Let’s count… Three, four .. and six! About changes in regulations concerning TiO₂

Have you noticed that recently the regulations on the use of titanium dioxide (TiO₂) in cosmetics have been changed significantly? According to the latest consolidated version of Regulation 1223/2009, the use of TiO₂is currently regulated in accordance with as many as 3 annexes:

• Annex III – TiO₂ meeting the definition of a carcinogen, details: TiO2 annex III

• Annex IV – TiO₂ meeting the criteria for a pigment used in cosmetics, details: TiO2 annex IV

• Annex VI – TiO2 as a UV filter (also nano form) , details:  TiO2 annex VI, no. 27 & TiO2 annex VI, no. 27a (nano)

But that’s not the end of the modifications!

There have also been significant changes in the use of TiO2 in food. Well, the ban on the use of E171 has become a fact!

The Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (E 171) was published, as a result TiO₂ (E171) is no longer a food colorant allowed for use (is removed form Annex II of Reg. 1333/2008). Transitional periods have been adopted, according to which until August 7 this year food produced in accordance with the regulations in force before February 7 this year, may still be placed on the market. After that date, they may remain on the market until their date of minimum durability or ‘use by’ date.

This regulation also affects the possibility of using titanium dioxide (E 171) as a colorant in medicinal products. Commissions consultations with the European Medicines Agency will certainly be necessary on this matter. The decision need to be done within three years after the date of entering into force of this Regulation.

As you can see, you need to be vigilant in regulatory matters – that’s why we recommend working with our experts!