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April 1, 2009

Baby Care Products Are Safe, Asserts The Council

After the Campaign for Safe Cosmetics (CSC) issued last month the results of study that found high levels of 1,4 dioxane and formaldehyde in personal care products, the Personal Care Product Council issued a statement challenging the results.

“Allegations made today that commonly used baby products are somehow contaminated with harmful levels of carcinogenic chemicals are patently false and a shameful and cynical attempt by an activist group to incite and prey upon parental worries and concerns in order to push a political, legislative and legal agenda,” said The Council. 

According to The Council, the levels of the two chemicals the group reportedly found are considered to be “trace” or extremely low, are well below established regulatory limits or safety thresholds, and are not a cause for health concern. When present, these chemicals would likely be found at very low levels precisely because companies have gone to great lengths in the formulation and manufacturing processes to ensure that the products are safe and gentle for children and also protected from bacterial growth.

“Contrary to their attempt to position this report as something new and scientifically noteworthy, there is nothing revelatory or scientifically objective in it,” said Dr. John Bailey, chief scientist for The Council. “The U.S. Food & Drug Administration (FDA), the Cosmetic Ingredient Review (CIR), an independent panel of scientific and medical experts who assess the safety of ingredients used in U.S. cosmetic and personal care products, and other authoritative bodies throughout the world have long been aware of the potential presence of 1,4 dioxane and formaldehyde in personal care products and found them to be safe when present at low levels.” 

According to The Council, the report is one of many the group has issued in the past several years attacking different preservatives and other chemicals used in personal care products and cosmetics, misrepresenting the science behind the products and their safety, and grossly distorting the facts about how the products are regulated in the U.S. and around the world.
The Council noted, for example, that while it is customary for authors of studies to include a detailed explanation of their methodology, such a discussion was absent from the report.

“This is particularly important for formaldehyde because the process for accurately determining and measuring its presence is a highly complex procedure that must be correctly performed,” The Council added, as
1,4 dioxane is a byproduct that can form in trace or miniscule amounts during the manufacturing process for ingredients that help to ensure mildness of some personal care products such as shampoo and bubble bath. The presence of 1,4 dioxane can be controlled and minimized, and raw material manufacturers routinely take necessary steps to reduce its presence to the lowest feasible levels.

The extremely low levels of 1,4 dioxane reported by CSC likely reflect efforts by manufacturers to control the levels of this contaminant through proper selection of raw materials and quality control of finished products.
FDA has monitored 1,4 dioxane in cosmetic and personal care products since the 1970s by assessing products and raw materials using sophisticated analytical methods. The levels at which any substance would be considered harmful in a cosmetic or personal care product depends on the conditions of use and exposure. FDA has stated that the 1,4 dioxane levels found in their monitoring of personal care products and cosmetics “do not present a hazard to consumers.”

The statement about 1,4 dioxane in personal care products is online at:

According to The Council, formaldehyde is a simple compound consisting of hydrogen, oxygen and carbon. It was first used as a biological preservative more than a century ago. Today, formaldehyde-releasing preservatives are ingredients that help to ensure the safety of products by protecting them from harmful contamination by microorganisms during storage and during continued use by consumers. These preservatives have the ability to replace used-up formaldehyde by releasing it in very small amounts over time as needed.

The use of formaldehyde-releasing preservatives ensures that the actual level of free formaldehyde in the product remains very low but sufficient enough to prevent or eliminate bacterial growth. Exposures to formaldehyde through personal care products are generally extremely low.

The CIR Expert Panel concluded that formaldehyde in cosmetics and personal care products is safe and should not exceed 0.2% (2,000 ppm) when measured as free formaldehyde.
Likewise, the European Union’s Cosmetic Directive allows use of formaldehyde in cosmetic and personal care products at a maximum concentration of 0.2% or 2,000 ppm (free formaldehyde). 

All of the levels allegedly found in the report are far below the 0.2% (or 2,000 ppm) safety threshold.
Under the Food, Drug, and Cosmetic (FD&C) Act, companies must substantiate the safety of all ingredients and products before they are marketed. The Act requires that labeling be truthful and not misleading. The laws give FDA broad legal authority to regulate cosmetic and personal care products and provides severe penalties for the manufacturers of products that do not meet these standards, including fines, seizures, bans and prosecution. 

“Cosmetic and personal care product companies take their commitment to safety and their responsibilities under the law very seriously and work hard to earn and keep the trust of consumers and their families,” Dr. Bailey said. “Parents should be given complete and accurate information about products based on sound science rather than on incomplete and alarmist reports.”

CSPA Responds to Gorsen’s Resignation

The Consumer Specialty Products Association (CSPA) recently learned that Maureen Gorsen, the director of California’s Department of Toxic Substances Control, submitted her letter of resignation to Gov. Schwarzenegger.

Ms. Gorsen, who had been in the position for more than five years, had spoken at CSPA meetings and worked closely with the Association on green chemistry and chemicals management issues. Ms. Gorsen’s resignation was effective March 15. At press time, no replacement had been announced for the position.

“The resignation of Maureen Gorsen from California’s Department of Toxic Substances Control is a big loss to the citizens of California. Ms. Gorsen has been an effective and dedicated leader in helping Gov. Schwarzenegger make California a leader in green chemistry and chemicals management issues. She listened to all sides and advocated sound chemical policy management.

Her approach of bringing different stakeholders to the table to find areas of common agreement was refreshing. Although we didn’t always agree, we had great respect for her approach to developing sound public policy,” said a statement from the CSPA to the media.

“We are appreciative of Ms. Gorsen’s approach in her work on the many issues surrounding green chemistry.”

EDANA Launches Code of Practice on Disposal of Personal Hygiene Wipes

EDANA, the international association representing the nonwovens and related industries, has launched the “Code of Practice for the Proper Disposal of Personal Hygiene Wet Wipes” which includes an on-pack symbol to denote those products that should not be flushed. The code, which resulted from extensive discussions with EDANA-member companies and other external stakeholders and supports the manufacturers and marketers of personal hygiene wet wipes to ensure the proper disposal of their product.

It draws on the “Guidance Document for Assessing the Flushability of Nonwoven Consumer Products,” first published in June 2008 together with INDA, the U.S.-based Association of the Nonwoven Fabrics Industry, which establishes an agreed definition of what “flushability” means and contains rigorous tests manufacturers can use to establish whether the products they make are flushable.

“An important role for industry, which we accept fully, is to ensure that consumers are given clear information about when nonwoven consumer products should not be flushed,” said Pierre Wiertz, general manger of EDANA.

By agreeing to adopt the code of practice companies commit to use the industry’s Guidance Document to determine the status of their personal hygiene wet wipe products, and to label all non-flushable products clearly and consistently.