Titanium Dioxide, a white powder, is the oxide of titanium. It has a formula of TiO2. Titanium Dioxide is used in a wide range of cosmetics and personal care products including makeup, nail products, bath soaps and foot powders. Titanium Dioxide is also used in Over-the-Counter (OTC) sunscreen drug products.
The Food and Drug Administration (FDA) lists Titanium Dioxide as a color additive exempt from certification. Titanium Dioxide is safe for use in coloring products, including cosmetics and personal care products applied to the lips, and the area of the eye, provided it meets certain specifications. Titanium Dioxide is also an approved colorant for food, drugs and medical devices.
The FDA has also approved the use of Titanium Dioxide for use in OTC sunscreen drug products at concentrations up to 25%.
FDA includes Titanium Dioxide on its list of indirect food additives. For example, it may be used as a colorant in polymers used in food contact materials.
Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.
You can find out more about FDA regulation of colors at:
http://www.cfsan.fda.gov/~dms/cos-col.html
The FDA has conducted extensive reviews of the safety of Titanium Dioxide for use as a color additive in drugs and cosmetics and as a sunscreen active ingredient. The results of these reviews are public processes. For example, you may view the public announcement that FDA published approving sunscreen active ingredients, including Zinc Oxide, at the following link:
http://www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen_FR...
FDA Regluations:
Links to the FDA Code of Federal Regulations for Titanium Dioxide in the following applicatons:
Colors
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
OTC Sunscreen Drug Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Food Additives
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
More information about Titanium Dioxide.
Titanium Dioxide is listed as CI 77891 in the Cosmetics Directive of the European Union (see Annex IV) and may be used without restriction as a colorant when purity requirements are fulfilled. When used as a colorant in cosmetic products in the European Union, this ingredient must be called CI 77891.
In Europe, Titanium Dioxide is also an approved UV Filter and may be used at concentrations up to 25% (see Annex VII).
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has determined that is it not necessary to limit the daily dietary intake for Titanium Dioxide.
http://www.inchem.org/documents/jecfa/jeceval/jec_2278.htm
You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/Content/NavigationMenu/Co...
