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1.   BACKGROUND AND RATIONALE

In 2005, the Department of Health (DOH) - Food and Drug Administration (FDA), then called Bureau of Food and Drugs (BFAD), has adopted and implemented the ASEAN Harmonized Cosmetic Regulatory Scheme and the ASEAN Common Technical Documents through Administrative Orders No. 2005-0015 and 2005-0025, respectively. The harmonization scheme involves the conduct of alignment meetings for the purpose of eliminating trade barriers and enhancing cooperation within the ASEAN Member States (AMS) in ensuring the safety, quality and claimed benefits of cosmetic products.

On  1-4  May  2018,  the  ASEAN  Cosmetic  Committee  (ACC)  convened  in Vientiane, Lao PDR for the 28th ACC, 28th ASEAN Cosmetic Scientific Body (ACSB) and 11th ASEAN Cosmetic Testing Laboratories Committee (ACTLC) Meetings. As part of our continuous commitment to provide timely and relevant information on standards, rules, and regulations, the Center for Cosmetics Regulation and Research (CCRR) of the FDA hereby reports the highlights of the aforementioned meetings and presents the updates to the ASEAN Cosmetic Directive (ACD).

2.   OBJECTIVE AND SCOPE

This Circular aims to provide the updates and amendments to the ACD as adopted in the 28th ACC meeting and its related meetings which covers cosmetic products made available in the local market. This Circular shall guide 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.

3.    UPDATES AND AMENDMENTS TO THE ACD

3.1 Updates and Amendments to the ACD Ingredient Annexes

The  following  items  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 are accessible at the FDA website.

For easy reference, a table of the new and modified entries as well as the given grace period is provided in Annex A.

3.1.1 Thioglycolic Acid and Thiolactic Acid (ACD Annex III Ref. Nos. 2a and
A9 respectively)

3.1.1.1 The Meeting agreed to revise an existing restriction in both Thioglycolic acid and Thiolactic acid entries in ACD Annex III to provide further clarification on the combination use of these ingredients.

3.1.1.2  The restriction is changed from “Percentages calculated as total thioacids, i.e. either singly (thiolactic acid or thioglycolic acid alone) or combination of thiolactic acid and thioglycolic acid in a given formula” to  “For general use of hair waving or straightening products the maximum concentration for combination of Thioglycolic acid and Thiolactic acid must not exceed 8% calculated as Thioglycolic acid.”

3.1.2  EU 2013/344 (ACD Annex III Ref. Nos. 103 to 184 and 186)

3.1.2.1  ACD Annex III Ref. Nos. 103 to 184 and 186 will continue to be “intentionally left blank” after the Meeting agreed that there was no need to make changes in the annex.

3.1.2.2 This resulted after the discussion on EU 2013/344 which determined that chemicals in EU 2013/344 (Ref. Nos. 103- 184, 196) are commonly used fragrance ingredients and are already   controlled   by   IFRA   standards   while  the   other chemicals in the EU regulation including Diethylene Glycol (Ref. No. 186, CAS No. 111-46-6) are already included in ACD Annex II or Annex III.

3.1.3  EU 2017/237

3.1.3.1  The meeting agreed to include the following new entries into
Annex III:

3.1.3.1.1  N,N’-Bis(2-Hydroxyethyl)-2-Nitro-p- Phenylenediamine (Ref. No. 8c)
3.1.3.1.2  2,6-Dihydroxyethylaminotoluene (Ref. No. 9b)

3.1.3.1.3  HC Red No. 17 (Ref. No. 314)

3.1.3.1.4  HC Yellow No. 17 (Ref. No. 315)

3.1.3.1.5  1-Hexy14,5-Diamino  Pyrazole  Sulfate  (Ref.  No 316)

3.1.3.1.6  2, 5, 6-Triamino-4-Pyrimidinol (Ref. No. 317)

3.1.3.1.7  Hydroxyethoxy  Aminopyrazolopyridine  HCI  (Ref. No. 318)

3.1.3.1.8  3-Amino-2,6-Dimethylphenol (Ref. No. 319)

3.1.3.1.9  Basic Brown 17 (Ref. No. 320)

3.1.3.1.10 Basic Blue 124 (Ref. No. 321)

3.1.3.2  Effective  01 December 2019, only compliant products can be placed in the market, and non-compliant products must be completely withdrawn from the market.

3.1.4  EU 2017/1410

3.1.4.1 During the 27th ACC Meeting and its Related Meetings, all ASEAN Member States (AMS) with the exception of Indonesia has agreed to adopt EU 2017/1410 and include entries for (a) Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde or Lyral, (b) 2,6-Dihydroxy-4-methyl-benzaldehyde or Atranol, and (c) 3- Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde    or Chloroatranol into ACD Annex II.

3.1.4.2 During the 28th  ACC Meeting and its Related Meetings, Indonesia informed the Meeting that following its review of adverse events associated with Lyral, Indonesia has decided to adopt the same implementation date as agreed to by the other nine (9) AMS. Effective  23 August 2021, no cosmetic product with the banned materials can be placed in the market in Indonesia and non-compliant products must be completely withdrawn from the market.

3.1.5  EU 2017/1413, Zinc Oxide (Annex IV Color Index 77947)

3.1.5.1  Following the adoption of a new restriction for Zinc Oxide in Annex IV (Color Index 77947) -  not be used in applications that may lead to exposure of the end-user’s lungs by inhalation,  the  Meeting  discussed  that  expert  risk assessment based on multiple factors is needed to determine whether product use may lead to exposure of the end-user’s lungs by inhalation.

3.1.6  ACD Annex II Ref. No. 307

3.1.6.1  The Meeting agreed to revise ACD Annex II Ref. No. 307 to clarify the scope of the entry.

3.1.6.2  The entry is changed from Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H- atoms of the -NH2 groups) and their salts to “Sulphanilamide and  its  derivatives  obtained  by  substitution  of  one  or more H-atoms of the -NH2 groups, and their salts.”

3.1.7  EU 2017/2228

3.1.7.1  The Meeting with the exception of Indonesia agreed to include Peanut Oil and Hydrolyzed Wheat Protein in ACD Annex III.

3.1.7.2  Effective  01 December 2019, only compliant products can be placed in the market, and non-compliant products must be completely withdrawn from the market.

3.2 1,4-Dioxane

Following  the  discussion  on  1,4-Dioxane  as  trace  impurity,  the  Meeting agreed to adopt a maximum trace limit of 25 parts per million (ppm) in finished cosmetic products. The ASEAN Guideline for Limits of Contaminants for Cosmetics shall be updated accordingly and shall be posted in the FDA website in due course.

3.3 ASEAN Cosmetic Methods (ACM)

Aside from the FDA website, the revised versions of the first eight (8) ACM’s are uploaded and are available for download from the following links:

ASEAN Trade Repository - http://atr.asean.org/standards/result/body/13/1
ASEAN Secretariat’s website - http://asean.org/?static post-asean-sectoral-mras

ACM 009 Revision N°0 “Determination of Salicylic Acid (Beta Hydroxy Acid) in Cosmetic Products by High Performance Liquid Chromatography (HPLC)” will be published and uploaded in the aforementioned sites in due course.

3.4 Updated List of Cosmetic Accredited Laboratories

The list of accredited testing laboratories in the Philippines may be found in the Department of Trade and Industry - Philippine Accreditation Bureau (DTI- PAB) website (www.pabaccreditation.dti.gov.ph/public/public_test.php) and includes the scope of their accreditation.

AMS’s web-linkages to National Accreditation Bodies may also be found in the    ASEAN    Secretariat’s    website    -    http://asean.org/asean-economic- community/sectoral-bodies-under-the-purview-of-aem/standards-and- conformance/links.

3.5 Question and Answer (Q&A) on Specific Provisions of the ACD

The Q&A on the Specific Provisions of the ACD has been uploaded in the ASEAN website and accessible at http://asean.org/storage/2012/05/QA-on- Specific-Provisions-of-the-ASEAN-Cosmetic-Directive-ACD.pdf.  The document is also posted and available for download in the FDA website.

4.   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 who are found to be operating  outside  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.”

5.   EFFECTIVITY

This Circular shall take effect immediately. Updates and amendments to the ACD Ingredient Annexes (Section 3.1) shall allow a grace period as specified above except for the entries with no specified grace periods.

(SGD) NELA CHARADE G. PUNO, RPh
FDA Director General