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The Personal Care Products Council Consumer Commitment Code

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Preamble

Cosmetic products are the safest products regulated by the U.S. Food and Drug Administration (FDA), a fact that has been recognized by a number of FDA Commissioners over the last several decades.

To further strengthen industry safeguards for consumers, the Personal Care Products Council has instituted a Consumer Commitment Code for the cosmetic industry. This incorporates and strengthens some practices already in place for most companies, such as the current reporting of manufacturing establishments; and it includes new practices such as a Safety Information Summary Program that makes information relevant to cosmetic product and ingredient safety readily available to the FDA upon request.

The Council's Board of Directors unanimously supports the principles and practices embodied in this Code. It will formally take effect for all Council members on January 1, 2007. Throughout 2006, the Council will commit substantial resources to educating its members on the practices embodied in the Code and gaining their commitments to the Code. The Council will also reach out to many related trade associations and other organizations to encourage broad recognition of the Code by 2007.

During this time, we will continue to work closely with the Food and Drug Administration to provide as much information regarding cosmetic safety as the agency needs to evaluate the safety of the products. In providing FDA with access to this information we seek to provide consumers with the continued confidence that the proper steps are being taken by government and industry to assure the continued safety of all cosmetic products, and to allow consumers to make fully informed choices when purchasing cosmetic products.

The Personal Care Products Council Consumer Commitment Code

The following principles constitute the Personal Care Products Council Consumer Commitment Code:

1. A company should market cosmetic products only after ensuring that every ingredient and finished product has been substantiated for safety. The decision that an ingredient has been substantiated for safety may be based on a finding by the Cosmetic Ingredient Review Expert Panel that such ingredient is safe for the use intended by the company or on other appropriate data and information.

2. When marketing a cosmetic product containing an ingredient that exceeds limits on concentration or product type established by the Cosmetic Ingredient Review Expert Panel, a company should possess information sufficient to substantiate the safety of the ingredient for its intended use in such product and be willing to make that information available for inspection by the Food and Drug Administration.

3. When marketing a cosmetic product containing an ingredient for which the Cosmetic Ingredient Review Expert Panel has found insufficient data to determine safety, a company should possess information sufficient to substantiate the safety of the ingredient for its intended use in such product and be willing to make that information available for inspection by the Food and Drug Administration.

4. A company should participate in the applicable parts of the FDA Voluntary Cosmetic Reporting Program set forth in 21 CFR Parts 710 and 720 for products marketed in the United States, and file timely reports regarding its manufacturing establishments and ingredient usage.

5. Although adverse events that are both serious and unexpected are extremely rare for cosmetic products, a company should notify the Food and Drug Administration of any known serious and unexpected adverse event as a result of the use of any of its cosmetic products marketed and used in the United States. “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 the Council's Safety Information Summary Program should be maintained in the safety information summary described in Paragraph 6 below. Such information should be made available for inspection by FDA under the conditions specified in that program.

6. A company should maintain a safety information summary of ingredient and product safety information and data regarding its cosmetic products marketed in the United States as specified in the Council's Safety Information Summary Program Guideline, and make any information in that safety information summary available for inspection by FDA under the conditions specified in that program.

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The Code should not be construed as a legal standard. All companies have an independent obligation to ascertain that their cosmetic products comply with all current laws and regulations.

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The Council'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 cosmetic, 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 that formulations that change only by color may have a single compilation for all), 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 the Council's Quality Assurance Guidelines.
  • A statement that the product’s safety has been substantiated in accordance with the principles of the Council'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.