Colourants Exempt from Certification – Irena Marchu

This was compiled by Irena Marchu based on information taken from the FDA website.

There’s 65 colors are exempt from certification of FDA.

Our mica glitters and matte pigments ingredients are mica, iron oxides, and titanium dioxides, ultramarines etc., these ingredients are all belonged to the 65 colors.

So it doesn’t need a FDA licence (certificate), all world manufacturers don’t need to have the license, because these ingredients are all “EXEMPT FROM CERTIFICATION”.

Here is the link for products OK for use in the USA for cosmetics, it is very short, only about 65 colors, from FDA official website.  

And please see the words I marked red as below.

http://www.fda.gov/cosmetics/labeling/ingredientnames/ucm109084.htm

Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics
(
21 CFR Part 73 Subpart C?osmetics3)

Color Additive

Eye Area

Generally
(Includes
Lipsticks)

External Use

Specific Limitations
and Comments

21 CFR
Section

Aluminum powder

Yes

No

Yes

73.26454

Annatto

Yes

Yes

Yes

73.20305

Bismuth citrate

No

No

Subject to limitations

Hair on the scalp

73.21106

Bismuth oxychloride

Yes

Yes

Yes

73.21627

Bronze powder

Yes

Yes

Yes

73.26468

Caramel

Yes

Yes

Yes

73.20859

Carmine

Yes

Yes

Yes

73.208710

β-Carotene

Yes

Yes

Yes

73.209511

Chromium
hydroxide green

Yes

No

Yes

73.232612

Chromium oxide greens

Yes

No

Yes

73.232713

Copper powder

Yes

Yes

Yes

73.264714

Dihydroxyacetone

No

No

Subject to limitations

For use in tanning preparations

73.215015

Disodium
EDTA-copper

No

No

Subject to limitations

Shampoos

73.212016

Ferric ammonium
ferrocyanide

Yes

No

Yes

73.229817

Ferric ferrocyanide

Yes

No

Yes

73.229918

Guaiazulene

No

No

Yes

73.218019

Guanine

Yes

Yes

Yes

73.232920

Henna

No

No

Subject to limitations

Hair on the scalp

73.219021

Iron oxides

Yes

Yes

Yes

73.225022

Lead acetate

No

No

Subject to limitations

Hair on the scalp; ≤0.6% lead

73.239623

Luminescent
zinc sulfide

No

No

Subject to limitations

Externally applied facial makeup and nail polish; <10%; for infrequent use (e.g., Halloween)

73.299524

Manganese violet

Yes

Yes

Yes

73.277525

Mica

Yes

Yes

Yes

73.249626

Potassium sodium
copper chlorophyllin
(chlorophyllin-copper
complex)

No

No

Subject to limitations

Dentifrices; ≤0.1%

73.212527

Pyrophyllite

No

No

Yes

73.240028

Silver

No

No

Subject to limitations

Fingernail polish; ≤1%

73.250029

Titanium dioxide

Yes

Yes

Yes

 

73.257530

Ultramarines

Yes

No

Yes

73.272531

Zinc oxide

Yes

Yes

Yes

73.299132

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