The Commission has not asked EFSA to re-assess the safety of titanium dioxide (Tio2) directly but to provide an opinion on four separate scientific studies that raised a red flag on the additive’s safety, and to indicate whether these studies merit “re-opening” the existing opinion, which dates from 2016.
“It came to our attention that four scientific articles describing a potential adverse health effect of titanium dioxide used as a food additive (E 171) have been published in 2016 and 2017, after the adoption and publication of EFSA’s scientific opinion […] in 2016,” reads the mandate signed by Sabine Juelicher, director for food and feed safety and innovation at the Directorate General for Health and Food Safety DG SANTE.
Time to fill the data gaps?
The 2016 evaluation okayed the additive, saying it did not raise a concern for genotoxity or carcinogenicity but highlighted several data gaps.
“These [data gaps] warranted a follow-up by the European Commission and new scientific evidence is being generated by interested parties in order to address the uncertainties highlighted by EFSA in its scientific opinion,” reads the mandate, issued on 22 March and published on the EFSA database this week.
“Nevertheless, authorised food additives should be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information”
EFSA scientists have until the end of May this year to publish their opinion on the studies.
Titanium dioxide is a colouring additive, approved for use in the EU, that is used to give a white colour or shiny, iridescent appearance to food products. It is also used in cosmetic products such as sun cream and lipstick.
The safety concerns centre on the fact it contains nano-sized particles, which could potentially pass through biological barriers such as human skin tissue.
Depending on the definition used, the size of which varies between 1 and 100 nanometres,. One nanometre is one billionth of a metre, or 0.000000001 m.
The four studies are:
“Risk assessment of titanium dioxide nanoparticles via oral exposure, including toxicokinetic considerations” published in Nanotoxicology Journal;
“Food-grade TiO2 impairs intestinal and systemic immune homeostasis, initiates preneoplastic lesions and promotes aberrant crypt development in the rat colon” in Scientific Reports;
“TiO2 induces ROS formation and genotoxicity: contribution of micro and nano-sized fractions” in Mutagenesis Journal and
“TiO2 nanoparticle ingestion alters nutrient absorption in an in vitro model of the small intestine” in NanoImpact.
Following the publication of the above study in Scientific Reports, French food safety authority ANSES conducted its own evaluation and recommended food manufacturers to start looking for alternatives, urging them to choose “safe products that do not contain nanomaterials and are equivalent in terms of function, efficiency and cost".
Manufacturers are required by EU law to clearly label products that contain nano-particles but do not always do so.
The Commission received a rap on the knuckles this month by the European Ombudsman over its refusal to grant public access to a catalogue it was legally required to compile containing information on chemicals and nanoparticles in cosmetics.
Civil society organisation ClientEarth filed a complaint to the Ombudsman, Emily O’Reilly, who said it had shown maladministration. The Commission’s argument in its defence was “neither citizen friendly, nor in line with the EU public access rules”.
Full details of the case and the Ombudsman’s recommendation can be read here.