Jul 2021
Cosmetics Regulations in ASEAN countries

The Association of Southeast Asian Nations (ASEAN) is a regional intergovernmental trade group made up of the ten countries in Southeast Asia: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

Since global trade has become more competitive, the ASEAN region has attempted to build a strong economic alliance to enhance trade facilitation. In 2003, the ASEAN member countries recognized the need to put in place regulations as a collective standard and agreed to work together after signing an Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS)[1] to enhance cooperation amongst its member states and share expertise required to facilitate the trade and import of cosmetic products within these countries, and other countries whilst ensuring the safety, quality and claimed benefits of all cosmetic products.[2]

The requirements for cosmetic products were implemented in Singapore in 2008 as the ASEAN Cosmetic Directive (ACD). The ACD is an agreement among ASEAN countries to harmonize the requirements of cosmetic products to establish a common marketplace and reduce technical barriers to trade in the region, as well as other countries.[3] ACD is inspired by the European Union (EU) Cosmetic Regulation 1223/2009 and has used it as a guide in developing their own cosmetics regulations.[4]

The ACD describes cosmetic products as any substance or preparation that is intended to be placed in contact with the various external parts of the human body. This includes the epidermis (the outer and top layer), hair system, nails, lips, and external genitalia. It also covers products that come in contact with the teeth and mucous membranes of the oral cavity for the purpose of cleaning or protecting them or enhancing or correcting odor.[5] Examples of products that could be considered as cosmetic products include creams, emulsions, make-up, perfumes, deodorants, hair cleansing products, and teeth whitening, etc.

All products marketed in ASEAN member states must adhere to the cosmetic regulations of the ACD and its Annexes and Appendices. The common technical requirements under the ACD includes the definition and scope of cosmetics products, a ‘negative list’ of banned ingredients, a ‘restricted list’ of ingredients subject to specified limits, a ‘positive list’ of permitted ingredients (colors, preservatives and UV filters), labeling, product claims, and Good Manufacturing Practices (GMP).

Cosmetic companies supplying cosmetic products are responsible for ensuring that the ingredients used in a product are safe for use and do not contain substances that are prohibited for use. In terms of regulation on cosmetics within the ASEAN member states, cosmetic companies intending to place a cosmetic product on the ASEAN market are required to notify regulatory authorities of each member state individually, where the product will be sold, through an online notification process, for pre-market approval.

A product notification needs to be filed by a registered Responsible Person (RP) from each member state. The RP is appointed to represent the cosmetic product that will be sold within the ASEAN market and is responsible for product safety and must submit safety and technical information if requested from the regulatory authority of the member state. They must also maintain the Product Information File (PIF).[6] A new product notification is required if changes are made to the following: brand name, product name, product type, and formulation of a cosmetic product or changes to the distribution rights of the company. The RP appointed by the cosmetic company could be a manufacturer, importer, a consulting firm, an agent, or a distributor of the cosmetic product within ASEAN.

Similar to the EU cosmetic regulations, each cosmetic product requires a PIF, which will contain the most important information about the finished product. The PIF is a key element that is necessary to place cosmetic products on the ASEAN market. This information serves to identify the cosmetic product, its safety evaluation to confirm the cosmetic product is safe for use and does not cause harm to human health, the full ingredient list of the finished product, the packaging, manufacturing process, and product labeling.[7] There is a mandatory ASEAN Cosmetic labeling requirement.[8] Using the ACD as a guide, labels must be written in English and/or the national language and/or a language understood by the consumer where the product is marketed.[9] The labels on the outer packaging of cosmetic products or, on the immediate packaging of cosmetic products must include:

  1. The name of the cosmetic product and its function (unless it is clear from the presentation of the product).
  2. The full ingredients listing in the correct descending order of concentration and specified using International Nomenclature of Cosmetic Ingredients (INCI) standards. Ingredients considered to be allergens have special labelling requirements.
  3. Country of origin
  4. Instruction of use of the cosmetic product (unless it is clear from the presentation of the product).
  5. Name and address of the RP
  6. Nominal content by weight or volume, in either metric or both metric and imperial system.
  7. The date of minimum durability (expiry date) or period after opening (PAO).
  8. Precautions and warnings
  9. The manufacturer’s batch number.

Under the Regulations, the PIF must also contain documents which demonstrate a cosmetic company’s commitment to GMP for safeguarding the quality and safety of their finished cosmetic products. GMP emphasizes the requirements for cosmetic manufacturers to adopt tools and technologies that are consistent with the standards presently set.[10] Any product claims made in terms of the benefits of cosmetic products must be justified by supporting data, to demonstrate the product’s efficacy and to ensure implied claims will not mislead consumers or exaggerate the effects of their product contents, quality or safety. Cosmetic product claiming to prevent or treat a disease/medical condition are not permitted in cosmetic products or to present such claims in any advertisements for cosmetic products in the ASEAN market region.[11]

Lastly, demonstrating that the cosmetic product is fully compliant with the ASEAN cosmetic regulations, the RP responsible for the product notification must ensure that each manufactured batch of the cosmetic product meets the requirements of the ACD and will not cause damage to human health under any circumstances. This is where the pre-market approval system shifts to a post-marketing surveillance system, to ensure full compliance with the ACD.[12] A part of the post-market controls requires the RP to keeps records of the supply of the cosmetic product and reports must be readily accessible to the regulator of the member state on supporting data for any claims, manufacturing methods, product defects, recall of unsafe products, and adverse effects of the cosmetic products. This ensures harmonized standards in the adverse event reporting process and also facilitates important cosmetic product safety information sharing among ASEAN Regulatory Bodies.[13]

 

[1] Nottage, L., Malbon, J., Paterson, J., & Beaton-Wells, C. (2019). The ASEAN Cosmetics Regulation – Trading Up. In ASEAN Consumer Law Harmonisation and Cooperation: Achievements and Challenges (Integration through Law: The Role of Law and the Rule of Law in ASEAN Integration, pp. 192-204). Cambridge: Cambridge University Press.

[2] ASEAN Cosmetic Regulation | ChemLinked

[3] ASEAN Cosmetic Directive

[4] Regulations in ASEAN Countries

[5] ASEAN Cosmetic Directive

[6] Guidelines on The Control Of Cosmetic Products

[7] https://www.hsa.gov.sg/docs/default-source/hprg/cosmetic-products/appendix-ii-04-september-2007a.pdf

[8]  https://www.hsa.gov.sg/docs/default-source/hprg/cosmetic-products/appendix-ii-04-september-2007a.pdf

[9] cosmetics legislation and product registration - CE.way

[10] Appendix VI  

[11]  Guidelines on the Control of Cosmetic Products

[12] History

[13]https://www.hsa.gov.sg/docs/default-source/hprg/cosmetic-products/guidance/attachment-a---a-guide-manual-for-the-industry---adverse-event-reporting-of-cosmetic-products.pdf

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