The Association of Southeast Asian Nations (ASEAN) is a regional intergovernmental organization comprising 10 countries in Southeast Asia (namely Brunei Darussalam, Cambodia, Indonesia, Malaysia, Myanmar, Lao PDR, Philippines, Singapore, Thailand and Vietnam), which promotes intergovernmental cooperation and facilitates economic, political, security, military, educational, and sociocultural integration among its members and other countries in Asia.
In order to enhance cooperation amongst Member States in ensuring the safety, quality and claimed benefits of all cosmetic products marketed in ASEAN and eliminate restrictions of trade of cosmetic products amongst Members, ASEAN Ministers signed the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) during the 35th ASEAN Economic Ministers Meeting on 2 September 2003.
The AHCRS lays down the requirements for cosmetic products for all signatory ASEAN Member Countries starting from 1 January 2008. A product produced or marketed in any signatory country and meeting the requirements of AHCRS would be able to enter other signatory countries. The most significant aspect of this harmonized scheme is that all ASEAN Member Countries will move from the traditional and preferred approach of "pre-market approval" to the new approach of "post-market surveillance" for cosmetic products, considered being more effective.
Part 1 Regulatory Framework and Competent Authority
1 Main Cosmetic Regulations
The AHCRS, which has been co-developed with the cosmetic industry, comprises the signed Agreement and its 2 Schedules as follows:
SCHEDULE A: MUTUAL RECOGNITION ARRANGEMENT OF PRODUCT REGISTRATION APPROVAL. The product registration approval in an ASEAN country is recognized in Member Countries, where a mutual recognition arrangement has been agreed upon.” Schedule A is a preparatory stage for Member Countries to proceed to Schedule B but a Member Country can opt to proceed directly to Schedule B.
SCHEDULE B: THE ASEAN COSMETIC DIRECTIVE: PRODUCT NOTIFICATION The manufacturer or the person responsible for placing cosmetic products on the ASEAN market, shall notify the cosmetic regulatory authority of each Member State where the product will be marketed of the place of manufacture or of the initial importation of the cosmetic product before it is placed on the ASEAN market. In most ASEAN countries, this is a transition from a pre-market approval (registration) system to post -market surveillance. All ASEAN countries are committed to implement Schedule B – The ASEAN Cosmetic Directive by January 2008.
The following are the highlights of the ASEAN Harmonized Cosmetic Regulatory Scheme Common Technical Documents. These have been the result of close collaboration between the ASEAN governments and the cosmetic industry with the objective to harmonize cosmetic technical requirements among ASEAN Member Countries for the marketing of safe and quality cosmetic products.
Appendix I (Illustrative List by Categories of Cosmetic Products)
The current ASEAN's illustrative list has been adopted with emphasis that this list is not exhaustive. Products satisfying the definition of cosmetic in the ASEAN Directive (similar to the EU definition) shall be allowed as a cosmetic.
Full Ingredient Listing will become mandatory. The International Nomenclature of Cosmetic Ingredients names (INCI) would be the primary reference for ingredient names on the label. Please refer to the ASEAN labeling requirements for details
There will be no negative or positive list of claims. Claims will be subject to local country control because of difference in languages, interpretations, culture and religions. The definition of a cosmetic product, llustrative List by Category of Cosmetic Products, Ingredient Lists and and the ASEAN Cosmetic Claims Guideline shall be the technical documents that will guide the countries in the review of the acceptability of a cosmetic claim.
Appendix IV (ASEAN Cosmetic Product Registration Requirements)
Appendix V (Asean Cosmetic Import Export Requirements)
Appendix VI (ASEAN Guidelines for Cosmetic Good Manufacturing Practices)
This document has been the result of close collaboration between the regulatory authorities and the cosmetic industry with the objective to provide a simple guideline on Cosmetic GMP that addresses the needs of both the industry and government.
Annexes of the ASEAN Cosmetic Directive
They detail the ingredients that cannot be used in cosmetics as well as listings of permitted preservatives, UV absorbers and colorants.
· Annex II Part 1: List of substances which must not form part of the composition of cosmetic products
· Annex III Part 1: List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down
· Annex IV Part 1: List of colouring agents allowed for use in cosmetic products
· Annex VI: List of preservatives allowed
· Annex VII: List of permitted UV filters which cosmetic products may contain
2 Competent Authority
The ASEAN Cosmetic Committee (ACC) under the ASEAN consultative Committee on Standards and Quality (ACCSQ) has been established since 2003 to conduct the following activities:
Coordinating, reviewing and monitoring the implementation of the Agreement on ASEAN Harmonized Cosmetic Regulatory Scheme, including the ASEAN mutual Recognition Arrangement of Product Registration Approvals for Cosmetics and the ASEAN Cosmetic Directive
Monitoring the implementation of the technical documents and reviewing and updating these documents when necessary
Providing a forum for discussion of issues that may arise concerning the implementation of the Agreement
Considering measures to enhance the operation of the Agreement
The ACC are composed of one official representative from each Member State's regulatory authority responsible for cosmetics and the ASEAN Cosmetic Association (ACA).
The ASEAN Cosmetic Scientific Body (ACSB) has been established to assist ACC in reviewing the safety and technical data of ingredients and making recommendations on other technical and safety issues for adoption by the ACC. The ACSB consists of representatives from the regulatory authorities, the industry and the academe. At present, the ACSB is reviewing the ASEAN Handbook of Cosmetic Ingredients as well as additions to the annexes of the Directive.
The ACC and ACSB meet twice a year to exchange information and draft or implement the amendments to the AHCRS and related technical documents.
Part 2 Cosmetic Products
1 Definition and classification
According to the "Illustrative List by Category of Cosmetic Products", cosmetics refer to any substance or preparation intended to be placed in contact with the external parts of the human body... or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting or keeping them in good condition.
The following types of products are categorized as cosmetics:
Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.)
Face masks (with the exception of chemical peeling products)
Tinted bases (liquids, pastes, powders)
Make-up powders, after-bath powders, hygienic powders, etc.
Toilet soaps, deodorant soaps, etc.
Perfumes, toilet waters and eau de Cologne
Shower preparations (salts, foams, oils. gels, etc.)
Deodorants and anti-perspirants
Hair care products
- hair tints and bleaches.
- products for waving, straightening and fixing,
- setting products,
- cleansing products (lotions, powders, shampoos),
- conditioning products (lotions, creams, oils),
- hairdressing products (lotions, lacquers, brilliantines).
Shaving products (creams, foams, lotions, etc.)
Products for making-up and removing make-up from the face and the eyes
Products intended for application to the lips
Products for care of the teeth and the mouth
Products for nail care and make-up
Products for external intimate hygiene
Products for tanning without sun
2 Company Obligation
2.1 Good Manufacturing Practice (GMP)
All cosmetic products put on the ASEAN market must be manufactured according to the ASEAN GMP Guidelines. The ASEAN Cosmetic GMP contains minimum requirements for personnel, equipment, sanitation and hygiene, etc. to ensure safe and quality products.
The schedule B of AHCRS regulates that the manufacturer or the person responsible for placing cosmetic products on the ASEAN market, shall notify the cosmetic regulatory authority of each Member State where the product will be marketed of the place of manufacture or of the initial importation of the cosmetic product before it is placed on the ASEAN market.
The specific notification requirements and procedures are formulated by each member state.
2.3 Product Information File (PIF)
The company or person responsible for placing the cosmetic product in the market shall keep the PIF readily accessible to the regulatory authority at the address specified on the label.
The PIF requires the following information:
The qualitative and quantitative composition of the product, in case of perfume compositions, the name and code number of the composition and the identity of the supplier
Specifications of the raw materials and finished product
The method of manufacture complying with the good manufacturing practice as laid down in the ASEAN Guidelines
Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure
Existing data on undesirable effects on human health resulting from use of the cosmetic product
Supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect
It is recommended that the PIF is kept for a minimum period of 3 years after the product is last placed in the market.
2.4 Safety Assessment
According to the Article 8 of the ASEAN Cosmetics Directive an assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure is required. This safety assessment shall be performed by a qualified professional defined as the "Safety Assessor".
To ensure the safety of products, a number of issues have to be taken into account, including:
Applying Cosmetic Good Manufacturing Practice Guidelines (ASEAN Cosmetic Directive -Technical Documents) or approved equivalent
Careful selection of cosmetic ingredients, making sure that they will be safe at a given concentration in a given finished product
Checking local tolerance of the finished product
Selection of adequate packaging to maintain the quality of the product and to avoid, as far as possible, risks of misuse or accident
Quality control, mainly microbiological and chemical
Stability studies e.g. to evaluate shelf life, preservative effectiveness (challenge test), compatibility of the product and the packaging, etc
Appropriate labelling - presentation of the product, instructions for use and disposal, warnings (if relevant) and appropriate action to take in case of accident
Adequate procedures in case of side effects with the marketed product - case-by-case treatment, appropriate medical, dermatological, ophthalmological etc., advice as necessary, follow-up of the product on the market and consumer comments, information storing etc. In case of serious adverse event, the procedure must be identical to the ASEAN Cosmetic Committee approved guidelines (Annex I)
Ensuring corrective action/ follow-up, if any visible product change or adulteration is advised from the market place
ASEAN Cosmetic Labeling Requirements Guidelines regulates that the following particulars shall appear on the outer packaging of cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products:
The name of the cosmetic products and its function
Instructions on the use of the cosmetic products
Full ingredient listing
Country of manufacture
The name and address of the company or person responsible for placing the product on the local market
The contents given by weight or volume, in either metric or both in metric and imperial system
The manufacturer's batch number
The manufacturing date or expiry date of the product in clear terms (e.g. month/year)
Special precautions to be observed in use
In cases where the size, shape or nature of the container or package does not permit the above particulars to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap etc. shall be allowed. However, the following particulars at least shall appear on small immediate packaging:
the name of the cosmetic products
the manufacturer's batch number
As a general rule, cosmetic products must only make cosmetic claimed benefits; and not medicinal or therapeutic claimed benefits. Any cosmetic claimed benefits made shall be aligned with what is accepted internationally and shall be justified either by technical data and/or cosmetic formulation or preparation itself. Manufacturers/product owners will be allowed to use their own scientifically accepted protocols/design in generating the technical data provided there is justification why such protocol/design is used.
Part 3 Ingredients
The Annexes of the ASEAN Cosmetic Directive include 5 lists of ingredients that are banned or restricted for use, the positive list of colorants, preservatives and UV filters that are allowed for use in cosmetic products marketed in ASEAN. Company shall refer to these listings during product formulation to ensure products comply with the ASEAN Ingredient Requirements.
The Restricted List indicates ingredients that are allowed for use in cosmetic products but subject to restrictions and conditions. It defines the restrictions on the field of application and/or use, the maximum authorized concentration in the finished product, other limitations and requirements and conditions of use and warning, which must be printed on the labels.
The Negative List indicates ingredients that are NOT allowed for use in cosmetic products. It is usually referred to as the Banned List or defined as the List of Ingredients which must NOT form part of the cosmetic products.
The Positive List indicates ingredients that are allowed for use in cosmetic products. Ingredients outside this list will not be allowed. For ASEAN, the positive lists are for colorants, preservatives and UV filters for cosmetic products.
In addition, ASEAN sets the limits of microbial and heavy metal contaminants to ensure the quality and safety of marketed cosmetics, which are clearly specified in ASEAN Guidelines on Limits of Contaminants for Cosmetics.