Parabens – the pariah of preservatives?

The 2004 study, in which parabens were found in breast cancer tissue, did not demonstrate a link between parabens and breast cancer, nor did it say it did. This study had several limitations and has been criticised widely.⁶

Limitations? The small sample size (only 20 breast tumour samples were analysed), no comparison to healthy tissue (to see if healthy tissue also contained parabens), the source of the parabens in the tissue was not identified (it could have been from multiple sources, including foods or medicines), parabens were also found in blank samples without any breast tissue (yes, really!) and no evidence of any link between the presence of parabens and the breast cancer.

It has since been shown that parabens can be present in breast tumour tissue even when underarm deodorant or antiperspirant is not used.⁷ 

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'.⁸ 

Australia’s industrial chemicals regulator, AICIS (then NICNAS) reviewed parabens for safety in 2016 and concluded ‘Based on the weight of evidence from the available well-conducted in vivo carcinogenicity studies, the chemicals in this assessment are not considered to be carcinogenic.’⁹ 

Click here for more on underarm deodorants and the breast cancer myth.

There have been many, many animal studies into potential male reproductive effects of parabens.

In its extensive 2008 report, the US Cosmetic Ingredient Review (CIR) Expert Panel reviewed all the available evidence and data on effects of single- and multi-paraben exposure of adults and infants on male fertility. It concluded that there was ‘no adverse male reproductive toxicity’ and that parabens were ‘safe as cosmetic ingredients in the practices of use and concentrations described in [its] safety assessment’.¹⁰  

In 2015, the Australian industrial chemicals regulator NICNAS (now AICIS) stated that ‘parabens possess oestrogenic activity, although at much lower potency than endogenously produced oestrogens. There are currently no established adverse outcome pathways for weak oestrogenic activity’.⁹ The oestrogenic effect varies depending on the specific paraben but is over a thousand times less than that of the natural hormone.

There are also many naturally occurring substances that act as hormone mimics. These include substances with oestrogenic effects, or ‘phytoestrogens’, which are found in plant-based foods such as soy, fruits and vegetables. No need to avoid these, either.

Parabens have been extensively studied. Any new data of significance is reviewed by international scientific and regulatory bodies.

Many regulatory authorities allow parabens to be used without restriction in cosmetic and personal care products. Australia, the USA and Canada, for example. 

In Australia, parabens were most recently assessed by the cosmetic and personal care product ingredients regulator NICNAS (now AICIS) in 2015, confirming their safety. ‘The available data do not indicate any risks associated with exposure to the chemicals in this group. The chemicals have been shown to have weak oestrogenic activity, but there are no established adverse outcome pathways for this effect.’⁹

Methylparaben is listed on Australia’s Poisons Standard. 'Uh-oh..?' Not at all! It’s on the list of ‘Substances considered not to require control by scheduling’. That’s to show that methylparaben has been considered and no action was needed. No other parabens are listed on the Poisons Standard.

What is the Poisons Standard

Ingredients that are more hazardous, at certain or any concentrations, are included on the Poisons Standard. 
This national classification system controls how chemicals are made available to the public and any mandatory safety warnings on labels. 

In the USA, methyl and propylparaben are classified as ‘Generally Recognized as Safe’ (GRAS).¹¹ This means qualified experts believe there is enough evidence for the safety of these substances under the conditions of their intended use.

In Europe, parabens are ‘Approved Preservatives’,¹² with a maximum of 0.8% total parabens allowed in cosmetics as preservatives and lower limits for individual parabens. South Korea has the same limits as Europe, and Japan has a slightly higher total paraben limit of 1%.

Europe and South East Asia also ban five less-used parabens (isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben) from use in cosmetics. 'Uh-oh?' Again, no. This ban was due to a lack of data necessary for their assessment, not any proven concerns.

Regulatory authorities uphold the safety of parabens in cosmetics

‘The available data do not indicate any risks associated with exposure to the chemicals in this group’
NICNAS (now AICIS), 2015⁹

‘At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health’.
US FDA, 2020¹³

‘In addition to propylparaben and butylparaben, other parabens, like methylparaben and ethylparaben, are safe, as repeatedly confirmed by the Scientific Committee on Consumer Safety (SCCS). They are also some of the most efficient preservatives.’
European Commission 2014¹⁴