This is an update on the article of 22nd July 2019, which you can read here.
The story so far….
Titanium Dioxide is currently considered a non-hazardous chemical, which is used in a multitude of ways, from cosmetics and sunscreens through to the paint on a white car or van.
The European Commission has proposed that it should be classified as a Category 2 Carcinogen, Suspected of causing cancer, as a Harmonised Classification, on the grounds that it causes tumours in rats lungs when they are exposed to Titanium Dioxide dust at 2,000 mg/kg.
This is agreed by ECHA, even though they know, and pretty much the entire scientific community (with a few exceptions) knows that rats will grow tumours in response to dusts at 2,000 mg/kg regardless of what that dust is; and that rats are much more prone to this than other animals or humans.
It is also known that there is no evidence that this tumour-causing effect occurs in other animals which have been exposed to 2,000 mg/kg of titanium dioxide.
And the epidemiological evidence for carcinogenic behaviour of titanium dioxide dust in the human population does not appear to exist.
The balance of probabilities indicates that the “evidence” for Titanium Dioxide being carcinogenic is a mis-reading of a generic response to dusts in a individual species which does not translate across into other animals or the human population.
Even if it were to be considered a potential carcinogen, the use of Titanium Dioxide as a sunscreen would save far more lives through preventing skin cancer than would be lost in people exposed to the dusts, e.g. in industry. Yet this argument does not appear to be accepted either, although it is a common regulatory tool.
To make matters worse, ECHA have also stated that the proposed classification for Titanium Dioxide will be rolled out to all Poorly Soluble Low Toxicity substances (PSLTs), which potentially affects all powders or suspensions. It would be bad enough if just Titanium Dioxide were to be affected, yet this would propagate the error even more widely.
The last we had heard of the situation in July 2019 was that the vote on whether the new Harmonised Classification should be accepted had been withdrawn from CARACAL, the meeting of the Competent Authorities. At the time, there were suspicions that this was because the vote would have been against the classification, and if that vote had been made it would have been legally binding.
We now have new information on what the European Commission propose (courtesy of Martin Engelmann’s excellent article here).
The proposal has been changed slightly, so now a classification of Cat 2 carcinogen, H351, Suspected of causing cancer through inhalation, would apply to titanium dioxide as a substance and in mixtures containing 1% or more:
a) titanium dioxide particles < 10 micrometer and
b) all particles < 10 micrometer containing titanium dioxide [new]
This includes solid mixtures in which titanium dioxide is bound in the matrix (such as industrial applications like coated pigments and powder coatings and maybe even cement and fillers), as well as powders containing free titanium dioxide particles.
There would still be a mandatory warning label on the packaging of liquid and solid mixtures containing “1% or more of titanium dioxide particles with aerodynamic diamater equal to or below 10 μm”, either:
- “EUH211: Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.“ or
- “EUH212: Warning! Hazardous respirable dust may be formed when used. Do not breathe dust”.
Martin points out that the EUH211 warning is contradictory, because the hazard classification only applies to dust.
We have already described the effects of this Harmonised Classification for Titanium Dioxide, but as Martin points out in his article, these would be far wider than anticipated, and would even extend into childrens’ toys. Childhood favourites such as modelling clays and paintboxes would be banned, as no carcinogens or suspected carcinogens are allowed, and these toys are made from PSLTs in powder format.
What is far more worrying is that, as well as tinkering with the proposal, the European Commission have decided to “review” the 400 comments on their proposal, and have discussed them in a mere 1 1/2 pages, and dismissed them all out of hand on the basis of there being “no new information”.
This political tactic means that the European Commission are technically following their own code of practice, and an appeal cannot be made against them on the grounds that they ignored the responses to the consultation.
This is very worrying, because it is not as if industry is ignoring the potential impact of dusts in industry. Many of the people and organisations who responded to the proposal have suggested that the dust limit values for Occupational Exposure Limits should be harmonised across the EU, which would protect workers against all types of health hazards from every possible dust.
Although there are calls from various industry bodies for a full Impact Assessment, the next consultation meeting is due on the 18th September.
My personal view is that the European Commission will try to push the Harmonised Classification through before the 1st November 2019. This is because the current European Commission, currently headed by President Jean-Claude Junker, will be replaced on 1st November 2019 by the incoming European Commission, to be headed by Ursula von der Leyen.
This change may mean that the proposal would have to be dropped and reissued, or that the incoming European Commission might not take it up (presumably there are rules on what happens when the EC changes, I don’t know about these though).
I originally said that if we do have Brexit on 31st October, the UK may manage to avoid this Harmonised Classification, but the rest of the EU may be affected by it.
However, if my hunch is correct, and the EC will try their best to push it through before 1st November, then the UK may be caught up in this scandal as well, and industry will be affected in both the UK and the EU.
As I said before, it is difficult to overstate the bad effects on people’s health and wellbeing if this ruling goes ahead, not to mention the harmful effects on the EU chemical industry.
Yet the European Commission, and ECHA, are “doubling down”, rather than withdrawing a classification proposal which is unjustified for Titanium Dioxide, and which would be made much worse by extending it to all PSLTs.
Jean Claude Junker is behaving more and more like King Canute, telling the tide of scientific evidence to withdraw because the European Commission’s Harmonised Classification is correct.
It is looking very much like the EC and ECHA are ignoring the science, although why this should be happening is unclear. A cynic might suggest pressure from NGOs, or foreign interests who would try to pick up business which could no longer be carried out in the EU, but I really don’t know what to think.
I will continue to keep you updated as the situation changes.
GHS Classification Courses from TT Environmental Ltd
1st September 2019
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PS The original work allegedly demonstrating that Titanium Dioxide is carcinogenic, along with Carbon Black and Talc, was carried out on behalf of the IARC by ANSES, the French Health and Safety regulator equivalent to the UK HSE. The evidence for Carbon Black and Talc being carcinogenic appears to be of a similar standard to Titanium Dioxide. If you’re interested, you can read the IARC monograph at https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-28/ .