Titanium Dioxide - E171 / FDA

Titanium Dioxide - Also known as Pigment White 6 or Colour Index number CI77891, is the principal white colourant used in many cosmetic and food products today.

 

To meet rigids standards in food safety and for use in cosmetics, certain key elements need to be highly controlled and impurity levels kept well below the maximum levels dictated by law.

 

The titanium dioxide pigment E171 / FDA offered by International Speciality Chemicals meets and surpasses the requirements of the European Pharmacopeia, the European Commission Directive 95/45 EC, the United States FDA regulations CFR21, as well as the additional requirements of:

73.575 (Foods)

73.1575 (Drugs)

732575 (Cosmetics)

 

The information below, shows a comparison of the requirements stipulated by the European Directive and the United States FDA, both of which are met by the International Speciality Chemicals product titanium dioxide E171

 

 

 

Comparison of the Requirements of EU Directive E171 and FDA Standard 

 

 Purity Requirements

Specification

Specification

 

E171

 

FDA

 

 

 

Assay / Purity

 99.0% Min

99.0% Min

 

AVERAGE PARTICLE SIZE

 

 

 

Loss on Ignition (800 Deg. C)

0.5% Max

0.5% Max

 

Loss on Drying

0.5% Max

 

 

Water Soluble Substances

0.3% Max

0.5% Max

 

Acid Soluble Substances (0.5N HCl)

0.5% Max

0.5% Max

 

Al2O3 and/or SiO2

2.0% Max

2.0% Max

 

As

3ppm

1ppm

 

Cd

1ppm

Not Listed

 

Sb

50ppm

2ppm

 

Pb

10ppm

10ppm

 

Hg

1ppm

1ppm

 

Zn

50ppm

Not Listed

 

 

 

 

Titanium Dioxide white is also used in cosmetics and pharmaceuticals, such as capsule cases and in sunscreen / sunblock formulations