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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

Učinkovitost biocidnih proizvodov

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Page 1: Učinkovitost biocidnih proizvodov

UČINKOVITOST BIOCIDNIH PROIZVODOV

Asist.Dr. Darja Duh, univ.dipl.mikrobiol.

Posvet o biocidnih proizvodih, 7. november 2013, GZS, Center za poslovno usposabljanje

Page 2: Učinkovitost biocidnih proizvodov

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,…)

Page 3: Učinkovitost biocidnih proizvodov

PREDPISI O BIOCIDIH - UČINKOVITOST

BPR No. 528/2012 (predhodnik: BPD 98/8/EC)

… dovolj učinkovit… (člen 25, poglavje V)

Page 4: Učinkovitost biocidnih proizvodov

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…

Page 5: Učinkovitost biocidnih proizvodov

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

Page 6: Učinkovitost biocidnih proizvodov

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)

Page 7: Učinkovitost biocidnih proizvodov

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

Page 8: Učinkovitost biocidnih proizvodov

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

Page 9: Učinkovitost biocidnih proizvodov

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

Page 10: Učinkovitost biocidnih proizvodov

EN 14885/2006!

Kemična razkužila in antiseptiki – uporaba evropskih

standardov za kemična razkužila in antiseptike

Pripravila ga je komisija: CEN/TC 216

Page 11: Učinkovitost biocidnih proizvodov

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

Page 12: Učinkovitost biocidnih proizvodov

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)).

Page 13: Učinkovitost biocidnih proizvodov

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,…

Page 14: Učinkovitost biocidnih proizvodov

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

Page 15: Učinkovitost biocidnih proizvodov

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

Page 16: Učinkovitost biocidnih proizvodov

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

Page 17: Učinkovitost biocidnih proizvodov

ČAS IN UČINEK DELOVANJA

Določeni s standardom

primer (EN1276):

temperatura: 20°C

čas delovanja: 5 min

učinek: zmanjšanje (redukcija) števila bakterij: 5 log

Page 18: Učinkovitost biocidnih proizvodov

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

Page 19: Učinkovitost biocidnih proizvodov

ETIKETA - MIKROORGANIZMI

Odprto vprašanje: izpis posameznih mikroorganizmov na etiketi?

Page 20: Učinkovitost biocidnih proizvodov

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,…‖

Page 21: Učinkovitost biocidnih proizvodov

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

Page 22: Učinkovitost biocidnih proizvodov

ETIKETA - MIKROORGANIZMI

ZA:

Utemeljitev:

- etiketa mora biti poučna

- uporabnik ne pozna standarda

- ni zavajanje, podprto z rezultati

Page 23: Učinkovitost biocidnih proizvodov

ETIKETA - MIKROORGANIZMI

PROTI:

Spekter delovanja:

bakteriociden, fungiciden, viruciden, sporociden!

Utemeljitev:

- v standardu opisano kateri

- zavajanje uporabnika

- vtis večje kvalitete

Page 24: Učinkovitost biocidnih proizvodov

ETIKETA MIKROORGANIZMI

S. aureus in MRSA:

- odpornosti na antibiotike!

- odpornosti na razkužila!

PROTI:

Page 25: Učinkovitost biocidnih proizvodov

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

Page 26: Učinkovitost biocidnih proizvodov

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

Page 27: Učinkovitost biocidnih proizvodov

NAJLEPŠA HVALA ZA POZORNOST!

UČINKOVITOST! (3. GLAVNA SKUPINA,

18. VRSTA IZDELKOV:

Insekticidi,…)