Cosmetic Preservatives
All preservatives are listed in alphabetical order
FORMALDEHYDE
Their are natural cosmetic companies who will deliberately mislead consumers when it comes to formaldehyde. One recent Australian publication was found to do a story on lip balms and preservatives that should be avoided. Of course this magazine is pro-natural and anything synthetic is painted as being bad for you. The article of course did not tell you what preservatives are safe either.
In this story consumers are told to avoid formaldehyde and formaldehyde donor preservatives, along with a whole host of other synthetic preservatives. The implication being that using formaldehyde will give you cancer. Pure scare mongering and urban myth at it's best. These are the facts as they currently stand:
Formaldehyde is NOT USED IN COSMETICS. Well there is some enlightenment. Formaldehyde is only used in nail hardeners and in that capacity it is not used as a preservative. As far as Formaldehyde causing cancer, the article mentions the IARC (International Agency for Research on Cancer) which found that formaldehyde was a probable human carcinogen.
However under what conditions is it a carcinogen?
It is from cosmetic use? NO!!. If you actually read the IARC Report it is from inhalation of formaldehyde. Not an occurrence that occurs in cosmetics. This report is referring to persistent high doses of formaldehyde in an industrial setting. Interesting don't you think they don't present all of the facts, and only the ones they choose to.
What is the regulatory status of Formaldehyde?
As the FDA observed in a 2006 statement explaining its current position on Formaldehyde, in 1984, the Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of Formaldehyde and concluded that when it makes up less than 0.2 percent of a cosmetic product applied to the skin, it is safe to the great majority of consumers. The Panel believed that, because of skin sensitivity (allergy) of some individuals to this agent, the formulation and manufacture of a cosmetic product should be such as to ensure use at the minimal effective concentration of Formaldehyde, not to exceed 0.2 percent measured as free Formaldehyde.
The safety of Formaldehyde as used in nail hardeners has been reviewed by the Food and Drug Administration. In this case, Formaldehyde is not used as a preservative but as part of a system used to coat and harden the surface of brittle or cracking nails. Formaldehyde is used as an ingredient only in nail hardeners, not in nail polish. As in the case of preservatives, the Formaldehyde used in nail hardeners is not pure formaldehyde, but rather a solution (formalin). According to the recommendations issued by FDA, nail hardeners often contain Formaldehyde as the active ingredient. Although Formaldehyde may be irritating to the skin or cause allergic reactions, the FDA has in the past, not objected to its use as an ingredient of nail hardeners provided the product:
• Contains no more than 5% Formaldehyde,
• Provides the user with nail shields which restrict application to the tip (and not the nail bed or fold),
• Furnishes adequate directions for safe use, and
• Warns consumers about the consequences of misuse and potential for causing adverse reactions in consumers who are sensitized to formaldehyde.
The typical levels of formaldehyde used in nail hardeners are well below 5%.
Formaldehyde gas is a listed substance under California’s Proposition 65. However, the state of California has determined that Formaldehyde exposure from nail hardeners in salons and elsewhere is so low that no warnings are required under Proposition 65.
http://www.oehha.ca.gov/prop65.html
The FDA recommends that cosmetic manufacturers follow the recommendations of the CIR Expert Panel. The levels of free Formaldehyde released from the preservative ingredients currently used in cosmetic and personal care products is well below the levels recommended by the CIR.
What about recent reports about the safety of Formaldehyde?
The International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO), was founded in 1969 to evaluate the carcinogenic risk of chemicals to man. IARC coordinates and conducts research on the causes of human cancer and develops scientific strategies for cancer control. The Agency is involved in both epidemiological and laboratory research but does not make recommendations for regulation or legislation.
In 1987 IARC classified Formaldehyde as 2A “probable human carcinogen” for a rare form of nasal cancer. The U.S. Environmental Protection Agency (EPA) has similarly classified Formaldehyde as a probable human carcinogen under conditions of unusually high or prolonged exposure. In fact, formaldehyde is not typically added directly to cosmetics and personal care products, other than as a component of some nail hardening products. Therefore, Formaldehyde is not inhaled. Some ingredients release very small amounts of Formaldehyde into the product as needed to protect against the growth of bacteria. Regarding inhalation of large amounts of Formaldehyde, IARC considered new studies again in 1995 and maintained the rating at 2A. In 2004, IARC convened a Working Group of scientists to review all available scientific data. The Working Group voted to recommend reclassification of Formaldehyde as a known human carcinogen. The IARC Working Group based its reclassification decision on new information from studies of persons exposed to Formaldehyde, which in its view provided sufficient evidence to establish that exposure to Formaldehyde causes nasopharyngeal cancer in humans under certain circumstances. It is important to recognize, however, that the IARC Working Group’s reclassification decision appears to have been based on findings for Formaldehyde at high concentrations with exposure to gaseous Formaldehyde such as those seen in industrial settings. These exposures do not occur in cosmetic and personal care products.
Despite some claims, there is no higher level of skin reaction to formaldehyde-releasing preservatives than to other preservatives (Source: British Journal of Dermatology, March 1998, pages 467–476). In fact, there is a far greater risk to skin from a product without preservatives, because of the contamination and unchecked growth of bacteria, fungus, and mold that can result if no preservatives are used. However, there is concern that when formaldehyde-releasing preservatives are present in a formulation that also includes amines, such as triethanolamine (TEA), diethanolamine (DEA), or monoethanolamine (MEA), nitrosamines can be formed, and nitrosamines are carcinogenic substances that can potentially penetrate skin (Source: Fundamentals and Applied Toxicology, August 1993, pages 213–221). Whether or not that poses a health risk of any kind has not been established.
Allegations recently made 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.
The allegations about the presence of 1,4 dioxane and formaldehyde in personal care products were made in a report to be released March 12, 2009, by the Campaign for Safe Cosmetics (CSC). (Of which I am a member but that does not mean I will agree with everything they say). 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 harmful 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 Personal Care Products 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."
The report is one of many the group has issued in the last 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.
1,4 dioxane in personal care products 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."
FDA’s statement about 1,4 dioxane in personal care products may be found at:
http://www.cfsan.fda.gov/~dms/cosdiox.html.
Formaldehyde in personal care products
Formaldehyde is a simple compound consisting of hydrogen, oxygen and carbon. It occurs naturally in the air we breathe and is even part of the human metabolism. Plants and animals also produce formaldehyde, and it is released as a byproduct of certain vegetables, such as Brussels sprouts and cabbage, when they are cooked.
Historically, formaldehyde 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 percent (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 percent or 2,000 ppm (free formaldehyde). The EU Cosmetics Directive may be found at:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_dir.htm
The FDA regulation for formaldehyde may be found at:
All of the levels allegedly found in the report are far below this 0.2 percent (or 2,000 ppm) safety threshold. Under the Food, Drug, and Cosmetic Act (FD&C), 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,” Bailey said. “Parents should be given complete and accurate information about their products based on sound science rather than on incomplete and alarmist reports.”
For more information on cosmetic and personal care products and their ingredients, visit www.CosmeticsInfo.org.
Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the $250 billion 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 everyday, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.
PARABENS (HYDROXYBENZOATES)
Parabens are one of most wrongly maligned ingredients in the cosmetic industry. Most "natural" companies embelish a study done by Dr Darbre and implicate that by using any cosmetic with parabens in will put you at a higher risk of breast cancer. The fact that only a handful of scientists felt any need to comment on this study goes unmentioned. They also would like you to believe that parabens are no good for sensitive and eczema prone skins as they will cause allergies.
These are the facts:
The parabens are not carcinogenic or mutagenic. As far as parabens causing allergies, contact sensitisation has occurred when parabens have been applied to damaged or broken skin but high concentrations of 5-15% in patch testing are needed to elicit reaction in susceptible individuals.” (Soni M, et al, Food Chem Toxicol, 39(6), 2001); (Soni M, et al, Food Chem Toxicol, 40(10), 2002). These amounts they are referring to do not occur in cosmetic use. Individually parabens are not used higher than 0.4% in a product, and total combined parabens in a product is limited to 1.2%. Interestingly enough parabens are found naturally in raspberries and blackberries where it acts as an antimicrobial agent. According to the American Academy of Dermatology “The best preservatives for sensitive skin are those containing parabens” (2002 Prof Zoe Draelos, Summer Scientific Meeting, New York, AAD, 2002.)
The Darbre study showed that parabens can be absorbed through the skin and accumulate in breast cancer tissue in their original form, without being degraded. The study also did not identify the route by which the parabens entered the body. No data was collected as to whether or not the patients from whom the tumours were excised used personal care products that contained parabens. Scientists have also proposed that parabens were present in the tissues samples only due to contamination because they were also detected in the control samples, which should have been clear of all traces of the compounds. For this, and several other reasons, this study has been largely discredited by many cancer research organisations, and much of the rest of the scientific community. The fact that no further research since 1994 has been able to prove this urban myth, does not seem to be questioned by natural magazines who are intent on selling their own agenda to consumers.
The cancer argument is based on the ability of parabens to mimic the hormone estrogen, which is known to play a role in the development of breast cancers. Laboratory research however has shown that they would have to be 500 to10,000 more potent to do this, and even the strongest oestrogen mimetic out of the parabens – butylparaben – is 100,000 times weaker than oestrogen. In a review of the estrogenic activity of parabens, (Golden et al., in Critical Reviews in Toxicology, 2005) the author concluded that based on maximum daily exposure estimates, it was implausible that parabens could increase the risk associated with exposure to estrogenic chemicals. Methyl and propyl parabens have such weak oestrogenic activity that no activity was detected in vivo in classical uterotrophic assays using high dose oral or subcutaneous rodent administrations (AFC Panel, European Food Safety Authority, 13 July 2004). In fact parabens offer substantially less risk than naturally occurring endocrine active chemicals in the diet such as the phytooestrogen daidzein. In addition, the American Cancer Society has concluded that there is no good scientific evidence to support the claim using cosmetics containing parabens increases an individual's risk of developing breast cancer.
The oestrogenic activity of parabens is so weak that no more than a handful of scientists have even mentioned the fact. Perhaps we should also avoid the following foods as well because they have far more potent oestrogenic activity than parabens: alfalfa, almonds, anise, apple, banana, barley, broccoli, cabbage, canola, cauliflower, carrot, cherry, chickpea; clover, coffee, corn, cumin, damiana, fennel, flaxseed, garlic, green bean, hop, lemon, lemon balm, licorice, lima bean seeds, mint, oats, oregano, pea, pinto bean seeds, pomegranate, plum, potato, rice, rice bran, rye, rape, sage, sesame, soybean, split pea, sunflower seed, thyme, turmeric, verbena, wheat, wheat bran, wheat germ, yam & yeast. Included are the oils of olive, corn, safflower, wheat germ, soybean, rice bran, peanut and coconut. (Sob M, Naturally Occurring Estrogens, in CRC Handbook of Naturally Occurring Food Toxicants, Miloslav R (Ed), CRC Press, 1983); (Davis D & Bradlow H, Sci Amer, Oct 1995); (Davis D et al, Nature Sci Med, May/June 1997); (Zava D et al, Proc Soc Exp Biol Med, 217(3), 1998)
All of the abovementioned foodstuffs naturally contain phytoestrogens. All are in fact endocrine disrupters, ie. exogenous agents that interfere with the production, release, transport, metabolism, binding, action or elimination of natural hormones in the body. Most phytoestrogens show some beneficial effects on estrogen-dependent disease. However, these can also promote tumour growth (Hilakivi-Clarke L et al, Oncol Rep, 6(5), 1999); (Newbold R et al, Cancer Res, 61(11), 2001) and cause developmentally adverse effects (Delclos K et al, Reprod Toxicol, 15(6), 2001); (Jefferson W, Newbold R, Nutrition 16(7-8), 2000).
Parabens are used because they have been shown to be very effective and are stable under heat. The majority of consumers have no allergies to them.
