Nanotechnology in cosmetics and how the EU, UK and US regulate it

Nanotechnology in cosmetics and the rules that apply to it

Nanotechnology in cosmetics means using ingredients engineered at 1 to 100 nanometres, most often nano zinc oxide and nano titanium dioxide as UV filters in sunscreens. The EU and Great Britain require "(nano)" labelling, a six-month notice for most nanomaterials and positive annex listing for nano UV filters, colorants and preservatives, while the US has no nano-specific provision and treats sunscreens as OTC drugs (Commission overview; GB notification guidance; FDA, MoCRA; FDA sunscreen Q&A).

What counts as a nanomaterial in cosmetics

In the EU, Article 2(1)(k) of Regulation (EC) No 1223/2009 defines a nanomaterial as "an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm" (legislation.gov.uk, Article 2; EUR-Lex).

The material must be intentionally manufactured, and either insoluble or biopersistent, with the size or internal structure above. Solubility alone does not exclude a biopersistent material. Natural or incidental particles are not covered (Article 2).

Recommendation 2022/C 229/01 of 10 June 2022 is a general definition, not a cosmetics one. It replaced Recommendation 2011/696/EU. It covers natural, incidental or manufactured solid particles when 50% or more, by number, have an external dimension in the 1-100 nm range, with further rules for elongated and plate-like particles (EUR-Lex, 2022 Recommendation). The cosmetics text of 1 May 2026 still uses Article 2(1)(k) (EUR-Lex consolidated text). For cosmetics, Article 2(1)(k) still applies.

Great Britain kept that cosmetics definition (legislation.gov.uk, Article 2). FDA has not set one. Its June 2014 guidance asks whether a product is engineered with a dimension or structure "in the nanoscale range (approximately 1 nm to 100 nm)", or shows dimension-dependent properties up to one micrometre (1,000 nm) (FDA, considering nanotechnology).

"(nano)" labelling

Article 19(1)(g) says: "All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word 'nano' in brackets." (legislation.gov.uk, Article 19). An ingredient list can read Zinc Oxide (nano). Great Britain has the same labelling rule (GB Article 19).

Notifying nanomaterials before sale

In the EU, Article 16(3) requires electronic notification to the Commission six months before the product is placed on the market, as well as the Article 13 notification. The file includes the IUPAC name, particle size, physical and chemical properties, estimated quantity per year, toxicological profile, safety data and reasonably foreseeable exposure (legislation.gov.uk, Article 16).

Colorants, UV filters and preservatives regulated under Article 14 do not use Article 16 unless expressly specified. They need an Annex IV, V or VI listing. The six-month notice also does not apply to a nanomaterial that conforms with Annex III (Article 16).

COM(2025) 531 of 8 July 2025 would have deleted Article 16(3) (Commission proposal). The provisional agreement of 16 June 2026 put the notice back. On the Parliament page dated 20 September 2026 the file is close to adoption, and it is not in the Official Journal (Parliament legislative train). Keep filing the six-month notice.

In Great Britain, the responsible person notifies the Secretary of State at least six months before placing on the market, with the same carve-out for Article 14 colourants, UV filters and preservatives but no Annex III exemption (legislation.gov.uk, GB Article 16). The SCPN service runs two routes. A nanomaterial listed in Annex 4, 5 or 6 and used within its limits goes in the product notification, with IUPAC name, use and exposure. Any other nanomaterial needs its own notification, and the product can go on the market six months after the first GB notification of that nanomaterial made after 1 January 2021 (SCPN guidance). An unlisted nanomaterial cannot serve as a colourant, preservative or UV filter: that needs an OPSS safety dossier and an annex listing (OPSS guidance).

Nano zinc oxide and nano titanium dioxide in sunscreen

An Annex VI entry for zinc oxide or titanium dioxide without "(nano)" does not cover the nano form (Regulation (EU) 2016/1143). Nano zinc oxide and titanium dioxide nanoparticles in sunscreen have their own entries, summarised below.

Sources: Regulation (EU) 2016/621 and Regulation (EU) 2016/1143. Entry 30a also sets water solubility under 50 mg/L.

Regulation (EU) 2019/1857 added further coatings for titanium dioxide (nano). With the alumina and manganese dioxide coating, face products must carry "not to be used on the lips" (Regulation (EU) 2019/1857).

The Commission lists four authorised nano UV filters: MBBT, titanium dioxide, zinc oxide and tris-biphenyl triazine, plus carbon black (nano) as a colorant (Commission nanomaterials page). MBBT (nano) is capped at 10% (Regulation (EU) 2018/885). Tris-biphenyl triazine, nano included, is capped at 10% and is not allowed in sprays (Regulation (EU) No 866/2014).

Is nano zinc oxide safe?

For the materials it assessed, the SCCS found nano zinc oxide safe up to 25% on skin, with no evidence of absorption through skin or by mouth (Regulation (EU) 2016/621). Nano titanium dioxide was found safe up to 25% on healthy, intact or sunburnt skin, and not safe in sprays (Regulation (EU) 2016/1143). Those lines do not cover every particle size, coating or exposure route.

What "non-nano zinc oxide" means

"Non-nano" is not a term in the cosmetics Regulation. A label that says non-nano zinc oxide, or non-nano zinc oxide mineral sunscreen, still has to be checked against Article 2 (Article 2). Compare particle size, internal structure, solubility and biopersistence. Zinc oxide nanoparticles used as a UV filter need entry 30a, not the zinc oxide entry without "(nano)" (Regulation (EU) 2016/621). The SCCS lines above are not a finding that every non-nano grade is safe.

EU and GB bans on nano forms

Regulation (EU) 2024/858 adds these nano forms to Annex II: styrene/acrylates copolymer and sodium styrene/acrylates copolymer (1725), copper and colloidal copper (1726), colloidal silver (1727), gold and colloidal gold (1728), and platinum and colloidal platinum (1729). Hydroxyapatite (nano) is limited to toothpaste at 10% and mouthwash at 0.465%, with no inhalation exposure. Products could not be placed on the market from 1 February 2025, or made available from 1 November 2025 (Regulation (EU) 2024/858).

From 1 May 2026, Regulation (EU) 2026/78 replaces entry 1727 with silver (nano) (diameter over 1 nm, up to 100 nm) and silver (massive) (1 mm or more), and adds multi-walled carbon tubes as entry 1752 (Regulation (EU) 2026/78).

GB dates differ, and each SI starts its Annex 2 ban later than the instrument itself. SI 2026/23 came into force on 15 July 2026. Its Annex 2 entry 1756, multi-walled carbon tubes including multi-walled carbon nanotubes (diameter from 30 nm to under 3 µm, length of 5 µm or more, aspect ratio over 3:1), applies from 15 August 2026. Products placed on the market before then may be sold until the end of 14 February 2027 (SI 2026/23). SI 2026/109 came into force on 15 August 2026, but regulation 2(2), which adds Annex 2 entry 1772 for silver (nano) (over 1 nm, up to 100 nm) and silver (massive) (1 mm or more), applies from 23 March 2027. Products placed on the market before then may be sold until the end of 22 September 2027 (SI 2026/109).

Read GB Annex 2 and Annex 3 before applying the other 2024/858 bans, or the hydroxyapatite (nano) limits, in Great Britain. The OPSS guide does not cover Northern Ireland. The responsible person there must be established in Northern Ireland or the EU (OPSS guidance).

How the US regulates nanotechnology in cosmetics

FDA's June 2014 guidance, "Safety of Nanomaterials in Cosmetic Products", says FDA does "not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful". Firms should cover characterisation, agglomeration and size distribution, impurities, exposure routes and toxicology, and ask FDA for an early meeting (FDA guidance). Firms must make sure "their products and ingredients, including nanoscale materials, are safe". Only colour additives need premarket approval (FDA cosmetics nanotechnology). MoCRA requires safety substantiation records and has no nano-specific provision (FDA, MoCRA).

Sunscreens are OTC drugs under Monograph M020. Proposed order OTC000008 of 24 September 2021 proposed zinc oxide and titanium dioxide as GRASE (generally recognised as safe and effective) up to 25%, with no separate nano conditions. The order issued on 10 September 2026, published the next day, only removed PABA and trolamine salicylate. FDA will deal with the rest of that proposal in a future order or orders. Neither the notice nor the Q&A mentions nano or particle size (Federal Register, 11 Sep 2026; FDA sunscreen Q&A).

The ICCR reports

The International Cooperation on Cosmetics Regulation includes Brazil, Canada, Chinese Taipei, the EU, Israel, Japan, Korea, the UK and the US (ICCR). The nano page links a 2011 report on characterisation methods and the November 2013 report "Safety Approaches to Nanomaterials in Cosmetics" (ICCR nano topic). The 2013 report says standard chemical risk assessment applies, case by case, with attention to accumulation where absorption is low. Measuring total zinc cannot show whether nano zinc oxide penetrates skin.

For an EU file, use SCCS/1655/23, the nanomaterials guidance, 2nd revision, adopted 6 June 2023 (SCCS guidance).

RegAffairs AI provides a citation-backed answer on nanomaterials in cosmetics covering the EU, UK and US.