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Behind the testing

Behind the testing

What does EN mean?

EN or European Norm are technical standards drafted and maintained by the European Committee for Standardization and other EU bodies. Set up for the harmonisation of standards across the EU single market, they have been adopted by all European nations to ensure that consumers can compare and have trust in products claiming a certain level of performance. You often see BS EN and not just EN - this just means that the British Standard (BS) has been aligned to the EN. And thus the two are identical. The EN system is well trusted and up to date. For hand sanitisers, they have essentially become the world standard.

TIP: When looking for a reliable hand sanitiser, check to see if they have been tested to EN standards. And by all means, ask for the certificates.

Relevant hand sanitiser EN tests?

There are a handful of EN tests which are applicable to surface disinfectant cleaning products and hand sanitisers. Let's peel back the layers and understand them.

EN 1276 - The first test that a hand sanitiser product must pass is the EN 1276 test which is a quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics (incl. hand sanitisers) used in food, industrial, domestic and institutional areas.

This test is in-vitro. This means the test is completed in a test tube. A sample of the hand sanitiser is placed in a test tube containing >10 million bacteria and mixed. After 5 minutes (for a surface cleanser) or 1 minute (for a hand sanitiser) a sample is taken to determine the number of bacteria killed by the hand sanitiser. Under these conditions, a 5-log reduction is required to pass. You may additionally test for shorter 'contact times'.

It is possible to do these tests economically using a single dilution. However to allow the product to be registered as a biocidal or medical product (BPR submission), then three dilutions must be made.

At the time of writing (May 2020) there is a derogation in place across the world meaning that even non-registered products tested on a single dilution can be sold with sanitising claims. This accounts for many products arriving from the Far East and even UK made products. The rationale is sensible at this time. To allow more products to come onto the market to satisfy the unprecedented demand, and for the greater good. But when this derogation ends, only those three-dilution BPR submitted products can continue to be sold. fluidnotgel has been tested to three dilutions to ensure the compliance with best practice.

EN 13727 - This test is the advanced version of the EN 1276. Also a quantitative suspension test for the evaluation of bactericidal activity of hand sanitisers, but for those used in medical areas. If a product passes EN 13727, testing to the lower EN 1276 standard is not required.

This test is in-vitro. This means the test is completed in a test tube. A sample of the hand sanitiser is placed in a test tube containing >10 million bacteria and mixed. After 5 minutes (for a surface cleanser) or 1 minute (for a hand sanitiser) a sample is taken to determine the number of bacteria killed by the hand sanitiser. Under these conditions, a 5-log reduction is required to pass. You may additionally test for shorter 'contact times'.

It is possible to do these tests economically using a single dilution. However to allow the product to be registered as a biocidal or medical product (BPR submission), then three dilutions must be made.

At the time of writing (May 2020) there is a derogation in place across the world meaning that even non-registered products tested on a single dilution can be sold with sanitising claims. This accounts for many products arriving from the Far East and even UK made products. The rationale is sensible at this time. To allow more products to come onto the market to satisfy the unprecedented demand, and for the greater good. But when this derogation ends, only those three-dilution BPR submitted products can continue to be sold. fluidnotgel has been tested to three dilutions to ensure the compliance with best practice.

EN 1500 - The above in-vitro tests are important (and mandatory) but they are the first step in a two step process. Once a product passes either EN 1276 or EN 13727 it can move onto the second step, EN 1500, which is in-vivo ie. testing on people. If the product is to legally and properly make claims as a hand sanitiser, it must pass EN 1500 which is stringent and not easy to pass.

The hands of approximately 20 human volunteers are artificially contaminated with E.coli and the hands are then treated with either a reference product (60% propan-2-ol) or the test product. The log reduction is calculated by comparing the counts on the hand before and after application of the products. The test product must be at least as effective as the reference product to meet the requirements. And it provides statistical requirements that must be fulfilled by the test products. Furthermore, EN 1500 only allows the testing of hand sanitisers with durations between 30 seconds and 60 seconds. Notably, application times shorter than 30 seconds are not authorised.

EN 12791 - This test is very similar to EN 1500 (medical grade) but has an even more stringent requirement for pre-surgical hand disinfection (surgical grade) and often requires a large dosage, repeat application and a 90 second contact time.

We have not tested fluidnotgel against the EN 12791 standard as this is beyond the scope of the usage of this product. At this time, the main concern people have is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) also known as Coronavirus (COVID-19) and EN 12791 is an anti-bacterial test.

EN 14476 - This is the standard for testing virucidal activity (kills viruses). The product must kill a broad spectrum of viruses to a four-log reduction ie. 99.99% between 30 and 120 seconds. This is a complicated area but for simplicity, you can think of viruses split into two groups. Enveloped and non-enveloped viruses. 'Coronavirus' is an enveloped virus.

The envelope means a lipid (fat) soluble 'soap bubble' encasing the virus. When the envelope is 'popped', the virus dies. It is known that products containing more than 60% w/w ethanol (alcohol) can kill enveloped viruses to this four log standard. However this 'low' level of ethanol will not meet the standard for the vast array of viruses, especially Poliovirus which is used as the 'high-water mark' in virucidal testing, as it is so hard to kill to log 4. That is why EN 14476 has different standards that can be chosen for testing against. A limited efficacy virucidal test against enveloped viruses is required to make claims that the product can kill coronavirus. fluidnotgel is about to be tested at a specialist lab in Germany to this exact standard - results very soon. In the meantime, be assured that health experts including NHS, Public Health England and the WHO have confirmed that formulations containing 80% v/v alcohol are effective against coronavirus. The vast majority of hand sanitisers on the market have not been tested to EN 14476 and are not in the process of being tested.

Log reduction - how results are measured

In any of these EN tests, the results are measured in what scientists call 'log reductions'. If a product kills 99% of bacteria, this has a "two log reduction". If it kills 99.9% of bacteria then it has a "three log reduction", and so on. Crucial in this claim are three things: a) the dosage ie. how much was applied eg. 5ml, b) the contact time ie. how long the product was applied before the test was stopped and result measured, and c) the organisms tested

In the EN 1271 test for example, it uses a standard panel of bacteria including E.coli, Enterococcus hirae, Pseudomonas aeruginosa and Staphylococcus aureus. For the most basic EN 1271 test, there must be a log reduction of five ie. 99.999% in 5 minutes to pass. However while this 5 minute contact time is suitable for surface disinfectants, it is usual to have a separate test with a 60 second time point for hand sanitisers as this represents a more likely normal use scenario (people will not wait for 5 minutes before touching their face). Plainly, with a much shorter contact time of one minute, the log reduction would be lower eg. 99.99%. At 15 seconds, the usual claim you see on packaging, a typical result is a three log reduction ie. 99.9%. So if you see a claim that states "Kills 99.999% of bacteria" what you are actually seeing is a claim that expects the user to sanitise for 5 minutes. Remember this is just an in-vitro test on bacteria, not viruses, yeast, fungi etc. Often you see "Kills all known germs..." (germs includes bacteria, viruses, fungi etc.) which is quite simply impossible to know from the EN 1276 and EN 13727 tests. Always be circumspect about any product that claims to kill all known germs without any detail on the various EN standards such a product would need to pass.

Crowd-sourcing truth.
Ask for test certificates.

Any reputable brand making a claim of effectiveness (especially if quoting an EN number) must have completed independent testing. Beware of anti-microbial claims where the manufacturer cannot provide robust data. If you do get a certificate sent to you, check the data on the certificate and compare to the directions on the product including the contact time and the dosage. It is vital that all sanitisers making claims are being truthful as people thinking they are protected when they are not is harmful to all of society.

Our certificates are available on request.

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