FastColours LLP USA and European Cosmetic Regulations
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USA and European Cosmetic Regulations

One of the complexities of complying with cosmetic regulations are the differences between the USA and Europe.  There are many instances where what is allowed in USA is not allowed in Europe and vice-versa.  There also differences between the descriptions of the applications.

IN USA there are considerably less colours allowed as compared to Europe.  Below is a summary of FDA regulations and a comparison with the EU Cosmetic Directive.  There is also additional information including restrictions in applications.

The summary is split into two.  In the first section, the dyes and pigment shown are those that FastColours can offer that are batch exempt for usage in USA (Highlighted names)

In the second section, it lists all those dyes and pigments that are allowed to used in cosmetics in USA with batch certification. 

Those with highlighted names, FastColours are able to offer colours that are batch certified by FDA.

Application Areas

 
USA Europe
Application 1 coloring cosmetics generally Application 1 All
Application 2 externally applied cosmetics Application 2 Eyes (not allowed)
Application 3 use in the area of the eye Application 3 Mucous Membranes (not allowed)
Application 4 mouthwashes and dentifrices Application 4 Cosmetic products except  for Eyes & Mucous Membranes
Application 5 Lips
 
Batch Certification Exempt.
 
USA Name CI Index Name INCI Name US App. 1 US App. 2 US App. 3 US App. 4 US App. 5 US Additional Uses & Info Allowed in Europe EU App. 1 EU App. 2 EU App. 3 EU App. 4
Annatto Natural Orange 4 75120 yes yes yes yes
Caramel Natural Brown 10 Caramel yes yes yes yes
Carmine Natural  Red  4 75470 yes yes yes yes
Beta -Carotene Food Orange 5 40800 yes yes yes yes
Iron Oxides (Yellow) Pigment Yellow 42 77492 yes yes yes yes
Iron Oxides (Red) Pigment Red 101 77491 yes yes yes yes
Iron Oxides (Black) Pigment Black 11 77499 yes yes yes yes
Iron Oxides
(Brown)
Pigment  Red 101 
Pigment   Yellow 42    
Pigment Black 11
77491

77492

77499
yes yes yes yes
Chromium Oxide Green Pigment Green 17 77288 yes yes yes yes
Titanium Dioxide Pigment White 6 77891 yes yes yes yes
Ultramarines (Blue) Pigment Blue 29 77007 yes yes yes yes
Ultramarines
  (Violet)
Pigment Violet 15 77007 yes yes yes yes

Batch Certification Required
 
USA Name CI Index Name INCI Name US App. 1 US App. 2 US App. 3 US App. 4 US App. 5 US Additional Uses & Info Allowed in Europe EU App. 1 EU App. 2 EU App. 3 EU App. 4
D & C Black No. 2 Pigment Black 6 77266 yes See Below yes yes
D & C Black No. 3 Pigment Black 9 77267 See Below yes yes
FD & Blue No. 1 Food Blue 2 42090 yes yes yes yes
FD & C Blue No. 1 Al. Lake Food Blue 2:1 42090:1 yes yes yes yes
D & C Blue No. 4 Acid Blue 9 42090 yes no
D & C Brown No.1 Acid Orange 24 20170 yes no
FD & C Green No. 3 Food Green 3 42053 yes yes yes
D & C Green No. 5 Acid Green 25 61570 yes yes yes yes
D & C Green No. 6 Solvent Green 3 61565 yes yes yes
D & C Green No. 8 Solvent Green 7 59040 yes See Below yes no no yes
D & C Orange No. 4 Acid Orange 7 15510 yes yes no yes yes
D & C Orange No. 5 Acid Orange 11 45370 yes yes yes See below yes yes
D & C Orange No. 10 Acid Red 95 45425. yes no
D & C Orange 11 Acid Red 95 45425 yes no
FD & C Red No. 4 Food Red 1 14700 yes yes yes
D & C Red No. 6 Pigment Red 57:2 15850:2 yes yes yes
D & C Red No. 7 Pigment Red 57:1 15850:1 yes yes yes
D & C Red No. 17 Solvent Red 23 26100 yes yes no no yes
D & C Red No. 21 Solvent Red 43 45380.2 yes yes yes
D & C Red  No.27 Solvent Red 48 45410:1 yes yes yes
D & C Red No. 27 Al. Lake Pigment Red 174 45410.2 yes yes yes
D & C Red No. 28 Acid Red 92 45410 yes yes yes
D & C Red No. 30 Pigment Red 181 73360 yes yes yes
D & C Red No. 31 Pigment Red 64 15800 yes yes no no yes
D & C Red No. 33 Acid Red 33 17200 yes yes yes yes yes
D & C Red No. 34 Pigment Red 63 15880 yes yes yes
D & C Red No. 36 Pigment Red 64 12085 yes yes See below yes yes
FD & C Red No. 40 Food Red 17 16035 yes yes yes yes
FD & C Red No. 40 Lake Food Red 17:1 16035:1 yes yes yes yes
D & C Violet No. 2 Solvent Violet 13 60725 yes yes yes
Ext. D & C Violet No. 2 Acid Violet 43 60730 yes yes no no yes
FD & C Yellow No. 5 Food Yellow 4 19140 yes yes yes yes
FD & C Yellow No. 5 Lake Food Yellow 4:1 19140:1 yes yes yes yes
FD & C Yellow No. 6 Food Yellow 3 15985 yes yes yes yes
D & C Yellow No. 7 No CI Name yes no
Ext. D & C Yellow No. 7 Acid Yellow 1 10316 yes yes no yes yes
D & Yellow No. 8 Acid Yellow 73 45350 yes yes yes
D & C Yellow No. 10 Food Yellow 13 47005 yes see below yes yes
D & C Yellow No. 11 Solvent Yellow 33 47000 yes yes no no yes

Additional Uses & Info.
 
D&C Black No. 2 Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
D&C Black No. 3 Eyeliner, eye shadow, mascara, and face powder.
D&C Green No. 8 not exceeding 0.01 percent by weight of the finished cosmetic product.
D&C Orange No. 5 For intended lip products, amounts not to exceed 5.0% by weight of the finished cosmetic products
D&C Red No. 33 For intended lip products, amounts not to exceed 3.0% by weight of the finished cosmetic products
D&C Red No. 36 For intended lip products, amounts not to exceed 3.0% by weight of the finished cosmetic products
D & C Yellow No. 10 Although the EU and USA product have the same CI number, they are not interchangeable as the specifications are different.

Please call the company if you require additional help.