Chemicals Coffee Time Monthly, June 2023

Dear Friend,

Welcome to the compilation from the June 2023 editions of Chemicals Coffee Time! We've got some updates on EU and UK REACH, and quite a bit on Poison Centre Notification.

Good news - UK-REACH deadline extensions confirmed

The UK-REACH registration deadline extensions have been placed into UK law, after a rather circuitous approval route where the Devolved Governments in Wales and Scotland had to agree as well as Westminster. (Briefly, UK-REACH is considered to be an environmental regulation as well as a safety regulation, and environment comes under the scope of the Devolved Governments).

This update is called The REACH (Amendment) Regulations 2023, SI 2023 No 722,? https://www.legislation.gov.uk/uksi/2023/722/contents/made

Many thanks to Nicola Kaye of REACHLaw for spotting this and circulating the news.

EU PCN deadline 1st January 2024

A quick reminder – all industrial mixtures which are:

• liable for Poison Centre Notification, that is have GHS hazards for physical and or health hazards
• which are sold into the EU or NI
• and which haven’t already been notified eg by pre-portal methods

will need to be notified by 1st January 2024, either via the Portal (EU) or by sending an IUCLID PCN file to NPIS (NI).

When you take the Christmas holidays into account, that’s effectively 6 months time! (And all PCN-liable mixtures must be notified via the Annex VIII method by 1st January 2025).

For companies within GB, remember that the PCN obligation is on the Importer in EU or NI, not on you, although you can make voluntary notification to protect your intellectual property in your mixtures. There are several approaches, see the infographic at the top of this page.

At least GB PC notification will revert to being voluntary under CLP at the end of 2023, when Annex VIII to CLP is removed from UK law, although it’s possible that notification to NPIS may be required under other regulations.

EU Poison Centres update

Slovakia is now accepting Poison Centre Notifications via the EU-portal, see??https://poisoncentres.echa.europa.eu/-/slovakia-now-accepts-poison-centre-notifications-through-echas-submission-portal??. No fees are payable.

The tracking document on which country accepts PCN via the Portal has now been updated, and it appears that only Bulgaria can’t accept Poison Centre Notifications via the Portal now:??https://poisoncentres.echa.europa.eu/documents/1789887/5674408/msd_en.pdf/982d9115-58cb-75c8-80ae-8eb16f5c0009??.

However, this doesn’t mean that the system is completely harmonised yet (if it ever will be):

• the Czech Republic requires extra information over and above the Portal data (according to the ECHA document)
• some jurisdictions require notification in a specific language, or more than 1 language of notification; others permit English as well as their own language
• there are fees for PCN or related activities (such as the use of an Emergency Telephone Number) in some jurisdictions, (currently Belgium, Hungary, Republic of Ireland and Italy), see??https://www.chem-consulting.si/post/ufi-code-and-pc-notification-price?

ECHA’s poison centre website now has links to the national support desks to help you with Poison Centre Notification, see??https://poisoncentres.echa.europa.eu/appointed-bodies?, including phone numbers and contact emails, although the latter use text (a) rather than the @ symbol, so you will have to copy and amend the email address rather than just click through to use it (presumably an anti-spam measure).

Titanium dioxide - new test results

A new study on the oral toxicity of nano-sized Titanium Dioxide particles has been published in Japan, news courtesy of Dave Schoneker of Black Diamond Regulatory Consulting, LLC , see? https://www.dhirubhai.net/posts/black-diamond-regulatory-consulting-llc_oral-toxicological-study-of-titanium-dioxide-activity-7077882086732263425-74vD .

This study shows no signs of toxicological effects from this size of Titanium Dioxide powders in rats. Will this new evidence change EFSA’s mind about their ban on TiO2 in food and animal feedstuffs?

“Top-Up” EU-REACH dossier cost notes

Mark Selby of Denehurst Chemical Safety Ltd writes:

We are noting that some consortia and Lead Registrants (LR) are asking for ‘top-up’ fees for those given EU letters of access, often with a reason being ‘recalculation of costs’. Those who are formal members of consortia of course must abide by their membership rules, but if the only contact with an industry group or LR has been to pay for the Token for a past EU Registration, it is important to question those asking for more money.

EU LR or groups representing the LR have no right to charge you more money for the old letter of access unless these conditions apply;

1. ECHA have demanded more testing or more work from all Registrants in your tonnage band and the amount you are being charged reflects your ‘fair share’ of the extra work needed. If this was the case, you would have received notice from ECHA to say more work was needed and the consortium would need to inform you of what they planned to do and to give prior notice of expected costs. If the consortia chose to do extra work that was not needed (and failed to consult with you), it is their problem.
2. The original LoA costs were estimated early in the process prior to the final Registration deadlines (eg before 2018 for < 100 t) and genuine miscalculations were made. It was not always possible to estimate costs accurately back then as some were based on ‘x’ number of Registrations, and fewer organisations actually converted from pre-Registration to full than was expected. If the LR can provide evidence that the costs prior to the date of your Registration were mis-calculated, then you ought to pay. However, they first need to provide you with evidence and justification with full cost breakdown and division factors. This scenario is unlikely as most LR over-charged to cover shortfalls. Not many refunds have been given – to be fair, some groups have.

Either way, before refusing to pay, you need to ask what the extra costs are for and ask for a breakdown on their calculations. The last time we had a conversation like this with a major consortium, they got bored and gave up.

Even if refusing to pay, the LR cannot cancel your Registration – if it is a genuine issue, they would need to contact ECHA, complain that you are not paying a fair share and provide ECHA with the evidence. ECHA could then rescind your Registration if they agreed you had not paid fair and equitable fees. In my knowledge, this has never happened.

Of course, if post-brexit you have Grandfathered into GB REACH and have no EU REACH, you can ignore any demand for top-up costs in the EU.

Many thanks to Mark for his comprehensive explanation, which potentially affects anyone holding an EU-REACH registration within the EU or indirectly via an Only Representative.

UK recognises other jurisdictions' decisions on some chemicals as valid

The UK is extending recognition of medicines from other jurisdictions, see??https://www.dhirubhai.net/posts/dave-schoneker-0938133_uk-mhra-regulatory-activity-7069330832951259136-n18K??.

Which rather begs the question, if HM Government can recognise other medical regimes, why not accept EU-REACH registration as valid in GB without the need for re-registration?

Divergence - two new EU SVHCs

More divergence! Many thanks to Phil Rowley , one of our eagle-eyed readers, who picked up this announcement from ECHA on Wednesday 14th June.

The two new SVHCs adopted in the EU only are:

• Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (CAS no 75980-60-8)
• Bis(4-chlorophenyl) sulphone (CAS no 80-07-9)

This triggers the following EU requirements:

• chemical products containing these SVHCs require an SDS at or above 0.1% w/w (if one is not required otherwise);
• article notification to ECHA under REACH if present at or above 0.1% w/w and made or imported at 1 tonne per annum of the SVHC
• article notification to the SCIP database if present at or above 0.1% w/w under the Waste Framework directive

More details here:? https://echa.europa.eu/en/-/echa-adds-two-hazardous-chemicals-to-candidate-list

These substances do not hold SVHCs status in GB at the time of writing.

Dubious chemical claims about deodorant are misleading

Regular newsletter readers will be familiar with my frustrations at misleading claims such as “chemical free” made by certain cosmetics companies, so it was refreshing to find out that the Advertising Standards Authority have stopped at least one company from making this type of claim on YouTube:

Details at??https://www.dhirubhai.net/posts/tmcallaghan_wild-cosmetics-ltd-activity-7064477649863110656-umWe??and the full decision is here:??https://www.asa.org.uk/rulings/wild-cosmetics-ltd-a22-1178272-wild-cosmetics-ltd.html?

Infographic of the month

An excellent infographic showing the potential for nanoparticles to help with drug delivery:? infographic nanoparticles for drug delivery.pdf .

The Weekend Read

A very good article from Gareth Lock, “The Human Diver”, on near misses and how we handle them (or not) in terms of being aware and learning from them:? https://www.thehumandiver.com/blog/were-you-lucky-or-were-you-good-2 ?(please note this was chosen before the Titan tragedy).

The Weekend Recipe

The British asparagus season traditionally ends on St John’s Day, June 24th, so we need to make the most of any late asparagus we can find.

Grace, our student, recommends a pasta and asparagus recipe from BBC Good Food, with a few tweaks to make the cooking even easier. The original is here:? https://www.bbcgoodfood.com/recipes/asparagus-cream-pasta , but for Grace’s version, including pecorino cheese which she thinks goes better with asparagus than parmesan, read on…

Ingredients (for 2 people)

• small tub of double cream, 142ml/ 1/4 pint
• a large bunch of British asparagus, or two small bunches
• 2 cloves of garlic, peeled but left whole
• grated pecorino or parmesan cheese, 25 g/ 1 oz
• shaved pecorino or parmesan cheese, 25 g/ 1 oz
• tagliatelle, 250g/ 1/2 lb

Method: First, place your cream in a small saucepan with the cloves of garlic, and bring to the boil, then remove the cloves and leave the cream to cool. Bend the asparagus spears to find the breaking point, then snap them off. Discard the woody base, and then cut the tips off, as the stems and tips will be cooked at different times. Make the pasta according to the instructions on the packet, and when the pasta has about 4 minutes to go, add in the stems. The asparagus stems and tips will be floating on the surface of the water, so pick these out of the hot water before you drain it off (fork, strainer, tongs – the choice is yours). Then drain the pasta well and put on one side. Take the asparagus stems and grated pecorino or parmesan, and add to the garlicky cream, then either blitz with a hand blender, or pour into a jug blender and blitz until smooth.

To serve: place the cooked pasta in a large dish, add the sauce and asparagus tips, and toss to mix. Serve in pasta bowls, topped with the shaved parmesan.

Food nerd note – Grace isn’t sure if she’s using pecorino sardo or pecorino romano, as she’s buying it just labelled “pecorino”. We suspect it’s pecorino romano. The main difference between pecorino and parmesan is that it’s a hard sheep’s milk cheese, whereas parmesan is made from cow’s milk.

My findings:

• don’t add too much cheese or you may have a less strong asparagus flavour
• using a stick blender is better than a jug blender otherwise the sauce cools down, and your husband complains when he reheats his food in the microwave
• grating the cheese helps it blend more quickly, I just added shaved cheese and it took longer (to shave, simply use your potato peeler)
• use packet pasta, with durum wheat and water, and not home made egg pasta to avoid reducing the asparagus flavour
• pecorino romano is pretty much lactose free, and if you use Arla’s lactose free cream to make the dish lactose free (and use a gluten free pasta if you are gluten free)

Reasons to be Cheerful

Our June Reasons to be Cheerful were from "it's a Southern Thing", and mainly covered food:

• 2nd June - Things you find at Grandma's house
• 9th June - No one can cook like Meemaw (grandma) and When you try to make your Granny's old recipe
• 16th June: If Law and Order: SVU was Southern
• 23rd June: When your Southern Mom calls you by your full name
• 30th June:? If Regular People were Cooking Show Judges and Types of People on a Diet

And finally, Glastonbury - for those of us of a certain age and taste in music, who could beat Rick Astley singing and drumming to AC/DCs "Highway to Hell"? https://www.youtube.com/watch?v=O7TEkRRC9eE

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 July or early August.

Kind regards,

Janet

Janet Greenwood, TT Environmental Ltd