Registration Dossier

Administrative data

Description of key information

Evaluated by authoritative bodies as safe for use as recommended in consumer cosmetic/oral care formulations and as a residue in human food products.

Additional information

CPC is used in the consumer products market in cosmetics and in the food industry as a disinfectant in preparation of poultry products. The SCCS, FDA and EFSA have reviewed the data on this substance and have undertaken risk assessments for these applications. EFSA concluded that there are no safety concerns for humans from the proposed use of the product (Cecure®) for removal of microbial surface contamination from poultry under the usage conditions specified in this opinion. The data on which this conclusion is based was judged to be satisfactory for selection of a NOAEL as a point of departure for a margin of safety assessment.

Similarly, risk assessments have been undertaken by the SCCS and the U.S. FDA for oral care products for consumers. The safety of cetylpyridinium chloride has been extensively evaluated in a variety of controlled, clinical and nonclinical studies. The SCCS concluded that there are no safety concerns for humans from the proposed use of CPC in selected cosmetic products under the usage conditions specified in this opinion. This is based on the same NOAEL in animal studies as that used by EFSA. Similarly, the FDA reviewed submitted safety information, in addition to adverse event data collected during more than 55 years of U.S. marketing of mouthrinses containing cetylpyridinium chloride, and the FDA Subcommittee concludes that cetylpyridinium chloride is safe when used at concentrations of 0.045% to 0.1% in mouthrinse formulations.

The evaluations by these authoritative bodies support the conclusions of this risk assessment.