A French Safety Agency Has Declared a Common Cosmetic Preservative an Endocrine Disruptor

Methylparaben, a preservative found across cosmetics, skincare, medicines and food, has been assessed by France's national health and safety agency (ANSES) as an endocrine disruptor for both human health and the environment. The agency now intends to propose a formal European classification.

Anses. (2025). Avis de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail relatif à l'évaluation du methyl 4-hydroxybenzoate (n° CAS 99-76-3) dans le cadre de l'évaluation des substances sous REACH (saisine 2014-REACh-0261). Maisons-Alfort: Anses, 21 p.

Please note: this is a preservative, not a UV filter

This article sits slightly apart from the rest of our UV filter series. Methylparaben is not a sunscreen active and does not absorb ultraviolet light. It is a preservative, used to stop bacteria and mould growing in a product. We are covering it because the finding is significant for cosmetic safety generally, and because parabens often appear in the same formulations as sunscreen filters.

In plain language

A note on this summary: the original ANSES document is written in French. This article is a plain-English summary of what the agency reported and concluded. Every finding below is attributed to ANSES, drawn faithfully from its published opinion.

Methylparaben is one of the most widely used preservatives in the world. ANSES describes it as a preservative valued for its antimicrobial properties, used mainly in cosmetics and personal care products, and also in pharmaceuticals, fragrances and food.

This document is not a single laboratory experiment. It is a formal regulatory evaluation carried out under the European REACH chemicals regulation, drawing together the registration dossiers submitted by industry and the wider scientific literature. After more than a decade of assessment, ANSES reached a clear and serious conclusion.

What ANSES set out to examine

Methylparaben was placed on Europe’s rolling action plan for substance evaluation (known as CoRAP) because of two initial concerns. The first was a suspicion of endocrine-disrupting properties. The second was potential CMR properties, meaning possible carcinogenicity, mutagenicity or reproductive toxicity. The agency also flagged that the substance is sold in high volumes, between 100 and 1000 tonnes per year in the European Economic Area, so the environment, sensitive groups such as pregnant women, and ordinary consumers could all be heavily exposed.

The evaluation ran in two phases, starting in 2014. ANSES requested extra data from industry, received it in 2020, and finalised its analysis in 2024.

What ANSES found

The central finding concerns hormones. After weighing both the test-tube (in vitro) and live-animal (in vivo) evidence, ANSES concluded that methylparaben has estrogenic and anti-androgenic endocrine activity. In plain terms, the agency found the substance can mimic the female hormone estrogen and can block the action of male hormones (androgens).

On reproduction, ANSES described harmful effects on the male reproductive system in animal studies. These included effects on the epididymis, seminal vesicles and prostate, and on sperm count, mobility and shape, with an increase in abnormal sperm. According to the agency, some of these effects appeared even at the lowest tested dose. ANSES also pointed to human evidence, reporting that several epidemiological studies show a decline in sperm quality in men exposed to methylparaben through their environment.

The agency relied in part on a specific biological marker, the anogenital distance (AGD), which it describes as a sensitive indicator of exposure to anti-androgenic compounds. Changes to this marker in rat pups exposed in the womb formed part of the evidence.

The concerns, in ANSES’s assessment

The conclusions are unusually direct for a regulatory document, and they go high in this article because they are the heart of it.

On human reproduction, ANSES concluded that methylparaben meets the definition of an endocrine disruptor for human reproductive function. The agency then extended that conclusion to the environment as well, stating that, on the available data and the weight of evidence, methylparaben is considered an endocrine disruptor for both the environment and humans, acting through estrogenic, androgenic and steroidogenic pathways.

ANSES warned the effects may not be limited to individuals. The agency assessed that the harmful effects linked to disruption of endocrine function are liable to lead to population-level effects on wildlife and on humans.

The agency also signalled it may go further on reproductive toxicity specifically. It said it proposes to examine the possibility of classifying the substance as reprotoxic, based on the observed effects on sperm production.

The caveats ANSES keeps in view

A fair reading has to hold the limits of the evidence alongside the strong conclusion, because the agency itself does.

On cancer, ANSES did not find a problem. In the three in vivo studies available, methylparaben did not induce tumours after skin or under-skin exposure in mice and rats, and the agency proposes no classification for carcinogenicity. The literature hints at possible epigenetic effects, but the agency did not request new testing.

On mutation, the picture is genuinely unresolved. Some tests were positive, others negative, and ANSES says it is not possible to conclude on the mutagenic and genotoxic character of methylparaben.

On skin irritation and allergy, the agency noted that the EU’s cosmetics science committee (the SCCS) concluded in a recent opinion that methylparaben is not a skin irritant, and that fewer than 1% of contact-allergy tests are positive for parabens. ANSES also noted that the substance is not currently subject to a harmonised European classification, which is precisely the gap the agency now wants to close.

It is also worth being clear that many of the strongest reproductive findings come from animal studies at doses far higher than everyday human exposure, and that ANSES set aside some older, contradictory studies for methodological weaknesses. The agency’s conclusion rests on the overall weight of evidence, not a single decisive experiment.

What ANSES recommends

The agency’s recommendations are short and pointed. ANSES concluded that methylparaben presents endocrine-disrupting properties for human health and the environment, and said it will prepare and submit to the European Chemicals Agency (ECHA) a proposal to classify the substance under the CLP regulation in the hazard class for endocrine disruptors.

This matters because an EU-wide classification carries regulatory consequences well beyond a single agency’s opinion. ANSES also notes that ECHA’s own expert group on endocrine disruptors reached the same view, that methylparaben should be considered an endocrine disruptor for human health and the environment.

How does this relate to Australian sunscreens?

Methylparaben is a preservative, not one of the UV filters tracked on the Australian Register of Therapeutic Goods (ARTG), so it does not appear in our filter prevalence figures. It is not octocrylene, octisalate or homosalate, and it is not added to a sunscreen to provide sun protection.

That said, preservatives like methylparaben can appear in the same products as chemical UV filters, since both go into the broad category of leave-on cosmetic and skincare formulations. Consumers who scan an ingredients list may well see a paraben alongside the active filters.

Beyond the paper (regulatory context)

In the European Union, methylparaben remains permitted in cosmetics under the Cosmetics Regulation, with a maximum concentration limit. In Australia, parabens are permitted as preservatives in cosmetics and therapeutic goods, regulated by the TGA and the relevant cosmetics standards. ANSES’s evaluation is a proposal to reclassify the substance at EU level; it is an agency opinion and a step in a regulatory process, not an automatic ban. Any classification would follow review by ECHA and the European institutions.

Common questions

Is methylparaben a sunscreen ingredient?

No. It is a preservative that stops microbial growth in a product. It does not absorb UV and does not provide any sun protection. It can, however, appear on the ingredients list of products that also contain UV filters.

What does "endocrine disruptor" actually mean here?

ANSES found that methylparaben can mimic estrogen and block androgens (male hormones). The agency links this to harmful effects on the male reproductive system in animals, supported by human studies showing reduced sperm quality in exposed men.

Did ANSES find that methylparaben causes cancer?

No. The agency found no tumour formation in the available animal studies and proposed no cancer classification. The endocrine and reproductive findings are the basis of its concern, not cancer.

Is methylparaben banned now?

No. ANSES has concluded it is an endocrine disruptor and says it will propose an EU classification. That is a step in a regulatory process. The substance remains legally permitted in cosmetics in the EU and Australia, subject to concentration limits.

Should I throw out products containing parabens?

This article reports a regulatory agency’s findings; it is not personal medical advice. ANSES’s concern centres on hormonal and reproductive effects, with sensitive groups such as pregnant women flagged for higher exposure. Consumers who want to limit exposure can check ingredient lists for "methylparaben" and similar paraben names, and choose paraben-free formulations if they prefer.

About the assessing body

ANSES is the French Agency for Food, Environmental and Occupational Health and Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail). It is a government scientific agency that carries out independent risk assessment and provides expertise to support regulation. This evaluation was conducted under the European REACH regulation and adopted by its specialist committee on chemicals (CES REACH-CLP) on 6 February 2024, with the opinion signed by the director general, Pr Benoit Vallet, and published in 2025.

The assessment drew on dozens of named experts in endocrinology, reproduction, toxicology and ecotoxicology, working through ANSES’s specialist committees and its endocrine disruptors working group. ANSES states that it analyses the declared interests of its experts before appointment and throughout their work to avoid conflicts of interest, and that those declarations are published publicly.

Source

Anses. (2025). Avis de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail relatif à l'évaluation du methyl 4-hydroxybenzoate (n° CAS 99-76-3) dans le cadre de l'évaluation des substances sous REACH (saisine 2014-REACh-0261). Maisons-Alfort: Anses, 21 p.