Sanitisers and Disinfectants

Quality & Compliance

Disinfectants and sanitisers are a means of rapidly and effectively
inactivating a wide array of potentially harmful microorganisms on hands,
skin and surfaces.

Product and regulatory a safe level according to public health

standards or requirements. This process
scenario works through cleaning and physically
Chemical disinfection: reduction of removing germs from surfaces.
the number of microorganisms in or on Sanitising is generally a gentler process
a matrix, achieved by the irreversible than disinfecting.
action of a product on their structure
or metabolism, to a level judged to be Regulatory overview
appropriate for a defined purpose. Field Europe US
For disinfection claims, as Disinfectants FDA Over-the-
microorganisms we refer to: vegetative / Hands Biocidal Products Counter Monographs
sanitisers Regulation (BPR) for Consumer and
bacteria, yeasts, mould spores, bacterial (not Regulation (EU) Healthcare Personnel
spores and viruses. wounded 528/2012) PT1*1 Handwashes and
skin) Handrubs
Disinfectants do not necessarily kill all Biocidal Products
EPA Antimicrobial
organisms (sterilisation) but reduce them Disinfectants
Regulation (BPR)
pesticides OCSPP
to a harmless level for human and/or Regulation (EU)
(Surface) performance test
528/2012) PT2-
animal health. Disinfectants are applied guidelines 810 series
3-4
to inanimate objects and materials such Biocidal Products
as instruments, containers and surfaces. Disinfectants Regulation (BPR) EPA – Drinking water
(water) Regulation (EU) regulations
They may also be used to disinfect 528/2012) PT5
hands and skin or other living tissues.
It is important to clarify that, in Europe,
disinfectants applied onto wounded skin
or to a patient’s skin before surgery are
considered medicinal products and are
those used to disinfect medical devices
are classified as medical devices.
* For products specifically intended for the cleaning,
Sanitisers are products that lower disinfection or sterilisation of medical devices the
the number of germs on a surface to applicable document is REGULATION (EU) 2017/745

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Test methods and and/or step2 CEN tests as well as ASTM
E 2315 time-kill tests.
requirements
Hand rub and hand wash studies
Basic quality control
Simulated in-use hand rub/wash
• Chemical product appearance - procedures based on EN 12791, EN
Visual examination 1500 and EN 1499, ASTM E2755 and
• Weight or Volume - Gravimetry ASTM E1174 to evaluate the products’
efficacy.
• Density at 20 °C - PE 2.2.5
Minimum Inhibitory Concentration
• pH – Potentiometry (MIC)
• Ethanol - GC/FID Default variation; Benchmark the lowest concentration
Digital photography - Default of an antimicrobial drug (Antifungal,
variation Antibiotic or Bacteriostatic) that will inhibit
• Glycerol the visible growth of a microorganism
after overnight incubation. MICs can be
• Isopropanol
determined on plates of solid growth
• Benzalkonium chloride medium or broth dilution methods after a
• “Brookfield viscosity” test pure culture is isolated.

• “H2O2” dosage Virucidal activity

• Alcohol concentration of raw The aim of the test is to evaluate the

materials and final product capability of a chemical disinfectant
formulation to reduce the number of
• Additives - Should be as non-toxic infecting viral particles on suitable human
as possible (considering accidental / animal-derived host cells.
ingestion)
• Perfumes or dyes - Not Toxicology and Regulatory
recommended, to avoid risk of Eurofins offers personalised support
allergic reactions to assurance the compliance of your
• Labelling - in accordance with products.
national and international regulations Our toxicologists and regulatory experts
• Flammability can assist you from the choice of
ingredients according to legislation,
• Virucidal activity versus standard validation of labeling, claims, product
and specific human viruses including registration in destination countries, audit
Betacoronavirus models of the dossier, signature of the safety
Test methods report and monitoring entire compliance
lifecycle of the product.
Test methods should applied based on a
product’s classification and claims. Below, Eurofins can support its clients, through
test methods specifically applicable to testing and consultancy services, to
disinfectant products are outlined. claim the product’s efficacy against
coronavirus, based on the client’s
Germ kill efficacy test benchmark and the regulations of the
Measurement of the time required for targeted country.
a certain product concentration to kill a
certain level of bacteria/ fungi. Include
(Phase 1 tests are not permitted to
support a biocidal claim) phase2/step1

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Efficacy testing standards
Please note, in order to put a biocidal product on the market, the supplier has to perform all
mandatory tests (“Basic requirements” in the table). The supplier cannot simply perform
optional tests without performing the mandatory tests.
Europe (Biocidal Products Regulation (BPR) Regulation (EU) 528/2012))
Hygienic Handrub Hygienic handwash Surgical hand
PT1 (hydroalcoolic hand (not hydroalcoolic disinfection
sanitisers) hand sanitisers)
Bacteria Basic requirements- 2,1 test EN 13727 / EN 1276 EN 13727 / EN 1276 EN 13727
Bacteria Basic requirements- 2,2 test EN 1500 EN 1499 EN 12791
Yeast Basic requirements- 2,1 test EN 13624 / EN 1650 EN 13624 /EN 1650 EN 13624
Mycobacteria/ tuberculosis Optional – 2,1 test EN 14348 EN 14348 EN 14348
Viruses Optional – 2,1 test EN 14476 EN 14476 EN 14476
Fungal spores Optional – 2,1 test EN 13624 / EN 1650 EN 13624 / EN 1650 EN 13624

Hard surfaces and other uses Hard surfaces and other uses
PT2
(use in healthcare) (use other than in healtcare)
Bacteria Basic requirements- 2,1 test EN 13727 / EN 1276 Basic requirements- 2,1 test EN 13727 / EN 1276
Bacteria Basic requirements- 2,2 test EN 13697 / EN 16615 Basic requirements- 2,2 test EN 13697 / EN 16615
Yeast Basic requirements- 2,1 test EN 13624 / EN 1650 Optional – 2,1 test EN 13624 / EN 1650
Yeast Basic requirements- 2,2 test EN 13697 / EN 16615 Optional – 2,2 test EN 13697 / EN 16615
Mycobacteria/ Optional – 2,1 test EN 14348 Optional – 2,1 test EN 14348
tuberculosis
Viruses Optional – 2,1 test EN 14476 Optional – 2,1 test EN 14476
Viruses Optional – 2,2 test EN 16777 Optional – 2,2 test EN 16777
Fungal spores Optional – 2,1 test EN 13624 / EN 1650 Optional – 2,1 test EN 13624 / EN 1650
Fungal spores Optional – 2,2 test EN 13697 Optional – 2,2 test EN 13697

Room disinfection Instrument Disinfestation

PT2 Textiles
(including use in healthcare) by immersion or filling
Basic require- EN 13727 / Basic require- Basic require- EN 13727 /
Bacteria EN 13727
ments- 2,1 test EN 1276 ments- 2,1 test ments- 2,1 test EN 1276
EN 16616 /
Basic require- EN Basic require- Basic require-
Bacteria EN 14561 ASTM E2406 /
ments- 2,2 test 17272:2020 ments- 2,2 test ments- 2,2 test ASTM E2274
Basic require- EN 13624 / Basic require- Basic require- EN 13624 /
Yeast EN 13624
ments- 2,1 test EN 1650 ments- 2,1 test ments- 2,1 test EN 1650
EN 16616 /
Basic require- EN Basic require- Basic require-
Yeast EN 14562 ASTM E2406 /
ments- 2,2 test 17272:2020 ments- 2,2 test ments- 2,2 test ASTM E2274
Mycobacteria/ Optional – 2,1 test EN 14348 Optional – 2,1 test EN 14348 Optional – 2,1 test EN 14348
tuberculosis
EN 16616 /
Mycobacteria/ Optional – semi-field EN Optional – 2,2 test EN 14563 Optional – 2,2 test ASTM E2406 /
tuberculosis trial 17272:2020 ASTM E2274
Basic require-
Viruses Optional – 2,1 test EN 14476 EN 14476 Optional – 2,1 test EN 14476
ments- 2,1 test
EN 16616 /
EN
Viruses Optional – 2,2 test Optional – 2,2 test EN 16777 Optional – 2,2 test ASTM E2406 /
17272:2020 ASTM E2274
EN 13624 / Basic require- EN 13624 /
Fungal spores Optional – 2,1 test EN 13624 Optional – 2,1 test
EN 1650 ments- 2,1 test EN 1650
EN 16616 /
EN Basic require-
Fungal spores Optional – 2,2 test EN 14562 Optional – 2,2 test ASTM E2406 /
17272:2020 ments- 2,2 test ASTM E2274

Note: EN 14476 includes additional test conditions allowing us to test product against specific
strains which present an interest in this context i.e. Human coronavirus HCOV 229E.

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US
FDA Over-the-Counter Monographs for Consumer and Healthcare Personnel Handwashes and Handrubs
Efficacy testing on handrub Efficacy testing on handwash
ASTM E2752
ASTM E1174
ASTM E2755
Bactericidal activity (Antimicrobial)
ASTM E1115
ASTM E2315
Fungicidal / yeasticidal activity ASTM E2613 ASTM E2613
Virucidal activity ASTM E1052 ASTM E1052

EPA guidelines OCSPP 810.2200

Disinfectants for Use on Environmental Surfaces
Summary of Testing for Base Disinfectant Claims
Claim Formulation / Test Methods
Limited spectrum disinfectant / hard
Water soluble powders / liquids AOAC Use-Dilution Method (ref. 1)
non-porous surfaces
AOAC Germicidal Spray Products as
Broad spectrum disinfectant/hard Spray products
Disinfectants Test (ref. 2)
non-porous surfaces
AOAC Germicidal Spray Products as
Hospital or healthcare disinfectant / Towelettes Disinfectants Test modified for towelettes or
hard non-porous surfaces ASTM E2362 (ref. 3)
Summary of Testing for Additional Disinfectant Claims
Claim Formulation/Test Methods
Water soluble powders / liquids AOAC Use-Dilution Method (ref. 1)
AOAC Germicidal Spray Products as
Additional bacteria /hard non-porous Spray products
Disinfectants Test (ref. 2)
surfaces AOAC Germicidal Spray Products as
Towelettes Disinfectants Test modified for towelettes or
ASTM E2362 (ref. 3)
AOAC Use-Dilution Test to include a
Internal toilet and urinal bowl surfaces Water-soluble powders / liquid 5% organic soil challenge added to the
(refer to section (F)(1) for guidance on bacterial inoculum
above vs. below the waterline claims) Spray products (for above waterline and dry AOAC Germicidal Spray Products as
flush only) Disinfectants Test (ref. 2)
Water soluble powders / liquids
Virucidal disinfectant/hard non-porous ASTM E1053 (ref. 5) modified for the
Spray products
surfaces formulation type
Towelettes
AOAC Use-Dilution Method modified for
Water soluble powders / liquids fungi or AOAC Fungicidal Activity of Disin-
fectants (ref. 4)
Fungicidal disinfectant/hard non-po- AOAC Germicidal Spray Products as
Spray products
rous surfaces Disinfectants Test modified for fungi
AOAC Germicidal Spray Products as
Towelettes Disinfectants Test modified for towelettes or
ASTM E2362 (ref. 3)
AOAC Tuberculocidal Activity of Disinfec-
Water soluble powders / liquids tants (ref. 8), Quantitative Tuberculocidal
Activity Test (ref. 9)
Tuberculocidal disinfectant/hard AOAC Germicidal Spray Products Test
Spray products
non-porous surfaces modified for tuberculocidal activity
AOAC Germicidal Spray Products as
Towelettes Disinfectants Test modified for towelettes or
ASTM E2362

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 EPA guidelines OCSPP 810.2300
Sanitizers for Use on Hard Surfaces
Tests for basic claims
Level of efficacy Test methods
Non-food Contact Sanitizer Water soluble powders / liquids Spray ASTM E-1153
products 99.9% reduction within 5 minutes

Towelettes Reserved
99.9% reduction within 5 minutes

Sanitizers for Urinal and Toilet Bowl Water Water soluble powders/liquids/tablets Simulated-use study
and In-tank Sanitizers Simulated-use study 99.9% reduction over parallel control
counts
Residual Selfsanitizing – wet surfaces Simulated-use study
99.9% reduction over parallel control
counts
update after the date of issue. Please check with our product experts or with the respective local Authorities for eventual updates, prior to using these contents for your testing plan.
Due to the ever-changing international regulatory scenario, the information displayed on this flyer may be subject to changes, should any of the referred Authorities publish an

EPA guidelines OCSPP 810.2400

Disinfectants and Sanitizers for Use on Fabrics and Textiles
Efficacy Data Recommendations
Type of product Test procedures
Disinfecting pre-soak treatments / AOAC International Use-Dilution Methods1 (Ref. 1), modified to include 5% organic soil
Hospital or healthcare disinfectants

Sanitizing pre-soak treatments Inanimate Non-Food Contact Surfaces (ASTM E1153) modified to include 5% organic
soil, (Ref.2)

Laundry Sanitizers and Disinfectants Basic bacteriological procedure (Simulated-use study):

Sanitizing laundry additives • ASTM E 2274 (Ref. 3) or
Disinfecting laundry • Use in High Efficiency Washing Operations (ASTM E 2406) (Ref. 4)
Laundry additives (Residual) Test Method:
Self-sanitizing additives • 100-2004 Quantitative Procedure: Assessment of Antibacterial Finishes on Textile
Materials (Ref. 5) or
• Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under
Dynamic Contact Conditions (ASTM E2149-01) (Ref. 6)
Impregnated self-sanitizing fabrics and Carpet sanitizers There is no standard test method. contact
textiles the Agency (EPA).

Mattress, pillows and upholstered furniture Simulated- Page 7 use studies, in which
treatments artificially contaminated articles.

Surface Sanitization of Fabrics and Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces (ASTM
Textiles E1153-03) (Ref. 2)
Ef-COVID-19-GO-Sanitisers-and-Disinfectants-EN-Issue-2020.04.16

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