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UČINKOVITOST BIOCIDNIH PROIZVODOV
Asist.Dr. Darja Duh, univ.dipl.mikrobiol.
Posvet o biocidnih proizvodih, 7. november 2013, GZS, Center za poslovno usposabljanje
Univerzitetni diplomirani mikrobiolog
Doktorica znanosti (molekularna biologija in biokemija)
Asistentka na medicinski fakulteti v Mariboru
NLZOH - klinični molekularni laboratorij
URSK - področje učinkovitosti od leta 2008
EU delovna skupina (2009-2012) - TNsG (poglavje PT2,…)
PREDPISI O BIOCIDIH - UČINKOVITOST
BPR No. 528/2012 (predhodnik: BPD 98/8/EC)
… dovolj učinkovit… (člen 25, poglavje V)
AKTIVNA SNOV – PODATKI ZA UČINKOVITOST
1. Uporaba (npr: baktericid…) in način kontrole
2. Organizmi, ki jih je treba nadzirati in zaščititi
3. Učinki na ciljne organizme
4. Verjetna koncentracija a.s. v proizvodih in tretiranih materialih
5. Način delovanja (zapoznelo delovanje)
6. Uporabnik…
7. Predlagano besedilo na etiketi…
8. Omejitve glede učinkovitosti…
9. Predvidena teža v tonah…
BIOCIDNI PRIPRAVEK– POD. ZA UČINKOVITOST
1. Vrsta pripravka in področje uporabe
2. Uporaba (npr: baktericid…) in način kontrole
3. Organizmi, ki jih je treba nadzirati in zaščititi
4. Učinki na ciljne organizme
5. Verjetna koncentracija a.s. v proizvodih
6. Način delovanja (zapoznelo delovanje)
7. Uporabnik…
8. Predlagana etiketa pripravka in oznaka za tretirane materiale
9. Predlagano besedilo na etiketi…
10. Omejitve glede učinkovitosti…
11. Povzetek in ocena
SEZNAMI TESTOV IN STANDARDOV
http://www.cen.eu/cen/pages/default.aspx
CEN on-line catalogue/international classification of standards
(plačljivi)
swedish chemicals agency (kemikalieinspektionen),
department of pesticides and biotechnical products:
efficacy testing of biocidal products - overview of available
tests, Göteborg 2008. (zastonj na internetu)
PT PT- description available methods and other information
Maingroup 1 - Disinfectants and general biocidal products
•CEN on-line catalogue/international classification of Standards (ICS)
EN 14885:2006 Application of European Standards for chemical disinfectants and antiseptics
1 Human hygiene biocidal product
•EN 1040: 2005 Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and
antiseptics - Test method and requirements (phase 1)
•EN 12353:2006 Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and
fungicidal activity
•EN 1275:2005 Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical
disinfectants and antiseptics - Test method and requirements (phase 1)
2 Private area and public health area disinfectants and other biocidal
products •EN 14347:2005 Basic sporicidal activity - Test method and requirements (phase 1)
•EN 14348:2005 Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area
including instrument disinfectants - Test methods and requirements (phase 2, step 1)
•EN 14476:2005+A1:2006 Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test
method and requirements (phase 2, step 1)
•EN 12791:2005 Surgical hand disinfection - Test method and requirement (phase 2/step 2)
•EN 13624:2003 Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the
medical area - Test method and requirements (phase 2, step 1)
•EN 13727:2003 Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the
medical area - Test method and requirements (phase 2, step 1)
•EN 14561:2006 Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and
requirements (phase 2, step 2)
•EN 14562: 2006 Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test
method and requirements (phase 2, step 2)
•Report of the OECD Efficacy Workshop On Certain Antimicrobial
Biocides(published on OECD homepage)
3 Veterinary hygiene biocidal products
•EN 1656:2000 Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and
antiseptics used in veterinary field - Test method and requirements(pahse 2, step 1)
•EN 1657:2005 Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants
and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
•EN 1657:2005/AC:2007 Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical
disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
•EN 14204:2004 Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and
antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
•EN 14675:2006 Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and
antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
4 Food and feed area disinfectants
•EN 13610:2002 Quantitative suspension test for the evaluation of virucidal activity against bacteriophages of chemical
disinfectants used in food and industrial areas - Test method and requirements (phase 2, step 1)
•EN 13697:2001 Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical
disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical
action (phase 2/step2)
5 Drinking water disinfectants
Maingroup 2 - Preservatives
6 In-can preservatives
7 Film preservatives
An OECD report (ENV/JM /MONO(2007)4) lists test methods for efficacy testing of treated articles / treated materials (3.3 surface coatings )
8 Wood preservative •CEN/TR 14723:2003 Field and accelerated conditioning tests (FACT) for wood preservative out of ground contact (2003-12-17)
•CEN/TR 14839:2004 Determination of the preventive efficacy against wood destroying basidiomycetes fungi
•CEN/TS 12037:2003 Field test method for determining the relative protective effectiveness of a wood preservative exposed out of ground contact
- Horizontal lap-joint method
•CEN/TS 15082:2005 Determination of the preventive effectiveness against sapstain fungi and mould fungi on freshly sawn timber - Field test
•CEN/TS 15397:2006 Method for natural preconditioning out of ground contact of treated wood specimens prior to biological laboratory test
•CR 14244:2001 ecommendations for measurement of emissions to the environment from treated wood in service
•EN 113:1996 Document title Wood preservatives - Test method for determining the protective effectiveness against wood destroying
basidiomycetes - Determination of the toxic values
•EN 113:1996/A1:2004 Test method for determining the protective effectiveness against wood destroying basidiomycetes - Determination of the
toxic values
•EN 117:2005 Determination of toxic values against Reticulitermes species (European termites) (Laboratory method)
•EN 118:2005 Document title Wood preservatives - Determination of preventive action against Reticulitermes species (European termites)
(Laboratory method)
Maingroup 3 - Pest control 14 Rodenticides
15 Avicides
16 Molluscicides
17 Piscicides
18 Insecticides, acaricides and products to control other arthropods
•US-EPA-OPPTS: Series 810 Product Performance Test Guidelines—Finals
•WHO Guidelines for efficacy testing of insecticides for indoor and outdoor ground-applied space
spray applications. (The document provides specific and standardized procedures and criteria
for efficacy testing and evaluation of insecticides for indoor and outdoor, ground-applied space
spray applications against vectors and pests of public health importance)
Ref:WHO/CDS/NTD/WHOPES/2009.2
•WHO Guidelines for efficacy testing of mosquito repellents for human skin. (The document
provides specific and standardized procedures and criteria for efficacy testing and evaluation of
mosquito repellents for human skin)
Ref:WHO/CDS/NTD/WHOPES/2009.4
•WHO Guidelines for efficacy testing of household insecticide products - Mosquito coils,
vaporizer mats, liquid vaporizers, ambient emanators and aerosols. (The document provides
specific and standardized procedures and criteria for efficacy testing and evaluation of specific
household insecticide products intended for indoor use against mosquitoes, namely, mosquito
coils, vaporizer mats, liquid vaporizers, ambient emanators and aerosols)
Ref:WHO/CDS/NTD/WHOPES/2009.3
PRISTOP PRI IZBIRI TESTOV
Standardne metode - mednarodne (CEN, OECD, AOAC, EPA, ASTM)
Standardne metode na državnem nivoju
Metode, ki jih uporablja industrija*
Metode, ki jih uporablja posamezni proizvajalec*
Podatki iz same proizvodnje BP*
* - ocenjevalec odloči o kredibilnosti testa
DEZINFEKCIJSKA SREDSTVA
1. GLAVNA SKUPINA
1. – 5. vrsta izdelkov
1. BP za človekovo osebno higieno
2. Razkužila in drugi BP
3. Veterinarsko higienski BP
4. Dezinfekcijska sredstva za območja s hrano in krmo
5. Sredstva za razkuževanje vode
EN 14885/2006!
Kemična razkužila in antiseptiki – uporaba evropskih
standardov za kemična razkužila in antiseptike
Pripravila ga je komisija: CEN/TC 216
DEFINICIJA RAZKUŽILA (EN 14885/2006)
reduction of the number of micro-organisms in or on an
inanimate matrix, achieved by the irreversible action of a
product on their structure or metabolism, to a level judged to
be appropriate to a defined purpose
Reduction / Irreversible action / Micro-organisms
TNSG: 7. POGLAVJE – UČINKOVITOST, PT2
Predstavniki/strokovnjaki iz držav članic, CEN in industrije
Novost: claims matrix – matrika oznak/etiket:
zahtevana informacija v strnjeni obliki, živ dokument!
NORMALLY the following
is applicable:
SOFT
FURNISHINGS
Version: February 2012
Product Description
Type
Use area target site (examples) purpose min. spectrum of
activity
additional optional
activity
User Type application
type
Appropriate
methodology
Appropriate
performance
standard relevant to
target site
Description of product
within a specific PT:
Intended sector of
application:
Where the product is
typically used:
Primary objective of
the product and
expected result by
the user
Obligatory range of
targeted harmful
organisms
As defined by BPD
(Professional/
industrial, non-
professional)
Method how
the product is
applied
Types of test to be
used
soft furnishings and
fabrics biocidal
products
health care and
health care
facilities and
institutions
matrass, non-
removable soft
furnishings,
upholstery, carpets
reducing risk of
infection
bactericidal,
yeasticidal
fungicidal,
mycobactericidal,
virucidal professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
soft furnishings and
fabrics biocidal
products household
matrass, non-
removable soft
furnishings,
upholstery, carpets
reducing risk of
infection
bactericidal,
yeasticidal
fungicidal,
virucidal,
mycobactericidal non-professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
soft furnishings and
fabrics biocidal
products household
matrass, non-
removable soft
furnishings,
upholstery, carpets
control of
malodour by
antimicrobial
activity, aesthetics
incl. staining
bacteriostatic or
fungistatic
bactericidal and/or
fungicidal non-professional
wiping,
scrubbing,
spraying,
foaming,
soaking
suspension and
(soft)surface test
and odour test
EN14885 for
suspension test,
Japanese test
Modification of the
AOAC Germicidal
Spray Products Test
method (961.02).
(recognized test
standard in
accordance to U.S.
EPA Pesticide
Assessment
Guidelines
Subdivision G,
Series 91-52 (b)
(1)).
MATRIKA OZNAK/ETIKET
Kategorija
Vrsta izdelka
Območje uporabe
Ciljno mesto
Namen uporabe
Učinek izdelka
Uporabnik
Način uporabe
Metodologija
Obstoječi standardi
Primer (PT2)
Razkužila za mehke površine
Zdravstvene inštitucije, dom,…
Ležišča, preproge,…
Zmanjšati možnost okužbe,…
Baktericiden, fungiciden, viruciden,…
Industrijski, poklicni, splošni
Brisanje, namakanje, močenje, pršenje,…
suspenzijski, površinski testi
EN 14885,…
VRSTA RAZKUŽILA
za trdne površine
za mehke površine
za prostore (uplinjanje)
za bazene (kopališča, terme, masažne kopeli)
za straniščne školjke
za prezračevalne in klimatske naprave
za opremo (namakanjem)
za perilo in tekstil
za odstranjevanje biofilmov
za odpadne materiale in drugo
METODOLOGIJA
SUSPEZIJSKI TESTI POVRŠINSKI TESTI
organizmi so prosti v raztopini
določeno fiziološko okolje
optimalen stik z razkužilom
organizmi so pritrjeni na površino
dodatek organskih spojin
manj določeno fiziološko okolje
slabši stik z razkužilom
STOPENJSKI PRISTOP
1. stopnja Enostaven suspenzijski test,
splošna učinkovitost
Bakterije EN 1040
Glive EN 1275
Virusi --
2. stopnja,
1. korak
Suspenzijski test,
specifična učinkovitost
Bakterije EN 1276/14348/12054
Glive EN 1650
Virusi EN 14476
2. stopnja,
2. korak
Površinski test,
specifična učinkovitost,
simulacija uporabe
Površine EN 13697
Roke EN 1499/1500/12791
Brisače v razvoju
Perilo v razvoju
3. stopnja Testi na terenu,
praktična učinkovitost
Nedefinirani
ČAS IN UČINEK DELOVANJA
Določeni s standardom
primer (EN1276):
temperatura: 20°C
čas delovanja: 5 min
učinek: zmanjšanje (redukcija) števila bakterij: 5 log
UČINEK RAZKUŽILA
Razkužilo - ciden učinek!
definicija BPR (člen 3)
definicija razkužila (EN14885)
―… with the intention of destroying,
deterring, rendering harmless,
preventing the action or otherwise
exerting a controlling effect…‖
= ireverzibilno delovanje (- ciden)
= statičen učinek, odbijajoč učinek,
saniteten učinek, idr.
RAZKUŽILO
DRUGI BIOCIDNI PROIZVODI
ETIKETA - MIKROORGANIZMI
Odprto vprašanje: izpis posameznih mikroorganizmov na etiketi?
ETIKETA - MIKROORGANIZMI
BPD (člen 20):
―…labels should not be misleading or give an exaggerated
impression of the product…‖
BPR (člen 69):
―…that labels are not misleading in respect of the risks from the
product to human health, animal health or the environment or
its efficacy,…‖
ETIKETA - MIKROORGANIZMI
ZA:
Imenovanje referenčnih in dodatnih mikroorganizmov (EN1276)
P. aeruginosa ATCC15442 S. typhimurium ATCC13311
E. coli ATCC10536 L. brevis DSM 6235
S. aureus ATCC6538 E. cloacae DSM 6234
E. hirae ATCC10541
ETIKETA - MIKROORGANIZMI
ZA:
Utemeljitev:
- etiketa mora biti poučna
- uporabnik ne pozna standarda
- ni zavajanje, podprto z rezultati
ETIKETA - MIKROORGANIZMI
PROTI:
Spekter delovanja:
bakteriociden, fungiciden, viruciden, sporociden!
Utemeljitev:
- v standardu opisano kateri
- zavajanje uporabnika
- vtis večje kvalitete
ETIKETA MIKROORGANIZMI
S. aureus in MRSA:
- odpornosti na antibiotike!
- odpornosti na razkužila!
PROTI:
BIOFILMI – DVE VRSTI DELOVANJA
BIOFILM – kooperativni konzorcij mikroorganizmov, ki je z
ekstracelularnim materialom zaščiten in pritrjen na površino.
1. Preprečitev nastanka biofilma
- ni adhezije,
- redukcija mikroorganizmov
2. Odstranjevanje formiranega biofilma
- ločitev biofilma od podlage,
- redukcija mikroorganizmov
BIOFILMI – UČINKOVITOST
Ni standardnih metod!
Testi za učinkovitost razkužil ne vključujejo:
ekstracelularni material – fizična bariera
Statični in tekoči pogoji pri nastanku biofilma!
Testna organizma: P. aeruginosa in S. aureus
NAJLEPŠA HVALA ZA POZORNOST!
UČINKOVITOST! (3. GLAVNA SKUPINA,
18. VRSTA IZDELKOV:
Insekticidi,…)