CARACAL Defers Action on ECHA Titanium Dioxide Classification Recommendation, Seeks Comment
November 29, 2017
On Nov. 15, the Competent Authorities for REACH and CLP (CARACAL) deferred action on the European Chemicals Agency’s (ECHA) Risk Assessment Committee’s (RAC) opinion on classifying titanium dioxide (TiO2) as a Category 2 (Animal) carcinogen, by inhalation. CARACAL has delayed any regulatory decision and will continue to take comments on the RAC opinion, as well as the applicability of the Classification, Labeling and Packaging (CLP) Directive for inert, non-toxic, poorly soluble dusts such as TiO2. CARACAL will next consider the TiO2 classification at its meeting in March 2018.
The paint and printing ink industries extensively utilize TiO2 in a wide variety of forms to make nearly all their finished products. TiO2 is considered the primary pigment for paints and coatings, providing essential performance functionalities of hiding and coverage. Paints and coatings cannot be manufactured without this material. TiO2, along with a wide variety of other raw material feedstocks are critical to the industry, where good manufacturing practices ensure safe use, including protections of worker health and product safety.
Should the proposed classification as a Category 2 (Animal) Carcinogen be finalized under the CLP, onerous new labeling requirements will be required for TiO2-containing products, leading to market unease, with implications for product quality, performance and waste management.
ACA, working in conjunction with its European counterpart, CEPE, will continue to press for open discussion and evaluations that embrace sound science and follow established risk assessment practice, by which the inherent safety of TiO2 use by the paint industry may be acknowledged.
ECHA has a program to develop harmonized hazard classifications for chemicals and the products containing them that are offered for sale and use in the EU. ECHA’s RAC must adopt an opinion on a proposed harmonized classification brought by member states. Established under the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the RAC applies hazard criteria adopted in the CLP regulation when evaluating proposed harmonized classifications. Using these criteria, the RAC does not consider exposure information when evaluating proposed harmonized classifications.
In November 2015, the French government agency ANSES offered a proposed dossier to support classification of TiO2 as a human carcinogen (Category 1).
Over the last year, ECHA held a public consultation period which generated a large volume of comments objecting to and criticizing 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 consideration, 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 filed comments during ECHA’s public consultation period, and submitted its concerns directly to the WTO and through the U.S. Department of Commerce’s (DOC) International Trade Administration (ITA). Working with CEPE and other allied paint industry associations in the International Paint and Printing Ink Council (IPPIC), ACA organized the submission of industry comments from around the globe. In addition, ACA has been monitoring efforts advanced by the coatings industry associations in Europe to influence national delegations, engage with CARACAL officials, and secure formal consideration of key industry positions that include the following:
- The toxicity data being considered to classify TiO2 is really “non-substance specific” and characteristic of all inert, poorly soluble, low toxicity particulates and accordingly, the CLP regulations are not relevant for this type of hazard classification;
- The scientific basis for the proposed cancer hazard classification is not valid, and unjustified, given that the animal studies relied on are more than 20 years old, as well as negated by human epidemiology studies showing workers exposed to TiO2 dust face no increased cancer risk; and
- When used in formulated products, like paint and printing ink, TiO2 dust is no longer available for exposure, and required product warnings have no validity and will raise unwarranted concerns and needless deselection.
ACA has repeatedly cited the many other national chemicals management schemes that acknowledge the lack of exposure and pursuant health risk for substances embedded in polymers. Paints, coatings, inks and other polymers have a long history of safe use, as do the organic and organo-metallic pigments and dyes that have been used in these and other applications.
ITA Voices Concern at World Trade Organization
At the request of ACA and the coatings industry, the ITA recently voiced its concern before the World Trade Organization’s (WTO) Committee on the Technical Barriers to Trade that the RAC opinion, if adopted by CARACAL, could result in a non-tariff trade barrier. The United States was the only governmental body to express any opinions on this issue.
Since the issuance of the formal RAC opinion, ACA has had extensive engagement with ITA on the potential trade impacts of the proposed classification. Continued follow up with the ITA is expected, since it will maintain a presence at future CARACAL meetings to observe how their deliberations impact U.S. interests.
CARACAL November Meeting
At CARACAL’s meeting on Nov. 15, 2017, the RAC opinion was on the agenda along with a formal paper developed by CEPE, the European coatings association, and cosigned by 14 other European end-user associations.
Discussion among the CARACAL member states revealed concerns about the formal RAC opinion. Issues were raised with respect to the applicability of the CLP regulations for all inert, non-toxic, poorly soluble dusts (like TiO2, carbon black, and iron oxide). Other pending assessments under ECHA that could have an impact on the decision before CARACAL were also cited. It is significant that several EU member delegations echoed the concerns about the applicability of CLP and consequently, CARACAL has requested additional information. CARACAL will accept additional comments through Dec. 15, 2017. CARACAL members and observers may submit comments on the issue, and address the question of whether CLP is the appropriate vehicle to address low toxicity dust. CARACAL will once again consider the RAC opinion on TiO2 in March.
While the next CARACAL deliberations will not take place until March, it is expected that the EU member states will submit additional comments to direct continued discussion. DOC and its ITA have arranged for follow-up discussions on additional ways to engage effectively.
ACA will continue to work with CEPE and other industry associations to stress the need for scientific evaluation that embraces both hazard and exposure risks as most authoritative for any effort to establish a meaningful classification. A sound scientific assessment as such confirms the inherent safety of TiO2 use by the paint industry.
Contact ACA’s Steve Sides for more information.