Regulatory

FDA Information

The Federal Food, Drug and Cosmetic Act of 1958 and its regulations under 21 CFR describes the compliant uses of titanium dioxide in direct and indirect food contacts, as well as in drugs and cosmetics. Millennium Inorganic Chemicals manufactures many different titanium dioxide products that contain chemical treatments to enhance the performance of these products in various applications, including plastics. The use of these treatments, as well as the percentage of titanium dioxide as a percentage of the entire pigment product affects the compliance status of the product under various FDA regulations. Therefore, although untreated titanium dioxide pigment may be used in many FDA compliant applications, Millennium Inorganic Chemicals' treated titanium dioxide pigments are intended to be compliant under the indirect food additive regulations when used in food packaging.

Millennium Inorganic Chemicals' plastic grade titanium dioxide product TiONA 188 and RCL-6, are fully compliant with all applicable FDA indirect food additive regulations for use in plastic applications for food packaging. RCL-4 is FDA compliant for most indirect food additive applications. Your Millennium Inorganic Chemicals technical service representative can provide you with specific FDA compliant status based on the product's intended use.

NSF (National Sanitation Foundation) Certification of Titanium Dioxide

With the trend towards replacing traditional metal and concrete piping for cost, weight, corrosivity, and ease of installation issues, it became necessary to assure the new materials of construction would perform as well as those they were replacing. The polymers of choice are PVC, ABS, and HDPE. The PPI (Plastics Pipe Institute) established standard tests to assess long term performance and product quality. In addition to certifying materials, design thickness, etc. the effect of additives and colorants in the formulation also needed to be determined. Once a specific additive from a specific manufacturing site has been found compliant with PPI standards as tested by the NSF, it is listed, for an annual fee, in the NSF publication.

The following Millennium Inorganic Chemicals grades are currently listed under NSF Standard 014; Plastic Piping System Components and Related Materials for loading up to 5pph.