Regulatory context

The ASEAN Cosmetic Directive regulates the cosmetics market in the following 10 ASEAN member states: Singapore, Brunei Darussalam, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Laos, Cambodia and Myanmar, and defines cosmetics products as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair and scalp, nails, lips or external genital organs) or with the teeth and the mucous membranes of the oral cavity with the exclusive or main intent of cleaning them, scenting them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.”

Any product introduced to the ASEAN market needs an ASEAN dossier and compliance labels. The cosmetics dossier must include the formula information and a safety report.

A notification is also needed for each targeted country. This notification can be performed by the distributor, manufacturer or by a local agent. The company must also have an address in the local market to be appointed as responsible party and to allow the cosmetics brand to introduce the product into this market.

How does it work?

BIORIUS ensures the compliance of cosmetics products according to the requirements of the ASEAN authorities.

The ASEAN regulatory review consists of three services:

1. The formula review, which takes into consideration the specific bans, restrictions and conditions of use implemented in each targeted country.
2. The ASEAN Dossier covering the 10 member states: Singapore, Brunei Darussalam, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Laos, Cambodia and Myanmar.
3. The label review, which must be performed individually for each targeted country.

This assessment is based on the ASEAN Cosmetic Directive Annex II, III, IV, V, VI and VII.

The process is divided into three phases:

Formula Review of the targeted country or countries

A toxicological and regulatory assessment of the ingredients and impurities and establishment of the INCI list as well as the analysis of the required documents regarding the finished product.

At the end of the analysis, a Formula Review Report is issued, which includes a conclusion from the experts and highlights the following elements:

• Ingredients
• Percentage of each ingredient
• Restrictions
• Requested data for the finished product
• INCI list

ASEAN Dossier

1. Safety Report

• Cosmetic product safety information, whose goal is to gather all the necessary information for the safety assessment
• Cosmetic product safety assessment, which sets out the reasoning and the declaration of  safety.

The final warnings to be applied to product labels are determined upon conclusion of the safety report.

2. Dossier compilation

• Part I: Administrative documents and product summary administrative document, qualitative and quantitative formulations, label, safety assessment summary, manufacturing statement, adverse effects and efficacy statement summary
• Part II: Quality data for raw material
• Part III: Quality data for finished product
• Part IV: Safety and efficacy data

Label & Claims Review

Evaluation of the product label (mandatory information, symbols and claims).

Regarding claims, supporting data (including literature review, for claimed benefits of cosmetics products) should be made available to justify the nature of its effect. Based on this information, an efficacy assessment will be performed.

Corrective actions and comments are provided for updating the label.

The labels & claims review is a report with all the information that needs to appear on the labeling material:

• Mandatory elements
• Presence of mandatory elements (primary packaging, secondary packaging & leaflet)
• Symbols
• Claims
• Substantiation
• Comments from the experts – strategic recommendations are provided for updating the label