How did it happen?
This week Harris Organic started production of its own certified organic hand sanitiser for the need of Harris Organic customers.
After many enquiries, Harris was able to obtain a recipe from the WHO and a statement from the TGA regarding the exemption on excise of food-grade alcohol for hand sanitiser to assist in the battle against COVID-19 virus.
For Harris Organic to make ethanol firstly he has to grow the grapes on the certified organic land (the only block in Perth), harvest and make wine in a particular style for distillation before the refinement process. The spirit is distilled three times to reach its ultimate purity before it is made into certified organic Hand Sanitiser.
What You Need To Know:
– Organic Hand Sanitiser makes no claims it kills 99.9% of germs
– It contains 80% organic ethyl alcohol (ethanol) which is the approved amount for the TGA recipe
– It only contains organic ethanol, glycerine, hydrogen peroxide, water & no other additives.
– It’s not as effective as soap and water.
– It’s more effective than lower alcohol hand sanitisers
– It comes in a 750 mL bottle
– It can be sprayed or pumped and has a beautiful natural brandy fragrance
– This product is certified organic, vegan and cruelty-free
– It dries super quickly so you can get back to what you were doing
– It’s suitable to use on all skin types, even on children’s skin
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 the 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.
The products will continue to be regulated as consumer goods under Australian Consumer Law. Manufacture of this product is not considered compounding.