Testimony of Dr. Jay Ansell Before California Assembly Committee on Environmental Safety and Toxic Materials

Chairman Quirk and Members of the Assembly Committee on Environmental Safety and Toxic Materials:

Good afternoon, I am Dr. Jay Ansell, Vice President for Cosmetic Programs at the Personal Care Products Council.  I am both a Ph.D. chemist and board-certified toxicologist, and I am here to express our strong opposition to Assembly Bill 495.

This bill proposes an outright ban on many ingredients extensively reviewed by independent experts worldwide and found safe for use in cosmetics. The ban would adversely affect tens of thousands of products and potentially compromise the ability to provide consumers with the safe high-quality products they expect.

Simply stated, no other authority in the world agrees that an outright ban for many of these ingredients is needed.

PCPC is the leading national trade association representing more than 600 companies, including 100 that either call California home or have a presence here.  The beauty and personal care industry is an important part of California’s economy, employing approximately 415,000 people throughout the state while contributing $28 billion to the state’s economy.

More specifically, PCPC is opposed to AB 495 for the following reasons:

  • S. federal law governing cosmetics and personal care products absolutely requires that cosmetics products and ingredients must be safe for consumers, AND that companies and individuals who market cosmetics are legally responsible for assuring the safety of their products.
  • Federal law provides enforcement authority and sets severe penalties for product manufacturers that do not meet these strict requirements. The law allows inspections of manufacturing plants; issuing Warning Letters; requesting voluntary recalls with the issuing of press releases; and, working with the Department of Justice, having restraining order issued; products seized; up to and including criminal prosecution.
  • The bill would ban whole classes of preservatives used in tens of thousands of products. These preservatives are widely used and have been reviewed and found safe for use in cosmetics by authoritative bodies both within and outside the United States.  Having a suitable pallet of preservatives is an essential requirement in cosmetic formulation science making sure that products maintain their integrity over time, particularly during storage and use by consumers. Lack of proper preservation can lead to contamination of products with harmful microorganisms – which can result in eye, skin and respiratory infections.
  • The bill places a ban on products containing naturally occurring impurities that are found in everything from the air we breathe to the food and water we consume. Lead, for example, is never an intentionally added ingredient.  It can be found in trace amounts in water and soil and therefore may be found in extremely low levels as a trace contaminant in many raw materials. Manufacturers and Regulatory bodies around the world know this and have already addressed this issue.  As an impurity in cosmetics, limits for lead have been set under the International Cooperation on Cosmetics Regulation program, which includes cosmetic regulators from the U.S., Canada, Japan, Brazil and the European Union. Even California’s own OEHHA has set a No Significant Risk Level for lead in the Safe Drinking Water and Toxic Enforcement Act of 1986.
  • In 2008, the legislature agreed that the best venue for science-based decisions is with DTSC and State Agency scientists. The Safer Consumer Products Law was enacted so that the legislature would not be faced with bills like AB 495, which puts them in the position of making complex scientific decisions on an ingredient-by-ingredient basis. AB 495 contradicts OEHHA by proposing an outright ban on several chemicals already addressed or are currently under review by DTSC. At a minimum, California should let DTSC continue the role it was given by this legislature before stepping in and introducing additional regulation.
  • Last but not least, cosmetics companies work with and employ thousands of chemists, toxicologists, biologists, and environmental scientists and has invested hundreds of millions of dollars in research advancing 21st century safety assessment science – all to ensure we are providing safe, high-quality products to our consumers.

In summary, this bill proposes to ban ingredients that play a critical role in assuring the safety of cosmetics relied on by consumers, addresses other substances that are not and would not be used as ingredients and in many ways’ conflicts with conclusions of California’s own experts.

For all of the above reasons, we oppose AB 495.

Thank you for the opportunity to hear our views and we respectfully ask for your NO vote.

Testimony of Francine Lamoriello, Executive Vice President, Global Strategies, Personal Care Products Council at US Trade Representative Hearing – Negotiating Objectives Regarding Modernization of NAFTA

Good Afternoon. On behalf of the U.S. Personal Care Products Council, I am pleased to be here today to discuss our industry’s objectives for the renegotiation of NAFTA.

The Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, our more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the United States. Our members continually strive to uphold and surpass the most stringent regulatory and product integrity standards worldwide.

Over the past two decades, NAFTA has contributed significantly to the ability of our member companies to expand manufacturing and employment here at home, and to achieve scientific and technological innovations that benefit consumers worldwide.

International trade is a critical component to the success of our industry. In 2016, the U.S. personal care products industry exported over $12 billion to the world. And, more relevant to today’s discussion, our exports to Mexico and Canada made up over 30% of our global exports, reaching $3.7 billion.

The strong export performance of the U.S. cosmetic and personal care industry reflects preference and loyalty to our brands by consumers in North America and, indeed, around the world. And, in developing the exciting, innovative products that consumers love, our member companies must think globally: searching worldwide for ingredients that offer unique quality and performance characteristics; special designs and packaging that support the brand’s image and fashions of the day; and services, such as marketing and advertising, that allow us to promote our products on the ground. Canada and Mexico are not only important markets for U.S. products, but are also important sources of our products’ components and services.

Thus, our industry firmly supports free trade in North America. Preserving and expanding the benefits that our industry has already experienced under NAFTA will be critical in any future negotiation. NAFTA must remain a trilateral agreement. Customs benefits and rules of origin criteria and zero tariff rates for our products and raw materials must be retained, and our companies must be able to move our products efficiently throughout the North American region.

Beyond retaining the commercial and economic benefits already achieved, the U.S. cosmetic and personal care products industry supports an ambitious agenda for “NAFTA 2.0” that eliminates remaining trade and regulatory barriers and also sets additional commitments to international best regulatory practices.

In particular, the re-negotiation of NAFTA offers an opportunity to deepen the commitment of NAFTA partners to comprehensive regulatory convergence in the cosmetics sector.

The goal of comprehensive cosmetic regulatory convergence with Canada and Mexico would significantly reduce industry costs related to product formulation, marketing, labeling, and supply chain management; would avoid unnecessary duplication, and would facilitate market access and trade, especially for small and medium-sized companies. Consumers would enjoy access to a wider array of safe and effective products at more competitive prices, and regulators would be positioned to conserve resources for product categories that may pose greater risks to public health and safety.

We believe the goal of comprehensive cosmetics regulatory convergence throughout the NAFTA region can best be achieved by including in NAFTA 2.0 a sector-specific Annex that would confirm regulatory good practice for cosmetics products, allow for deeper regulatory convergence for the cosmetics sector in North America, and encourage the wider goal of global regulatory convergence.

A NAFTA Cosmetic Annex should include commitments to a risk-based regulatory approach that recognizes that cosmetic products pose minimal potential risk to human health and safety; Should eliminate burdensome registration and testing requirements that are not in keeping with international best practices; and, should align labeling requirements wherever possible, in particular with respect to ingredient labeling, which should be fully harmonized based on the International Nomenclature of Cosmetic Ingredients (INCI).

We have detailed these and other aspects of a NAFTA Cosmetics Annex in our written submission. I would like to point out that our objectives for a NAFTA Cosmetics Annex go beyond what was achieved in the TPP Agreement. In our view, the modern and robust regulatory systems already in place in the United States, Canada and Mexico should provide the basis for trust and confidence that will allow regulators to pursue broader and deeper alignment.

This will be particularly important in considering ways in which Canada and the United States can better align their regulatory practices for over- the-Counter (OTC)-type cosmetics (Mexico does not recognize this category of products).

U.S.-Canada trade in OTC products, such as sunscreens, antiperspirants, antiseptic cleansers and others, is very significant.

We believe that NAFTA should include commitments by the U.S. and Canada to take steps such as aligning requirements for good manufacturing practices; allowing for mutual acceptance of products compliance with either system’s requirements; eliminating redundant inspection procedures; and harmonizing recognized test methods.

Measures such as these would recognize the fundamentally similar regulatory approach already being followed for these products by the U.S. FDA and Health Canada, and would reduce administrative burdens and costs for the two regulators as well as for industry.

The U.S. Personal Care Products Council is working closely with our sister associations in Canada and Mexico to support the renegotiation of NAFTA, and we are in agreement on all of the objectives I’ve described.

In short, we believe strongly that an updated NAFTA can advance our goals of providing global consumers with safe, innovative products and expanding international trade and economic growth.

Once again, we appreciate this opportunity to present the views of our industry and would be pleased to respond to any questions.

Thank you.

Testimony of Beth Lange Jonas, Ph.D. Chief Scientist Personal Care Products Council Before the Senate Committee on Health, Education, Labor & Pensions (HELP) “Exploring Current Practices in Cosmetic Development and Safety”

Chairman Alexander, Ranking Member Murray and distinguished Members of the Committee, thank you for the opportunity to appear before you on behalf of the Personal Care Products Council.  My name is Beth Jonas. I am the Chief Scientist for the Personal Care Products Council and I hold a Ph.D. in Radiation Biology from the University of Iowa, College of Medicine. I also am a member of the American Academy of Dermatology.  

Prior to joining the Council, I was the Chief Scientific Officer at Mary Kay Inc.  I joined Mary Kay from Schering Plough Consumer Health where I served as Senior Director of Worldwide Skin Care and International over-the-counter medicines.  I have held management positions at Kimberly-Clark and Unilever corporations and have been granted more than 20 U.S. and European patents. I am here today to speak about the important role that science plays in the cosmetics and personal care products industry and how this industry enhances the lives of millions of American families who trust and rely on these products every day.  

The Personal Care Products Council is one of the oldest and most established trade associations in Washington.  We represent approximately 600 large, medium and small sized companies that manufacture and distribute many of the most trusted and beloved brands in beauty and personal care today.

Cosmetics and personal care products are among the safest product categories regulated by the Food & Drug Administration (FDA).  FDA has clear authority to regulate the safety of these products under the Food, Drug & Cosmetic Act, which requires that every product and its individual ingredients be substantiated for safety before they are put on the market, and that the labeling of those products be truthful and not misleading.  It is a company’s clear responsibility to ensure that its products comply with the law and the current law provides penalties for manufacturers that do not meet these standards. Companies take their responsibility for safety very seriously.

Consumer and product safety are top priorities for our industry, with careful and thorough scientific research and development serving as the foundation for everything that we do.  The U.S. cosmetics industry invests nearly $3 billion each year in scientific research and development. As a result of this research, approximately 2,000 new products are launched annually, and numerous scientific papers are published on enhancing or developing new safety methods.

The industry employs nearly 6,000 scientific and technical professionals dedicated to ensuring product and ingredient safety.  Companies also work with a number of scientific and medical experts – chemists, toxicologists, microbiologists, dermatologists, epidemiologists, environmental scientists and other technical experts – to evaluate and ensure the safety of their products before they reach the consumer.  In addition to outside experts, companies use pre-clinical and clinical safety testing as a means to substantiate the safety of both ingredients and finished cosmetic products. Pre-clinical testing may include in vitro alternative methods using cell and tissue cultures following accepted regulatory guidelines when available.  In silico methods, such as the use of structure-activity relationships, may add to the overall weight of the evidence for safety evaluation. Clinical testing involves confirming safety testing with human volunteers. Once the relevant safety data are assembled, a risk assessment must be conducted to see if the data provide an adequate margin of safety given the particular exposure circumstances.

Companies conduct product safety evaluations using the same science-based approaches embedded in the research practices at FDA, EPA, and other regulatory agencies around the world.    Cosmetic safety assessments are thorough and address numerous health questions, including, but not limited to the potential for cancer, reproductive harm, allergic reactions, and how an ingredient is cleared if it goes through the body.   The foundation of science-based safety assessments is that any ingredient has a safe range and an unsafe range whether it is water, or a vitamin, or a newly discovered compound. An ingredient’s safe range is defined through many studies before it can be used in a product.  Safety is about choosing ingredients that can be used well within their safe range and within certain formulations, and avoiding ingredients that cannot be used safely. A complete safety assessment also accounts for who uses the products, how they are used and how often, over a lifetime.  Finally, companies’ post market surveillance of the consumer experience acts to affirm product safety. The product development cycle can take up to two years to complete, sometimes longer.

Once a product is on the market, an active and structured surveillance of consumer experience during use can be used to further support product safety.  For most products, the marketplace represents a much larger and diverse population than any of those used to evaluate a product during pre-market activities. Therefore, unanticipated safety-related concerns with a product may be revealed.  A manufacturer should establish a post-market surveillance process for the reporting, recording and review of adverse health effects related to their products. A properly structured surveillance process will also help identify consumer use patterns, such as alternate uses or product combinations, which may contribute to adverse effects.

In addition to the work of each individual company, our trade association supports independent programs to review product and ingredient safety.  Perhaps the most significant example of this is the Cosmetic Ingredient Review Expert Panel, which was established in 1976 with involvement and support from the FDA and the Consumer Federation of America.

Today, CIR is the only scientific program in the world dedicated to a thorough and continuous review of cosmetic ingredient safety in a public forum.  The CIR Expert Panel, which meets in public in Washington, D.C. four times a year, is an independent, non-profit body of world-renowned physicians and scientists who examine and assess cosmetic ingredient safety data in an open, public manner. Their work is critical to our industry.  The FDA and the Consumer Federation of America, along with the Council, serve as non-voting members of CIR and play a valuable role in the deliberations. These reviews define safe ranges for ingredients used in products, and each ingredient report often involves the panel’s scrutiny of hundreds of studies.  CIR has also evaluated the safety of certain cosmetic ingredients at the request of FDA and all of its findings are published in the peer-reviewed scientific journal, The International Journal of Toxicology.

In addition, the cosmetic industry plays a unique role in the lives of American families and is committed to enhancing their lives in a number of ways.   We are a major source of high-paying manufacturing and management jobs and are committed to a diverse workforce. Our companies employ more women and people of color in management positions than the national average.  Women and people of color account for nearly 74% of all employment in the personal care products sector and 61.2% of management positions. We support a wide range of corporate and social programs, issues and causes that make our communities better places to live.

Council member companies that are direct sellers like Avon, Mary Kay, and Amway, among others, offer strong entrepreneurial opportunities for women across America – opportunities that allow for personal growth and economic freedom.

We look forward to working with Congress and key stakeholders – as we have for nearly a decade – to modernize FDA’s regulatory authority over our industry.  We support the creation of a national standard that maintains the continued safety of our products while providing the Agency with the resources it needs to offer peace of mind to the families who trust and rely on our products every day.  Despite this strong safety record, a comprehensive national program is needed to assure uniform regulation of cosmetics throughout the country and to prevent an unworkable patchwork of differing state requirements across the nation. We also believe that a strong national standard will give businesses the certainty they need to continue to innovate and provide consumers access to both legacy brands and the new, exciting and safe products they have come to expect.  

We also support mandatory registration with FDA of manufacturing facilities and ingredient statements; authorizing FDA to issue Good Manufacturing Practices for cosmetics; reporting to FDA serious adverse events; and creation of a program for FDA to review the safety of cosmetic ingredients.

In summary, our work and that of our members is based on sound scientific principles.  Our industry puts consumer safety first, and we will continue to proactively work to ensure the products we manufacture contribute to the well-being of American consumers.

Thank you for the opportunity to be here today.  On behalf of the members of the Personal Care Products Council, we look forward to working with Congress to move reform forward.     

Testimony of John Hurson, Executive Vice President, Government Affairs, Personal Care Products Council Before the U.S. House Committee on Energy and Commerce

Chairman Pitts, Ranking Member Green, Chairman Upton, Ranking Member Pallone, and members of the Committee, thank you for the opportunity to testify in support of discontinuing the use of plastic microbeads in personal care cleansing products and specifically to address H.R. 1321, the Microbead-Free Waters Act.

The Personal Care Products Council is the leading trade association representing approximately 600 large, medium and small sized companies that manufacture and distribute the vast majority of cosmetic and personal care products marketed in the U.S.  As makers of a diverse range of products that consumers trust and rely on every day, from sunscreen, shampoo and toothpaste to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to safety, quality and innovation.

The American cosmetics industry employs more than 2.8 million people nationwide with more than $260 billion in global annual sales.  Our industry is dynamic, and continuously develops innovative products to meet consumer demands and expectations. Our member companies invest more than $3.6 billion each year on scientific research and development.  As a result of this research, 2,000 new products are launched each year, and numerous scientific studies are published on enhancing or developing new safety methods.

Equally important, is that our industry shares a common interest with other stakeholders in protecting the environment, and our members take questions regarding the presence of microbeads in our waterways very seriously.  Our industry has a long standing commitment to the global environmental stewardship of its products.

Historically, plastic microbeads have been used in some personal care cleansing products because of their safe and effective exfoliating properties. These plastic beads have an excellent health and safety profile, do not present adverse effects such as allergic reactions, are gentle on the skin, especially for consumers with sensitive skin conditions.

Over the last five years, numerous reports in the press and some scientific literature have indicated the occurrence of plastic microbeads in our oceans and lakes.  It should be noted that the sources of these plastic microbeads are varied and difficult to ascertain. These may include clothing fibers, boat paint particles, degrading plastic bags, plastic bottles, and personal care products.  However, out of an abundance of caution and despite the absence of any peer-reviewed science on the contribution from personal care products to plastic microbeads in the aquatic environment, our member companies have committed to discontinue formulating products with plastic microbeads in favor of other viable alternatives.

While we do support the discontinued use of plastic microbeads, it is important to recognize that product reformulation is an extremely complex process.  Various and necessary steps include raw materials research and development, product testing and qualification to meet safety and regulatory requirements, manufacturing, and post market surveillance for continual evaluation – this process takes many years.  Furthermore, because of our commitment to the safety of our products, we must affirm that the alternative ingredient will not cause unintended consequences and will meet our consumers’ safety and product needs.

In 2014, a wide range of environmental, government and business stakeholders came together in the state of Illinois to negotiate legislation to phase out plastic microbeads.  All stakeholders supported the bill, which passed both houses unanimously and was signed into law in June of last year. New Jersey, Maine, Indiana and Colorado have enacted similar legislation, and the Council of State Governments, a bi-partisan government organization of state government officials, has adopted the Illinois law as suggested model legislation.

Our industry supports federal plastic microbeads legislation establishing a national uniform standard that provides certainty for both consumers and businesses, by setting appropriate and pragmatic phase out dates, appropriate definitions of synthetic plastic microbeads, and inclusion of over the counter drugs containing plastic microbeads.

It is especially important to carefully define synthetic plastic microbeads in the statute to avoid inadvertently prohibiting the use of natural alternatives and to make sure the prohibition provides clear direction to companies regarding reformulation.  The dates for prohibition of manufacture and sell through of both personal care products and OTC products are also critical to assure a level playing field for both large and small companies as they reformulate.

With the right policy framework, we can remain an innovative industry providing our consumers with the safest, high quality products they expect and deserve while also doing our role to continue to protect the environment.  

Thank you again for the opportunity to be here today.  On behalf of the members of the Personal Care Products Council, we look forward to working with the Committee on this legislation.