International. On November 15, the Competent Authorities for REACH and CLP (CARACAL) postponed the opinion of the Risk Assessment Committee (RAC) of the European Chemicals Agency (RAC) on the classification of titanium dioxide (TiO2) as a Category 2 carcinogen (Animal), by inhalation.
CARACAL reported that it has delayed any regulatory decision and will continue to receive comments on the RAC's opinion, as well as on the applicability of the Classification, Labelling and Packaging Directive (CLP) for inert, non-toxic and poorly soluble powders such as TiO2. CARACAL will consider the TiO2 classification at its March 2018 meeting.
If the proposed classification as a Category 2 (Animal) carcinogen is finalized under the CLP, new onerous labelling requirements will be required for products containing TiO2, leading to market unrest, with implications for product quality, performance and waste management.
The American Coatings Association (ACA), working in conjunction with its European counterpart, UNECE, will continue to push for an open discussion and assessments that encompass sound science and follow established risk assessment practice, by which the inherent safety of TiO2 use in the paint industry can be recognized.
History
In November 2015, the French government agency ANSES offered a proposed dossier to support the classification of TiO2 as a human carcinogen (Category 1).
Over the past year, ECHA held a public consultation period that generated a large volume of comments objecting to and criticising the proposal to classify TiO2 as a human carcinogen as premature, lacking scientific validity and creating widespread uncertainty.
ECHA's RAC met this summer to consider the proposed dossier and the public comments received. After some considerations, RAC issued a formal opinion in September 2017, proposing to classify TiO2 as a category 2 (animal) carcinogen, or a substance suspected of causing cancer by inhalation.
ACA Efforts to Address TiO2 Issues
ACA has been monitoring the efforts made by coating industry associations in Europe to influence national delegations, interact with CARACAL officials, and ensure formal consideration of key industry positions including the following:
- The toxicity data that are considered to classify TiO2 are actually "non-substance specific" and are characteristic of all inert, poorly soluble and low toxicity particles and, consequently, CLP regulations are not relevant to this type of hazard classification;
- The scientific basis for the proposed cancer risk classification is invalid and unjustified, given that animal studies are more than 20 years old, and is denied by human epidemiology studies showing that workers exposed to TiO2 dust do not face an increased risk of cancer; and
- When used in formulated products, such as paint and printing ink, TiO2 powder is no longer available for exposure, and the required product warnings are invalid and will raise unwarranted concerns and unnecessary override.
While the next CARACAL deliberations won't take place until March, EU member states are expected to submit additional comments to lead the ongoing discussion. DOC and its ITA have organized follow-up discussions on additional ways to engage effectively.
Source: American Coatings Association.
