Appendices

Table 1: Internationally Recognized Contact Allergens 

PCPC’s Safety Information Summary Program Guideline

The Program:

The purpose of the program is to provide a means for the U.S. Food and Drug Administration (FDA) to access proprietary information on cosmetics, toiletry, and fragrance formulations. In order to assure the availability of necessary information, companies should compile the following information on each individual formulation they market in the U.S. (except as allowed by 21 CRF 701.3(g)) and should make those compilations (Safety Information Summaries) available to FDA for inspection when requested as described below.

Safety Information Summary Contents:

• An identification code for each product using the formulation so that individual products can be related to the relevant formulation.
• The semi-quantitative formula for the formulation, using INCI nomenclature to identify the raw materials and providing their concentrations in ranges of >50%, 50 to >25%, 25 to >10%, 10 to >5%, 5 to >1%, 1 to >0.1%, and 0.1% or less.
• Raw material specifications, particularly considering limitations for possible impurities such as microbial flora, heavy metals, etc., and reference to the methods used to determine the specifications (or general discussions of the methods if they are not published).
• Finished product specifications, including limitations on microbial content, and reference to the methods used to determine the specifications (or general discussions of the methods if they are not published).
• A summary of the manufacturing process, which may be represented by a simple flow chart.
• A statement that the product has been manufactured under the good manufacturing principles as outlined in PCPC’s Quality Assurance Guidelines.
• A statement that the product’s safety has been substantiated in accordance with the principles of PCPC’s Safety Testing Guidelines, and a summary of the elements that are the basis of the safety assessment, with appropriate citations.
• A computation of the incidence of adverse health effects in the United States (e.g., number per 100,000 or million units distributed) that have been medically confirmed as caused by the product in question. Minor, transient health effects need not be included in this computation.

Safety Information Summary Availability:

• All of a company’s relevant safety information summaries may be kept in one central location, in multiple locations, or may be a part of a database or databases from which a safety information summary can be readily assembled. Request for a particular safety information summary should be made by written request by the FDA District Director stating the basis for the request. The request should be made to the CEO, General Counsel or other official designated by the company to receive such requests. The request should specify the information the FDA is relying on to question the safety of the product, and must be based on a legitimate and specific safety concern or question related to a product, or ingredient in a product, manufactured by that company. The company should provide the safety information summary for inspection at a mutually agreed location within a reasonable time after receiving the request.
• The terms “Serious” and “Unexpected” are defined in accordance with FDA’s definition for such experiences related to drugs in 21 CFR 314.80(a). Information related to other product experiences as described in PCPC’s Safety Information Summary Program should be maintained in the safety information summary. Such information should be made available for inspection by FDA under the conditions specified in that program.