14th ATP to CLP published

The 14th ATP to CLP has finally been published, here, despite several efforts in the European Parliament to remove the controversial classification of Titanium Dioxide as a suspected carcinogen, which I have written about previously here and here.

If you have been following this debate, you will be aware that the grounds for classifying Titanium Dioxide as a Category 2 carcinogen are flimsy, to say the least, as they are based on two old studies where rats were exposed to 2,000 mg/kg of Titanium Dioxide dust.

It is well known in toxicological and classification circles that rats are uniquely prone to forming tumours, particularly when exposed to these levels of any type of dust. Other studies on other animals do not show this effect, and there is no evidence that it occurs in humans either.

But this has not stopped the European Commission ploughing on with a flawed classification, unfortunately backed up by ECHA. I would have hoped that ECHA and the various committees would have thrown this proposed classification out, but instead we have had the unedifying spectacle of perfectly good evidence being ruled out on very thin grounds, and rules being bent to accommodate the European Commission’s decision.

Not only that, but ECHA announced, even before the 14th ATP was published, that this classification will be extended to all Poorly Soluble Low Toxicity materials, which could have a catastrophic effect on powder classification throughout the EU.

The cosmetics industry, for example, will not countenance any suspected carcinogens in their raw materials.

In effect, this is taking a bad decision and propagating it even further.

It is difficult to understand why ECHA, who should be standing up for sound science, and who are very quick to insist on it in our REACH dossiers, have rolled over to a political decision made by unelected and unaccountable bureaucrats (because the European Commission is appointed, not elected, and the European Parliament does not have much real power).

It is good to see the British Coatings Federation, BCF, standing up for commonsense https://www.coatings.org.uk/article/workers-and-users-should-not-be-alarmed-by-titanium-dioxide-384.aspx .

So when does this ATP come into legal effect? The date on the front page of the 14th ATP is “COMMISSION DELEGATED REGULATION (EU) 2020/217 of 4 October 2019”.

This is the date when everything was signed off at the EU. However, because of all the various appeals, there was a significant delay between then and the actual publication, which was the 18th February 2020, as you can see in the top left hand corner of every page.

The 14th ATP comes into force 20 days after publication, which is the 9th March 2020. However the application date is 9th September 2021.

The difference between these two dates is that:

• the 14th ATP is not legal to use until the 9th March 2020
• it becomes mandatory on the date of application, 9th September 2021
• its provisions can be used voluntarily between the 18th February 2020 and 9th September 2021

I can only hope that the UK leaves the EU before the “application date” of the 14th ATP to CLP, 9th September 2021, which will mean that this classification will not be automatically applied in the UK.

We must also be vigilant that there are no moves within the UK Government to bring it into force after Brexit.

Leaving the politics on one side, what does the 14th ATP to CLP contain? There are a number of changes as follows:

• The new Titanium Dioxide Harmonised classification
• Two new EUH statements applicable to liquid and solid mixtures containing Titanium Dioxide
• Changes to 12 existing Harmonised Classifications
• 16 other new Harmonised Classifications

The new Titanium Dioxide Harmonised classification

The Titanium Dioxide Harmonised Classification reads:

Index no: 022-006-002

Chemical name: titanium dioxide [in powder form contain­ ing 1 % or more of particles with aerodynamic dia­ meter ≤ 10 μm]

EC no: 236-675-5, CAS no: 13463-67-7

Classification: Carc. 2, H code: H351 (inhala­tion)

Labelling information:

• Pictogram: GHS08
• Signal Word: Wng
• H code: H351 (inhala­tion)

Notes: V, W, 10

Note V: If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.

Note W: It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.

This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.

Note 10

The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.

(These three notes, V W and 10 are all new, and currently only apply to Titanium Dioxide).

2 new EUH statements for Titanium Dioxide mixtures

There are 2 new EUH statements applicable only to Titanium Dioxide (at the moment):

• For liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 μm: EUH211, Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.
• And for solid mixtures containing 1 % or more of titanium dioxide: EUH212, Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.

The reason for the differences between the solid and liquid EUH statements is likely to be because the TiO2 particles in the liquid are unlikely to be made smaller before they are inhaled, but in a powder they may be milled or processed further.

I suspect that the use of these EUH statements may be extended to all PSLTs if ECHA do go ahead with extending the TiO2 classification to all “PSLTs”.

Changes to 12 existing Harmonised Classifications

There are some very interesting changes to these 12 existing Harmonised Classifications.

7 classifications have new or more severe hazard information, which is what you’d expect as substances go through the REACH registration process, and new test data becomes available.

• phenyl bis(2,4,6-tri­methylbenzoyl)-phosphine oxide, CAS no: 162881-26-7
• cobalt, CAS no: 7440-48-4
• nickel sulfamate, CAS no: 13770-89-3
• ethylene oxide, CAS no: 75-21-8
• metaldehyde (ISO), CAS no: 108-62-3
• 2-benzyl-2-dimethylami­no-4′-morpholinobutyrophenone, CAS no: 119313-12-1
• pyridate (ISO), CAS no: 55512-33-9

4 classifications have reduced hazard information, sometimes with extra health information such as ATEs being added:

• dodecyl methacrylate, CAS no: 142-90-5
• 2-phenylhexanenitrile, CAS no: 3508-98-3
• thiabendazole (ISO), CAS no: 148-79-8
• diethyltoluamide (ISO)[deet], CAS no: 134-62-3

It is good to see that some Harmonised Classifications are being reduced in line with new test data, and that the science is being respected (in these cases). When CLP came in, there was a real concern that the Harmonised Classifications would be retained, regardless of whether the new test data from REACH contradicted these.

1 further classification is listed in the 14th ATP as being a “correction”, rather than an “amendment”, which probably means that the information was incorrect in the first place.

• pitch, coal tar, high-temp., CAS no: 65996-93-2

This classification has had its environmental classification of Aquatic Acute 1, H400, M factor = 1000 and Aquatic Chronic 1, H410, M factors = 1000 completely withdrawn.

16 other new Harmonised Classifications

These Harmonised Classifications are much less controversial than Titanium Dioxide and are:

• methylmercuric chloride, CAS no: 115-09-3
• benzo[rst]pentaphene, CAS no: 189-55-9
• dibenzo[b,def]chrysene; dibenzo[a,h]pyrene, CAS no: 189-64-0
• ethanol, 2,2’-iminobis-, N- (C13-15-branched and linear alkyl) derivs., CAS no: 97925-95-6
• cyflumetofen (ISO), CAS no: 400882-07-7
• Glycine, N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-, potassium salt (1:5), CAS no: 7216-95-7
• DTPA , CAS no: 67-43-6
• DTPA pentasodium salt, CAS no: 140-01-2
• diisohexyl phthalate, CAS no: 71850-09-4
• fludioxonil (ISO), CAS no: 131341-86-1
• chalosulfuron-methyl (ISO), CAS no: 100784-20-1
• 2-methylimidazole, CAS no: 693-98-1
• (RS)-2-methoxy-N- methyl-2-[α-(2,5-xyly­ loxy)-o-tolyl]acetamide, CAS no: 173662-97-0
• carboxin (ISO), CAS no: 5234-68-4
• metaflumizone (ISO), CAS noz: 139968-49-3 and 852403-68-0
• dibutylbis(pentane-2,4- dionato-O,O’)tin, CAS no: 22673-19-4

I hope this is useful, and will let you know if there are any further developments in the Titanium Dioxide situation. As usual, if you’ve any queries, please email me.

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24th February 2020

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