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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, of the following information which have been adopted during the 35th ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings hosted by the ASEAN Secretariat via video conferencing and held as follows:

Date

Meeting

10-11 May 2022

35th ASEAN Cosmetic Scientific Body (ACSB) Meeting
11-12 May 2022 18th ASEAN Cosmetic Testing Laboratories Committee (ACTLC) Meeting
23-24 May 2022 ASEAN Cosmetic Committee Heads of Delegations (HODs) Meeting
25 & 27 May 2022

35th ACC Meeting

The following are the updates and amendments to the ACD. For reference, the new and modified entries as well as the given grace period are listed in Annex A.

  1. Climbazole (Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. No. 326 and Annex VI – List of preservatives allowed for use in cosmetic products, Ref. No. 32)

Referring to the proposed options provided by ASEAN Cosmetics Association (ACA), Brunei proposed that if foot care products are not extensively used in ASEAN Member States (AMS), removing this product type in the list may be considered. The product mix would then include – shampoo (2% as anti-dandruff) + hair lotion + face cream + hair conditioner (0.5%) with the Margin of Safety (MOS) = 116.

The AMS, except Myanmar, agreed to Brunei’s proposal and adopted the option of the above list of products (without foot care) for the Climbazole entry in ACD Annexes VI and III (0.5% rinse-off hair conditioner) with a grace period of 18 months – Effective 11 November 2023, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. The ACSB Secretary will inform Myanmar on the adoption and request her position.

  1. Titanium Dioxide (Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. No. 338) (EU 2021/850)

Recalling that based on the Scientific Committee on Consumer Safety (SCCS) conclusion, the use of Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm should not be authorized for use in applications that may give rise to inhalation exposure by the end user and added to the list of restricted substances in EU Annex III for use as face products in loose powder form and in hair aerosol spray products. The use of titanium dioxide as colorant (entry 143 of EU Annex IV) and as UV filter (entry 27 of EU Annex VI) are updated to reflect the restricted use.

ACA presented the safety assessment on Titanium Dioxide and highlighted that the CMR 2 classification of the substance is mainly on the inhalation route and not on oral and dermal routes. In their review of the SCCS safety assessment, ACA proposed to adopt the EU amendment for the Titanium Dioxide entry in ACD Annex III with a grace period of 24 months.

The AMS, except Myanmar, agreed to the ACA proposal including the grace period – Effective 11 May 2024, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. The ACSB Secretary will inform Myanmar on the adoption and request her position.

  1. Inclusion of 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one (HEPB) in Annex VI – List of preservatives allowed for use in cosmetic products, Ref. No. 60 (EU 2019/1858)

ACA presented the SCCS safety assessment of 4-(3-ethoxy-4-hydroxyphenyl) butan-2-one (HEPB) as a preservative. With the SCCS assessment affirming the safety via MOS calculation of the substance in oral care and dermally applied products, ACA proposed to adopt the EU amendment and include HEPB as a new entry in ACD Annex VI.

It was agreed in the meeting to adopt the ACA proposal effective immediately. Thailand will implement within the next 6 months as she needs to go through her process of issuing local regulations. The ACSB Secretary will inform Myanmar on the adoption and request her position.

  1. Amendment of Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. Nos. 336, 337 and 330-335 and Annex VI – List of preservatives allowed for use in cosmetic products, Ref. No. 28 (EU 2019/831, EU 2020/1683)

Consistent with the ACSB adoption of EU 2019/831 and EU 2020/1683 respectively, Indonesia updated the AMS on her decision to include the following substances in ACD Annex III – Diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide, 2-Furaldehyde; in ACD Annex VI Polyhexamethylenebiguanide hydrochloride (EU 2019/831) and; in ACD Annex III, substances Ref #s 315-320 (EU 2020/1683), with a grace period of 24 months – Effective 11 May 2024, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market.

  1. Amendment of Annex II – List of substances which must not form part of the composition of cosmetic products, Ref. No. 1657 and Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. Nos. A8 (EU 2021/1099)

a. The AMS, except Myanmar, agreed to the ACA proposal to add the entry of Deoxyarbutin in ACD Annex II with a grace period of 12 months – Effective 11 May 2023, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. It was noted that the ban is already implemented in Indonesia per her local regulation.

b. Additionally, it was agreed in the meeting to adopt the EU Regulation and amend the current entry of Dihydroxyacetone in ACD Annex III, with a grace period of 18 months – Effective 11 November 2023, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. Indonesia also added to reflect “Use for dyeing eyelashes and eyebrows is not permitted” in this entry as this is the standing agreement on use of dyes in ASEAN.

c. The ACSB Secretary will inform Myanmar on the adoption and request her position. 

  1. Amendment of Annex II – List of substances which must not form part of the composition of cosmetic products, No. 573

The AMS agreed to ACA’s proposal to remove CAS # 68171-33-5 from ACD Annex II Entry 573 as this is not included in Regulation (EC) No 1223/2009.

  1. Category 2 Material (Annex II – List of substances which must not form part of the composition of cosmetic products)

It was agreed in the meeting to correct the letter sequencing in ACD Annex II Category Material to reflect (f) instead of the current (g) for “Mixtures of Category 2 material with Category 3 material”.

This announcement shall only serve as a prior notification to the cosmetic industry and shall be subsequently supplemented by an official FDA Circular. The aim of this document is to give the industry sufficient time / grace period to conduct operational activities (i.e. reformulation, testing of new formulations, phase out of products with old formulation, etc.) to ensure continued compliance with the ACD.

Should you have any inquiries and/or clarifications, you may contact us at cchuhsrraseannotification2@fda.gov.ph.

For your information and guidance. Thank you very much.

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