FAQs for Cosmetics Companies About the Safe Cosmetics and Personal Care Products Act of 2013
Introduced in the U.S. House of Representatives on March 21, 2013, the Safe Cosmetics and Personal Care Products Act of 2013 (H.R. 1385) aims to ensure that all personal care products are safe by establishing a system to assess the safety of cosmetics ingredients and to phase out the most harmful substances that are suspected of causing cancer, reproductive harm or other adverse health effects.
By shifting away from the toxic chemistry and polluting technologies of the past, American companies will lead the way in a global marketplace where consumers are demanding the next generation of safer, non-toxic products.
The bill is similar to the Safe Cosmetics Act that was first introduced into Congress in 2010, with some important changes made in response to concerns from the small business community that will make this legislation more effective and workable while still protecting consumer health. Most notably, changes were made to the fee structure and registration requirements for small businesses, and clarifications were made to the labeling and contaminants sections. See the frequently asked questions below and our chart of changes for more information about specific improvements made to the bill.
Understandably, cosmetics manufacturers may have questions about how safe cosmetics legislation will affect their businesses. Based on our interpretation of the bill language of the Safe Cosmetics and Personal Care Products Act of 2013, we've answered some of the most common questions below. Manufacturers, if you don't see the answers to your questions here, please contact us.
Frequently Asked Questions
According to our understanding of the Safe Cosmetics and Personal Care Products Act of 2013, cosmetics companies will have to:
The FDA's Voluntary Cosmetic Registration Program (VCRP) is a post-market reporting system for manufacturers, packers and distributors of cosmetic products that are in commercial distribution in the United States. According to the Congressional Research Service, as of 2010, approximately 1,903 cosmetics establishments (mostly manufacturing facilities) participated in the FDA voluntary registration program. This represents a small fraction of the industry.
The FDA cannot regulate an industry if it doesn't understand the industry's breadth and depth. Therefore, the Safe Cosmetics and Personal Care Products Act requires all domestic and foreign establishments that manufacture, package or distribute cosmetics in the U.S. to register annually with the FDA and pay a sliding scale registration fee; microbusinesses with under $2 million in annual sales are exempt from registration and fees, and small businesses with sales of less than $10 million per year are exempt from fees. Registration requirements include: the name, address and trade names of the manufacturers or packaging companies; a description of the cosmetics-related activities; the gross receipt of sales (for calculating the fee schedule); and the name and address of any company that supplies the manufacturer with cosmetics ingredients, including fragrance. The FDA is required to make the registration list publicly available, but registration documents would not be disclosed.
How will the fee mechanism work?
The Safe Cosmetics and Personal Care Products Act requires cosmetic products be substantiated for safety. However, it allows manufacturers to use supplier safety assessments to certify ingredient safety and asserts if every ingredient in a product has been substantiated for safety, a product is "assumed safe." The FDA has authority to require product testing if there is reason to believe the combination of ingredients poses a health concern.
Health endpoints and testing protocols are to be defined by the FDA. Food-grade ingredients are to be prioritized for safety assessment by the agency.
The Safe Cosmetics and Personal Care Products Act requires that within one year of enactment all product labels include the name of each ingredient in descending order of prominence, including the ingredients that make up fragrance. It's up to the FDA to determine whether all ingredients are to be listed on the product label or online. Botanicals such as essential oils and olive oil will continue to be listed as under current law, although the FDA will be allowed to require listing of specific constituent ingredients of concern (e.g. an allergen in an essential oil), similar to what is already required in the EU.
The bill requires the FDA to create a list of specific contaminants likely to be found in certain cosmetics ingredients, provide testing protocols for these contaminants and determine the level at which these contaminants must be listed on ingredient labels. It also creates a petition process for adding contaminants to the testing list. In addition, suppliers will be required to test for and provide a list of specific contaminants present in specific ingredients to manufacturers. This places the responsibility for safety assessment of ingredients on the suppliers rather than on manufacturers of cosmetics products.
Since most cosmetics manufacturers use purified or filtered water in their products (to avoid bacterial or other contamination and remove components that could interfere with stability and performance), it is unlikely the FDA would direct those companies to test water used in cosmetics for contaminants.
The Safe Cosmetics and Personal Care Products Act directs the FDA to distinguish between "safe" and "dangerous" cosmetic ingredients by applying a standard definition of safety to those chemicals. The safety standard included in the bill is designed to protect the most vulnerable populations, including infants, children, pregnant women and workers.
Within 2 years of bill enactment, the FDA will develop a list of cosmetics ingredients shown to be strongly associated with cancer and reproductive and developmental harm based on lists of these chemicals generated by authoritative scientific and regulatory bodies (such as the National Toxicology Program, IARC, and NIH). These chemicals, as well as other harmful chemicals, will be prohibited or restricted for use in cosmetics based on the safety standard. The agency will also generate a list of ingredients that are considered safe without limits for use in cosmetics within that same 2-year timeframe.
Not later than 1 year after the bill is enacted, the FDA will set up a publicly accessible database containing safety data related to cosmetics ingredients to provide guidance to industry about the safe use of ingredients. There will be no immediate changes to the ingredients allowed in cosmetics under the Safe Cosmetics and Personal Care Products Act. As ingredients are added to the prohibited or restricted list, companies will have one year to reformulate if they are using prohibited ingredients or if their use of ingredients on the restricted list violates the restriction (e.g. related to the type of use or concentration).
The Act requires companies to provide existing safety data on the cosmetic ingredients they are using to the FDA. It also requires suppliers of cosmetic ingredients to make available to manufacturers purchasing those ingredients a full listing of the chemicals in fragrance and preservatives and information regarding the toxicological properties and the safety – including any safety tests they've conducted – of those ingredients. This "producer right-to-know" provision will make it easier for cosmetic companies to make the safe products that consumers are asking for and deserve. Under the current system, suppliers do not have to disclose ingredients to manufacturers and they often won't provide that information.
The new system will aggregate all of this safety data, and make it publicly available to all companies so they can make more informed decisions about formulation and product safety.
The Campaign for Safe Cosmetics strongly supports small businesses and we have always been major advocates for elevating the work and values of the independent businesses that are the driving force of innovation toward health and safety in the personal care products industry. Preserving opportunities for small businesses to succeed, while also making sure that U.S. products meet a high bar of safety, is critical for the continued success of the personal care industry, as well as for the U.S. economy as a whole.
We worked with the small to medium sized companies in our Compact for Safe Cosmetics community to generate feedback and suggestions regarding the Safe Cosmetics Act of 2010 to make this bill more effective and workable for small businesses and shared these recommendations with the bill authors.
Small companies will be required to meet the provisions of the bill, such as disclosure of fragrance ingredients (which many Compact signers are already doing) and safety substantiation of product ingredients (which is a requirement of current law but not enforced by the FDA due to lack of authority). We believe these challenges can be met without harm to small businesses and we believe the benefits of the Safe Cosmetics and Personal Care Products Act to small businesses will far outweigh the challenges.
This is the direction many countries and smart businesses are headed: toward policies that require precaution (eliminating chemicals of highest concern, as Europe and other countries are doing) and transparency (because consumers and manufacturers have a right to know what's in the products they buy) and toward the open flow of information.
The Safe Cosmetics and Personal Care Products Act of 2013 contains specific provisions to protect and help small businesses, including:
In the big picture, the Safe Cosmetics and Personal Care Products Act will benefit small businesses by increasing the flow of information to businesses and consumers, leveling the playing field and increasing consumer awareness about their choices at the store. In the current marketplace, where ingredients are kept secret and toxicity data is inaccessible, consumers are confused and do not have easy access to the information they need to make informed choices. The data and product transparency provisions of the Act will help clear up confusion and give consumers the tools to more easily choose the best and safest products.
The Act will also lift the cosmetics industry as a whole. While many large companies do not want to change, it is not helpful to the American cosmetics industry to be using decades-old formulations with known toxicity problems, and ignoring the new science that makes it clear that low-dose toxic chemical exposures are a health hazard. The Safe Cosmetics and Personal Care Products Act of 2013 will bring the American cosmetics industry to the forefront of global competitiveness by setting a bottom line of safety all companies have to abide by, moving the industry as a whole away from the polluting chemistry of the past, and spurring the innovation of green chemistry and the development of the next generation of safer products that the world market is demanding – increasing consumer confidence in U.S.-made products and ensuring that we all have access to safe personal care products.
Currently, nail and beauty salon workers have little access to information about the chemicals they are exposed to on a daily basis. Unlike products sold at stores, salon products do not even have to carry an ingredient label. While Material Safety Data Sheets (MSDSs) outlining the hazards of chemicals in salon products are required, they are ineffective tools for disseminating information because of language barriers present in many salon workers and because MSDSs are often incomplete or aren’t made accessible workers.
The Safe Cosmetics and Personal Care Products Act of 2013 would require full listing of ingredients on the labels of professional salon products and would require distributors of salon products to make available to salon operators expanded MSDSs for products used by workers in salons that include health hazards listed by authoritative bodies or found in scientific studies. It would also require the translation of the MSDSs into Spanish and Vietnamese.
No, just the opposite. We often hear that "regulation holds back innovation," but when it comes to chemicals used by the beauty industry, the opposite is true. Lack of information about cosmetic ingredients is holding back innovation and slowing down the inevitable move to safer products that will benefit health and the environment. According to a University of California report, signed by more than 100 academics, green chemistry innovation will not happen without new policies that stimulate the market.
Setting a bottom line of safety in the marketplace doesn't limit the ability of companies to innovate safer alternatives and lift the bar even higher in terms of safety and sustainable production—it just creates a level playing field and a common set of rules on safety and transparency.
The Campaign for Safe Cosmetics supports uses of non-animal testing methods where available and effective, and fully supports initiatives to fund research on alternative, non-animal health and safety testing. We believe it is possible to achieve dramatic reductions in the number of animals tested, while improving protection of the health and safety of people and other animals, through more efficient and humane testing protocols, reduction or elimination of unnecessary, duplicative or archaic tests, and by developing policies to improve sharing of animal test data across companies within the chemical and personal care product industries.
The Safe Cosmetics and Personal Care Products Act of 2013 works to minimize animal testing by:
Another bill recently introduced into Congress, the Safe Chemicals Act, reforms the Toxic Substances Control Act of 1976, which governs industrial chemicals under the Environmental Protection Agency (EPA). Cosmetics are explicitly exempt from this bill because they fall under the purview of the FDA. The Safe Cosmetics and Personal Care Products Act of 2013 reforms the Food, Drug and Cosmetics Act of 1938. Both bills contain safeguards to design a fair system that assesses chemicals for safety, phasing out the most toxic substances and making chemical information more available and transparent. The bills support and reinforce each other, and both are needed to protect consumers, product manufacturers and the environment.
The Campaign for Safe Cosmetics is a coalition of non-profit breast cancer prevention, environmental, health and consumer public interest organizations working to ensure that everyone has access to safer body care products. Learn more about us.
Growth in the natural beauty sector in recent years is being driven largely by concerned consumers seeking safer alternatives to toxic chemical-laden products and the Campaign for Safe Cosmetics has been at the forefront of educating the public about this issue via our reports, website, public outreach and EWG's Skin Deep website since 2002.
We work with companies who are leading the way in making safer products and invite these companies and other members of the health and beauty industry to join us in our efforts for sensible policies that set a bottom line of safety, give consumers better information so they can make informed choices about the products they buy, and are a win-win for our health, innovation, sustainable businesses of all sizes and the planet.