Philippine FDA Circular Provides Updates and Amendments of the ASEAN Cosmetic Directive

The ASEAN Cosmetics Directive (ACD) is one of the ASEAN Common Technical Documents relevant to the ASEAN Harmonized Cosmetic Regulatory Scheme which was adopted by the Department of Health of the Philippines.?The scheme aims to eliminate trade restrictions as well as to increase cooperation within ASEAN member countries for safety and quality regulation of cosmetic products.?Only cosmetic products that conform to the provisions of the ACD may be sold in the ASEAN member countries.

FDA Circular No. 2023-007 provides a summary of the updates and amendments to the ACD as adopted in the ASEAN Cosmetics Committee Meetings and its related meetings held during November to December 2023.?FDA Circular No. 2023-007 applies to the manufacture, import, export, sale, offering for sale, distribution, donation, transfer, as well as use, testing, promotion, advertisement or sponsorship of cosmetic products.

Annex II of the ACD was amended to provide a summary of banned ingredients were listed, i.e., substances which must not form part of the composition of cosmetic products.?Effective 21 November 2024, only compliant products should be available in the local markets and non-compliant products should be withdrawn.?Perboric acid, Sodium Perborate and Boron compounds Octamethylcyclotetrasiloxane (D4), and 2-(4-tert-butylbenzyl) propionaldehyde (p-BMHCA), are listed as new entries to ACD Annex II.

Annex IV of the ACD lists the colouring agents allowed for use in cosmetic products while Annex VII lists the UV filters which cosmetic products may contain.?The revisions on the entries of Titanium Dioxide in EU Annexes IV and VI into ACD Annexes IV and VII were adopted.

Annex III of the ACD lists down substances which cosmetic products must not contain except subject to restrictions and conditions while Annex VI lists down preservatives allowed for use in cosmetic products.?The corresponding entries for Salicylic Acid were adopted into ACD Annexes III and VI.

Violation of FDA Circular 2023-007 shall be deemed a violation of Republic Act No. 3720 as amended by Republic Act No. 9711.?

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