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. 2005-0015 and 2005-0025, respectively. The harmonization scheme aims to eliminate restrictions to trade of cosmetic products and enhance cooperation within the ASEAN Member States (AMS) in ensuring the safety, quality and claimed benefits of cosmetic products.
Under the ACD, the AMS, through the National Regulatory Authorities (NRA), shall undertake all necessary measures to ensure that only cosmetic products that conform to the provisions of the ACD, its Annexes and Appendices may be placed in the market.
Amidst challenges brought about by the current COVID-19 pandemic, the ASEAN Cosmetic Committee (ACC) Meeting and Its Related Meetings, through the ASEAN Secretariat, were held virtually as follows:
|13-14 October 2021||ASEAN Cosmetic Committee Heads of Delegations (HODs) Meeting|
|05-06 October 2021||34th ASEAN Cosmetic Scientific Body (ACSB) Meeting|
|11-12 October 2021||17th ASEAN Cosmetic Testing Laboratories Committee (ACTLC) Meeting|
|15-16 November 2021||34th ACC Meeting|
To provide the industry with timely and relevant information on standards, rules, and regulations, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR), hereby, reports the highlights of the aforementioned meetings and presents the updates to the ASEAN Cosmetic Directive (ACD) as adopted in the 34th ACC Meeting.
This Circular aims to provide the updates and amendments to the ACD as adopted in the 34th ACC meeting and its related meetings which covers cosmetic products made available in the local market.
This Circular applies to establishments that are engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of cosmetic products.
IV. UPDATES AND AMENDMENTS TO THE ACD
A. Updates and Amendments to the ACD Ingredient Annexes
The following are the updates and amendments on cosmetic ingredients and their restrictions as indicated in the ACD Ingredient Annexes. The latest revision of the ACD Ingredient Annexes is accessible at the FDA website.
For reference, the new and modified entries as well as the given grace period are listed in Annex A.
1. Amendment of Annex II – List of substances which must not form part of the composition of cosmetic products
a. The updated consolidated list of banned substances under EU 2019/1966 and 2019/831, indicating the 119 substances that are not used for cosmetic products in the ASEAN market was presented during the meeting. The list incorporates inputs from all AMS and ASEAN Cosmetics Association (ACA). It was agreed in the meeting to include the 119 substances in ACD Annex II. The AMS except for Vietnam agreed to the following grace period – Effective 06 October 2022 (12 months), only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. Vietnam will seek consultation with her local industry and update in the next Meeting.
b. Thailand and Vietnam gave an update that they will be adopting the option to move Formaldehyde from ACD Annex III, Ref. No. 31 (Restricted Ingredients) to Annex II (Prohibited Ingredient) as previously agreed in the 32nd ACSB Meeting.
2. Amendment of Annex II – List of substances which must not form part of the composition of cosmetic products, Ref. Nos. 1642, 1643 and 1644 and Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. Nos. 330-335, 328 and 329 (EU 2020/1682 and EU 2020/1683)
a. During the 33rd ACSB Meeting, the AMS, except for Singapore, agreed to the ACA proposal to adopt 3 substances namely 1,2,4-Trihydroxybenzene, 4-Amino-3-hydroxytoluene and 2-(4-Amino-2-nitrophenyl-amino-benzoic acid) into ACD Annex II (Prohibited) and the 2 substances namely 2-hydroxyethyl methacrylate and Di-HEMA Trimethylhexyl Dicarbamate into ACD Annex III (Restricted).
In the 34th ACSB Meeting, Singapore informed the Committee on the outcome of their further review of the said EU Regulations and agreed to adopt the with the same grace period as agreed in the 33rd ACSB Meeting.
For Annex II: Effective 28 May 2022 (12 months), only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market.
For Annex III: Effective 28 November 2022 (18 months), only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market.
b. The AMS updated the Meeting on the review of the safety data on substances Reference #s 315-320 under Annex III of EU 2020/1683. Following this, the AMS, except Indonesia, agreed to adopt these substances into ACD Annex III with a grace period of 18 months – Effective 06 April 2023, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. Indonesia will do further review and advise accordingly.
3. Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (Annex VII – List of UV filters which cosmetic products may contain, Ref. No. 31)
ACA presented the safety data on UV Filter 2-ethoxyethyl (2Z)-2-cyano- 2-[3-(3-methoxypropylamino) cyclohex-2-en-1- ylidene] acetate (otherwise known as, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate) to support the proposal to adopt the EU Regulation (2020/1684) and add this ingredient into ACD Annex VII (UV Filter).
In summary, at 3% there is no local and systemic safety issue anticipated for using Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate in cosmetic product as a UV filter and it is a secondary amine which makes the control of generating nitrosamine to be reasonable. In consideration of the safety data presented, it was agreed in the meeting to adopt the revision and add the ingredient into ACD Annex VII, effective immediately.
4. Amendment of Annex III – List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down, Ref. No. 336 and 337 and Annex VI – List of preservatives allowed for use in cosmetic products, Ref. No. 28
During the 31st ACSB Meeting, there are balance substances classified as CMR substances category 2 under EU 2019/831 that need further review. These are the following: trimethylbenzoyl diphenylphosphine oxide (Annex III – restricted ingredient), furfural (Annex III – restricted ingredient) and polyhexamethylene biguanide hydrochloride (Annex V – preservative). While these substances were classified as CMRs under Regulation (EC) No 1272/2008, there are SCCS Opinions which support that these ingredients can be used for certain types of cosmetic products within specific restrictions establishing the conditions laid down for CMRs are fulfilled. Therefore, these substances were incorporated into the EU Annexes as follows:
a. EU Annex III – Diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide (Trimethylbenzoyl diphenylphosphine oxide (TPO) is safe when used as a nail product and added to the list of restricted substances in Annex III for professional use in artificial nail systems with a maximum concentration of 5 %.
b. EU Annex III – 2-Furaldehyde (Furfural) added to the list of restricted substances in Annex III with a maximum concentration of 0.001%.
c. EU Annex V – Polyhexamethylene biguanide hydrochloride (PHMB), (Polyaminopropyl Biguanide) added as a preservative in all cosmetic products, except in applications that may lead to exposure of the end-user’s lungs by inhalation, with a maximum concentration of 0.1%. The conditions set out in Annex V to Regulation (EC) No 1223/2009 should be adapted accordingly.
ACA presented the safety data on PHMB which basically supports the SCCS Opinion on this ingredient, and in turn, requested sufficient grace period for implementation.
In consideration of the above, the AMS except for Indonesia agreed to adopt the revisions into the ACD Annexes III and VI respectively with the grace period of 18 months – Effective 06 April 2023, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. Indonesia will defer her decision until such time that the EU workshop is conducted.
5. Silver Nitrate inclusion in Annex II – List of substances which must not form part of the composition of cosmetic products, Ref. No. A1143
Recalling the 30th and 31st ACSB Meeting agreements to remove Silver Nitrate from Annex III as the intended use is as colorant for eyelashes/eye areas, there is a pending discussion whether this ingredient is used in cosmetics other than colorant or will be moved to ACD Annex II. As noted in the previous Meetings, there are no products in ASEAN except for Thailand, that contain Silver Nitrate.
Following discussions, the AMS except for Thailand agreed to include Silver Nitrate in Annex II with a grace period of 12 months – Effective 06 October 2022, only compliant products shall be made available in the market and non-compliant products shall be withdrawn from the market. Thailand will make internal consultations on the time frame and inform in the next ACSB Meeting.
V. PENALTY CLAUSE
Establishments engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of cosmetic products which are found to be operating in violation of the rules and regulations of FDA shall be subjected to sanctions and penalties as prescribed by Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009.”
VI. SEPARABILITY CLAUSE
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 affected by this updates/amendments, shall remain in full force and in effect.
VII. REPEALING CLAUSE
All other administrative issuances, circulars and memoranda and other regulations which are inconsistent with the remaining and valid provisions of ACD and this update/amendment are hereby withdrawn, repealed and/ or modified accordingly.
This Circular shall take effect after fifteen (15) days after its publication in a newspaper of general circulation and filing with the University of the Philippines, Office of the National Administrative Register.