Parabens
Number 6 of the “Top 10 Unfounded Health Scares of 2010”[1]
What are they?
Parabens are used as preservatives in many cosmetics and personal care products, as well as in some foods and pharmaceuticals. Because of their low toxicity, parabens have been in safe use for over 50 years.
Preservatives are important ingredients. They protect cosmetic and personal care products against microbial growth, from contamination by consumer use, and extend product shelf life, thereby protecting consumer health and product quality.
There are several different parabens. The most common parabens used in cosmetic and personal care products are methylparaben, ethylparaben, propylparaben, and butylparaben. Parabens are present in most products at less than 1%.
What’s the myth?
There are a couple of circulating myths regarding parabens in cosmetics and personal care products.
Myth #1: Parabens in underarm deodorants and antiperspirants increase the risk of breast cancer in women.
Myth #2: Parabens may affect male fertility.
Myth #1: Parabens in underarm deodorants and antiperspirants increase the risk of breast cancer in women.
This myth appears to have stemmed from one study conducted in 2004,[2] in which parabens were found in breast cancer tissue from close to the armpit. The authors coupled this finding with the fact that parabens have been shown to weakly mimic the hormone oestrogen, which is considered to play a role in breast cancer development.
FACT: The presence of a substance in the body doesn’t mean it causes harm.
The 2004 study, in which parabens were found in breast cancer tissue, did not demonstrate a link between parabens and breast cancer. Indeed, serious flaws in this study[3] have led to its widespread criticism from other researchers in the field.
In fact, no study has established a link between parabens in underarm products and breast cancer.
It has also since been demonstrated that parabens can be present in breast tumour tissue even when underarm deodorant or antiperspirant is not used.[4]
The European Commission’s Scientific Committee on Consumer Safety (SCCS) concluded in 2005 that “there is no evidence of a demonstrable risk for the development of breast cancer by the use of underarm cosmetics”.[5]
FACT: Parabens are not strong hormone mimics
In their 2008 Report, the US Cosmetic Ingredient Review (CIR) Expert Panel state that “parabens are, at most, weakly estrogenic”.[6] The effect varies depending on the specific paraben, but the oestrogenic effects are over a thousand times less than that of the body’s oestrogen.
There are also many naturally occurring substances that act as hormone mimics. These include substances with oestrogenic effects, known as ‘phytoestrogens’, which are found in foods such as soy, fruits and vegetables.
Click here for more on underarm deodorants and the breast cancer myth.
Myth #2: Parabens affect male fertility
Since parabens are known to be weak oestrogen mimics, it has been suggested that they may have a role in male infertility. Some studies have indicated that parabens may affect sperm health and sperm counts. The fact that parabens have been detected in the blood and urine of male volunteers after paraben-containing personal care product was applied to the skin is seen by some as further evidence for an adverse effect of parabens.
FACT: The effect of parabens on male fertility has been extensively studied.
Numerous animal studies of male reproductive effects have produced mixed results, all of which are considered by the US Cosmetic Ingredient Review (CIR) Expert Panel in their extensive 2008 Report.[6]
Following review of the data on effects of single- and multi-paraben exposure of adults and infants on male fertility, and considering the exposure to parabens from cosmetics, the CIR Expert Panel concluded that they “support the safety of cosmetic products in which parabens preservatives are used”.
FACT: The presence of a substance in body fluid doesn’t mean it causes harm to the body
Every day we are exposed to many chemical substances, from natural and man-made sources. This has been the case for thousands of years.
Our bodies are equipped to eliminate many things that have the potential to cause harm. The main ways in which our body does this is by metabolising the substance in the liver or kidneys, and excreting it from the body – primarily via urine or faeces.
So, just because a substance is found in the body doesn’t mean that it will have any adverse health effect.
FACT: There is no evidence that the presence of low levels of parabens in cosmetics and personal care products causes cancer or affects male fertility – or has any adverse effect on human health
The safety of parabens has been extensively studied, and continues to be reviewed by international scientific and regulatory bodies. Parabens are considered safe at the levels used to preserve cosmetic and personal care products.
The bottom line? You can continue to use cosmetic and personal care products containing parabens with confidence.
Parabens play an important role in preserving the shelf life of cosmetic products and preventing bacterial contamination.
Parabens have additional beneficial features as cosmetic product ingredients. They very rarely cause irritation or sensitisation in normal skin, do not accumulate in the body, and are almost completely metabolised in the skin.[6][7]
For more about parabens in cosmetics and personal care products:
www.thefactsabout.co.uk
www.cosmeticsinfo.org/HBI/9
Sources
[1] The American Council on Science and Health 2010. http://acsh.org/news/2010/12/29/the-top-ten-unfounded-health-scares-of-2010
[2] Darbre P. D., Aljarrah A., Miller W. R., Coldham N. G., Sauer M. J. and Pope G. S. 2004, Concentrations of Parabens in Human Breast Tumours, Journal of Applied Toxicology, Vol. 24, pages 5-13
[3] Only 20 breast tumour samples were analysed (parabens were found in 18); no comparison to healthy tissue was made; the source of the Parabens in the tissue was not identified.
[4] Barr, L. et al 2012, “Measurement of parabens concentrations in human breast tissue at serial locations across the breast from axilla to sternum”, in the Journal of Applied Toxicology 32, 219-232
[5] Scientific Committee on Consumer Safety (SCCS) 2010, “Opinion on Parabens”
[6] CIR Expert Panel 2008, Final amended report on the safety assessment of methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben as used in cosmetic products, International Journal of Toxicology, 27 (Suppl. 4), pages 1-82. www.cir-safety.org/sites/default/files/PR427.pdf
[7] NICNAS, Human Health Tier II Assessment for Parabens
[8] Entry 12 in Annex V to the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products, http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=ref_data.annexes_v2
[9] Personal Care Products Council 2012, ‘Cosmetic Ingredient Review (CIR) Expert Panel Reaffirms the Safety of Parabens Used in Cosmetics and Personal Care Products – Preservatives Vital to Product Integrity’
What are they?
Parabens are used as preservatives in many cosmetics and personal care products, as well as in some foods and pharmaceuticals. Because of their low toxicity, parabens have been in safe use for over 50 years.
Preservatives are important ingredients. They protect cosmetic and personal care products against microbial growth, from contamination by consumer use, and extend product shelf life, thereby protecting consumer health and product quality.
There are several different parabens. The most common parabens used in cosmetic and personal care products are methylparaben, ethylparaben, propylparaben, and butylparaben. Parabens are present in most products at less than 1%.
What’s the myth?
There are a couple of circulating myths regarding parabens in cosmetics and personal care products.
Myth #1: Parabens in underarm deodorants and antiperspirants increase the risk of breast cancer in women.
Myth #2: Parabens may affect male fertility.
Myth #1: Parabens in underarm deodorants and antiperspirants increase the risk of breast cancer in women.
This myth appears to have stemmed from one study conducted in 2004,[2] in which parabens were found in breast cancer tissue from close to the armpit. The authors coupled this finding with the fact that parabens have been shown to weakly mimic the hormone oestrogen, which is considered to play a role in breast cancer development.
FACT: The presence of a substance in the body doesn’t mean it causes harm.
The 2004 study, in which parabens were found in breast cancer tissue, did not demonstrate a link between parabens and breast cancer. Indeed, serious flaws in this study[3] have led to its widespread criticism from other researchers in the field.
In fact, no study has established a link between parabens in underarm products and breast cancer.
It has also since been demonstrated that parabens can be present in breast tumour tissue even when underarm deodorant or antiperspirant is not used.[4]
The European Commission’s Scientific Committee on Consumer Safety (SCCS) concluded in 2005 that “there is no evidence of a demonstrable risk for the development of breast cancer by the use of underarm cosmetics”.[5]
FACT: Parabens are not strong hormone mimics
In their 2008 Report, the US Cosmetic Ingredient Review (CIR) Expert Panel state that “parabens are, at most, weakly estrogenic”.[6] The effect varies depending on the specific paraben, but the oestrogenic effects are over a thousand times less than that of the body’s oestrogen.
There are also many naturally occurring substances that act as hormone mimics. These include substances with oestrogenic effects, known as ‘phytoestrogens’, which are found in foods such as soy, fruits and vegetables.
Click here for more on underarm deodorants and the breast cancer myth.
Myth #2: Parabens affect male fertility
Since parabens are known to be weak oestrogen mimics, it has been suggested that they may have a role in male infertility. Some studies have indicated that parabens may affect sperm health and sperm counts. The fact that parabens have been detected in the blood and urine of male volunteers after paraben-containing personal care product was applied to the skin is seen by some as further evidence for an adverse effect of parabens.
FACT: The effect of parabens on male fertility has been extensively studied.
Numerous animal studies of male reproductive effects have produced mixed results, all of which are considered by the US Cosmetic Ingredient Review (CIR) Expert Panel in their extensive 2008 Report.[6]
Following review of the data on effects of single- and multi-paraben exposure of adults and infants on male fertility, and considering the exposure to parabens from cosmetics, the CIR Expert Panel concluded that they “support the safety of cosmetic products in which parabens preservatives are used”.
FACT: The presence of a substance in body fluid doesn’t mean it causes harm to the body
Every day we are exposed to many chemical substances, from natural and man-made sources. This has been the case for thousands of years.
Our bodies are equipped to eliminate many things that have the potential to cause harm. The main ways in which our body does this is by metabolising the substance in the liver or kidneys, and excreting it from the body – primarily via urine or faeces.
So, just because a substance is found in the body doesn’t mean that it will have any adverse health effect.
FACT: There is no evidence that the presence of low levels of parabens in cosmetics and personal care products causes cancer or affects male fertility – or has any adverse effect on human health
The safety of parabens has been extensively studied, and continues to be reviewed by international scientific and regulatory bodies. Parabens are considered safe at the levels used to preserve cosmetic and personal care products.
- The Australian regulator responsible for cosmetic and personal care product ingredients, AICIS (formerly NICNAS), assessed parabens and concluded "the available data do not indicate any risks associated with exposure" to the public, and that "current risk management measures are considered adequate to protect public and workers’ health and safety".[7]
- Parabens are listed as ‘Approved Preservatives’ in European Cosmetics Regulation.[8]
- The US Cosmetic Ingredient Review (CIR) Expert Panel has reviewed the safety of parabens as they are used in cosmetics in 1984, 2005 and 2012, at the request of the European cosmetic industry. Their 2012 conclusion was to “reaffirm its earlier conclusions that parabens are safe for use in cosmetic products”.[9]
- The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published opinions on the safety of parabens again in 2006, 2008 and 2010, confirming the safety of methylparaben and ethylparaben at the levels used, and recommending maximum limits for propylparaben and butylparaben.
- The US Food & Drug administration lists methylparaben and propylparaben as ‘generally regarded as safe’ (GRAS) for use in preserving food.
The bottom line? You can continue to use cosmetic and personal care products containing parabens with confidence.
Parabens play an important role in preserving the shelf life of cosmetic products and preventing bacterial contamination.
Parabens have additional beneficial features as cosmetic product ingredients. They very rarely cause irritation or sensitisation in normal skin, do not accumulate in the body, and are almost completely metabolised in the skin.[6][7]
For more about parabens in cosmetics and personal care products:
www.thefactsabout.co.uk
www.cosmeticsinfo.org/HBI/9
Sources
[1] The American Council on Science and Health 2010. http://acsh.org/news/2010/12/29/the-top-ten-unfounded-health-scares-of-2010
[2] Darbre P. D., Aljarrah A., Miller W. R., Coldham N. G., Sauer M. J. and Pope G. S. 2004, Concentrations of Parabens in Human Breast Tumours, Journal of Applied Toxicology, Vol. 24, pages 5-13
[3] Only 20 breast tumour samples were analysed (parabens were found in 18); no comparison to healthy tissue was made; the source of the Parabens in the tissue was not identified.
[4] Barr, L. et al 2012, “Measurement of parabens concentrations in human breast tissue at serial locations across the breast from axilla to sternum”, in the Journal of Applied Toxicology 32, 219-232
[5] Scientific Committee on Consumer Safety (SCCS) 2010, “Opinion on Parabens”
[6] CIR Expert Panel 2008, Final amended report on the safety assessment of methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben as used in cosmetic products, International Journal of Toxicology, 27 (Suppl. 4), pages 1-82. www.cir-safety.org/sites/default/files/PR427.pdf
[7] NICNAS, Human Health Tier II Assessment for Parabens
[8] Entry 12 in Annex V to the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products, http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=ref_data.annexes_v2
[9] Personal Care Products Council 2012, ‘Cosmetic Ingredient Review (CIR) Expert Panel Reaffirms the Safety of Parabens Used in Cosmetics and Personal Care Products – Preservatives Vital to Product Integrity’
