- INCI Info
- What is INCI
- INCI FAQs
- On-line Application
- INCI Application - Complete Details
- INCI Nomenclature Conventions
- INCI Application - Name Assignment Timetable
- INCI Name Change Procedure
- INCI Process Flow Chart
- INCI Name Changes
- The International Cosmetic Ingredient Nomenclature Committee
- 2017 INCI Meeting Dates
- Regulatory Information
- Typographical Corrections to INCI Names
- Contact Information
- Member & Industry Resources
- On-Line INFOBASE
- Certificates for Export
- Council Committees
- Events & Webinars
- Career Center
- Industry Connections
- Ingredient Buyers' Guide
- Standardized Raw Material Information Form (RMIF)
- INCI Application
- Supplier Directory
- Science & Safety
- Legislation & Regulation
- Legislative Advocacy
- Industry Regulation
- Labeling & Packaging
- Political Action Committee
- Related Agencies & Regulations
- Global Strategies
- Public Information
- News Room
Statement by Farah Ahmed, Chair Personal Care Products Council Sunscreen Task Force, Response to the 2011 EWG Sunscreen Report
Submitted by CLOVER2 on May 23, 2011
May 23, 2011
Contact: Kathleen Dezio, (202) 454-0302 or Lisa Powers, (202) 466-0489
“Despite the extensive body of credible scientific research that demonstrates the safety, efficacy, and public health benefits of sunscreen products, the Washington, DC-based activist group, the Environmental Working Group (EWG), has again questioned the safety and efficacy of sunscreens in another unscientific and unsubstantiated report released just in time for Memorial Day. EWG’s assertions about the safety and efficacy of sunscreen products and ingredients lack the rigor and reliability of formal, expert evaluation, are not peer-reviewed, and confuse and alarm consumers.
“In its 2011 sunscreen report, EWG once again challenges the scientific community’s consensus that sunscreen products are safe and effective. The group’s allegations are in direct conflict with established scientific safety assessments of sunscreen products and their ingredients and the assessments of regulatory authorities in the U.S., European Union, Canada, and several other countries. Ignoring the established scientific and regulatory safety assessment process for sunscreen products and ingredients, EWG invents its own sunscreen product rating system not based on credible scientific methodology. In fact, EWG’s methodology for calculating SPF values has been proven to be inaccurate and unreliable by sunscreen experts, both in the U.S. and abroad.
“Compounding this lack of scientific objectivity is the fact that sunscreen products ranked highly by EWG are promoted for sale on the group’s Web site via their partnership with Amazon.com, generating revenue for EWG and demonstrating a clear and inappropriate commercial interest.
“Consumers can be confident that the sunscreen products they rely on for protection against the harmful effects of the sun are both safe and effective. Sunscreen products have been thoroughly studied and tested by qualified scientists and regulatory authorities throughout the world. In the U.S., sunscreens are regulated as over-the-counter (OTC) drugs by the U.S. Food & Drug Administration (FDA) and are subject to rigorous scientific assessment, including safety and efficacy substantiation according to FDA standards that are among the most rigorous in the world.
“In addition to FDA, the Centers for Disease Control (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation, physicians and other health care professionals also emphasize the safety of sunscreens and the importance of their use as part of a safe sun regimen.
The dangers of the sun are clear and widely recognized by sunscreen experts and dermatologists. A National Institutes of Health “Report on Carcinogens” identifies solar UV radiation as a “known human carcinogen.” Further, a single bad burn as a child is known to increase the skin’s susceptibility to damage and skin cancer throughout life. In light of this scientifically sound and somber evidence of the dangers of the sun, it is alarming that EWG’s “annual report” could cause some consumers to avoid using sunscreens on themselves and their children.
“EWG’s report is fraught with unsubstantiated assertions, contradictions, and distorted facts. Some examples include:
“EWG’s report cites increasing skin cancer rates and questions sunscreen efficacy in fighting this dangerous disease. EWG fails to consider that the higher skin cancer rates of today are the result of excessive unprotected sun exposure from several previous decades as well as the ability to better track, monitor, and report occurrence of the disease.
“It is important to understand that approximately 90 percent of nonmelanoma skin cancers are associated with exposure to ultraviolet (UV) rays from the sun.1 Each year there are more new cases of skin cancer than the combined incidence of cancers of the breast, prostate, lung and colon.2 Further, up to 90 percent of the visible changes commonly attributed to aging are caused by the sun.3
“EWG’s assertions are contrary to the body of scientific and medical data that recognizes the use of sunscreens as part of an overall program of sun safety to help protect against skin cancer and other forms of damage caused by the sun.
Vitamin A in Sunscreen
“Retinyl palmitate, commonly known as Vitamin A, has been used safely in various cosmetic and cosmetic/OTC drug preparations, including sunscreen products, for many years. In its latest sunscreen report, EWG once again questions the safety of Vitamin A in sunscreens. Vitamin A, an important vitamin in humans, is made up of a family of compounds called retinoids. Retinoid esters, including retinyl palmitate, account for more than 70 percent of Vitamin A. Retinyl palmitate is approved by FDA as a food additive. Retinyl palmitate has been reviewed by the Cosmetic Ingredient Review (CIR) twice and found to be safe for use in cosmetics. CIR is an independent panel of renowned scientific and medical experts that assesses the safety of cosmetic ingredients used in the U.S.
“There is no compelling evidence that retinyl palmitate in sunscreen products presents any human health risk to consumers. In 2000, the National Toxicology Program (NTP) published a notice stating that it would study the potential of retinyl palmitate to enhance UV radiation-induced photocarcinogenicity. The NTP issued a report for this study in 2011, conducting a peer review in January 2011. The Personal Care Products Council filed extensive and detailed comments highlighting the serious methodological flaws associated with this study. In spite of these flaws, the NTP Peer Review Panel nevertheless concluded there was an effect above the control cream (cream without retinyl palmitate) used in the test. Unfortunately, the control cream, which in all toxicological tests should not cause any effect on the test animals, was improperly formulated for this test and caused a significant response that all but obscured the ability to detect any affect arising from retinyl palmitate. In fact, the flaws are so significant that the results of the study cannot be used for a science-based assessment of risk. It should be noted that there is a large body of evidence that in humans, retinoids have anti-cancer effects, in contrast to the effects sometimes seen in mouse models.
“Unfortunately, EWG has inappropriately used these findings to alarm consumers by telling them that products containing retinyl palmitate, including sunscreens, may not be safe. Their position is simply not supported by the available scientific data.
Safety of Oxybenzone
“In its latest sunscreen report, EWG again questions the safety of an FDA-approved active ingredient in some sunscreens called oxybenzone. When used as a sunscreen ingredient, oxybenzone, also known as Benzophenone-3, protects the skin from harmful UV rays.
“FDA and regulatory authorities in Canada and the European Union have approved the use of oxybenzone as a safe and effective OTC sunscreen ingredient. The safety of oxybenzone has also been reviewed and confirmed by the CIR expert panel (http://www.cir-safety.org/index.shtml). CIR has confirmed that oxybenzone is safe for use as a photo stabilizer (to protect the formulation) in cosmetic products.
“EWG also alleges a connection between UV filters found in sunscreens and hormone or endocrine disruption, but to date, available scientific data does not support a link between UV filter exposure and endocrine-disruptive effects in humans.
Sunscreen and Free Radicals
“It is well known that UV light can produce free radicals in the surface of the skin and that this leads to the damage associated with excessive exposure to sunlight, most often observed as redness or sunburn.4 The skin produces natural barriers that absorb the UV light to protect against damage. The interaction of solar UV with these natural barriers can produce free radicals.
“The application of a sunscreen supplements the natural UV absorbers and protects against free radical formation and the associated damage that can occur. Even if sunscreens were to form free radicals, this would occur on the surface of the skin and would not affect the underlying structures.
“Every sunscreen is tested in an SPF test to establish the level of protection provided by the product. These tests confirm that the level of damage in sunscreen-protected skin is well below what occurs in the absence of sunscreen application since there is no ‘redness’ produced. Moreover, even with doses of UV light, which do produce free radicals and redness, the presence of sunscreens blocks such reactions.
“By virtue of their ability to absorb UV radiation before it can interact with skin, sunscreens provide significant protection against UV-induced free radical formation within skin compared with unprotected skin. Studies have documented the protective effects of individual sunscreen actives as well as commercial sunscreen products for their ability to protect against UV-induced free radical formation within skin compared with untreated or bare skin.5
“EWG outlines the benefits of vitamin D, but then creates confusion and mischaracterizes the role of sunscreens in cases of alleged Vitamin D deficiency. AAD notes that getting Vitamin D primarily from sun exposure is not advisable.6 While UV radiation is one source of Vitamin D, it is not the best source because the benefits of obtaining Vitamin D through UV exposure cannot be separated from an increased risk of skin cancer. Instead, the AAD recommends that ‘…an adequate amount of vitamin D be obtained from a healthy diet that includes foods naturally rich in Vitamin D (e.g., dairy products and fish), foods/beverages fortified with Vitamin D (e.g., fortified milk and fortified cereals), and/or Vitamin D supplements.’7
“EWG also questioned the safety of the inclusion of nanoparticles in sunscreen products, despite the fact that the general scientific consensus is that nano-sized titanium dioxide and zinc oxide in personal care products pose no risk to human health. Sunscreen active ingredients, some of which utilize sun-protecting nanoparticles, go through an extensive FDA review process to demonstrate they are safe and effective.
“The 2011 EWG report also claims that many sunscreen ingredients break down significantly when exposed to sunlight and quickly stop working. This is simply not true. Sunscreen formulators take into account the physical and chemical properties of the active ingredients to ensure they perform effectively and meet all established FDA requirements, including chemical stability. FDA also requires that sunscreens meet strict stability testing requirements to ensure they are effective when purchased by consumers.
FDA Sunscreen Monograph
“EWG asserts that FDA has intentionally delayed issuing the final sunscreen regulations. We are not aware of any evidence to support this assertion. We support FDA’s commitment to making decisions based on sound science. Finalizing sunscreen safety standards is a highly complex regulatory undertaking that requires the careful application of scientific principles and consideration of the evolving science and thousands of data submissions received by FDA. The Council has submitted extensive technical and scientific comments as part of FDA’s public and transparent OTC rulemaking process. We understand that FDA is considering these comments, along with thousands of others that have been submitted, and will publish their conclusions after their review is complete. It is critical that FDA has a sound scientific basis for ensuring that sunscreens provide consumers with the protection they need.
“Consumers who have questions about sunscreen use and the safety and efficacy of sunscreens should visit FDA's Web site at http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Tanning/ucm116445.htm, or the Personal Care Products Council's safety Web site at http://www.cosmeticsinfo.org/product_details.php?product_id=47.
“The Personal Care Products Council joins with the American Academy of Dermatology, the Skin Cancer Foundation, Centers for Disease Control, FDA and other health professionals in urging consumers to minimize their sun exposure as part of an overall safe sun strategy. This includes all of the following: limiting outdoor activities or seeking shade between 10:00 a.m. – 4:00 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreen."
1 Pleasance ED, Cheetham RK, Stephens PJ, et al. A comprehensive catalogue of somatic mutations from a human cancer genome. Nature; 2009; 463:191-196.
2 Stern, RS. Prevalence of a history of skin cancer in 2007: results of an incidence-based model. Arch Dermatol 2010; 146(3):279-282.
3 U.S. Environmental Protection Agency. Health effects of overexposure to the sun. July 1, 2010.
4 T Herrling, K Jung, E Chatelain and M Langenauer, Radical Skin/Sun Protection Factor RSF - Protection against UV-induced Free Radicals, SOFW-Journal 132, 24-28 (2006).
5 T Herrling, K Jung, E Chatelain and M Langenauer, Radical Skin/Sun Protection Factor RSF - Protection against UV-induced Free Radicals, SOFW-Journal 132, 24-28 (2006); K Jung, M Seifert, T Herrling and J Fuchs, UV-generated free radicals in skin: their prevention by sunscreens and their induction by self-tanning agents, Spectrochim. Acta Part A 69, 1423-1428 (2008); KM Hanson and RM Clegg, Bioconvertible vitamin antioxidants improve sunscreen photo protection against UV induced ROS, J. Cosm. Sci. 54, 589-598 (2003).
For more information about cosmetic and personal care products, visit www.cosmeticsinfo.org.
Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, the Council's more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on every day, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.