ASEAN Revises and Supplements Cosmetic Ingredient Standards (2017-2018)

Type of change

Type of List

Entry No./Ref. No.

Description of changes

Implementation period

Amendment

List of Restricted Ingredients

8, 8a, 9, 9a, 16,22, 189-205, 208, 209, 215-218, 222, 223, 225, 227, 230, 232, 234, 237-239, 241- 246, 248-278, 303- 311

All hair dye ingredients:

The use of hair dye ingredients for dyeing eyelashes or eyebrows will not be allowed under the ASEAN Cosmetic Directive. The following phrase will be included "the use for dyeing eyelashes and eyebrows is not permitted". In List of restricted ingredients, products are required to be labeled with the warning statement "do not use to dye eyelashes or eyebrows".

1 Jun 2018

New Entry

List of Restricted Ingredients

312

A new entry for 2-(ethoxyethoxy)-ethanol(DEGEE) has been included into List of restricted ingredients

1 Dec 2018

New Entry

List of Restricted Ingredients

313

A new entry for Laureth-9 (Polidocanol) has been included into List of restricted ingredients

1 Dec 2018

Amendment

List of Preservatives Allowed

57

A note indicating that the maximum permitted level for methylthiazolinone in rinse-off products would be further restricted to 15ppm has been proposed

To be announced when decision is made in the future meeting.

Amendment

List of UV filters which cosmetic products may contain

4

The maximum permitted level of Benzophenone-3 is reduced from 10% to 6%

1 Dec 2018

Amendment

List of UV filters which cosmetic products may contain

A29a

The sentence "coating materials can be used that have been demonstrated  to be safe and not to affect the nanoparticle properties related to the behavior and/or effects" replaces the previous sentence "Uncoated, or coated with triethoxycaprylysilane, dimenthicone, dimethoxydlphenylsilane-triethoxycaprylylsilane cross-polymer, or octyltriethoxysilane" under the column for other limitations

30 Nov 2017

Amendment

List of UV filters which cosmetic products may contain

27a

The sentence "Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects" replaces the previous sentence "Coated with silica, hydrated silica, alumina, aluminium hydroxide, aluminium stearate, stearic acid, trimethoxycaprylylsilane, glycerine, dimethicone, hydrogen dimethicone, simethicone" under the column for other limitations

30 Nov 2017

Ref No ACD # (EU #)

Substance

Restrictions

Conditions of use and warnings which must be printed on the labels

Field of application and/or use

Maximum authorized concentration in ready for use preparation

Other limitations and requirements

312 (EU: TBA)

2-(ethoxyethoxy)-ethanol Diethylene glycol monoethyl ether (DEGEE) Ethoxydiglycol CAS No 111-90-0

(a) Oxidative hair dye products

(b) Non-oxidative hair dye products

(c) Rinse-off products other than hair dye products           

(d) Other non-spray cosmetic products 

(e) The following spray products: fine fragrances, hairsprays, antiperspirants and deodorants.

(a) 7%

(b) 5%

(c) 10%

(d) 2.6%

(e) 2.6%

(a) to (e):

The level of ethylene glycol impurity in Ethoxydiglycol must be ≤0.1%

Not to be used in eye products and oral products.

313 (257)

Polidocanol Laureth – 9 CAS No 3055-99-0

(a) Leave-on products (b) Rinse-off products

(a) 3.0%

(b) 4.0%

Reference number

Substance

Maximum authorized concentration

Limitations and requirements

Conditions use and warnings which must be printed on the label

57

2-Methyl-2H-isothiazol-3-one (INCI)

Methylisothiazolinone(14)

CAS No.2682-20-4

0.01%

(In Indonesia the maximum

authorized concentration is

0.0015%)

(Note: At the 26th ACSB

Meeting a future maximum

authorized concentration of

0.0015% was proposed – to

be considered at a future

ACSB Meeting.)

Rinse-off products only

Reference number

Substance

Maximum authorized concentration

Other limitations and requirements

Conditions of use and warnings which must be printed on the label

4

Oxybenzone (INN)

6%

Contains oxybenzone

A29a

Zinc Oxide (nano)

25%

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.

Only nanomaterials having the following characteristics are allowed:

— Purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total,

— Median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, — Water solubility < 50 mg/L

— Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects

27a

Titanium Dioxide (nano)

25 %

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.

Only nanomaterials having the following characteristics are allowed:

— Purity ≥ 99 %,

— Rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, — Median particle size based on number size distribution ≥ 30 nm,

— Aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,

— Coating materials can be used that have been demonstrated to be safe and not to affect the nanoparticle properties related to the behaviour and/or effects, — Photocatalytic activity ≤ 10 % compared to corresponding non-coated or nondoped reference,

— Nanoparticles are photostable in the final formulation.