The European Union (EU) adopted Regulation (EU) 2022/63 removing the authorization of food additive titanium dioxide and considers deleting it from the EU’s list of additives for the use as color in medicinal products within three years. This amends Annexes II and III to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council
A scientific opinion published last 06 May 2021 by the European Food Safety Authority (EFSA) indicated that, based on all the evidence available, a concern for genotoxicity on titanium dioxide could not be ruled out. This indicates a possibility that the use of titanium oxide as a food additive might cause DNA or chromosomal damage.
Given the uncertainties on the effects of titanium oxide, the EFSA concluded that the said ingredient can no longer be considered safe when used as a food additive. Hence, food that contains titanium dioxide as food additive may continue to be placed in the market until 07 August 2022 and may continue to be used until their date of minimum durability or “use by” date.
As titanium dioxide (E171) would no longer be authorized for use in foods, Regulation (EU) 2022/63 also removes the reference to it from the entry on the use of potassium aluminium silicate (E 555) in Part 1 of Annex III to Regulation (EC) No 1333/2008.
In medicinal products, titanium dioxide will still be authorized for use until other suitable alternatives are found. This is to avoid causing shortages of medicinal products that could negatively impact public health or animal health and welfare. This approach is supported by the European Medicines Agency’s (EMA) analysis on the use of titanium dioxide in medicines, which was published on 8 October 2021.
The Commission, together with the EMA, will re-evaluate the use of titanium dioxide in medicines soon. In this regard, Article 3 of Regulation (EU) 2022/63 states that the Commission, following consultation with the EMA, is to review the necessity to maintain titanium dioxide or to delete it from the Union list of food additives for the exclusive use as color in medicinal products in Part B of Annex II to Regulation (EC) No 1333/2008, within three years after 7 February 2022.
DTI strongly advises all stakeholders to carefully monitor developments on the regulation on the use of titanium dioxide in the EU. For further questions and clarifications, you may contact EMB Market Officers for Europe at firstname.lastname@example.org and/or The Philippine Trade and Investment Center-Brussels at email@example.com.
Further information and copy of the regulation (EU) 2022/63 can be accessed thru this link.