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Takehome: ASEAN has held the 28th ASEAN Cosmetic Committee (ACC) Meeting during which it updated regulations and added some substances in ASEAN Cosmetic Directive (ACD).
According to Philippines’ Circular on July 9, ASEAN revised cosmetic ingredients standards and requirements and supplemented some new entries in the directive during the 28th ACC. The revision has been in effect except for any reforms subject to grace periods. Details of the latest amendments are as follows:
Revised regulations
1. Ref. No. 307 in ACD Annex II clarified the scope of the entry 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”.
2. To provide further clarification on the combination use of Thioglycolic acid and Thiolactic acid in Annex III, the restriction has been changed.
|
Ref. No |
Substance/CAS No. |
Restrictions – Maximum authorized concentration in the ready for use preparation |
After Amending |
|
2a |
Thioglycolic acid and its salts 68-11-1 |
(a)
(b) 5% ready for use at pH 7-12.7 (c) 2% ready for use at pH 7-9.5
|
(a)
(b) 5% ready for use at pH 7-12.7 (c) 2% ready for use at pH 7-9.5
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. |
|
A9 |
Thiolactic acid and its salts |
(a) 8.5% ready for use at pH<9.5 (b) 5% ready for use at pH 7-12.7 (c) 2% ready for use at pH 7-9.5
|
(a) 8.5% ready for use at pH<9.5 (b) 5% ready for use at pH 7-12.7 (c) 2% ready for use at pH 7-9.5
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. |
Newly-added substances
1. EU 2017/237
The following 10 substances will be added as new entries into Annex III.
|
No. |
Ref. No |
Newly-added Substances |
Effective Date |
|
1 |
8c |
N,N’-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine |
2019.12.01 |
|
2 |
9b |
2,6-Dihydroxyethylaminotoluene |
|
|
3 |
314 |
HC Red No.17 |
|
|
4 |
315 |
HC Yellow No.17 |
|
|
5 |
316 |
1-Hexy14,5-Diamino Pyrazole Sulfate |
|
|
6 |
317 |
2,5,6-Triamino-4-Pyrimidinol |
|
|
7 |
318 |
Hydroxyethoxy Aminopyrazolopyridine HCI |
|
|
8 |
319 |
3-Amino-2,6-Dimethylphenol |
|
|
9 |
320 |
Basic Brown 17 |
|
|
10 |
321 |
Basic Blue 124 |
2. EU 2017/2228
ASEAN Member States (AMS) except Indonesia add these two substances in Annex III.
|
Ref. No |
Newly-added Substances/CAS No. |
Applicable countries |
Effective Date |
|
322 (306) |
Peanut Oil |
AMS except Indonesia |
2019.12.01 |
|
323 (307) |
Hydrolyzed Wheat Protein |
Other changes
1. EU 2017/1410
Indonesia has determined to include (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 Annex ACD II and adopt the same implementation date – August 23rd, 2021 in accordance with other 9 AMS.
2. 1,4-Dioxane
1,4-Dioxane is regarded as trace impurity and it was decided at the meeting that a maximum trace limit of 25 parts per million (ppm) will be adopted in finished cosmetics.
Stakeholders shall pay attention to the amendments and the entries with grace periods and note that any violation of the rules and regulations specified in ACD will subject to sanctions and penalties as prescribed as by Food and Drug Administration Act of 2009.
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