(NAR) VOL. 29 NO. 3/ JULY - SEPTEMBER 18
3.1.1 Thioglycolic Acid and Thiolactic Acid (ACD Annex III Ref. Nos. 2a andThe 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.
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.3.3 ASEAN Cosmetic Methods (ACM)
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.3.1.3 EU 2017/237
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.
3.1.3.1 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)3.1.3.2 Effective 01 December 2019, only compliant products can be placed in the market, and non-compliant products must be completely withdrawn from the market.
3.1.3.1.2 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)
3.1.4 EU 2017/14103.1.4.1 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.3.1.5 EU 2017/1413, Zinc Oxide (Annex IV Color Index 77947)
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.3.1.5.1 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. 3073.1.6.1 The Meeting agreed to revise ACD Annex II Ref. No. 307 to clarify the scope of the entry.3.1.7 EU 2017/2228
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.”3.1.7.1 The Meeting with the exception of Indonesia agreed to include Peanut Oil and Hydrolyzed Wheat Protein in ACD Annex III.3.2 1,4-Dioxane
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.
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.3.4 Updated List of Cosmetic Accredited LaboratoriesAside 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.3.5 Question and Answer (Q&A) on Specific Provisions of the ACDThe 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.
(SGD) NELA CHARADE G. PUNO, RPh
FDA Director General