Chemicals Coffee Time, 5th April 2024
Dear Friend,
Happy Easter! And Happy Friday!
It has been another busy week for Regulatory News. As many of you know, we try to prepare the newsletter a couple of days in advance, and this one is bursting at the seams by Wednesday afternoon. That usually means something significant is likely to drop into the mailbox on Friday morning (about 30 minutes before we hit send) but ‘Que sera sera’!
Indian inventory update
Dr Rashmi Naidu, Independent Advisor and Trainer, writes:
Just wanted to elucidate a few issues mentioned in previous emails and in the Chemicals Coffee Time Monthly post at https://www.linkedin.com/posts/janet-greenwood_lots-of-important-regulatory-updates-in-this-activity-7179854212502036480-4WgS?utm_source=share&utm_medium=member_desktop, for clarity sake.
The DCPC has been conducting physical events in various Indian cities to help the Indian chemical and petro-chemical manufacturers to start using the ChemIndia portal for the online submission. Further, this exercise is to have a central database with the DCPC for generating the index of industrial production (IIP) reports. At this point in time, ChemIndia is not related to India’s chemical (management & safety) rules.
Many thanks to Dr Rashmi for her information direct from India.
Baltimore incident news
A temporary shipping channel has been opened up to provide tugboat and small vessel access to the Port of Baltimore, see https://www.msn.com/en-us/news/other/maryland-opens-temporary-channel-at-collapsed-bridge-site-governor/ar-BB1kTO4A, with a second planned soon.
There are concerns that some of the Dali’s cargo, which includes hazardous chemicals, may have leaked into the Patapsco River, see https://www.msn.com/en-us/news/us/hazardous-material-leaking-from-dali-ship-after-baltimore-bridge-crash/ar-BB1kL1md.
Hearing from the HSE and the UK
GB Mandatory Classifications
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 H361d
- This 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.
GB Biocidal Substances
Big news from the HSE on Tuesday as they confirmed the withdrawal of 63 Biocidal substance/Product type combinations under GB BPR.
As this news was much too large for an email, they’ve added a tab to the BPR Active Substance List detailing all these ‘non-approval decisions’. This tab is called the ‘GB Supplementary Bulletin Information’ tab.
Biocidal Products with these substances/Product types cannot be supplied after 2/2/2025 in GB, and (products already on the market) cannot be used in GB after 2/8/2025.
However, as always, I am much more concerned with treated articles. Suppliers of Biocidal Products are usually quite well informed, but treated article manufacturers can struggle to understand their obligations.
A treated article (under GB BPR) is any product which contains a biocidal substance but does not itself have biocidal properties. These are most commonly products that contain preservatives to protect the product in storage.
For these substance/product types that are being withdrawn, you can no longer import or place a new treated article into the supply chain after 31st July 2024. (Although you may use up stocks of existing treated articles that are already in the supply chain.)
You can view the withdrawn active substance/product types on the additional tab of the BPR active substance list here: https://www.hse.gov.uk/biocides/uk-list-active-substances.htm
I did take some time to go through the list looking for red flags or patterns, but in truth it’s a mixed picture.
A small handful are no real loss to industry – they are also unsupported in the EU as they are replaced with alternative chemistry, lower classified options, or even just newer substance identifiers.
A greater number are items that are either going through approval or re-approval in the EU where the applicant is an EU based company with no GB entity. These will be difficult for GB companies to gain access to, as the data package may be incomplete (the assessing member state may be in the process of requesting additional studies or evaluation) – meaning the costs are not yet known.
There is one particular group of substances which draws the eye. A number of quaternary ammonium salt biocides (ADBAC, ADEBAC, DDAC etc…) are being withdrawn. In the EU, the costs for these substances are being shared (consortium style) by a task force with a single legal representative. It’s an interesting model – spreading the costs over multiple companies, multiple substance and multiple product types with the assumption that bridging is likely to be applicable.
However, any GB company trying to support a substance in this group may have to pay a high amount to access the data compiled by the EU taskforce. This may well put those substances off the GB market permanently.
We’re finally seeing the start of the withdrawal of active substances from the GB market. Something that we’ve been loudly protesting in this newsletter. I thought I’d be angry, but I’m mostly disappointed.
No one is denying that biocidal substances should be more highly regulated than regular industrial chemicals. But losing active substances from the market because we can’t afford access to the (pre-existing!) data that proves they can be safely used seems to be madness.
Export Control List
A new version of the Strategic Export Control List was issued on Wednesday 3rd April. This list combines several UK export restriction legislations into one consolidated format:
The controlled goods list is usually updated twice a year and it is the responsibility of all UK companies to check if the goods they export are subject to controls and to take action to obtain licenses where necessary.
Keeping an Eye on ECHA and the EU
New Harmonised Classification Proposals
New Intentions to harmonise classification and labelling for 4 substances in the EU:
- Sodium Fluoride (CAS# 7681-49-4)
- Resorcinol (CAS# 108-46-3)
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one (EC# 216-133-4 and EC# 244-240-6)
- 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran (CAS# 1222-05-5)
The 3 French proposals are all for Repro tox and endocrine disruption, so I think we can see what Anses are focussed on at the moment!
The RAC adopted 19 opinions on previously proposed HCLs in the week prior to Easter, so if you haven’t taken a look at the Registry of CLH Intentions in a while, now is probably a good time: https://echa.europa.eu/registry-of-clh-intentions-until-outcome
IUCLID 6 (Version 8)
The latest version of IUCLID (6.8) is due to be released on April 29th, and ECHA will be providing a webinar on May 16th to cover the major changes:
- C&L Notifications
- Product Characteristics for Biocidal Products
- Notifications and applications under the Drinking Water Directive
The webinar will be at 11am (Helsinki time), which is 9am BST on May 16th.
You can find more details here: https://echa.europa.eu/-/major-release-of-iuclid-6-with-format-changes
EU expansion
Bulgaria and Romania have just joined the Schengen area, see https://www.linkedin.com/posts/eucouncil_schengen-euschengen-freemovement-activity-7180118212976488448-wvp_; and accession negotiations have opened with Bosnia and Herzegovina, see https://www.linkedin.com/posts/eucouncil_euco-euenlargement-activity-7176900663300239360-1GHh
Explanation of trilogues
The EU commission must have noticed how many people were searching for their trilogues because they’ve posted a video on Linked In explaining the Trilogue process: https://www.linkedin.com/posts/eucouncil_trilogue-activity-7175769213691645952-plup
As we’ve previously said, it’s an extra round of closed negotiations, which results in an amended draft. The link we’ve been providing for the CLP legislative act is the outcome of the December trilogue, but please don’t act until it’s formally published (less than a month to go until the vote!)
Trilogue draft of CLP legislative act: https://data.consilium.europa.eu/doc/document/ST-16721-2023-REV-1/en/pdf
Swedish Occupational Exposure Limits
The amendment to Workplace (Occupational) Exposure Limits in Sweden [AFS 2022:5) enters into force today – 5th April 2024.
There are staggered implementation dates for the various substances listed in the amendment, but the new limit for Acrylonitrile will apply from today.
You can download the amendment, and the Swedish OEL list in full here: https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/
Cosmetics Europe
This association has some useful information, such as a list of questions on EPR (packaging): https://www.linkedin.com/posts/cosmetics-europe—the-personal-care-association_ce-key-asks-to-eu-policymakers-on-ppwr-activity-7168263735613112321-p1ff
And guidance on microplastics: https://www.linkedin.com/posts/cosmetics-europe—the-personal-care-association_ceeffci-guidance-on-the-eu-microplastics-activity-7163569758112583682-3WWd
USA Proposes New Reporting Requirements for 16 Substances
The US Environmental Protection Agency (EPA) has proposed new requirements to report any health and safety study (including currently unpublished data) held by manufacturers or importers of the following 16 substances:
- 4,4-Methylene bis(2-chloraniline) (CAS# 101-14-4)
- 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CAS# 140-66-9)
- Acetaldehyde (CAS# 75-07-0)
- Acrylonitrile (CAS# 107-13-1)
- Benzenamine (CAS# 62-53-3)
- Benzene (CAS# 71-43-2)
- Bisphenol A (CAS# 80-05-7)
- Ethylbenzene (CAS# 100-41-4)
- Naphthalene (CAS# 91-20-3)
- Vinyl Chloride (CAS# 75-01-4)
- Styrene (CAS# 100-42-5)
- Tribomomethane (Bromoform) (CAS# 75-25-2)
- Triglycidyl isocyanurate (CAS# 2451-62-9)
- Hydrogen Fluoride (CAS# 7664-39-3)
- N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (CAS# 793-24-8)
- 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CAS# 2754428-18-5)
This would include the substance present in mixtures or articles, but not where present as an impurity.
Comments are being accepted on or before May 28th. You can find all the information about the proposed rule here: https://www.regulations.gov/document/EPA-HQ-OPPT-2023-0360-0001
Israel Proposes Draft Ordinance for Cosmetics
Israel’s Ministry for Health have announced a new draft amendment to the Pharmacists Ordinance 5741-1981, which would cover cosmetic products.
Whilst only available in Hebrew, the text appears to grant equal recognition to the EU Cosmetics regulation (EC) 1223/2009 – including all future updates, and then permits the import of products from the EU, Switzerland or the UK.
The aim of the legislation is to facilitate trade and lower the cost of living for Israeli citizens.
There is no implementation date known for the draft ordinance. You can access the documents here and here.
Jobs update (UK stats from LinkedIn)
Regulatory affairs, 1,989 jobs; Health and Safety Manager, 982 jobs (but check for other H&S job titles like advisor, specialist etc, as the LinkedIn algorithms have been playing up lately).
Infographic of the week
Another productivity infographic, this time habits of very productive people: https://www.linkedin.com/posts/victoria-repa-115a1987_the-1-secret-of-high-achievers-backed-activity-7178002685357416448-bBT0 (although one of the best pieces of advice I’ve received is to find what works for you and stick to it)
The Weekend Read
An excellent report on “bullshit tasks” from Ben Hutchinson, about some work carried out by a group of Norwegian scientists. Ben’s article is here: https://www.linkedin.com/pulse/untangling-safety-management-from-reasonable-bullshit-ben-hutchinson-814hc, and he’s put a link to the study as well.
Note that this piece goes very well with the one on “auditism” from the 8th March edition, see https://chemicalscoffeetime.co.uk/archive-2/chemicals-coffee-time-8th-march-2024/ (you’ll need to be logged in to view this post).
One of the most frustrating aspects of my job is when people confuse what we do apart from regulatory affairs, that is systems and consultancy for Environmental Permit and COMAH, with bullshit tasks.
We’re on the front line of pollution prevention, and complying with these regulations actually gives important information which helps you run your processes better and more safely. This particularly applies to Environmental/ IPPC Permits, where monitoring your waste streams can give you a valuable insight into how well the process is performing overall. (Apologies for the rant, just wanted to get that off my chest – and perhaps it’s my fault in not explaining what we do well enough).
The Weekend Recipe
It simply wouldn’t be Easter without my yeast-free hot cross buns, and this year I’ve trialled a lactose free version, and ended up using self raising flour as I didn’t have enough plain flour in the house.
Ingredients
Buns
- 1 lb plain flour, or 1 lb self-raising flour
- 4 oz sugar, I used soft brown but granulated sugar is fine
- Either 1 tablespoon baking powder (plain flour) or 1 teaspoon baking powder (SR flour)
- 1 tsp ground allspice
- 1 tsp ground cinnamon
- 1 tsp freshly ground nutmeg
- Optional spices – 1/2 teaspoon mace, pinch of cloves, pinch of cardamom
- 4 oz flora margarine (or other non-dairy fat)
- 2 eggs, beaten
- 6 oz (weighed) almond milk, or 8 oz coconut greek-style yoghurt
- 3 1/4 oz dried fruit
- 2 oz Mixed peel (or use dried fruit if you haven’t any, or if you don’t like peel)
Bun wash
- water
- granulated syrup
- ground mixed spice
Method: 1. Set your oven to Gas Mark 4, and get out a large baking tray. Place all the dried ingredients except the fruit and mixed peel in a large bowl and stir to mix thoroughly (balloon whisk time!). Rub in the margarine, and when it’s a fine breadcrumb texture, tip in the almond milk and beaten eggs and stir / knead to make a sticky but manageable dough – but don’t knead it too much. Place the dried fruit across the dough (as you would with a yeasted dough) and knead so they’re reasonably evenly distributed. Cut into 12 pieces (small) or 8 pieces (large), and shape into hemispheres. Finally, press a table knife into the top to make the cross shape. Place on baking tray(s) a long way apart, and bake for around 25 minutes until done (the base is light brown).
While in the oven, make a light syrup with water, granulated sugar and some ground mixed spice. As soon as the buns come out of the oven, take them off the baking tray, place on a cooling rack, and coat with the syrup. Leave to cool, and store in a tin. (This is more of a scone than a traditional Hot Cross Bun, but you do get the flavours without all the yeast raising faff).
Tips: You don’t want the dough to be too wet, so if it is, add some more flour to get the right texture. It is sticky though, so make sure you have your flour tin out of the cupboard and opened up before you start adding the wet goods to the dried goods (voice of experience). You may need to swap the buns round in the oven so they bake evenly. The baked hot cross buns freeze well.
Findings: the almond milk I used was quite brown as it has the skins in, so the dough mixture is brown itself – slightly tricky when looking to see if they are baked, you need to look for the baked pale brown colour to appear. When you use all of the spices, the flavour is very similar to buns made with dairy (butter and greek yoghurt or buttermilk).
Reasons to be Cheerful
It’s time for some Monty Python, starting with “What have the Romans…” https://www.youtube.com/watch?v=Qc7HmhrgTuQ .
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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