Phthalates
Number 4 of the “Top Ten Unfounded Health Scares of 2010”, and Number 10 in 2011. “Year in and year out, alarmist environmental groups target phthalates…”[1]
What are they?
Phthalates are a group of chemicals that have been in use for over 50 years. Their primary use is in flexible plastics for applications such as medical tubing and blood bags, shower curtains, life jackets (and rubber duckies). Certain phthalates are also used in some cosmetic and personal care products.
Phthalates are also found in food, tap water and indoor air.
There are several different types of phthalates. Different phthalates have different properties, and therefore also different applications and hazards.
What’s the myth?
It has been suggested that the presence of phthalates in certain products, including cosmetics and personal care products, puts human health at risk of a range of adverse health effects, including hormone disruption (or endocrine disruption), reduced fertility, cancer and behavioural problems.[2][3]
Recently a myth has also arisen that phthalates in cosmetic and personal care products are linked to diabetes.
FACT: Some phthalates are present in some personal care and cosmetic products.
Diethyl phthalate (DEP) is the most commonly used phthalate in cosmetic and personal care products. However, even anti-phthalate campaigners acknowledge that it is “not generally characterised as an endocrine active compound”.[3]
Other phthalates may also be present in cosmetic products in very low or trace amounts, mostly through contact with plastic materials during production or storage.
FACT: The mere presence of phthalates does not mean that the product poses a health risk.
It is nonsense to talk about adverse health effects without considering the exposure to the substance.
For example, a recent study in which everyday products were analysed for a range of chemicals, including phthalates, found that “the highest DEP concentrations were in fragrance/perfume (14,000 ug/g*) and car air freshener (8,000 ug/g*)”.[2] Do these look like pretty big numbers? These concentrations are equivalent to 1.4% and 0.8%, respectively. And remember that DEP is not considered to be a hormone disrupter!
Other phthalates were identified as being present at very low levels (0.0001-0.1%).
Most exposure to diethyl phthalate results from inhalation of contaminated air or swallowing of contaminated drinking water or foods; 4 milligrams is the estimate daily human intake of diethyl phthalate from food.[4]
The presence of phthalates in human urine, blood and other body fluids does show that there is widespread human exposure to phthalates. However, these exposure levels “fall far short” of the established safe limits.[5]
FACT: There is no evidence that the presence of low levels of phthalates in cosmetics and personal care products has adverse effect on human health.
The health and environmental effects of phthalates have been extensively researched due to their widespread use. The data concerning phthalates continues to be reviewed by regulatory agencies around the world.
It is in no one’s interest to have unsafe products on the market.
The US Statistical Assessment Service slams activists who lobby against phthalates, stating that “almost every regulatory body that has looked at the research has found [phthalates] to be without risk”.[6]
This includes Australia’s chemicals regulator, NICNAS, whose September 2011 assessment found “the risk of adverse acute effects for consumers exposed to DEP through cosmetics is very low”. [7] The only restriction on use of DEP in personal care and cosmetic products in Australia is a maximum of 0.5% in leave-on products.
The US Food & Drug Administration (FDA), upon review of phthalate safety, “does not have evidence that phthalates, as used in cosmetics, pose a safety risk”.[8]
The US National Toxicology Program reviewed six different phthalates and classified these as posing “minimal” or “negligible” potential risk to human health.[4]
In March 2007 the Scientific Committee on Consumer Products, an independent committee providing scientific advice to the European Commission, reviewed the safety of diethyl phthalate. They concluded that “new studies on DEP…did not provide sufficient new information to change the conclusions” – i.e. that use of DEP in cosmetic products is safe. This Committee also evaluated the safety of other phthalates found in cosmetics and concluded that all of these at the levels present posed “no measurable risk for the consumer” or did “not seem to be a concern for human health”.[9]
In 2002, the Cosmetic Ingredient Review reaffirmed its 1985 conclusion that DEP, dibutyl phthalate (DBP) and dimethyl phthalate (DMP) are safe as used in cosmetic products, and that exposure to phthalates from cosmetics is low compared to levels that could cause adverse effects in animals.
FACT: There is no evidence to support a causal link between phthalates in cosmetics and diabetes
There has been recent media reporting on a possible link between diabetes and phthalates in women. This link is based on a study[10] which demonstrated an association between phthalates in urine and increased risk of diabetes in women. Many of these media reports have suggested cosmetics and personal care products as the phthalate culprits, hence headlines such as “Skin cream: killing you softly?”[11], and other similar anti-cosmetic sentiments. According to the American Council on Science and Health (ACSH), the study upon which this myth is based was “flawed beyond any semblance of scientific validity”.[12] The researchers themselves acknowledge limitations of their study, and that no direct links have been found between diabetes and the use of phthalates in personal care products. Of key importance is the fact that no link between diethyl phthalate, the main phthalate used in cosmetics and personal care products, and diabetes was found.
Another key point is that of “reverse causation” - the fact that phthalates are found in medications and medical devices, to which diabetes sufferers may have greater exposure.
The authors acknowledge that more research is needed.
The bottom line? Phthalates in personal care and cosmetic products no threat to your health – you can continue to use these products with confidence.
*micrograms per gram
Sources
[1] The American Council on Science and Health
[2] Campaign for Safe Cosmetics and Environmental Working Group 2010, Not so sexy: The health risks of secret chemicals in fragrance.
[3] Silent Spring Institute 2012, Endocrine disrupters and asthma-associated chemicals in consumer products, Environmental Health Perspectives
[4] Toxicological profile for diethyl phthalate, U.S. Department of Health and Human Services Public Health Service Agency for Toxic Substances and Disease Registry, June 1995
[5] Childs, D. 2008, “Potentally Harmful Chemicals in Baby Products”, ABC News Medical Unit. http://abcnews.go.com/Health/ReproductiveHealth/story?id=4230408&page=1#.T_t0avXIc1J
[6] Statistical Assessment Service (STATS), A Health Scare that Stinks, http://accord.asn.au/wp-content/uploads/2015/09/A-Health-Scare-That-Stinks_STATS.pdf
[7] NICNAS, 2011, Priority Existing Chemical Report No. 33: Diethyl phthalate.
[8] www.fda.gov/cosmetics/productsingredients/ingredients/ucm128250.htm
[9] European Commission 2007, “Opinion of the SCCP on phthalates in cosmetic products”
[10] James-Todd, T., Stahlhut, R., Meeker, J. D., Powell, S.-G., Hauser, R., Huang, T. and Rich-Edwards, J. 2012, “Urinary Phthalate Metabolite Concentrations and Diabetes among Women in the National Health and Nutrition Examination Survey (NHANES) 2001-2008, Environmental Health Perspectives, http://dx.doi.org/10.1289/ehp.1104717
[11] Berry, S. August 6, 2012, “Skin cream: killing you softly?”, Sydney Morning Herald. www.smh.com.au/lifestyle/beauty/skin-cream-killing-you-softly-20120806-23pb1.html
[12] Ross, G. July 19, 2012, “Can your lipstick cause diabetes. No”, American Council on Science and Health. www.acsh.org/news/2012/08/15/can-your-lipstick-cause-diabetes-no
What are they?
Phthalates are a group of chemicals that have been in use for over 50 years. Their primary use is in flexible plastics for applications such as medical tubing and blood bags, shower curtains, life jackets (and rubber duckies). Certain phthalates are also used in some cosmetic and personal care products.
Phthalates are also found in food, tap water and indoor air.
There are several different types of phthalates. Different phthalates have different properties, and therefore also different applications and hazards.
What’s the myth?
It has been suggested that the presence of phthalates in certain products, including cosmetics and personal care products, puts human health at risk of a range of adverse health effects, including hormone disruption (or endocrine disruption), reduced fertility, cancer and behavioural problems.[2][3]
Recently a myth has also arisen that phthalates in cosmetic and personal care products are linked to diabetes.
FACT: Some phthalates are present in some personal care and cosmetic products.
Diethyl phthalate (DEP) is the most commonly used phthalate in cosmetic and personal care products. However, even anti-phthalate campaigners acknowledge that it is “not generally characterised as an endocrine active compound”.[3]
Other phthalates may also be present in cosmetic products in very low or trace amounts, mostly through contact with plastic materials during production or storage.
FACT: The mere presence of phthalates does not mean that the product poses a health risk.
It is nonsense to talk about adverse health effects without considering the exposure to the substance.
For example, a recent study in which everyday products were analysed for a range of chemicals, including phthalates, found that “the highest DEP concentrations were in fragrance/perfume (14,000 ug/g*) and car air freshener (8,000 ug/g*)”.[2] Do these look like pretty big numbers? These concentrations are equivalent to 1.4% and 0.8%, respectively. And remember that DEP is not considered to be a hormone disrupter!
Other phthalates were identified as being present at very low levels (0.0001-0.1%).
Most exposure to diethyl phthalate results from inhalation of contaminated air or swallowing of contaminated drinking water or foods; 4 milligrams is the estimate daily human intake of diethyl phthalate from food.[4]
The presence of phthalates in human urine, blood and other body fluids does show that there is widespread human exposure to phthalates. However, these exposure levels “fall far short” of the established safe limits.[5]
FACT: There is no evidence that the presence of low levels of phthalates in cosmetics and personal care products has adverse effect on human health.
The health and environmental effects of phthalates have been extensively researched due to their widespread use. The data concerning phthalates continues to be reviewed by regulatory agencies around the world.
It is in no one’s interest to have unsafe products on the market.
The US Statistical Assessment Service slams activists who lobby against phthalates, stating that “almost every regulatory body that has looked at the research has found [phthalates] to be without risk”.[6]
This includes Australia’s chemicals regulator, NICNAS, whose September 2011 assessment found “the risk of adverse acute effects for consumers exposed to DEP through cosmetics is very low”. [7] The only restriction on use of DEP in personal care and cosmetic products in Australia is a maximum of 0.5% in leave-on products.
The US Food & Drug Administration (FDA), upon review of phthalate safety, “does not have evidence that phthalates, as used in cosmetics, pose a safety risk”.[8]
The US National Toxicology Program reviewed six different phthalates and classified these as posing “minimal” or “negligible” potential risk to human health.[4]
In March 2007 the Scientific Committee on Consumer Products, an independent committee providing scientific advice to the European Commission, reviewed the safety of diethyl phthalate. They concluded that “new studies on DEP…did not provide sufficient new information to change the conclusions” – i.e. that use of DEP in cosmetic products is safe. This Committee also evaluated the safety of other phthalates found in cosmetics and concluded that all of these at the levels present posed “no measurable risk for the consumer” or did “not seem to be a concern for human health”.[9]
In 2002, the Cosmetic Ingredient Review reaffirmed its 1985 conclusion that DEP, dibutyl phthalate (DBP) and dimethyl phthalate (DMP) are safe as used in cosmetic products, and that exposure to phthalates from cosmetics is low compared to levels that could cause adverse effects in animals.
FACT: There is no evidence to support a causal link between phthalates in cosmetics and diabetes
There has been recent media reporting on a possible link between diabetes and phthalates in women. This link is based on a study[10] which demonstrated an association between phthalates in urine and increased risk of diabetes in women. Many of these media reports have suggested cosmetics and personal care products as the phthalate culprits, hence headlines such as “Skin cream: killing you softly?”[11], and other similar anti-cosmetic sentiments. According to the American Council on Science and Health (ACSH), the study upon which this myth is based was “flawed beyond any semblance of scientific validity”.[12] The researchers themselves acknowledge limitations of their study, and that no direct links have been found between diabetes and the use of phthalates in personal care products. Of key importance is the fact that no link between diethyl phthalate, the main phthalate used in cosmetics and personal care products, and diabetes was found.
Another key point is that of “reverse causation” - the fact that phthalates are found in medications and medical devices, to which diabetes sufferers may have greater exposure.
The authors acknowledge that more research is needed.
The bottom line? Phthalates in personal care and cosmetic products no threat to your health – you can continue to use these products with confidence.
*micrograms per gram
Sources
[1] The American Council on Science and Health
[2] Campaign for Safe Cosmetics and Environmental Working Group 2010, Not so sexy: The health risks of secret chemicals in fragrance.
[3] Silent Spring Institute 2012, Endocrine disrupters and asthma-associated chemicals in consumer products, Environmental Health Perspectives
[4] Toxicological profile for diethyl phthalate, U.S. Department of Health and Human Services Public Health Service Agency for Toxic Substances and Disease Registry, June 1995
[5] Childs, D. 2008, “Potentally Harmful Chemicals in Baby Products”, ABC News Medical Unit. http://abcnews.go.com/Health/ReproductiveHealth/story?id=4230408&page=1#.T_t0avXIc1J
[6] Statistical Assessment Service (STATS), A Health Scare that Stinks, http://accord.asn.au/wp-content/uploads/2015/09/A-Health-Scare-That-Stinks_STATS.pdf
[7] NICNAS, 2011, Priority Existing Chemical Report No. 33: Diethyl phthalate.
[8] www.fda.gov/cosmetics/productsingredients/ingredients/ucm128250.htm
[9] European Commission 2007, “Opinion of the SCCP on phthalates in cosmetic products”
[10] James-Todd, T., Stahlhut, R., Meeker, J. D., Powell, S.-G., Hauser, R., Huang, T. and Rich-Edwards, J. 2012, “Urinary Phthalate Metabolite Concentrations and Diabetes among Women in the National Health and Nutrition Examination Survey (NHANES) 2001-2008, Environmental Health Perspectives, http://dx.doi.org/10.1289/ehp.1104717
[11] Berry, S. August 6, 2012, “Skin cream: killing you softly?”, Sydney Morning Herald. www.smh.com.au/lifestyle/beauty/skin-cream-killing-you-softly-20120806-23pb1.html
[12] Ross, G. July 19, 2012, “Can your lipstick cause diabetes. No”, American Council on Science and Health. www.acsh.org/news/2012/08/15/can-your-lipstick-cause-diabetes-no
