Commission Implementing Regulation (EU) 2025/263 of 10 February 2025 granting a U... (32025R0263)
    EU - Rechtsakte: 13 Industrial policy and internal market
    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 m
    3
    /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 m
    3
    /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)
    Markierungen
    Leseansicht
    Verwendung von Cookies.

    Durch die Nutzung dieser Website akzeptieren Sie automatisch, dass wir Cookies verwenden. Cookie-Richtlinie

    Akzeptieren