Last week, the European Commission (EC) has adopted the 14th adaptation to technical progress (ATP) of the CLP Regulation (“Classification, Labeling, and Packaging”) and included the controversial classification of inhalable powder forms of titanium dioxide (TiO2; CAS 13463-67-7) as a category 2 carcinogen. TiO2 has been in use a whitener, notably for paint, and in the food sector.
The CLP Regulation is a European Union (EU)’s regulation from 2008, which aligns the EU system of classification, labeling, and packaging of chemical substances and mixtures to the Globally Harmonized System (GHS).
The classification is reported to apply to liquids as well as powders “containing 1% or more of titanium dioxide in the form of incorporated in particles with aerodynamic diameter ≤ 10 µm”. The EC will now submit the act to the European Parliament &its Council and have two months to raise any objections; if there are no objections, the Act is expected to be published early in 2020, with the changes becoming a legal requirement after 18 months.
As some hazardous dust may be produced during the use of some mixtures that contain TiO2, Annex II to CLP introduces the requirement to warn users via the product label using supplemental label statements:
- For liquid mixtures containing 1 % or more of Titanium dioxide particles with an aerodynamic diameter equal to or below 10 μm: EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’
- For solid mixtures containing 1% or more of titanium dioxide: EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.
The harmonized classification and labeling of hazardous substances is updated through an “Adaptation to Technical Progress (ATP)” which is issued yearly by the EC. Following the adoption of the opinion on the harmonized classification and labeling of a substance by the Committee for Risk Assessment (RAC), the EC takes a decision and publishes the updated list in an ATP. The excel table contains all updates to the harmonized classification and labeling of hazardous substances.
Based on the experimental evidence from animal inhalation studies, TiO2 nanoparticles are classified as “possibly carcinogenic to humans” by the International Agency for Research on Cancer (IARC) and as occupational carcinogen by the National Institute for Occupational Safety and Health (NIOSH) while the U.S. Food and Drug Administration (FDA) generally recognizes titanium dioxide as safe (GRAS).
France is a part of the EU and its Agency for Food, Environmental and OccupationalHealth & Safety (ANSES) will ban the use of titanium dioxide as a food additive from 2020 because there was not enough evidence to guarantee the safety of the substance.
Titanium dioxide is widely used in industry as a whitener, notably for paint, and in the food sector, where it is labeled E171 and goes into products from chocolate to chewing gum. France had ordered a review of the substance in 2017 after a study found health effects in animals that consumed it.
Based on the experimental evidence from animal inhalation studies, TiO2 nano-particles are classified as “possibly carcinogenic to humans” by the International Agency for Research on Cancer (IARC) and as an occupational carcinogen by the U.S. National Institute for Occupational Safety and Health (NIOSH).
The new requirement for titanium dioxide products to carry cancer warnings on the label applies only to mixtures in powder form containing 1% or more of the substance with an aerodynamic diameter of 10μm or less.
In total, the 14th ATP makes 28 changes to the harmonized classification and labeling of substances in Annex VI. They include the substance N-carboxymethyliminobis (ethylenenitrilo)tetra (acetic acid) (DTPA), classified as toxic for reproduction. DTPA is used in coating products, fillers, polishes, and waxes, as well as textile treatment products and dyes, among others.
The ATP also includes harmonized acute toxicity estimate (ATE) values for certain substances to facilitate the harmonization of the classification of mixtures and provide support for enforcement authorities. Additionally, it corrects the classification for the substance pitch, coal tar, high temperature, following an earlier erroneous classification.
The American Chemistry Council’s (ACC) Titanium Dioxide Stewardship Council (TDSC) said the decision is “unwarranted” and it is “considering all options” for challenging it, although it is “very difficult” to do this during the scrutiny stage.
The proposal is “vague and ambiguous”, the US trade body said, reiterating the need for an impact assessment.
The classification forms part of the 14th adaptation to technical progress (ATP) of CLP, and includes cobalt metal as a category 1B carcinogen. See the EC adoption by the amendment web page at: https://ec.europa.eu/info/law/better-regulation/initiatives/c-2019-7227_en.
It is recommended to consider reclassifying of substances and mixtures according to the new or amended Annex VI changes and updating the EU Labels and safety data sheets (SDSs) by the deadline. For details, see the references below:
- CLP Regulation, web page at: https://en.wikipedia.org/wiki/CLP_Regulation
- European Union, web page at: https://europa.eu/european-union/index_en.
- Table of harmonized entries in Annex VI to CLP, web page at: https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
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