You may wonder why I’m writing about an individual Harmonised Classification for Titanium Dioxide which probably isn’t something you use or handle at work, although you probably do use it in your personal life in a multitude of ways, from cosmetics and sunscreens through to the paint on a white car or van.
The reason is that ECHA have explicitly stated that the proposed classification for Titanium Dioxide will be rolled out to all Poorly Soluble Low Toxicity substances (PSLTs, they do love an acronym at ECHA, don’t they?). So if you’ve got a solid which is a powder, or in suspension, you may suddenly find it ends up with a carcinogen classification because of this ruling (if it gets passed).
This proposed Harmonised Classification sits within the draft 14th ATP to CLP (at least the 14th ATP should be published in number order, unlike the “13th ATP then 12th ATP” situation).
It would classify Titanium Dioxide as a Carcinogen Category 2.
When you examine the evidence, the case for the carcinogenicity of Titanium Dioxide is very slim.
- there is no evidence of lung cancer or other lung effects in a cohort study on titanium dioxide industry workers (problems usually show up first in people working with a chemical, because they tend to be in contact with it most) – although the authorities refused to include this evidence in their literature review, rather than including it and then saying why they were going to discount it (which would have allowed debate to happen)
- rats grow tumours on their lungs when exposed to 2,000 mg/kg titanium dioxide dusts
- no other lab animals tested in this way form tumours on exposure to titanium dioxide dusts
- it is a well-known phenomenon that rats will form lung tumours when exposed to any type of dust at 2,000 mg/kg levels, but this does not necessarily translate to carcinogenicity in humans
So the politicians who have proposed this classification are already skating on thin ice, in scientific terms.
The other approach, which is relevant where there is harm being caused to a specific group of people, and benefits for another group of people, would be to weigh up the harm caused and compare it to the benefits:
- there is no evidence of worker deaths due to titanium dioxide exposure in the titanium dioxide industry itself
- there is also no evidence of deaths among users of titanium dioxide in downstream industries, or in consumers
- but classifying titanium dioxide as a category 2 carcinogen would immediately render it impossible to use in sunscreen, leading to zinc oxide (harmful) being substituted, or the ending of high SPF factor sunscreens, which rely on a combination of physical and chemical sunscreens to work
- ending high SPF sunscreens will certainly lead to multiple deaths from skin cancer, for example see the recent blaming of low cost flights to hot countries on an “epidemic” of skin cancer in the UK, see https://www.independent.co.uk/news/health/skin-cancer-sun-healthy-tan-holiday-melanoma-a9008551.html . (It will come as no surprise to learn that sunscreen is being offered as the main protection against skin cancer in this article).
So even if there were say 10 deaths a year from titanium dioxide within industry, which there doesn’t seem to be, the thousands of deaths from skin cancer each year would far outweigh those deaths, and one would hope that a logical and responsible regulator would continue to ensure a supply of titanium dioxide for cosmetics use. This hope may be in vain.
The issue was due to be voted on at the last meeting of CARACAL, that is the collective group of Competent Authorities, including the HSE. They are experts, scientists, and they take advice from industry. It looked like the proposal, which seems to have a political source rather than a technical one, would be voted down.
So the vote was not held. Yes, the probable losers refused to allow the vote to go ahead.
Their reasons for this is that under the Lisbon Treaty, there is going to be a change in the way (I’ll be talking about these Lisbon Treaty changes in another email soon, as it’s very important to the way chemicals are going to be regulated in the EU in future).
There are other procedural problems with the whole issue, which have been detailed by Martin Engelmann at https://www.linkedin.com/pulse/case-titanium-dioxide-continues-dispute-over-rules-martin-engelmann/ .
To summarise, it looks like the EU is determined that Titanium Dioxide should be classified as a carcinogen, even though this will affect its use as a vitally important cosmetic in sunscreen.
It is possible that a regulatory work-round will occur to allow its use in sunscreen, but this ignores the massive pressure on cosmetics companies to use “safe” ingredients. For commercial reasons, many cosmetics companies would probably give up on a reclassified Titanium Dioxide, and we would all lose, especially those of us who are fair-skinned.
Some of the Competent Authorities are fighting a strong rearguard action against this, including our own HSE, but when the politicians are determined to ignore science, what can they do?
And, of course, if Titanium Dioxide is classified like this, ECHA have decreed that all other PSLTs (Poorly Soluble Low Toxicity materials) will automatically incur the same classification.
To which you might ask – on the back of what evidence? and there will be no answer, because the evidence is simply not there, in many cases.
It is difficult to overstate the bad effects on people’s health and wellbeing if this ruling goes ahead, not to mention the bad effects on the chemical industry.
In the event of Brexit, the UK will adopt all EU regulations in force at the date of exit, so it is possible that we may not end up with this potential Harmonised Classification, but the next CARACAL meeting to discuss this issue is early September, so we can’t assume anything.
As well as the effects on Titanium Dioxide, and all other PSLTs, the most worrying aspect is that the politicians are prepared to ignore science and scientific opinion to pursue their own ideas of what classifications should be.
In the UK, we have been here before, with King Canute in the 9th Century showing his nobles he could not command the tide, but at least there was an immediate and obvious outcome. With the Titanium Dioxide reclassification, the adverse outcomes may not be visible for decades.
In practical terms, if Titanium Dioxide is reclassified, then anyone using it will have to review the classifications in their mixtures as the change comes through the supply change, and there will be a similar “cascade” effect as other PSLTs are reclassified as well. This will inevitably mean more work for people classifying PSLTs and products which contain them.
By the way, 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/ .
I will do my best to keep you updated as the situation changes.
GHS Classification Courses from TT Environmental Ltd
22nd July 2019
Like this article? You’ll love our free guide to CLP (and you’ll also get our articles delivered direct to your inbox every week!)