BS EN 1499:2013

The EN 1499 is the phase 2 step 2 test for hand wash product in all markets.  The only exception would be if it a pre surgery hand wash in which case the EN 12791 would be required.  The EN 1499 is required for hand soaps when their primary purpose is to disinfect.  Anything that has a primary use of disinfection automatically becomes a biocide and therefore falls under the ECHA and BPR guidelines.  If you wanted to keep a soap as a cosmetic, then the antibacterial properties must be the secondary use.  This would mean you would have to sell the soap with a different primary use.  For example, you could sell a soap as a moisturizing hand soap with antibacterial properties and keep it classed as a cosmetic.  If you are looking to sell into healthcare, then you would need a primary antibacterial claim.

The EN 1499 is an in-vivo test meaning it is carried out on volunteers’ hands rather than in a suspension or on a hard surface.  Due to the fact it is tested on volunteers hand its different to other tests in as much as a log reduction isn’t the decider as to whether the product has passed or failed.  To achieve a pass the product must be significantly better than the reference soap.  The reference soap is a product called soft soap which doesn’t contain antibacterial properties.  To carry out the EN 1499 test we assemble a group of 12-15 volunteer.  We then clean the hands to remove proteins and bacteria, so all hands start off pretty much the same.  Once the hands are clean we immerse them in a solution of E.coli which is grown in a enrichment broth. Once the hands have been fully immersed, we then take them out and let them dry.  Once the hands are dry, we added the test product on and the volunteers use the product for the contact time while focusing on the finger tips as this is what is tested.  After the contact time is up the volunteer put their fingers in a neutralizer.  We then take the neutraliser and test to see how any organism are left after using the hand soap.  We do the same process for the reference product.

Unlike most other standards the test organism on the EN 1499 cannot be changed.  As it is being put on volunteers’ hands, we have to ensure that it is safe even though we disinfect the hands after the testing is completed.  Due to this we do not use other organisms as they could be potentially dangerous.

For BPR submission only one concentration is required to be tested and this would be the end usage concentration.  If you are selling the product at different dilutions, you would need to have each one tested.

The table shows what the standard states as the test parameters but often the NHS will insist on different conditions.  This is especially true when selling hand soaps into the NHS as they usually will only accept 30 second contact times.