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So the TGA have relaxed the laws on hand sanitiser, how good is that…

March 31, 2020

CAUTION, THIS POST CONTAINS SWEAR WORDS BECAUSE I’VE NOT SLEPT WELL FOR WEEKS…

I’ve been reading, writing, training, selling, answering questions and generally living and breathing hand sanitiser for what seems like months now.  Over the weekend, in a swift change of Australian law, a new category of hand sanitiser was created by the TGA, opening up the field for more manufacturers to come into the market and fill the gap that has been created by COVID19.  This change is good in one way, not in another, I’ll attempt to explain both in my own, non regs-specialist way.

F**k, F**K, F**K.

There you have it.

So, without going into the boring detail which you can read for yourself by following the link above, before this change we had either cosmetic or TGA hand sanitisers. Cosmetic were for the general market – people who wanted to sanitise their work spaces (cosmetic factories, high traffic public areas, homes etc).  Being places where people are generally well and not in imminent danger of succumbing to a microbial attack, these sanitisers were seen as low-risk and regulated as such.  While the formulations that companies made to cater for this market were not necessarily any different to TGA formulations, the burden of material control, factory regulatory framework, material specification,  batch testing and (most visibly) and pack claim scope and proof was generally lower and more general than is the case for therapeutic goods.

NOTE: IN A LOT (BUT NOT ALL) OF CASES, HOSPITAL GRADE FORMULATIONS ARE THE SAME AS REGULAR FORMULATIONS.

The reason for the extra bureaucracy and control over TGA products is that the people using them are generally expected to be weakened/ prone to infection/ already infected or the like, so a tighter ship has to be run, variability between batches and manufacturers has to be reduced.  That’s it.

Because the cosmetic classification of hand and work space sanitisers are for use by healthy populations it makes no sense to make specific anti-viral or anti-bacterial claims for these products.  It is enough to say that a product is broadly anti-microbial or anti-bacterial.  The term ‘anti-viral’ or to single out a particular microorganism and make claims about controlling that is over-the-top for this market and in breach of TGA laws so we can’t do it EVEN IF OUR FORMULATIONS ARE THE SAME AS TGA FORMULATIONS.  You get the picture…

So now, a third category of sanitiser has been made available, a twilight zone category.  This is where the TGA have agreed to allow non-TGA manufacturers to start making a TGA approved formula (it’s actually just the World Health Organisations very basic recommendation, not really an optimised formula but hey, ho, desperate times and all that…)  without having to go through all of the red tape.  But if you are a manufacturer wanting to heed the call and get on with doing this, be aware that you still have to comply with the material specification part of the rigmarole rather than just buying any old crap to put in.  This is, except for alcohol where they have opened up the criteria to allow manufacturers to access drinkable alcohol, the type that breweries are making, to make the sanitiser, that is if the breweries will release any as they too are making sanitiser now it seems (aaaahhhhhhh).

This third category is explained here:

Specific formulations excluded from TGA regulation for the duration of the COVID-19 pandemic

On 28 March 2020, specified hand sanitiser formulations were excluded from TGA regulation, as long as they only contain particular ingredients in particular quantities in the final formulation, and comply with certain manufacturing practices, and advertisement and labelling conditions. Provided that the exact formulation and other requirements are followed, this formulation is permitted for use in both healthcare facilities and consumer use.

This exclusion will facilitate the urgent and continued supply of large volumes of hand sanitisers in Australia.

The formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration. The final formulation of the hand sanitiser must contain only the following ingredients:

  • EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
  • sterile distilled water or boiled cold water;
  • glycerol 1.45% v/v (pharmacopoeial grade);
  • hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
  • does not contain any other active or inactive ingredients, including colours, fragrances or emollients.

There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping. The legislation enabling production of these sanitisers is the Therapeutic Goods (Excluded Goods – Hand Sanitisers) Determination 2020.

So who will be able to take advantage of this law change?

Ok, so I say ‘take advantage’ in very lose terms, there have been issues with some sections of the cosmetic industry feeling that others are ‘cashing in’ on the desperate need for hand sanitiser and I’m sure that some little buggers are but on the whole, most reputable companies remain reputable during a crisis and just try to do the best they can.  Reputable companies will read the information set out by the government and will go all out to comply with testing requirements, ingredient traceability and quality, batch control, good manufacturing practice and label compliance.   Shit-head companies and people who just think that during a time of crisis, anything goes either won’t read the document, will read it and feel it doesn’t apply to them or will read it and not understand it.  We can’t waste time worrying about that, that’s for the police to sort out.

Make no mistake about it, complying with this new category of hand sanitiser is not a piece of cake and is not something that all people who have a NICNAS permit will be able to achieve. This will really benefit those factories that are already set up to produce this type of product, have a history of doing so, an understanding of chemistry and the ‘why’s’ and ‘wherefores’ of what is being spelled out and are able to do a good job and take some pressure off the supply chain.  In that regard this law change is good.

Where is the law change a bit crap?

Whoever rushed this through didn’t appreciate the nuanced difference between the World Health Organisations presentation of a basic framework formula and industries work to turn that into an optimised applied formula.  As a consequence we are now only able to comply with the TGA’s third category by producing a sub-optimal watery spritz that contains peroxide as well as high strength alcohol and too much glycerin (the TGA clearly didn’t go on to read the WHO’s follow up report on glycerin levels and skin conditioning).

Peroxide is also known as rocket fuel – check this out for my prediction of how your friendly and clueless bucket chemists will be blowing themselves up in the following weeks thanks to hydrogen peroxide fuelled ‘experimentations’.  The last 20 seconds of this video are the best 🙂

In terms of hand sanitiser, the peroxide bit is the bleaching agent or a secondary antimicrobial active within the formula.  Peroxide is very unstable and can easily lead to bottles distorting and blowing off the shelf.  I would not be surprised if people trying to follow this formula don’t blow themselves or at least their bottles off the shelf – this is a big reason why most commercial formulations omit the peroxide part.

It also pays to note that this third category of sanitiser is not thick, has no aroma and is a bit stronger in terms of ethanol than your day-to-day formula which tends to sit at around the 70% Volume/Volume alcohol rather than the 80% mandated here.

So what’s the net result of this change?

Ummmm, I’m not sure as to how many legitimate manufacturers will take up the invitation of making this third category of product but I do think the general relaxation of laws around alcohol (which I was lobbying for) is a good thing as it may just keep some professional sanitiser manufacturers in business due to freeing up the alcohol supply chain somewhat.   I am worried that the way this law has been written could increase the risk of manufacturing accidents and incidents and also could put high strength potable (drinkable) alcohol in the hands of vulnerable people, either in the form of very simple (and therefore drinkable) sanitiser solutions containing deathly levels of alcohol or by way of further encouraging those without adequate training to ‘give it a go’.   On the increased risk of ingestion, one reason manufacturers ‘optimise’ their formulations by adding fragrance and additives is to reduce the potability of the product – most fragrances taste like shite and most accidental ingestions are limited by this factor.  Take away the fragrance component and you have one less barrier to poisoning in my opinion.

These are strange times indeed.  I really hope that this works out for everyone.

Stay safe, don’t play with peroxide and please, just put a fragrance in your sanitiser, preferably one that tastes bad.

 

5 Comments leave one →
  1. Ded permalink
    April 1, 2020 12:50 am

    Hydrogen peroxide at 3% is sold in supermarkets and pharmacies and I doubt is also rocket fuel….

    • RealizeBeautyEd permalink*
      April 1, 2020 1:06 am

      I know it is but how many people who’ll try their hand at making this will recognise the difference between stabilised and non stabilised peroxide and handle whatever they get their hands on safely? Don’t forget that I’m taking to people doing this everyday and they are mostly not chemists.

      • Mike permalink
        April 2, 2020 1:34 am

        The use of denatured ethanol (has a small % of methanol) would negate this problem of the sanitiser being drinkable?

      • RealizeBeautyEd permalink*
        April 2, 2020 1:44 am

        It would make it less palatable yes but under these changes there’s no obligation to consider doing that and some of the new outlets for hands sanitiser wouldn’t even be thinking this way. I’m hoping it’s just me over thinking as usual. However, looking at what has happened in Iran shows that desperate people will do desperate things, granted that’s a very different place to here though.

  2. Mike permalink
    April 2, 2020 8:50 am

    The issue I suppose is if the small amount of methanol in denatured alcohol will cause skin problems? Isn’t denatured alcohol usually cheaper and easier to source? By default, this may “guide” the idiots in this world.

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