It’s Semi-lockdown day 690, and it’s a frosty start to the day with us, with fog rolling in across Midgley Moor towards the house.
Apologies for another longer newsletter due to the Annex VIII to CLP news, and also the BDO/GBL issue, which I’ll start with.
If you haven’t already heard 1,4 Butanediol (CAS no 110-63-4) and gamma-Butyrolactone (CAS no 96-48-0) have been placed on the Controlled Drugs List. Traditionally, they have been on the list, but taken out of meeting the obligations via a clause which has now been repealed.
This means that, if your products are affected, you need to gain security clearance for people responsible for these materials, and perhaps increase your record-keeping and security arrangements. It is unclear whether mixtures containing these chemicals are affected, and if so, down to what percentage.
The Chemical Business Association, via Douglas Leech, have very kindly provided us with information on how to go about making an application for your business: Changes to regime 2021 v2i.pdf
If you are affected, you will have to act today, 11th February, as there is a deadline on making applications.
This issue has blindsided many people, particularly those importing mixtures containing these products, who are unsure if they are affected; and the timescale for start compliance, of 2 months, is ridiculously short compared to many regulations.
The other issue has been the almost complete lack of publicity from the regulators, in this case, the Home Office. Usually DEFRA and the HSE are very good at informing the chemical industry and downstream industries about chemical regulations, but this is not within their remit.
Coming completely fresh to this piece of legislation, It is quite tricky to work out exactly what the requirements are, and whether you might be affected, as there are 3 pieces of legislation to check:
- The Misuse of Drugs (Amendment) (England, Wales and Scotland) Regulations 2021 : https://www.legislation.gov.uk/en/uksi/2021/1427/made (brings BDO and GBL into scope)
- The Misuse of Drugs Regulations 2001 https://www.legislation.gov.uk/en/uksi/2001/3998/contents (some info on what to do to comply)
- The Misuse of Drugs Act 1971 https://www.legislation.gov.uk/ukpga/1971/38/contents (other info on compliance and applicability)
There is also guidance here: https://www.gov.uk/guidance/controlled-drugs-domestic-licences
If you are affected by this, please read the information from CBA and at least start the application process as soon as you can.
If any of our readers is a specialist in this area and can provide support, please let me know, as we are getting requests for help and don’t know where to refer people to.
Annex VIII to CLP being legally binding in UK law – more information
As regular readers will be aware, we raised this issue publicly just over a week ago, as soon as it came to light via NPIS asking a client to comply retrospectively with Annex VIII to CLP, as it was still effective in UK law.
NPIS originally provided some information on how to do this (email an .i6z file to themselves; if you’ve already done that for Northern Ireland, you are considered to have notified; you should use a UFI, although NPIS were unclear on how it should be generated).
However, a couple of days into this crisis, they stopped providing information, and their website now says “As of 3rd February 2022 this section is under review. Please check back later for updated guidance“. The guidance on PCN on the .gov.uk website and the HSE website has not been altered, and only refers to the previous situation where PCN in the UK was voluntary.
So we have inconsistent advice from the regulators.
We have now carried out more research into this area, and it is clear from looking at the legislation trail that:
- all of CLP was brought into effect via the European Union Withdrawal Act, 2018
- this includes Annex VIII, which was brought in separately as an addition to CLP via two amendments, both of which had an applicability date of 1st January 2020. (There is also a third amendment which consolidates both of these, but doesn’t have an applicability date itself)
- if we had left on the original Brexit date, before 1st January 2020, then Annex VIII would not have applied
- however, we left during a period from 31st January 2020 to 31st December 2020, so taking 31st January 2020 as “Brexit day” (which is what happens on the legislation.gov.uk website), Annex VIII did become applicable to the UK
- as far as we can ascertain, (but we’re not lawyers, never mind constitutional lawyers), Article 45 and Annex VIII have not been repealed in any of the CLP amendments – this may be down to oversight, or perhaps error, as Article 45 of REACH has been repealed
So the whole situation is a bit of a mess, and it is likely to take a lot of sorting out. CLP has a lot of links to other regulations, and I can’t see that there will be any quick action.
If you are interested in the details of the regulations, CHCS will be sending out a list of them later on today, and if you’re not already on their discussion forum list, you can sign up here: https://chcs.org.uk/chemical-hazards-forum
Peter Robins has pointed out that the main difficulty is that, if Annex VIII is valid in law, this includes deadlines on compliance for consumer and professional mixtures of 1st January 2021, and that it would be very sensible to extend these deadlines via a one-line Statutory Instrument, to buy industry and the regulators time to sort things out.
I think that this is an excellent suggestion, not least because the legal situation is so complicated that when (or if) Annex VIII is removed, it has to be done correctly, without causing further problems. It would also mean that industry is not out of compliance with UK law, as some companies have inadvertently found themselves.
It would be good to have some guidance on the situation, so that we all know where we stand. This law change does not just affect UK industry, but also EU companies selling into the UK.
One concern is whether this might affect the ongoing Brexit negotiations, or be affected by the terms of Brexit itself, but I would hope that this is not an issue – the EU industry were told exactly the same as UK industry, that is “Annex VIII is not being brought into UK law”.
What we can do about this in practical terms: get prepared
- analyse your products and PCN submissions
- what PCN-liable mixtures do you sell into mainland GB?
- have you notified some or all for N Ireland? (Northern Ireland notification via sending in an IUCLID6, .i6z file will be deemed to be notified for GB too, as far as we are aware)
- if you’ve notified to the EU, can you get a copy of the .i6z files in case you also need to notify to GB? this facility is available from IUCLIDcloud, as well as desktop versions of IUCLID
- what mixtures might you need to notify if the legal obligation is confirmed?
- focus on the potentially mandatory submissions – mixtures with physical and health hazard classifications (not products which are substances, not EUH-only products, or environmental hazard classified products, or non-classified products)
- remember that, if it has to be complied with, this will include professional and industrial products as well as consumer products (consumer and professional deadline 1st Jan 2020; industrial deadline 1st Jan 2024, although you may have to notify industrial products used in consumer or professional products)
- work out the costs if your labels have to change to include a UFI, or the costs of adding an extra label with the UFI
And then wait for an official announcement on what steps to take.
Obviously we’ll do our best to keep you up to date with this, but given the complexity of the laws involved, it may take some time to resolve.
Keeping an Eye on ECHA (and the EU)
Last week, I mentioned the ECHA consultation on Authorising 8 substances, which includes lead, seehttps://echa.europa.eu/-/do-you-have-information-on-uses-of-eight-substances-proposed-for-authorisation-
There is considerable concern about the proposed lead authorisation within industry, as per the discussions under the International Lead Association announcement, https://www.linkedin.com/feed/update/urn:li:activity:6894943215506841600/ .
If you hold any data on where lead is being used and is essential, please provide it formally to ECHA, and it may be an idea to contact Lisa Allen https://www.linkedin.com/in/lisa-allen-5b40322/ at the ILA https://ila-lead.org/ as well, so they can make a comprehensive submission to ECHA separately. I suspect that lead is used much more widely than the regulators realise, and is much more important than any of us understand.
Jobs update (UK stats from LinkedIn)
Regulatory affairs jobs: 2,932 ; Health and Safety jobs 71,075. The jobs market is healthy at the moment.
FujiFilm Sonneborn are looking for a Compliance Administrator, see Vacancy Compliance Administrator 18.01.2022.pdf Gerry McArdle writes: Although the closure date has gone we are still looking. Although we are primarily a paint/coatings industry the person whose role is vacant is going to work for the Chemical Industries Association, so clearly there are a lot of cross over skills. If you have any queries about this role, please email Gerry on email@example.com .
CPG are looking for a SHEQ assistant at Wigan: https://www.linkedin.com/feed/update/urn:li:activity:6896377005718528000/
Process Safety Corner
- two dead, over a dozen injured at a paper mill fire at Kasur, Pakistan: https://www.linkedin.com/posts/shahid-iqbal-365b4a18b_today-fire-incident-at-bulleh-shah-paper-ugcPost-6897236297925181440-mSXg
- single Layer of Protection failure, one person dead: https://www.linkedin.com/feed/update/urn:li:activity:6896724143463563265
- interesting comment on dust explosions happening at lower temperatures (ethanol plant fire, no fatalities): https://www.linkedin.com/posts/tijs-koerts-0a67636_york-fire-provides-mutual-aid-at-fairmont-activity-6895369781437157376-XvSU
162 people died in industrial accidents in India last year, see https://www.newsclick.in/162-workers-died-industrial-accidents-india-2021. At least some of this is down to shutdowns/ startups related to the coronavirus crisis.
A very interesting article on how engineers are managing their workload and themselves, and what support can be provided so they are working optimally (from the aviation industry, but also applicable to many other industries): https://humanisticsystems.com/2022/02/09/we-need-to-talk-about-engineering/.
HSE advice – high levels of CO2 indicate your ventilation systems aren’t working – https://www.linkedin.com/posts/health-and-safety-executive_high-levels-of-carbon-dioxide-in-the-air-ugcPost-6897179182376251392-mUDZ. This may be in the context of coronavirus, but it’s a great way of checking ventilation in other circumstances too.
A video and more detailed explanation of Donald Rumsfeld’s “known knowns” speech: https://www.linkedin.com/posts/globalhsemanager_safetyprofessional-ehs-healthandsaftey-ugcPost-6897047140976123904-Bux4 . Like the author, I consider there to be 4 points, the unknown knowns, things you know but have forgotten.
And a summary of hydrogen safety, from someone in favour of it being used as a fuel (other links I’ve put in have been on the “against” side: https://exprofessional.com/2022/02/07/so-just-how-dangerous-is-hydrogen-fuel/
Occupational H&S corner
Nippin Anand is running a webinar on the dangers of bureaucracy in health and safety management and what businesses can do about it. https://www.linkedin.com/posts/nippin-anand_healthandsafety-compliance-riskmanagement-activity-6896788990180356096-r14I
And the HSE have announced that you need to provide PPE for temporary workers, starting 6th April 2022: https://www.linkedin.com/posts/health-and-safety-executive_the-personal-protective-equipment-at-work-activity-6896785041322496003-jUpQ
The Weekend Read
After last week’s celery soup recipe I thought I’d better confess that we didn’t make it this year because there seems to be some kind of shortage of celery.
However it has been possible to get hold of celeriac, which is a root vegetable tasting rather like celery. I have not tried to make it into soup but I did discover a really good way of cooking it quite accidentally.
Like all root vegetables it’s possible to turn celeriac into a mash and we did that in late 2021, boiling it up then mashing it, but the results weren’t terribly impressive (at least in terms of texture). So I thought the best way to make mash is usually to bake the vegetable first.
So I cut a celeriac up into wedges, drizzled it with Sunflower oil, and it was so tasty I never even bothered making mash from it!
Baked celeriac wedges
• A head of celeriac
• Sunflower oil
Set your oven to gas mark 6. Pour some sunflower oil onto a large baking tray. While the oven is heating up, peel your celeriac and chop it into chunks about the same size as potato wedges. Immediately roll the sides of the celeriac wedges in the sunflower oil to cover the surface completely. This will help prevent the discoloration that will otherwise occur.
Place the tray of wedges in your oven and bake for 1/2 to 3/4 of an hour until fully cooked through.
The celeriac wedges are beautifully sweet with a flavour of celery, the nearest comparison I can think of is a roasted parsnip.
Eat straight away, or freeze and reheat in the microwave later on. You can, of course, make these into mash although I didn’t bother.
If you are on a low carb diet, celeriac can be a substitute for potatoes, although the sweetness means you shouldn’t you eat too many (a bit like carrots). For people on warfarin celeriac is not recommended because it has high levels of vitamin K.
In the interests of domestic economy, you should only ever bake vegetables while you are using the oven for other reasons. In this case, I had the stove (and oven) up to make another batch of spicy tomato chutney (as I’d bought too many tomatoes and peppers they were in danger of going off), and also to heat the steak pie from the farm shop which we had for our New Year’s Day dinner, which is a great Scottish tradition. The celeriac wedges went very well with the steak pie and garden peas, instead of chips (which Mike had).
Reasons to be cheerful
Continuing our happy songs theme, we have uplifting songs from the 1980s: https://www.youtube.com/watch?v=m4xp163TvVc . I’m showing my age, and I just don’t care :)!
Many thanks to everyone who has contributed to the newsletter 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.
TT Environmental Ltd
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