Asean cosmetic directive ingredients. British Pharmacopeia 3.

Asean cosmetic directive ingredients. United States Pharmacopeia 4.

• Asean cosmetic directive ingredients h) UV filters listed in Annex VII, Part 1 beyond a cosmetic ingredient listing and asean handbook of cosmetic ingredient _____ _____ This document provides guidance for the labeling requirements of cosmetic products to which Article 6 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. 2 Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that ASEAN COSMETIC LABELING REQUIREMENTS . 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 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. ii. Annex VII - List of UV filters which cosmetic products may contain Version No. : 2024-2, 6th December 2024 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. ASEAN Cosmetic Directive; Publications; News & Events; Newsletter; Gallery; Business Opportunities . No Malononitrile 109-77-3 149 Succinonitrile 110-61-2 150 Dinitrophenol isomers 51-28-5/329- 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 Version No. Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 17 Added, 11 Revised, and 1 Deleted . No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24-9 147 Revised as per August 2015 ASEAN Cosmetic Documents 1 ANNEX VI LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN Preamble 1. Apr 12, 2024 . DONE in Phnom Penh, Cambodia on this 2nd day of September in the year Two Thousand and Three, in a single copy in the English language. No Malononitrile 109-77-3 149 Succinonitrile 110-61-2 150 Dinitrophenol isomers 51-28-5/329- ASEAN COSMETIC LABELING REQUIREMENTS A. ASEAN: Cosmetics Ingredient Prohibitions and Restrictions. 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. Parabens 9 iii. importers, distributors and retailers of cosmetic products as well as the suppliers of cosmetic ingredients and packaging materials. ACC agreed. Specifically, the ASEAN Harmonised Cosmetics Regulatory Scheme (AHCRS) was signed in 2003 and the ASEAN Cosmetic Directive (ACD), which is Schedule products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. 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 During the 40th ASEAN Cosmetic Scientific Body (ACSB) Meeting, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient annexes. Antimony is a prohibited ingredient in ASEAN cosmetics and included in Annex II of the ACD. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP should be kept in 3. Illustrative List by Categories of Cosmetics 3 ii. The amendments include: 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. : 2023-2, 15th December 2023 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. I. Registration number Version No. Under the regulation, 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 Version No. Posted on 4th February 2022 24th October 2024 by Anum Qazi. 2535 and ACD were compared • 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 The ASEAN Cosmetic Directive (ACD) is a key component of the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS). • 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 • 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 The provisions of this “Updates and Amendments to the ASEAN Cosmetic Directive (ACD) Ingredient Annexes” are hereby declared separable and in the event of any such provision is/are declared invalid or unenforceable, the validity or enforceability of the remaining portions or provisions including other provisions of the ACD which are not The operation of the ASEAN Harmonized Cosmetic Regulatory Scheme will, no doubt" assist regulators in networking for best practices and ensuring safety for consumers. No Barium salts, with the exception of barium sulphide under the condition laid down in Annex III part 1 reference # 23, and the 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 Version No. For the purpose of this document: Name of the cosmetic product means the name given to a cosmetic product, Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 27 Additions and 5 Revisions During the 40th ASEAN Cosmetic Committee Meeting, amendments were made to the ASEAN Cosmetic Directive (ACD) regarding the ingredient Annexes II, III, and VII. Annex I, for instance, lists prohibited substances, ensuring consumer safety by excluding harmful ingredients from cosmetic formulations. No Metformin (INN) and its salts 657-24-9 147 Isosorbide dinitrate (INN) 87-33-2 148 products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. 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. The ASEAN-EU FTA is still in I. ARTICLE 5. 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 Version No. Annex V of the ASEAN Cosmetic Directive deals specifically with good manufacturing practices (GMP). Ingredients listed in Annexes III to VII of the ASEAN Cosmetics Directive do not need supporting evidence provided that they are used as specified in the Annexes. More Details . 2005-0015 and 2005-0025, respectively. 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 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 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). : 2021-02 28 December 2021 ASEAN Cosmetic Documents 4 Substances CAS Number Ref. This means that the ingredient will be subjected to the normal safety assessment requirements covering all other ingredients. 7. ACA has also helped to define limits on ingredients in matters of great urgency. The Association of Southeast Asian Nations (ASEAN) has agreed to harmonize its cosmetic regulatory scheme. 007% For eye make-up and eye make-up The ASEAN Cosmetic Directive shifts from a pre-market approval system, to a post-marketing surveillance system. The Regulatory Authority will carry out a range of post-marketing monitoring and surveillance activities to ensure compliance with the Directive. Relevant documents: ASEAN Cosmetics Directive Schedule B - The ASEAN Cosmetic Directive: 2 Product Notification B. A few weeks ago, on mid-November, the 27th ASEAN Cosmetic Committee (ACC) meeting occurs in Bandung, in Indonesia. : 2023-1, 5th June 2023 ASEAN Cosmetic Documents 1 Annex II Part 1: List of substances which must not form part of the composition of cosmetic products Version No. Member States may implement the ASEAN Cosmetic Directive ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; d) Information about cosmetic ingredients 8 Ingredients in the news: Fact or Fallacy? i. 007% For eye make-up and eye make-up remover only - Contains thiomersal . 2 Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that compliance with the provisions of the ASEAN Cosmetic Directive. These amendments were approved in the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, and will officially take effect on November 21, 2024. ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. Jump to a section of the page . markets in ASEAN with a total value estimated at approximately US$16. The Annexes of the ASEAN Cosmetic Directive include 5 lists of ingredients that ment the ASEAN Cosmetic Directive by 1st January 2008. 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 details allowed colorants, providing a clear framework for ASEAN Cosmetic Documents Appendix III – ASEAN Cosmetic Claims Guidelines Version Date 04 September 2007 Page 2 iii. Thus it should not be intentionally added into cosmetic products. ( I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Southeast Asian Nations (ASEAN) Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents, including the ASEAN Cosmetic Directive (ACD), through Administrative Orders No. HTML; PDF; Word; Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007. 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, Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in active 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 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 Revision as per August 2015 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product GMP 3. exhaustive. No Dextropropoxyphene (INN) 469-62-5 116 O,O’-Diacetyl-N-allyl-N-normorphine; Diacetylnalorphine 2748-74-5 117 Pipazetate (INN) and its salts 2167-85-3 118 The provisions of this “Updates and Amendments to the ASEAN Cosmetic Directive (ACD) Ingredient Annexes” are hereby declared separable and in the event of any such provision is/are declared invalid or unenforceable, the validity of enforceability of the remaining portions or provisions including other provisions of the ACD which are not Understanding ASEAN Cosmetic Regulations. On Jan. OBJECTIVE . 20. The main resolutions voted on the last day were about cosmetic ingredients listed in annexes of ASEAN Cosmetic Directive. Information about cosmetic ingredients 8 Ingredients in the news: Fact or Fallacy? i. 14993/QLD-MP on the Updates of the Substa The objects of this book are to provide an overview of the cosmetic regulations in ASEAN and also educate on the safe use of cosmetic products and their ingredients. Preservatives are substances which may be added to cosmetic products for the primary purpose Directive, the maximum concentration of Hg remains fixed at 0. FOURTH SCHEDULE Standard References Used for Cosmetic Ingredient Nomenclature. The 29th ASEAN Cosmetic Scientific Body (ACSB) Meeting was held in Singapore in October 2018, during which it decided to amend and append cosmetic ingredients listed in the annexes of ACD. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24-9 147 compliance with the provisions of the ASEAN Cosmetic Directive. 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 Member States may implement the ASEAN Cosmetic Directive earlier than the date referred in Paragraph 3 of this Article and this Directive shall be effective as of the date when and between the Member States who may accede thereto beginning 1st January 2003. A. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24-9 147 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 Version No. Author: ASEAN Secretariat: Barcode: 000000001653> 000000001654> 000000001655> 000000012015> Edition: Place: Jakarta: As a member state of ASEAN, Vietnam fully implemented the ASEAN Cosmetic Directive (ACD) by the release of Circular 06/2011/TT-BYT Providing Cosmetic Management on January 25 th, 2011. Advertisements v. International Cosmetic Ingredient Dictionary 2. 8314/QLD-MP on July 28, 2023, to announce the updated use requirements for cosmetic ingredients. Grace Wang. The annexes of the ASEAN Cosmetic Directive are crucial for anyone involved in the cosmetics industry within the ASEAN region. British Pharmacopeia 3. 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 Annex II Part 1 – List of substances which must not form part of the composition of cosmetic products Version No. No Dextropropoxyphene (INN) 469-62-5 116 O,O’-Diacetyl-N-allyl-N-normorphine; Diacetylnalorphine 2748-74-5 117 Pipazetate (INN) and its salts 2167-85-3 118 Annexe III: List of Substance Which Cosmetic Products Must Not Contain Except Subject to Restriction and Condition Laid Down: June-24: Annexe IV: List of Colouring Agent Allowed for Use in Cosmetic Products: Dec-23: Annexe V: List of Excluded from the Scope of the Directive: May-10: Annexe VI: List of Preservatives which Cosmetic Products May 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, The 32 nd ASEAN Cosmetic Scientific Body (ACSB) Meeting was held in September 2020, during which it adopted 9 changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD). The 10 nations that are part of the ASEAN group include Brunei , Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam(see Table 1). Cosmetic Ingredient Lists 3 What are the ASEAN Cosmetic Ingredient Listings? 13 How do I use them? What is a restricted List? What is a Negative List? What is a Positive List? 21. SCOPE AND DEFINITIONS 1. The Regulatory full ingredient listing (one can use “may contain” to list the colorants used in each product in the palette) and the percentage of restricted substances will have to be declared for each colour in the range or ASEAN Cosmetics Directive 20 3. ACSB has imposed restrictions on the substance 1-(4-chlorophenoxy)-1 (imidazole-1-yl)-3,3-dimethylbutan-2-one (INCI: Climbazole). 2 billion in 2013. 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 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 Version No. : 2022-2, 23rd December 2022 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. 1. (Lippia citriodora Kunth. Ingredients from human placenta must be declared specifically on the product label. 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 products specified in its national authorization, subject to I. The presence of antimony as trace impurity is subject to 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 of ingredients of cosmetic products and/or methods for checking compliance with In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). SCOPE AND DEFINITIONS . vi. Vision. Cosmetic and Personal Care. (Annex VIII – the ASEAN Handbook of Cosmetic Ingredients) given national authorization in accordance with paragraph 1. The new common cosmetics legislation came into force in 2008. No Isosorbide dinitrate (INN) 87-33-2 148 Malononitrile 109-77-3 149 Succinonitrile with the provisions of the ASEAN cosmetic Directive. 2 Recommended PIF format In view of the above ACD requirements, companies placing products in the market ASEAN COSMETIC LABELING REQUIREMENTS Page 1 of 3 Annex I, Part 7 products to which Article 6 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. It has held dialogue sessions, and organize activities like this workshop. Talc 9 iv. ment the ASEAN Cosmetic Directive by 1st January 2008. IFRA Guidelines The meeting considered the proposal to incorporate IFRA guidelines into the ASEAN Cosmetic Directive. Annex III : List of Substances which cosmetic products must not contain except subject to restriction and conditions laid 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 Annex II – List of substances which must not form part of the composition of cosmetic products Version No. The tabulation below representing the new and modified entries (highlighted in yellow) of 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: Name of the cosmetic product means the name given to a ASEAN adopted significant changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD), including adding 223 prohibited ingredients, 8 restricted ingredients, 1 permitted preservative and 1 permitted UV Filter, as well as amending requirements for 3 prohibited ingredients and 3 restricted ingredients. No Isosorbide dinitrate (INN) 87-33-2 148 Malononitrile 109-77-3 149 Succinonitrile At present, the ACSB is reviewing the ASEAN Handbook of Cosmetic Ingredients as well as additions to the annexes of the Directive. Manufacturer's Licence application Guidance on PRISM Application for Active Ingredients Manufacturer's Licence and GMP Certificate 1739 KB Directive, the maximum concentration of Hg remains fixed at 0. : 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 This study was conducted to determine whether Thailand has complied with ASEAN Cosmetic Directive (ACD) after 5 years of implementation in 2012. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24 ment the ASEAN Cosmetic Directive by 1st January 2008. 4. For the purpose of this document: Name of the cosmetic product means the name given to a complied with ASEAN Cosmetic Directive (ACD) after 5 years of implementation in 2012. The changes align with the updates to the ASEAN Cosmetics Directive (ACD) passed by the 37th ASEAN Cosmetic Scientific Body (ACSB) meeting. Formaldehyde 10 v. Products satisfying the definition of cosmetic in the ASEAN Directive (similar to the EU definition) shall be allowed as a cosmetic. accordance with the ASEAN Cosmetic Directive to facilitate the development of a quality management system by manufacturers 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 Version No. International Cosmetic Ingredient Dictionary; 2 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 Version No. Select All Clear All. The changes include adding three prohibited ingredients and two restricted ingredients, and revising the requirements for colorant carbon black and permitted ingredients. 2 Overview of ASEAN Cosmetics Directive Implementation The ASEAN Cosmetics Directive (ACD) had already been implemented in some ASEAN Member States (AMS). At the same time, it shall supply supporting documents The ASEAN Cosmetic Directive shifts from a pre-market approval system, to a post-marketing surveillance system. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24 ingredient in cosmetics. As early as 2003, the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS) was adopted and it was fully implemented by ASEAN Member States (AMS) in In-house experience with the particular ingredient and cosmetic products containing it; Expert judgment based on similarities with chemically related substances. Phthalates 8 ii. Australian cosmetic regulations 24 4. Content analysis and in-depth interview was The cosmetics ingredients were a part of the harmonised areas because they impact directly on the safety of with the provisions of the ASEAN cosmetic Directive. 12, 2023, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. The harmonization scheme aims to eliminate restrictions to trade of cosmetic products and - cosmetic Good Manufacturing Practices (GMP) Antimony, one of such possible trace impurities, is a naturally occurring heavy metal. : 2019-02 29 Oct 2019 ASEAN Cosmetic Documents 6 Substances CAS Number Ref. 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. 2 Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that On 22 December 2021В the Drug Administration of Vietnam (DAV), under the Ministry of Health, published Letter No. Concerning ingredients, at each meeting, the last evolutions of European regulation are commented and the These Regulations are the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) (Amendment) Regulations 2024 and come into operation on 1 November 2024. Thai cosmetics Act B. ÐÏ à¡± á> þÿ Arsenic (As) NMT 5mg/kg or 5 mg/L (5 ppm) when tested by ASEAN Cosmetic Method Cadmium (Cd) NMT 5 mg/kg or 5 mg/L (5 ppm)** when tested by ASEAN Cosmetic Method The test method for Mercury, Lead, Arsenic and Cadmium follows ACMTHA05 that has been adopted in the 8th ACSB Meeting (10 - 11 December 2007, Viet Nam). United States Pharmacopeia 4. For purposes other than preservation, the substance may only be used in anti-dandruff rinse shampoos up to a concentration of 2%. Chemical Abstract 14 IN WITNESS WHEREOF, the undersigned, being duly authorized by their respective Governments, have signed this Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme. Promotional literature, including testimonials and literature issued by third parties on behalf of the supplier iv. OBJECTIVE 1. : 2024-1, 7th June 2024 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria” 2. capsule, tablet, injection etc. The product form and the way it is to be used e. Chemical Abstract ASEAN COSMETIC LABELING REQUIREMENTS A. These amendments will officially take effect on May 8, 2025. The tabulation below representing the new and modified entries (highlighted in yellow) of This document provides guidance for labeling requirements requirements of cosmetic products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) meet twice a year 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, The updated ASEAN Cosmetic Directive (ACD) Ingredient Annexes incorporating the new and amended entries adopted during the 38th ASEAN Cosmetic Committee (ACC) Meeting and its related meetings are posted in the Food and Drug Administration (FDA) website. This decision went into effect in January 2008. • ASEAN FTA negotiations underway include the ASEAN-China MOU, the ASEAN-Japan Comprehensive Economic Partnership, the ASEAN-Republic of Korea Trade in Goods Agreement and the ASEAN-Australia/New Zealand FTA. Full ingredient listing (as per labeling requirements) and the Drug Administration of Vietnam (DAV) released official letter No. Technical Documents i. No Isosorbide dinitrate (INN) 87-33-2 148 Malononitrile 109-77-3 149 Succinonitrile 110-61 exhaustive. This legislation is called the ASEAN Cosmetic 3. The 35th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in May 2022, during which it introduced new changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD), including adding 1 prohibited ingredient, 1 restricted ingredient, 1 permitted preservative, as well as amending requirements for 1 prohibited ingredient, 10 restricted ingredients and 2 Malaysia Amends Cosmetic Ingredient Use Requirements. : 2019-01 15 July 2019 ASEAN Cosmetic Documents 6 Substances CAS Number Ref. 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 1. The tabulation below representing the new and modified entries (highlighted in yellow) of On the local level, CTFAS has worked with H S A to help and guide members to adopt the Asean commonly adopted Asean Cosmetic Directive. : 2023-1, 5th June 2023 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. OVERVIEW product under the ASEAN Cosmetic Directive is a potential source of confusion and a barrier to free trade and innovation. 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 The Association of Southeast Asian Nations (ASEAN) consists of 10 countries. P-phenylenediamine (PPD) 11 The ASEAN Cosmetic Directive (ACD) The ASEAN Cosmetic Committee (ACC) has been established since 2003 to coordinate, review and monitor the The provisions of Article 3 of the ASEAN Cosmetic Directive stipulates that A cosmetic product put on the market must not cause damage to the human health when applied under normal or reasonably foreseeable condition of use taking into account in particular of the product presentation, Cosmetic ingredients are mostly chemicals and often 14 IN WITNESS WHEREOF, the undersigned, being duly authorized by their respective Governments, have signed this Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme. Ling stressed that the ingredient annexes go through updates at least twice a year and cosmetic companies needed to ensure that they have the most updated information. Member States may implement the ASEAN Cosmetic Directive ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; d) The provisions of this “Updates and Amendments to the ASEAN Cosmetic Directive (ACD) Ingredient Annexes” are hereby declared separable and in the event of any such provision is/are declared invalid or unenforceable, the validity or enforceability of the remaining portions or provisions including other provisions of the ACD which are not ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 On March 4, 2024, the Drug Administration of Vietnam (DAV) issued amendments to the annexes of the ASEAN Cosmetic Directive (ACD). At the same time, it shall supply supporting documents Takehome: Entries of cosmetic prohibited ingredients and permitted UV filter in ASEAN Cosmetic Directive (ACD) have been updated at the 29th ACSB Meeting. ) and derivatives other than absolute Verbena, when used as a fragrance ingredient: 451: Methyleugenol except for normal content in the natural essences In Singapore, the “Health Products (Cosmetic Products — ASEAN Cosmetic Directive) (Amendment) Regulations 2024” (hereinafter referred to as the “Amendment Regulations”) were promulgated on October 25, 2024. Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection; Protection of human health or safety; Harmonization 8. ASEAN Cosmetic Committee 6th Meeting - 15/16 June 2006 Siem Reap, Kingdom of Cambodia Claims Guidelines. For the purpose of this document: List of Standard References to be used for Cosmetic Ingredient Nomenclature 1. However, if required by the regulatory authority, full ingredient listing (one can use “may contain” to list the colorants used in each product in the palette) and the percentage of restricted substances will have to be ASEAN Cosmetic Definition, the ASEAN Cosmetic Ingredient Listings and the ASEAN Cosmetic Claims Guidelines to fully assess whether your product will be classified as cosmetic. 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 ASEAN has held the 33rd ASEAN Cosmetic Scientific Body (ACSB) meeting, during which it adopted changes to cosmetic ingredients in the Annexes of ASEAN Cosmetic Directive (ACD). Annex II Part 1 – List of substances which must not form part of the composition of cosmetic products Version No. P-phenylenediamine (PPD) 11 The ASEAN Cosmetic Directive (ACD) The ASEAN Cosmetic Committee (ACC) has been established since 2003 to coordinate, review and monitor the The 34th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in October 2021, during which it introduced significant changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD), including adding 223 prohibited ingredients, 8 restricted ingredients, 1 permitted preservative and 1 permitted UV Filter, as well as amending requirements for 3 This document provides guidance for labeling requirements requirements of cosmetic products to which Article 5 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. The ASEAN Cosmetic Directive (ACD)is an agreement among ASEAN countries to harmonise requirements of cosmetic products so as to reduce technical See more For ingtedients from bovine and porcine origin, the exact animal must be declared. The ASEAN Cosmetic Directive is the law regulating cosmetic products in ASEAN countries. BACKGROUND. 1/2023 Information on the Updated Status of Ingredients in the 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 Version No. These amendments were approved in the 36th ASEAN Cosmetic Scientific Body (ACSB) meeting, ASEAN COSMETIC LABELING REQUIREMENTS . 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. The amendments to the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations have been published on 13 Jan 2023; Updates to lists of regulated cosmetic ingredients; Contact RegASK to get prepared for potential cosmetics regulatory changes in Asia . No Barium salts, with the exception of barium sulphide under the condition laid down in Annex III part 1 reference # 23, and the 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 approved. Print . 2 Household products containing non-hazardous materials/ingredients and cosmetic products can share the same premises and equipment provided that 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 (EU #)---products - exhaustive. Chemical Abstract 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 Version No. Full ingredient listing. It was introduced to establish uniform safety and quality standards for cosmetics across ASEAN member states, including Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Laos, Singapore, the Philippines, Brunei, and Timor-Leste. The meeting concluded that this would 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 Version No. No Malononitrile 109-77-3 149 Succinonitrile 110-61-2 150 Dinitrophenol isomers 51-28-5/329- Cosmetic Directive ASEAN Handbook of Cosmetic Ingredients. No Metformin (INN) and its salts 657-24-9 147 Isosorbide dinitrate (INN) 87-33-2 148 of cosmetic products which covers cosmetic products made available in the local market. For the purpose of this document Listed of Standard References to be use for Cosmetic Ingredient Nomenclature 1. : 2020-01 27 Oct 2020 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. Member States may implement the ASEAN Cosmetic Directive ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; d) ASEAN Cosmetics Association Room 306, Parc 15th Avenue Condomium, 226 15th Avenue, Barangay San Roque, Cubao, Quezon City, Philippines 1109 +632-8912-5148 The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria” 2. 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 Navigating Annex V of the ASEAN Cosmetic Directive: A Closer Look. g. New Zealand cosmetic regulations 31 approach which focuses on the safety and control of banned or restricted ingredients, through positive lists, product notification, and the requirement to have a safety assessment and to keep a technical file. E. This document provides guidance for the labeling requirements of cosmetic products to which Article 6 of the ASEAN Cosmetic Directive 05/01/ACCSQPWG apply. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24-9 147 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. 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 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 Annex II – List of substances which must not form part of the composition of cosmetic products Version No. For the purpose of this document: Name of the cosmetic product means the name given to a cosmetic product, Although the objective of the ASEAN Cosmetic Directive is to harmonise regulations across the region, several key differences still pose challenges to entering certain markets. 2 Recommended PIF format In view of the above ACD requirements, companies placing products in the market The ASEAN Cosmetic Directive shifts from a pre-market approval system, to a post-marketing surveillance system. To ensure the smooth implementation of the Agreement, seven technical documents were developed ASEAN Cosmetic Ingredient Listings and ASEAN Handbook of Cosmetic Ingredients; c) ASEAN Cosmetic Labeling Requirements; In January 2023, ASEAN introduced the latest amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). ln turn, this will assist the cosmetic industry in reducing the cost of doing business and gaining market access for its products in ASEAN and international markets. : 2022-1 22 June 2022 ASEAN Cosmetic Documents 1 Annex II Part 1: List of substances which must not form part of the composition of cosmetic products 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 Member States shall adopt the Cosmetic Ingredient Listings of the EU Cosmetic Directive 76/768/EEC including the latest amendments. No Amitriptyline (INN) and its salts 50-48-6 146 Metformin (INN) and its salts 657-24-9 147 Registration Approvals for Cosmetic; and (ii) the ASEAN Cosmetic Directive. We aim to be the most trusted, leading cosmetics industry regional association in promoting consumer protection and enhancing industry competitiveness 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 Revision as per August 2015 ASEAN Cosmetic Documents 7 Substances CAS Number Ref. Revised based on agreement of 17th ACSB Meeting ASEAN Cosmetic Documents162 (10) For non . Status: (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 and shall come into operation on 1st January 2008. 2535 and ACD were compared in 2008, and in 2012. CURRENT STATUS - 1 cleansers containing harsh ingredients such as kerosene, etc) identified by ACC • The updated ASEAN Trade Facilitation Work Program was endorsed by the 53rd CCCA. wac qltmst qkti lzuyoh yycpm dqeauk ohjte pmcg ouqko fsxcob