What's the Verdict?

Topical Exposure 

However, humans are not exposed to E171 in drinking water at any significant quantity over a long duration, so this potential effect is irrelevant to the human experience. It’s important to understand that a potential hazard is not the same thing as an actual risk. 

3. Regulatory Compliance It is crucial for suppliers to adhere to industry regulations, especially in sectors like food, pharmaceuticals, and cosmetics. Reliable suppliers will ensure their products meet relevant regulatory standards, providing proper documentation and certifications.

No. EFSA’s role was limited to evaluating the risks linked to titanium dioxide as a food additive. This included an assessment of relevant scientific information on TiO₂, its potential toxicity, and estimates of human dietary exposure. Any legislative or regulatory decisions on the authorisations of food additives are the responsibility of the risk managers (i.e. European Commission and Member States).

The FDA and certain others say titanium dioxide is safe to use in foods and personal care products. The FDA provides strict guidelines on how much can be used in food. The limit is very small: no more than 1% titanium dioxide.

ZnSO4+BaS→ZnS+BaSO4

LITHOPONE

Although barium sulfate is almost completely inert, zinc sulfide degrades upon exposure to UV light, leading to darkening of the pigment. The severity of this UV reaction is dependent on a combination of two factors; how much zinc sulfide makes up the pigments formulation, and its total accumulated UV exposure. Depending on these factors the pigment itself can vary in shade over time, ranging from pure white all the way to grey or even black. To suppress this effect, a dopant may be used, such as a small amount of cobalt salts, which would be added to the formulation. This process creates cobalt-doped zinc sulfide. The cobalt salts help to stabilize zinc sulfide so it will not have as severe a reaction to UV exposure.

French researchers studied how and where E171 nanoparticles enter the bloodstream, first studying the route through pigs and then in vitro with human buccal cells, for a 2023 study published in the journal Nanotoxicology. The research showed that the nanoparticles absorbed quickly through the mouth and then into the bloodstream, before damaging DNA and hindering cell regeneration.

Lithopone

Public health groups urge FDA to cancel titanium dioxide in food, by Center for Science in the Public Interest, May 30, 2023

Titanium dioxide (TiO₂) is commonly applied to enhance the white colour and brightness of food products. TiO₂ is also used as white pigment in other products such as toothpaste. A small fraction of the pigment is known to be present as nanoparticles (NPs). Recent studies with TiO₂ NPs indicate that these particles can have toxic effects. In this paper, we aimed to estimate the oral intake of TiO₂ and its NPs from food, food supplements and toothpaste in the Dutch population aged 2 to over 70 years by combining data on food consumption and supplement intake with concentrations of Ti and TiO₂ NPs in food products and supplements. For children aged 2-6 years, additional intake via ingestion of toothpaste was estimated. The mean long-term intake to TiO₂ ranges from 0.06 mg/kg bw/day in elderly (70+), 0.17 mg/kg bw/day for 7-69-year-old people, to 0.67 mg/kg bw/day in children (2-6 year old). The estimated mean intake of TiO₂ NPs ranges from 0.19 μg/kg bw/day in elderly, 0.55 μg/kg bw/day for 7-69-year-old people, to 2.16 μg/kg bw/day in young children. Ninety-fifth percentile (P95) values are 0.74, 1.61 and 4.16 μg/kg bw/day, respectively. The products contributing most to the TiO₂ intake are toothpaste (in young children only), candy, coffee creamer, fine bakery wares and sauces. In a separate publication, the results are used to evaluate whether the presence of TiO₂ NPs in these products can pose a human health risk.

Zinc oxide. Zinc oxide is a popular cross-linking agent for rubber and for various resins. It is essential in the formulation of solvent-borne polychloroprene adhesives. Furthermore, zinc oxide is a good UV stabilizer, has biocidal activity and has a relatively high refractive index (2.0) which makes it an efficient white pigment. Some typical properties are: density 5.6 g/cm³; particle size 0.036-3 μm; oil absorption 10–20 g/100 g; specific surface area 10–45 m²/g. Zinc oxide is produced by reaction of the metal in the vapour state with oxygen. Zinc oxide is nonporous and is quite pure. Thus, the high surface area of some grades is due to the small particle size of zinc oxide. Some grades, especially for use in the rubber industry, are surface modified by deposition of 0.2-0.4% of stearic acid, propionic acid, or light oil [47].

The updated evaluation revises the outcome of EFSA’s previous assessment published in 2016, which highlighted the need for more research to fill data gaps.  

References

0.1% Max

At the present JECFA meeting, the committee considered additional toxicological studies relevant to the safety assessment of the chemical that investigated its toxicokinetics, acute toxicity, short-term toxicity, long-term toxicity and carcinogenicity, genotoxicity, and reproductive and developmental toxicity, as well as special studies addressing its short-term initiation/promotion potential for colon cancer. The experts acknowledged that a large number of toxicological studies have been conducted using test materials, including nanoparticles, having size distributions and physico-chemical properties not comparable to real-world uses of titanium dioxide as a food additive. The studies on non-representative materials were evaluated by JECFA, but the committee concluded that such studies are not relevant to the safety assessment of the additive.