Disinfectant products are regulated under the Biocidal Product Regulation and a number of approval schemes.
The EN methods below are designed to evaluate the bactericidal, fungicidal, yeasticidal, virucidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply.
The test organism is exposed to a sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralised and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.
Type of organism tested, test temperature and contact time may be varied but still utilising the EN protocols.
Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, domestic, and institutional areas. This will test the product when diluted in hard water, against clean and dirty conditions at 20°C for a 5-minute contact time.
The product should demonstrate at least a 5-log reduction (99.999% kill) in viable counts. Other temperatures and contact times can be used once the product has been shown to meet the requirements. The micro-organisms used are Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and Enterococcus hirae. Other micro-organisms can be added (such as Listeria monocytogenes and Salmonella Typhimurium).
A European Standard test method simulating practical conditions for establishing whether a product for hygienic handwash reduces the release of transient microbial flora on hands when used to wash the artificially contaminated hands of volunteers.
A European Standard test method that evaluates the efficacy of a hygienic handrub by measuring the number of viable bacteria remaining on the fingertips after contamination and handrub exposure. A handrub is defined as a treatment that involves rubbing the hands without the addition of water. This method specifically simulates conditions for establishing if a hygienic handrub decreases the release of transient flora from the hands.
Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, domestic, and institutional areas. This will test the product when diluted in hard water, against clean and dirty conditions at 20°C for a 15-minute contact time.
The product should demonstrate at least a 4-log reduction (99.99% kill) in viable counts. Other temperatures and contact times can be used once the product has been shown to meet the requirements. The strains used are Candida albicans and Aspergillus niger.
In EN13697, the test organisms are dried onto a surface, and then covered with the test disinfectant.
The method is applicable to bacteria where the test organisms are Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli and Enterococcus hirae. A log 4 reduction in population is required in 5 minutes.
EN13697 can also be used for yeast and fungi, where the test organisms are Candida albicans and Aspergillus niger. A log 3 reduction in population is required in 15 minutes.
Test temperatures for EN13697 are usually 20°C in hard water under either clean or dirty conditions. As with EN1276 and EN1650, additional organisms can be added to the test.
Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas.
Quantitative suspension test for the evaluation of virucidal activity which can be used for both surface disinfectants and hand hygiene products. The product can be tested for:
This test establishes whether the product will or will not cause tainting of food if left on a food contact surface at its recommended concentration. Referred to as the ‘Triangular Test’ method it essentially involves spraying a stainless steel plate with a 2% solution of the disinfectant (twice the recommended strength) and allowing to dry overnight.
The plate is then placed in contact with a high fat material such as butter, stored at ambient temperature (16-18°C) for 24 hours and then chilled for 1 hour before testing. Assessors will then taste various samples of the butter, some of which have come into contact with the disinfectant and some not, before commenting.
Once the product has passed the test then the standard will be awarded. Note: high fat material is used as the example food stuff because these are the most likely to absorb taint components of a disinfectant, they are therefore useful models.
In the 1990s, it was recognised in the EU that a common system of disinfectant approval was needed and the result was the Biocidal Products Directive (BPD). This provided a system that would give a common approval for biocides in all EU member states. The Biocidal Products Directive was later updated to become the Biocidal Products Regulation (EU) 528/2012). It is expected that once the UK leaves the EU, BPR will be written into UK law and will still apply, although at the time of writing, there is much uncertainty as to how this will work.
An approval processes in the UK is the DEFRA (previously MAFF) approval of disinfectants for diseases of animals. Strictly this is not applicable to food production plants, but because it relates to the housing and transportation of livestock, food plants are often captured via lairage areas or the need to disinfect vehicles.
