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 |