European Court Decision on TiO2: Regulatory Lessons for Canada
The draft screening assessment report for TiO2 and related titanium compounds is scheduled for publication in Canada in 2023, under the federal Government’s Chemicals Management Program. The Canadian government was clearly leaning towards a declaration for TiO2 similar to that of the European Union in 2020. Industry is now hopeful Canada will seriously consider recent decisions taken in Europe in November 2022 wherein the European General Court quashed the European Commission’s 2020 classification of TiO2 as a Category 2 carcinogen. Until that happened the coatings industry and others were bracing for the impact if the same classification were to happen here in Canada as TiO2 is widely used in the coatings and many other industries. No further data is being collected by Canadian officials on TIOs as there adequate toxicological data to make a fully informed decision in the upcoming TiO2 assessment. Industry stakeholders are still waiting to see the selected data endpoints and calculated margins of exposure once the Government’s draft assessment is published later in 2023.
When the EU classification was issued in 2020 the coatings industry in Europe, North America and other countries strongly contested it and argued that the decision was flawed. It was not based on substantive scientific data. Industry organizations lobbying the European Commission’s technical agencies demanded a more rational science-based approach, but it was ignored. These groups included association members of the World Coatings Council (WCC) such as CPCA, ACA, BCF, ABRAFATI, CEPE and others. Of course, the Titanium Dioxide Manufactures Association (TDMA) was leading the effort and left no stone unturned in refuting such an arbitrary approach to the data supporting the Category 2 classification.
The final push came with an appeal to the European General Court, which quashed the 2020 decision by EU authorities as it clearly made an error in classifying TiO2 without robust data to back it up. Industry would never be able to secure an outcome for any chemical assessment without the substantive scientific data to support its case. The growing concern today is legislators are seeking more restrictive chemical regulations, which are held to a lower data threshold than in the past. Conversely, industry is increasingly required to meet a much higher threshold to maintain the status quo of a chemical in commerce. Many maintain that this is an unsustainable approach and begs the question, will the final arbiter of regulatory decisions be played out with legal challenges in the courts rather than as a matter of reasonable public policy?
The European Court ruling was viewed by the courts as an ‘interpretation’ of limited data leading to a significant error in the final TiO2 assessment. In fact, EU agencies relied essentially on just one particular study in making the classification based on the ‘potential’ for TiO2 to become toxic in future. Moreover, it infringed on the established criterion for a Category 2 classification for chemical substances, that is, it did not prove that it had an ‘intrinsic property’ to cause cancer, but merely the ‘potential’ to do so. Thankfully, the judgement reversed the highly disruptive classification and labelling requirements under the 2020 declaration.
The EU Court’s decision makes a very strong point on the role of public policy in the quest for more stringent chemical restrictions however well intentioned. Indeed, the hope is this precedent will inform future classification and prioritization decisions, which will demand regulatory authorities submit to a higher regulatory standard for chemical regulations that is science-based. Had it been left to stand, the EU classification would have also set a bad precedent for other chemical assessments of substances in a powder form (poorly soluble low toxicity particles or PSLT), not only in the EU, but in other jurisdictions around the world. This may still influence the upcoming TiO2 risk assessment in Canada should stronger data come to light.
Furthermore, and as important, is the hope that the TiO2 decision will inform current deliberations on the reform of the Canadian Environmental Protection Act (CEPA) as outlined in the proposed amendments in Bill S-5 for chemicals in commerce. While industry generally supported the Government of Canada’s CEPA amendments for chemical assessment, it raised many serious concerns about the 62 additional amendments by the unelected Senate. Senators admitted they did not have the technical or scientific background to propose such amendments and yet those amendments went forward to the House of Commons for consideration. The Parliamentary committee is about to resume its review of the Bill and finalize the amendments over the coming weeks.
Some of these proposed amendments are concerning. For example, imposing a specific ‘time-clock’ for chemical assessment; loosely defining environmental justice concepts; removing protection of critical Confidential Business Information (CBI) submitted by industry for chemicals in the assessment process; and, a controversial ‘watch-list’ of already regulated substances submitted to the Minister by the public and without an established protocol for removing them from list, if ever. The arbitrary watch-list will only harm the reputation of established product brands even though they are already regulated and sold in Canada. Some of these amendments that are expected to be passed into law without full clarity on how the regulations will be administered. This amounts to a ‘trust us’ approach to legislative change. Such amendments, if passed, are very likely end up in the courts in Canada similar to what happened in the EU’s wrongful classification of TiO2, which was thrown out of court after almost two years. That was done after causing industry and authorities much grief as well as time and money.
If the EU situation on TiO2 or any chemical assessment in Canada it would serve nobody’s interest, neither the Government, nor industry or the public. It would call into question the best practices used for chemical assessment approach used in Canada to date and weaken Canada’s image in the world, further dampening direct foreign investment and innovation in Canada. It would also do little – if anything – to further the protection of human health or the environment. It will likely cause consumers to question already regulated products. There will be fewer competing products on the market and compliance will be very difficult.
We may be at the point in Canada, wherein chemical regulations have been ramping up for the past 15 years, and now in several areas there are diminishing environmental benefits and increasing negative economic returns.