Guidance for Industry Safety of Nanomaterials in Cosmetic Products

Publication Date : 2012
1,064 Visited Entry Date : 2013/04/10


Document type Guide & Procedure
Subject Human Health ; Characterization & Testing
Application/Product Health Care & Cosmetics
This document provides guidance to industry and other stakeholders (e.g., academia, other regulatory groups) on FDA’s current thinking on the safety assessment of nanomaterials in cosmetic products. It is intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them. This guidance also provides contact information for manufacturers and sponsors who wish to discuss with FDA safety considerations regarding the use of specific nanomaterials in cosmetic products.
I. Introduction

II. Background

III. Discussion
A. General Framework for Assessing the Safety of Cosmetic Products    
B. Points to Consider in Assessing the Safety of Nanomaterials in Cosmetic Products    
1. Nanomaterial Characterization         
a. Physico-Chemical Properties              
b. Impurities              
2. Toxicology Considerations         
a. Routes of Exposure              
b. Uptake and Absorption              
c. Toxicity Testing              
C. Summary of Recommendations    

IV. How to Contact FDA About this Guidance

V. References
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