Description
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. The guidance document 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 safety considerations regarding the use of specific nanomaterials in cosmetic products with FDA. This guidance is not applicable to other products regulated by FDA, including over-the-counter and prescription drugs and medical devices.
Scope & Applicability
Product Classes
1The primary product category addressed in the guidance; Safety of nanomaterials in cosmetic products; safety assessment of cosmetic products using nanomaterials; Subject of EU Directive 2003/15/EC and Council Directive 76/768/EEC
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
5Factor for consideration in analytical assessment.
Characteristic relevant to nanotechnology NDIs
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
Surface charge measurement for characterization
The area in direct contact with the TDS which affects drug delivery.
Related CFR Sections (1)
- 21CFR701.3§ 701.3 Designation of ingredients.
(a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functionsRead full regulation →