Q.01

How are nanomaterials in cosmetics regulated in the EU, UK and US? Cover the definition of a nanomaterial, [nano] labelling, notification, and the status of nano zinc oxide and nano titanium dioxide as UV filters, including SCCS opinions and ICCR reports.

EU and GB: both use the same legal definition of a nanomaterial, the same "(nano)" labelling rule and the same six-month pre-market notification, and both list nano zinc oxide and nano titanium dioxide as UV filters on identical terms. US: there is no legal definition, labelling rule or notification for nanomaterials. Sunscreens are regulated as OTC drugs, and the FDA does not set separate conditions for nano forms of ZnO and TiO2. The one real EU/GB difference is that GB has not adopted the EU's later nano-specific changes since Brexit.

Approach: I searched Regulation (EC) No 1223/2009 (the consolidated text of May 2026 and its amending acts), the GB retained version, the SCCS Notes of Guidance (12th revision), the GB SAG-CS opinions, the ICCR nanomaterial reports and 21 CFR Parts 700-740. SCCS opinions themselves are not in the sources I can search, so I give their dates and conclusions as the EU amending regulations quote them. US sunscreen status comes from fda.gov and federalregister.gov search results.

1. Definition

  • EU: Article 2(1)(k) 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" [1]. Article 2(3) requires the Commission to adapt this to scientific progress and to internationally agreed definitions [2].
    • The SCCS expects the definition to be aligned with Commission Recommendation 2022/C 229/01. It also warns that slow, partial dissolution can lead to a material being wrongly called "soluble" and so falling outside the definition [3].
    • Substances in Annexes III to VI do not cover nano forms unless the entry says so [4][5]. A nano UV filter therefore needs its own "(nano)" entry.
  • GB: the wording is identical [6].
  • US: the FDA's 2014 guidance is non-binding and asks two questions:
    • Is the material engineered to have a dimension or structure of about 1-100 nm?
    • Does it show size-dependent properties up to 1,000 nm?
  • ICCR (2010): an ingredient is a nanomaterial if it is insoluble, intentionally manufactured, has one or more dimensions of 1-100 nm in the final formulation, and is stable and persistent enough in biological media to interact with biological systems [7]. The ICCR working group rejected "unique properties" as a criterion [8].

2. "(nano)" labelling

  • EU and GB (Article 19): every ingredient present as a nanomaterial must be clearly shown in the ingredient list, with its name followed by "nano" in brackets [9][10].
  • US: I found no nano-specific provision in 21 CFR Parts 700-740.

3. Notification

  • EU (Article 16(3)): the responsible person must notify the Commission electronically six months before placing the product on the market. This is on top of the normal product notification. The dossier covers:

    • identity, size and properties of the nanomaterial;
    • tonnage per year;
    • toxicological profile and safety data;
    • foreseeable exposure.

    [11]

  • Exemptions: colorants, UV filters and preservatives regulated under Article 14 do not go through this route; they need a positive Annex listing. Products that comply with an Annex III entry are also exempt [11].

  • Safety concerns: if the Commission has concerns it refers the material to the SCCS and can then amend Annex II or III, including where data are insufficient [11]. The Commission must also publish a catalogue of nanomaterials and an annual status report [12].

  • GB: the same six-month notice, sent to the Secretary of State. GB differences:

    • a competent authority can ask which nanomaterials a product uses;
    • a designated person can notify on the responsible person's behalf;
    • the GB text I read does not repeat the Annex III exemption.

    [13][14] OPSS takes these notifications through the Submit cosmetic product notifications service.

  • US: no nano notification. A cosmetic that uses the word "sunscreen" in a therapeutic sense is a drug [15].

4. Nano ZnO and nano TiO2 as UV filters

Nano zinc oxideNano titanium dioxide
EU Annex VIEntry 30a, max 25 %. Not for uses that expose the lungs by inhalation. Purity ≥96 %, wurtzite structure, D50 >30 nm, D1 >20 nm, water solubility <50 mg/L. Uncoated or one of four listed coatings [16]Entry 27a, max 25 %, same inhalation exclusion. Purity ≥99 %, rutile (up to 5 % anatase), median size ≥30 nm, aspect ratio 1-4.5. Listed coatings plus three coating combinations. Photocatalytic activity ≤10 %. Not on lips if coated with alumina and manganese dioxide [17]
SCCS opinions behind the listingOpinion 18 Sept 2012 and addendum 23 July 2013: safe up to 25 % on the skin; no evidence of skin or oral absorption. Clarification 23 Sept 2014 on sprays [18][19]. Listed by Reg. (EU) 2016/621 [20]Opinion 22 July 2013, revised 22 April 2014: safe up to 25 % on healthy, intact or sunburnt skin; not safe in sprays [21][22]. Listed by Reg. (EU) 2016/1143. Coating combinations added by Reg. (EU) 2019/1857 after the SCCS opinion of 7 March 2017 (corrected 22 June 2018) [23]
GBEntry 30a identical [24]Entry 27a identical, including the 2019 coatings [25]
USUp to 25 % in OTC Monograph M020Up to 25 % in M020
  • TiO2 powder: in 2021 the EU added Annex III entry 321 for TiO2 powders that contain respirable particles. Entry 27a needed no change because it already excludes inhalation exposure [26][27]. The GB non-nano entry 27 carries no such cross-reference [28].
  • US position on nano forms: the FDA's September 2021 proposed order (OTC000008) proposed both filters as safe and effective (GRASE) up to 25 %. It did not set separate conditions for nano forms and did not classify nano sunscreens as acceptable or not on that basis alone. Search snippets say a final order (OTC000008-1) of 10 September 2026 removed PABA and trolamine salicylate. The snippet does not say how that order treats ZnO or TiO2.

5. Other nano entries and where GB has diverged

  • Other EU nano listings:
    • UV filters: MBBT (nano), Tris-biphenyl triazine (nano) and HAA299 (nano) [29][30][31];
    • colorant: Carbon Black (nano) [32];
    • restricted (Annex III): Hydroxyapatite (nano), toothpaste and mouthwash only [33].
  • EU bans: Regulation (EU) 2024/858 put nano copper, gold, platinum, colloidal silver and styrene/acrylates copolymers in Annex II (prohibited), because the SCCS had too little data to assess them [34]. Regulation (EU) 2026/78 extended entry 1727 to silver nano and massive silver [35].
  • GB: I found no GB entries for any of those nano bans or for nano hydroxyapatite. GB has followed its own SAG-CS route:
    • Opinion 08 found HAA299 and HAA299 (nano) safe up to 10 % combined, but not in sprays or aerosols [36]. This is reflected in GB Annex VI entry 34 [37].
    • Opinion 26 accepted that a micron-sized silver product is not a nanomaterial under the GB definition [38].

6. ICCR reports (2008-2013)

  • 2008: the industry panel advised against fixed regulatory definitions at that time [39].
  • 2011: an industry survey listed TiO2 and ZnO among nanomaterials used in sun protection products [40].
  • 2012 characterisation reports II and III: reliable methods to measure persistence in biological media, or particle size inside finished formulations, were not yet available [41].
  • 2013 safety approaches: the standard chemical risk-assessment approach applies to nanomaterials, assessed case by case, with attention to accumulation where absorption is low [42][43]. It used nano ZnO to show that measuring total zinc cannot show whether the nano form penetrates skin [44].

Sources:

Q.02