Ingredients

1,4-Dioxane – a threat in products?

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What is it?

1,4-Dioxane is associated with cancer in humans. 'Presumably'.

Presumably? Don’t we know? 

The classification of 1,4-dioxane varies in different regions of the world, but in 2022, the Australian industrial chemicals regulator (AICIS) reclassified it from a ‘suspected human carcinogen’ to a higher level, ‘presumed human carcinogen’.1 This is also the classification in Europe.2

This means there is evidence from animal and/or human studies suggesting 1,4-dioxane could cause cancer. But not enough evidence to definitively classify it as a ‘known carcinogen’.

Let’s assume it does cause cancer in humans.

Very small amounts of 1,4-dioxane can be detected in some cosmetic, personal care, cleaning and other products. It isn’t there as an ingredient but is an impurity that forms during the manufacturing of certain other ingredients.

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What's the myth?

Because 1,4-dioxane can be detected in some cosmetics, personal care and cleaning products, it has been suggested that these products are unsafe.

It’s a case of ‘same myth, different substance’…trace amounts being equated with risk of harm.

So, do you need to worry about traces of a presumed carcinogen in some of your products?

No, the levels are too low to pose a concern. Read more below.

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What are the facts?

  • Industry has phased 1,4-dioxane impurities to trace levels

    1,4-Dioxane is not an ingredient in cosmetic and personal care products, it’s an impurity.

    The cosmetic and cleaning products industries have focused on decreasing contamination by 1,4-dioxane as much as possible, with great success.

    According to the 2022 AICIS assessment,1 ‘contaminant levels of 1,4-dioxane have declined substantially over time’. For example, the majority of cosmetics now contain 1,4-dioxane levels below 10 parts per million (ppm). In other words, less than 0.001%.

    icon-science-spot@2000x Impurity – why?

    1,4-Dioxane is an unavoidable by-product of the ethoxylation reaction, which is used to make many chemicals including some surfactants.

    Careful control of the reaction conditions and subsequent removal can minimise 1,4-dioxane levels but it cannot be removed completely. 
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The bottom line?

Any trace levels of 1,4-dioxane in your products do not pose a health risk.
No need to…

worry!

But please do...

continue using your favourite products with confidence.

Sources
  1. Australian Industrial Chemicals Introduction Scheme, 30 June 2022, ‘1,4-Dioxane Evaluation statement’
  2. European Chemical Agency, ‘Member State Committee support document for identification of 1,4-dioxane as a substance of very high concern because of its hazardous properties which cause probable serious effects to human health and the environment…’, adopted on 17 June 2021 
  3. Scientific Committee on Consumer Safety (SCCS), ‘SCIENTIFIC OPINION ON The Report of the ICCR Working Group: Considerations on Acceptable Trace Level of 1,4-Dioxane in Cosmetic Products’, Adopted 15 December 2015
  4. US EPA, Final Risk Evaluation for 1,4-Dioxane
  5. Sydney Morning Herald, 29 March, 2009, ‘Toxins found in children’s shampoos’ 
  6. Cosmetics Alliance Canada, ‘The Safety/Risk Equation’ (YouTube video)
  7. See ECETOC (1983) Joint Assessment of Commodity Chemicals, No. 2, 1,4-Dioxane for a summary
  8. US FDA, 1,4-Dioxane in Cosmetics: A Manufacturing Byproduct
  9. Therapeutic Goods Administration, The Poisons Standard (the SUSMP)