Asean cosmetic directive ingredients For a range of colours/shades or products in a single kit, complete the Product Ingredient List in the following format: List ingredients in the Base Formulation FAQ ON INTERPRETATION OF ASEAN COSMETIC GMP ; ASEAN InformationBooklet on AHCRS ; Appendix 6 ASEAN Cosmetic GMP ; Appendix 3 ASEAN Cosmetic Claims Guidelines ; Appendix 2 ASEAN Cosmetic Labeling ; Annex II - List of substances which must not form part of the composition of cosmetic products ; Annex III - List of substances which cosmetic Jul 11, 2022 · The 35th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in May 2022, during which it approved amendments to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD). Safety requirements 4. ASEAN Cosmetic Labeling Requirements 4 v. The Thai Ministry of Public Health (MOPH), through its Food and Drug Administration (FDA), has announced plans to expand the list of substances prohibited in cosmetic formulations by adding 17 more chemical • Ingredients prohibited under the ASEAN Cosmetics Directive in Annex II 1; • Ingredients restricted under the Cosmetics Directive when used beyond the allowed conditions and restrictions laid down in Annex III 1; • Ingredients with toxicological data incompatible with the intended concentration and use; • Ingredients which do not have Understanding ASEAN Cosmetic Regulations. exhaustive. SCOPE AND DEFINITIONS. The amendments include the prohibition of 14 substances as cosmetic ingredients, the establishment of the maximum concentration limits for specific cosmetic ingredients, and some other requirements. For the latest development on cosmetic ingredients, please refer to HSA Check that the ingredients in your cosmetic product comply with the requirements of the Annexes of the ASEAN Cosmetic Directive; Check that your product complies with labelling requirements. In 2005, the Department of Health (DOH) – Food and Drug Administration (FDA), then Bureau of Food and Drugs (BFAD), has adopted and implemented the Association of Southeast Asian Nations (ASEAN) Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents, including the ASEAN Cosmetic Directive (ACD), through Administrative Orders No. Jul 5, 2024 · During the 39th ASEAN Cosmetic Scientific Body (ACSB) Meeting, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient annexes. For the purpose of this document 4. The 37th ASEAN Cosmetic Scientific Body (ACSB) meeting was held on May 8-9, 2023, during which new amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD) were The ASEAN Cosmetic Directive (Contents) 1. The ASEAN Handbook of Cosmetic Ingredients captures ingredients currently regulated differently from the ASEAN Common Ingredient Listings. Dec 17, 2021 · ASEAN has held the 33rd ASEAN Cosmetic Committee Meeting (ACC), during which it adopted changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD). OBJECTIVE. The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to discuss the latest developments in ASEAN cosmetic industry and related regulations, annexes related to ingredients. The changes include adding three prohibited ingredients and two restricted ingredients, and revising the requirements for colorant carbon black and permitted ingredients. Mar 8, 2018 · 29 January, 2018, ASEAN Cosmetics Committee releases the amendments of the ASEAN Cosmetics Directive and bans three fragrance ingredients for use in cosmetics. Cosmetic Ingredient Lists The ASEAN Cosmetic Directive has the following Annexes: Annex II: List of Substances which must not form part of the composition of cosmetic products The harmonisation of cosmetic regulations in the region will benefit all stakeholders: a wider choice of safe cosmetic products for the consumers, simplified regulatory system for the regulatory bodies, and open ASEAN as one single market for manufacturers for the cosmetic industry. ASEAN Cosmetic Claims Guideliness 4 vi. 2005-0015 and 2005-0025 The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with article 6 of this Directive”. Implementation Sep 5, 2006 · exhaustive. No Aminophylline 317-34-0 A1136 Theophylline 58-55-9 A1137 Oct 30, 2024 · 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. : 2021-02 28 December 2021 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 exhaustive. Ingredients listed in Annexes III to VII of the ASEAN Cosmetics Directive do not need This version was adopted at the 26th ASEAN Cosmetic Scientific Body (ACSB) Meeting 2nd-3rd May 2017, Siem Reap, Cambodia and endorsed at the 26th ASEAN Cosmetic Committee (ACC) MEETING 4th - 5th May 2017, Siem Reap, Cambodia. Version No. 007% For eye make-up and eye Jul 8, 2022 · In the 35th ASEAN Cosmetic Scientific Body (ACSB) meeting, ASEAN adopted new changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD): 1) Annex II: List of prohibited ingredients – 1 added and 1 revised 2) Annex III: List of restricted ingredients – 1 added and 10 revised 3) Annex VI: List of permitted preservatives – 1 added and 2 revised meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices. Schedule B or the ASEAN Cosmetic Directive shifts from a pre- market approval system (product registration) to a post marketing I. h) UV filters listed in Annex VII, Part 1 beyond the limits and outside the conditions laid down therein. ASEAN COSMETIC LABELING REQUIREMENTS Page 1 of 3 Annex I, Part 7 ASEAN COSMETIC LABELING REQUIREMENTS A. Information about Cosmetic Ingredients With the increasing numbers of published reports and discussions on the safety concerns of cosmetic ingredients, consumers may often ponder whether the ingredients may present a health hazard. ASEAN Cosmetic Product Registration Requirements/ 4 Procedure (Schedule A) viii. Product Claims 8. These annexes cover a broad range of topics, from prohibited substances to labeling requirements. this Directive. Feb 2, 2023 · In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). Entries 423 to 1136 of EU CD Annex II would be included in ACD Annex II, in addition to the 3 banned ingredients from the ASEAN Handbook of Cosmetic Ingredients. Annex II – List of substances which must not form part of the composition of cosmetic products Version No. 1 ASEAN Updates ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes. Member States shall adopt the Cosmetic Ingredient Listings of the EU Cosmetic Directive 76/768/EEC including the latest amendments. : 2021-02 28 December 2021 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Version No. The ACD ensures product Version No. What is the ASEAN Cosmetic Directive. Apr 12, 2024 · During the 38th ASEAN Cosmetic Scientific Body (ACSB) Meeting held on November 15 and 21, 2023, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient annexes. 3) List of permitted preservatives: 1 entry revised. The document outlines the ASEAN Harmonized Cosmetic Regulatory Scheme, which includes the ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics and the ASEAN Cosmetic Directive. What is Schedule B - the ASEAN Cosmetic Directive? A. : 2023-1, 5th June 2023 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 I. (ACA) consists of organizations from different countries that aim to harmonize and maintain cosmetics regulations, upgrade the standards of technical competence and scientific expertise in the local industries and expand the cosmetics trade in ASEAN. They are composed of the ASEAN National Cosmetic Regulatory Authorities and the ASEAN Cosmetic Association (ACA). The substances marked with the symbol (+) may also be added to cosmetic products in concentration other than those laid down in this ANNEX The definition of a cosmetic product which has been adopted by the ACCSQ Product Working Group on Cosmetics is that of the European Directive. 11 b) The ASEAN Cosmetic Directive appearing as Schedule B of this Agreement. b. Advertisements v. These include certain heavy metals, carcinogenic substances, and specific preservatives. Schedule B - ASEAN Cosmetic Directive 10. For the purpose of this document: Annex VII - List of UV filters which cosmetic products may contain Version No. ASEAN Cosmetic Notification; ASEAN Cosmetic Formula/Label Review; and; ASEAN Cosmetic Compliance Consultation. No Aminophylline 317-34-0 A1136 Sep 11, 2023 · 2003年9月3日，东盟各国签署《东盟统一化妆品监管协定》（Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme, AHCRS），文件中包含《东盟化妆品指令》（ASEAN Cosmetic Directive, ACD）。 In the interest of service, and in order to provide timely dissemination of the updates and amendments to the ASEAN Cosmetic Directive (ACD), the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) hereby informs all cosmetic manufacturers, traders and distributors and other interested stakeholders Sep 20, 2024 · HSA also administers the subsidiary legislation under the HPA. ASEAN continually reviews the safety of these cosmetic ingredients to ensure their safe use in cosmetic products. SCOPE AND DEFINITIONS 1. What is the ASEAN Handbook of Cosmetic Ingredients? A. The objectives are to enhance cooperation on cosmetic safety and quality, and eliminate trade restrictions through harmonization. • Ingredients prohibited under the ASEAN Cosmetics Directive in Annex II 1; • Ingredients restricted under the Cosmetics Directive when used beyond the allowed conditions and restrictions laid down in Annex III 1; • Ingredients with toxicological data incompatible with the intended concentration and use; • Ingredients which do not have Mar 21, 2025 · The ASEAN Cosmetic Directive (ACD), which is based on the EU cosmetics regulation, unifies ASEAN’s cosmetic laws. S 683/2007) are deleted and the following Parts substituted therefor: ASEAN Handbook of Cosmetic Ingredient List of Substances Which Must Not Form Part of the Composition of Cosmetic Products No. 2005-0015 and 2005-0025 Appendix II – ASEAN Cosmetic Labeling Requirements APPENDIX II ASEAN COSMETIC LABELING REQUIREMENTS A. The directive also covers herbal cosmetics, ensuring their compliance with safety and quality standards. Jul 17, 2023 · 2) List of restricted ingredients: 2 entries added. Member states will implement the Directive by 2008 and Annex II Part 1 – List of substances which must not form part of the composition of cosmetic products Version No. Institutional Arrangements 11. ASEAN Guidelines for Cosmetic 4 Good Manufacturing Practice (GMP) iv. : 2020-01 27 Oct 2020 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Dec 17, 2024 · Unpacking the Key Annexes of the ASEAN Cosmetic Directive. I. 2 Overview of ASEAN Cosmetics Directive Implementation The ASEAN Cosmetics Directive (ACD) had already been implemented in some ASEAN Member States (AMS). This directive addresses specifications like labeling, ingredient limitations, and product safety. The tabulation below representing the new and modified entries (highlighted in yellow) of 1. In order to understand the thought processes behind the words it does help to look at the way that the original 1976 definition was modified in 1993. Jan 18, 2019 · Parts I to V of the Third Schedule to the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (G. • The cosmetic notification applicants are responsible for safety, efficacy and quality of products. Member State may provisionally prohibit the marketing of a cosmetic product in its territory or subject it to special conditions, if the Member State finds out that on the basis of a substantiated justification, the cosmetic product, although complying with the requirements of the Directive, represents a hazard to health or for reasons specific to religious or cultural sensitivity. The use of colouring agents, preservatives and UV filters are subject to the conditions specified, if any. History of adoption and endorsement ACSB adoption Reasons date ACC endorsement date 0 7th ACSB Meeting Cosmetic product dealers in Singapore must comply with the cosmetic products regulation, which is in line with the ASEAN Cosmetic Directive. The substances marked with the symbol (+) may also be added to cosmetic products in Jan 1, 2020 · Regulatory Framework for Cosmetics • Vietnam is an ASEAN member state and follows the ASEAN Cosmetic Directive (ACD). 제 2장 아세안 화장품 지침(ASEAN COSMETIC DIRECTIVE) 1. 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 Sep 5, 2006 · exhaustive. 화장품의 정의 및 그 범위 (1) 화장품의 정의 (SCHEDULE B ASEAN COSMETIC DIRECTIVE : ARTICLE 2) Apr 20, 2020 · What kind of products are defined as Cosmetics in ASEAN Cosmetic Directive? The ASEAN Cosmetic Directive defines cosmetic products as: “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the The Association of Southeast Asian Nations, or ASEAN, was established on 8 August 1967 in Bangkok, Thailand, with the signing of the ASEAN Declaration (Bangkok Declaration) by the Founding Fathers of ASEAN: Indonesia, Malaysia, Philippines, Singapore and Thailand. 아세안화장품지침(ASEAN cosmetic directive) 영문 국문 ASEAN Cosmetic Directive 아세안 화장품 지침 ARTICLE 1 General Provisions 1. In February 2001, the ASEAN Cosmetic Association, Inc Feb 4, 2022 · The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) meet twice a year to discuss regulation amendments and harmonization across the region to reduce technical trade barriers. : 2024-2, 6th December 2024 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Jul 11, 2023 · On July 5, 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). Ingredient listings 5. • In-house experience with the particular ingredient and cosmetic products containing it; • Expert judgment based on similarities with chemically related substances. N. The ACD was implemented in Singapore from 1 January 2008. There is an ASEAN Cosmetic labeling requirement which means you need to label your products locally with the name and address of the company or person responsible for placing the product in the local market. Our ASEAN Compliance Services. Cosmetic Ingredient Lists 3 iii. BACKGROUND. 1. 2025-002, which implements updates and amendments to the ASEAN Cosmetic Directive (ACD) as adopted during … The Association of Southeast Asian Nations (ASEAN) consists of 10 countries. 2005-0015 and 2005-0025 ANNEX III - List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down Release Version: 2023-1, 5 th June 2023 ANNEX III the ASEAN Cosmetic Directive is implemented, notification of product will apply. Mar 4, 2024 · On March 4, 2024, the Drug Administration of Vietnam (DAV) issued amendments to the annexes of the ASEAN Cosmetic Directive (ACD). Methods of Analysis 10. ALL COSMETIC MANUFACTURERS, TRADERS, DISTRIBUTORS AND OTHER CONCERNED PARTIES Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings 1. For the purpose of this document: Name of the cosmetic product means the name given to a cosmetic product, ii. : 2019-02 29 Oct 2019 ANNEX VII LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY CONTAIN For the purpose of this Directive, UV filters are substances which, contained in cosmetic sunscreen products, are specifically Southeast Asian Nations (ASEAN) Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents, including the ASEAN Cosmetic Directive (ACD), through Administrative Orders No. The amendments align with the updates made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 40th ASEAN Cosmetic Committee (ACC) meeting 1. 2005-0015 and 2005-0025, respectively. Differences between ASEAN Member States in interpretation of what constitutes a cosmetic product under the ASEAN Cosmetic Directive is a potential source of confusion and a barrier to free trade and innovation. On December 30, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. ARTICLE 11 1. Cosmetic Ingredient Lists The ASEAN Cosmetic Directive has the following Annexes: Annex II: List of Substances which must not form part of the composition of cosmetic products ANNEX III - List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down Release Version: 2023-1, 5th June 2023 Ref No ACD # (EU #) ready for use preparation Substance/CAS No(19) Restrictions Conditions of use and warning which must be printed on the labels Field of application and/or use Appendix II – ASEAN Cosmetic Labeling Requirements APPENDIX II ASEAN COSMETIC LABELING REQUIREMENTS A. org: ASEAN Cosmetics Association FB Page GlobalCosIng is a comprehensive global cosmetic ingredient regulatory database that empowers cosmetic companies and ingredient suppliers with quick access to the latest regulatory statuses of over 40,000 ingredients across key markets, including the EU, USA, China, Korea, and ASEAN. REGULATIONS IN THE ASEAN The ASEAN Cosmetic Directive (ACD) The ASEAN Cosmetic Committee (ACC) has been established since 2003 to coordinate, review and monitor the implementation of the ASEAN Cosmetic Directive (ACD). Adoption of Latest Changes to Annex II of the EU Cosmetics Directive (CD) • It was proposed that ACD Annex II should be updated to include latest additions to the EU CD Annex II. 1-1. ASEAN COSMETIC LABELING REQUIREMENTS A. 2005-0015 and 2005-0025 ASEAN COSMETIC LABELING REQUIREMENTS A. ii. The percentage of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive. ASEAN Cosmetic Documents Appendix III – ASEAN Cosmetic Claims Guidelines Version Date 04 September 2007 Page 2 iii. 2 billion in 2013. They are effective from 23 August 2019 for new cosmetic products and 23 August 2021 for those already available on the market. BACKGROUND AND RATIONALE In 2005, the Department of Health (DOH) — Food and Drug Administration (FDA), The ASEAN cosmetics directive – ingredients list showing positive, negative and restricted list can be found here. During the 40th ASEAN Cosmetic Scientific Body (ACSB) Meeting, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient annexes. Aug 2, 2023 · All ASEAN member countries must incorporate the revised content of the ACD into their national legislation. 2. Products satisfying the definition of cosmetic in the ASEAN Directive (similar to the EU definition) shall be allowed as a cosmetic. The amendments include the prohibition of 15 substances as cosmetic ingredients, the establishment of the maximum concentration limits for three cosmetic ingredients, and some other requirements. ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 Dec 17, 2021 · ASEAN has held the 33rd ASEAN Cosmetic Committee Meeting (ACC), during which it adopted changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD). B. Cosmetic Ingredient Lists The ASEAN Cosmetic Directive has the following Annexes: Annex II: List of Substances which must not form part of the composition of cosmetic products Aug 21, 2024 · Prohibited Ingredients: Products must not contain banned substances as listed in the ASEAN Cosmetic Directive. The product form and the way it is to be used e. Labeling 7. This document provides guidance for labeling requirements of cosmetic products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. The harmonization scheme aims to eliminate restrictions to trade of cosmetic products and a) ASEAN Definition of Cosmetics and Illustrative List by Category of Cosmetic Products; b) ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; d) ASEAN Cosmetic Claims Guidelines; e) ASEAN Cosmetic Product Registration Requirements; f) ASEAN Cosmetic Impoit/Export Requirements The ASEAN Cosmetics Association, Inc. 20. Apr 21, 2025 · On March 4, 2025, the Philippines Food and Drug Administration (FDA) issued FDA Circular No. b) the Member State must carry out an official check on cosmetic products manufactured from the substance or preparation use of which it has authorized; c) cosmetic products thus manufactured must bear a distinctive indication which will be defined in the authorization. For the purpose of this document The 36th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in November 2022, during which it introduced new changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD), including adding 42 prohibited ingredients, as well as amending the use requirements for 1 prohibited ingredient, 4 restricted ingredients, 1 permitted colorant, 3 permitted preservatives, and 1 Version No. As early as 2003, the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS) was adopted and it was fully implemented by ASEAN Member States (AMS) in 2008. : 2024-1, 7th June 2024 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 ii. The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonise requirements of cosmetic products so as to reduce technical barriers to trade in exhaustive. ASEAN Cosmetics Labeling Requirements. : 2022-2, 23rd December 2022 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Sep 18, 2024 · 5. capsule, tablet, injection etc. Member States may take measures as they deem necessary with regard to those products. These include the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (Cosmetic Products Regulations) which sets out rules specifically for cosmetic products. General provisions 2. 2005-0015 and 2005-0025 Registration Approvals for Cosmetic; and (ii) the ASEAN Cosmetic Directive. g. These amendments were approved in the 37th ASEAN Cosmetic Scientific Body (ACSB) meeting, and will officially take effect on May 8, 2025. 2005-0015 and 2005-0025 ii. Product Information 9. ASEAN Handbook of Cosmetic Ingredients 6. Cosmetic Ingredient Lists The ASEAN Cosmetic Directive has the following Annexes: Annex II: List of Substances which must not form part of the composition of cosmetic products ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 Appendix II – ASEAN Cosmetic Labeling Requirements APPENDIX II ASEAN COSMETIC LABELING REQUIREMENTS A. To eliminate restrictions to trade of cosmetic products amongst Member States through adoption and implementation of harmonised technical requirements (ASEAN Cosmetic Directive) After 6 years of negotiation, the ASEAN Agreement on Harmonisation was agreed and signed by ASEAN Economic Ministers on 2nd Sept 2003 in Cambodia by all 10 countries 8 Jul 11, 2022 · The 35th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in May 2022, during which it approved amendments to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD). ingredient in cosmetics. The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonise requirements of cosmetic products so as to reduce technical barriers to trade in the region. After all, she said, the ASEAN Cosmetic Directive (ACD) was “a directive, not a regulation”. The ASEAN Cosmetic Directive (ACD) remains In the ASEAN cosmetics label, the naming of raw materials refers to Appendix A of the ASEAN Cosmetics Directive. These amendments were approved in the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, and will officially take effect on November 21, 2024. Navigating these annexes can be complex, so let’s break down some of the most important ones. : 2023-1, 5th June 2023 ASEAN Cosmetic Documents 2 Annex II Part 1 List of substances which must not form part of the composition of cosmetic products Substances CAS Number Ref. 2) List of restricted ingredients: 2 entries added. In 2003, these countries agreed to harmonize the requirements for cosmetic products in order to facilitate the movement of goods and decrease the trade barriers within the region. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP should be kept in mind. These rules cover several topics, such as notification, contents, labelling, advertising . The meeting concluded that this would ANNEX III - List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down Release Version: 2024-2, 6 th December 2024 ANNEX III Version No. 2005-0015 and 2005-0025 The updated ASEAN Cosmetic Directive (ACD) Ingredient Annexes incorporating the new and amended entries adopted during the 37th ASEAN Cosmetic Committee (ACC) Meeting and its related meetings are posted in the Food and Drug Administration (FDA) website. 1 Substance Aminophylline Country Malaysia, Singapore, Thailand Revised as per August 2015 ASEAN Cosmetic Documents 1 ANNEX VI Directive, the maximum concentration of Hg remains fixed at 0. c. : 2019-01 15 July 2019 ASEAN Cosmetic Documents 2 Annex II Part 1 List of substances which must not form part of the composition of cosmetic products Substances CAS Number Ref. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products. : 2022-2, 23rd December 2022 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Version No. The ASEAN Cosmetic Directive utilizes a series of annexes to detail specific regulations. 3/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. Member States shall undertake all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive, its Annexes and Appendices may be placed in the May 31, 2023 · In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). IFRA Guidelines The meeting considered the proposal to incorporate IFRA guidelines into the ASEAN Cosmetic Directive. This document provides guidance for labeling requirements requirements of cosmetic products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. In their 32nd meeting held in September 2020, the ACSB introduced 9 amendments regarding the prohibition or restriction of cosmetic ingredients and V respectively of the Third Schedule of the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations are allowed to be used in cosmetic products. This means that the ingredient will be subjected to the normal safety assessment requirements covering all other ingredients. Cosmetic Ingredient Lists The ASEAN Cosmetic Directive has the following Annexes: Annex II: List of Substances which must not form part of the composition of cosmetic products Mar 11, 2024 · On March 4, 2024, the Drug Administration of Vietnam (DAV) issued amendments to the annexes of the ASEAN Cosmetic Directive (ACD). : 2023-2, 15th December 2023 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 I. OBJECTIVE 1. The ASEAN Cosmetic Committee (ACC) created the ACSB (ASEAN Cosmetic Scientific Body) with the primary task to review a) ASEAN Definition of Cosmetics and Illustrative List by Category of Cosmetic Products; b) ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; d) ASEAN Cosmetic Claims Guidelines; e) ASEAN Cosmetic Product Registration Requirements; f) ASEAN Cosmetic Impoit/Export Requirements Apr 10, 2025 · As part of ongoing efforts to align with the ASEAN Cosmetic Directive (ACD) and the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS). To ensure the smooth implementation of the Agreement, seven technical documents were developed which include illustrative list of cosmetic products by category; product registration requirements and Dec 24, 2024 · The ASEAN Cosmetic Committee (ACC) and the ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to review and amend the ASEAN Cosmetic Directive (ACD). 1 The detailed amendments are related to 2 prohibited ingredients, 11 restricted ingredients and 3 preservatives, as shown in the tables below (the text in Apr 1, 2025 · Acid Yellow 3 has been included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) and the List of Allowed Colorants in the Safety and Technical Standards for Cosmetics. For the purpose of this document: Name of the cosmetic product means the name given to a cosmetic product, Version No. 1 The detailed amendments are related to 2 prohibited ingredients, 11 restricted ingredients and 3 preservatives, as shown in the tables below (the text in ASEAN Cosmetic Documents Appendix VI – ASEAN Guidelines for Cosmetic Good Manufacturing Practice _____ 1 APPENDIX VI ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE PREAMBLE The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN Cosmetic Directive. Member States may implement the ASEAN Mutual Recognition Arrangement of Product Registration Approvals for Cosmetics, which ASEAN ANNEX II Part 1 – List of Substanc es which Must Not Form Part of the Composition of Cosmetic Products Reference Substance Number 30 1,3-dimethylpentylamine and its salts 21. APPENDIX II. A. Malaysia has updated its cosmetic substances list so it aligns with the revision the ACD passed during the 36th and 37th ASEAN Cosmetics Committee (ACC) meetings held in November last year and May this year. The 37th ASEAN Cosmetic Scientific Body (ACSB) meeting was held on May 8-9, 2023, during which new amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD) were LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN Preamble 1. For the purpose of this document Schedule B – ASEAN Cosmetic Directive ARTICLE 5 ASEAN Handbook of Cosmetic Ingredients 1. Registration No : B1373 Author : ASEAN Secretariat Edition : The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN cosmetic Directive. Specifically, the ASEAN Harmonised Cosmetics Regulatory Scheme (AHCRS) was signed in 2003 and the ASEAN Cosmetic Directive (ACD), which is Schedule Oct 30, 2019 · Ling explained that regulations still vary across all ten ASEAN member states because that factors such as time-lag, translation and overlapping regulations inherently create differences. vi. The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with article 6 of this Directive”. Special Cases 12. 4) List of permitted UV filters: 2 entries revised . During these meetings, authorities generally review the updates from the European Union (EU) and decide whether to implement any bans or revisions to the ASEAN region. ASEAN Cosmetic Documents Appendix VI – ASEAN Guidelines for Cosmetic Good Manufacturing Practice _____ 1 APPENDIX VI ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE PREAMBLE The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN Cosmetic Directive. The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to discuss the latest developments in ASEAN cosmetic industry and related regulations I. • In order for companies to sell cosmetics in Vietnam, they need to submit notification to authorities. ACC agreed. ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 I. Notwithstanding the Article 4, a Member State may authorize the use within its territory of other substances, not contained in the lists of substances allowed, for certain cosmetic Version No. No. This document provides guidance for the labeling requirements of cosmetic products to which Article 6 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. Promotional literature, including testimonials and literature issued by third parties on behalf of the supplier iv. markets in ASEAN with a total value estimated at approximately US$16. Definition and Scope of Cosmetic Product 3. : 2019-02 29 Oct 2019 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 Before expiry of the three-year period provided for in paragraph 1, the Member State may submit to the ACC a request for the inclusion in the list of permitted substances (Annex VIII – the ASEAN Handbook of Cosmetic Ingredients) given national authorization in accordance with paragraph 1. I undertake to abide by the following conditions: Ensure that the product’s technical and safety information is made readily available to the regulatory authority concerned (“the Authority”) and to keep records of the distribution of the products for GlobalCosIng is a comprehensive global cosmetic ingredient regulatory database that empowers cosmetic companies and ingredient suppliers with quick access to the latest regulatory statuses of over 40,000 ingredients across key markets, including the EU, USA, China, Korea, and ASEAN. Ingredients with a content of more than 1% are listed in descending order, and ingredients with a content of less than 1% are listed in any order after the above ingredients. Submitting a product notification: Apply for a Client Registration and Identification Service (CRIS) account. : 2023-2, 15th December 2023 ASEAN Cosmetic Documents 1 ANNEXES OF THE ASEAN COSMETIC DIRECTIVE 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 ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148: secretary@aseancosmetics. wjdiyx fpywyt yet rjjwb fxlg mkmodg opka qvj naltz prgrijr