November 10, 2021
New entry in Annex III of Regulation (EC) 1223/2009 for titanium dioxide
The EU Cosmetics Regulation has recently been updated regarding the use of titanium dioxide. Since October 1, 2021, new restrictions now apply to products containing this ingredient. Titanium dioxide is widely used in cosmetic products and manufacturers must ensure new and existing products are compliant with these new restrictions.
On May 26, 2021, the third CMR "Omnibus" Regulation — which includes all substances recently classified as carcinogenic, mutagenic, or toxic to reproduction (CMR) under the Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 — was published in the Official Journal of the European Union, amending Regulation (EC) 1223/2009 on Cosmetics. The update includes a new Annex III entry for titanium, following its harmonized classification as a category 2 carcinogen by inhalation.
Article 15 of The European Cosmetics Regulation 1223/2009 states that ingredients classed as category 2 CMRs may be used in cosmetics if the substance has been evaluated by the EU Scientific Committee on Consumer Safety (SCCS) and found safe for use.
The SCCS has reviewed the safety of titanium dioxide, and based on their published opinion, changes will be made to Annexes III, IV, and VI of the regulation.
New addition to Annex III (restricted ingredients)
The restriction applies only to titanium dioxide in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10 µm:
- In face products in loose powder form: maximum 25%. Only pigmentary titanium dioxide permitted.
- In hair aerosol spray products: maximum 1.4% allowed for general consumers and 1.1% for professional use. Only pigmentary titanium dioxide permitted.
Other products: not to be used in applications that may lead to exposure of the end user's lungs.
Change to Annex IV (permitted colourants)
- Must meet purity criteria set out in Commission Directive 95/45/EC (E171).
- Titanium dioxide in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10 µm, to be used in compliance with Annex III.
- Nano form — up to a maximum of 25% permitted.
Change to Annex VI (permitted UV filters)
- Maximum 25% permitted. Titanium dioxide in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10 µm, to be used in compliance with Annex III.
- For "other products" referred to in Annex III, the maximum permitted use level is also 25%.
- Nano form, up to a maximum of 25%.
The regulation entered into force on June 15, 2021, and applied from October 1, 2021. Therefore, new and existing cosmetics products in the EU must now be compliant with the new restrictions. These restrictions are not currently applicable in Great Britain but are applicable in Northern Ireland.
How Exponent Can Help
Exponent's experts in chemical and cosmetic regulations are ready to help cosmetics manufacturers and brands selling products in the EU to keep their products legal and compliant by carrying out thorough formulation reviews and providing timely updates on future ingredient restrictions.