• Curious About the Latest EU Regulations on Titanium Dioxide? Let’s Dive in and Interpret Them!

Curious About the Latest EU Regulations on Titanium Dioxide? Let’s Dive in and Interpret Them!

On February 18, 2020, according to the latest revised EU Regulation (EC) No 1272/2008 on Classification, Labeling, and Packaging (CLP) of Substances and Mixtures, the EU officially classified titanium dioxide as a Class 2 suspected carcinogen that may cause cancer through inhalation.


In the scientific opinion on titanium dioxide on September 14, 2017, the Risk Assessment Committee (RAC) classified titanium dioxide as an inhalable carcinogen in category 2, based on the fact that titanium dioxide can be inhaled in particulate form, remain in the lungs, and is difficult to dissolve. It is inferred that it is related to observed lung toxicity and subsequent tumor development, thus suggesting the need to remind users to take preventive measures, To minimize harm to human health.


Appendix 1 provides additional information on the specific product label content:

EUH211: For gases containing 1% or more titanium dioxide particles with a gas kinetic diameter equal to or less than 10 μ A liquid mixture of m, it should be noted that harmful inhalable particles may form when spraying the product. Do not breathe spray.

EUH212: For solid mixtures containing 1% or more titanium dioxide, it should be noted that harmful inhalable dust may form when used. Do not inhale dust.

How to interpret

According to the International Institute for Cancer Research (IARC), a subsidiary of the World Health Organization, carcinogens are classified into four categories:

Category 1: Substances or mixtures with clear carcinogenicity to the human body. For example: formaldehyde, alcoholic beverages, tobacco.

Class 2A: Substances or mixtures with a high likelihood of causing cancer to humans, and sufficient evidence of carcinogenicity has been found in animal experiments. For example: 65 ℃ hot drinks, beef and mutton, etc.

Category 2B: Substances or mixtures with a low likelihood of carcinogenicity to humans, and the evidence of carcinogenicity found in animal experiments is insufficient, with limited evidence of carcinogenicity to humans. For example: gasoline, mobile phone radiation, kimchi, etc.

Category 3: Substances or mixtures that have not yet been classified as carcinogenic to humans, with insufficient evidence of carcinogenicity to humans. For example: caffeine, xylene, saccharin, mercury and its inorganic compounds.

Category 4: Substances that are carcinogenic to the human body and may not be carcinogenic to the human body.


6.1 There is insufficient evidence to suggest that titanium dioxide is carcinogenic in the human body.

6.2 Only limited evidence shows carcinogenicity in experimental animals.

Conclusion: The carcinogenicity of titanium dioxide is Class 2B, and its risk is much lower than drinking a 65 ℃ hot drink and eating beef and mutton; The level of danger is equivalent to playing with a mobile phone.


As is well known, when it comes to the harm of inhaling doses, they are all playing hooligans.

Let's take a look at the data from the intratracheal administration experiment in mice: the lesion was caused by inhaling high concentrations of titanium dioxide instead of low doses (experimental concentration of 250mg/m) ³). Only when inhaling high concentrations of titanium dioxide, there is a possibility of danger.

According to the Chinese "Hygienic Standard for Titanium Dioxide Dust in the Air of Workshops (GB 11522-89)", the occupational exposure limit for titanium dioxide in the air of workshops is specified as MAC: 10 (mg/m ³). The maximum concentration of titanium dioxide that the workers in the actual production workshop are exposed to is about 6.258mg/m ³, The minimum value is about 0.319mg/m ³

Conclusion: The inhalation concentration of small and medium-sized white mice in the experiment (250mg/m ³), Almost 40 times the highest concentration in the titanium dioxide production workshop. In this high concentration of dust environment, there is a risk of cancer.

In fact, long-term exposure to dust environments, whether it is dust or flour, may cause damage to the lungs, stimulate the bronchial mucosa, lead to chronic tracheal inflammation, and even induce the occurrence of tumors. This pot cannot be carried by titanium dioxide alone.

Other sounds

The European Titanium Dioxide Production Alliance (TDMA) released a public statement on February 18th regarding the EU's initiative, stating that RAC has not provided any new scientific evidence or interpretation of this potential hazard, attempting to forcibly link excessive inhalation of titanium dioxide dust with the hazard. In theory, this dust hazard is not specific to titanium dioxide, but covers over 300 substances.

The European paint industry has criticized this regulation. The CEPE (European Council of Paint, Printing Ink, and Art Pigment Manufacturers) believes that the reason for the European Commission's decision is not related to the chemical substances in titanium dioxide, but rather to chronic inflammation of rat lung cells caused by the presence of only excessive dust particles in the lungs.

Understanding of Joint Micropowder

1. From the perspective of the health of consumers and practitioners, it is a beneficial and responsible behavior to clearly indicate the health risks that excessive inhalation of powder may bring, and this is highly recognized by the United Micropowder.

2. In the future, solid and spray cosmetics exported to the EU with titanium dioxide content of 1% or more, including but not limited to loose powder, dry pressed powder, eye shadow (solid powder will be formed during use), sunscreen spray and other products, may be required to be marked at a conspicuous position with a label similar to "dust may be formed during use, which is harmful to health by inhalation". Emulsion products (such as liquid foundation and foundation cream) and ointment products (such as lip gloss and lipstick) should not be affected much.

3. It remains to be seen whether the revision of the EU regulation will lead to adjustments in relevant policies and regulations in other countries and regions such as the United States and Japan. It remains to be seen whether the Chinese FDA will revise cosmetics related policies and regulations based on this.

4. Titanium dioxide is a mature inorganic metal oxide with stable chemical properties, widely used in various industries such as coatings, plastics, paper making, ink printing, rubber, food, pharmaceuticals, cosmetics, etc. Its safety under normal use conditions (including external skin use, oral administration, etc.) has been fully demonstrated. To arbitrarily define titanium dioxide as a carcinogen solely based on the health risks that may arise from inhalation into the lungs in extreme concentrations is a biased and objective view.

5. At present, with the same level of technological development and application fields, there are no other pigments that can be compared to titanium dioxide in terms of performance, cost, safety, stability, etc.

6. The overall supply and demand relationship of titanium dioxide in the cosmetics industry will not be significantly affected.

7. At present, there are no plans to search for and develop alternatives to titanium dioxide in the United Micropowder.

Future measures

01. As a professional cosmetics powder manufacturer, Lianhe Micropowder always pays attention to product safety issues and is constantly committed to improving its quality and safety management level. In recent years, Lianhe Micropowder has passed frequent audits by numerous international and domestic customers and authoritative third-party organizations in various aspects such as ISO22716, GMP, and social responsibility. In the future, United Micro Powder will continue to strengthen employee labor protection, ventilation and purification in factory workshops, increase investment in software and hardware, and ensure the physical health of frontline employees.

02. Joint micro powder will optimize packaging design to reduce dust generation; Add risk warning content in a prominent position on the label; Update product information such as TDS and MSDS to provide customers with safer and higher quality products.

03. United Micropowder will increase the research and development, production, and promotion of slurry products, explore technical solutions with customers, and solve dust pollution in various links such as transportation, production, and storage from the source.

04. United Micro Powder will increase the application research and development of wet powder, powder and ointment products, and come up with alternative solutions for loose powder, dry powder and spray cosmetics containing titanium dioxide as soon as possible for customers' reference.


Post time: Aug-29-2023

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