We have updated the article. This article was originally published on July 20, 2022.

You may have noticed that the ingredient titanium dioxide is officially banned as a food additive in the EU from August 2022 with a transition period since February 7 until August 7, 2022. This ingredient has been suspected of being carcinogenic for several years.

“This decision was based on a scientific opinion of the European Food Safety Authority. This concluded that titanium dioxide can no longer be considered safe when used as a food additive. This is particularly so because concerns about genotoxicity, the ability of chemical substances to alter genetic cell material, cannot be ruled out” German representation of European Commission.

(Inhalation) Hazard Statement by EUROPEAN CHEMICALS AGENCY (ECHA):

 “The classification of certain forms of titanium dioxide (TiO2) as suspected carcinogens by inhalation was published on 18.02.2020. The hazard class Carc. 2 was assigned with the hazard statement H351 (inhalation) ‘suspected of causing cancer (inhalation)’ in Commission Delegated Regulation (EU) 2020/217 (14th Adaptation to Technical and Scientific Progress, ‘ATP’) amending Regulation (EC) No 1272/2008 (CLP Regulation). In addition, provisions have been made for the classification of mixtures as well as the labelling of certain mixtures containing TiO2 with EU- specific EUH statements.”

What Labeling Code Has Titanium Dioxide on Packaging?

When used in food, titanium dioxide is indicated with the code E171.
In cosmetics, titanium dioxide is indicated with the code CI 77891.

See the Guide on the classification and labelling of titanium dioxide here.

Functions of Titanium Dioxide

OPACITY: Reduces the transparency and translucency of cosmetic products.
COLORANT: Titanium dioxide is used as a colorant to enhance and brighten the color of white foods, pharmaceuticals etc.
UV FILTER: Filters certain UV rays to protect the skin or hair from their harmful effects. All UV filters listed are substances from the positive list of UV filters (Annex VII of the Cosmetics Directive).
UV ABSORBER: Protects the cosmetic product from the effects of UV light.

“Titanium dioxide is mainly used as an opacifier and colourant in pharmaceuticals” European Medicines Agency.

Titanium Dioxide in Pharmaceuticals

Approximately 91,000 human medicinal products and 800 veterinary medicinal products contain TiO2 in the EU according to EU Trade Associations.

Final feedback from European Medicine Agency (EMA) to the EU Commission request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives on medicinal products:

“Due to its opacity, whiteness, chemical inertness, and the protection it provides from UV light, titanium dioxide is a widely used excipient in pharmaceuticals. It is used frequently in oral solid dosage forms (e.g., tablets, soft capsules, hard capsules, granules/powders for oral solution and oral suspensions). In veterinary medicinal products, it is also used in oral semi-solid dosage forms (e.g., oral paste, oral gel). It is present in a number of essential medicines for human including antidiabetics, antibiotics and others and several veterinary medicinal products, e.g. for bees.

Each medicinal product will need an individual review and assessment, which will require investigation of alternatives, reformulation, generation of new data related to manufacture, dissolution and stability etc. and potentially new clinical data (e.g. generation of bioequivalence studies).

Taking into account the potential direct and indirect impact on the quality of medicines as described above as well as major supply disruption expected, it is not considered feasible that replacement of TiO2 can be achieved without a negative impact on the quality and availability of medicines in EU/EEA. Given the volume of products potentially impacted by a decision to require removal of TiO2 in medicinal
products, it is considered highly likely that many products may be discontinued and particular concerns arise in relation to certain classes/types of products (e.g. paediatric, orphan, low sales volume, bee products, etc.).

In conclusion, the impact of a potential requirement for replacement of TiO2 in every medicinal product on global harmonisation, product development, availability and access to medicines should be carefully considered.”

Read the full final feedback here.

Titanium Dioxide in Cosmetics

However, titanium dioxide is also present in other products, particularly in (certified natural) cosmetic products, such as lipsticks, cream blushers, toothpaste and sunscreen. Titanium dioxide is not yet banned in cosmetics, as it has not yet been proven that it is harmful to health.

By the way: the ingredient Red 7 Lake (CI 15850), a synthetic color additive, also known as Red No. 30, Red Lake 30 is commonly found in blush, lipstick and other makeup products. Although approved for use in cosmetics, it is often derived from petroleum and/or coal tar and is commonly used in conventional as well as natural cosmetics.

Our Recommendations for Consumers

1. Pharmaceuticals: Unfortunately, certain medications without titanium dioxide are often not available, such as many antidepressants. Talk to your doctor and naturopath and see if it is possible to swap out these medications for herbal alternatives. For example, L-Tryptophan could help with serotonin production.

2. Toothpaste: Use one of the various alternatives for toothpaste without titanium dioxide.

3. Sunscreen: Be careful when buying spray sunscreens containing titanium dioxide. Make sure that you and your children do not inhale or orally ingest products containing this ingredient. Use one of the various mineral sunscreens without titanium dioxide.

4. Make-up / Cosmetics: There are still hardly any alternatives to titanium dioxide in make-up. Certified natural cosmetics manufacturers may continue to use titanium dioxide in small quantities as an ingredient. The only alternative we have found at the moment is fruit-pigmented make-up by the brand 100% Pure.

5. General caution with children: Make sure your kids don’t put titanium dioxide in their mouths with cosmetics or toothpaste. Therefore, since children take many things in their mouth, as a sense of touch, make sure your child does not play with products that contain titanium dioxide or hazardous ingredients in general.

This article is for informational purposes only. Products or information presented are not a substitute for professional medical advice, diagnosis or treatment and should not be relied upon as a substitute for specific medical advice.