COSME LAB

• The ACSB consists of representatives from the regulatory authorities, the industry and the academe.
• The ASEAN Consultative Committee for Standards and Quality (ACCSQ) and the ASEAN Secretariat provide support in coordinating and monitoring the implementation of this Directive and assist the ACC in all matters relating thereto.
• The ACC may establish an ASEAN Cosmetic Scientific Body (ACSB) to assist the ACC in reviewing the ingredient lists, technical and safety issues.
• The ASEAN Cosmetic Committee (ACC) coordinates, reviews and monitors the implementation of this Directive.
• The Governments of Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People's Democratic Republic, Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Vietnam, Member States of the Association of Southeast Asian Nations (ASEAN), have adopted the ASEAN Cosmetic Directive.
• Member States shall undertake all necessary measures to ensure that only cosmetic products which conform to the provisions of the ASEAN Cosmetic Directive may be placed in the market.
• Notwithstanding to Article 4 and without prejudice to Article 5 and Article 11, a Member State may not, for reasons related to the requirements laid down in the ASEAN Cosmetic Directive, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of the ASEAN Cosmetic Directive.
• The company or person responsible for placing the cosmetic products in the market shall notify the regulatory authority responsible for cosmetics of each Member State where the product will be marketed of the place of the manufacture or of initial importation before the product is placed in the market.
• The company or person responsible for placing the cosmetic products in the market shall for control purposes keep the product’s technical and safety information readily accessible to the regulatory authority of the Member State concerned.
• A “cosmetic product” shall mean 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 mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.
• The products to be considered as cosmetic products within the meaning of this definition are listed in Appendix I.
• Cosmetic products containing any substances in Annex V shall be excluded from the scope of this Directive.
• A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product’s presentation, its labeling, instructions for its use and disposal, warning statements as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the market.
• Member States shall allow the marketing of cosmetic products containing substances and other ingredients listed in Annex III, Part 2 within the limits and under the conditions laid down, up to the dates in column(g) of that Annex, colouring agents listed in Annex IV, Part 2, used within the limits and under the conditions laid down, until the admission dates given in that Annex, preservatives listed in Annex VI, Part 2, within the limits and under the conditions laid down, until the dates given in column (f) of that Annex, and UV filters listed in Part 2 of Annex VII, within the limits and un
• Notwithstanding 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 the conditions provided in Article 5.
• Some of these substances may be used in other concentrations for specific purposes apparent from the presentation of the product.
• A decision shall be taken on the basis of the latest scientific and technical knowledge, after consultation, at the initiative of the ACC or of a Member State, as to whether the substance in question may be included in a list of permitted substances (Annex VIII – the ASEAN Handbook of Cosmetic Ingredients) or whether the national authorization should be revoked.
• Before expiry of the three-year period provided for in Article 5, 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 Article 5.
• The Member State shall forward to the ASEAN Secretariat and to the other Member States the text of any authorization decision taken pursuant to Article 5 within two months of the date on which it came into effect.
• The presence of traces of substances listed in Annex II is allowed provided that such presence is technically unavoidable in good manufacturing practice and conforms with Article 3.
• Member States shall prohibit the marketing of cosmetic products containing substances listed in Annex II, substances listed in the first part of Annex III beyond the limits and outside the conditions laid down, colouring agents other than those listed in Annex IV, Part 1, preservatives other than those listed in Annex VI, Part 1, UV filters other than those listed in Annex VII, Part 1, and substances listed in Annex VII, Part 1 beyond the limits and outside the conditions laid down.
• The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.
• Member States shall adopt the Cosmetic Ingredient Listings of the EU Cosmetic Directive 76/768/EEC including the latest amendments.
• The company or person responsible for placing the cosmetic products in the market shall make available to the cosmetic regulatory authority the available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the Certificate of Analysis and the criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria.
• Member States shall take all necessary measures to ensure that product claims of cosmetic products comply with the ASEAN Cosmetic Claims Guideline, appearing as Appendix III.
• The national authorization for cosmetic products remains in force until a decision is taken on the request for inclusion in the list.
• The information referred to in paragraph 1 of this Article must be available in the national language or languages of the Member State concerned, or in a language readily understood by the regulatory authority.
• Member States shall ensure that cosmetic products may be marketed only if the product label is in full compliance with the ASEAN Cosmetic Labeling Requirements appearing as Appendix II and the information required thereunder is in legible and visible lettering.
• The company or person responsible for placing the cosmetic product in the market shall keep the following information 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: 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
• A Member State may, for purposes of prompt and appropriate medical treatment in the event of difficulties, require that appropriate and adequate information on substances used in cosmetic products be made available to the regulatory authority which shall ensure that this information is used only for the purposes of such treatment.
• As a general rule, claimed benefits of a cosmetic product shall be justified by substantial evidence and/or by the cosmetic formulation or preparation itself.
• In general, product claims shall be subjected to national control.
• Special precautions to be observed in use, especially those listed in the column “Conditions of use and warnings which must be printed on the label” in Annexes III, IV, VI, VII and VIII, must appear on the label, as well as any special precautionary information on cosmetic products.
• Member States shall take all necessary measures to ensure that, in labeling, putting up for sale and advertising of cosmetic products, text names, trademarks, pictures and figurative or other signs are not used to imply that these products have characteristics which they do not have.
• The Governments of Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People's Democratic Republic, Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Vietnam, Member States of the Association of Southeast Asian Nations (ASEAN), have adopted the ASEAN Cosmetic Directive.
• Member States shall undertake all necessary measures to ensure that only cosmetic products which conform to the provisions of the ASEAN Cosmetic Directive may be placed in the market.
• The ACSB consists of representatives from the regulatory authorities, the industry and the academe.
• The ASEAN Consultative Committee for Standards and Quality (ACCSQ) and the ASEAN Secretariat provide support in coordinating and monitoring the implementation of this Directive and assist the ACC in all matters relating thereto.
• The ACC may establish an ASEAN Cosmetic Scientific Body (ACSB) to assist the ACC in reviewing the ingredient lists, technical and safety issues.
• The ASEAN Cosmetic Committee (ACC) coordinates, reviews and monitors the implementation of this Directive.