Commission Implementing Regulation (EU) 2025/263 of 10 February 2025 granting a Union authorisation for the biocidal product family Ecolab CMIT-MIT BPF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-02-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, food safety, market approval, preservative








L_202500263EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/263


11.2.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/263
of 10 February 2025
         
granting a Union authorisation for the biocidal product family ‘Ecolab CMIT-MIT BPF’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 23 June 2017, Ecolab Deutschland GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Ecolab CMIT-MIT BPF’ of product-types 4, 11 and 12, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-SP032736-15 in the Register for Biocidal Products.












(2)


‘Ecolab CMIT-MIT BPF’ contains C(M)IT/MIT (3:1) as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 4, 11 and 12.












(3)


On 1 December 2023, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 26 June 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Ecolab CMIT-MIT BPF’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘Ecolab CMIT-MIT BPF’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.












(6)


On 15 July 2024, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Ecolab CMIT-MIT BPF’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0032881-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab CMIT-MIT BPF’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 3 March 2025 until 28 February 2035.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  ECHA opinion of 30 May 2024 on the Union authorisation of ‘Ecolab CMIT-MIT BPF’ (ECHA/BPC/436/2024), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Ecolab CMIT-MIT BPF

Product type(s)

PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides
PT04: Food and feed area

Authorisation number EU-0032881-0000

R4BP asset number EU-0032881-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Ecolab CMIT-MIT BPF




1.2.   Product type(s)







Product type(s)


PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides
PT04: Food and feed area




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1 40789 Monheim am Rhein Germany




Authorisation number


 


EU-0032881-0000





R4BP asset number



 


EU-0032881-0000




Date of the authorisation


3 March 2025




Expiry date of the authorisation


28 February 2035




1.4.   Manufacturer(s) of the product







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse 7 8304 Walliselen Switzerland




Location of manufacturing sites







Ecolab Europe GmbH site 1




Richtistrasse 7 8304 Walliselen Switzerland

















Name of manufacturer


Ecolab Limited




Address of manufacturer


Brunel Way, Baglan Energy Park SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Ecolab Limited site 1




Brunel Way, Baglan Energy Park SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Laboratoires Prodene Klint




Address of manufacturer


Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory France




Location of manufacturing sites







Laboratoires Prodene Klint site 1




Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory France

















Name of manufacturer


Ecolab Leeds




Address of manufacturer


Lotherton Way, Garforth LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Ecolab Leeds site 1




Lotherton Way, Garforth LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Ecolab SRL




Address of manufacturer


Viale del Lavoro 10 45100 Rovigo Italy




Location of manufacturing sites







Ecolab SRL site 1




Viale del Lavoro 10 45100 Rovigo Italy

















Name of manufacturer


Nalco Deutschland Manufacturing GmbH und Co.KG




Address of manufacturer


Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany




Location of manufacturing sites







Nalco Deutschland Manufacturing GmbH und Co.KG site 1




Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany

















Name of manufacturer


Ecolab NETHERLANDS BV




Address of manufacturer


BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands (the)




Location of manufacturing sites







Ecolab NETHERLANDS BV site 1




BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands (the)

















Name of manufacturer


Ecolab Weavergate




Address of manufacturer


Winnington Avenue, Northwich CW8 3AA Cheshire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Ecolab Weavergate site 1




Winnington Avenue, Northwich CW8 3AA Cheshire United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Ecolab Mullingar, Ireland




Address of manufacturer


Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar Ireland




Location of manufacturing sites







Ecolab Mullingar, Ireland site 1




Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar Ireland

















Name of manufacturer


Ecolab d.o.o.




Address of manufacturer


Vajngerlova 4 2000 Maribor Slovenia




Location of manufacturing sites







Ecolab d.o.o. site 1




Vajngerlova 4 2000 Maribor Slovenia

















Name of manufacturer


Ecolab Rozzano




Address of manufacturer


VIA GRANDI 9/11 20089 Rozzano Italy




Location of manufacturing sites







Ecolab Rozzano site 1




VIA GRANDI 9/11 20089 Rozzano Italy

















Name of manufacturer


Ecolab BVBA




Address of manufacturer


Havenlaan 4 3980 Tessenderlo Belgium




Location of manufacturing sites







Ecolab BVBA site 1




Havenlaan 4 3980 Tessenderlo Belgium

















Name of manufacturer


Nalco Española Manufacturing, SLU




Address of manufacturer


C/Tramuntana s/n Polígono Industrial de Celrà 17460 CELRÀ 17460 Girona Spain




Location of manufacturing sites







Nalco Española Manufacturing, SLU site 1




C/Tramuntana s/n Polígono Industrial de Celrà 17460 CELRÀ 17460 Girona Spain

















Name of manufacturer


Ecolab production France SAS




Address of manufacturer


BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France




Location of manufacturing sites







Ecolab production France SAS site 1




BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France

















Name of manufacturer


Ecolab Mandra, Greece




Address of manufacturer


25KLM Old National Road 19600 Attica Mandra Greece




Location of manufacturing sites







Ecolab Mandra, Greece site 1




25KLM Old National Road 19600 Attica Mandra Greece

















Name of manufacturer


NALCO FINLAND MANUFACTURING OY




Address of manufacturer


Kivikummuntie 1 FIN-07955 Tesjoki Finland




Location of manufacturing sites







NALCO FINLAND MANUFACTURING OY site 1




Kivikummuntie 1 FIN-07955 Tesjoki Finland

















Name of manufacturer


NALCO Water Italy




Address of manufacturer


Via Ninfina II 04012 Cisterna Di Latina Italy




Location of manufacturing sites







NALCO Water Italy site 1




Via Ninfina II 04012 Cisterna Di Latina Italy

















Name of manufacturer


Manufacturing Plant Fawley Nalco




Address of manufacturer


One business centre 1180 SO45 3NP Hardley United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Manufacturing Plant Fawley Nalco site 1




One business centre 1180 SO45 3NP Hardley United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Nalco Ltd Scotland




Address of manufacturer


Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Nalco Ltd Scotland site 1




Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Microtek Medical B.V.




Address of manufacturer


Hekkehorst, 24 7207 Zutphen Netherlands (the)




Location of manufacturing sites







Microtek Medical B.V. site 1




Hekkehorst, 24 7207 Zutphen Netherlands (the)

















Name of manufacturer


Dow Europe GmbH




Address of manufacturer


Bachtobelstrasse 3 8810 Horgen Switzerland




Location of manufacturing sites







Dow Europe GmbH site 1




Bachtobelstrasse 3 8810 Horgen Switzerland

















Name of manufacturer


Troy Chemical Company B.V. Troy




Address of manufacturer


Uiverlaan 12e 3145 XN Maassluis Netherlands (the)




Location of manufacturing sites







Troy Chemical Company B.V. Troy site 1




Uiverlaan 12e 3145 XN Maassluis Netherlands (the)

















Name of manufacturer


Thor GmbH




Address of manufacturer


Landwehrstrasse 1 67346 Speyer Germany




Location of manufacturing sites







Thor GmbH site 1




Landwehrstrasse 1 67346 Speyer Germany

















Name of manufacturer


A.F.P. GmbH




Address of manufacturer


Otto-Brenner-Strasse 16-18 21337 Lueneburg Germany




Location of manufacturing sites







A.F.P. GmbH site 1




Otto-Brenner-Strasse 16-18 21337 Lueneburg Germany

















Name of manufacturer


ANIOS




Address of manufacturer


Pavé du moulin 59260 Lille-Hellemmes France




Location of manufacturing sites







ANIOS site 1




Pavé du moulin 59260 Lille-Hellemmes France

















Name of manufacturer


BELINKA-LJUBLJANA




Address of manufacturer


Belinka Zasavska Cesta 95 1001 Ljubljana Slovenia




Location of manufacturing sites







BELINKA-LJUBLJANA site 1




Belinka Zasavska Cesta 95 1001 Ljubljana Slovenia

















Name of manufacturer


Bentus Laboratories Ltd




Address of manufacturer


RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the)




Location of manufacturing sites







Bentus Laboratories Ltd site 1




RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the)

















Name of manufacturer


BIO_PRODUCTIONS Ltd Inc STAPRO




Address of manufacturer


72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE RH15 9LH BURGESS HILL United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







BIO_PRODUCTIONS Ltd Inc STAPRO site 1




72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE RH15 9LH BURGESS HILL United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


BORES S.R.L.




Address of manufacturer


Via Pioppa, 179 44030 Pontegradella (FE) Italy




Location of manufacturing sites







BORES S.R.L. site 1




Via Pioppa, 179 44030 Pontegradella (FE) Italy

















Name of manufacturer


BRENNTAG CEE - GUNTRAMSDORF




Address of manufacturer


Bahnstr. 13 A-2353 Guntramsdorf Austria




Location of manufacturing sites







BRENNTAG CEE - GUNTRAMSDORF site 1




Bahnstr. 13 A-2353 Guntramsdorf Austria

















Name of manufacturer


BRENNTAG GmbH Duisburg




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG GmbH Duisburg site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Glauchau




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG Glauchau site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Hamburg




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG Hamburg site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Heilbronn




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG Heilbronn site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Kaiserslaute




Address of manufacturer


Merkurstr. 47 67663 Kaiserslautern Germany




Location of manufacturing sites







BRENNTAG Kaiserslaute site 1




Merkurstr. 47 67663 Kaiserslautern Germany

















Name of manufacturer


BRENNTAG Kleinkarlbac




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG Kleinkarlbac site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Lohfelden




Address of manufacturer


Humboldtring 15 45472 Muehlheim Germany




Location of manufacturing sites







BRENNTAG Lohfelden site 1




Humboldtring 15 45472 Muehlheim Germany

















Name of manufacturer


BRENNTAG Nordic - HASLEV




Address of manufacturer


Høsten Teglværksvej 47 4690 Haslev Denmark




Location of manufacturing sites







BRENNTAG Nordic - HASLEV site 1




Høsten Teglværksvej 47 4690 Haslev Denmark

















Name of manufacturer


BRENNTAG Nordic - VEJLE




Address of manufacturer


Vivaa 7100 Vejle Denmark




Location of manufacturing sites







BRENNTAG Nordic - VEJLE site 1




Vivaa 7100 Vejle Denmark

















Name of manufacturer


BRENNTAG Normandy




Address of manufacturer


12 Sente des Jumelles - BP 11 76710 Montville France




Location of manufacturing sites







BRENNTAG Normandy site 1




12 Sente des Jumelles - BP 11 76710 Montville France

















Name of manufacturer


BRENNTAG PL -Zgierz




Address of manufacturer


ul. Kwasowa 5 95-100 Zgierz Poland




Location of manufacturing sites







BRENNTAG PL -Zgierz site 1




ul. Kwasowa 5 95-100 Zgierz Poland

















Name of manufacturer


BRENNTAG Quimica - Madrid




Address of manufacturer


Calle Gutemberg no 22,.Poligono Industrial El Lomo. 28906 Getafe (Madrid) C/ Gutemberg, 22 Polig. Ind. El Lomo 28906 Madrid Spain




Location of manufacturing sites







BRENNTAG Quimica - Madrid site 1




Calle Gutemberg no 22,.Poligono Industrial El Lomo. 28906 Getafe (Madrid) C/ Gutemberg, 22 Polig. Ind. El Lomo 28906 Madrid Spain

















Name of manufacturer


BRENNTAG Schweizerhall




Address of manufacturer


Elsaesserstr. 231 C-4056 Basel Switzerland




Location of manufacturing sites







BRENNTAG Schweizerhall site 1




Elsaesserstr. 231 C-4056 Basel Switzerland

















Name of manufacturer


Budich International GmbH




Address of manufacturer


Dieselstrasse 10 32120 Hiddenhause Germany




Location of manufacturing sites







Budich International GmbH site 1




Dieselstrasse 10 32120 Hiddenhause Germany

















Name of manufacturer


Caldic Deutschland Chemie B.V




Address of manufacturer


Am Karlshof 10 D 40231 Duesseldorf Germany




Location of manufacturing sites







Caldic Deutschland Chemie B.V site 1




Am Karlshof 10 D 40231 Duesseldorf Germany

















Name of manufacturer


CARBON GROUP




Address of manufacturer


Ringaskiddy P43 R772 Cork Ireland




Location of manufacturing sites







CARBON GROUP site 1




Ringaskiddy P43 R772 Cork Ireland

















Name of manufacturer


COMERCIAL GODO SL




Address of manufacturer


Carrer de Franca, Igualada 13 08700 Barcelona Spain




Location of manufacturing sites







COMERCIAL GODO SL site 1




Carrer de Franca, Igualada 13 08700 Barcelona Spain

















Name of manufacturer


DAN MOR (DR WIPE) Natural Products and Chemicals Ltd.




Address of manufacturer


Or Akiva Industrial Zone 30600 Or Akiva Israel




Location of manufacturing sites







DAN MOR (DR WIPE) Natural Products and Chemicals Ltd. site 1




Or Akiva Industrial Zone 30600 Or Akiva Israel

















Name of manufacturer


DETERGENTS BURGUERA




Address of manufacturer


S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) Spain




Location of manufacturing sites







DETERGENTS BURGUERA site 1




S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) Spain

















Name of manufacturer


ECL MICROTEK BV




Address of manufacturer


GESINKKAMPSTRAAT 19 705 HR VARSSEVELD Netherlands (the)




Location of manufacturing sites







ECL MICROTEK BV site 1




GESINKKAMPSTRAAT 19 705  HR VARSSEVELD Netherlands (the)

















Name of manufacturer


ECL MICROTEK MOSTA




Address of manufacturer


SORBONNE CENTRE, F20 MOSTA TECHNOPARK MST 3000 MOSTA Malta




Location of manufacturing sites







ECL MICROTEK MOSTA site 1




SORBONNE CENTRE, F20 MOSTA TECHNOPARK MST 3000 MOSTA Malta

















Name of manufacturer


Ferdinand Eimermacher GmbH & Co. KG




Address of manufacturer


Westring 24 48356 Nordwalde Germany




Location of manufacturing sites







Ferdinand Eimermacher GmbH & Co. KG site 1




Westring 24 48356 Nordwalde Germany

















Name of manufacturer


GALLOWS GREEN SERVICES LTD




Address of manufacturer


Cod Beck Mill Industrial Estate Dalton Lane YO7 3HR Thirsk United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







GALLOWS GREEN SERVICES LTD site 1




Cod Beck Mill Industrial Estate Dalton Lane YO7 3HR Thirsk United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


GIRASOL NATURAL PRODUCTS BV




Address of manufacturer


De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht Netherlands (the)




Location of manufacturing sites







GIRASOL NATURAL PRODUCTS BV site 1




De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht Netherlands (the)

















Name of manufacturer


HENKEL ENGELS




Address of manufacturer


Prospekt Stroitelei 413116 Engels Russian Federation (the)




Location of manufacturing sites







HENKEL ENGELS site 1




Prospekt Stroitelei 413116 Engels Russian Federation (the)

















Name of manufacturer


imeco GmbH & Co. KG




Address of manufacturer


Boschstraße 5 D-63768 Hösbach Germany




Location of manufacturing sites







imeco GmbH & Co. KG site 1




Boschstraße 5 D-63768 Hösbach Germany

















Name of manufacturer


INNOVATE GmbH




Address of manufacturer


Am Hohen Stein 11 06618 Naumburg Germany




Location of manufacturing sites







INNOVATE GmbH site 1




Am Hohen Stein 11 06618 Naumburg Germany

















Name of manufacturer


INTERFILL LLC-TOSNO




Address of manufacturer


Moskovskoye shosse 1 Tosno 187000 Leningradskaya oblast Russian Federation (the)




Location of manufacturing sites







INTERFILL LLC-TOSNO site 1




Moskovskoye shosse 1 Tosno 187000 Leningradskaya oblast Russian Federation (the)

















Name of manufacturer


Kleinmann GmbH




Address of manufacturer


Am Trieb 13 72820 Sonnenbühl Germany




Location of manufacturing sites







Kleinmann GmbH site 1




Am Trieb 13 72820 Sonnenbühl Germany

















Name of manufacturer


KOMPAK NEDERLAND BV




Address of manufacturer


Ambachtsweg 4 4854 Bavel Netherlands (the)




Location of manufacturing sites







KOMPAK NEDERLAND BV site 1




Ambachtsweg 4 4854 Bavel Netherlands (the)

















Name of manufacturer


La Antigua Lavandera SL




Address of manufacturer


Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58 41500 Alcal de Guadaira, Seville Spain




Location of manufacturing sites







La Antigua Lavandera SL site 1




Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58 41500 Alcal de Guadaira, Seville Spain

















Name of manufacturer


LICHTENHELDT GmbH




Address of manufacturer


Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt Germany




Location of manufacturing sites







LICHTENHELDT GmbH site 1




Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt Germany

















Name of manufacturer


Multifill B.V.




Address of manufacturer


Constructieweg 25-A 3641 SB Mijdrecht Netherlands (the)




Location of manufacturing sites







Multifill B.V. site 1




Constructieweg 25-A 3641 SB Mijdrecht Netherlands (the)

















Name of manufacturer


PAL INTERNATIONAL LTD




Address of manufacturer


Sandhurst Street LE2 5AR Leicester United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







PAL INTERNATIONAL LTD site 1




Sandhurst Street LE2 5AR Leicester United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


PLANOL GmbH




Address of manufacturer


Maybachstr. 17 63456 Hanau Germany




Location of manufacturing sites







PLANOL GmbH site 1




Maybachstr. 17 63456 Hanau Germany

















Name of manufacturer


PLUM A/S




Address of manufacturer


Frederik Plums Vej 2 DK 5610 Assens Denmark




Location of manufacturing sites







PLUM A/S site 1




Frederik Plums Vej 2 DK 5610 Assens Denmark

















Name of manufacturer


QUIMICAS MORALES




Address of manufacturer


Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA Spain




Location of manufacturing sites







QUIMICAS MORALES site 1




Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA Spain

















Name of manufacturer


RNM PRODUCTOS QUIMICOS




Address of manufacturer


Lda Rua da Fabrica, 123, Segada 4765-080 Carreira Vila Nova de Famalicao Portugal




Location of manufacturing sites







RNM PRODUCTOS QUIMICOS site 1




Lda Rua da Fabrica, 123, Segada 4765-080 Carreira Vila Nova de Famalicao Portugal

















Name of manufacturer


ROQUETTE & BARENTZ




Address of manufacturer


Roquette Freres Route De La Gorgue F-62136 Lestrem France




Location of manufacturing sites







ROQUETTE & BARENTZ site 1




Roquette Freres Route De La Gorgue F-62136 Lestrem France

















Name of manufacturer


RUTPEN LTD.




Address of manufacturer


MEMBURY AIRFIELD RG16 7TJ Lambourn United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







RUTPEN LTD. site 1




MEMBURY AIRFIELD RG16 7TJ Lambourn United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


SOLIMIX Montseny




Address of manufacturer


17-19 Pol. Ind. Sant Pere Molanta 08799 Olerdola, Barcelona Spain




Location of manufacturing sites







SOLIMIX Montseny site 1




17-19 Pol. Ind. Sant Pere Molanta 08799 Olerdola, Barcelona Spain

















Name of manufacturer


STAUB & CO - SILBERMAN GMBH




Address of manufacturer


Industriestraße 3 86456 Gablingen Germany




Location of manufacturing sites







STAUB & CO - SILBERMAN GMBH site 1




Industriestraße 3 86456 Gablingen Germany

















Name of manufacturer


SYNERLOGIC BV ( - IN2FOOD)




Address of manufacturer


L.J. Costerstraat 5 6827 Arnhem Netherlands (the)




Location of manufacturing sites







SYNERLOGIC BV ( - IN2FOOD) site 1




L.J. Costerstraat 5 6827 Arnhem Netherlands (the)

















Name of manufacturer


Univar Ltd




Address of manufacturer


Argyle House, Epsom Avenue SK9 3RN Wilmslow. United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Univar Ltd site 1




Argyle House, Epsom Avenue SK9 3RN Wilmslow United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


VAN DAM BODEGRAVEN




Address of manufacturer


Postbus 48 NL 2410 AA Bodegraven Netherlands (the)




Location of manufacturing sites







VAN DAM BODEGRAVEN site 1




Postbus 48 NL 2410 AA Bodegraven Netherlands (the)








1.5.   Manufacturer(s) of the active substance(s)







Active substance


C(M)IT/MIT (3:1)




Name of manufacturer


Microbial Control (Switzerland) GmbH




Address of manufacturer


Hungerbüelstrasse 22 8500 Frauenfeld Switzerland




Location of manufacturing sites







Microbial Control (MC)




Jiangsu FOPIA Chemicals Co. Ltd., Touzeng Village, Binhuai Town, Binhai Country, Jiangsu, 224555 Yancheng City China








2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


2,6  - 7,51  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid




PART II

SECOND INFORMATION LEVEL - META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: META 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides




2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


2,6  - 2,9  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 1







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H290: May be corrosive to metals.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H410: Very toxic to aquatic life with long lasting effects.




Precautionary statements


P391: Collect spillage.
P234: Keep only in original packaging.
P260: Do not breathe mist.
P272: Contaminated work clothing should not be allowed out of the workplace.
P273: Avoid release to the environment.
P280: Wear gloves/protective clothing/eye protection/face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a POISON CENTER or doctor/ physician.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P333+P313: If skin irritation or rash occurs: Get medical POISON CENTER or doctor/ physician.
P362+P364: Take off contaminated clothing and wash it before reuse.
P390: Absorb spillage to prevent material damage.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use 1.1 Preservatives for liquid-cooling and processing systems (Preservatives)







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: bacteria
Development stage: no data
Scientific name: no data
Common name: yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: algae
Development stage: no data
Scientific name: no data
Common name: Legionella pneumophila
Development stage: no data
Scientific name: no data
Common name: biofilm
Development stage: no data




Field(s) of use


indoor use
outdoor use
Preservation of fluids in cooling systems with discharge to the municipal sewer in:
Open recirculating cooling systems,
closed cooling system.
Preservation of processing liquids in:
Pasteurizers and sterilizers,
air washers and scrubbers.




Application method(s)


Method: closed system
Detailed description:
Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation.




Application rate(s) and frequency


Application rate: Maintenance: Bacteria 100-200 ppm product (1,5-3 mg as/l (active substance per liter of fluid to be preserved)) Legionella 50-200 ppm product (0,75-3 mg as/l) Biofilm 200 ppm product (3 mg as/l) Curative: Bacteria 400 ppm product 6 hours contact time (6 mg as/l) Legionella 100-400 ppm product 6 hours contact time (1,5-6 mg as/l) Yeast and fungi 200-400 ppm product 6 hours contact time (3-6 mg as/l) Algae 100-400 ppm product 6 hours contact time (1,5-6 mg as/l) -
Number and timing of application:
Maintenance frequency: four times daily to once per week.
Curative: This may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months in cases of heavy fouling.




Category(ies) of users


industrial ; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene Intermediate bulk container (IBC)




4.1.1.   Use-specific instructions

The product should be slug-fed to recirculating cooling and process water in such a way to achieve maximum dispersion and exposure to the areas of the system with the highest level of microorganisms. The product should be added to the system according to the size of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
The interval between two doses depends on the system’s hydraulic retention time and removal of the active substance by degradation and blow-down. The product may accumulate in preserved fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
4.1.2.   Use-specific risk mitigation measures

Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection consistent with the European Standard EN ISO166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
The use is restricted to small cooling systems with a maximum blowdown of 2 m3/h. Waste water must be discharged to the municipal sewer or purified in an on-site industrial sewage treatment plant including a biological treatment step.
The product can only be applied when the cooling towers are equipped with drift eliminators that reduce drift with at least 99%.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use.
4.2.   Use description


Table 2


Use 1.2 Slimicide in the pulp and paper industry (Preservatives)







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: bacteria
Development stage: no data
Scientific name: no data
Common name: yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: biofilm
Development stage: no data




Field(s) of use


indoor use
For use as a slimicide in the pulp and paper industry, de-inking process, wet end / white water, pulp including during machine shut-down. Thick stock (including broke, blend, machine chests as well as the recycled pulp). White water, cloudy water and clear water. Thin stock. Control of Microbiologically Induced Corrosion (MIC) and biofouling of deaerators and filters. Control of slime growth in additives specifically intended to be used in the paper production process.




Application method(s)


Method: closed system
Detailed description:
Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation.




Application rate(s) and frequency


Application rate: For pulp and paper industry, feed on an intermittent (slug) basis: Additives used in paper production: Maintenance: Bacteria 50-400 ppm product (0,75-6 mg as/l(active substance per liter)) Yeast 100-400 ppm product (1,5-6 mg as/l) Curative: Bacteria 50-400 ppm product 24 hours contact time (0,75-6 mg as/l) Yeast and fungi 200-400 ppm product 6 hours contact time (3 - 6 mg as/l) Paper machine system (including wet end, white water and pulp) Maintenance: Bacteria and yeast 25-400 ppm product (0,38-6 mg as/l) Biofilm 200-400 ppm product (3 - 6 mg as/l) Curative: Bacteria 200-400 ppm product 24 hours contact time (3-6 mg as/l) Yeast 25-400 ppm product 24 hours contact time (0,38-6 mg as/l) Fungi 400 ppm product 6 hours contact time (6 mg as/l) -
Number and timing of application:
For pulp and paper industry, feed on an intermittent (slug) basis. Additives used in paper production and paper machine system (including wet end, white water and pulp):






—


Maintenance frequency: four times daily to once per week.










—


Curative: this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months.








Category(ies) of users


industrial ; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene IBCs




4.2.1.   Use-specific instructions

Feed the product on an intermittent basis to provide preservation of acceptable (low level) microbial counts in the paper machine system. Feed the product in the wet-end intermittently in the machine chest or similar stock chest or to additives used in paper production. Alone, it should never be used in the short loop but back in the system.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. The interval between two doses also depends on the system’s hydraulic retention time and removal of the active substance by e.g. degradation and dilution. The product may accumulate in processing fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
The product should be added based on the volume of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
4.2.2.   Use-specific risk mitigation measures

Human Health:
Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection consistent with the European Standard EN ISO166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Environment:
Application is only allowed in paper factories that comply to the Industrial Emission directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance with the Best Available Techniques (BAT) as prescribed in the BAT reference document (BREF) for the production of pulp, paper and board. the effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge to the municipal sewer.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Resistance management procedures shall be adopted in use as follows:






—


products shall always be used in accordance with label recommendations










—


elimination of microbial growth shall be attempted by using application rates demonstrated to be efficacious










—


levels of effectiveness shall be monitored and instances of reduced effectiveness shall be investigated for possible evidence of resistance.




In commercial use, C(M)IT/MIT is often used in combination or rotation with other biocides in various applications. Microbial resistance to C(M)IT/MIT can be avoided by switching or alternating biocides or using combinations with other actives.
All workers and individuals handling the product shall have access to the Safety Data Sheets (SDS) and Technical Data Sheets (TDS)
5.2.   Risk mitigation measures

Refer to use-specific risk mitigation measures
Organisational risk management measures:






—


Loading should be restricted to automated processes.










—


Workers involved in performing repairs or cleaning activities should rinse the system before opening and cleaning.










—


Eye wash station and safety shower are necessary.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Protection of first-aiders: Wear adequate personal protective equipment.
First aid instructions:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation or rash occur: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Environmental precautions:
In the event of a spill, prevent material from entering sewers or waterways. Do not allow material to contaminate ground water system. Prevent product from entering drains. If drains, streams, soil or sewers become contaminated, notify local authority. Spilled product may pose a risk to the aquatic ecosystem if released.
Methods and materials for containment and cleaning up:
SMALL SPILLS: Dike and absorb with inert material (e.g. dry earth, sand), shovel all contaminated solids into a pail or drum and then treat with enough deactivation solution to wet the solids thoroughly. Let these containers stand open for 48 hours to prevent pressure build up and then seal for disposal. Equipment containing residues should be decontaminated before carrying out maintenance or repair work or using for other service. Contaminated surfaces should be swabbed with deactivation solution, wait for the reaction to subside and rinse thoroughly with clean water.
LARGE SPILLS: Soak up with inert absorbent material. Transfer contaminated material to suitable containers for disposal. Contaminated surfaces should be swabbed with deactivation solution, let stand for 30 minutes and rinse thoroughly with clean water.
DO NOT add deactivation solution to the waste container to deactivate the absorbed material.






*


DEACTIVATION SOLUTION - prepare fresh a solution of 5% Sodium bicarbonate and 5% Sodium hypochlorite in water. Use a ratio of 10 volumes decontamination solution per estimated volume of residual spill. Contact an approved waste hauler for disposal of contaminated recovered material. Dispose of material in compliance with regulations indicated in Safety Data Sheet.




5.4.   Instructions for safe disposal of the product and its packaging

Dispose of in accordance with the European Directives on waste and hazardous waste. Waste codes should be assigned by the user, preferably in discussion with the waste disposal authorities.
The product must not be released to soil, water courses or any kind of sewer. Where possible recycling is preferred to disposal. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging: Dispose of as unused product. Empty containers should be taken to an approved waste handling site. Do not re-use empty containers.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months.
Do not store at temperatures above 40°C.
Keep container tightly closed. Store in suitable labelled containers.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:
EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms.
EN ISO 166 – Personal eye protection standard
EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB equipment)
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


NALCO® WT-735


Market area: EU




NALCO® 77352


Market area: EU




Authorisation number


 


EU-0032881-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


2,9 % (w/w)




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


NALCO® WT-730


Market area: EU




NALCO® 7330


Market area: EU




Authorisation number


 


EU-0032881-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


2,6 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: META 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT04: Food and feed area
PT12: Slimicides




2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


5,2  - 5,2  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 2







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H290: May be corrosive to metals.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H410: Very toxic to aquatic life with long lasting effects.




Precautionary statements


P391: Collect spillage.
P234: Keep only in original packaging.
P260: Do not breathe mist.
P272: Contaminated work clothing should not be allowed out of the workplace.
P273: Avoid release to the environment.
P280: Wear gloves/protective clothing/eye protection/face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a POISON CENTER or doctor/ physician.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P333+P313: If skin irritation or rash occurs: Get medical POISON CENTER or doctor/ physician.
P362+P364: Take off contaminated clothing and wash it before reuse.
P390: Absorb spillage to prevent material damage.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use 2.4 Off-line preservative for RO membranes in the food and feed industry







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: bacteria
Development stage: no data
Scientific name: no data
Common name: yeasts
Development stage: no data
Scientific name: no data
Common name: biofilm
Development stage: no data




Field(s) of use


indoor use
For use as off-line preservation of cleaned filtration membranes and reverse osmose (RO) in the food and feed industry. Intended to produce a biostatic effect.




Application method(s)


Method: closed system
Detailed description:
Feed the product to the filtration system upstream of any peripheral equipment that may contain biological growth. Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection.




Application rate(s) and frequency


Application rate: Maintenance: Bacteria 50 ppm product (1,5 mg as/l(active substance per liter)) Yeast 12,5 ppm product (0,38 mg as/l) Biofilm 100 ppm product (3 mg as/l) -
Number and timing of application:
As a membrane preservative during prolonged storage periods up to 6 months, dosage as stated above based on an active content of 3 % and a product density of 1,199 g/mL (dependent on the length of time the systems will be off-line).




Category(ies) of users


industrial; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene IBCs




4.1.1.   Use-specific instructions

Membranes must be clean prior to storage off-line.
The product is intended only for off-line preservation of filtration membranes or preservation of filtration membranes during shutdown up to 6 months (which may include RO membrane in the production of potable water). The stored filtration membrane and treated storage solution should be checked on a regular (weekly) basis. The solution shall be assessed for the total microbial content. Additional biocide should be added if required. After both events proper rinsing (min 5x) and/or cleaning in place (after prolonged preservation) procedures should take place before the system restarts again. Ensure that there is no residual biocide present in the final rinse water and ensure neutralization of the biocide in the discharge water.
4.1.2.   Use-specific risk mitigation measures

Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO 166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
A minimum of 5 rinsing procedures is obligatory before the system restarts.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use.
4.2.   Use description


Table 2


Use 2.2 Slimicide in non-potable water systems







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Biofilm
Development stage: no data




Field(s) of use


indoor use
Used for the on-line maintenance of non-potable (not drinking water) water systems by prevention of slime growth on equipment




Application method(s)


Method: closed system
Detailed description:
Feed the product to the RO or UF system upstream of any peripheral equipment that may contain biological growth. Should be fed via a closed feed system. Product applied via automated process with use of pumps or injection.




Application rate(s) and frequency


Application rate: Maintenance: Bacteria 50 ppm product (1,5 mg as/l(active substance per liter)) Yeast 12,5 ppm product (0,38 mg as/l) Biofilm 100 ppm product (3 mg as/l) Curative: Bacteria 200 ppm product 6 hours contact time (6 mg as/l) Yeast 25 ppm product 6 hours contact time (0,75 mg as/l) -
Number and timing of application:
Feed on an intermittent (slug) or continuous basis.
Maintenance frequency: once per day to once per week
Curative: this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months in case of heavy fouling.




Category(ies) of users


industrial ; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene IBCs




4.2.1.   Use-specific instructions

For best results, it is important to start with clean membranes.
An on-line preventive maintenance program in non-potable water systems aims to prevent increasing differential pressure (inlet and outlet of the system) due to biofilm growth.
When the on-line preventive maintenance biocidal program is correctly used, the RO membrane can maintain differential pressure, and therefore, maintain membrane performance over time. The frequency of addition varies from every day for heavily fouled systems to every 7 days for lightly fouled systems. When differential membrane pressure increases by 10 to 15% from startup conditions, corrective actions should be undertaken.
The product should be added to the system according to the size of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
4.2.2.   Use-specific risk mitigation measures

Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Use product only in premises that are connected to a sewage treatment plant.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

Resistance management procedures shall be adopted in use as follows:






—


products shall always be used in accordance with label recommendations










—


elimination of microbial growth shall be attempted by using application rates demonstrated to be efficacious










—


levels of effectiveness shall be monitored and instances of reduced effectiveness shall be investigated for possible evidence of resistance.




In commercial use, CMIT/MIT is often used in combination or rotation with other biocides in various applications. Microbial resistance to CMIT/MIT can be avoided by switching or alternating biocides or using combinations with other actives.
5.2.   Risk mitigation measures

Refer to use-specific risk mitigation measures
Organisational risk management measures:






—


Loading should be restricted to automated processes.










—


Workers involved in performing repairs or cleaning activities should rinse the system before opening and cleaning.










—


Eye wash station and safety shower are necessary.




All workers and individuals handling the product shall have access to the Safety Data Sheets (SDS) and Technical Data Sheets (TDS).
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Protection of first-aiders: Wear adequate personal protective equipment.
First aid instructions:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation or rash occur: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Environmental precautions:
In the event of a spill, prevent material from entering sewers or waterways. Do not allow material to contaminate ground water system. Prevent product from entering drains. If drains, streams, soil or sewers become contaminated, notify local authority. Spilled product may pose a risk to the aquatic ecosystem if released.
Methods and materials for containment and cleaning up:
SMALL SPILLS: Dike and absorb with inert material (e.g. dry earth, sand), shovel all contaminated solids into a pail or drum and then treat with enough deactivation solution to wet the solids thoroughly. Let these containers stand open for 48 hours to prevent pressure build up and then seal for disposal. Equipment containing residues should be decontaminated before carrying out maintenance or repair work or using for other service. Contaminated surfaces should be swabbed with deactivation solution, wait for the reaction to subside and rinse thoroughly with clean water.
LARGE SPILLS: Soak up with inert absorbent material. Transfer contaminated material to suitable containers for disposal. Contaminated surfaces should be swabbed with deactivation solution, let stand for 30 minutes and rinse thoroughly with clean water.
DO NOT add deactivation solution to the waste container to deactivate the absorbed material.






*


DEACTIVATION SOLUTION - prepare fresh a solution of 5% Sodium bicarbonate and 5% Sodium hypochlorite in water. Use a ratio of 10 volumes decontamination solution per estimated volume of residual spill. Contact an approved waste hauler for disposal of contaminated recovered material. Dispose of material in compliance with regulations indicated in Safety Data Sheet.




5.4.   Instructions for safe disposal of the product and its packaging

Dispose of in accordance with the European Directives on waste and hazardous waste. Waste codes should be assigned by the user, preferably in discussion with the waste disposal authorities.
The product must not be released to soil, water courses or any kind of sewer. Where possible recycling is preferred to disposal. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging: Dispose of as unused product. Empty containers should be taken to an approved waste handling site. Do not re-use empty containers.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months
Keep container tightly closed. Store in suitable labelled containers.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:
EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms
EN ISO 166 – Personal eye protection standard
EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB equipment)
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


PermaClean® PC-55


Market area: EU




Authorisation number


 


EU-0032881-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


5,2 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC: META 3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides




2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


7,51  - 7,51  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 3







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H290: May be corrosive to metals.
H302: Harmful if swallowed.
H332: Harmful if inhaled.
H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H410: Very toxic to aquatic life with long lasting effects.




Precautionary statements


P391: Collect spillage.
P234: Keep only in original packaging.
P260: Do not breathe mist.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P272: Contaminated work clothing should not be allowed out of the workplace.
P273: Avoid release to the environment.
P280: Wear gloves/protective clothing/eye protection/face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a POISON CENTER or doctor/ physician.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P333+P313: If skin irritation or rash occurs: Get medical contents.
P362+P364: Take off contaminated clothing and wash it before reuse.
P390: Absorb spillage to prevent material damage.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use 3.1 Preservatives for liquid-cooling and processing systems (Preservatives)







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: bacteria
Development stage: no data
Scientific name: no data
Common name: yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: algae
Development stage: no data
Scientific name: no data
Common name: Legionella pneumophila
Development stage: no data
Scientific name: no data
Common name: biofilm
Development stage: no data




Field(s) of use


indoor use
outdoor use
Preservation of fluids in cooling systems with discharge to the municipal sewer in:
Open recirculating cooling systems,
Closed cooling system.
Preservation of processing liquids in:
Pasteurizers and sterilizers,
Air washers and scrubbers.




Application method(s)


Method: closed system
Detailed description:
Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation.




Application rate(s) and frequency


Application rate: Maintenance: Bacteria 34-69 ppm product (1,5-3 mg as/l (active substance per liter)) Legionella 17-69 ppm product (0,75-3 mg as/l) Biofilm 69 ppm product (3 mg as/l) Curative: Bacteria 137 ppm product 6 hours contact time (6 mg as/l) Legionella 33-137 ppm product 6 hours contact time (1,5-6 mg as/l) Yeast and fungi 69-137 ppm product 6 hours contact time (3-6 mg as/l) Algae 33-137 ppm product 6 hours contact time (1,5-6 mg as/l) -
Number and timing of application:
Maintenance frequency: once per day to once per week.
Curative: this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months in cases of heavy fouling.




Category(ies) of users


industrial ; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene IBCs




4.1.1.   Use-specific instructions

The product should be slug-fed to recirculating cooling and process water in such a way to achieve maximum dispersion and exposure to the areas of the system with the highest level of microorganisms.
The product should be added to the system according to the size of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
The interval between two doses depends on the system’s hydraulic retention time and removal of the active substance by degradation and blow-down. The product may accumulate in preserved fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
4.1.2.   Use-specific risk mitigation measures

Wear compatible Personal Protective Equipment:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
The use is restricted to small cooling systems with a maximum blowdown of 2 m3/h. Waste water must be discharged to the municipal sewer or purified in an on-site industrial sewage treatment plant including a biological treatment step.
The product can only be applied when the cooling towers are equipped with drift eliminators that reduce drift with at least 99%.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the general direction for use
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use
4.2.   Use description


Table 2


Use 3.2 Slimicide in the pulp and paper industry (Preservatives)







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: bacteria
Development stage: no data
Scientific name: no data
Common name: yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: biofilm
Development stage: no data




Field(s) of use


indoor use
For use as a slimicide in the pulp and paper industry, de-inking process, wet end / white water, pulp including during machine shut-down. Thick stock (including broke, blend, machine chests as well as the recycled pulp). White water, cloudy water and clear water. Thin stock. Control of Microbiologically Induced Corrosion (MIC) and biofouling of deaerators and filters. Control of slime growth in additives specifically intended to be used in the paper production process.




Application method(s)


Method: closed system
Detailed description:
Feed the product via a closed feed system. Product applied via automated process with use of pumps or injection. Product can be added whilst the process is in operation.




Application rate(s) and frequency


Application rate: Additives used in paper production Maintenance: Bacteria 17-137 ppm product (0,75-6 mg as/l(active substance per liter)) Yeast 34-137 ppm product (1,5-6 mg as/l) Curative: Bacteria 17-137 ppm product 24 hours contact time (0,75-6 mg as/l) Yeast and fungi 68-137 ppm product 6 hours contact time (3-6 mg as/l) Paper machine system (including wet end, white water and pulp) Maintenance: Bacteria and yeast 9-137 ppm product (0,38-6 mg as/l) Biofilm 69-137 ppm product (3-6 mg as/l) Curative: Bacteria 69-137 ppm product 24 hours contact time (3-6 mg as/l) Yeast 9-137 ppm product 24 hours contact time (0,38-6 mg as/l) Fungi 137 ppm product 6 hours contact time (6 mg as/l) -
Number and timing of application:
For pulp and paper industry, feed on an intermittent (slug) basis:
Additives used in paper production and Paper machine system (including wet end, white water and pulp)
Maintenance frequency: four times daily to once per week.
Curative: In cases of heavy fouling this may be implemented when control is lost or when monitoring data suggests that curative implementation is required, however this should not be more than once every two months.




Category(ies) of users


industrial ; professional




Pack sizes and packaging material


20-100 kg opaque polyethylene pails
50-500 kg opaque polyethylene drums
1 000 -2 000  kg opaque polyethylene IBCs




4.2.1.   Use-specific instructions

Feed the product on an intermittent basis to provide preservation of acceptable (low level) microbial counts in the paper machine system. Feed the product in the wet-end intermittently in the machine chest or similar stock chest or to additives used in paper production. Alone, it should never be used in the short loop but back in the system.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. The interval between two doses also depends on the system’s hydraulic retention time and removal of the active substance by e.g. degradation and dilution. The product may accumulate in processing fluids when dosed too often. It is the responsibility of the end-user to determine the effective dose on-site (e.g. by chemical or microbiological tests) for the specific location/system to ensure that the system is efficacious under the use conditions. If needed, consult the authorisation holder (as specified in the label).
The product should be added based on the volume of the system, for example to achieve a 100 ppm concentration in a 10 000 liter system 1 000 ml (1 liter) of product will need to be added.
4.2.2.   Use-specific risk mitigation measures

Human Health:
Wear compatible Personal Protective Equipment (PPE)
Wear protective chemical resistant gloves meeting the requirements of European Standard EN ISO 374 or equivalent during product handling phase (glove material to be specified by the uthorisation holder within the product information).
Wear a protective coverall type 6, consistent with the European Standard EN 13034 or equivalent.
The use of eye protection according to the European Standard EN ISO 166 or equivalent during handling of the product is mandatory.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.
Environment:
Application is only allowed in paper factories that comply to the Industrial Emission directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance with the Best Available Techniques (BAT) as prescribed in the BAT reference document (BREF) for the production of pulp, paper and board. the effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge to the municipal sewer.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to the General directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to the general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

Resistance management procedures shall be adopted in use as follows:






—


products shall always be used in accordance with label recommendations










—


elimination of microbial growth shall be attempted by using application rates demonstrated to be efficacious










—


levels of effectiveness shall be monitored and instances of reduced effectiveness shall be investigated for possible evidence of resistance.




In commercial use, CMIT/MIT is often used in combination or rotation with other biocides in various applications. Microbial resistance to CMIT/MIT can be avoided by switching or alternating biocides or using combinations with other actives.
All workers and individuals handling the product shall be trained, have access to the Safety Data Sheets (SDS) and Technical Data Sheets (TDS).
5.2.   Risk mitigation measures

Refer to use-specific risk mitigation measures
Organisational risk management measures:






—


Loading should be restricted to automated processes.










—


Workers involved in performing repairs or cleaning activities should rinse the system before opening and cleaning.










—


Eye wash station and safety shower are necessary.




5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Refer to Sections 4.1.3 and 4.2.3 ‘Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment’.
Protection of first-aiders: Wear adequate personal protective equipment.
First aid instructions:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation or rash occur: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Environmental precautions:
In the event of a spill, prevent material from entering sewers or waterways. Do not allow material to contaminate ground water system. Prevent product from entering drains. If drains, streams, soil or sewers become contaminated, notify local authority. Spilled product may pose a risk to the aquatic ecosystem if released.
Methods and materials for containment and cleaning up:
SMALL SPILLS: Dike and absorb with inert material (e.g. dry earth, sand), shovel all contaminated solids into a pail or drum and then treat with enough deactivation solution to wet the solids thoroughly. Let these containers stand open for 48 hours to prevent pressure build up and then seal for disposal. Equipment containing residues should be decontaminated before carrying out maintenance or repair work or using for other service. Contaminated surfaces should be swabbed with deactivation solution, wait for the reaction to subside and rinse thoroughly with clean water.
LARGE SPILLS: Soak up with inert absorbent material. Transfer contaminated material to suitable containers for disposal. Contaminated surfaces should be swabbed with deactivation solution, let stand for 30 minutes and rinse thoroughly with clean water.
DO NOT add deactivation solution to the waste container to deactivate the absorbed material.






*


DEACTIVATION SOLUTION - prepare fresh a solution of 5% Sodium bicarbonate and 5% Sodium hypochlorite in water. Use a ratio of 10 volumes decontamination solution per estimated volume of residual spill. Contact an approved waste hauler for disposal of contaminated recovered material. Dispose of material in compliance with regulations indicated in Safety Data Sheet.




5.4.   Instructions for safe disposal of the product and its packaging

Dispose of in accordance with the European Directives on waste and hazardous waste. Waste codes should be assigned by the user, preferably in discussion with the waste disposal authorities.
The product must not be released to soil, water courses or any kind of sewer. Where possible recycling is preferred to disposal. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.
Contaminated packaging: Dispose of as unused product. Empty containers should be taken to an approved waste handling site. Do not re-use empty containers.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 24 months.
Do not store above ambient storage temperature (25°C).
Keep container tightly closed. Store in suitable labelled containers.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in sections “Use-specific risk mitigation measures” are:
EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms
EN ISO 166 – Personal eye protection standard
EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB equipment)
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


NALCO® BACTOLYSE 74824


Market area: EU




NALCO® 74824


Market area: EU




Authorisation number


 


EU-0032881-0004 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




C(M)IT/MIT (3:1)


Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1)


active substance


55965-84-9


 


7,51 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/263/oj
ISSN 1977-0677 (electronic edition)