Titanium Dioxide

Update on EU Classification and Labelling of TiO2On February 18, 2020, the European Commission
published the 14th ATP to CLP Regulation (EU)2020/217) which includes a harmonized classification forcertain powder forms of TiO2 as a Carcinogen Category
2 by inhalation (with notes). The classification came into
enforcement on October 1, 2021.
Chemours, together with TDMA, has worked to interpretand put into practice the classification proposal under
the CLP guidelines. In the absence of an officiallydesignated method to measure compliance with theclassification criteria, TDMA undertook a comparative
study of available test-methods and came to theconclusion that of all methods tested, the internationallyrecognized test method for dustiness of bulk materials
in the workplace environment, EN 15051-2 provides
the most consistent and repeatable results and was alsochosen by Chemours to determine classification criteria.
Chemours has carried out testing on all Ti-Pure™ titanium
dioxide pigments to measure the content of particles withaerodynamic diameter ≤10 μm, (one of the two criteria
for classification – the other being the “powder” form). The
data from the Chemours testing consistently shows that
all the Ti-Pure™ grades of TiO2 contain <1% of particles
with aerodynamic diameter ≤10 μm and therefore, basedon this testing, do not meet the criteria for classification.
On November 23, 2022 the General Court of theEuropean Commission delivered a judgement annullingthe classification of certain powder forms of titanium
dioxide as a Carcinogen Category 2 by inhalation as
introduced by Regulation (EU) 2020/217. The principal
reasons for the annulment were that an error had been
made in the assessment of the reliability and acceptabilityof the study on which the classification was based andthat a carcinogen classification can only apply to asubstance that has the intrinsic property to cause cancer.
France and the European Commission have appealed thejudgement of the General Court of the European Union of23 November 2022 concerning titanium dioxide (TiO2) incertain powder forms. The appeal process is expected totake 1 to 2 years. In practice, the classification will remainin place until the end of the appeal process.
Although none of the Chemours Ti-Pure™ pigments fulfill
the classification criteria of the EU CLP regulation, ourTMP surface treated TiO2 pigments, which are considered
mixtures, do carry additional CLP Annex II labelling
warning phrases related to powder mixtures containing
TiO2 (as published under Regulation (EU) 2020/217).
These warning phrases will remain on the packagings andSDS’s of our TMP surface treated Ti-Pure™ grades until
the regulatory process is finalized. Once finalized, we willassess any required changes to our Chemours Ti-Pure™
packaging and labeling.
Chemours, as an Associate member of the TDMA, has
actively worked to bring forward relevant information
related to the safety of TiO2 and will continue to seek
meaningful and effective discussions with authorities toimprove worker safety. With TDMA we continue to invest
in a major scientific programme with the objective togenerate additional safety data and new scientific studies
in line with the latest guidelines and scientific techniques
related to the use of TiO2 and our Chemours Ti-Pure™
pigments. This Link brings you to the TDMA publicationfrom February 16, 2023 on the appeal.

Ti-Pure™

Titanium Dioxide

Information available on Chemours SDS’s:
Carcinogenicity — Assessment: Weight of evidence
does not support classification as a carcinogen.

results, Chemours scientists conclude that titanium
dioxide will not cause lung cancer or chronic respiratory
diseases in humans at concentrations experienced in
the workplace.

In lifetime inhalation studies rats were exposed for 2 years
to respectively 10, 50 and 250 mg/m3 of respirable TiO2.
Slight lung fibrosis was observed at 50 and 250 mg/m3
levels. Microscopic lung tumours were also observedin 13 percent of the rats exposed to 250 mg/m3,
an exposure level that caused lung overloading andimpairment of rat lungs clearance mechanisms. In
further studies, these tumours were found to occur
only under particle overload conditions in a uniquely
sensitive species, the rat, and have little or no relevancefor humans. The pulmonary inflammatory response toTiO2 particles exposure was also found to be much more
severe in rats than in other rodent species. In February
2006, IARC has re-evaluated Titanium dioxide aspertaining to Group 2B: “possibly carcinogenic to humans”,
based upon inadequate evidence in humans and sufficientevidence in experimental animals for the carcinogenicity
of titanium dioxide. IARC evaluation guidelines consider
the generation of tumours, in 2 different studies within
the same animal species, to be adequate criteria foran assessment of sufficient evidence. The conclusionsof several epidemiology studies on more than 20000
TiO2 industry workers in Europe and the USA did notsuggest a carcinogenic effect of TiO2 dust on the humanlung. Mortality from other chronic diseases, including
other respiratory diseases, was also not associated with
exposure to TiO2 dust. Based upon all available study

Additional EU SDS Info:
Section 11.1 Information on toxicological effects
Carcinogenicity — Remarks
The Commission Regulation (EU) 2020/217, amending
REGULATION (EC) No 1272/2008, introduces anew harmonized classification for certain forms ofTiO₂ as a category 2 carcinogen by inhalation whichapplies from 1 October 2021. To be classified, the TiO₂
must be in powder form and contain 1% or more ofparticles with aerodynamic diameter ≤ 10 µm. Througha rigorous evaluation of available test methods andavailable standards, EN 15051-2 (Workplace exposure– Measurement of the dustiness of bulk materials –rotating drum method) was identified as the best available
method for complying to the regulation. Data from thetesting following EN 15051-2 consistently shows thatTi-Pure™ grades of TiO2 contain < 1% of particles withaerodynamic diameter ≤ 10 µm and therefore do notmeet the criteria for classification. The respirable andthoracic dust content of Ti-Pure™ grades fall inthe very low or low dustiness categories by theEN 15051-2 method.
Further questions should be directed to:TiO2ProductStewardship@chemours.com

CAUTION: Do not use or resell Chemours™ materials in medical applications involving implantation in the human body or contact with internal body fluids or tissues unless agreed to by Seller in a writtenagreement covering such use. For further information, please contact your Chemours representative. These products may not be directly added to food, pharmaceuticals, cosmetics, or cigarette
papers/filters for tobacco products.
For medical emergencies, spills, or other critical situations, call (844) 773-2436 within the United States. For those outside of the United States, call (302) 773-1000. The information set forth
herein is furnished free of charge and based on technical data that Chemours believes to be reliable. It is intended for use by persons having technical skill, at their own discretion and risk. The handlingprecaution information contained herein is given with the understanding that those using it will satisfy themselves that their particular conditions of use present no health or safety hazards. Because
conditions of product use are outside our control, Chemours makes no warranties, express or implied, and assumes no liability in connection with any use of this information. As with any material,evaluation of any compound under end-use conditions prior to specification is essential. Nothing herein is to be taken as a license to operate under or a recommendation to infringe any patents.
NO PART OF THIS MATERIAL MAY BE REPRODUCED, STORED IN A RETRIEVAL SYSTEM OR TRANSMITTED IN ANY FORM OR BY ANY MEANS ELECTRONIC, MECHANICAL, PHOTOCOPYING, RECORDING OR OTHERWISEWITHOUT THE PRIOR WRITTEN PERMISSION OF CHEMOURS.

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