Hand Sanitiser & Disinfectant Testing.
Alcohol-based hand rubs, often referred to as hand sanitisers, are a means of rapidly and effectively deactivating a wide variety of potentially harmful microorganisms on hands, skin and surfaces.
Product and regulatory scenario
Chemical disinfection refers to the reduction of the number of microorganisms in or on a matrix, this is achieved by irreversible action to structure or metabolism of a product, to a level judged to be appropriate for a defined purpose.
For disinfection claims relating to microorganisms we refer to: vegetative bacteria, yeasts, mould spores, bacterial spores and viruses.
Disinfectants do not necessarily kill all organisms (sterilisation) but reduce them to a harmless level for human and/or animal health.
Hand sanitisers, gels and rubs can be categorised as cosmetics or biocide products, depending on the product’s primary function, claims, ingredients and intended use.
Cosmetics products are designed to primarily clean and / or moisturise the skin. When categorised as cosmetics, the product would be referred to as a hand rub or hand gel, and would fall within the cosmetics regulations with efficacy testing required to support claims.
Regulatory overview
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Field
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Europe
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US
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Disinfectants / Hands sanitisers (not wounded skin)
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Biocidal Products Regulation (BPR) Regulation (EU) 528/2012 PT1
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FDA Over-the-Counter Monographs for Consumer and Healthcare Personnel Handwashes and Handrubs
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Cosmetics
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Cosmetic Products Regulation (EC) No 1223/2009
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Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FPLA)
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Test methods and requirements for hand hygiene products
Basic quality control
- Chemical product appearance – Visual examination
- Weight or Volume – Gravimetry
- Density at 20 °C – PE 2.2.5
- pH – Potentiometry
- Ethanol – GC/FID Default variation; Digital photography – Default variation
- Glycerol
- Isopropanol
- “Brookfield viscosity” test
- “H2O2” dosage
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- Alcohol concentration of raw materials and final product
- Additives – Should be as non-toxic as possible (considering accidental ingestion)
- Perfumes or dyes – Not recommended, in order to avoid risk of allergic reactions
- Labelling – In accordance with national and international regulations
- Flammability
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In Vitro testing
These tests can assess the impact of raw materials used as well as finished product, using cells and reconstructed tissues. Irritation, skin-sensitisation and/or endocrine disrupting effects can be evaluated using these non-animal testing models.
Test methods
Dependent on a product’s classification and claims, some specific test methods should applied, the following tests are required for disinfectants:
- Germ kill efficacy test
- Hand rub and hand wash studies
- Minimum Inhibitory Concentration (MIC)
- Virucidal activity versus standard and specific human viruses including Betacoronavirus models
Efficacy testing standards
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Field
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Europe
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US
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Bactericidal activity (Antimicrobial)
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EN 1276, EN 14348, EN 13727, EN 1500, EN 1040, EN 1499
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ASTM E2752, ASTM E2755, ASTM E1174, ASTM E1115, ASTM E2315
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Fungicidal / yeasticidal activity
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EN 1650, EN 13624
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ASTM E2613
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Virucidal activity
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EN 14476
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ASTM E1052
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Toxicology and Regulatory
Eurofins offers you personalized support for your products compliance procedures.
Our toxicologists and regulatory experts can assist you from the choice of ingredients according to legislation, validation of labeling, claims, product registration in destination countries, audit of the dossier, signature of the safety report and monitoring entire compliance lifecycle of the product.
Eurofins can support its clients, through testing and consultancy services, to claim the product’s efficacy against coronavirus, based on the client’s benchmark and the regulations of the targeted country
For more information about Hand Sanitiser and Disinfectant Testing, please contact a member of our team on:
[email protected]
+44 (0)1604 679999
Alternatively complete the contact form below: