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.
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 PCPC developed the core elements of the industry’s Code, it engaged with consumers, policymakers, and experts in the industry to carefully consider their views. The safety and quality of products is a top priority for cosmetics and personal care companies, and that priority is reflected in the 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.
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.
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.
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.
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.
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.
Will PCPC terminate the membership of a non-compliant member company?
PCPC will not terminate membership for noncompliance. Rather than push companies outside this system by terminating their membership, PCPC will work with them to encourage compliance. Industry leadership is committed to the Code, and believes every company will understand it is in their interest to support it.
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 products. 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.
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.
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 FDA, the Consumer Federation of America and 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.