Consumer Commitment Code

 


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Preamble

Providing consumers with safe high-quality products is of paramount importance to our industry and our member companies. As such, the Personal Care Products Council (PCPC) instituted a Consumer Commitment Code (Code) strengthening practices already in place for many companies and incorporating new practices, such as a Safety Information Summary Program that makes information relevant to cosmetics product and ingredient safety readily available to the U.S. Food & Drug Administration (FDA) upon request.

The Code will assure FDA is provided the information it needs to evaluate the safety of cosmetics products. In providing FDA with access to this information, consumers can be reassured the proper steps are being taken by government and industry to assure the safety and high quality of all cosmetics products, and allow consumers to make fully informed choices when purchasing cosmetics and personal care products.

The Personal Care Products Council Consumer Commitment Code

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

  1. A company should market cosmetics products only after ensuring 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 (CIR) Expert Panel that such ingredient is safe for the intended use or on other appropriate data and information.
  2. When marketing a cosmetics product containing an ingredient that exceeds the concentration or applications reviewed by the CIR Expert Panel, or for which the CIR Expert Panel has found the “Use Not Supported by the Data and Information Submitted to the CIR,” a company should possess information sufficient to substantiate the safety of the ingredient as used in such product and be willing to make that information available for inspection by the FDA.
  3. When marketing a cosmetics product containing an ingredient identified as a “fragrance,” a company should disclose the presence of internationally recognized contact allergens identified in, and in conformance with, PCPC’s “Voluntary Fragrance Ingredient Disclosure Guideline.”
  4. A company should participate in the applicable parts of the FDA Voluntary Cosmetic Reporting Program (VCRP) 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 serious and unexpected adverse events are extremely rare for cosmetics products, a company should notify the FDA of any known serious and unexpected adverse event as a result of the use of any of its cosmetics products marketed and used in the United States.
  6. A company should maintain a safety information summary of ingredient and product safety information and data regarding its cosmetics products marketed in the United States as specified in PCPC’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 is voluntary and should not be construed as a legal standard. All companies have an independent obligation to ascertain their cosmetics products comply with all current laws and regulations.
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APPENDICES

PCPC’s Voluntary Fragrance Ingredient Disclosure Guideline

While PCPC is confident in the safety and quality of fragrances used in personal care products, we recognize the desire for consumers to have more information about the products they use. This guideline provides a framework for the voluntary disclosure of the presence of any of the 26 internationally recognized contact allergens identified in Table 1 in accordance with the following principles:

  • Fragrance ingredient disclosure will be provided for ingredients present in cosmetics product sold in the United States in concentrations greater than 0.001% for leave on products or 0.01% for rinse off products. The thresholds refer to the concentration of the of intentionally added substances in the final product.
  • Fragrance ingredient disclosure can be provided on labels or in labeling, including written, printed, or graphic materials accompanying a product or other electronic means generally available to the public.

Table 1: Internationally Recognized Contact Allergens 

Chemical Name/INN INCI Name CAS Number
3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one Alpha-Isomethyl Ionone 127-51-5
2-Benzylideneheptanal Amyl Cinnamal 122-40-7
2-Pentyl-3-phenylprop-2-en-1-ol Amylcinnamyl Alcohol 101-85-9
4-Methoxybenzyl alcohol Anise Alcohol 105-13-5
Benzyl Alcohol Benzyl Alcohol 100-51-6
Benzyl Benzoate Benzyl Benzoate 120-51-4
2-Propenoic acid, 3-phenyl-, phenylmethyl ester Benzyl Cinnamate 103-41-3
Benzyl Salicylate Benzyl Salicylate 118-58-1
2-(4-tert-Butylbenzyl)propionaldehyde Butylphenyl Methylpropional 80-54-6
2-Propenal, 3-phenyl Cinnamal 104-55-2
Cinnamyl Alcohol Cinnamyl Alcohol 104-54-1
3,7-Dimethyl-2,6-octadienal Citral 5392-40-5
Citronellol /+-3,7-dimethyloct-6-en-1-ol Citronellol 106-22-9
2H-1-Benzopyran-2-one Coumarin 91-64-5
Phenol, 2-methoxy-4-(2-propenyl)- Eugenol 97-53-0
Treemoss Extract Evernia Furfuracea 90028-67-4
Oak Moss Extract Evernia Prunastri 90028-68-5
2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl Farnesol 4602-84-0
2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)- Geraniol 106-24-1
2-Benzylideneoctanal Hexyl Cinnamal 101-86-0
Hydroxycitronellal Hydroxycitronellal 107-75-5
Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde or Hydroxy-methylpentylcyclohexenecarboxaldehyde Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde or Hydroxy-methylpentylcyclohexenecarboxaldehyde 31906-04-4
Isoeugenol Isoeugenol 97-54-1
Limonene Limonene 5989-27-5
1,6-Octadien-3-ol, 3,7-dimethyl Linalool 78-70-6
Methyl 2-Octynoate Methyl 2-Octynoate 111-12-6

 

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.

QUESTIONS AND ANSWERS

  1. What was the purpose of developing a Consumer Commitment Code? The Code, by strengthening practices already in place for many companies, and incorporating new practices, goes beyond the minimum requirements of the law and highlights the proactive and responsible approach to product safety and quality supported by cosmetics companies. PCPC’s Board of Directors unanimously approved the development of the Consumer Commitment Code in 2007 to provide consumers, regulators and other interested parties with a clear outline of the specific commitments by cosmetics companies in providing consumers with safe, high quality products.
  2. Why did the industry adopt this Consumer Commitment Code? The industry adopted this Code in the course of its continued commitment to the best safety and quality practices. As we developed the core elements of our industry’s Code, we engaged with consumers, policymakers, and experts in our industry to carefully consider their views. The safety and quality of our products is a top priority for cosmetics and personal care companies, and that priority is reflected in our industry’s long history of marketing safe and high-quality products. The Code provides an even greater degree of assurance of safety for consumers and transparency for government regulators. The Code does this by strengthening the safety practices many cosmetics companies have followed for decades and incorporating new practices such as the Safety Information Summary Program.
  3. Isn’t product safety the responsibility of the U.S. Food and Drug Administration (FDA)? It is the industry’s responsibility to ensure that products and ingredients are safe before they are marketed. To that end, PCPC has supported a broad range of programs–many in cooperation with FDA–to ensure safety.Cosmetics safety is regulated by the Federal Food, Drug and Cosmetic Act, and FDA’s Office of Cosmetics and Colors enforces the law and establishes safety standards for cosmetics. In the unlikely event that an unsafe product reaches the market, the law gives FDA the authority to ban or restrict ingredients, to seek product recalls, to seize unsafe or misbranded products, to mandate warning labels, and to prosecute violators.
  4. Who will be asked to adhere to the Code? PCPC member companies that manufacture or market cosmetics products or ingredients are strongly encouraged to adhere to the Code.
  5. What are the key elements of the Code? a) A company should use only ingredients that are substantiated for safety, either by findings of the Cosmetic Ingredient Review (CIR) Expert Panel and/or by data and information and that this information is available for inspection by FDA upon request;b) A company should provide FDA with the information on manufacturing establishments and ingredient usage called for by the Voluntary Cosmetic Reporting Program;c) A company should immediately inform the FDA of any serious and unexpected adverse experience from the use of a product marketed in the U. S.; and d) A company should maintain a Safety Information Summary related to product and ingredient safety that is available for inspection by FDA under specified circumstances.
  6. Isn’t this just an agreement to comply with existing law? No. The Code goes beyond existing law by recommending (1) the reporting of serious and unexpected adverse consumer experiences with cosmetics products, a current requirement for prescription medicines; (2) the maintenance of a Safety Information Summary on product and ingredient safety for products marketed in the US.; (3) that certain safety information be made available for inspection by the FDA; and (4) that companies participate in the FDA Voluntary Cosmetic Reporting Program (VCRP) for products marketed in the United States.
  7. Does the Code offer legal advice? No. The Code is not intended to be, nor should it be, construed as legal advice. Companies have an independent obligation to ascertain that their marketing of cosmetics products or ingredients complies with all current laws and regulations.
  8. Will you terminate the PCPC membership of a non-compliant member company? We will not terminate PCPC membership for noncompliance. Rather than push companies outside this system by terminating their membership, we will work with them to encourage compliance. Industry leadership is committed to the Code, and we believe every company will understand it is in their interest to support it.
  9. What does the new Safety Information Summary requirement of the Code entail? A company should maintain information about its formulas, product testing, and adverse consumer experiences with its cosmetics products for inspection by FDA officials under specified circumstances when FDA has a specific concern about the safety of that company’s product’s. Maintenance of a safety information summary will provide FDA with faster and easier access to this information, should a safety concern arise with a company’s product.If the FDA determines a product is unsafe, it has extensive authority to take corrective action, including seeking a recall, banning or restricting ingredients, seizing unsafe or misbranded products, inspecting manufacturing facilities and even prosecuting violators.
  10. How will cosmetics products manufactured outside the United States but sold in the U.S. be affected under the Code? Who will keep the safety information summaries in the U.S. for foreign manufacturers? Companies that market their products in the United States should adhere to the principles of the Code. Companies that operate in the U.S. will be asked to maintain safety information summaries that will be available whenever requested by FDA officials.
  11. What other self-regulatory programs does the industry have in place to ensure cosmetics safety? There are several:
  • CIR: The industry has, since 1976, supported the existence of an independent scientific body called the Cosmetic Ingredient Review (CIR) Expert Panel. CIR reviews the safety of cosmetics ingredients in a public process that prioritizes ingredients for review based on several factors, including how widely they are used and their potential to pose a risk to consumers. CIR’s Expert Panel is made up of world class scientific experts who meet the same conflict of interest standards as do members of FDA advisory committees. Representatives of the FDA, the Consumer Federation of America and the industry sit as liaison members of CIR’s Expert Panel. CIR’s ongoing review has evaluated thousands of ingredients, and its integrity and effectiveness have been praised by several FDA Commissioners over the four decades of its existence.
  • INCI: Recognizing the need for a uniform, internationally harmonized system for identifying cosmetics ingredients, the industry established the International Nomenclature Cosmetic Ingredient (INCI) program to create and assign specific ingredient names. Today, in the United States, and many countries around the world, INCI names are referenced by regulation for ingredient labeling cosmetics products. INCI names are developed by the International Nomenclature Committee and published in the International Cosmetic Ingredient Dictionary and Handbook. The first edition was published in 1976, and new editions are published every two years.
  • Quality, Safety and Microbiology Guidelines: The industry develops and publishes guidelines on a variety of topics. Among these are the Quality Assurance Guidelines, which provide approaches that cosmetics manufacturers can use for establishing their good manufacturing practices and quality assurance programs; the Safety Evaluation Guidelines, which provide manufacturers with guidance in the use of pre-clinical and clinical safety testing as a means to substantiate the safety of both ingredients and finished cosmetics products; and Microbiology Guidelines, which are intended to provide manufacturers with best practices in establishing and maintaining a microbiological quality program within their companies.
  • Cosmeticsinfo.org: CosmeticsInfo.org is an informational database containing science and safety information on cosmetics and personal care products – how they work, data to corroborate safety, and science behind commonly used ingredients. Developed and maintained by scientists and subject-matter experts, CosmeticsInfo.org is a trusted resource visited by millions of women, men, and families around the world each year. Importantly, the Website includes factual, publicly available scientific information on ingredients most commonly used in cosmetics and personal care products globally. PCPC and its member companies sponsor this website in an effort to provide consumers with easily accessible and understandable science and safety information about the products they trust and enjoy every day.
  • ICCR & ISO: ICCR is an international group of regulatory authorities from Brazil, Canada, the European Union, Japan, and the United States working together to promote regulatory alignment, in an effort to maximize consumer protection while minimizing barriers to trade. Likewise, the International Standards Organization (ISO) is an independent, non-governmental international organization with 164 national standards bodies as participating members. Through these members, ISO brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.