VCI Statement on the Proposal for a Harmonised Classification of Titanium dioxide

The french agency ANSES has proposed Titanium Dioxide for a harmonised classification and labelling according to the CLP Regulation, namely as "potentially carcinogenic to humans" and "may cause cancer by inhalation". At the European level, this proposal is currently undergoing the prescribed discussion and decision-making procedure. From the viewpoint of the chemical industry, the proposed classification and labelling is inappropriate and would have serious and disproportionately negative impacts:

Background

The French agency “Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail” (ANSES) elaborated a so-called CLH report with a proposal for a harmonised classification and labelling of Titanium Dioxide as “potentially carcinogenic to humans” (category 1B) / “may cause cancer by inhalation” (H350i).

At the European level, this proposal is currently undergoing the discussion and decision-making procedure, as prescribed by the CLP Regulation.

The arguments of the chemical industry in a nutshell

1. No indications of problems from epidemiological studies and application practice

Titanium Dioxide has been used safely for many decades. No increased incidence of lung cancer has been observed. In epidemiological studies no connection was found between exposure at the workplace and a cancer risk. This is also noted in the CLH report: “Human data do not suggest an association between occupational exposure to TiO2 and risk of cancer […]” [CLH Report, page 8].

2. Animal studies cannot be transferred to humans

The classification proposal in the CLH report is based essentially on studies in rats exposed to extremely high concentrations of titanium dioxide dusts, which led to so-called “lung overload” effects.

However, all relevant guidance documents by ECHA, OECD and the ECETOC Report unanimously observe that the results from “lung overload” studies in rats should not be transferred to humans for several reasons. Therefore, a classification is neither justified nor appropriate from the toxicological perspective.

3. Existing legislation provides sufficient safety

The carcinogenic effect found exclusively in animal testing is based on particle-caused inflammatory processes in the lungs due to dust exposure by inhalation. However, this is not substance-specific for Titanium Dioxide but characteristic of a large number of dusts, irrespective of the underlying substance.

Exposure by inhalation to Titanium Dioxide can be expected primarily at the work¬place. Consequently, relevant dust limit values are in place in several EU Member States. In Germany, there are additionally a number of provisions for further-going protection measures to minimise dust exposure. At the European level, dust exposure could be regulated in a binding and uniform manner in the directives on occupational health and safety. A classification of Titanium Dioxide s not necessary for this purpose.

4. Major and disproportionately negative impacts due to automatic refer-ence to classification and labelling in existing legislation

In many sets of legislation – e.g. on industrial plant safety and environmental or con-sumer protection or special legislations on biocidal products or cosmetics – classification and labelling give rise to comprehensive obligations and bans or restrictions, au-tomatically and without any further examination of whether the use of the substance really poses risks. For example, mixtures (like titanium-dioxide containing white wall paint) could be no longer placed on the market for private end consumers.

5. No suitable alternatives are available

Because of the outstanding properties of titanium dioxide regarding health, safety, environment and performance, no suitable alternatives are available. As the carcinogenic effect in animal testing is not substance-specific but characteristic of dusts, this can be expected to occur with all potential alternative substances too.

6. Considerable negative impacts in all industrial sectors

Because of its outstanding properties, Titanium Dioxide is an all-rounder raw material in almost all sectors of industry. This substance is widely used, mainly as white pigment and particularly in paints, coatings, plastics, textiles, foods and feedstuffs, in paper production as well as in pharmaceutical and cosmetic products. A classification as “potentially carcinogenic to humans” would have considerable negative impacts on entire value chains.

Conclusion

The submitted proposal for classification and labelling of Titanium Dioxide is inappropriate from the toxicological perspective. Therefore, no classification should be made. A classification would not contribute to improving the protection of health and environment, while it would have serious and disproportionately problematic effects in almost all legal fields.

In the future, additional risk and impact assessments should be carried out for all substances as soon as a harmonised classification of a substance is possibly upcoming. Where sufficient risk management is already in place in uses for consumers, for work-ers and environment, exemptions should be granted in accordance with proportionality. This would ensure that the legislations, which refer to classification and labelling, do not result in automatic and disproportionate restrictions or bans.

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• Source: VCI Press Release - 4.7.2016