Cosmetic Advisories

FDA Advisory No. 2018-034 || Reiteration of Grace Periods Given to the Cosmetic Industry for Ingredients Banned or Restricted During the Recent ASEAN Cosmetic Committee (ACC) Meetings and Its Related Events

FDA Advisory No. 2018-034

Reiteration of Grace Periods Given to the Cosmetic Industry for Ingredients Banned or Restricted During the Recent ASEAN Cosmetic Committee (ACC) Meetings and Its Related Events 

In the interest of public service and in line with the Food and Drug Administration’s (FDA’s) thrust to strengthen its enforcement of existing rules, regulations and standards, the Center for Cosmetics Regulation and Research (CCRR) hereby reiterates the impending end of the grace periods given to the cosmetic industry through FDA Circulars No.  2017-006 and 2017-007 for newly banned ingredients or ingredients with new restrictions adopted during the 25th and 26th ASEAN Cosmetic Committee (ACC) meetings and its related events.

  • FDA Circular No. 2017-006 “Updates and Amendments of the ASEAN Cosmetic Directive as Adopted During the 25th ASEAN Cosmetic Committee Meeting and Its Related Events

ACD Annex and Reference No.

Chemical / Substance

Maximum Authorized Concentration and/or Other Limitations and Requirements

Grace Period

Annex III Ref. No. 15d

Potassium Hydroxide

1.5% as callosity softener / remover

Conditions of use and warning which must be printed on the label:

·         Contains alkali.

·         Avoid contact with eyes

·         Keep out of reach of children

·         Read directions for use carefully

31 August 2018

Annex IV Color Index (CI) 77266

Carbon Black

Additional Restriction/Conditions of Use:

Purity >97 %, with the following impurity profile: Ash content ≤ 0.15%, total sulphur ≤ 0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤ 5ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, total Hg ≤ 1ppm.

31 August 2018

Annex IV CI 77266 (nano)

Carbon Black (Nano)

10%

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 >97%, with the following impurity profile: Ash content ≤0.15%, total sulphur ≤0.65%, total PAH ≤500 ppb and benzo(a)pyrene ≤5 ppb, dibenz(a,h)anthracene ≤5 ppb, total As ≤3 ppm, total Pb ≤10 ppm, and total Hg ≤1 ppm;

— Primary particle size ≥20 nm.

31 August 2018

Annex VI Ref. No. 57

2-Methyl-2H-isothiazol- 3-one

 

Methylisothiazolinone

0.01%

Allowed to be used only in rinse-off products.

Prohibited in leave-on products.

31 August 2018

Annex VII Ref. No. A29

Zinc Oxide

 

Additional Restriction/Conditions of Use:

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

31 August 2018

Annex VII Ref. No. A29a

Zinc Oxide (nano)

25%1

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 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) >20nm.

-          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 effects2

31 August 2018

Annex VII Ref. No. 27a

Titanium Dioxide (nano)

25%3

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 effects4

- Photocatalytic activity ≤ 10% compared with corresponding non-coated or non-doped reference,

- Nanoparticles are photostable in the final formulation.

31 August 2018

 

1 In case of combined use of Zinc Oxide and Zinc Oxide (nano), the sum shall not exceed the maximum authorized concentration which is 25%.

2The amendment to the original restriction on the coating material for Zinc Oxide (nano) is adopted during the 26th ACC Meeting and its related events and disseminated through FDA Circular No. 2017-007.

3 In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the maximum authorized concentration which is 25%.

4The amendment to the original restriction on the coating material for Titanium Dioxide (nano) is adopted during the 26th ACC Meeting and its related events and disseminated through FDA Circular No. 2017-007.

  • FDA Circular No. 2017-007 “Updates and Amendments of the ASEAN Cosmetic Directive as Adopted During the 26th ASEAN Cosmetic Committee Meeting (ACC) and Its Related Events

ACD Annex and Reference No.

Chemical / Substance

Maximum Authorized Concentration and/or Other Limitations and Requirements

Grace Period

Annex III Ref. No. 312

Diethylene Glycol Monoethyl Ether (DEGEE)

 

Ethoxydiglycol

a.       Oxidative hair dye products – 7%

b.       Non-oxidative hair dye products – 5%

c.        Rinse-off products other than hair dye products – 10%

d.       Other non-spray cosmetic products – 2.6%

e.        The following spray products: fine fragrances, hair sprays, anti-perspirants and deodorants – 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.

01 December 2018

Annex III Ref. No. 313

Polidocanol

 

Laureth-9

 

a.       Leave-on products – 3.0%

b.       Rinse-off products – 4.0%

01 December 2018

Annex III

Hair Dye Entries

Additional conditions of use and warning which must be printed on the label:

Do not use to dye eyelashes or eyebrows

01 June 2018

Annex VII Ref. No. 4

Oxybenzone (INN)

6%

 

Conditions of use and warning which must be printed on the label:

Contains oxybenzone

 

01 December 2018

Cosmetic establishments are strongly advised to recall their products containing the abovementioned ingredients whose use is outside the new restrictions and conditions laid down in the ASEAN Cosmetic Ingredient Annexes by the end of the grace period. Violation of the new restrictions and conditions after the grace period has ended shall subject the violator to appropriate regulatory actions.

For more information, cosmetic establishments may check the FDA website (www.fda.gov.ph) for updates and amendments to the ASEAN Cosmetic Directive (ACD), its annexes and appendices.

Dissemination of the information to all concerned is requested.

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