Wet Wipes Regulations by Market: US, Canada, UK, EU, Australia and GCC

No, not as a category, and a supplier who says “FDA approved wipes” is usually describing something else. The FDA explains that wipes are regulated according to their intended use (FDA):

• Wipes for cleansing skin, such as baby wipes and makeup remover wipes, are cosmetics. Cosmetics do not need FDA approval before sale, but MoCRA added facility registration, product listing and safety substantiation duties.
• Wipes that claim to kill germs on skin, such as antiseptic hand wipes, are OTC drugs.
• Wipes that sanitise or disinfect hard surfaces are pesticides, which must be registered with EPA.
• Ordinary household cleaning wipes with no antimicrobial claim are consumer products, overseen by the CPSC.

The same principle, the claim decides the category, runs through every market below. That is why the first compliance step is to fix your claims, before artwork and before choosing a formula. For germ-killing and disinfecting claims in detail, see antibacterial vs disinfecting wipes.

The sections below explain each market in more detail, with links to the official sources.

For cosmetic wipes, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the responsible person, the company named on the label, to list each product with FDA. It also requires facilities that manufacture or process cosmetics for the US to register. MoCRA exempts certain small businesses from registration and listing (FDA). The responsible person also has to keep safety substantiation records and report serious adverse events.

Labelling also differs by state. California’s AB 818, for example, requires “Do Not Flush” labelling on covered non-flushable wipes (see our flushable wipes guide).

Manufacturers and importers must submit a Cosmetic Notification Form to Health Canada within 10 days after first selling a cosmetic in Canada. The notification lists ingredients and their concentrations. Health Canada states that notification is not an approval, and that failure to notify can lead to products being denied entry or removed from sale (Health Canada). Surface disinfectants are regulated as drugs and need a pre-market assessment and a DIN before sale (Health Canada). Canadian labels are normally bilingual (English and French).

In the EU, cosmetic wipes fall under Regulation (EC) No 1223/2009. An EU-based Responsible Person holds the product information file and safety report and notifies the product through the CPNP (EUR-Lex). Wet wipes containing plastic must carry the harmonised marking set by Implementing Regulation (EU) 2020/2151 (see what wet wipes are made of). Packaging is now also governed by the Packaging and Packaging Waste Regulation, which has applied since 12 August 2026 (see our packaging guide).

Great Britain has a parallel system: a UK Responsible Person and SCPN notification before sale (GOV.UK). It also has the ban on wet wipes containing plastic, which starts in Wales on 18 December 2026 and in England on 19 May 2027 (UK ban guide).

In both the UK and the EU, disinfecting claims make a wipe a biocidal product, which needs an authorisation before it is made available on the market (HSE).

Australia regulates most cosmetic ingredients as industrial chemicals. An importer of cosmetics must register its business with AICIS before importing, regardless of quantity. AICIS registers businesses, not products, and the importer must then categorise each ingredient (AICIS). Products with therapeutic claims, including disinfectants, fall to the TGA. Household and commercial disinfectant wipes with non-specific claims (such as “kills 99.9% of germs”) are “exempt” disinfectants that still have to meet TGO 104. Wipes making specific claims (virucidal, fungicidal and so on) must be listed on the ARTG before supply (TGA). Flushable claims are covered by AS/NZS 5328:2022.

In Saudi Arabia, cosmetic products must be listed with the SFDA, through the eCosma / GHAD system, before import. The importer lists the product and the foreign manufacturer and supplies the artwork and a full ingredient list with concentrations. SFDA’s FAQ says a listing is valid for five years (SFDA). In Dubai, Dubai Municipality requires cosmetic and personal care products to be registered in its Montaji system before they are imported, sold or distributed. The applicant must be a Dubai-licensed company (Dubai Municipality). Labelling follows the Gulf technical regulation GSO 1943, which requires certain items in both Arabic and English. For Halal, alcohol-free and labelling detail, see our Middle East guide.

1. Fix the claims. Cleansing only, skin antiseptic or surface disinfecting. This decides the regulatory route.
2. Name the responsible company in each market. It goes on the label and owns the notifications.
3. Collect the product documents: full formula with INCI names and concentrations, safety assessment where required, microbiology and preservative efficacy results, and stability data.
4. Check substrate rules: plastic content (UK ban, EU marking) and any flushability claims.
5. Draft labels per market: languages, ingredient list, warnings, batch and expiry, “Do Not Flush” where needed.
6. Notify or register before sale, and keep the records.

LX Wipe is a supplier, not your regulatory representative. We provide the formula, specification and test documents that the producing partner factory holds, so that you or your consultant can complete the notifications.