What topic are you interested in?

Subscribe | About | Help

< All Topics
Print

Chemicals Coffee Time Monthly, April 2024

Posted02/06/2024
Updated06/08/2024
Byghsclassif1stg

Dear Reader,

I hope you are safe and well, and not suffering from nervous exhaustion over the sheer volume of chemical regulations which have been pouring out of the EU in the run up to the European elections and the appointment of the next European Commission.

But first, a shameless plug – Chemicals Coffee Time (that is my colleague Alison Potts and me) will be at ChemUK 2024, giving a presentation on “Regulatory Affairs is a Team Sport – A Chemicals Coffee Time report“, on Day 2, 16th May, 1:45 pm, Stage 5.

If you’re at ChemUK, you can find us on the Chemical Regulations Self Help Group stand at Q120, right next door to the Regulatory Stage (Stage 1). Many thanks to Ian Stone and his lovely team for inviting the Self Help Group, and also giving us a speaking slot, we are really looking forward to the event.

We’d love to see you at ChemUK if you’re attending, so do come along and say hello.

Right, on with the rest of the newsletter! We’ll start with the EU news.

Keeping an Eye on ECHA and the EU

CLP Legislative Act

The biggest news was, of course, that the CLP Legislative Act has been passed in the European Parliament, bringing with it some changes to the CLP label in the EU and Northern Ireland (which follows EU rules for CLP and REACH under the terms of the Windsor Framework).

Alison Potts writes: We’ve had a few questions about the Parliamentary process behind this one. In particular, questioning whether it will need a second and third reading. And the short answer is ‘No’.

The longer answer is that the CLP legislative act has had a long journey to get here! It bounced around committee and had votes back in September and October which resulted in a lot of amendments – so many amendments that it was referred to ‘Trilogue’. The trilogue is a closed negotiation process that results in a ‘compromise text’. This compromise text is the version that goes to final vote, and it cannot be further amended.

Because there are no opportunities to amend the trilogue text, it does not need additional debate or vote, and will not get a second or third reading.

So, what happens now?

The text gets rubber stamped by the council, and published in the EU LEX. The longest possible delay permitted is 8 weeks while the legal linguistic team check the translations for EU LEX (according to the EU Policy handbook!).

The partial ‘Legal-Linguistic’ Finalisation text is available here: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0296_EN.pdf

(Handy hint: You can change ‘EN’ for ‘FR’, ‘DE’ or the language of your choice in that URL. It took them a while but they did eventually get all 24 online!)

Fantastic, that’s the process sorted. But most of you are probably here for the content! And… that’s a mixed picture. It could fill multiple newsletters if we didn’t determinedly shove Ali off her soapbox. We’ll try and pick out the high(low)lights, but if you think we’ve missed something critical to your business then please send us your thoughts!

Labels

  • Mandatory formatting rules for labels – Minimum font sizes: Packs not exceeding 0.5L (Font x-height 1.2mm); Pack greater than 0.5L but not exceeding 3L (Font x-height 1.4mm); Pack greater than 3L but not exceeding 50L (Font x-height 1.8mm); Pack greater than 50L but not exceeding 500L (Font x-height 2.0mm); Pack greater than 500L (Font x-height 2.0mm). Text must be black on a white background. Distance between two lines shall be at least 120% of the font size. Text must be a single font size without serifs. Letter spacing must be appropriate and easily readable
  • Added flexibility for the use of foldout labels
  • Layout and content requirements for foldout labels
  • Voluntary provision for digital labels (in addition to the physical label)Where digital labels are provided, the supplementary label elements may be removed from the physical label
  • Labelling requirements for products supplied via refill stations
  • The ‘contains statement’ (Mixture identifier) on labels to include substances with additional hazard categories

Updating information on labels

  • Following a change to the classification or labelling: If the classification becomes more severe, or new supplemental information is added to the label, the supplier must update the labels without undue delay (and no later than 6 months). For any other change to classification or label the label must be updated without undue delay (and no later than 18 months). If the change was triggered by a harmonised classification covered by an ATP, then the date(s) specified in the ATP take precedence. If the label falls within the scope of the detergent or biocide regs then any specified timeframe within those regulations take precedence.

Advertising

  • All adverts for hazardous substances or mixtures must include pictograms, H-Statements and EUH-Statements.
  • Any advert for hazardous substances or mixtures sold to the general public must also include the statement “Always read and follow the information on the label”
  • For any substance or mixture sold via distance sales (online sales), the offer must clearly and visibly show the label elements

Harmonised Classification and Labelling and C&L Notification

  • CLH is updated to not just include groups of substances, but to prioritise groups of substances over individual substance proposals
  • The Commission may request proposals (rather than waiting for a competent agency to trigger)
  • The Commission has imposed a new deadline upon itself to adopt CLH proposals into published ATPs. (Without undue delay and before the end of the calendar year following publication of the RAC opinion)
  • C&L notifiers have 6 months to update their notification following a classification change
  • They must justify any notification that diverges from the most hazardous listing in the C&L inventory
  • The identity of C&L notifiers will be published on the inventory (unless a claim for confidentiality is made)

Transition Dates

The application dates of this legislation for new products are an absolute mess.

For example:

  • The new timescales on updating labels after classification changes – kick in 18 months after this regulation appears in EU LEX.
  • The rules about advertisements – 18 months after publication
  • The black text on white background (but none of the other label formatting rules!) – 18 months after publication
  • The rest of the label formatting rules! – 24 months after publication

If you have a product already on the market with label formatting according to the existing legislation in the 2 years following EU LEX publication, then it’s fine for 4 years after EU LEX publication.

However, if you have a product already on the market where the label elements will change (because of the the changes to the ‘contains’ statement, or the addition of the Endocrine hazards, PBT or PMT classes) then that timescale is a little shorter, around 3.5 years (Look at Article 61 for more details).

And all the rest…

There’s plenty more packed into that legislation, and Mel Cooke of Alchemy Compliance was quickest off the mark on Tuesday when he sent us his initial thoughts:

I was amazed at Recital 3 stating that there is ‘scientific data’ that constituents of plant extracts should be treated differently to other chemical products. The legislation has a derogation for the hazard classification of plant extracts because ‘specific constituents considered in an isolated way can have hazard properties that might not be expressed in the substance as a whole’. Really? Is there evidence that the generic classification thresholds should be different for components of plant extracts compared to general chemicals?

The generic threshold are set low so as to be precautionary. Also, testing of complex substances – plant extracts or other – for CMR properties is unreliable and therefore not appropriate, as stated in the CLP Regulation. So I am curious as to the what ‘scientific data’ has been provided to support this position.

I understand there is political expediency in regulating ‘natural’ chemicals differently, but the lack of consistency and rigour is annoying.

Mel is quite right of course. There is no such ‘scientific data’ that constituents of plant extracts should be treated differently to other chemical products. There are however vast numbers of MEPs who threatened to pull support from the entire Legislative Act because of the detrimental impact on the natural plant extract industry. (Bulgaria is the worlds largest producer of Rose Oil, and France is a significant producer of Lavender Oil).

The concern over essential oils is one of the primary reasons the CLP Legislative Act got thrown to Trilogue negotiation (and Ali is therefore blaming it for the return of the label formatting rules).

We look forward with interest to the outcome of ‘Article 54a’ – The Commission shall present a scientific report to the EU Parliament and the council regarding the examination on substances containing more than one constituent extracted from plants’. I wonder if they’ll think they are still subject to special derogation after they’ve finished looking for actual evidence?

Anyway, we can’t spend the whole day talking about CLP. Let’s take a look at some other news…

Essential Use Definition

Phil Rowley, retired but open to consultancy, has also spotted a very important document from the European Commission, published on Monday, which lays out guidance for the criteria of their “essential use” concept for chemicals: https://environment.ec.europa.eu/publications/communication-essential-uses-chemicals_en .

The main definition is:

A use of a most harmful substance is essential for society if the following two criteria are met: 1) that use is necessary for health or safety or is critical for the functioning of society, and 2) there are no acceptable alternatives.

The document goes on to explain this definition, and give examples and criteria by which to make the assessment. It’s a surprisingly light read – I was expecting another 100+ pages, but this is a very reasonable 23 and quite manageable if you’re new to the topic.

Eco-Design of Products

I haven’t given this one as much airtime as the CLP Legislative Act, but Tuesday’s EU Parliamentary session also saw the vote on the Framework for Setting Eco-Design Requirements for Sustainable Products.

This is the base regulation that opens the door for secondary regulations introducing measures like Digital Product Passports, Sustainability requirements for chemical products, Bans on the destruction of unsold products, and a whole host of other ‘eco-friendly’ policies.

The priority product groupings are iron, steel, aluminium, textiles, furniture, tyres, detergents, paints, lubricants and chemicals. And in fact, we’ve already seen the first measures in the draft Detergents legislation covered in this newsletter (Head to the archive if you missed it!)

The basic legislation is thin on details. The measures themselves will all be in the secondary legislation which will start to appear en masse now.

The Eco-Design parent legislation is awaiting legal-linguistic review before publication in the EU LEX. The partial finalisation version is here: www.europarl.europa.eu/doceo/document/TA-9-2024-0303_EN.pdf

Microplastics

Honestly, I cannot stress enough just how busy Tuesday the 22nd April was in the EU parliament for chemicals and chemical products!

Tuesday also saw the EU Environment Committee take another swing at their microplastics legislation, having decided that they weren’t entirely satisfied with the legislation passed last year. The proposal is 2023/0373(COD) and it saw a raft of amendments at its reading, although it did pass (71 for, 5 against, 1 abstention).

The regulation would improve the definition of plastic pellets, powders, cylinders, beads and flakes, and then impose responsibilities and reporting requirements on all handlers in the supply chain. The interesting thing buried in the regulation would be the introduction of a new specific pictogram for containers storing or transporting microplastics, alongside mandatory label content.

This one is not skipping straight to publication! It’ll have to wait until after the EU elections to progress to the next reading.

You can keeps tabs on the progress here: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2023/0373(COD)&l=en

Although – they aren’t great at updating these procedure files and the current file doesn’t consolidate the amendments from Tuesday!

Many thanks to Ali for her diligence in keeping track of all this EU legislation. The new EU Parliament will sits for the first time on July 16th. In the meantime, Ali will be delighted to take a break from tracking the EU Parliamentary channel.

Hearing from the HSE

It’s not all been EU changes, there are some more UK (or more properly, GB) alterations which are going to give divergence from the British side of things.

HSE WTO notifications, April 2024

The HSE have notified the World Trade Organisation about another batch of 48 substances which will be added to the GB MCL (Mandatory Classification List) later this year. The substances are due to be added in Q3 2023 and would be voluntary from Q4 2024, becoming mandatory sometime early in 2026.

This link should open the list of notified substances with their proposed classifications: ​https://members.wto.org/crnattachments/2024/TBT/GBR/24_02176_00_e.pdf​

All the substances listed are also found on either the 21 ATP to CLP (Commission Regulation EC 2024/197) which comes into force September 1st 2025, or in the draft of the 22nd ATP to CLP which is expected to be published this quarter.

The 21st ATP can be found here: ​https://eur-lex.europa.eu/eli/reg_del/2024/197/oj​

And the draft 22nd ATP can be found here: ​https://members.wto.org/crnattachments/2024/TBT/EEC/24_00555_01_e.pdf​

The GB List is a pretty good match for the EU classifications. 45 are identical – (barring a couple of typos with missing ATEs, which are resolved when you check the technical reports).

There are 3 substances with actual differences.

  • (3E)-dec-3-en-2-one (CAS# 18402-84-1)The EU is introducing additional Aspiration Toxicity (H304) and Corrosive to the Respiratory Tract (EUH071) classifications which the HSE feel are unwarranted.This should have minimal impact as the substance is a plant protection product with no recorded usage in the UK
  • Benthiavalicarb-isopropyl (ISO) (CAS# 177406-68-7)The EU have assigned Repr. 2 H361fd – Suspected of causing damage to fertility and the unborn child. The HSE do not agree that the criteria for effects on fertility have been met, and are only classifying as H361dThis substance is also a plant protection product and has 7 recorded authorised uses in the UK or GB.
  • Trimethyl borate (CAS# 121-43-7)Tying in nicely to our ongoing newsletter discussion about ‘Note 11’The EU have assigned Note 11, which describes the use of additivity to assess repro-toxicity for certain compounds (to date these have all been borates)The UK have not introduced Note 11, however as CLP requires classifiers to consider synergistic effects when substances have similar modes of toxicity, the note should not be required.The UK technical report fully supports the additive classification method for borates but mentions that additional legislation (i.e. a Statutory Instrument) would be needed to formally introduce the note.

It would appear that the originally envisaged timeframe of 1 MCL update per year has gone out the window. However with the EU bringing in a minimum turnaround time for implementing Harmonised Classification and Labelling proposals, the UK will need to do its best to keep up!

For those keeping track, the EU will need to publish the 22nd ATP and then produce at least one more ATP this quarter to bring themselves up to date with their own internal targets.

UK Draft Amendment to the Cosmetics Act

A draft amendment to the Cosmetics Products Act, which will be known as the The Cosmetics Products (Restriction of Chemical Substances) Regulation 2024, has been notified by the Department for Business and Trade to the World Trade Organisation.

The draft legislation (here: ​https://members.wto.org/crnattachments/2024/TBT/GBR/24_02536_00_e.pdf​), will add 52 substances to Annex 2 (prohibited CMR substances in cosmetics), and will add 1 substance to Annex 3 (Restricted substances in cosmetics) of the Cosmetics Regulation.

The regulation is expected to apply to products from 20th April 2025.

GB MCL

3 more MCL Technical Reports have been published in GB

The next batch of GB MCL technical reports is now available for download from the ​GB MCL publication table (.xlsx)​ (this is a direct download of the table):

  • Bixlozone,
  • Solvent Violet 13 and
  • Pigment Red 83

There are still a few steps in the process before these are brought in as mandatory classifications. There will be an impact and policy assessment next, the Agency Opinion will be Published and then a batch of Recommendations will be put forward for a final decision. We’ll see them again at that stage.

For those interested, at this early stage, the technical reports indicate that the Solvent 13 and Pigment Red 83 classifications would be in-line with the EU Harmonised classifications. The Bixlozone (a plant protection product would be classified more severely in GB).

Consultation on GB Mandatory Classification

The HSE has opened a public consultation on the classification and labelling of several Copper Compounds. The consultation opened on Monday and will run until June 14th. Many thanks again to ​Phil Rowley​, one of our most regular correspondents, for sending this through.

Ali writes: If, like me, you saw ‘Copper’ and immediately assumed this was related to the GB MCL entry for Granulated Copper that is due to be removed this month as part of the ‘amendments/revision’ to substances from the 14th and 15th ATP – then nope! It’s unrelated. The future classification of Granulated Copper remains in limbo. (The technical report covers multiple forms, and an agency opinion is not yet available).

This consultation involves 9 copper compounds that are (and will remain) on the MCL. The consultation is specifically looking at proposed Oral and Inhalation ATE values. The majority of these ATEs appeared on the EUs 17th ATP, however there is at least one proposed value which differs.

You will find the consultation here: ​https://consultations.hse.gov.uk/crd-clp/clp-005-copper-substances-gb-mcl-proposal​. The substances are:

  • Copper (I) Oxide
  • Copper (II) Hydroxide
  • Copper (II) Carbonate – Copper (II) Hydroxide
  • Dicopper chloride trihydroxide
  • Copper thiocyanate
  • Copper sulphate pentahydrate
  • Tetracopper hexahydrate sulphate [1], tetracopper hexahydroxide sulphate hydrate [2]
  • Bordeaux mixture, reaction products of copper sulphate with calcium dihydroxide
  • Copper flakes (Coated with aliphatic acid)

Infographic of the Month

How does your organisation rate on the “Move Fast and Fix Things” matrix? another excellent sketchnote from Tanmay Vora , this time summarising the work of Anne Morriss and Frances Frey: ​https://www.linkedin.com/posts/naritarai_leadership-movefastandfixthings-mondaymood-activity-7180440127360438272-iLC3​

The Weekend Read

Another excellent article from Gareth Lock The Human Diver ​https://www.thehumandiver.com/blog/diving-accidents-the-want-to-know-what-happened-and-why​ .

So much to unpack here which affects the chemical industry: the reason why our recollections of events can change, and why; two quotes from someone called Dave Snowden “We only know what we know when we need to know it”, and “We can always know more than we can tell, and we will always tell more than we can write down.”

Another idea – The greater the shared understanding, the less information that needs to be transferred. (This certainly relates to my experiences of culture on well-run sites, which is be mostly based on conversation, with minimal formal meetings, and a strong sense of shared purpose).

Nerd Notes

Regular newsletter readers will be familiar with my theory that we “techies” in the chemical industry (chemists, engineers) are all nerds/ on the Aspergers/ autistic spectrum.

It seems that this also tends to run in families, and if this observation is correct, then some of our lovely readers may have children/ grandchildren/ nieces and nephews who may be showing signs of autism spectrum disorders in childhood.

So I was delighted to find this excellent article in the Telegraph about spotting the signs of autism in children, which I hope may be useful: ​https://www.telegraph.co.uk/health-fitness/parenting/children/autism-children-signs/​ .

The Weekend Recipe

I was inspired by a recent historic recipe to delve a little more into old British recipes, and came across a reference to Seed Cake, a great Victorian specialty (and certainly a favourite of my Victorian grandmother!).

There are a number of online recipes available, including Mrs Beeton who gives two recipes, a “rich” one, and a nursery version, see ​https://nottinghamindustrialmuseum.org.uk/caraway_seed_cake/​; Mary Berry ​https://britishchefstable.com/mary-berry-caraway-seed-cake/​; and a National Trust recipe ​https://www.theenglishkitchen.co/2016/03/traditional-seed-cake.html​.

Mrs Beeton’s was too large, and the method was too complicated (because it was from the days before baking powder); Mary Berry’s had too many non-standard flavourings; and the National Trust one had ground almonds, which I didn’t fancy, so I made a cut-down version of the Mrs Beeton’s rich recipe merged with a little of the Mary Berry quantities, to get the flavourings without too much fuss.

Caraway Seed Cake

Ingredients

  • 6 oz butter
  • 6 oz sugar
  • 3 eggs, beaten
  • 8 oz self-raising flour
  • 2 tbsp caraway seed
  • 1/4 teaspoon ground mace
  • 1/4 teaspoon nutmeg
  • 4 tablespoons milk, or 2 of brandy and 2 of milk (you may need a little more liquid to get the correct consistency)
  • 2 tablespoons demerara sugar (cake topping – optional)

Method

Set your oven to Gas Mark 4, and grease and line a 2lb loaf tin (or a similar volume of round or square tin – I used a metric loaf tin of around 1 litre capacity). Stir the caraway seeds, mace and nutmeg into the flour with a fork. Make the cake by the creaming method – cream the butter and sugar together, beat in the eggs gradually, adding a spoonful of flour each time, the fold in the rest of the flour, and the liquids – apparently you are aiming for a “dropping” consistency, where the cake mixture drops (slowly) off the spoon under gravity (but see findings, below).

Spoon into your baking tin, flatten with a spatula or the back of a spoon and scatter with the demerara sugar. Bake for around 3/4 of an hour until done (times may vary depending on the shape of your tin, loaf tin cakes tend to take longer).

Findings: This is really just a fancy version of Madeira cake (which uses a bit more flour compared to a traditional Victoria sponge). I used all milk, rather than adding brandy, and, as I didn’t have any demerara sugar, substituted soft brown sugar instead.

The sugar partially melted to make a lovely brown crust on top of the cake, with a few intact sugar crystals. There was a crack along the top of the cake – either slightly too quick an oven, or slightly too much liquid in the cake, but that’s a minor point. This is a lovely flavour of cake, especially when made with good quality butter (I use Longley’s Jersey butter, ​https://longleyfarm.com/collections/all/products/jersey-butter​, not an affiliate link), and I think the nutmeg and mace somehow balance the caraway seed flavour. From memory, a caraway seed cake without those spices is not as nice.

To make this lactose free, use margarine instead of butter, and non-dairy milk instead of cow’s milk. Interestingly, the “nursery” Mrs Beeton’s recipe apparently uses dripping instead of butter, presumably beef dripping. I may come back to that recipe another time!

Reasons to be Cheerful

In April, I’ve been in a Monty Python mood:

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.

It would be great if you’d like to subscribe to this newsletter, or even our weekly email one : https://chemicalscoffeetime.co.uk/. This new website includes the email archive, with both open-access and subscriber-only content, for example in March we’ve had a discussion about the impacts of the EU Detergents Legislation update; a forthcoming PFHxA restriction in the EU, and much more.

Look forward to chatting to you in late April or early May.

Kind regards,

Janet

Janet Greenwood, TT Environmental Ltd

PS We’re happy for you to use this content in your own social media or newsletters, as long as you credit Chemicals Coffee Time. Please note that this newsletter highlights issues which may be of interest to your business, but is not intended as specific advice. We always recommend that you should do your own research. If you need consultancy help, please book a Quick Consultancy Call here: (https://chemicalscoffeetime.co.uk/quick-consultancy-calls/).

Table of Contents