must be listed in descending order of weight at the time they are added. Crucially, these must use INCI nomenclature (International Nomenclature of Cosmetic Ingredients) to ensure transparency across borders.
• Country of Manufacture: Transparency regarding the origin is vital for supply chain accountability.
• Local Company Details: The label must clearly state the name and address of the local company (the Notification Holder or Importer) responsible for placing the product on that specific market. This ensures authorities have a direct point of contact for audits or safety concerns.
• Manufacturing and Expiry Dates: Products with a durability of less than 30 months must show an expiry date. Batch numbers are also mandatory to facilitate efficient product recalls if a safety issue is identified during post-market surveillance.

4. The Product Information File (PIF)

The PIF is a technical dossier that must be kept at the address of the local distributor/importer and made "readily accessible" to authorities for audits. It seres as the definitive proof of safety and compliance.

It consists of four distinct sections, each requiring meticulous documentation:

Because authorities allow for rapid market entry without pre-market testing, the PIF acts as a comprehensive technical dossier that must be available for immediate audit during post-market surveillance.

5. Good Manufacturing Practice (GMP)

All manufacturers supplying the ASEAN market are mandated to adhere strictly to the ASEAN Guidelines for Cosmetic GMP or an equivalent international standard (ISO 22716). Compliance with these standards ensures that every batch is manufactured under controlled conditions that minimize risks of contamination, mix-ups, or errors. Key components of these guidelines include:

• Personnel and Facilities: Requirements for trained staff and hygienically designed premises that prevent cross-contamination.
• Equipment and Raw Materials: Mandatory calibration of machinery and rigorous incoming inspections for all raw materials.
• Documentation and Internal Audits: A comprehensive system for logging every step of the production cycle, coupled with regular self-inspections to ensure continuous improvement. 

For international brands, providing proof of GMP certification from their home country’s regulatory body is often a prerequisite for the local notification process. Failure to demonstrate GMP compliance can lead to the immediate rejection of your notification or the revocation of your right to sell in the region.

When you register a cosmetic product in a specific jurisdiction, you are required to produce a GMP certificate from your home country's regulatory body. For example, if a US-based organic skin care brand wants to enter Indonesia, they need to provide a ISO 22716 certification (along with a CFS) to BPOM.

Post-Market Surveillance (PMS) & Liability

The AHCRS is built on a foundation of trust, but that trust is strictly verified through a robust Post-Market Surveillance (PMS) system. Health authorities in signatory states such as BPOM in Indonesia or the NPRA in Malaysia, actively monitor the market to ensure ongoing compliance and consumer safety. 

Product Information File (PIF) Audits

Authorities may conduct routine audits where they give notice to inspect your PIF at your local representative's office. During these inspections, they verify that the technical data in the file matches the claims and formulations submitted during notification. If the file is found to be missing or incomplete, the responsible company faces severe legal consequences, including heavy fines and the potential revocation of all product notifications.

Adverse Event Reporting

Liability rests heavily on the "Person Responsible for Placing the Product on the Market." If a consumer experiences a severe adverse reaction, the local representative is legally obligated to report the incident to the national authority. The reporting timelines are strict: serious events (e.g., hospitalization or permanent damage) must be reported within 7 days, while other significant side effects must be disclosed within 15 days. Failure to report these events is a criminal offense in many ASEAN jurisdictions.

Market Sampling and Analysis

Regulators frequently pull products from store shelves or online marketplaces to test them in government laboratories. They screen for prohibited substances (like mercury or steroids) and check for microbial contamination. Any discrepancy between the physical product and the registered notification triggers immediate enforcement action.

Cosmetic Product Registration: A Case Study for Entering Philippines and Thailand

While AHCRS harmonizes technical standards, the administrative process remains national. It allows brands to treat Southeast Asia as a single technical block. This way, you can speed up market entry for multiple jurisdictions within the region.

To better illustrate AHCRS pillars, let's say a European cosmetic company aims to launch its flagship anti-aging serum in Thailand and the Philippines. Under the old system, their product would have needed to submit separate samples for lab testing in both Manila and Bangkok. But with the AHCRS, the company only needs to perform one compliance check.

Here's how the AHCRS can help ease product registration:

1. Unified Formula Audit: the anti-aging serum simply need to follow the same Ingredients annexes since both Thailand and follow the same regulations restrictions.
2. The Master PIF: When notifying the Thai FDA and the Philippines FDA, they can use a single master PIF used the same safety assessments and manufacturing data.
3. Synchronized Notification: Using a local Importer of Record (IOR) in both countries, they can submit notifications simultaneously. Thailand issues an acknowledgment in 5 days; the Philippines will follow shortly after.

Due to unified regulations under the AHCRS, the European cosmetic company can avoid duplicate laboratory fees and save approximately 10 months of lead time.

Emerhub's local compliance experts can help organize product registration so you can seamlessly enter multiple countries at the same time. Our experts are well-versed in both local regulations and the AHCRS so you can enter the market with ease.

Strategy for Foreign Investors: Importer of Record (IOR)

The biggest hurdle for international brands is the requirement for a local entity in every signatory state. Setting up a subsidiary in 10 different countries is an administrative nightmare for most. 

Emerhub’s Importer of Record (IOR) service can help you import cosmetics across multiple countries in Southeast Asia. We act as your local legal representative and notification holder in multiple ASEAN markets simultaneously. Furthermore, we can help manage your PIF maintenance and local health authority audits across your entire Southeast Asian portfolio.

Tell us about your products you want to import into Southeast Asia. Fill out the form below for a free consultation with our local experts in the region.