Chemicals Coffee Time Monthly, August 2024

Dear Reader,

I hope you've had a lovely summer (although it's hardly been typical summer weather here in the UK), and have managed to have a break from work. As you might expect, the regulators have been a bit quieter as well, but there's still plenty going on which we need to keep an eye on.

Hearing from the HSE, DEFRA and the UK - divergence

Titanium Dioxide classification

A recent classification and labelling project for a client has reminded me about the Titanium Dioxide divergence.

Regular readers will recall the jaw-dropping moment on the 11th January 2024, when the HSE announced that the 14th and 15th ATPs to CLP had not been brought into UK law, as had been promised repeatedly during the Brexit negotiations. The situation was finally resolved on the 27th June 2024, when an updated Mandatory Classification List was published. A summary of the whole sorry saga is available here: https://www.hse.gov.uk/chemical-classification/update-gbmcl.htm.

However, the HSE took the opportunity of "removing entries for titanium dioxide (in powder form) and granulated copper." This means that Titanium Dioxide (and granulated copper) does not have an official classification in GB, as it no longer sits on the Mandatory Classification List.

As things currently stand, Titanium Dioxide is still very much on the Harmonised Classification List in the EU, despite the court case which ruled against the classification as a carcinogen, see https://curia.europa.eu/jcms/upload/docs/application/pdf/2022-11/cp220190en.pdf, as the French competent authority and other parties are appealing this decision.

What this means is that:

• you must assign the (disputed) H351i classification to Titanium Dioxide in the EU and NI, and either that classification or EUH 211 or EUH212 to applicable mixtures, although some mixtures may not be classified, depending on the particle size of the Titanium Dioxide (full details in EU-CLP, ANNEX II, Special rules for labelling and packaging of certain substances and mixtures, paragraph 2.12) .
• you could choose to follow the EU ruling in GB, but we think this is quite risky. Firstly, the appeal against removing the carcinogenic classification is a dispute on whether the ECJ is competent, not that the action to remove it is scientifically unjustified (which you really couldn't make up! it's like saying, yeah, ECJ, you're right, but we think you shouldn't have the power to correct us); and secondly, the HSE have made their technical opinion quite clear by removing the classification of Titanium Dioxide from the Mandatory Classification list. And we think the HSE are correct, Titanium Dioxide isn't carcinogenic, based on current evidence.

So we are in a truly divergent situation, where there are two different classifications in the EU/NI and GB; and you should have different labels for each jurisdiction. I know it's a pain in the neck for a lot of companies, meaning two identical products with different labels and SDSs (needing separate product codes etc), but hopefully the situation may resolve itself in time, if the appeal against the ECJ's ruling fails. Watch this space!

Label divergence between the EU and GB

Are you aware that the new EU hazards (Endocrine Disruptors for Human Health and the Environment, PBT/vPvB and PMT/vPvM) now need to be listed on the CLP label under "contains"?

And because the EU have placed their new hazards into Schedule 1 of CLP, they are to be treated the same as the GHS hazards, and sit with them, not in the supplemental portion of the label like all the other EUH statements.

This is on top of the new EU CLP label formatting rules which are being brought in by the EU-CLP Legislative Act (not officially published yet, still going through the official translation process - watch this space).

Keeping an Eye on ECHA and the EU

ICYMI - Eco-Design Regulation officially published

This Regulation was finally published on the 18th July: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1781 , and there is an overview of what the Regulation does and how it replaces the previous EcoDesign regulation here: https://commission.europa.eu/energy-climate-change-environment/standards-tools-and-labels/products-labelling-rules-and-requirements/sustainable-products/ecodesign-sustainable-products-regulation_en . Many thanks to Yogendra Solanki for spotting this.

Proposed EU Harmonised Classifications

The EU is getting back up and running after the summer hiatus and we have two new Harmonised Classification and Labelling Proposal Consultations from ECHA.

• Diacetone alcohol (123-42-2)
• 8-methyldecan-2-yl propionate; 8-methyldecan-2-yl propanoate (81931-28-4)

The Diacetone alcohol may be worth a look. It's fairly widely used as a lab solvent and also in paints, varnishes, inks and other coatings. The proposal (from France) would make this a Repro 1B.

You can view HCL consultations here: https://echa.europa.eu/harmonised-classification-and-labelling-consultation#

Another proposed EU-SVHC

Phil Rowley , one of our regular correspondents writes: ECHA reports that the Netherlands intends to propose barium chromate as an SVHC - proposal expected to be submitted Feb 2025. See https://echa.europa.eu/registry-of-svhc-intentions/-/dislist/details/0b0236e18a7f9d92.

Carcinogens update

Titanium Dioxide

Well, its been a while since we updated you on the Titanium Dioxide scandal, and a couple of things have cropped up recently that regulatory nerds (like me) might be interested in.

Firstly, Alison Hill of Lomon Billions writes:

I wanted to share some important information regarding the classification of TiO2 supplied by TDMA members. In case I haven’t sent this previously, here are the details:

• Testing Programme: TDMA conducted a testing programme to measure the content of particles with an aerodynamic diameter ≤ 10 μm, which is one of the criteria for classification under the CLP Regulation.
• Methods Used: In the absence of an officially designated method, several grades of TiO2 were tested using internationally recognised test methods for dustiness. These methods have shown minimal variability and are suitable for this application.
• Results: The data consistently indicates that the vast majority of TiO2 grades do not meet the criteria for classification. Consequently, most bags of TiO2 will not require the warning labels noted in Annex VI of CLP.

For more detailed information, please refer to this document: https://www.tdma.info/wp-content/uploads/2023/02/2021-04-21-TDMA1140j-TiO2-Classification-methods.pdf

If any readers have any questions or need further clarification, please go to your supplier, who can provide justification and test certification.

Many thanks to Alison for this detailed information.

Secondly, Dave Schoneker , a staunch defender of Titanium Dioxide, writes on LinkedIn:

Great News!! The UK Committee on Toxicity (COT) has concluded, after significant review of all the data, that TiO2 (E171) when used in food has NO SAFETY CONCERNS!!! See the report at the link below. I’m really glad to see them align their opinion with the opinions of the rest of the worldwide regulatory community outside of Europe. This is clearly what the science shows. The FSA will be publishing a final report by September 30, 2024.

The report summary itself is here: https://cot.food.gov.uk/node/11291 .

Talc reclassified by the IARC

Many thanks to our friends at Lisam , who have spotted that IARC have decided that Talc is carcinogenic on its own merits, and not just because it may contain (or have historically contained) asbestos or asbestos-like minerals. They have a excellent article on this here: https://www.lisam.com/news/iarc-new-classification-of-talc-and-its-implications-for-the-chemical-industry/.

You can find the paper announcing this classification at the Lancet Oncology, herehttps://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00384-X/abstract (sign up for free access - when I tried to do that, I discovered I already had a sign-up, although that may be due to having a ScienceDirect account (they are both Elsevier publications).

It is worth a read if you are interested in the Titanium Dioxide reclassification scandal, and I suspect that we may be in a similar (but not identical) situation, as the main evidence for carcinogenicity is, surprise surprise, inhalation by rats. However, the fact that some unusual cancers were formed, as well as the more typical ones expected, seems to be the reasoning behind the classification - despite the fact that we know rats don't have "clearing mechanisms" to move dusts out of their lungs, which is why they tend to form tumours. The paper itself describes the human "clearing mechanisms", and one wonders if they have properly taken that into consideration. Another "watch this space" moment.

The Lancet Oncology paper also includes news that acrylonitrile has been classified as carcinogenic, which does seem to be based on more data than the Talc classification. This will clearly have an impact on the chemical industry as well

The Monthly Read

Of course, the reason that we're still talking about Titanium Dioxide, and are now having to worry about Talc which doesn't contain asbestos or similar silicates, is because of the workings of the IARC, the International Agency for Research on Cancer.

So I was very pleased to find another excellent article from Andrea C. Love, Ph.D. , this time on how the IARC works: https://immunologic.substack.com/p/what-does-carcinogenic-really-mean .

Infographic of the Month

An excellent infographic from Rachael Cowin on Hazards and the Project Lifecycle .

This reminded me of a sketchnote I made on the chemical innovation process, which you can find here.

The Weekend Recipe

I made this lactose-free, vegan pastry a couple of weeks beforehand, and stored it in the freezer, which is perfectly acceptable for all forms of pastry.

Vegan flaky pastry (made with all coconut oil)

Ingredients:

• 8 oz plain flour
• a good pinch of salt
• 6 oz coconut oil
• chilled water

Method:

Having read up quite a few different methods for coconut oil flaky pastry, I decided to try and synthesise them into a practical way forward. When I made up the pastry, it was quite a warm morning, and some of the oil was quite soft and squidgy, so I weight out the full amount, then took 2 oz and rubbed it into the flour. The dry mixture was placed on one side, with a tea towel over the bowl. The remaining 4 oz was placed in the fridge to firm up.

After about half an hour, it was just firm enough to grate into the dry mixture, stirring the grated coconut oil in regularly so it wouldn't form clumps (you can use your hands to do this, or a knife, which may be better as it will be cooler than your hands, and you need to stop the coconut oil melting as much as you can). A small amount of chilled water was added, and stirred in with a knife, then drawn together to make the pastry. The pastry was placed in the fridge again for another half hour to stop the coconut oil melting into the pastry, as we want the shredded fat to help from the flaky layers.

The pastry was then removed from the fridge, rolled out and folded in a book fold, then turned 90 degrees and rolled out and folded into another book fold. The pastry was placed back in the fridge for another rest, then the rolling and folding process was repeated, with a half hour rest between them. The pastry may get too hard in the fridge, in which case you'll have to leave it out on the worktop for a while to warm up sufficiently to handle (voice of experience). You will definitely need to flour your rolling pin, and the worksurface, to prevent the coconut oil getting everywhere (also flour the palm of your hands lightly).

After the last rolling and folding, the pastry was placed in a plastic bag, sealed, and stored in the freezer. To use the pastry, it was removed on the day of use, and thawed out partly in the kitchen, and partly in the fridge (it depends on how long you have to thaw it out - overnight in the fridge is ideal, if you can plan ahead that much).

To test the pastry, I made some Eccles cakes, which I usually just make with pastry scraps to pop in the oven as an extra treat (no pastry is wasted in this household!). Take a small piece of pastry, and roll it ou into a thin circle. Into the middle of the circle, pop some dried fruit, a tiny amount of brown sugar, a tiny pinch of spice like mixed spice or nutmeg can help too, but be sparing. If you are making a larger batch of Eccles cakes (or one big one, a bit like a Scottish Fly Cemetery), you can make up a larger amount of dried fruit, and plump up with hot tea (or cold brandy!), and add in your sugar and spice that way. Draw the edges in to seal the pastry, then flip onto its tummy and press or roll so they are flat. Score three slashes across the pastry, wash with eggy wash (or milk), and bake at gas mark 6 -or 7 (flaky) or 5 to 6 (shortcrust). Cool on a wire rack when done.

Findings: this actually worked well - there were layers, they cooked properly. Of course, you don't get the buttery flavour, but the texture was good. And of course this is vegan as well as lactose free.

Events #1

CLP Mastery, our training programme for chemical Regulatory Affairs Professionals, resumes on the 11th September, so if you're interested you'll need to sign up by the 10th September.

It's a combination training course and membership, which comprises a 13-module training course with weekly support meetings, and monthly meetings outside the training phase. Former trainees of the online course (or its in-person predecessor) are eligible for annual membership, at a much reduced rate, so they can keep up to date with all of the changes.

More details at www.clpmastery.com, where there's an explanatory video, and you can also book a tour round the system here: https://calendly.com/tt-environmental/clp-mastery-online-demo-20-minutes .

Events #2

Neil Hollis of BASF writes:

Have you seen this conference on Tuesday 24th September? https://www.cia.org.uk/events/chemical-reactions-uk-chemicals-conference/469.article

It will cover topics such as "UK REACH Alternative Transitional Registration model (ATRm) and initial improvements, Classification, Labelling and Packaging (CLP) and biocides. The work of key public sector actors will be discussed including the Department for Environment, Food & Rural Affairs (DEFRA), Health and Safety Executive (HSE), the Environment Agency, Office for Product Safety and Standards (OPSS) and Office for Environmental Protection (OEP).

This event is a joint initiative by the Chemicals Industries Association (CIA), Steptoe and Ramboll. It is aimed at those wishing to stay abreast of new developments and building pan-European compliance and market access strategies."

Many thanks to Neil, this does look a very good conference, and at ￡50 per person, very reasonable rates.

Reasons to be Cheerful

In August, we continued our "summer of sport" Reasons to be Cheerful:

• The Brat, by the Umpire Strikes Back, from 1983, a parody of John McEnroe: https://www.youtube.com/watch?v=j7InXchA_Ko (this video has been shared by someone from Holland, so there's an explanation in Dutch at the start of the video, but it's in English).
• 20 Olympic fails: https://www.youtube.com/watch?v=cs1RHsVk-Ug (although some of them do look painful!). What I do like is the way a lot of the athletes just pick themselves up and keep going, an example to us all.
• Fishing fails: https://www.youtube.com/watch?v=-rnqDae3kUs (and for those of you who don't think fishing is a sport, my late Father used to say that Hunting, Shooting and Fishing are the true sports, everything else is just games and pastimes).
• Swimming fails: https://www.youtube.com/watch?v=V_cRKk7y4OA
• Funny football moments https://www.youtube.com/watch?v=zqxV0ken2jg

Many thanks for reading this LinkedIn newsletter, and many thanks to everyone who has contributed, through sending in links, queries, comments etc. If you have anything you'd like to share, please email me or send a DM, and I'll do my best to include it in the next Chemicals Coffee Time Monthly.

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Look forward to chatting to you in late September or early October.

Kind regards,

Janet

Janet Greenwood, TT Environmental Ltd

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