Chemicals Coffee Time Monthly, November 2023

Dear Friend,

Well, November has been quite a month here at TT Environmental, both professionally and personally. On the professional front, we have had quite a bit of news on the EU’s CLP Legislative Act, so let’s start with that.

EU CLP Legislative Act update

First of all, we learned that the Trilogue process was due to end on 6th December. At the time of writing, this process has ended, an agreement has been reached, but there is no information on what the agreement contains!

This is unfortunate, as the details are what matter to industry. The Trilogue process meant that we could end up with the current European Parliament proposal, or one of the previous ideas, or a completely new proposal! (We’ll let you know as soon as that information becomes available).

However, we also discovered in mid-November that we’d been reading the CLP minimum font sizes wrong!

It turns out that we’d been thinking the minimum font sizes in mm referred to text height, but it refers to the height of the lower case x, the x-height! So what we thought was a large reduction in minimum font sizes, by about half, turns out to be nothing of the sort, more like 1/7th reduction, at best.

More on this issue here: https://www.linkedin.com/pulse/newsflash-clp-label-font-size-problems-continue-janet-greenwood-7ml7e . This issue was initially raised by Tracey Hemingway-Wright of HIBISCUS PLC. Chemical Labels | Chemical Labelling / SDS Software, and we worked together to get to the bottom of the situation.

On a more positive note, I learned that CEPE and other trade organisations had sent a letter to the European Commission, the Rapporteur in the European Parliament and the Spanish Presidency on the 17th November. British Coatings Federation had also been working hard with CEPE behind the scenes. Many thanks to Kerry Knowles of Tremco CPG Europe for spotting this.

The letter is here. It also references a study funded by CEPE which has been carried out on the difference between the current minimum x-height of 1.2 mm versus 1.4mm, which shows very little improvement, which you can find here.

We also found out that there was a lot of disagreement within the EU themselves about what the minimum x-height should be, with differing opinions between the initial Commission proposal, the European Parliament position, and the Council, see p 173/174 of this document: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14625_2023_REV_1. It is interesting to find such a lot of disagreement. Many thanks to Kathryn Tearle of BCF for sending this information through.

So at the moment, all we can do is wait and see what has been decided.

Unless there’s some miraculous change of heart and the idea of minimum font sizes is dropped altogether, I’m afraid that we’re in for a rough couple of years. Industry will have to attempt to cope with labelling restrictions which do nothing for people’s safety, but which cause a great deal of wasted time, effort and expense.

Watch this space!

d-limonene classification divergence

Commenting under the Monthly edition of Chemicals Coffee Time, Adam Hunniford noted “Both concerning and unsurprising that limonene comes up as a ‘conflict’. As long as I’ve been formulating, it’s been one to debate as everyone has a different view (primarily on its environmental consequences).”

There’s a bit of a story there! As I understand the situation, prior to Brexit, the decision was made in the EU to assign H412 to d-Limonene on the basis of data, basically because the HSE representative pushed it through.

Unfortunately, due to the arcane procedures at the EU, they failed to extend this to the other Limonene isomers! So the EU’s HC has been split in two (un-necessarily, in industry’s view).

However, by the time the d-Limonene new Harmonised Classification was published, we’d left the EU so it wasn’t brought in to the Mandatory Classification list… even though it was the HSE/ UK representative who had promoted it!

So the GB Mandatory Classification is (a) for all isomers (good) but (b) is H410 (less accurate, we think); and the EU Harmonised Classification is (a) for d-Limonene as H412 (accurate), but (b) the other isomers are still H410! Truly, you couldn’t make it up.

We then had a response to this information from Mark Selby of DENEHURST CHEMICAL SAFETY LIMITED in our 10th November email newsletter, who writes:

Regarding limonene and divergence in the UK/EU harmonised classification, there was a disappointing adherence to rules by the UK where-as the EU committee (led by the Dutch) showed pragmatism.

The EU assessment for (R)-p-mentha-1,8-diene EC 227-813-5 (natural form of Limonene most commonly used) took into account data submitted for EU REACH covering Daphnia reproduction, different results on algae and the fact it is rapidly biodegradable; the conclusion was that ‘chronic’ environmental effects in the 0.1 – 1 mg/l range and the rapid biodegradation led to Aquatic Chronic 3.

Although it was noted in the EU assessment that the reported partition coefficient of Log Kow 4.83 (or even preferred result of Log 4.3) is over the limit of 4 described in CLP, and negates the rapid biodegradation, the Dutch led committee chose to ignore this. Although not published, the opinion was that these terpenoids occur widely in nature and are part of the diet of many organisms (think lemon in your gin and tonic). Accumulation is therefore not likely. The UK argument was to stick to the data and not ‘assume’ the potential to accumulate or not.

However, with chronic environmental toxicity in the range 0.1 – 1 mg/l, the hypothetical ability to accumulate would only put the classification at Aquatic Chronic 2 using EU/GB CLP.

Despite the annoyance of differing information in Section 3 of the SDS, when supplying mixtures with limonene, remember that the harmonised classification can be ignored. Instead, use ‘self classification’ where you can use data you consider appropriate for classification. I would recommend following the Dutch (EU) lead when it comes to self-classification, but clearly justify your decisions; even if not following the Dutch lead, starting at Chronic 2 is valid.

For a copy of the RAC decision document, see here ​https://echa.europa.eu/documents/10162/10c233b2-019e-4e59-e0c1-550133aed912.

Thanks very much to Mark for his views on this.

I asked Ali for her opinions as she’s done a lot of work on mixture classification and bridging. Here’s what she had to say:

“Mark has some great points when it comes to looking at the core data, but I’m not sure I’d use the term ‘ignore’ when it comes to a substance classification. You should always take it into account, even if having used your expert judgement on all the data you have available, you then select a different classification for the mixture than that which results from the basic algorithm. The two CLP evaluation methods supporting this approach are ‘Weight of Evidence’ and ‘Expert Judgement’ – both of which (as Mark states) must be adequately justified.

A safer approach may be to test a product (or a lab sample which is representative of several similar products) and then use those results to classify your mixtures via bridging principles. For companies without in house eco-toxicologists you may feel more confident diverging from the basic calculation method with test data to rely on.”

Mark’s contribution was followed by a further article on the topic by Paul Thomas of KREATiS in the 17th November edition. Paul writes:

I’d like to comment on Mark Selby’s point on d-limonene.

I was wearing the IFRA IND hat defending the dossier in the RAC. The Dutch had accepted to be pragmatic but it was a close shave as some of the MS (and the chair himself) questioned the ready biodeg data (which admittedly was kind of diverse and not totally convincing except for an overlooked study by MITI which had failed to get attention in the paperwork put before the RAC for reasons I can’t explain). I pointed out this study as convincing supplementary evidence for rapid biodegradation (71% within 14 days!) which the Chair denigrated as being poor quality, BUT, and here’s the rub, the UK rapporteur, putting in his final appearance before BREXIT, defended our position on the MITI study on the basis that it had been performed by a regulatory body and was therefore trustworthy.

The issue on the chronic fish study was that it was an OECD 212 and indeed could have been criticized as not being the right study on the basis of the logP but we put forward arguments that the substance had reached equilibrium within the time frame of the study and there was no reason for a non-polar narcotic, or from acute studies to expect the substance to be more toxic to fish than to daphnids. I was ready for a fight on this one but the position was not even questioned by the RAC!

On the other hand, after BREXIT, the UK jumped on these points to reject the RAC decision (notably criticizing the fish study as not being chronic) and to fall back on the old acute data.

This was their statement:

“This disagreement regarding aquatic chronic toxicity is due to uncertainties around the studies used by RAC when considering the classification. The Agency also believe d-limonene is potentially bioaccumulative. The Agency consider that an alternative study, utilising a surrogate approach using a mean measured Pimephales promelas 96-hour LC50 of 0.702 mg/L should be used instead. As this endpoint falls in the 0.1 < LC50 ≤ 1 mg/L range, this would result in a more stringent classification as Aquatic Chronic 1 with an M-factor of 1. The Agency noted that if further data on the chronic toxicity to fish become available in the future, the environmental classification may need to be reassessed.”

In the UK technical report they say:

“As EC10 values are preferred over NOEC values for the purpose of hazard classification, the Agency considers that the lowest reliable endpoint from the study is an 8-day EC10 of 0.32 mg/L based on survival. This endpoint is not in the same concentration range as the QSAR-predicted NOEC values of 0.080 and 0.073 mg/L for fish. Therefore, the Agency does not consider that the study should be used to assess the chronic toxicity of d-limonene to fish…. The QSAR-predicted NOEC values of 0.080 and 0.073 mg/L for fish would result in a less stringent classification as Aquatic Chronic 2 for the rapidly degradable substance. The NOEC of 0.080 mg/L was calculated using the iSafeRat® HA-QSAR which was provided with a QSAR model reporting format (QMRF) document.”

So despite the existence of 2 reliable QSARs both with very similar outcomes but values 4 times more conservative than the OECD 212 study, which could have been used to classify as Chronic 2 (a good compromise), they just decided to ignore all the data and fall back, for no good reason whatsoever, on the acute data.

We had hitherto spent 3 years trying to obtain quality chronic data to support the (de)classification of d-limonene. We had to run the daphnid study 3 times to get a valid study and one reason was because the substance degraded so fast in the study it was hard to maintain measurable concentrations in a closed semi-static test! Running a valid chronic fish study will be a challenge therefore!

Many thanks to Paul for his comments.

I know the HSE CLP team are extremely busy, but it would be very helpful to industry if they could review the d-Limonene Mandatory Classification in the light of the information from Mark and Paul.

DEFRA announcement on the UK-REACH alternative model

Ali writes: here in GB, we were interested to hear from Alastair Gardner of Department for Business and Trade and Sarah White of Prime Surfactants who tipped us off about DEFRAs statement on UK-REACH: ​https://www.gov.uk/government/publications/uk-reach-alternative-transitional-registration-model-atrm/uk-reach-alternative-transitional-registration-model-atrm​

It does at least categorically confirm that EU REACH continues to apply in Northern Ireland (under the Windsor Framework), which is something.

Mick Goodwin of WSP noted that although there is some talk about permitting lower levels of information for intermediates and low-tonnage band materials, this may be at odds with the HSE’s requirement to produce information quickly on request!

Another “watch this space” moment…

The weekend read

A very important Weekend Read from the HSE on Radiograph Duplication and Falsification: ​https://www.hse.gov.uk/safetybulletins/radiography-duplication-falsification.htm​ .

I find it very sad that people are so motivated by saving time or money that they would falsify the vitally important work of non-destructive testing. Call me old-fashioned, but I think that if a weld is considered important enough to need NDT, that means people could die or be injured if it’s not safe enough, so please ensure your NDT tests are being carried out properly.

“If you think safety is expensive, try an accident”.

Infographic of the month

How old do you think an organisation chart might be? How about 1855, in the Victorian era? see https://psychsafety.co.uk/the-first-organisational-chart/

The weekend recipe

We’re firmly into the pheasant shooting season now, and one of our friends has come up with an excellent curry recipe (of course you can substitute chicken for pheasant, although it won’t be exactly the same flavour).

Luke’s Pheasant and Chickpea Curry

• 4 pheasant breasts

• 1 tin of chickpeas

• 1 red chilli

• Cinnamon stick

• 3 cardamom pods

• Cube of root ginger

• 4 shallots (or a medium onion if you can’t get hold of shallots)

• 3 garlic cloves

• 2 teaspoons turmeric

• 2 teaspoons cumin

• Curry paste (probably about a tablespoon, you can adjust this to suit your own tastes)

• Creamed coconut

• Chicken stock (made with a stock cube is fine)

Method

1. Finely slice the shallots, garlic and ginger. Heat oil in a pan and the cardamom pods, shallots, garlic, ginger and chilli. Cook until the shallots are soft.

2. Add the cumin, turmeric, curry paste and a splash of water and stir.

3. Slice or cube the pheasant breast and add. Stir until all the pheasant is coated. Add the chickpea and do the same.

4. Add the creamed coconut and stir until melted.

5. Add 200-300ml chicken and leave to simmer. for about 20 minutes until cooked through (you can leave it longer though).

Serve with rice or naan bread.

Many thanks to Luke for this.

Reasons to be Cheerful

November was another Dead Ringers classic comedy month:

• Dr Who spends the weekend with the Cybermen

   

• Battle of the Historians

   

• Desperate Newsreaders

   

• Drink shopping

   

I mentioned that November had been a tough month personally, and I’d like to thank everyone who offered moral and practical support while Ali was off work recovering from an accident, and I was ill with shingles, we appreciate your help and good wishes more than you may realise. Luckily I’m back at work, and Ali is recovering steadily.

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 (which includes access to the email archive).

Look forward to chatting to you in late December, or early January 2024.

Kind regards,

Janet Greenwood

TT Environmental Ltd