ECHA names butylparaben a ‘hazardous chemical’ and announces phase-out goal

By Kacey Culliney contact

- Last updated on GMT

Butylparaben (chemical name Butyl 4-hydroxybenzoate) is most widely used in cosmetics and personal care formulations as an antimicrobial preservative, particularly in skin care products (Getty Images)
Butylparaben (chemical name Butyl 4-hydroxybenzoate) is most widely used in cosmetics and personal care formulations as an antimicrobial preservative, particularly in skin care products (Getty Images)

Related tags: ECHA, REACH, butylparaben, Paraben, Endocrine disruptor, Chemical compound

The European Chemicals Agency (ECHA) has added butylparaben to its Candidate List of substances of very high concern (SVHCs) because of its endocrine-disrupting properties – companies importing or producing products containing the substance now have six months to notify the agency.

From January 2021, use of the chemical at levels above 0.1% weight by weight (w/w) in products on the EU market – and use of any other SVHCs in the Candidate List – also had to be declared in ECHA’s upcoming SCIP [Substances of Concern in articles as such or in complex objects (Products)] database. 

The database, ECHA said, aimed to ensure transparent information on products containing hazardous chemicals throughout the entire lifecycle, for both waste operators and consumers.

Total phase-out goal for butylparaben

ECHA said the end goal would be a total phase-out of butylparaben – a chemical the agency defined an “endocrine-disrupting substance”.​ Butylparaben (chemical name Butyl 4-hydroxybenzoate) was most widely used in cosmetics and personal care formulations as an antimicrobial preservative but also featured in some pharmaceutical formulations. Use of butylparaben in cosmetic and personal care formulations had already been restricted to 0.14% in acid form​ for some years under an amended Annex of the Cosmetics Regulation​.

In a press announcement issued today, ECHA said butylparaben was one of “four new hazardous chemicals to be phased out”. ​Butylparaben had been added to the Candidate List of SVHCs​ alongside three other substances considered toxic to reproduction: 1-vinylimidazole (used as a monomer in the production of polymers), 2-methylimidazole (used as a catalyst and in the production of coating products) and Dibutylbis(pentane-2,4-dionato-O,O’)tin (used as a catalyst and additive in the production of plastics).

ECHA’s Member State Committee was involved in the decision to include butylparaben and Dibutylbis(pentane-2,4-dionato-O,O’)tin on the Candidate List, which now featured 209 substances “that may have serious effects on people or the environment”.

Christel Musset, director of hazard assessment at ECHA, said: “Chemicals on the Candidate List are among the most regulated in the EU, and our aim is to gradually phase them out. In the meanwhile, companies need to ensure their safe use and be transparent towards consumers who have the right to know where these chemicals are used.”

Substitution with ‘safer alternatives’ suggested

Use of any of the 209 chemical substances on the SVHCs Candidate List at levels above 0.1% w/w had to be accompanied by “sufficient information”​ to customers and consumers to allow safe use, ECHA said.

“Companies are urged to check their legal obligations relating to the safe use of their substance,”​ the agency noted – all of which came under ECHA’s Reach Regulation​.

Musset said companies and formulators, ideally, should start substituting these chemicals with “safer alternatives” – ​a move that would not only boost innovation but also create “a more sustainable circular economy”.

On the topic of endocrine disruptors, the European Commission (EC) was currently in the middle of an ongoing EU market analysis – labelled a ‘fitness check’ – and was soon set to publish a final synopsis report and evaluation following public, stakeholder and SME consultations.

The overall goal of the ‘fitness check’ was to identify concerns, needs and opportunities that could improve the way endocrine disruptors were assessed, managed and potential risks communicated in the EU. All three consultations had now been completed, with a public summary report​ and targeted stakeholder summary report​ published; the summary report for the SME consultation was yet to be published.

Butylparaben in the scientific spotlight

Earlier this year, researchers from the Helmholtz Centre for Environmental Research (UFZ) published a two-part study in Nature Communications​which reported children born to women who use cosmetics containing butylparaben during pregnancy were at an increased risk of obesity and that butylparaben can lead to epigenetic changes that may interfere with appetite regulation.

Whilst the researchers had not, so far, been able to draw firm conclusions on how stable these epigenetic modifications were – or whether they could be passed on to the next generation – they warned that use of cosmetics containing these parabens during pregnancy was a risk and said the ‘unambiguous’ recommendation should be not to use such products during pregnancy.

The team said it hoped the study​ would “help to focus greater attention on such factors in the future”.

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