1 (38) Appendix 1 BPR Efficacy Working Group Document March Claims Matrices

Transcription

1 Appendix 1 BPR Efficacy Working Group Document 1 (38) Claims Matrices These claims matrices are a set of tables which support the Biocidal s Regulation, Guidance on Efficacy Assessment for Types 1-4, Disinfectants, available in Volume II Efficacy Assessment Evaluation (Parts B+C) 1. The claims matrices are intended to cover those biocidal s covered under the scope of Type 1, 2, 3 4. The claims matrix is a tool for the applicant Competent Authorities. It is intended to capture the information that is needed in the authorisation dossier, to adequately describe typical combinations of s, formats of application of the s, as well as s. It also includes the claims made the requirements for testing these claims (in terms of stards) for a to be used in this way. The reader should note that the matrices are not exhaustive in terms of use patterns, scenarios test methods. The claims matrix must be used together with the relevant sections within the efficacy guidance document so as to provide both applicants Competent Authorities alike with clear direction as to the nature extent of the efficacy data required to support a claimed effect. The claims matrix acts as a guide to the information required when compiling an efficacy dataset for a PT1, PT2, PT3 or PT4 biocidal. NOTES to the reader: Each row (entry) within the matrices is not independent can be linked to other entries. These matrices only address biocidal claims made for these s. The claims matrix will be updated regularly according to the state-of-the-art.

2 2 (38) PROCEDURE for updating this document This document can be updated or revised by submitting a request for review to the BPC Efficacy Working Group to the following address: BPC-WGs@echa.europa.eu. The request should include the following: Describe explain the text to be revised giving reasons justification for the proposed changes; Submit proposed revised text; Identify table number/name section with page numbers of text to be reviewed revised. Tables Table 1: PT 01 Claims matrix: H Skin... 3 Table 2: PT 02 Claims matrix: Hard Surfaces... 6 Table 3: PT 02 Claims matrix: Toilet Bowls Table 4: PT 02 Claims matrix: Laundry Soft Furnishings Table 5: PT 02 Claims matrix: Equipment by immersion Table 6: PT 02 Claims matrix: Swimming Pools Table 7: PT 03 Claims matrix: Veterinary Hygiene Table 8: PT 04 Claims matrix: Disinfection in Food Feed Industry Table 9: PT 1-5 Claims matrix: Treated Articles... 37

3 3 (38) Table 1: PT 01 Claims matrix: H Skin PT 01 spectrum of stard Description of within a specific PT Intended sector of application Where the is typically used Primary objective of the expected result by the user Obligatory range of targeted harmful organisms Method how the is applied Types of test to be used HAND 1 Hygienic hrub health care, domestic, institutional, veterinary, industry, food preparation hling (kitchen, restaurants, grocery shops, butcher etc.) skin of hs reduce risk of infection, prevent spoilage plus tuberculocidal (obligatory for the use in tuberculosis departments), myco,, limited spectrum or (medical area viruses for humans veterinary area relevant viruses if used in veterinary areas) rubbing (liquid, gel, foam, spray), wiping test (under clean conditions) + hygienic h rub test with volunteers (with artificial contamination) ; like application under medical area 2 Surgical hrub health care, veterinary skin of hs arms reduce risk of infection plus tuberculocidal, myco,, limited spectrum rubbing (liquid, gel, foam, spray) test (under clean conditions) + surgical h rub test with ; like application under medical area

4 4 (38) PT 01 spectrum of stard or (medical area viruses for humans veterinary area relevant viruses if used in veterinary areas) volunteers (without artificial contamination) 3 Hygienic hwash health care domestic, institutional, veterinary, industry, food preparation hling (kitchen, restaurants, grocery shops, butcher etc.) skin of hs reduce risk of infection, prevent spoilage plus tuberculocidal (obligatory for the use in tuberculosis departments), myco,, limited spectrum or (medical area viruses for humans veterinary area relevant viruses if used in veterinary areas) washing (liquid, gel, foam, spray) test (under dirty conditions, if used in nonmedical areas use soiling as specified for the specific purpose) + hygienic h wash test with volunteers (with artificial contamination) ; like application under medical area 4 Surgical hwash health care, veterinary skin of hs arms reduce risk of infection plus tuberculocidal, myco,, limited spectrum washing (liquid, gel, foam, spray) tests (under dirty conditions) + surgical ; like application under medical area

5 5 (38) PT 01 spectrum of stard or (medical area viruses for humans veterinary area relevant viruses if used in veterinary areas) hwash (without artificial contamination) SKIN 1 Human skin wash, the use should be specified health care human skin reduce risk of infection (by decolonisation) plus tuberculocidal, myco,, limited spectrum or washing (liquid, gel, foam, spray), wipes tests (under dirty conditions) + surgical hwash (without artificial contamination) (due to lack of official guidance); application under medical area Notes It cannot be excluded that depending on the medical claim used the way the works, s may be classified as medicinal s (or medical devices). All s can be applied under professional or non-professional use.

6 6 (38) Table 2: PT 02 Claims matrix: Hard Surfaces PT 02 Hard Surfaces stard relevant to Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user [Several purposes can be combined in one ] Obligatory range of targeted harmful organisms [ / or] As defined by BPD (Professional/ industrial, nonprofessional) Method how Types of test to the is be used applied [ / or] 1 Hard biocidal health care hospital rooms, bathroom, operation room, laboratories, dental centres, isolation rooms reduce risk of infection professional sporicidal mycobacteric idal tuberculocidal wiping, mopping, scrubbing, foaming, flooding lab tests (medical area) when not applicable OECD 187 as 2 Hard biocidal industry, (e.g. cosmetic, pharmaceuti cal), institutions, health care facilities hard s, e.g. floors, walls, work s, kitchen s (excluding food contact s), bathroom seats, toilet bowls (outside), outdoor s reduce risk of infection, prevention of contamination to prevent spoilage sporicidal professional wiping, mopping, scrubbing, foaming, flooding lab tests (institutional area, domestic area, industrial area; : medical area) when not applicable OECD 187 as 3 Hard biocidal institutions, health care facilities, hard s, e.g. kitchen s (excluding food reduce risk of infection, prevention of sporicidal professional impregnated wet wipes tests + lab (relevant area) (EN 16615

7 7 (38) PT 02 Hard Surfaces stard relevant to industry contact s), bathroom, hospital rooms, dentists, isolation rooms contamination to prevent spoilage mycobacteric idal tuberculocidal tests with action, information on storage after opening should be given, simulated in use testing test with action) 4 Hard biocidal institutions, health care facilities, industry s, e.g. bathroom s cellars, outdoor s anti-staining reduction of fungal spores with allergenic potential n.a. professional spray, wipe lab tests (relevant area) 5 Hard biocidal institutions, health care facilities, industry indoor or outdoor s anti-staining, anti-slipping algaecidal n.a. professional wiping, scrubbing lab test (if available) or field trial to be developed, field trial demonstrating difference before after treatment 6 Hard biocidal institutions s, e.g. control of kitchen s malodour (excluding food caused by contact s), microorganisms bathroom s, toilet seats, outdoor s, drains, e.g. bathroom, sink plug bacteriostatic / or fungistatic sporicidal professional wiping, mopping, scrubbing, foaming, flooding lab tests odour panel test bacteriostatic or fungistatic tests (growth inhibition but not killing; : VAH method 7; : ISO DIS

8 8 (38) PT 02 Hard Surfaces stard relevant to holes or ASTM 2180 or modified EN 1104); for microbicidal tests when not applicable OECD 187 as ; odour panel test: applicant method 7 Hard biocidal households household s, including bathroom s devices for baby care other risk groups, cellars, outdoor s reduce risk of infection sporicidal nonprofessional wiping, mopping, scrubbing, foaming, soaking (immersion) lab tests (domestic area) when not applicable OECD 187 as 8 Hard biocidal households general treatment of household s, including bathroom s, cellars, outdoor s reduce risk of bacterial infection sporicidal nonprofessional wiping, mopping, scrubbing, foaming, soaking (immersion) lab tests (domestic area) when not applicable OECD 187 as 9 Hard biocidal households household s, including bathroom s cellars reduce fungal spores with allergenic potential n.a. nonprofessional wiping, mopping, scrubbing, foaming, soaking lab tests (domestic area/ ) when not applicable OECD

9 9 (38) PT 02 Hard Surfaces stard relevant to (immersion) 187 as 10 Hard biocidal households household s, incl. bathroom s cellars anti-mildew, anti-staining, anti spoilage fungistatic nonprofessional wiping, mopping, scrubbing, foaming, soaking (immersion) lab tests (domestic area/ ) when not applicable OECD 187 as, fungistatic tests (growth inhibition but not killing; : VAH method 7; : ISO DIS or ASTM 2180 or modified EN 1104) 11 Hard biocidal households indoor /or outdoor s anti-staining, anti-slipping, anti spoilage algaecidal n.a. nonprofessional wiping, mopping, scrubbing, foaming, soaking (immersion) test (if available) or field trial to be developed, field trial demonstrating difference before after treatment 12 Hard biocidal households household s, incl. bathroom s, outdoor s, drains e.g. control of malodour caused by micro- bacterio- static / or fungistatic nonprofessional wiping, mopping, scrubbing, lab tests odour panel test bacteriostatic or fungistatic tests (growth inhibition but not

10 10 (38) PT 02 Hard Surfaces stard relevant to bathroom sink plug holes organisms foaming, soaking (immersion), impregnated wet wipes killing; : VAH method 7; : ISO DIS or ASTM 2180 or modified EN 1104); for microbicidal tests when not applicable OECD 187 as ; odour panel test: applicant method 13 Hard biocidal households household s, incl. bathroom s, outdoor s reduce risk of infection sporicidal myco tuberculocidal nonprofessional impregnated wet wipes tests + lab tests with action, information on storage after opening should be given, simulated in use testing (domestic area; : medical area) (EN test with action)

11 11 (38) PT 02 Hard Surfaces stard relevant to 14 Hard biocidal veterinary health care prevent the transmission of disease causing microorganisms sporicidal myco tuberculocidal professional immersion, spray or wipe laboratory tests with or without action. Long contact times may be applicable if equipment is treated overnight. (veterinary area) or other tests as available Rem arks Target sites: Healthcare= hospitals; Healthcare facility= nursing home, patient care, dentist, doctors when methods are used in a different area, soiling specific to the intended use area should be employed Note: In some cases EN14885 differs from the EU guidance. The EU guidance is leading for biocide authorisation.

12 12 (38) Table 3: PT 02 Claims matrix: Toilet Bowls PT 02 Toilet Bowl spectrum of stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user [Several purposes can be combined in one ] Obligatory range of targeted harmful organisms [ / or] As defined by BPD (Professional/ industrial, nonprofessional) Method how the is applied [ / or] Types of test to be used 1 Biocidal for toilets health care, healthcare facilities, institutions toilet bowls reduce risk of infection sporicidal professional wiping, mopping, scrubbing, foaming lab tests (medical area) when not applicable OECD 187 as 2 Biocidal for toilets institutions toilet bowls control of malodour caused by microorganisms, anti-staining bacteriostatic fungistatic professional wiping, mopping, scrubbing, foaming lab tests + odour test Bacteriostatic or fungistatic tests (growth inhibition but not killing; : DGHM method 7; : ISO DIS or ASTM 2180 or modified EN 1104); for microbicidal

13 13 (38) PT 02 Toilet Bowl spectrum of stard tests when not applicable OECD 187 as ; odour panel test, stain panel test: applicant method 3 Biocidal for toilets households toilet bowls reduce risk of infection nonprofessional wiping, mopping, scrubbing, foaming, flooding lab tests (domestic area, : medical area) when not applicable OECD 187 as 4 Biocidal for toilets households toilet bowls control of malodour caused by microorganisms, anti-staining fungistatic bacteriostatic nonprofessional wiping, mopping, scrubbing, foaming, flooding, impregnated wet wipes, block lab tests + odour test bacteriostatic or fungistatic tests (growth inhibition but not killing; : DGHM method 7; : ISO DIS or ASTM 2180 or modified EN 1104); for microbicidal

14 14 (38) PT 02 Toilet Bowl spectrum of stard tests when not applicable OECD 187 as ; odour panel test, stain panel test: applicant method 5 Biocidal for toilets households toilet bowls reduce risk of infection sporicidal myco tuberculocidal nonprofessional impregnated wipes, with action tests + lab tests with action, information on storage after opening should be given, simulated in use testing (domestic area; : medical area) (EN test with action) 6 Biocidal for toilets health care, healthcare facilities, institutions, households toilet bowls reduce risk of infection sporicidal myco tuberculo- non- professional to be added to the water reservoir tests + lab test; determination of concentration (relevant area); concentration of active in water: chemical test or calculation

15 15 (38) PT 02 Toilet Bowl spectrum of stard cidal of the active substance in the reservoir before, in between after flushing 7 Biocidal for toilets households toilet bowls reduce risk of infection sporicidal myco tuberculocidal nonprofessional is a block that is hanging in the toilet bowl releases active substance during each flush tests + lab test; determination of concentration of the active substance in the reservoir before, in between after flushing (domestic); concentration of active in water: chemical test or calculation Re ma rks Target sites: Healthcare= hospitals; Healthcare facility= nursing home, patient care, dentist, doctors when methods are used in a different area, soiling specific to the intended use area should be employed Note: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation.

16 16 (38) Table 4: PT 02 Claims matrix: Laundry Soft Furnishings PT 02 Laundry Soft Furnishings stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user [Several purposes can be combined in one ] Obligatory range of targeted harmful organisms [ / or] As defined by BPD (Professional/ industrial, nonprofessional) Method how the is applied [ / or] Types of test to be used LAUNDRY 1 Laundry biocidal healthcare healthcare facilities, institutions linen textiles, mops, sponges, cleaning cloths reducing risk of infection sporicidal myco tuberculocidal professional pre-wash soaking test 2 Laundry biocidal healthcare healthcare facilities, institutional linen textiles, mops, sponges, cleaning cloths reducing risk of infection sporicidal myco tuberculocidal professional machine soaking (main wash cycle) test machine test incl. machine test (EN 16616) 3 Laundry biocidal household linen textiles, mops, sponges, cleaning reducing risk of infection nonprofessional h soaking test soft test, test plus ASTM E2406 or ASTM E2274

17 17 (38) PT 02 Laundry Soft Furnishings stard cloths (modified to be performed in static conditions, e. g. without moving the spindle) 4 Laundry biocidal household linen textiles, mops, sponges, cleaning cloths reducing risk of infection, nonprofessional machine soaking, (main wash cycle or last rinse) test machine test; (soft) s test for last rinse including machine test (EN 16616) or test plus ASTM E2406 or ASTM E2274 (modified to be performed in static conditions, e. g. without moving the spindle) (last rinse) 5 Laundry biocidal household linen textiles, mops, sponges, cleaning cloths, shower curtains control of malodour caused by microorganis ms; or antimildew (antistaining) bacteriostatic or fungistatic nonprofessional h soaking, machine soaking (main wash cycle or last rinse) test machine test; (soft) s test for last rinse; bacteriostatic or fungistatic tests (growth inhibition but not killing; : VAH method 7;

18 18 (38) PT 02 Laundry Soft Furnishings stard odour test : ISO DIS or ASTM 2180 or modified EN 1104); for microbicidal tests EN 14885; odour panel test: applicant method SOFT FURNISHINGS 1 Soft furnishings fabrics biocidal s health care health care facilities institutions mattress, nonremovable soft furnishings, upholstery, carpets reducing risk of infection myco professional wiping, scrubbing, foaming, soaking (soft) test with action (if ) for test, Modification of the AOAC Germicidal Spray s Test method (961.02). (recognised test stard in accordance to U.S. EPA Pesticide Assessment Guidelines Subdivision G, Series 91-52

19 19 (38) PT 02 Laundry Soft Furnishings stard (b) (1)). 2 Soft furnishings fabrics biocidal s household mattress, soft furnishings, upholstery, carpets reducing risk of infection mycobacterici dal nonprofessional wiping, scrubbing, foaming, soaking (soft) test with action (if ) for test, test on suitable fabric 3 Soft furnishings fabrics biocidal s household mattress, soft furnishings, upholstery, carpets bacteriostatic or fungistatic control of malodour caused by microorganis ms, or antimildew (antistaining) nonprofessional wiping, scrubbing, foaming, soaking (soft) test with action (if ) for -static tests: variations of JIS L 1902 or ISO (antimicrobial fabric tests). show growth prevention but not killing); for -cidal tests: see above Re m ar ks Target sites: Healthcare= hospitals; Healthcare facility= nursing home, patient care, dentist, doctors when methods are used in a different area, soiling specific to the intended use area should be employed Note: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation.

20 20 (38) Table 5: PT 02 Claims matrix: Equipment by immersion PT 02 Equipment spectrum of stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user [Several purposes can be combined in one ] Obligatory range of targeted harmful organisms [ / or] As defined by BPD (Professional/ industrial, nonprofessional) Method how the is applied [ / or] Types of test to be used 1 Biocidal for equipment tool disinfection by immersion healthcare, healthcare facilities, institutions, nurseries, industry, household, fire brigades, mine rescue equipment, including cleaning equipment (e.g. mops, cleaning towels) reducing risk of infection,,, tuberculocidal, myco professional/ nonprofessional immersion test immersion test (longer contact time than 1 hr possible) - clean (e.g. cleaning equipment) or dirty conditions test carrier test according to, contact time may be extended 2 Biocidal for equipment tool disinfection by immersion healthcare, healthcare facilities, institutions, nurseries, industry, household cleaning equipment (e.g. mops, cleaning towels) following the cleaning procedure control of malodour caused by microorganis ms, antistaining, (including long-term bacteriostatic yeastistatic /- cidal, fungistatic/-cidal professional/ nonprofessional immersion, last rinse test immersion test (longer contact time than 1 hr is possible), - clean Bacteriostatic or fungistatic tests (growth inhibition but not killing; : VAH method 7; :

21 21 (38) PT 02 Equipment spectrum of stard wet storage) conditions odour test ISO DIS or ASTM 2180 or modified EN 1104); for microbicidal tests EN 14885; odour panel test: applicant method Re m ar ks Target sites: Healthcare= hospitals; Healthcare facility= nursing home, patient care, dentist, doctors when EN methods are used in a different area, soiling specific to the intended use area should be employed Note: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation.

22 22 (38) Table 6: PT 02 Claims matrix: Swimming Pools PT 02 Swimming Pools spectrum of stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user [Several purposes can be combined in one ] Obligatory range of targeted harmful organisms [ / or] As defined by BPD (Professional/ industrial, nonprofessional) Method how the is applied [ / or] Types of test to be used 1 Swimming pool biocidal domestic, public institutional, such as sports centres, health clubs, hotels water in swimming spa pools reduce risk of infection protozoacidal /or /or /or algaecidal /or Legionella nonprofessional, professional automatic dispensing, pouring of solution, dissolution of tablet / powder, broadcasting test, simulated-use test field trial OECD guidance document (part 1 could be replaced by equivalent tests of EN (2/1), for Legionella also EN13623 can be used 2 Swimming pool biocidal, health clubs, hotels domestic, public institutional, such as sports water in swimming pools aesthetic algaecidal n.a. nonprofessional, professional automatic dispensing, pouring of solution, dissolution of test, field trial OECD guidance document

23 23 (38) PT 02 Swimming Pools spectrum of stard centres, health clubs, hotel tablet / powder, broadcasting 3 Swimming pool biocidal domestic, public institutional, such as sports centres, health clubs, hotels visible s swimming spa pools aesthetic, reduce risk of infection, reduce risks of slipping algaecidal /or protozoacidal /or /or nonprofessional, professional automatic dispensing, pouring of solution, dissolution of tablet / powder, wiping or brushing of s tests, field trial OECD guidance document EN14885, institutional disinfection methods when not applicable OECD 187 as 4 Swimming pool biocidal domestic, public institutional, such as sports centres, health clubs, hotels pipework, filters filter media in swimming pools spa pools remove, biofilms, maintain flow, reduce risk of infection, reduce odour n.a. nonprofessional, professional pouring of solution, dissolution of tablet / powder, soaking, brushing Suspension test, test, field trial, institutional disinfection methods, biofilm test Notes: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation. When in this table it is referred to OECD guidance document, this means: OECD 170-Oct Guidance document for demonstrating efficacy of pool spa disinfectants in laboratory field testing.

24 24 (38) Table 7: PT 03 Claims matrix: Veterinary Hygiene PT 03 Veterinary Hygiene stard Description of within the specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user Obligatory range of targeted harmful organisms As defined by BPR (Professional/ industrial, nonprofessional) Method how the is applied Types of test to be used 1 Hard disinfectant animal husbry animal houses, market pens, equipment, slaughterhouses (live animal end), etc. Also including equipment used in poultry houses, pig sheep pens, stables, milking parlours in aquaculture prevent the transmission of disease causing microorganisms /or /or /or sporicidal /or myco /or tuberculocidal /or protozoacidal /or endoparasiticidal professional spraying using low pressure application, misting or fogging, foaming, immersion with or without action laboratory tests with or without action. Long contact times may be where equipment is immersed or s are left to dry at ambient temperatures (veterinary area), or other tests as available 2 animal houses, market pens, equipment, slaughterhouses (live animal end), etc. in an emergency such

25 25 (38) PT 03 Veterinary Hygiene stard as an outbreak of an exotic disease 3 Hard disinfectant livestock transportation vehicles transportation vehicles, inside out including tyres prevent the transmission of disease causing microorganisms,, /or sporicidal /or myco /or tuberculocidal /or protozoacidal /or endoparasiticidal professional spraying using low pressure application, misting or fogging, foaming, immersion with or without action laboratory tests with or without action. Short contact times may be applicable for tyre disinfection (veterinary area,) or other tests as available 4 Hard Surface Disinfectant veterinary health care veterinary clinics, veterinary testing laboratories associated equipment prevent the transmission of disease causing microorganisms /or /or sporicidal /or myco /or tuberculocidal professional immersion, spray or wipe laboratory tests with or without action. Long contact times may be applicable if equipment is treated overnight (veterinary area) or other tests as available 5 veterinary clinics, veterinary

26 26 (38) PT 03 Veterinary Hygiene stard testing laboratories associated equipment in an emergency such as an outbreak of an exotic disease 6 Hard disinfectant animal husbry boots other personal protective equipment prevent the transmission of disease causing microorganisms /or /or sporicidal /or myco /or tuberculocidal professional immersion, spraying or brushing laboratory tests with or without action. Short contact times may be applicable. (veterinary area) or other tests as available 7 Hard disinfectant companion animals animal housing (such as kennels, hutches cages) associated equipment prevent the transmission of disease causing microorganisms /or /or sporicidal /or myco /or tuberculocidal nonprofessional spray, wipe or immersion laboratory tests with or without action (veterinary area) or other tests as available 8 Teat disinfectant animal husbry pre-milking post-milking udder teat disinfection prevent the transmission of disease causing microorganisms /or prevent spoilage of milk /or bacteriophagicidal /or algaecidal professional dipping, spray, foam or wipe laboratory tests with or without (veterinary area) with teat dip requirements or other

27 27 (38) PT 03 Veterinary Hygiene stard action. Short contact times are applicable for premilking disinfection. tests as available 9 Animal Foot Hoof Disinfectant animal husbry disinfection of animals' feet prevent the transmission of disease causing microorganisms /or /or /or sporicidal /or myco /or tuberculocidal professional immersion, spray, foam porous laboratory tests without action. Short contact times may be applicable. (veterinary area) or other tests as available 10 Skin disinfectant animal husbry companion animals disinfection of animals' skin prevent the transmission of disease causing microorganisms professional or nonprofessional wiping laboratory tests with action tests as available - could include (veterinary area) with teat dip requirements or a modified version of this 11 Egg disinfectant hatcheries poultry fish eggs prevent the transmission of disease causing professional airborne fumigation, spray / laboratory (veterinary area) or

28 28 (38) PT 03 Veterinary Hygiene stard microorganisms mist or immersion tests without action other tests as available 12 Bee hive disinfectant bee hives bee hives associated equipment prevent the transmission of disease causing microorganisms sporicidal /or /or /or protozoacidal /or endoparasiticidal professional nonprofessional spray, immersion, fumigation, wiping laboratory tests without or without action (veterinary area) modified if required or other tests as available 13 Manure (solid liquid) litter disinfectant animal husbry companion animals manure litter prevent the transmission of disease causing microorganisms /or /or /or sporicidal /or myco /or tuberculocidal /or protozoa-cidal /or endoparasiticidal /or specific organisms of concern professional nonprofessional mixing laboratory tests without action or field tests tests as available or simulated in use test? Note: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation.

29 29 (38) Table 8: PT 04 Claims matrix: Disinfection in Food Feed Industry PT 04 Disinfection in Food Feed Industry stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user Obligatory range of targeted harmful organisms Method how the is applied Types of test to be used Description of within a specific PT: 1 Hard disinfection (terminal disinfection after cleaning) dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic transport, filling or packaging machines, general equipment, tables, floors, walls, ceilings prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal, biofilms wiping, foaming test at low soiling (terminal disinfection) For claims against biofilms a simulated-use test or field test has to be provided in addition to a test ; like application under food, industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector.

30 30 (38) PT 04 Disinfection in Food Feed Industry stard 2 Hard disinfection (terminal disinfection after cleaning) dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic general equipment, tables, floors, walls, ceilings prevention of spoilage reduce risk of infection of humans against moulds (fungi) (moulds) wiping, foaming test at low soiling (terminal disinfection) ; like application under food, industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector. 3 Hard disinfection (disinfection in the presence of soil) dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation transport, filling or packaging machines, general equipment, tables, floors, walls, ceilings prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal, biofilms wiping, foaming test at high soiling (use soiling which is relevant for claimed industry sector). For claims against ; like application under food, industrial, domestic institutional areas. Use soiling which is

31 31 (38) PT 04 Disinfection in Food Feed Industry stard hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic biofilms test simulated use or field test phase 2, step 1 ( testing) phase 2, step 2 ( testing) at high soil (use soiling which is relevant for claimed industry sector). For claims against biofilms a simulated-use test or field test has to be provided in addition to a phase 2, step 1 test relevant for claimed industry sector. 4 Hard disinfection by fogging, dairy, nonalcoholic beverages, alcoholic transport, filling or packaging machines, prevention of spoilage,, phagicidal (dairy),, airborne diffusion, aerosol, smoke, Suspension test simulating intended use ; like application under food,

32 32 (38) PT 04 Disinfection in Food Feed Industry stard aerosol or vapour beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic general equipment, tables, floors, walls, ceilings reduce risk of infection of humans sporicidal vapour, fogging industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector. 5 CIP (cleaning in place) disinfection (terminal disinfection after cleaning) dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, pipes, tanks, fillers, mixer, other machine which come into contact with food prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal, biofilms CIP testing at low soiling (terminal disinfection). For claims against biofilms a simulated-use test or field test has to be provided in addition to a test. ; like application under food, industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector.

33 33 (38) PT 04 Disinfection in Food Feed Industry stard butcher etc.), pharmaceutical, cosmetic 6 CIP (cleaning in place= disinfectant (disinfection in the presence of soil) dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic pipes, tanks, fillers, mixer, other machine which come into contact with food prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal, biofilms CIP test at high soiling (use soiling which is relevant for claimed industry sector). For claims against biofilms a simulated-use test or field test has to be provided in addition to a test. ; like application under food, industrial, domestic institutional areas 7 Soaking disinfection dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, dishes, cutlery, equipment, small machinery, machine items, crates, boxes, prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal, biofilms soaking (manually) test at low soiling when treated items prior to soak were cleaned at high ; like application under food, industrial, domestic institutional

34 34 (38) PT 04 Disinfection in Food Feed Industry stard vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic soiling for items to be soaked in presence of soil. For claims against biofilms a simulated-use test or field test has to be provided in addition to a test. areas. Use soiling which is relevant for claimed industry sector. 8 Disinfection in washing machines dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), dishes, cutlery, equipment, small machinery, machine items, crates, boxes prevention of spoilage reduce risk of infection of humans,, phagicidal (dairy),, sporicidal soaking (automatically) at low soiling when treated items prior to soak were cleaned at high soiling for items to be soaked in presence of soiling. In addition to test a test under simulated use ; like application under food, industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector.

35 35 (38) PT 04 Disinfection in Food Feed Industry stard pharmaceutical, cosmetic conditions or a phase 3 test is recommended. 9 Disinfection of inner s in human drinking water systems dairy, nonalcoholic beverages, alcoholic beverages (e.g. breweries), processed food (meat, deli, vegetables, fruits etc.), food preparation hling (kitchen, restaurants, grocery shops, butcher etc.), pharmaceutical, cosmetic, homes, apartment buildings, hotels etc. drinking water systems prevention of spoilage reduce risk of infection of humans Legionella,,, sporicidal, biofilms CIP, st disinfection test at low soiling (terminal disinfection after cleaning). A test under simulated use conditions or phase 3 is required for claims against Legionella in case of biofilms it is recommended ; like application under food, industrial, domestic institutional areas. Use soiling which is relevant for claimed industry sector. 10 Disinfection of inner s in veterinary veterinary industry, dairy farms, animal farms, animal animal drinking water systems, prevention reduce risk of,, sporicidal, biofilms CIP, st disinfection test at low soiling (terminal ; like application under food,

36 36 (38) PT 04 Disinfection in Food Feed Industry stard water systems houses, stables, bioindustry water systems to prepare feed; tanks, pipes infection of animals disinfection after cleaning). A test under simulated use conditions or phase 3 is recommended for claims against biofilms. industrial, domestic institutional areas Note: In some cases differs from the EU guidance. The EU guidance is leading for biocide authorisation.

37 37 (38) Table 9: PT 1-5 Claims matrix: Treated Articles TREATED ARTICLES Use area Target site (examples) Claim Use condit ions Purpose Min spectrum of stard Description of within a specific PT: Intended sector of application: Where the is typically used: Primary objective of the expected result by the user Obligatory range of targeted harmful organisms Method how the is applied Types of test to be used 1 Biocidal s with the purpose of treating or being incorporated into materials, s or articles adding disinfective properties to that material, or article health care health care facilities, institutions, industry, households different material/ articles where disinfection properties are desired kills on contact dry to prevent crosscontamination with pathogens sporicidal incorporated into material, coating on a material * see Notes Tier 1 - Proof of principle: Tier one tests should document the efficacy of the incorporated biocide against the target organism(s) under relevant conditions. Tier 2 - Simulated Use: Does the biocide show efficacy under real-life conditions for how long? Min. log 3 reduction within 5-60 min, depending on exact use. 2 Biocidal s with the purpose of treating or being incorporated into materials, health care health care facilities, institutions, industry, households different material/ articles which are used in wet conditions where prevents bacterial growth, prevents fungal growth wet to prevent contamination with pathogens bacteriostatic fungistatic incorporated into material, coating on a material * see Notes Tier 1 - Proof of principle: Tier one tests should document the efficacy of the incorporated Prevents growth, e.g. ISO

38 38 (38) TREATED ARTICLES Use area Target site (examples) Claim Use condit ions Purpose Min spectrum of stard s or articles with the purpose of preventing microbial growth prevention of bacterial growth is desired biocide against the target organism(s) under relevant conditions. Tier 2 - Simulated Use: Does the biocide show efficacy under real-life conditions for how long? Notes: Note 1 on claims: The claims demonstrated for the biocidal /example are the claims which can be made for the treated article. It is not possible to add additional claims to the article. Note 2 on claims: Other claims than the two listed are in principal possible. These have to be discussed with the competent authority a testing strategy to prove such claims has to be agreed. Depending on the claims, tier 3 testing might be needed. Note on use conditions: The conditions under which the efficacy test was demonstrated become part of the approval/authorisation. Often, efficacy has only been demonstrated for wet conditions. Then only a claim for "prevents bacterial or fungal growth" can be made. The proof of efficacy cannot be extrapolated to killing on contact. Note on : See chapter 5.3 of Vol II, Part B/C