INFORMATION ON 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 are also differences between the descriptions of the applications.

In the 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 sections. In the first section, the dyes and pigment shown are those that FastColours can offer that are batch exempt for usage in USA.

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

Those with highlighted names, FastColours are able to offer as 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 EU EU App. 1 EU App. 2 EU App. 3 EU App. 4
Annatto Natural Orange 4 75120 ¦ ¦ ¦ ¦
Caramel Natural Brown 10 Caramel ¦ ¦ ¦ ¦
Carmine Natural Red 4 75470 ¦ ¦ ¦ ¦
Beta Carotene Food Orange 5 40800 ¦ ¦ ¦ ¦
Iron Oxide Yellow Pigment Yellow 42 77492 ¦ ¦ ¦ ¦
Iron Oxide Red Pigment Red 101 77491 ¦ ¦ ¦ ¦
Iron Oxides Black Pigment Black 11 77499 ¦ ¦ ¦ ¦
Iron Oxides Brown Pigment Red 101 
Pigment Yellow 42
Pigment Black 11
77491

77492

77499
¦ ¦ ¦ ¦
Chromium Oxide Green Pigment Green 17 77288 ¦ ¦ ¦ ¦
Titanium Dioxide Pigment White 6 77891 ¦ ¦ ¦ ¦
Ultramarine Blue Pigment Blue 29 77007 ¦ ¦ ¦ ¦
Ultramarine Violet Pigment Violet 15 77007 ¦ ¦ ¦ ¦

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 ¦ See Below ¦ ¦
D&C Black No 3 Pigment Black 9 77267 See Below ¦ ¦
FD&C Blue No 1 Food Blue 2 42090 ¦ ¦ ¦ ¦
FD&C Blue No 1 Lake Food Blue 2:1 42090:1 ¦ ¦ ¦ ¦
D&C Blue No 4 Acid Blue 9 42090 ¦
D&C Brown No 1 Acid Orange 24 20170 ¦
FD&C Green No 3 Food Green 3 42053 ¦ ¦ ¦
D&C Green No 5 Acid Green 25 61570 ¦ ¦ ¦ ¦
D&C Green No 6 Solvent Green 3 61565 ¦ ¦ ¦
D&C Green No 8 Solvent Green 7 59040 ¦ See Below ¦ ¦
D&C Orange No 4 Acid Orange 7 15510 ¦ ¦ ¦ ¦
D&C Orange No 5 Acid Orange 11 45370 ¦ ¦ ¦ See below ¦ ¦
D&C Orange No 10 Acid Red 95 45425 ¦
D&C Orange No 11 Acid Red 95 45425 ¦
FD&C Red No 4 Food Red 1 14700 ¦ ¦ ¦
D&C Red No 6 Pigment Red 57:2 15850:2 ¦ ¦ ¦
D&C Red No 7 Pigment Red 57:1 15850:1 ¦ ¦ ¦
D&C Red No 17 Solvent Red 23 26100 ¦ ¦ ¦
D&C Red No 21 Solvent Red 43 45380:2 ¦ ¦ ¦
D&C Red No 27 Solvent Red 48 45410:1 ¦ ¦ ¦
D&C Red No 27 Aluminium Lake Pigment Red 174 45410:2 ¦ ¦ ¦
D&C Red No 28 Acid Red 92 45410 ¦ ¦ ¦
D&C Red No 30 Pigment Red 181 73360 ¦ ¦ ¦
D&C Red No 31 Pigment Red 64 15800 ¦ ¦ ¦
D&C Red No 33 Acid Red 33 17200 ¦ ¦ ¦ ¦ ¦
D&C Red No 34 Pigment Red 63 15880 ¦ ¦ ¦
D&C Red No 36 Pigment Red 64 12085 ¦ ¦ see below ¦ ¦
FD&C Red No 40 Food Red 17 16035 ¦ ¦ ¦ ¦
FD&C Red No 40 Lake Food Red 17:1 16035:1 ¦ ¦ ¦ ¦
D&C Violet No 2 Solvent Violet 13 60725 ¦ ¦ ¦
Ext D&C Violet No 2 Acid Violet 43 60730 ¦ ¦ ¦
FD&C Yellow No 5 Food Yellow 4 19140 ¦ ¦ ¦ ¦
FD&C Yellow No 5 Lake Food Yellow 4:1 19140:1 ¦ ¦ ¦ ¦
FD&C Yellow No 6 Food Yellow 3 15985 ¦ ¦ ¦ ¦
FD&C Yellow No 6 Lake Food Yellow 3:1 15985:1 ¦ ¦ ¦ ¦
D&C Yellow No 7 No CI Name ¦
Ext D&C Yellow No 7 Acid Yellow 1 10316 ¦ ¦ ¦ ¦
D&C Yellow No 8 Acid Yellow 73 45350 ¦ ¦ ¦
D&C Yellow No 10 Food Yellow 13 47005 ¦ see below ¦ ¦
D&C Yellow No 11 Solvent Yellow 33 47000 ¦ ¦ ¦

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.