Chemicals Coffee Time Monthly, October 2023

Dear Friend,

I hope this newsletter finds you safe and well. October has seen some dreadful weather here in the UK, and I hope you managed to avoid the worst of it.

In chemical industry terms, it has been a very busy month for new regulations, so we’ll concentrate on that.

Hearing from the HSE/ GB

On Friday the 20th October, the HSE published the 98 new Mandatory Classifications which were notified to the WTO in the Spring and you can view the email here: https://content.govdelivery.com/accounts/UKHSE/bulletins/376bded .

These new MCLs have an implementation date of 20th April 2025.

The updated MCL list is here: GB MC List(a direct download .xlsx file, you need to save it to your device then open it).

The publication table, which shows the progress of MCL development, has been adopted with these dates (it also contains MCLs going through the process): GB CLP publication table(also a direct download .xlsx file).

Both files can also be accessed from the CLP page here: https://www.hse.gov.uk/chemical-classification/classification/harmonised-classification-self-classification.htm .

This is a very important step in Brexit divergence, as it is the first time that GB has deliberately chosen different MCs, rather than finding that the EU (and NI) has moved away from a previous classification which GB still holds.

It is important to remember that many of these MCLs actually bring GB back into compliance with EU updated HCLs in the 17th and 18th ATPs to EU-CLP, and publication means you can use those MCs voluntarily from now on.

However:

• there are some substances where either the classification itself or the mixture information (specified ATEs, SCLs or M-factors) means that they will give rise to different classifications in the two jurisdictions
• where a substance is a pesticide or biocide, and the HCL or MCL is therefore “complete” and in agreement with other legislation (PPP or BPR respectively), you have to use the HCL or MCL appropriate for the jurisdiction your are selling into (even where you might voluntarily use an extra classification in your jurisdiction if it was a general chemical)

1 substance has been removed from the HC list, and has a “null” entry in the MC list (which i think means it is not classified for GB-CLP for the relevant health hazards which are mandatory, that is CMRs :

• tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate, CAS no 139189-30-3

2 substances are general chemicals (not biocides or pesticides) which have an extra hazard under EU-CLP and which may be used

• methyl salicylate, CAS no 119-36-8
• barium diboron tetraoxide, CAS no 13701-59-2

The remaining 12 substances have different classifications in GB and EU/NI, either because they are pesticides or biocides, or because the differences are irreconcilable (either for the substance classification itself, or the mixture information, or both):

• beta-cyfluthrin (ISO), CAS no 1820573-27- 0
• bentazone (ISO), CAS no 25057-89-0
• azamethiphos (ISO), CAS no 35575-96-3
• cyfluthrin (ISO), CAS no 68359-37-5
• mancozeb (ISO), CAS no 8018-01-7
• trinexapac-ethyl (ISO), CAS no 95266-40-3
• tolpylarate, CAS no 1101132-67- 5
• 4,4′-isopropylidenediphenol (Bisphenol A; BPA), CAS no 80-05-7
• (R)-p-mentha-1,8-diene; d-limonene, CAS no 5989-27-5
• esfenvalerate (ISO), CAS no 66230-04-4
• trifloxystrobin (ISO), CAS no 141517-21-7
• mecoprop-P (ISO), CAS no 16484-77-8

Please check the WTO document yourself, in case we have not included all of the differences; and to identify those MCs which now agree with the EU’s HCs and can be used voluntarily.

For nerds, the stats are 98 MCs in the WTO submission:

• 83 MCs which agree with the new EU HCs in the 17th or 18th ATP to CLP
• 1 MC which is a “null entry”, similar to the EU’s HC withdrawal
• 2 HCs which include extra information to the MCs and which may be used voluntarily in GB
• 12 MCs which are different to the HCs and which must be used in GB, giving divergence either on substance classification; on mixture classification; or on both substance and mixture classifications

It is essential that businesses trading in both GB and the EU/NI are aware of their raw materials or finished products which may hold different classifications in the two jurisdictions, and I hope this information gives you a starting point for reviewing your products.

Keeping an Eye on ECHA and the EU

ECHA and the EC continue to be busy, and there has been quite a bit of confusion at times around both EU-REACH and EU-CLP.

EU work programme confusion – REACH updates are still going ahead

You may have seen a couple of news stories (here and here) recently based on a leaked copy of the European Parliaments 2024 Work Programme, which claimed that the REACH revision was no longer on the ‘to-do’ list. The document itself (2023/2862) was not available despite some fairly determined searching (although it has since been published here: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2023:638:FIN ), so my colleague Alison Potts ended up sitting through the entire EU parliamentary session to get some clarity on the situation. It’s a tough job, but someone has to do it!

Ali writes: Specifically regarding REACH, here’s what we’ve learned:

• REACH is not in the Work Programme for 2024 because it is an existing project (previously announced). Existing (ongoing) projects are not ‘re-announced’ in the upcoming Work Programme
• However, they are finding it more complex than initially expected (a situation DEFRA can probably relate to!)
• They are trying to find a balance between reducing the use of hazardous chemicals whilst still ensuring availability of chemicals which are essential to green technology projects
• They are not ‘on-schedule’!
• The new timeline is to complete the drafts, plan the phase-in timelines etc… and complete negotiations within the current mandate. But to actually introduce the legislation in the next Parliamentary term. In other words, Updated REACH legislation will not pass before June 2024 at the absolute earliest.

The wider context is of course the European Parliamentary elections (6th-9th June 2024). Change has been in the air for at least 6 months – ever since we started seeing reference to ‘burden of regulation’ and ‘additional cost to European Citizens’ appearing in the impact assessments to Regulatory Proposals. The M.E.P.s are looking to ensure their re-election and it’s not looking good for all of them.

Based on the debate, the European parliament is:

• Not doing enough to help Ukraine / Wasting billions in Ukraine at the expense of European citizens
• Besieged by illegal terrorist migrants / Incredibly privileged and ignoring the plight of billions of refugees
• Strangling its businesses and industry in red tape / Subsidizing fat cat corporations with billions whilst EU citizens can barely afford to eat or heat their homes
• Fulfilling 90% of their election mandate / Reneging on huge election promises
• Focused on fiscal stability and ignoring the very real suffering of people / Desperately in need of fiscal stability to allow it to sustainably invest in real, long term solutions
• Putting all its resources to tackle the biggest problems / Ignoring small issues where it can make a real impact in a short timeframe

Voting from this point on will be in line with their electoral base. German M.E.P.s need their industrial base, those representing the Netherlands need Agricultural votes etc…

The next few months will not be a productive time for the EU parliament. Whether we see an updated EU REACH next summer that looks anything like we expect (Polymer registration, Mixture Assessment Factors, etc…) will depend very much on the outcome of the next EU Elections.

If you too enjoy watching EU parliamentary debates then firstly – did you hit your head as a small child?, and secondly – here’s the link.

Questions on REACH are asked by Alex Agius Saliba, Bas Eickhout and David Cormand. The answers are provided in the rebuttal by Maros Sefcovic which begins at around 16:40.

EU-CLP update – the saga continues

EU CLP Legislative Act European Parliament debate

Ali spend an “interesting” couple of hours watching the plenary debate and subsequent vote (and I was very happy to delegate that task!). Her first report was “If I’ve learnt anything today, it’s how important Rose Oil is to the culture and economy of Bulgaria“.

She then spent a couple of hours looking up the relevant documents and translating the various MEPs comments (because the auto-translation was a bit patchy) while she stewed over her conclusions. Before, ultimately deciding that she was highly amused by some of the completely clueless comments made in the debate that seemed to be wilfully ignorant of hundreds of years of basic science. I’ll hand this one over to Ali…

Hi everyone!

I will eventually get around to talking about the Legislative Act – but honestly, I need to talk about some of the ridiculous points made in the poorly attended plenary debate first! It was fairly one-sided, with almost all the speakers giving broad support for the reform of CLP. But the real sticking point was Essential Oils.

At least 3 speakers spoke at length about Bulgarian Rose Oil, whilst a French delegate spoke passionately about the Lavender fields of Provence. The Commission Representative expressed that the EC was paying ‘Special’ (repeat – ‘Special’) attention to the MEPs concerns about their ‘famous’ essential oils. The Vice-President and the Rapporteur both pointed out that they had visited workers in Essential Oil industries in Bulgaria and Spain to explain that the reforms did not intend to destroy their livelihoods.

There was a suggestion from the French representative that Products of Botanical origin be legislated completely separately from Products of Petrochemical origin. And agreement from multiple speakers that plant based substances are not ‘risky’ (direct quote)! To which I can only remind them that Digitalis, Ricin, Belladonna and a host of other toxins were not dreamt up in a lab.

I would like to give credit to Pietro Fiocchi, Italian MEP. (Although, I’m sticking a massive disclaimer in here because I know nothing about his personal politics and I don’t want to inadvertently support anything dubious.) He was the only representative who spoke about the impracticality of the new labelling requirements, and specifically stated that the writers of the legislation had clearly never worked a day in industry! Also pointing out the conflict between larger labels with more content and the EC’s aims to reduce paper, plastics and packaging.

In contrast, his compatriot Danilo Oscar Lancini, also an Italian MEP, chose not to use his debate time to actually discuss the CLP regulation. Instead, he gave a somewhat bizarre statement objecting to the participation of Industry Associations in the negotiation phase of legislation. He called out CEFIC and AISE for ‘playing politics’ and demanded that representation of small and medium sized businesses should be left to the MEPs that are democratically elected.

We at Chemicals Coffee Time advocate strongly for the Industry Associations and have commended them for picking up the baton on several key regulatory topics in recent years. The work of the TDMA on Titanium Dioxide, and the CBA on the revocation of Annex VIII in Great Britain are just two that immediately spring to mind.

I get a frankly obscene amount of notifications of legislative drafts and proposals, consultations, amendments, and numerous other committee documents. Trying to filter out the less relevant ones to identify those that will have the greatest impact on our readers (without missing anything) is a delicate balance and we cannot expect individual businesses to do this on their own. The work of the industry associations to publicise, campaign, lobby and ultimately negotiate on the most impactful legislation is crucial to the chemical industry and I think a certain amount of outrage is warranted at the comments of Mr Lancini.

By the end of the debate I’d been amused, I’d been angry and I’d been surprised by the revelation that plenary was going to vote on another round of amendments. (Is anyone else getting tired of this?) Which left me scrambling for yet another version of the flipping draft text.

You will not be shocked to learn that the amendments poked at the definition of multi-constituent substances, and offered a time-limited exemption to several of the provisions for some essential oils (or ‘substances containing more than one constituent of renewable botanical origin that are not chemically or genetically modified’ as they are referred to in the text). I intend to refer to them as ‘Essential Oils for ease of typing.

My extremely rough summary of the contentious issue is:

• Substances that contain another constituent (like an impurity, a UVCB, or a multiconstituent) could previously be classified based on data of the overall substance
• The new amendments state that a hazardous property of a minor constituent cannot be overridden by data on the overall substance if that data shows the absence or reduced severity of the effect.i.e. the minor constituent property must always be classified
• Essential Oil manufacturers are VERY UPSET. (I cannot stress this enough) Very, very upset.
• So, an amendment has been added to exempt products if one of the constituents is an unmodified botanical – because plants are ‘Safe’!

And because the legislators are very confident of these changes, there is also an amendment that says: “Within 6 years of publication of the CLP Legislative Act, the EC will complete a report into evaluation and classification of [essential oils]”.

Other than that, we’re basically where we expected to be with the amendments. They removed one of the proposed hazard categories from ‘Child Safe Fastenings’, but doubled down on ‘Tactile Warnings of Danger’.

There is no further movement on font sizes, formatting, fold out labels, digital labels or multi-lingual requirements. These all stay as described in last weeks newsletter.

The only other tweak that caught my eye was a little insertion that states (paraphrasing heavily) ‘if a harmonised classification is successfully challenged and they find that information was omitted from a REACH dossier, they will enforce against the Registrant’. Which, to me seems like a little back door fundraiser.

To wrap up – because the plenary kicked out some of the proposals (like Eye damage products needing a Child Resistant Fastening), the Legislative Act needs to go to a Trilogue Meeting (which is an Intra-Institutional Committee negotiation). This doesn’t happen with all legislation but it is basically a conciliatory session where a small number of people sit around a table and agree the final text. That text cannot be changed, it can only be adopted or rejected. The trilogue is a closed session, so we can’t give you any news on it until the final text shows up to the Council Reading.

As always, you’ll hear from us when we know more!

Many thanks to Ali for an excellent summary.

I hadn’t really picked up on the mixture classification situation until now, and am astonished that the EU are going beyond the longstanding GHS principle of a classification based on test data over-riding a classification based on the percentage of a hazardous health or environmental component. If you want to check yourself, this is in GHS chapter 1.3, paragraph 1.3.2.3.1 .

This issue probably affects the essential oil industry the most, because these are some of the oldest UVCB products in the world, and therefore the most likely to have test data on health hazards which can currently over-ride a theoretical classification.

Many industrial mixtures are already classified on the basis of the percentage of components for health and environmental hazards, so it won’t affect them. And the effective ban on animal testing of mixtures means that they are unlikely to obtain the data necessary for classification.

However, this alteration brings yet more classification divergence between the EU and GB, and I wouldn’t be surprised if there are more UVCBs and mixtures already on the market which may have to alter their classifications within the EU.

Link to video of debate: https://www.europarl.europa.eu/plenary/en/vod.html?mode=chapter&vodLanguage=EN&internalEPId=1696359604939&providerMeetingId=2f51e2a7-69da-4801-e973-08dbbe783c02# .

Link to verbatim transcript of debate: https://www.europarl.europa.eu/doceo/document/CRE-9-2023-10-03-ITM-020_EN.html

EU-CLP Legislative Act Opinions and Comments

Following the above article, we had plenty of interest from readers and various industry news sites.

Secondly, many thanks to our readers who commented on the EU’s CLP legislative act.

Serhii Lytvynenko of Juul Labs reminded me to include the links to the video itself, so you can all have as much fun as Ali:

A reader asked:

On the CLP OLP revision, where did you find the quote ‘if a harmonised classification is successfully challenged and they find that information was omitted from a REACH dossier, they will enforce against the Registrant’? I had a quick search in the amendments texts but cannot immediately find it.

Ali replied: You’re looking for Amendment 64, which inserts Article 43 to CLP. ‘Right to Request Action from Competent Authorities and Commission’. Specifically paragraph 5:

Mel Cooke of Alchemy Compliance Ltd commented:

I note your comment: ‘I hadn’t really picked up on the mixture classification situation until now, and am astonished that the EU are going beyond the longstanding GHS principle of a classification based on test data over-riding a classification based on the percentage of a hazardous health or environmental component. If you want to check yourself, this is in GHS chapter 1.3, paragraph 1.3.2.3.1 .’

But recital 22 of the CLP Regulation confirms that testing of mixtures for carcinogenicity, mutagenicity, reproductive toxicity, etc does not override the calculation method. I think this is because the testing methods are not sensitive enough, and you can ‘hide’ an ingredient with these properties if it is diluted in the mixture. For these hazards the calculation method should be used.

I wonder if this is what the essential oil debate is about, i.e. there are known CMR ingredients that will lead to the classification of many essential oils for these properties.

Ali was late to the party on the classification method debate because she spent the earlier drafts being amused at the complete lack of a coherent definition of multi-constituent substances. But she thinks that Mel has hit the nail on the head here. The EU are really just trying to move bits of the existing guidance into the regulation – but have run into trouble because that has meant publicising some of the ‘wobbly’ concepts.

In theory, robust and conclusive product data should be able to override constituent data. But the EU don’t believe that any mixture/multi-constituent level CMR, endocrine or environmental test is more robust that a single constituent test because the dilution make it less detectable. So the GHS principle of data on the mixture for these end points (such as GHS 3.5.3.2) becomes irrelevant. They’re moving this idea out of the EU guidance and into Article 5 of CLP, while also bringing in an earlier provision to state that any multi-constituent with an identifiable sub-constituent must take the sub-classifications into account. Flagging it up so prominently has caught the attention of all the fragrance producers.

I know many of these substances are synthetically modified and wouldn’t be described as essential oils, but they may be considered as components in mixtures, derived from plants that could get quite serious diamonds (pictograms) at quite low loadings.

Alan Ritchie of WSP notes, (In response to Ali’s comment about the safety of natural materials): You might find these links of interest:

EU-CLP Legislative Act state of play – 31st October 2023

As the current state of play with EU-CLP is that the legislative Act has been passed back to committee (thetrilogue mentioned in Ali’s report above), this means that changes can be made without the need for further debate.

This could include adopting or rejecting any of the changes which we thought had been made!

Realistically we don’t know what’s going to happen until the final version is published. We don’t know when this will take place, but we hope it will be soon. We also don’t know what the implementation timescales will be until publication. Watch this space!

Medium Chain Chlorinated Paraffins – EU and UK issue

We have a final RAC opinion on the Restriction of Medium Chain Chlorinated Paraffins (MCCP) (Report here) and should be expecting this to progress to EU REACH Annex XVII (Restrictions) fairly swiftly.

It’s well timed because this substance also appeared at the POP review in Stockholm last week – having been proposed by the UK. The outcome being a recommendation to be listed in Annex A of the Stockholm convention.

If you’re still using Chloroalkanes C14-C17, its days are numbered! Start looking for alternatives immediately.

Chemical snippets

The weekend watch

A nice soothing watch this week, as we’ve got enough to worry about elsewhere. Especially good if you like mechanical engineering and a certain Danish set of plastic building blocks, you’ll love this video of a 20 different engineering mechanisms made using Lego: https://www.linkedin.com/feed/update/urn:li:activity:7105127493900103680/

Infographic of the month

As there are a lot of legislation changes this month, I thought you might like this infographic on the arcane EU parliament legislative process, highlighted by Aaron McLoughlin of FleishmanHillard recently: https://www.flickr.com/photos/194102805@N02/52224680423/in/album-72177720300625635/

The weekend recipe

I was staying with my sister and she made a delicious Moroccan-style butternut squash and chickpea stew, with a substitution of roast chicken pieces for green lentils (rather than veganising a meat recipe, is this carnivorising a vegan recipe?). Anyway, it’s a great “free from” recipe for either vegans or meat-eaters.

Moroccan style butternut squash and chickpea stew

• olive oil or coconut for frying
• 1 medium onion, chopped
• 6 cloves garlic
• spices – 2 teaspoon cumin seeds, 1 teaspoon cinnamon, 1 teaspoon turmeric, 1/4 teaspoon cayenne pepper
• 1 tin chopped tomatoes
• 1 pint vegetable stock (if using green lentils); about 1/4 pint if using roast chicken
• 1 tin chickpeas
• 4 cups butternut squash
• other protein – either 1 cup green lentils or some roast chicken pieces
• 1/2 teaspoon salt, and pepper to taste
• optional to serve – lemon juice, chopped coriander leaves, vegan or dairy yoghurt

Method: in a large pan, melt the onion gently in the oil for about 5 minutes, then add the garlic and stir for a minute. Then fry off the spices for another minute, adding the tomatoes, broth, chickpeas, squash, and lentils (if using). Stir well, season with the salt and pepper, and bring to the boil, and simmer for 20 minutes, or until the butternut squash is tender and the lentils are cooked. If using cooked or roast chicken pieces, add those after the stew is boiling.

Findings: This is delicious, and both gluten free* and lactose free. (We didn’t bother with the lemon juice etc for serving, although that might make the dish even tastier). It can be fully vegan if you use the green lentils, although the chicken went very well with the vegetables and spices. The butternut squash took the longest to cook, although if green lentils had been used then they may have been the limiting factor. There was too much liquid for the chicken version, which is why I have reduced the stock volume, although you may need to add a bit more liquid to prevent it catching – use your judgment here. You’re likely to need the full volume of stock if making the vegan green lentil version, as the lentils will absorb liquid as they cook. My sister simply boiled off some of the excess liquid instead.

* be aware that some stock cubes contain wheat flour and therefore gluten – Knorr are safe to use as they are gluten free

Reasons to be Cheerful

Ali has suggested a cheerful little song about the amount of radioactivity in bananas: https://www.youtube.com/watch?v=Yl_nN3aL1BA

We also had some comedy mash-ups from Dead Ringers:

• Crimewatch/Lord of the Rings mashup.
• Harry Potter/ Lord of the Rings mash-up https://www.youtube.com/watch?v=I75CUjmfQW8 .

Many thanks for reading this LinkedIn newsletter, and many thanks to everyone who has contributed. 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 newsletter.

It would be great if you’d like to subscribe to this newsletter, or even our weekly email one https://www.ghsclassificationcourses.com/home/news... (which includes access to the email archive).

Look forward to chatting to you in late November or early December

Kind regards,

Janet

Janet Greenwood, TT Environmental Ltd