TITANIUM DIOXIDE (CAS 13463-67-7) is a substance used in various fields, from cosmetics to paints.

Here are some important steps of investigation and proposed classification that the substance has undergone over the years by ECHA, European Chemicals Agency, up to the definition of a few days ago.

Nel settembre 2017 l’ECHA ha proposto di classificare il Titanium dioxide come cancerogeno di categoria 2 per inalazione;
nel settembre 2019 la Commissione europea ha proseguito con tale proposta di classificazione ed infine ha adottato il Regolamento delegato (UE) 2020/217 della Commissione del 4 ottobre 2019, pubblicato nella GUUE n. 44 del 18/2/2020, contenente il XIV ATP (adattamento al progresso tecnico)che di fatto ha modificato il Reg.1272/2008 (CLP), inserendo per le forme di polvere inalabili di TITANIUM DIOXIDE la controversa classificazione H315, ovvero cancerogeno di classe 2 per inalazione. Questa classificazione si applica unicamente alla sostanza TiO2 in polvere contenente ≥1 % di particelle con diametro aerodinamico ≤10 μm e alle miscele sotto forma di polveri contenenti ≥1 % di particelle di TiO2 sotto forma di, o incorporato in, particelle con diametro aerodinamico ≤10 μm. Le modifiche del CLP nell’allegato VI entreranno in vigore il 9 marzo 2020 e le classificazioni armonizzate si applicheranno 18 mesi dopo

L’Industria cosmetica intende difendere l’utilizzo di questo ingrediente e nei primi mesi di quest’anno saranno consegnati a SCCS tutti i dati necessari per garantirne la sicurezza. L’Industria ha intenzione di difenderlo anche nei prodotti che potrebbero comportare un’esposizione nei polmoni, ma non si sa se questa difesa andrà a buon fine.

Article 32 of Regulation 1223/2009 on cosmetic products prohibits the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, according to the CLP regulation.

However, there are cases where the use of CMR substances is allowed following specific evaluations by SCCS attesting to their safety for use in cosmetics.

Titanium dioxide is currently used in cosmetic products as a colorant (therefore present in All.IV of Reg. 1223 at no. 143) and as a UV filter (therefore present in All.VI of Reg. 1223 at no. 27, maximum concentration of use 25%).

In addition, the use of TiO2 (nano) as a UV filter has also been admitted (All.VI of Reg.1223 at no.27bis); in this case, however, the characteristics that the nanomaterials can have are specified. In accordance with what was established by SCCS in the Final opinion SCCS/1580/16 "Opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetics", Regulation (EU) 2019/1857 authorizes the use of three new forms of Titanium Dioxide (nano) coated

  • or with silica conc.max. 16% and cetylphosphate conc. max. 6%;
  • or with aluminum oxide conc. max. 3% and triethoxyprilysilane conc. max. 9%.
  • with aluminum oxide conc. max. 7% and manganese dioxide conc. max. 0.7%. With this specific coating, since under reasonably foreseeable conditions of use consumers may apply certain facial products, such as sunscreens intended for facial application, to their lips, the specific warning "Not for use on the lips" will need to be stated.

On the other hand, the use of Titanium Dioxide in nano form is not allowed in applications that could lead to exposure of consumers' lungs to titanium dioxide nanoparticles by inhalation (such as powders or sprays). In fact, Final Opinion SCCS/1583/17 "Opinion on Titanium Dioxide (nano form) as UV-Filter in sprays" specified that the data provided are insufficient to assess the safety of Titanium Dioxide in nano form in sun and personal care products when used in spray form, products that could result in end-user lung exposure by inhalation. For SCCS, the data dossier provided only describes exposure studies conducted with water-based spray products with low alcohol content, which currently represent about 80% of spray sunscreen products on the EU market. For non-water-based formulations or formulations containing alcohol in % greater than 10%, which may currently account for about 20% of sunscreen spray products on the EU market, no exposure data were submitted, and therefore the assessment cannot be performed.