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Chemicals Coffee Time Monthly, September 2023

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Updated
Byghsclassific1

Dear Friend,

I hope this newsletter finds you safe and well. September is the traditional “return to work” time, and, as you might anticipate, this applies to regulators just as much as to business.

We’ll start with the EU, who didn’t seem to take a summer break at all, and are focused on pushing forward to complete the “Green Deal” requirements before the end of the mandate term.

Keeping an eye on ECHA and the EU

EU-CLP Legislative Act updated proposals

The story so far: the EC have already published a Delegated Act (2023/707) which amends CLP to introduce the new EU hazards:

  • PBT/vPvB
  • PMT/vPvM
  • Endocrine Disruptors for Human Health
  • Endocrine Disruptors for the Environment

Delegated acts are considered to be required to keep the regulation in line with scientific and technical progress. They are not supposed to be reformative so should not require consultation/debate/vote etc. They should just amend the annexes and not the articles of legislation. This is not anti-democratic, as we had an opportunity to comment on the Delegated Act last autumn.

However, the changes to CLP also required a debate in the European Parliament to amend the CLP Articles, under a Legislative Act, and this has been going through the committee process. Within the Legislative Act, the EU chose to bring in some new proposals at the last minute in addition to the new CLP hazard classes. These additional proposals were not publicly known until the draft Legislative Act was published.

The committee at the European Parliament did take note of feedback from many interested parties, including industry representatives, and made a number of suggestions, some of which have been adopted.

Now read on…

Alison Potts writes: The Legislative Act will go to Plenary Debate on Thursday (05/10/2023) but we’re unlikely to see any further huge amendments now as the committees have all signed off. Which means it’s a good opportunity to take a look at the original draft and the new amendments and try and assess its potential impact on the industry.

Ultimately, a lot of the changes are practical. We already have the new classifications in the EU (courtesy of the Delegated act (EC 2023/707)) – Endocrine disruptors, PBTs/vPvBs, PMTs/vPvMs; and a lot of the changes are workability changes to ensure that the relevant CLP Articles are expanded to include references to these new classes. No complaints there!

The second biggest change is probably the introduction of digital labelling. At this stage, it remains optional, and it’s something you’ll see in a lot of proposed or draft legislation in the EU (Fertilisers, Plant Protection Products, Packaging etc…) The only thing that worries us is the clause that allows the EC to make changes to digital label provision and content via Delegated Act in future. This means they wouldn’t need to consult or have the changes approved by committee/parliament. They have granted themselves future free license.

Changes to physical labels were of huge concern to industry. The amendments have watered down the proposals, but we didn’t win on all fronts:

  • Minimum font sizes for labels are coming in:

Not exceeding 3 litres: 8pt/1.4 height in mm

Greater than 3 litres but not exceeding 50 litres: 12pt/1.8 height in mm

Greater than 50 litres but not exceeding 500 litres: 16pt/2.4 height in mm

Greater than 500 litres: 20pt/3.0 height in mm

  • However – There will be no mandatory formatting of font types, spacing, or background colours on labels!
  • Fold out labels will be acceptable for more packages in the EU (not just situations where packages are too small or awkwardly sized for regular labelling)

Manufacturers may find additional costs are required due to more hazard classifications now falling under Child-Resistant Fastenings, and Tactile Warnings of Danger requirements. In particular, tactile warnings will now be required for relatively low level hazards such as skin and eye irritants supplied to the general public.

We’re not going to walk you through the entire regulation, but we did agree to share our thoughts on the proposed reform of the C&L inventory. Mostly because Ali is cross (and it’s quite hard to get her to shut up when she’s angry).

In a nutshell (insert your own non-allergenic alternative), the proposals are:

  • If you are the owner of a C&L notification that differs from the ‘agreed’ classification (i.e. either the REACH classification, or for non-REACH substances the highest or majority classification), you will have to justify your classification. If you cannot justify your classification it will be removed by ECHA. Without a valid C&L notification you cannot import/manufacture the substance.
  • You will have 6 months after a REACH dossier is updated or an ATP is published to update your C&L – after which your C&L will be removed

Ali is annoyed about this because it’s almost a good idea. The problem is in the execution. Yes – the C&L inventory is full of absolute rubbish and needs to be cleaned up. But equally, ECHA needs to accept that ‘One CAS does not equal One Classification’.

There is no requirement to do any substance identity profile before submitting a C&L. Some CAS/EC#s are wide enough to drive a bus through (and that’s great for some inventory compliance elsewhere in the world!). We also know that sometimes material is cheap because the purity is shocking – but it does the job and we accept the classifications that come with that.

If you look at some of the surfactants and polymers, we know that the actual chemistry within those CAS#s varies hugely. So who is going to be approving which ‘deviations’ in the C&L are allowed, and which aren’t? I think CESIO will have something to say about this.

If you’d like to read the amendments yourself, you’ll find them here. The original text (without amendments) can be viewed here. The plenary session is currently scheduled to be recorded, but we can’t confirm if it will be live streamed or uploaded at a later date.

Obviously we will know more, including implementation and transition timescales, once the Legislative Act has been passed and adopted, but we wanted to make sure you are prepared for some major changes in the pipeline.

EU-PIC update

Phil Rowley wrote on 1st September: This Regulation has just appeared in the EU Official Journal and extends the substances covered by the Prior Informed Chemicals system for exports. I don’t understand why the Reg has only just appeared in the OJ when it was passed in June! https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R1656

More details at https://echa.europa.eu/-/35-hazardous-chemicals-added-to-the-prior-informed-consent-regulation

EU Microplastics restriction

Monday 25th September saw the official publication of EU REACH Restriction #78 – “Synthetic Polymer Microparticles” – or ‘microplastics’ as you probably recognise them.

Alison Potts writes: It feels like at least 18 months since I first sat down with the draft copy of this. And looking at it now, my first thoughts are that certain companies appear to have spent an awful lot of money fighting it.

As a result there are extensive exemptions, carefully worded definitions, and 10 different phase out dates for various different product types all the way up to 2035. I mean, the lobbyist who won another 12 years for microplastic glitter in nail varnish (78(6)g) probably deserved his bonus, but I’m not sure he’s doing his part for the planet in general.

Based on the restriction as published, if you need an exemption for your product you can probably find one. But I’m not sure you’ll feel good about it.

You can find the text of the restriction here

Statistics corner (or lies, damned lies, and….)

There was a snarky comment made on LinkedIn by someone who describes their job as “Advocacy, awareness-raising, public campaigning – Environmental health and social justice” that “So the EU regulations are working pretty well to boost the sector after all ”.

I think that this is a complete misreading of the situation on several grounds:

  • these figures do not appear to have been indexed to account for inflation, which is still a significant factor even at 1%, over an 11 year period
  • during 2022, we were still recovering from the effects of Lockdown and I suspect there was a consumer “bounce” which probably stimulated demand – it couldn’t be described as a normal trade year
  • the EC stats do not distinguish between chemical imports and chemical manufacturing. Those would be much more nuanced picture, as I suspect manufacturing volumes will be lower than they were in 2011, and imports higher (if you have any information on this, please do let me know).
  • finally, I don’t think extra EU regulations, such as REACH, which are ultimately a form of taxation, as they cost money and time to comply with, can have anything other than a negative effect on an individual business and the wider economy, purely in economic terms (leaving on one side the desirable effects of more knowledge about hazardous chemicals, better communication of those hazards, and potentially lower exposure to those hazards for workers and consumers). The difficulty is that we don’t know what the EU economy would have looked like without REACH. What we can say is that the number of chemicals available in significant quantity (1 tonne per annum or more, i.e. registered for REACH) is much lower than either the regulators or industry predicted before registration started.

Divergence details

As well as the proposals outlined above, in the last month, ECHA has announced that:

  • they are consulting on a new Harmonised classification and labelling proposals of EDTMP (CAS# 1429-50-1) and its sodium, potassium and calcium salts. Full details here (including many others): https://echa.europa.eu/registry-of-clh-intentions-until-outcome
  • Many thanks again to Phil Rowley who spotted that a further 6 substances have been proposed to be added to the Candidate List, (i.e. Substances of Very High Concern), with a view to being assessed further for Authorisation.

2,4,6-tri-tert-butylphenol, CAS no 732-26-3

2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol CAS no 3147-75-9

2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one CAS no 119344-86-4

Bumetrizole CAS no 3896-11-5

Dibutyl phthalate CAS no 84-74-2

Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol EC list no: 700-960-7

  • And I’m not quite sure how to describe this next issue – irony alert? Paracelsus in action? Anyway, there’s a consultation about substituting a hazardous chemical used as a rodenticide under the EU BPR (Biocidal Products regulation). This is cholecalciferol, which you may recognise under another name as Vitamin D3, and something which is essential for life (in tiny quantities). An excellent example of Paracelsus’s axiom “the dose makes the poison”, although like many axioms he probably didn’t say it in precisely that way. The consultation is open until 7/11/2023, see https://echa.europa.eu/en/public-consultation-on-potential-candidates-for-substitution/-/substance-rev/74401/term

Hearing from the HSE, DEFRA and the UK

Lithium salts classification – more divergence

An interesting issue cropped up at the recent Chemical Regulations Self Help Group meeting about deliberate UK divergence from the EU, many thanks to Neil Hollis for highlighting this.

Whether this decision has anything to do with the recent news that battery plants are opening in the UK, and lithium mining as well, is anybody’s guess. However there has been concern in the battery industry about the EU’s decision for some time, see https://www.spglobal.com/commodityinsights/en/market-insights/latest-news/metals/062822-europe-proposal-to-classify-lithium-as-toxic-could-hinder-battery-supply-chain

Infographic of the month

The Weekend Read

To paraphrase a well-known saying about safety being less expensive than an accident – if you think chemical and process engineers are expensive, try building or updating your plant without one!

The Weekend Recipe

Well, it’s that time of year again, where our courgette plants decide to really start producing, at least until the frosts nip them. I think it’s because we can’t start the plants too early because of the bad weather in Spring, so they tend to be later than people who live in a better microclimate.

So I had a thought – why not try courgette moussaka? There are only a few recipes for this that I could find on the internet, so it’s another culinary experiment!

Ingredients:

  • courgettes cut into diagonal slices, about 1/4 of an inch deep
  • oil or a mix of oil and butter for frying
  • 1 lb beef mince, and onions and grated carrots; or the same amount of mince already cooked beef mince (with onions and grated carrot already in it), which you have thoughtfully taken out of your freezer. You could use lamb mince, if you’re feeling like splashing out
  • about 2 to 3 tablespoons tomato puree
  • 1 tablespoon tomato ketchup
  • 1/2 teaspoon ground cinnamon
  • 1/2 teaspoon dried oregano
  • 3 cloves garlic, finely chopped
  • bechamel or white sauce made with 2 oz butter, 2 oz flour and about 1 pint milk (cheese optional)

Method:

Findings:

  • This was a winner! We really enjoyed it, and it’s a low-carb alternative to lasagne (as long as you don’t serve carbs with it)
  • Leftovers can be cooled down, stored in the fridge overnight, and reheated thoroughly in the microwave the next day
  • If you use a non-dairy milk for your bechamel, it’s relatively straightforward to make a lactose free version
  • And you could veganise it using e.g. some nice mixed mushrooms, or perhaps some cooked red lentils as the protein

If you want a full-on vegan option, this recipe from Tesco looks interesting: https://realfood.tesco.com/recipes/rich-vegetable-moussaka.html

Reasons to be Cheerful

We continued our Mitchell and Webb series of Reasons to Be Cheerful in September:

And finally, our friends at HIBISCUS PLC. Chemical Labels | Chemical Labelling / SDS Software shared an excellent website from Bristol University, Molecules with Silly or Unusual Names: https://www.chm.bris.ac.uk/sillymolecules/sillymols.htm .

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 October or early November

Kind regards,

Janet

Janet Greenwood, TT Environmental Ltd

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