TiO2 classification as 1B Carcinogen proposal by French for REACH

[DrP]

The French Dossier on TiO2 was made publically available on 31st May 2016. They are trying to make it a class 1 B Carcinogen by inhalation based on some test they did on rats in 1985 by Lee et al. The test was critiqued by many as rats aren't a great indicator in carcinogen tests for humans and the rats were overloaded with huge amounts of the powder.

 

Here is some background as to their proposal. It seems there still needs to be testing done on the nano form, but no-one, outside of the Lee et al French experiments in 1985 has shown any harm caused by normal industrial use of TiO2 powder.

 

A larger debacle is that if they get their proposal through, then, paint formulations will need to list TiO2 as a carcinogen under REACH on their labels..... even though it would only be relevant in its powdered form and would be perfectly safe bound up in a formulation or in a dried paint coating.

 

 

www.chemicalwatch.com/43791/france-proposes-carcinogen-1b-classification-for-titanium-dioxide

 

 

...

 

PS - as a further aside both aromatic and aliphatic Isocyanates are to have their use restricted to professional coating applicators. i.e. they will not be legal for basic decorative paints where the general public can use them. Only trained professionals will be able to use them. The long term drive will be to eventually replace them completely with some other tech. This move is recommended due to high cases of occupational asthma and respiratory sensitisation.

[CharonY]

From my understanding under REACH it was concluded that the data for TiO2 was inconclusive and did not warrant a stricter classification at this point. I am not sure why ANSES tries to change that, and assuming that they really only referred to that single study (I have not read the report) it is highly unlikely to go through.

It has been labelled under different regulations (and countries) as 2b, however.

 

I should also add that there are more toxicity studies out there (especially on nano variants, though there is little indication of acute dangers. There is evidence for bioaccumulation in certain organs, for example. Dose-dependency of cytotoxicty was also demonstrated as well as certain amount of DNA damage. However quite a bit was based under exposure routes that are not commonly expected (e.g. injection).

Edited September 6, 2016 by CharonY

[DrP]

Key dates for TiO2 according to the BCF.

 

Early 2017 - lobbying to start of UK authorities as to the socio economic importance of TiO2 containing products. Co ordinated with parallel lobbying campaigns across Europe.

June 2017 - European Chemicals Agency Risk Assessment Committee to review the French dossier.

November 2017 - Deadline for the Risk Assessment Committee to deliver it's verdict.

 

Personally I would like to see them conduct some kind of tests on the actual dangers. Can the French work be replicated or improved upon? Can we show the relevance to human exposure? Why are there no existing cases of cancers induced by TiO2 from the paint industry where it has been used as a powder extensively for many years? Is it safe once it is bound up in a formulation or just harmful as a loose powder?

[John Cuthber]

Are you concerned that TiO2 is going to be controlled like other carcinogens and thus no longer available such as SiO2 and alcohol

[DrP]

No - I am concerned that they might not have tested it properly and may have jumped to a wrong conclusion... If it turns out to be a carcinogen then of course we need to known so that we can act accordingly.

 

Problem I have with labelling pretty much everything as harmful is that when you get something that really is harmful how do you differentiate? How many people have contacted cancer from working with TiO2 in the paint industry?

 

The British coatings federation is concerned enough about this to lobby European bodies about it anyway... why are they doing this if they do not think the French results in error? What is so abhorrent about wanting to get proper tests done before jumping to conclusions that will effect our industry in a massive way?

[John Cuthber]

No - I am concerned that they might not have tested it properly and may have jumped to a wrong conclusion... If it turns out to be a carcinogen then of course we need to known so that we can act accordingly.

 

Problem I have with labelling pretty much everything as harmful is that when you get something that really is harmful how do you differentiate? How many people have contacted cancer from working with TiO2 in the paint industry?

 

The British coatings federation is concerned enough about this to lobby European bodies about it anyway... why are they doing this if they do not think the French results in error? What is so abhorrent about wanting to get proper tests done before jumping to conclusions that will effect our industry in a massive way?

" that will effect our industry in a massive way?"

 

Did you read what I wrote.

 

"TiO2 is going to be controlled like other carcinogens and thus no longer available such as SiO2 and alcohol "

[DrP]

There still needs to be proof that it IS a carcinogen. It is being argued that the French test wasn't good science - the doses were beyond the standards by a long way, the timescale for the test was longer than used in modern day tests and the whole procedure of there test is out of date. They do no just inject powder straight into the blood anymore as it doesn't give trusted results. Other more modern tests have shown absolutely no link between micronized TiO2 and cancer.

 

I learnt yesterday that this might be a political stab by the French as TiO2 manufacturers haven't registered TiO2 in more than one form - it has been registered as TiO2 and all risks, whether micronized or nano particulate come under the same registered substance. Due to the current uncertainty of the nano form they have registered it as class 2 - which means it's carcinogenic properties are unknown. Maybe this will shake up the manufacturers to register the nano form under a new listing.

 

To me it seems clear that it needs registering in BOTH of its forms and proper testing under the current most modern test standards for the nano form. The micronized form already has tests that show it to be in the clear - maybe these need repeating to make sure.

 

QUOTE:"TiO2 is going to be controlled like other carcinogens and thus no longer available such as SiO2 and alcohol"

 

Says who? That is what is being decided next year. Personally I would like them to split the registration between the nano and micronized forms and show any dangers of each. So far, apart from the invalid French test, there are none.

Edited November 23, 2016 by DrP

[DrP]

Update of objections from the BCF from their Spring 2017 magazine:

 

1 - Proposed ban based on study on rats from over 20 years ago

2 - At TiO2 concentration levels within the maximum tolerated dose (MTD) (10 and 50 mg/m³) there was no tumour formation even though the rats were in lung overdose

3 - Only at extremely high concentrations (250mg/m³), which far exceed the MTD, were tumours observed and were subsequently regarded as benign

4 - Inhalation of poorly soluble dusts in general can lead to lung overload and the formation of tumours in rats alone, this is not specific to TiO2 and is the same for any non soluble dust

5 - ECHA, OECD and the ECETOC (European Chemical Industry Ecology and Toxicology Centre) all observe that the results from lung overload studies in rats should not be transferred to humans

6 - They claim "Use of this data risks the whole validity of standardised chemical classification"

 

Conclusions they draw:

 

The study results are not relevant to humans

The absence of risk is confirmed by many years of practical use in the vast range of applications and extensive worker epidemiological data

The French proposal for classification and labelling of TiO2 is unjustified from a toxicological perspective

Given the high cost of TiO2, paint companies have invested heavily in the search for alternatives with the conclusions that there are no alternatives that match the performance of TiO2 in paints and inks.

 

The timeline for the RAC (Risk Assessment Committee) and their reviews is as follows:

March - Initial meetings to set the scene

June - Review of the scientific evidence

September - Considering the impact on human health

November - RAC will give their opinion

 

If they decide it is non carcinogenic then no further action or classification is necessary. If the decide it IS then in 2018: (estimated timeline)

June - Draft proposal reviewed by the REACH committee

September - Inclusion of TiO2 in Annex VI and CLP regulation.

[DrP]

OK -  I think they are only going for 2C classification now which is better than the 2B.  But still - it is based on tests doe back in the 80s and it assumes routes into the body from nano forms.  The registration was TiO2 across the board and not the separate nano and micro forms.

The vote is in the new year...   it will be tight.   It will be even tighter when the UK leave as we are one of the main countries championing proper testing/retesting and separation of the nano and micro forms.

Unfortunately  -  the people that will vote this through or not have no science backgrounds and know nothing about the differences between the micro and nano forms...  When I suggested we tell them so that we know it was met with laughter and the statement  - we can't do that as it will embarrass the EU scientists and we aren't allowed to discuss it anymore as it will upset people. WTF!?   There have been NO TiOP2 related deaths in the industry ever recorded.

 

SIMPLE SOLUTION:   Register the nano and micro forms separately and test both forms for possible inhalation cancer risks and publish the results fairly. Classify the 2 grades according to the up to date finding of the tests. EASY.

 

 

[John Cuthber]

It leads to an interesting question.

Why have the manufacturers not had the testing done?

OK, it's expensive- but the alternative would be massively problematic restrictions on the use of TiO2. The cost of testing is small compared to the cost of having the stuff classified as a carcinogen. Plenty of testing houses would be happy to take the money.

One possible reason they haven't done repeated, robust testing is that they are scared of the result. Perhaps TiO2 behaves like asbestos?
Who knows?
OK there are no reported excess deaths in the industry- but that might be simply because exposure to TiO2 is controlled- not for health reasons, but because of good process design. After all, you can't sell the stuff if it is your workers' lungs.