Chemicals Coffee Time, 26th April 2024

Dear Friend,

Happy Friday! This week was the final EU Parliamentary Session before the EU elections, and as a result it has been an incredibly busy week for EU legislation. In fact, it’s been so busy that we’ve made this newsletter an EU special edition. We’ve also added a few bonus pieces of advice from our lovely readers on dealing with SDS updates caused by EU-REACH dossier changes.

Normal service will be resumed next week (assuming the EU don’t continue to flood us with important new legislation!).

CLP Legislative Act

The biggest news of the week was the CLP Legislative Act, which passed the EU Parliamentary vote on Tuesday with a huge majority.

533 For, 11 Against, 65 Abstentions

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 18months 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 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.

Dealing with spontaneous EU-REACH dossier updates as a Downstream User – advice from a reader

Following Kerry Knowle’s query last week, Clive Foster of Dominion Colour writes:

Kerry’s sentiments are probably recognised by a number of readers but there are some things DUs may be able to do. ECHA’s PACT section is worth checking periodically and ECHA do notify of compliance checks etc (https://echa.europa.eu/assessment-regulatory-needs https://echa.europa.eu/information-on-chemicals/dossier-evaluation-status) and some of the severe classifications will require a testing proposal (https://echa.europa.eu/information-on-chemicals/testing-proposals/current). This doesn’t tell you the outcome but may help you add substances to a ‘risk register’. Alerting services usually charge extra for advanced warning (rather than announcing fait accompli) but they monitor which CAS number is on which ECHA watch list. (CoRAP, CLH, ATP routes to classifications tend to get mentioned in ECHA newsletters (and Chemicals Coffee Time!)

Another thing to do is keep your eye on the Classification and Labelling inventory. [Note ECHAs approach to CLI and how/when the website is (not) updated means this is not currently reliable.]. The lead registrant updates their dossier, and their classification (as seen in the “Brief Profile”) is in a different colour to everyone else’s. Other registrants will be obliged to follow and thus the classification filters through to downstream users. Spotting the change in LR’s classification indicates a change is coming, but I acknowledge no-one will do this unless they happen to be creating/updating their own datasheet at the time.

“At best, we get a “heads up” from a raw material supplier that an SDS update is imminent completely out of the blue.” I would cherish this supplier… They seem to be saying “We’ve found out we have a classification change which we have to apply without undue delay. From our next production we are going to be labelling according to a new classification and will be issuing an updated SDS.”

Peter Godfrey of CEA Research Associates adds: The other areas worth monitoring are CoRAP and the minutes from the various committees.

Many thanks to Clive and Peter for their comments, and if you have any other useful suggestions, I’d be happy to publish them.

Jobs update (UK stats from LinkedIn)

Regulatory affairs, 2,121 jobs; Health and Safety, 1,007 jobs (but remember to search with additional information, eg specialist, advisor, manager, as the LI algorithm is playing up at the moment).

I had a heart-breaking message on LinkedIn from a Regulatory Affairs manager working in the USA to say her role had been terminated. If you’re not aware, the legal minimum notice period in America is only 1 week, and many employers stick to that even for senior staff – it’s called “getting the pink slip”. All I could do was to point her towards my LinkedIn article on job-hunting, based on the mini-series we ran last year in this newsletter: https://www.linkedin.com/pulse/job-hunting-linkedin-janet-greenwood/​

Infographic of the week

Friction fixers from Tanmay Vora https://www.linkedin.com/posts/tnvora_leadership-sketchnotes-activity-7183356581500121088-Pd4H . Of course, we need to make sure that the friction which is being fixed is un-necessary, and we’re not throwing out the safety baby with the friction bathwater.

The Weekend Read

Fighting chemophobia – an excellent read from the FDA on chemicals and food: https://www.fda.gov/consumers/consumer-updates/food-safe-if-it-has-chemicals​

The Weekend Recipe

Did you know that yesterday 25th April, is Anzac Day, when we commemorate the sacrifices made by Australian and New Zealand soldiers in WW1 and WW2? This commemoration started in 1916, a year after Gallipoli, which makes it older than the Armistice commemoration in November, see https://www.express.co.uk/news/royal/1892109/prince-edward-anzac-day-service .

The most famous Anzac recipe is, of course, Anzac biscuits. Today, these are seen as a coconut-flavoured biscuit, but the original recipe didn’t include them, so I thought I’d give you both versions, from the Australian War Memorial website at https://www.awm.gov.au/articles/encyclopedia/anzac/biscuit/recipe​

Ingredients for no-coconut Anzac Biscuits

• 2 cups rolled oats
• 1/2 cup sugar
• 1 cup plain flour
• 1/2 cup melted butter
• 1 tbls golden syrup
• 2 tbls boiling water
• 1 tsp bicarbonate soda (add a little more water if mixture is too dry)

Method

• Combine dry ingredients.
• Mix golden syrup, boiling water and bicarbonate of soda until they froth. Add melted butter.
• Combine butter mixture and dry ingredients.
• Drop teaspoons of mixture onto floured tray, allowing room for spreading.

Bake in a slow oven (eg Gas Mark 3).

Ingredients for coconut Anzac biscuits

Ingredients:

• 1 cup each of rolled oats, sugar and coconut
• 1 tablespoon syrup
• 3/4 cup flour
• 2 tablespoons butter
• 1 teaspoon bicarbonate of soda (dissolved in 2 tablespoons boiling water)

Method

1. Melt butter.
2. Add syrup to dissolved soda and water. Combine with melted butter.
3. Mix dry ingredients and stir in liquid.
4. Place small balls on to buttered tray and bake in moderate oven (eg Gas Mark 4).
5. Lift out carefully with a knife as they are soft till cold.

I haven’t had time to try either version of these biscuits, although they are very similar to “Phyllis’s biscuits”, which I included in the 3rd February 2023 edition of Chemical Coffee Time (you can find this in the archive at www.chemicalscoffeetime.co.uk – you’ll need to be logged in to see this recipe).

Reasons to be Cheerful

Our next Monty Python sketch is “The dirty fork” https://www.youtube.com/watch?v=M91lzp1u7ww –

Many thanks for reading this newsletter, and many thanks to everyone who has contributed to it this week. As usual, if you have anything you’d like to share, please email me and I’ll do my best to include it in the next newsletter.

I hope you have a good day today, and a lovely weekend with your family and friends. Take care, stay safe and I hope to be able to write to you next week.

Kind regards,

Janet

Janet Greenwood

TT Environmental Ltd

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​www.ttenvironmental.co.uk​

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