Product Categories

Body Care & Hygiene

From rinse-off washes to leave-on lotions and deodorants: retained-exposure assessment, the deodorant-versus-antiperspirant classification, the preservative sensitisation rules, and the microplastics and antibacterial restrictions.

Body care and hygiene covers a wide range, from rinse-off shower gels, soaps and hand washes to leave-on body lotions and deodorants. The products cover a large surface area, but rinse-off items are retained on the skin only briefly, and a competent assessment reflects that difference in exposure rather than treating every product the same.

Deodorants and antiperspirants

The two are not the same in regulatory terms. A deodorant masks or neutralises odour and is a cosmetic. An antiperspirant reduces sweating, a physiological effect, and that difference is enough to make antiperspirants over-the-counter drugs in the United States, while in the EU and UK aluminium-salt antiperspirants remain cosmetics. The aluminium question that hung over the category has been resolved at the assessment level: after reviewing systemic exposure, the SCCS concluded that aluminium in antiperspirants and other cosmetics is safe at typical use levels, which the safety report now reflects rather than treating aluminium as an open concern.

Preservatives and sensitisation

Water-rich body products depend on preservation, and the preservative system is where much of the category’s regulatory history sits. Methylisothiazolinone, after a contact-allergy epidemic, was prohibited in leave-on products and restricted to 0.0015% in rinse-off products, and the methylchloroisothiazolinone and methylisothiazolinone mixture is limited to rinse-off use at the same level. Several parabens are prohibited and the permitted ones capped, and phenoxyethanol is limited to 1%. The system has to be both compliant against Annex V and effective, which is proven by preservative-efficacy testing.

Antibacterial agents

Antibacterial washes brought their own restrictions. Triclosan and triclocarban were reassessed and limited by Commission Regulation (EU) 2024/996, triclosan to 0.3% with use conditions and warnings, triclocarban to 0.2%, and in the United States the FDA banned both from consumer antiseptic washes in 2016. An antibacterial claim also has to be substantiated and can edge a product towards the biocidal or medicinal line if it goes beyond cosmetic cleansing.

Microplastics in scrubs and washes

Rinse-off exfoliating microbeads were banned from 17 October 2023 under Regulation (EU) 2023/2055, and rinse-off products containing other intentionally added microplastics must be reformulated by 17 October 2027, the earliest of the cosmetic deadlines, so scrubs and washes are the most immediately affected body products.

How we help

We assess body products to their real retained exposure, classify deodorants and antiperspirants correctly for each market, build and verify a preservative system that is both compliant and effective, and keep formulations ahead of the antibacterial and microplastics deadlines. Where an antibacterial or β€œantiperspirant” claim risks crossing into the drug or biocidal regime, we flag it before launch.

Relevant services

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CPSR

From Β£70 Β· 2 to 3 days

The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.

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Testing

From Β£75

Stability, microbiology, photoprotection and analytical testing carried out in our three in-house laboratories. Analytical work is not contracted out; results pass directly to the assessor preparing your CPSR.

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Labelling

From Β£195 Β· from receipt of artwork

Independent review of packaging artwork against Article 19, and of product claims against the six Common Criteria of Regulation (EU) 655/2013. Label review Β£195; per-claim review from Β£125; substantiation dossiers from Β£1,495.

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Frequently asked questions

Is an antiperspirant a cosmetic or a drug?

A deodorant that masks odour is a cosmetic. An antiperspirant reduces sweating, a physiological effect, which makes it an over-the-counter drug in the United States, while in the EU and UK aluminium-salt antiperspirants remain cosmetics. The SCCS has concluded aluminium in antiperspirants is safe at typical use levels.

What are the rules on preservatives like MIT and parabens?

In the EU and UK, preservatives may only be used if listed in Annex V, within its limits. Methylisothiazolinone is prohibited in leave-on products and limited to 0.0015% in rinse-off; several parabens are banned and the rest capped; phenoxyethanol is limited to 1%. The system must also be proven effective by challenge testing.

What is a CPSR?

A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.

What is a Preservative Efficacy Test (challenge test)?

A Preservative Efficacy Test, also called a challenge test, demonstrates that a product's preservative system controls microbial growth across its life. Oxford Biosciences performs it to ISO 11930 for Β£165: the product is inoculated with the five specified challenge organisms (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus brasiliensis), and viable counts are enumerated over a 28-day window against the Criterion A or B log-reduction thresholds. Typical turnaround is six weeks, reflecting the protocol duration plus enumeration and reporting.

Which cosmetics are regulated as OTC drugs in the United States?

Sunscreens, anti-dandruff shampoos, anticavity (fluoride) toothpastes, antiperspirants, acne treatments and skin protectants are over-the-counter drugs in the US, regulated under FDA monographs rather than as cosmetics, so they fall outside the cosmetic MoCRA pathway.

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