Coronavirus chemicals update, 1st July 2020

Dear Friend,

It’s now Day 100 of Lockdown here in the UK, and I hope this finds you and your family well, and that your roof isn’t leaking! (goodness knows when our builders will be back to fix ours… again…).

Methanol and hand sanitisers update

Following my email on Monday, which I have published on LinkedIn as an article for reference, a reader emailed to ask what the legal situation is if someone has classified as hand sanitiser as a Cosmetic, rather than a biocidal product. Luckily, my go-to Cosmetics expert had already emailed me with an explanation.

Alan Ritchie of WSP writes: Re the methanol, the derogations under the BPR do not allow a product to be marketed that isn’t safe regardless of CLP classifications.

I know this isn’t a cosmetics product, but we routinely do cosmetics product safety assessments, and there’s no way we’d approve a product with that amount of methanol for the kind of use patterns that would be normal for these sanitisers .

At the time of writing, the HSE have not replied to my email about the issue of methanol in alcohol based hand sanitisers.

How can you tell if a non-alcohol hand sanitiser is safe and effective?

This was discussed on our Chemicals Coffee Break call on Monday this week (we don’t just chat about crafting, baking and gardening!). Many thanks to Gina Dungworth of Thornton & Ross, and Joanna Sacks of CLEAPSS for their input. I also discussed this issue via email with Binny Todd of Whitesea and Baltic. So, if you’re ready, let’s dive into this issue.

As we’ve seen with the methanol in alcohol based hand sanitiser situation, it’s important to know is your hand sanitiser is safe to use multiple times a day for months at a time, as a lot of people are doing throughout the coronavirus crisis (although it’s recommended to wash your hands in soap and water for 20 seconds if at all possible).

However, you also need to know if it’s going to work, so that you know it’s going to kill bacteria and (especially) viruses. If your hand sanitiser doesn’t work, that’s even worse than not using it, because you’d think you’re safe when you’re not.

There are various types of non-alcohol biocides available, often using quaternary ammonium compounds such as benzalkonium chloride (for example). These biocidal actives are not sold as substances, instead they are turned into biocidal products such as “Zoflora” from Thornton & Ross (which contains benzalkonium chloride and other substances such as fragrances).

There is some advice on checking biocides on the “Chemicals in our Life” website at ECHA, which is designed for consumers: https://chemicalsinourlife.echa.europa.eu/what-s-in-a-biocide .

Biocides are heavily regulated in the EU under the Biocidal Product Regulation (BPR).

• Biocidal actives which are waiting to be assessed must be on the Article 95 list (otherwise they are not legal to use, unless there is a derogation – which in the UK is only for alcohol based biocides)
• Article 95 contains a list of biocidal actives and their legal suppliers, together with the specific Biocidal Product Types they are used for. There are 22 of these Product Types, and they are known as PT1, PT2 etc, for a full list see here: https://echa.europa.eu/regulations/biocidal-products-regulation/product-types​
• All Article 95 biocidal active go through an assessment process, for approval for use in the EU for each particular Product Type the biocidal active is used for (suppliers need to produce a dossier which is very thorough and expensive)
• Sometimes a biocidal active is approved for every Product Type it is used for; sometimes it is only approved for some Product Types; and if it is not approved at all, it must be withdrawn from the EU marketplace
• Once as an Article 95 biocidal active is approved, the BPR is updated with the details of the biocide and which Product Types it’s used for
• This triggers a 4 year deadline for formulators to apply for an Authorisation for their Biocidal Product, which can be done in several different ways, e.g. by their own country, by country and with agreement in other countries, or directly through the whole of the EU, see https://echa.europa.eu/regulations/biocidal-products-regulation/authorisation-of-biocidal-products. As you’d expect, this process involves a lot of efficacy testing of the formulation itself, and is therefore expensive.

So you might think – “it’s easy, all I need to do is find a biocidal product which holds an Authorisation, and then I’ll know that it works, and that it’s safe”. Or “I can find an SDS and check it out”.

Well, in theory, yes.

But in practice, many biocides used in hand sanitisers are going through the assessment process. And if your hand sanitiser has more than one biocide, all of them need to be approved before you have to have your formulation Authorised.

So although you can try and find an Authorised Biocidal Product for hand sanitisers (good luck), and then buy some (even more good luck during the coronavirus crisis!), this may not be possible. If you want to go down this route, you could check this list at ECHA: https://echa.europa.eu/information-on-chemicals/biocidal-products? .

However, you would also need to check the UK list at https://webcommunities.hse.gov.uk/connect.ti/pesticides/view?objectId=6020 (in case some are only Authorised in the UK).

A quick check on the UK database shows that only propan-2-ol containing biocidal products (that is an alcohol based biocide) are listed under PT1 (the hand sanitiser Product Type, which is human hygiene disinfectants), presumably because of the timescales around biocidal active approvals. There may be other types of biocidal product which hold EU authorisations, I haven’t checked on the ECHA database.

However, if you can’t find, or source, an Authorised Biocidal Product, your next step is to check whether the active(s) are on the Article 95 list, here: https://echa.europa.eu/information-on-chemicals/biocidal-active-substances . That should (in theory) tell you that the biocide is legally permitted on the EU marketplace.

In terms of whether the formulation is safe and effective, the best advice I can offer is:

• only use hand sanitiser where you can’t use soap and water
• buy from a reputable supplier
• get a copy of the SDS first
• do your research on the product and the supplying company

There are numerous companies offering hand sanitiser, e.g. through Amazon (other online suppliers are available), and many of them are jumping on the coronavirus bandwagon (you can check when a product has been placed for sale on Amazon quite easily). If you have a product which is being offered by someone since the crisis started, that is probably a red flag.

It may be sensible to source from a well-known supplier, or buy a branded product you recognise, rather than buying from someone new to the chemicals marketplace who may not understand their obligations, or even care about them.

How coronaviruses are attacked by biocides

A coronavirus is basically a ball of RNA, protected by protein and stuck together by fat (as shown brilliantly in this little video https://www.alucinoconfeisbuk.com/2020/03/coronavirus-info.html).

Ethanol and propan-2-ol works by dissolving the fat, so the virus structure collapes.

It looks like benzalkonium chloride also works by affecting the fats in the virus, although the actual mechanism doesn’t seem to be understood.

But did you know that noroviruses don’t have this fat layer? (Thanks to Stevie Dungworth for this fascinating fact). This is why they are harder to kill than other viruses.

So even though you’re using hand sanitiser, it may not protect you against norovirus if the biocide isn’t effective against it.

Update to Safety Data Sheets

You’re probably aware that the Safety Data Sheet part of REACH, that is Annex II, is not updated very often. The update we have been waiting for since Autumn 2019 has finally been published on 18th June. This will apply to new or updated SDSs from 1st January 2021, although existing SDSs can be used until 31st December 2022.

The published regulation is here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2020.203.01.0028.01.ENG&toc=OJ%3AL%3A2020%3A203%3ATOC​

Many thanks to Carlos Miguel Fazendeiro of Only Core Chem who published this link on LinkedIn. I’m planning on updating an article I wrote about this late last year, when the regulation was in draft format, and will let you know as soon as this is ready (although it may not be for a week or two).

“Ask me anything” session today on CLP and SDSs

I’m running a live “ask me anything” session on TT Environmental’s Facebook page at

https://www.facebook.com/ttenvironmental/

today at 12:30 pm (UK time). You can email your question(s), or post them via Facebook. Look forward to seeing you there!

As usual, if you have anything you’d like to share, please let me know and I’ll try to include it in the next newsletter.

Kind regards,

Janet

Janet Greenwood

TT Environmental Ltd